Welcome to our annual IR Diagnostics Day 2026 here in London. Let me quickly take you through today's agenda. We have today 10 speakers with us who will provide updates on the Roche Group strategy, the diagnostics strategy, the diagnostics business portfolios and priorities, as well as latest overviews on the pipelines of our 4 customer areas, which are core lab, molecular lab, including Foundation Medicine, pathology lab, and near patient care. This year, we will have a special focus on the upcoming global launch of our truly transformative next generation DNA sequencing technology, which is called AXELIOS, and on the end-to-end oncology ecosystem, which we have partly built already around it.
This ecosystem has recently been strengthened by partnerships with Freenome in early cancer detection and by the recent acquisition of Saga Diagnostics, a company known for ultra-sensitive MRD testing. In addition, this emerging ecosystem has also been completed, complemented by the most recent acquisition of PathAI. This is the announcement we made just last Friday, which is a company from Boston developing AI-based digital pathology solutions. Taken together, all these approaches will not only help us to revolutionize cancer detection and care, but also, they have the promise to contribute in the future to drug development efforts. Can I have please the agenda slide? I will take you through the agenda and also the changes we made last minute.
As last year, we will have 2 sessions, as you can see here, 2 presentation sections of 60 minutes each, followed by 20 minutes of Q&A, where we will have always the respective speakers of the presentation section on stage. For the first session, which is scheduled from 1:00 to 2:10, you see, this session will be opened by Thomas Schinecker, our CEO of the group. Thomas will provide us a quick update on the group strategy and comment on our longer-term ambition. The second presentation will then really open IR Day. It will be by Matt Sause, our CEO for Roche Diagnostics. Matt will provide an overview on the overall vision and strategy for diagnostics, and he will talk on the future ambition for the diagnostics division.
Third speaker, is Palani Kumaresan, our Global Head of Roche Diagnostics Solutions, will break down for us the strategic priorities of all our 4 customer areas. He will also provide a quick update on the ongoing mass spectrometry launch, one of our key growth drivers for the future. The final presentation then of the first session, focusing on Roche Information Solutions, will be given to 2 speakers. It will be held by Moritz Hartmann, our Global Head of Roche Information Solutions, and by Andy Beck. Andy is our surprise guest for today, founder and CEO of, sitting over there, of PathAI.
Moritz Hartmann will briefly summarize our overall efforts in digitalization, how we strengthen our product development capabilities, and also create new product opportunities, whereas Andy Beck will explain to us how AI-based digital pathology will strengthen our product development capabilities, especially in oncology and immunology, and also how this approach could contribute to scientific hypothesis generation and ultimately support future drug development efforts. Following these presentations, we will have a 20 minutes Q&A session before having a quick break of 15 minutes, and then we are back at 2:45 P.M. for the second session. Session 2 will be opened by Josh Lauer, our Global Head of Customer Area Molecular Labs. Josh Lauer will provide us with the latest and greatest of our truly revolutionary and game-changing AXELIOS sequencing technology.
He will highlight the unrivaled versatility of this technology and its potential to future applications by sharing some of the latest data snippets which were generated. Second speaker will then be Daniel Malarek, CEO of Foundation Medicine, which is Foundation Medicine is part of molecular labs customer area. Daniel will talk to our increasing product offering of FMI in oncology and the unique opportunity which we have here to integrate Roche Information Solutions, whether it's the AXELIOS sequencing, the Ventana platform or navify Digital Solutions. Following molecular labs, Laura Apitz, our Head of Pathology Lab Customer Area, will then cover the fastest-growing customer segment, pathology labs. She will drill down and take us through the strategic priorities of this segment.
Fourth speaker, as you can see here, will be Ildiko Amann-Zalan, our Head of R&D Roche Diagnostics Solutions. Ildiko will cover our near patient care portfolio, providing latest updates on the early launch days for our CGM solution and for LumiraDx. Finally, we will close the second session again with Olivier Gilliéron, our Lifecycle Leader, Cardiometabolic and Neurology, with an update on core lab assay highlights, which include novel assays in neurology, so that's the NfL assay, but also the p-tau217. You might have seen the news this morning. Also, some news on the long-awaited update in infectious diseases on our tuberculosis assays. Following the second session, we will have again our second 20 minutes Q&A before closing the broadcast part of the event.
Participants on-site will have the opportunity to meet all senior management at the closing apéro. Most management will be around for another 40 minutes. In terms of housekeeping items, let me just point out that we again have prepared our short survey to collect your feedback. Participants joining online will be invited to join the survey 10 minutes before the final Q&A ends. A pop-up window with the questions will show up, whereas participants on-site will receive an invitation to participate in the survey by email roughly one hour after the reception took place. With that, before handing over to Thomas, let me thank the speakers again for their time and their continuous efforts in improving the life of patients, and also the IR team and the members who contributed to this event.
First to name Birgit Masjost, who's leading diagnostics within the IR team. Birgit had the overall lead for the event, and she will also moderate both Q&A sessions. In addition, I have to call out Margot Keseide for speaker support and slide preparation, Giulio Mazzotta for speaker support and slide preparation and managing the master deck, Rafael Pawlowski for speaker support and slide preparation. Last but not least, Eva Losert, Melanie Wolf, Beatrice Hau, and Daniela Stoyanova for event organization. With that, it's time to hand over to Thomas for providing us an update on the overall group strategy and the longer-term ambition. Please.
Thank you, Bruno, for the introduction, and it's great to see you all here in London today. As mentioned in the Q1 call, in the future, the idea is that I would attend a pharma day and a diagnostic day always in separate years so that I give attention to both divisions. Of course, this time there are two highlights that I thought I cannot miss, and one is the sequencing launch. Something that I know for many years I've always been asked, "When are you gonna launch? When are you gonna launch?" I always said, "We are going to launch, and we will have a very competitive solution." I'm personally also very excited on that. Also I'm very excited that we made a agreement with PathAI so that Andy could also attend today.
Thanks, Andy, for joining us and welcome to the Roche family. Let me go through and give you a brief group strategy update, and then also give you an outlook on growth for the group over the next years and into the next decade. On the group strategy side, you've seen the strategy house before, the 10-year ambitions, so where do we wanna be in the next 10 years, but also the different elements of our strategy using AI, digital health, sustainability, people and culture, and then diagnostics and pharma. Good thing is not only did we complete the strategy house, so really define the direction of the company, we are also making superb progress when it comes to the implementation. Let me just go through a couple of things. First, on the 10-year ambitions.
Ten-year ambitions on the Pharma side, it's about delivering 20 transformative medicines by the end of the decade. Here we've made superb progress. Not only do we have now 66% of our portfolio with best-in-disease potential, but also we have increased average peak year sales of our pipeline per project by 67% and the total pipeline value by 63%. We have a higher pipeline value than ever before in our company. If you look at, the readouts that are gonna come over the next couple of years, we have up to 19 medicines that could launch by the end of the decade. This is a very strong late-stage pipeline. Not only have we accelerated what we did in late stage, we also did that in research.
If you look at lead identification and optimization, if you look back three years ago, we had around 50 of those every year. We've doubled that output. Clearly AI plays a role in here as well. On the diagnostic side, it's also about doubling our output on R&D and reaching more patients. Just a couple of numbers that really underline that. First, if you look at the industry, how many FDA approvals there were in the last six years, Roche Diagnostics has more than 50% of those diagnostics approvals. Certainly we're not spending more than 50% of the industry's budget. Clearly we have a very productive R&D. You can also see that we have three instrument launches, three instrument launches with blockbuster potential: CGM, MassSpec, and now coming next-generation sequencing.
Something that I don't think any other diagnostics company has in such a short period of time. We keep filling our menu with additional tests and digital solutions that augment and differentiate us from our competitors. Clearly making a lot of progress here. Let me also recap the group strategy and where do we wanna go and what are we gonna focus on. You have seen this slide before. These are the major trends that we see in healthcare and how we respond to those major trends. Clearly, there are 3 therapeutic areas, oncology, neurology, and CVRM, that are contributing to more than 50% of the global disease burden. You'll see the same later on the pharma slide.
Especially in situations where healthcare systems are really in tight budget situations, healthcare systems will continue to prioritize areas where they can have the biggest impact with the money that they have to spend. For us, it's important to prioritize these diseases with the highest societal burden, and clearly have differentiated medicines, transformative medicines. This is also where then you can address higher patient populations or larger patient populations. As mentioned already, healthcare costs continue to grow faster than GDP, so we have to provide solutions that improve outcomes, but at the same time reduce cost of care. Hemlibra being a good example. It improves the life of patients with hemophilia A, but also reduces the hospitalization with that cost in the system. We have to provide these kind of solutions in order to address this trend.
What else do healthcare systems do in order to address the trend? One is decentralization of care, meaning that people that go to the hospital today in the future will be treated in the outpatient setting, meaning primary care or sometimes even at home. For that, we need decentralized solutions, both in diagnostics and in pharma. Diagnostics, for example, solutions like Lumira, where you can do testing in the GP segment as well at a low cost. Also not diagnostics on the pharma side with drug delivery systems. People can actually take the medicine at home or in a GP setting and don't have to go into the hospital and drive costs in the system. For the patient, it's also a better experience because who wants to be going to the hospital all the time? It's better to do it in your home.
Also, what you will see is a trend towards early detection, monitoring intervention. Bruno mentioned Freenome for early cancer detection. We also mentioned Saga for minimal residual disease testing. Again, tests that detect disease early so you can intervene early and reduce costs in the system and improve the chance for the patients. Of course, access to healthcare is still a challenge. More than 50% of the world does not even have access to basic care. This is a big opportunity to reach more patients. There are transformative technologies, AI being one of them, that we have to be at the frontier of because they're going to change the way we either discover medicines or treat patients or even diagnose patients.
That's why we have this group strategy around prevention, stopping and curing diseases so that people don't only live longer, they live longer in a healthy way. Not only lifespan, but health span. The combination of diagnostics and pharma plays a significant role here because you need a diagnosis in order to have the right treatment. You need an early diagnosis to have a high chance for cure. Clearly focusing on the diseases that drive the highest societal burden and the highest cost to the healthcare system. Really innovating along the patient journey to improve care for these diseases and meeting where patients are, where they are, and not only in the hospital, but even in the home setting.
This is around prevention, identifying these patients early through diagnosis, making sure we have an early treatment, like with giredestrant in the adjuvant setting where you have a higher chance for cure, stopping the progression of disease or even moving towards cure, as we do, for example, with CAR T-cells, where you can reset the immune system for certain autoimmune diseases. Let me give you an update also on our progress on AI and data. As we implemented our AI strategy in the company, we implemented it in 3 levels. 1st level we call Everyday AI. Everyday AI means we've trained 100,000 people on AI. Almost everyone completed it. If we monitor it now, we can see that 75% of our people now use AI in their everyday work.
This is really using off-the-shelf tools to make them more productive. As we go into the next round of training, we'll also introduce agentic AI, so people continue to get trained so that we can use these tools to improve the productivity in our company. The second level of AI is what we call Reshape. Basically, we have 3 main processes in the organization. One is service, the other one is marketing and sales, and the 3rd one is R&D. We can use AI tools across the entire process to shape, reshape, and redefine the process, and also accelerate the process using AI tools in different steps of the way in order to become more efficient and more productive as a company faster and also create more output.
For example, if we generate, you know, kind of protocols, study protocols, we can use AI to generate those protocols. Clearly, this reduces the amount of time that people need to write those protocols, and we can become much more efficient. We do that along the entire journey. The third level is really around the big ideas. What are the areas of disruptive potential? AI can have disruptive potential in research in pharma. What we call lab in the loop, basically you use different AI tools to generate drug targets. You make those, and then you test them in the wet lab, you feed back the data, and you constantly update your model, and you train your models. These are proprietary models that our people have developed in order to accelerate drug discovery to find more targets, become more efficient.
For example, we've now embedded AI tools in 100% of large molecule, drug discovery programs. We have more than doubled target entry using AI. We also can accelerate, as you can see here, we have 3 def go accelerations. Another area that we can see as big ideas is digital pathology, and using AI in pathology is one of the areas that we'll talk about later as well. One area, as I mentioned, is digital pathology, and PathAI is clearly taking us into the next era here as well, bringing in the leader in this space to really accelerate our activities. Our activities in AI haven't just started with the acquisition of PathAI. It started much earlier. Back in 2016 when we did the first collaboration with NVIDIA.
Why did we do that in sequencing? We knew as we were developing the sequencer, we need to have chips that are able to handle the amount of data that we produce on a sequencer. The sequencer today, and it's only the start because we're gonna improve further on that, the amount of data it needs to handle is 3 high-definition movies per second. There was no computer chip in the past that could be able to do that. That's why we needed to work with NVIDIA. The speed will even go up further. This is all computing that actually happens on the chip. As you can see, 2019, for example, was the first time that an AI algorithm outperformed the radiologist.
It was already clear that time that imaging was one of the areas where AI would really play a significant role. That's why also the acquisition of PathAI. You probably remember also the protein structure prediction by AlphaFold. You can see a lot of progress that has been made, and we have invested in AI in that time period, and now expanded back in 2023 our collaboration with NVIDIA on drug discovery. This has now led to us also investing more into own chips and on-premise infrastructure. With that, we now have the highest compute power in the pharma industry. We need that as we continue to build our models and can train our models, feed the models with more data. We need that compute power in order to be able to leverage AI throughout our R&D.
We are founding member of the SAIL Foundation, this is a shared license agreement with companies like Anthropic, Microsoft or IBM. We already talked about digital health and PathAI clearly playing a role here. There's strong synergy to both diagnostics and pharma. Clearly on the diagnostic side because the cancer cases keep rising, the complexity of diagnostics keeps rising because there are just more markers they can look at. Actually the number of pathologists is actually decreasing. How do you generate better diagnosis? It's using AI. Clearly strong synergy with the diagnostics business, with our advanced staining business, with our PHC business in diagnostics, but it's also on the pharma side, leveraging those tools in research, increasing our speed in research, increasing our PTS in research as well. Andy and Moritz Hartmann will talk more about that as well.
Let me briefly dive into the area of sustainability, also an area where we've made significant progress and where also Roche is a front runner. Just to give you a couple of examples here. On the one hand, on environment, the other hand on access and innovation. In environment, since last year, we have 100% of all our sites globally now on sustainable energy. 100% of our sites. We've reduced water consumption by 10% last year, 26% since 2020. If you look at greenhouse gas emission alone last year, we reduced it by 34%. We're now reduced it by 78% since 2004. Our goal is not to have a net zero, our goal is to be have a real zero in terms of greenhouse gas emissions.
If you look at access and innovation, just last year, again, we claimed number 1 spot in the Global Patient Reputation Survey. This is done by patient organizations, and they rank pharma companies based on how we are to work with. We have global impact in diagnostics, 31 billion tests. That's more than 3 tests, 3 to 4 tests per inhabitant in the world. We've also invested in antimicrobial resistance with the first antibiotic in 50 years. Again, something where we contribute to society. Also in Africa, working together with different foundations to address the AIDS crisis and also expanding that into other areas such as cervical cancer screening. Again, significant progress in the area of sustainability, also making sure we take our responsibility here very seriously.
Let me talk about people and culture, because at the end of the day, we can only do what we do if we have the right people and the right culture in the organization. We have a highly motivated organization. Three years ago, we talked about high-performing organization. When I see some companies talking about culture in their organization, they also start to talk about high-performing organization. I just want to say we've been talking about that for three years now. Not only did we talk about it, we've done substantial changes in the organization. For example, the way we give incentives. We make sure that we have a strong differentiation between high performance and low performance in the organization. Three years ago, we changed our bonus system. What do I mean by that?
3 years ago, we changed that people who are low performers, so greater contribution needed, would not benefit from company multipliers. They would be capped in their bonus, so there is a significant differentiation to those people who have shown great performance. What we've done is we created Impact Awards or Spot Awards for those people who have really shown tremendous performance. Again, shifting money from low performance to high performance. If I look at our turnover rates, we have pretty much lowest turnover rate in the industry. If I look at the turnover rate between the different populations in our people, so between greater contribution needed, valuable and high performance, we have ultra-low turnover in high performance and valuable performance. Because of the incentive schemes that we introduced, we have significantly increased the turnover rate in the low performance groups.
In the high performance, in the very, very low single digits. In the low performance, we are 35% to 37% turnover. That's exactly what we want because we wanna make sure that we reward high performance in the organization, and with that, you change the culture in the organization to drive this kind of high performance. We also don't want to make it comfortable for those people who don't deliver the performance. Part of high performance is also leadership. We've invested significantly over the last three years in leadership training of our people. At the end, people leaders also need to make sure that the teams perform in a very high way. They need to drive accountability, they need to create clear expectations, and they also need to make sure that we focus on efficient decision-making.
We've also trained the organization more on different skill development areas because we feel that's also important in order for an organization to be a high-performing organization. What does that translate to? At the same time as we move into the shift of a high-performing organization, where we're on the journey already 3 years, we have excellent scores in terms of employee engagement. Just on Monday, we sent out the results of the employee satisfaction survey that we did over the last 3 weeks. If you look at it, we have 82, and it's +3 higher than what we had 3 years ago. At the same time, if you look at the global benchmark, we are 12 points above the global benchmark. 1 year ago, we were only 8 points above the global benchmark.
We increased the satisfaction of our employees, while at the same time in the industry, the satisfaction dropped by 3 points. We are also externally recognized as one of the best employers by LinkedIn, but also by the Science Magazine being number 8 and number 1 spot across all different pharma companies. We just put together a couple of quotes. These are not quotes from our internal employee survey. These are actually quotes from external sites where employees give kind of a sentiment on what's happening in the company. You clearly can see that we have a strong shift into faster decision-making, strong accountability, stronger link from incentives to achievement, clearly, in terms of speed, more science rigor, more debate. This is exactly the cultural shift that we wanted to make 3 years ago.
You can see that it's happened. It's happened while the satisfaction has gone up and while we still do the changes that are necessary. You may have seen that in some of our past presentations. We have cut about CHF 1 billion costs out of the system in R&D that we have reallocated into projects. That's about sourcing. This is about using AI to accelerate. It's also, for example, to give you 1 very concrete example, 3 years ago, Flatiron lost about CHF 250 million a year. This first quarter, Flatiron is positive in profitability. We've made a significant turnaround in that business, while at the same time growing high teens. That's exactly what we need to do.
We need to become very, very productive and make sure that our money goes to the areas where it has the highest impact and where it creates speed in the system. What I like, if I now see progress in different parts of our R&D, you know, I get emails from people in the organization, "Oh, we just broke another record in how fast we recruited here. We broke another record how quickly we went to filing. We broke another record." This is exactly this mentality that I want in the organization, that people take pride in achieving the speed that we need in order to be competitive, and this is exactly the direction that we wanna go. Now, let me briefly touch on the pharma strategy as well. You have seen this slide before. This is why we're focusing on these 5 therapeutic areas.
The 3 that I mentioned before, cardiovascular, metabolism, oncology, neurology, making up about 50% of the global disease burden. If you add immunology, which plays a role in multiple disease areas anyway, and ophthalmology, you are at about 60% of the global disease burden. These are the areas that actually grow. We are focusing on the areas of growth and where we can reach as many patients as possible and where we can make a difference. At the end, this translates into the market. This is the size of the market. That's why we're focusing on it. If you see the progress that we have made in the pipeline, I already mentioned that we are at an all-time high when it comes to the value of our pipeline. A 63% increase versus 2022. At the same time, we have lost less volume.
The volume will continue to increase again, the point is, we can't do everything at the same speed. We need to fast-track certain programs, we had to have more money available for programs where we need to go extra fast. Trontinemab being a great example for Alzheimer's, for Brainshuttle antibody, because it's one of the biggest opportunities we have with a clear differentiation. We fast-track those programs. At the same time, I already mentioned we need to become highly productive and efficient, that's why we work on constant reallocation of R&D resources. Just because we don't announce like other companies, 8 or 9 thousand people reductions, doesn't mean that we're not working very hard on productivity.
We just do it in a very calm way, and not in a very, I would say, that outspoken way. What we also introduced is these organizational, we changed the setup in terms of end-to-end accountability across our entire R&D, and also introducing bind, business and scientific boards. These are important because these are the challenge boards. What it translates to, you can see here. If you look at this on value and PTS, in dark blue you can see those projects that have gone into late stage, significantly higher value, significantly higher PTS. In fact, if I look in the past, usually the PTS prediction of our people was always correct. When our people predicted, PTS above 50%, usually that meant that that trial was successful.
If you look at the average PTS right now that we have in the pipeline, it's around 70%. Clearly a significant progress, not only in terms of value, but also in terms of PTS. Diagnostics I will not go into. I will let the Dia team handle that because I know you're going to be in very good hands with them. I look forward to listening into that as well. Let me finish with giving you a growth outlook. You've seen the slide before. Consistent strong delivery of growth, 5%, 8%, 5% in sales, 8% in core EPS. In fact, if you look at the last two years and three quarters, in fact we had an average growth of around 8%.
Significant delivery, and I can say we've actually really delivered, and we delivered in this time period when we actually had the cliff of MabThera, Herceptin, and Avastin as well. We continue to grow and we also continue to grow through digesting also the COVID sales. If I look forward, between 2027 and 2030 we have 19 medicines that could reach patients. 19 phase III readouts. This is a very full pipeline that we have, and so we have a lot of trials now ongoing in the late stage. In diagnostics as well, we have strong pipeline and we have already launched a number of blockbuster products. CGM, MassSpec, very soon the sequencer, but we also have a number of assays that are going to be very important for our menu.
Lp(a), I know this is also a big target right now in pharma, but also if you look at p-tau217, you saw the press release on that, for Alzheimer's NfL to look at the progression in multiple sclerosis and the Interferon-Gamma Release Assay for TB is also one that people are really looking forward to. Now you've seen the slide before, what does that translate to in terms of the growth outlook for our company? Diagnostics, as you can see on the bottom, will continue to drive growth. It will be growth in the mid to high single digits over the long term and core growth ahead of sales. If you look at the pharma portfolio, here's a big change to what we showed you in September.
In September we said the on-market portfolio and the data we have in hand is going to deliver growth until 2028, and then the on-market portfolio will compensate for any generic erosion. Now given all the positive readouts we had in the last six months, four positive phase IIIs of GAZYVA in a row, the data on giredestrant in adjuvant, which is a significant opportunity, adjuvant is more than 70% of the market for SIRT, and also the fenebrutinib data, you see that we will no longer have a situation even with what we have in hand where we are not going to grow. We will continue our good growth momentum not only until the end of the year, end of the decade, but beyond. We'll continue a strong growth momentum.
With all the medicines that we have in the pipeline that are going to read out in the next 3 years, this will add on top. BD will add on top. We can be confident about the growth momentum that we have and that we will continue to have. If you compare that to the consensus, you can see on the left-hand side the biosimilar gap that's expected if you take all of the different analysts' numbers together. It's about CHF 6.7 billion over a 5-year period. Then you see in the middle the growth on the on-market portfolio and what's in the pipeline. In many of those areas we already have the data in hand, Herceptin. GAZYVA is a significant opportunity with the different in lupus nephritis or SLE for example.
If you go through the list, personally I would say there is upside potential and there is definitely more potential for the upside than for the downside. There are many things that are not even covered by the models today. There is the opportunity to drive growth into the future here as well. Let me just say as I hand over to Matt, we have delivered in terms of what we have said 3 years ago in terms of growth, in terms of pipeline rejuvenation. Our outlook has fundamentally changed given all the positive readouts that we have seen, and we have a very full pipeline in pharma and in diagnostics that are going to drive growth also beyond the decade. Thank you very much. Now I hand over to Matt.
All right. Welcome everyone to Dia Day 2026. On behalf of myself and all of our colleagues, we're really looking forward to giving you insight into the diagnostic strategy, our rich pipeline of innovation, you got a bit of a preview there from Thomas, and some of the innovative diagnostic solutions that are gonna have a big impact on healthcare around the world and propel our business to that diagnostics financial ambition, which you just heard from Thomas. With that, let's get started. Anchoring ourselves first with the strategy. The strategy has been unchanged for the last six years, and it consists of three key pillars. The first, we will continue to innovate and deliver high medical value diagnostic solutions.
we will deliver clinical decision support tools, and you're gonna hear more about this from Moritz Hartmann and Andy Beck, to improve clinical decision-making. third, we combine these into solutions that span across the entire care journey and give patients and caregivers the tools to better navigate chronic conditions and diseases, and this also creates competitive differentiation from us against other diagnostics companies. How do we translate that into ambitious goals for the organization? we are number one in vitro diagnostics, and we have a goal to expand our position as the leader in the clinical lab. we have the goal to become a leader in decentralized testing. You heard quite a bit from Thomas Schinecker about why we feel that's an important area for us to remain focused as an organization.
The third is to differentiate ourselves from our competition by offering comprehensive solutions across the highest disease burden areas, and the fourth, to deliver these in a way that help patients and caregivers better navigate the entire disease continuum in a way that delivers better outcomes for patients in society. A great example of this is our ecosystem we're building in oncology and neurology. Now I'd like to explain a bit about how we are organized as Roche Diagnostics, which is centered around our customers. Going from left to right on the slide, starting with the core lab, this is the biggest business unit within diagnostics and is focused on routine laboratory operations. The heart of this is our leading serum work area, which includes clinical chemistry and immunochemistry testing.
I will also highlight that this includes the new cobas Mass Spec system, which you're gonna hear more about from Palani. Molecular Lab covers both molecular diagnostics and sequencing. This consists of our mid to high throughput PCR systems, syndromic panel testing, as well as the forthcoming AXELIOS sequencing solution, and Josh is gonna take you through that. Our Pathology Lab is centered around cancer diagnosis and companion diagnostics, so this includes our leading advanced and primary staining business as well as our digital pathology and personalized healthcare portfolio. Laura's here from Ventana, and she's gonna take you through that as well, and also you'll hear about this from Andy. Now, Near Patient Care provides solutions for decentralized and acute healthcare settings.
This includes diabetes management, which is our largest segment, as well as, if you look at our LumiraDx, molecular immunochemistry and clinical chemistry, and I'll cover that a bit later, but you'll hear more in depth from Ildiko, who's our head of R&D for diagnostics, in her section. Lastly, our precision oncology subsidiary, Foundation Medicine, which delivers comprehensive tests for oncology, including our recent merger, definitive merger agreement for minimal residual disease provider, Saga Diagnostics. I would call out that integrated across all of these, we integrate these lab solutions with digital products and solutions across the lab and the clinical settings to enhance their value to healthcare providers, I would also call out this improves our competitive position against other diagnostics providers. Now I'd like to talk a little bit about the size of these customer areas.
The first is the core lab, as I mentioned, our biggest business unit. This is a CHF 40 billion segment. It's growing at 3%. Again, we hold the number one position here, but as we expand with solutions like mass spec, we feel we can grow this segment in the future. The second, the molecular lab. PCR valued at CHF 9 billion, sequencing valued at CHF 7 billion. We are number one in the laboratory molecular diagnostics base market. This is growing at 4%. As I mentioned earlier, we are going to very ambitiously enter the sequencing space, which is growing at 7%. Here we see a lot of opportunity for growth, especially as testing moves more in the direction of the clinical space.
In the pathology lab, we're the number 1 provider for precision oncology diagnostics. This is a market growing strongly at 8%. Lastly, for near patient care, the market is growing at 3%. What I really want to call out is 1 of the fastest growing segments within that, which is continuous glucose monitoring, which is growing at 14%. Again, you'll hear more about this from Ildiko. Given the, you know, growth dynamics in the in vitro diagnostics market. As you heard, our ambition to grow above the market with mid to high single-digit growth, our focus is on the highest growth segments in the diagnostics market to drive our business above market levels. We will do this by focusing on the diseases with the highest burden on global health.
If you look collectively across our areas of focus, these represent 60% of the global health burden. I'll discuss some of the drivers that we expect to continue to accelerate tested in these areas. Starting with oncology, here mortality is expected to increase 50% by 2040. We expect testing to be driven by a significant rise in early blood-based cancer screening, precision oncology testing, and the rise in minimal residual disease testing. This is driven by its incorporation in early cancer regimens as well as the availability of those early-stage treatments.
Second, neurology, where mortality is going to increase by 67% by 2040 and as example, people living with Alzheimer's is going to reach 50 million people by 2030, the majority of which are never diagnosed. We expect testing to be driven by the approval and access of new disease-modifying therapies that require early detection and therapy initiation, but also combined with the availability of these new early blood-based biomarkers. Third, cardiometabolic mortality will grow by 40% by 2040. Here we expect testing to be driven by rising prevalence of type 2 diabetes and decentralization and growth of consumer-based testing. Lastly, infectious disease mortality will increase 29%, and here we expect this mortality and the testing to increase driven by the growth of STI testing as well as syndromic-based panel testing.
Here, this is where our strategic investment and acquisition of GenMark is gonna be a key part of this, an area where we're gonna continue to expand our menu. Now I'd like to talk how we're gonna achieve each of these goals, and I'm gonna start with how we plan to expand our number one position in the clinical laboratory. If you look at this slide and break it into the left and the right sides of the slide, our strategy here is very clear. We will continue to invest in delivering innovative solutions in the areas where we lead. We will not be complacent with our leadership position, and we plan to deliver innovation in our core areas of strength. The key examples are really on the slide. First, cobas Ultra.
Here we will combine pre-analytics and analytics and deliver high capacity together with intelligent sample handling. Our Smart E benchtop immunoassay platform, which we'll launch this year, this is going to be critical to enable our market capture of TB IGRA as we decentralize out into smaller customers. Our next-generation molecular work area, which will replace our industry-leading 5800, 6800, and 8800 with a next-generation molecular solution. In the same theme, we're building an advanced staining, fully automated next-generation solution for the pathology lab, which will replace our leading BenchMark ULTRA PLUS platform. Now, while we continue our growth in the areas we are strong, we also plan to disrupt the market with innovative solutions that we will launch with the scale that only Roche Diagnostics can bring to the market. Here I will call it our i 601, the industry's first fully automated clinical mass spec solution.
Palani will cover this. We are seeing really strong excitement from our customers. Some of our customers have even put out press releases when they've acquired this system. We're seeing very strong interest from the market. I'd say the same theme with our soon-to-launch AXELIOS sequencing solution, which will bring unprecedented throughput and flexibility combined with high accuracy. I would also say beyond platforms, I spoke with some of you at the break about this. We'll continue to innovate on our digital solutions as well as our chemistries. An example here on the slide on the bottom, you'll see our protein-to-DNA workflows that will enable detection of extremely low amounts of proteins. This is critical for early detection of neurologic illness as well as cancer.
A second example well, detailed by our definitive merger agreement with PathAI is our importance of AI-enhanced digital pathology as a significant area of focus. With that, I'd also like to talk about how we plan to become a leader in decentralized testing. If you look at this slide, you can see the different settings where decentralized testing is utilized from the emergency room and moving out farther away from the hospital to GPs, pharmacies, and then even consumer and patient-based testing. Then you can see on the left-hand side, infectious disease, cardiometabolic, and diabetes. These are the conditions where an answer is critical to know right away that are most amenable to these kind of point-of-care testing modalities.
Here what I would call out is that we're gonna cover every major point-of-care segment with our solutions in our pipeline, that we have been very intentional about how we built a portfolio that enables us to compete in terms of quality and our cost position. Ildiko will take you through this as well. For the last two goals, I will combine them in a single section, how we differentiate ourselves through high medical value solutions and comprehensive disease management. First, I want to really level set on how we define the different stages in the diagnostics patient journey. First, on the far left, early detection. This applies to screening tests, which enable healthcare systems to move to a preventative care model, reducing global health burden.
Again, as Thomas mentioned, our investment in Freenome, having that option space in early cancer detection. We have a strong level of interest in early cancer screening, but screening more broadly. Precision diagnosis. This refers to testing that provides precise characterization or disease and enables appropriate patient management. Therapy selection, solutions that enable optimal patient management and therapy selection. A great example is the CGP product delivered by Foundation Medicine. Disease monitoring. This refers to longitudinal testing solutions and digital tools that enable patients and physicians to manage chronic conditions. An example here is our diabetes care business, for example, our CGM. This is how we divide up how we view the diagnostics patient journey and where we build specific solutions.
Now I'd like to start by walking you through our four key disease areas, where we see the opportunity for diagnostics as well as the growth potential in each of these segments, and we give an outlook for the segment growth to 2030. You'll hear in detail from the team about our solutions that we're developing for each of these segments. I'll start with a segment that has high unmet medical need and where we're investing significantly as Roche to develop best-in-class diagnostics. Early detection for oncology is experiencing significant growth. You see this in the 35% compound annual growth rate for multi-cancer early detection, which is driving this segment to a CHF 5.3 billion opportunity by 2030. We feel we have a strong position and optionality in this space given our partnership with Freenome.
Therapy selection for oncology is a CHF 17 billion opportunity growing at 9%. Here we see growing demand for targeted companion diagnostics, digital pathology solutions, as well as comprehensive genomic profiling, all of which are an area of significant investment for Roche Diagnostics. Lastly, disease monitoring is also projected to grow at 32% to CHF 5 billion. This is driven by uptake of minimal residual disease testing. Here, our FMI portfolio and AXELIOS solutions will play a key role, especially with the recent acquisition of Saga Diagnostics. You heard Bruno mention this at the start, but just to be really clear, in oncology, we have built a unique set of assets that span the entire continuum of testing and uniquely position us versus other competitors to lead in this exciting space.
You hear in detail from the team in their sections, at a high level, what I want to point out is our industry-leading portfolio of assets. First, I would highlight we have the full complement of IVD technologies to enable leadership of lab-based oncology testing. I would really emphasize that our AXELIOS technology platform is key to drive the future of molecular-based oncology testing together with our digitally enabled IHC Ventana business, where you see the strong synergy between Ventana and PathAI. We're also well-positioned to compete in the precision laboratory business with our Foundation Medicine organization, especially with the soon-to-be-finalized addition of Saga Diagnostics to deliver on the opportunity in minimal residual disease testing. We've also, as mentioned previously, built a strong position and option space in early cancer detection with our partnership with Freenome.
Altogether, we have built a full end-to-end oncology portfolio that will enable us to shape the future of the oncology testing market in a way that no other company can. The team will take you through the details in their presentations. I'm very excited about how we've pulled this together and built a leading position from end to end in one of the most critical opportunity spaces in diagnostics. Now, you heard about this earlier, but I also want to take the opportunity to really highlight a key part of our oncology strategy, which is the recently announced definitive merger agreement with the PathAI team. PathAI, as you heard, is the leading provider of digital pathology image management systems. Again, this really enables pathologists to augment existing immunohistochemical or primary staining workflows with AI-powered digital insights to improve patient management.
What I really want to call out here is this business is entirely complementary to our Ventana business. It also has high levels of complementarity to our pharma services business, both in the pathology space but also at FMI. It gives us the ability to engage earlier with pharma companies to build companion diagnostics programs, and it provides that seamless complementarity again with our Ventana business. This is going to position us strongly for the future. You're going to hear more about this from their CEO, Andy Beck, as well as our Head of RIS, Moritz Hartmann, but this is a key part of our oncology strategy. With that, I'd like to continue to neurology, which is a disease area undergoing rapid growth, again, due to our aging society.
I will start with early detection, which represents a CHF 480 million opportunity by 2030, and this is going to be driven again by the availability and proliferation of blood-based biomarkers. Olivier will talk about this in his section, but here I would call out that we've just announced today the first CE mark for p-tau217 blood-based rule in, rule out with an intended use in primary care. One of the biggest barriers to diagnosis of Alzheimer's is the referral into secondary care, the availability of imaging and lumbar puncture-based CSF tests, and by having an intended use in primary care, we have a meaningful competitive differentiation against other test providers.
Therapy selection is projected to grow at 17%, and here we mostly focus on optimizing, selecting patients for side effect profiles based on their APOE4 status. We also see an opportunity, and Thomas mentioned this earlier, for looking at disease progression. As disease-modifying therapies enter the clinic, the need to understand progression and optimize patient therapy will increase. Here I would call out our Neurofilament Light Chain assay, which also received CE mark in the first quarter, which is able to detect neuroinflammation and be able to help physicians better optimize treatment for patients with multiple sclerosis. Now I'd like to continue with cardiometabolic testing, a segment where we are the market leader.
Early detection is a significant market, valued at CHF 6.9 billion by 2030, one where we are making significant investment both with our core lab and near patient care portfolios. In early detection, we focus on earlier risk stratification and triage through novel biomarkers and integrated digital and diagnostic solutions.
Acute diagnosis of cardiovascular disease is a CHF 4.2 billion opportunity. Here we feel that we have a focus on precision diagnosis of cardiovascular disease with biomarkers such as troponin, which we plan to augment with new and novel biomarkers to improve the diagnosis of myocardial infarction. Here I would also call it, as you heard, Lp(a), while not really for the acute setting, is a test that is really exploding in terms of its utilization. These are the kind of tests we will also use to augment our cardiovascular portfolio. Cardiovascular disease monitoring is one of the largest opportunities in medtech overall. This is primarily driven by glucose monitoring for people with diabetes. This segment is experiencing strong growth driven by the explosion of continuous glucose monitoring, again, growing at 14%.
This is a key market where we plan to expand. On that topic, I would like to transition to our Accu-Chek SmartGuide CGM. This is our AI-powered CGM solution that will help people living with diabetes manage their condition by addressing one of the biggest challenges that people living with this disease face, which is uncertainty. The algorithms we provide, such as our glucose predict and night low predict, address the concerns people with diabetes have around how their glucose values may affect them, especially during sleep. We are developing future algorithms around therapy initiation, as well as diet and exercise and you'll hear about this from Ildiko, a next-generation sensor that will add to this portfolio of tools to enable people with diabetes to live their lives as they choose rather than centered around their disease.
We're excited about our progress here in one of the largest and fastest-growing segments in medtech, and you'll hear more about this from Moritz and Ildiko. Now coming to our final disease area, infectious disease. Here, diagnosis is a very large segment. Predicted 20-30 market value is CHF 25 billion, and this is really driven by segments such as sexually transmitted infections, where, you know, you saw from Thomas' slide, our cobas BV/CV, and we are continuing to expand our menu there, and syndromic panel testing, as well as screening for diseases such as latent tuberculosis, which we will cover today as well. All of these are areas of significant focus and investment for Roche Diagnostics. Disease monitoring here is a CHF 1.6 billion opportunity and one where Roche has and will continue to have a significant presence.
This is driven by quantitative testing for patient viral load. This is an area where I would say we've really shaped and built the market over several decades. Now I'd like to summarize. We gave really where we are gonna be focused, how we are gonna win. I'd like to summarize that with our financial ambition. We are the leader in in vitro diagnostic testing. We have a clear strategy to stay ahead of our competition and outgrow the market by focusing on the highest growth segments with differentiated solutions. You heard about the AXELIOS solution, which has a differentiated value proposition, and will make a profound impact on the sequencing market for years to come. This will lead us to a mid to high single digit growth.
For core operating profit, you heard from Thomas Schinecker, we will grow our profit faster than our sales. This is going to come from the profit contribution of our core business as well as our new launches, as well combined with continued operational excellence. Mid to high single-digit growth with profit growth faster than sales. Now to get into our portfolio, I would like to hand it over to our Head of Roche Diagnostics Solutions, Palani Kumaresan. Thank you very much.
Thanks. Thank you. Thank you, Matt. A warm welcome from my side as well, to everyone in the room and also those who are joining virtually. I'll try to keep us moving faster because we do want to keep the time for Q&A with you guys. I know many of you have many questions. I'll spend the next few minutes going through the Roche Diagnostic Solutions pipeline. Let me get started. Matt very nicely already laid out the 4 customer areas that are within Roche Diagnostic Solutions. The important point I will mention additionally here is these customer areas very nicely mirror how our customers are set up in the markets. One of the core elements of our diagnostics business is instrument placement.
I wanted to start out also showing you how our instrument placements have grown over the course of 2025. These are some key instruments across the 3 lab-based customer areas. You can see very nice double-digit growth. As we look to the future, this is in 1 slide gives you a holistic view of some of the key instruments and platforms that are going to be hitting the market in the coming years. 2026, obviously AXELIOS is an important focus, but also cobas Smart E. I will spend a little bit of time talking about that for immunoassays. Over the next 3 years, 2027-2029, important additions to part of our automation portfolio, but also our near patient care portfolio.
As we go into 2030, early part of next decade, Matt already mentioned next-gen advanced staining, next-gen molecular work area, and continue to build on our automation portfolio. Now going hand-in-hand with our instruments is a very rich pipeline of tests. This is again a holistic view on one slide. Over 140 new tests that we will be looking to launch across the 4 disease areas with highest disease burden that Matt shared, but also across some other areas that you see in the bottom. On the right-hand side, some examples, some of them are highlighted in red dotted lines, and the team, after the break, will get into the details of many of these tests.
For the remainder of my presentation, what I'll do is I will very briefly for each of the 4 customer areas share with you the 5-year strategic priorities and then some key highlight, portfolio highlights. Let's start with Core Lab. Here are 3 important strategic priorities. Evolve our next generation systems portfolio. I'm here mainly talking about mass spectrometry and also our cobas Smart E. Develop integrated lab automation offering. Here, the centerpiece is going to be cobas Ultra, and I'll say a little bit more about it in a bit. Continue menu expansion with focus on high medical value assays, particular focus on neurology and infectious diseases, which we will of course get into more later on.
cobas Mass Spec, wanted to give you an update here, for some of you who might be a little bit new to this segment. CHF 3 billion segment, largely manual, labor-intensive, and laboratory-developed tests. With the introduction of our fully automated IVD solution a little over a year back, we have had some very positive feedback from customers. Performance, they really like. They absolutely like the end-to-end automation, as well as the robustness of the instrument as it has come into the market. We have had placements across influential labs in Asia, in Europe, as well as in North America with Labcorp. Now, by the end of this year, we are targeting a total install base of 100 instruments. We have 39 assays that are launched in CE mark countries, and we look to continue to grow this menu.
Talking about growing the menu, I wanted to quickly share on this slide, how is the menu coming along? Top of the slide, you can see the 39 tests that we have launched in CE mark countries. These are focused on steroids, vitamin D, and therapeutic drug monitoring. We are talking about immunosuppressive drugs, antibiotics, and antiepileptics. Going into 2026, we are looking at launching 4 more tests in CE mark countries. U.S. is the single biggest market for cobas i 601. Here we have already approval for the instrument along with vitamin D and 6 steroids tests in a CLIA-exempt setting, and we are actively working with the FDA to bring the rest of the tests that you see in the upper half through a 510(k) process towards the end of this year and then going into next year.
Simultaneously in development, we are already working on the next wave of mass spec tests, and that would be primarily drugs of abuse testing. Let's switch to cobas Smart E. This is a low throughput standalone immunoanalyzer targeting low volume labs. Low volume labs for immunoassays is around a CHF 1 billion market, growing at around 5% CAGR. In this market, we have had cobas e 411, and we have a very healthy install base, over 18,000 installations, and this is going to be a successor to e 411. On the left-hand side, you can see some key highlights of this instrument.
One important call-out, it will use the same reagent cartridge as it's used in our other immuno assay platforms, the E 402 as well as the E 801 that are widely available in the market. This is something that is really liked by our customers to have that family concept. You can see on the bottom right some key advantages of this platform. It's a benchtop, built very robust, for remote settings, with limited maintenance requirements. We are looking to launch this in CE mark countries towards the end of this year and then subsequently in other markets. It will have the full menu of immuno tests that we have on our other platforms like E 402 and E 801.
Now on automation, here I mentioned earlier about cobas Ultra, and here we are taking a very systematic approach to bring a series of innovations to the market. This year we will have a controlled launch of cobas Ultra pre-analytical system. This is the successor to our highly successful cobas p 512 and cobas p 612 pre-analytical solutions in the market. Next year, we will bring some important modules to this, like the centrifugation, which is very important for our customers, but also bidirectional movement of tubes, cobas Ultra Dual Transport, and mobile robots to allow for automation across islands of analyzers in the lab. Working towards our Omni Transport. This is the ultra-high throughput, two-dimensional, single-tube transport that we are working on with our partners Hitachi. We will also bring modular pre- and post-analytical systems and analytics capabilities.
What does this all mean? First of all, high level of modularity means our customers only pay for the hardware that they really need. Two, flexibility, space efficiency. It can really work with limited space, lab space, which is an important worry for a lot of our customers. Industry first ultra-high throughput, movement of tubes across different analyzers. Before I move on to molecular lab, I did want to very briefly talk about the neurology menu, especially on Alzheimer's. I won't go into the details here because you will later hear from Olivier Gilliéron very nice data on pTau217.
What I wanted to emphasize is we are taking a very systematic approach to introducing several different assets leading up to now p-tau217, and we will continue to increase or improve on and build on additional intended users and additional tests coming into the market in the future. Moving on to molecular lab, 2 important strategic priorities. On the PCR side, we want to continue to build a menu of tests, primarily looking at sexually transmitted infections, GI, gastrointestinal infections, also hospital-acquired infections on that ecosystem of PCR instruments we have. On the sequencing side, of course, launch our AXELIOS sequencer. On this slide, you can see that entire ecosystem of PCR platforms that we have in the market. Very briefly, on the left-hand side, we have our high volume, fully automated IVD solutions, 5800, 6800, 8800.
The pre-analytic solution, cobas prime. For point of care testing, this is of course LIAT. On the right-hand side, the open molecular solutions are 2. We're talking about Digital LightCycler and LightCycler PRO, where we have a broad menu of research use only and IVD tests from our TIB Molbiol side of our business, and syndromic panel on ePlex platform from GenMark. Josh will later tell you how that menu is evolving on these platforms, but I also wanted to shine a quick light on donor screening, which is an important part of our PCR portfolio, and this is essentially blood testing for blood donations as well as for plasma fractionation. Together, the serology and nucleic acid testing, NAT, is around a CHF 1.8 billion market. On the NAT side, we see good growth based on a few factors.
There's adoption of NAT in many NAT-naive countries which still only perform serology testing. We see increasing testing of emerging pathogens. A good example of this is testing for malaria. Increased demand for plasma-derived medicinal products. While there are many differentiating factors to our portfolio, the most important call-out is this end-to-end integrated solution across serology and nucleic acid testing using our automation solutions as well. Towards this, we are introducing some additional solutions. You see cobas Synergy Plus, which will allow for automated blood pooling, which is a common practice in many countries that are performing NAT testing. Last month, we launched a multiplex test, MPXE, which is bringing hepatitis E virus into our already multiplex assay for HIV 1, 2, HBV, and HCV.
This allows for essentially workflow simplification for our customers because they don't have to perform a separate HEV test. This is a great business for us, very robust, and we continue to maintain a good presence in this market. Now on AXELIOS, I wanted to mention only a couple of points. Now last year, we introduced the technology at AGBT in February, and since then we have systematically worked with early access sites like Hartwig Medical Foundation in Europe, like Broad Clinical Labs in the U.S. and so on, to systematically demonstrate many of the applications that you see on the left-hand side. As we get closer to launch in the summer of this year, we will be coming out with application notes that will lay out for our customers, future customers, how to realize these applications in their own labs.
Last month, we brought together a few hundred prospective customers from the U.S. and in Europe, we have had really tremendously positive feedback from the customers, both around speed, throughput, accuracy, the flexibility, and of course the pricing, the CHF 0.06 per million read pricing. Josh will definitely get into a lot of the details here because we know that you're very much looking forward to hearing more about this. Let me switch gears, go to pathology lab. 3 important strategic priorities. Strengthening our advanced staining core business, both in histology and cytology. Driving digital pathology adoption, and here of course, our definitive merger agreement with PathAI will play an important role. Continue to build our assay menu, the test menu. Here our pharma partnerships play a very important role, I'll talk to you a little bit about that.
How does advanced staining feature? Here, we have the largest installed base of our advanced staining platform, BenchMark ULTRA and ULTRA PLUS, which is the core of our business. You see we have primary staining, special staining platforms to go hand in hand, as well as our digital pathology scanners. When it comes to digital solution that you see in the bottom, we have important solutions for lab automation. PathAI's AISight Dx will become an important part of our digital offering for image management solutions. As we look to the future, our next generation advanced staining platform that we are developing with Hitachi, which will be a successor to BenchMark ULTRA PLUS, that will be important.
End-to-end workflow automation here, it's not only software automation, we are also talking about bringing some clever hardware in the form of mobile robotics, flexible robotics and so on into the pathology lab as well. The AI-driven ecosystem, again, PathAI will be a key underpinning for this. On the assay side, something that is quite remarkable is we have a menu of over 250 immunohistochemistry and in situ hybridization tests on our advanced staining platform, and we continue to bring more innovation. We are looking at bright field multiplexing tests, digital pathology algorithms. What I wanted to point out actually is on the right-hand side, our personalized healthcare services business. Standalone, this is a great business for us. We have right now over 85 plus pharma partnerships, over 150 ongoing in vitro diagnostics programs.
What this enables us is continuing to build this menu allows us to drive the placement of our instrument. As we place more instruments in the market, we drive more access to all of these tests. This is something that our pharma partners really like because they want to have broad access to the companion diagnostic tests to make sure that their drugs can be really available to patients all over the world. Not only it's a great standalone business for us, it's also synergistically works very nicely with our core business. Now to close out, I want to show you a couple of slides on near patient care. Key strategic priorities, building a leading portfolio in clinical chemistry, immunochemistry across hospital, decentralized and close to patient setting. Strengthening our position in molecular point of care through systematic menu expansion on LIAT.
Here, the important focus is on sexually transmitted infections. Deliver a competitive CGM solution. Now, Matt already showed these six platforms that form the base for our near patient care portfolio. I wanted to do one more click, share some key launches that are coming up, Ildiko will go into the details of some of these. cobas Sense is essentially our bench-top immunoanalyzer, bringing lab-like performance in an emergency room setting, particularly for cardiac markers like high sensitive troponin T. cobas Vital is our next generation blood gas and electrolyte platform. This builds on cobas b 123. It will bring some unique algorithms like venous to arterial conversion, but also significant sustainability and cost benefits. cobas Pulse is a handheld hospital blood glucose monitor.
We've had very nice growth in install base since the launch in ME-LATAM countries, over 24,000 placements. It also brings in nice integration of third party apps into this handheld device in a hospital point of care setting, and we're looking to launch it in the U.S. later this year. Cobas LIAT later this year, the lesion panel for herpes simplex virus, varicella zoster virus, which causes shingles, and syphilis, also with mpox. Following that, launch of trichomonas and candida vaginitis, again, really rounding off our STI menu. LumiraDx, our focus is on menu that will really drive its adoption in highly decentralized setting, and this is where we are looking at the lipids panel, but also the next generation of HbA1c.
When it comes to Accu-Chek SmartGuide, with our current generation in the platform getting factory calibration and pediatric claim is a big focus. We are also simultaneously working on the second generation patch, both of which actually Ildiko will later show you how do these patches look. With that said, I want to close out my section, I'll hand it over to Moritz and Andy to talk through the Roche Information Solutions portfolio. After the break, we'll come back, we'll double-click into some of the key parts of the Roche Diagnostics Solutions portfolio. Thank you for your attention, and Moritz, over to you.
Thanks, Palani. Yeah, thanks, Palani, and welcome as well from my side for being here today. I wanna highlight on how our digital solutions portfolio and pipeline play a strategic role in driving value for our customers and for Roche. I will talk specifically about how we're using AI to even elevate that value further. Of course, a good portion of this section will focus on the exciting opportunity with PathAI. Our ambition is to transform diagnostics with data and digital solutions, moving from our strengths in the central lab towards decentralized care. We have three main value propositions across our digital portfolio and pipeline. The foundation for us is the connected lab, where our diagnostics insights portfolio delivers operational excellence to labs.
We're making very strong progress in this segment, where we have already converted our industry leading analyzer footprint into the largest connected digital software footprint globally. Building on this foundation, we're expanding our offering into our second value proposition, the informed clinician. This is where our solutions for clinical workflows and clinical decision-making drive faster and earlier diagnosis and better patient outcomes. In our third value proposition, we're providing solutions for patients living with chronic diseases, such as diabetes, to better engage, control, and manage their diseases. Digital solutions contribute in two ways to accelerate the overall diagnostics value creation. First, our digital solutions drive important differentiation of our core diagnostics offering. This increases our win rates and actually drives longer customer lifetime value, including through our industry-leading portfolio of data security solutions.
With our clinical support solutions and our patient-facing solutions, we're focusing on additional value streams, utilizing our market-leading strengths and capabilities. This is why our digital solutions here are either FDA approved or CE marked, which is a very important and much appreciated differentiation factor for our customers. We're also seeing progress with reimbursement and adoption. Recently, the first European country has included an innovative algorithm in reimbursement, and an Asian country has included the same algorithm in their national guidelines. Let's move on to how we utilize AI to transform the laboratory space. Here, our focus is to turn a fragmented, highly customized, but inflexible software landscape into an AI native lab operating system environment, essentially doing for lab software what we have done with the Serum Work Area. We're approaching this in 3 phases.
Phase one, which we plan to make available at the end of this year, we will build a native AI foundation using operational data. This will allow us to optimize workflows such as better demand forecasting or quality control anomaly detection. In phase two, we will build lab clinical intelligence by adding lab results to our trained LLM and enabling use cases such as the interpretation of test trends or correlation between lab performance and outcomes. In the third phase, we will really create a holistic precision engine by now adding selected EMR data to this LLM, which will bring context-aware reasoning across the entire patient workflow. As you can see, we're executing on our digital strategy, and our broad digital solutions portfolio and pipeline demonstrates our commitment.
In the following presentations, you will hear more about our digital solutions that are very closely linked to other parts of the portfolio, those highlighted in red here. The navify Clinical Hub, which complements our FMI offering, or the Accu-Chek SmartGuide platform, and our leading customer experience, mySugr, which is now part of our CGM solution. For now, I would like to share more on the exciting news we shared with PathAI. As Matt Sause already highlighted, the digital pathology market outlook is very strong. While the PathAI transaction is currently subject to regulatory approvals, we're excited by the potential to augment our offering in digital pathology by complementing the scanners and actually the full portfolio of pathology and also our algorithm offering. We will enhance the workflows with the next generation AI-centric image management system.
When turning towards pharma and our biopharma customers, we have the potential to build on our already existing successful partnerships in developing companion diagnostics algos. Finally, we will be able to provide a strong portfolio of AI services for biopharma customers with clinical trial efficiency and biomarker discovery. With that, I'm very happy to welcome Andy Beck on stage, CEO of PathAI, who is our guest speaker for today, and to walk you through more details of that. Andy.
Great. Thanks, Moritz.
Happy to be here.
Thank you. Great. It's my pleasure to introduce you to PathAI. Our mission since founding the company 10 years ago is improving patient outcomes with AI-powered pathology. From the beginning, we've been focused on technical leadership in AI, as well as software engineering and medical leadership, really focused on developing this technology for applications in pathology. We're also very focused on discovery, science, as well as clinical and regulatory validation, and I'll provide a couple examples of those today.
A key focus of our strategy from the beginning, and where we see tremendous synergy with Roche, is, we're very focused on having one foot in biopharma and one in diagnostics and using those to strengthen each other, as Palani mentioned, with this virtuous flywheel, where if we make discoveries in biopharma and we're already widely distributed in diagnostics, we can then scale and distribute those insights globally. Lastly, we're very well-positioned early in a market that is just starting to inflect now. Today, the minority of pathology is digital. We expect in 10 years, it will be absolutely routine that pathology is done digital and with the assistance of AI. We're aiming to build the operating system for precision pathology to power patient diagnosis and drug development at a global scale.
We have these two synergistic customer segments, both supported by one underlying AI flywheel. For clinical diagnosis, we support the pathology lab by building tools, a broad menu of tools, to cover the full spectrum of needs in the lab with the overall value proposition that digital and AI will drive increased accuracy, increased efficiency, and increased access to precision AI tools to enable patients to get accurate diagnoses and to be recommended the right therapies. The work in biopharma is very focused on how we can best use AI-powered pathology to serve two of the major value drivers within pharma, which is increasing the probability of technical success in clinical development programs, generating new pathologic insights into mechanisms of response and resistance.
With this synergistic flywheel, how can we use AI to power digital pathology to not only increase the probability of success of a trial, but also to accelerate time to peak sales and even increase the amount of peak sales? To give you one example of this from our work in translational research, where we aim to unlock insights from whole site images to drive advances in drug development, I'll focus on our PathExplorer and IHC Explorer products because I think they very nicely highlight these concepts. These are our products focused on exploratory translational research in oncology. If you look at these two images on the left sides of both of these panels, the one on the left is the H&E, which is the standard stain in pathology. It's been used for 150 years.
If a pathologist were to look at that, they could easily say this is cancer. What would be impossible for them to do would be to provide a single cell dissection and enumeration of every cell within the image, as well as characteristics of the tumor and the tumor microenvironment. With our AI-powered system, we can provide not only the support the diagnosis, but also provide this rich quantitative feature set, which can then inform studies into insights of pathologic mechanisms of resistance and response to therapies.
We do something very similar with our IHC Explorer product, which is deployed on the core biomarker methodology in tissue pathology, IHC, except in addition to identifying every single cell within the image, we can also assess whether that cell is expressing a drug target of interest, which is valuable across oncology, but in particular in immuno-oncology and to support studies of antibody drug conjugates. We've been partnering since 2024 with Roche Diagnostics, a leader in tissue-based companion diagnostics, and the partnership is really focused on going from potentially finding a signal using an exploratory tool like IHC Explorer, but how do we plug that into Roche's industry-leading platform for turning insights, turning signals into potentially regulated diagnostics to not only support registrational trials, but also to support global commercialization.
I'd like to provide one case study of work led by our colleagues at Genentech that was presented as an oral presentation at the AACR meeting in 2023 that really, I think, highlights the power of the information that currently is hidden within these H&E images, which are literally created on every single patient in major therapeutic areas like oncology, inflammatory bowel disease, and MASH. The investigators from Genentech wanted to answer a question. They said, "If we applied deep learning powered technology to a large set of H&E images from the OAK trial, could we identify a novel patient population who may show the best response to anti-PD-L1 therapy?" Then beyond that, after finding potentially this population, could this generate new insights into the pathologic mechanisms of response and resistance?
Lastly, could there even be a world where identifying this new population in the future could expand the population of patients eligible for immunotherapy? What I wanna highlight in this Kaplan-Meier curve on the left is this very top curve of the patients who are showing the best response to immunotherapy had a signature which these investigators characterized as CP-one signature. This is the population that showed the best responsiveness to anti-PD-L1 therapy. When they looked into what was driving the signature, there's a very clear biological signal which was increased lymphocytes and increased plasma cells with decreased fibroblasts was really the sort of cellular milieu that caused or influenced the environment to make patients most responsive to this therapy.
That's a new biological insight and a new population showing best response to this therapy. They asked the question, is this only in all comers, or in the overall population, as indicated on the left, or would this even work within the PD-L1 negative population? They found interestingly that the CP1 low population also showed strong response to anti-PD-L1 therapy, even if they were PD-L1 IHC negative. This is a new biological insight, potentially a new prognostic signature, but also potentially a new strategy for increasing market for immunotherapy beyond just PD-L1 IHC. That was the biomarker discovery cohort.
Genentech had digitized so many of their clinical trials, they were then able to validate this finding on a held-out data set, which was IMpower150, and they found very similar response where overall strong predictive effect and even within the PD-L1 negative population, the hazard ratio for the anti-PD-L1 containing regimen was 0.56 compared to about 0.7 in the intent to treat or a biomarker valuable population or much higher within the CP1 high population. This is just an example of all the data that we have access to, but there are many insights to be discovered. This is one example of PathExplorer applied to oncology. We also have a rich algorithm menu in liver, IBD, inflammatory bowel disease, as well as a number of different products for the clinical lab.
Two that I'll quickly highlight is our PathAssist Derm product, which obtained FDA breakthrough device designation in Q1 of this year, and our AIM-MASH AI Assist, which is for use in registrational trials in MASH, which obtained both EMA and FDA biomarker qualification in 2025, which is the first AI algorithm to be qualified by both the EMA and the FDA for use in MASH trials. On our clinical side of our business, the distribution of our platform is really driven by AISight Dx, which you've heard is a best-in-class digital pathology image management system to support diagnosis, collaboration, as well as access to AI tools.
This received CE and CE-IVDR and FDA clearance last year, as well as was the first digital pathology image management system that obtained a predetermined change control plan to enable us to rapidly expand the label and add new scanners and new monitors as needed. In summary, we expect that although the minority of pathology today is digital and utilizes AI, by 2035 this will be completely routine. This will be driven by overall increased digitization as well as the massive increases of AI that we're already seeing today. You can only imagine where it'll be 10 years from now. Because of that AI-powered CDXs, we expect will accompany most new approvals, AI will be run on every single slide, driving increases in both quality and efficiency.
This will also enable the generation of massive real-world data sets from billions of slides that can drive R&D decisions, regulatory decisions, as well as policy decisions. We're really our mission is really how do we lead this over the next decade, enabling AI, native AISight Dx to become the operating system for pathology, to leverage the tremendous synergies we see with Roche to generate data at scale from many different areas where we're already synergistic that you already heard, including FMI, Ventana, as well as the new NVIDIA AI factory, to enable data at scale and frontier AI to accelerate precision medicine. We have ambitions to develop the broadest IVD approved menu in the industry and to continue to focus on pathologist-led innovation, to ensure that we're focusing on the products that matter most to physicians as well as to patients.
I just wanna end by thanking everyone for their attention. I'm super thankful for the Roche team for their amazing partnership as well as for including me today. I truly believe that this partnership will enable us to realize our mission of improving patient outcomes with AI-powered pathology at unprecedented scale and speed. With that, I'll hand it over to Birgit to lead Q&A. Thank you.
Hello, everyone, a very warm welc ome from my side as well. My name is Birgit Masjosthusmann, and I'm leading the diagnostics IR team. I welcome the speakers from the first session on stage now for the Q&A. I will be moderating the Q&A, and I would very much invite you to raise your hands if you have questions. For the people who are joining online, please enter your questions in the Q&A tool. Also, I would really like to ask you to restrict your questions on the topics that have been presented today, mainly focusing on the diagnostics division. Yes, I see Matthew has his hands up. Matthew, first question goes to you.
Thank you, everybody. It's Matthew Weston from UBS. Thomas, in your opening comments, you talked about the confidence in increasing growth in pharma. We haven't talked about the financial implications of all of the diagnostics growth opportunities that you've laid out today, Matt. I don't know if you can help frame that in terms of how you see the midterm growth outlook. Do you see it accelerating, particularly with the new acquisitions? When we get back to our desk, get our models out, what are the growth numbers we should be putting in? What's the profitability we should be putting in when we take everything we've learned today in terms of real financial performance?
Thank you.
Sir. Great question. If you think a bout our ambition, which is mid to high single-digit, we know that we still have this headwind that we're working through on China. I think as we get through this, really in the next year we expect it to stabilize and then return to growth afterwards, I think we can really have an assessment of if we'd want to take that ambition up. I think at the moment, we want to keep it at that mid to high single-digit as we digest this headwind. I think absolutely we expect to see significant, you know, tailwind coming from these acquisitions and the new launches. I think we want to make sure that we have the right baseline to set.
For the moment, we'd say our ambition is mid to high single digit. Again, on the, you said on the margin, profit will grow faster than sales. What that means is we will consistently improve the margin over time. That would be how we would frame it. Thank you.
Okay, next question goes to Peter Verdult.
Thanks. Peter Verdult, BNP. Could I ask a question just to you, Matt, on margins, and then hand over to my esteemed medtech colleague for some deep dive on diagnostics? For me on the margin, it's just, what's the real driver here? Is it mix? Is it SG&A leverage? Is it R&D efficiencies? Is it a little bit of everything? Just a little bit more about, you know, growing faster than sales, what's the key driver? Then just with oil, and it's topical, with oil looking like likely that it's going to sustain above CHF 100, some of your peers are talking about 100 basis points of headwind from that. I know it's not a big deal for pharma, Thomas, but maybe a bit more for diagnostics. Anything you can say about that would be helpful. Thank you.
All of those factors are factored in our financial ambition. To talk about margin, again, we have had and we've had since last year a focused operational improvement program. That's how we worked to stabilize it last year. I would say that's something we're continuing this year. As at the same time, we're also investing in our launches, and a big part of that operational efficiency was to make sure we have the space in our P&L to invest in our launches, which are going to drive future profitability. That's how we're going to get to that profit growing faster than sales.
If you think mid to high single-digit on sales, then you would assume mid to high growth on profit, and that's how we're going to continue to increase the margin over time. You know, you mentioned some of these headwinds this year. I mean, that's all factored into, you know, our ambition this year, which I think we talked about at the start of the year, which is to broadly stabilize the margin this year, and that's where we want to get to. Recognizing there are these headwinds, but they are something that we factored in when we talk about ambition.
Let me just bring it ba ck to the group level. If you look at group last two years, we grew profitability by 13% and 14% in cooperating profit. You see we have increased margins on a group level the last two years, and our commitment is to keep margins at least stable going forward. I think this is a very strong commitment on a group level, and we guide on a group level.
Thank you. May I follow up with a product specific one on AXELIOS? You noted it as a key part of your midterm sales target for a market that's not necessarily the largest one you're addressing on the diagnostics front. Could you give us a feeling of your market share expectations here? Fair to assume you're going for a number one? Secondly, on TB, just a clarification on the U.S. launch here, should we think it comes along with your full ultra automation upgrade at around 2028+, or is prior to that possible as well?
Maybe I'll take the AXELIOS question, then I think Palani is ideally suited to address the TB growth. I would say we've had, and I also want to not get ahead of Josh's presentation. You've seen the data, we've had really great response from the market and from cust omers. We've seen tremendous interest in, you know, the truly differentiated chemistry, which is a move away from sequencing by synthesis to sequencing by expansion, which is fundamentally different. I think that's been, you know, really received a warm welcome from the market. We're not gonna give you our market share ambitions specifically, although we will talk about how we feel the reception from the market is.
It's, it's encapsulated in our divisional ambition, which is mid to high single-digit growth, which again, is to address Matt Sause's question, we'll be addressing as we get through the China topic. We do expect this to be an accelerant on our growth, and we do expect to be able to capture significant market share, and we're very confident, especially with this ecosystem of assets we're building around sequencing to offer full solutions, especially as sequencing becomes more entrenched in the clinical space. We feel we'll be meaningfully differentiated on the technology, but also on the application side and on the channel when you think about things like Foundation Medicine.
I think what we can say is, what we had on the slide, it's blockbuster potential.
Blockbuster potential.
That's CHF 1 billion plus.
Yeah.
We don't give you exact timeline. I think that's a substantial growth opportunity. As Josh will talk about, I mean, we've already have the first orders.
Yes
You can see that the excitement is very high.
I would add that those are orders from around the world. The interest is truly global for this solution.
Quickly on TB, look, the clinical trials in the U.S. are coming along nicely. We are also having good conversations with the FDA. We se e the performance of, I mean, we also have readouts ex-U.S. as well. The positive person agreement, negative person agreement, at parity with standard of care. In terms of automation, there are two elements to it. One is the front-end automation, and then there is the readout. On the readout side, from the get-go, we have a broad install base of our Elecsys platform. Throughput-wise, super high throughput compared to anything that's in the market today. 100 tests per hour with a single module of E801, 400 tests per hour if you combine four modules.
On the front-end side, where you do the incubation of the tubes, here we will start out working with, of course, 3rd-party liquid handler automators, so that many of these labs already have those. We, of course, in our cobas Ultra roadmap that I shared with you, we will of course also try to bring in elegantly the front-end automation as well in the coming years. We feel very good about the automation from the get-go. Good automation, bringing some important workflow improvements off the gate on the reading side. On the front end, we will of course work with 3rd parties and build out in our own automation platform.
Okay. I think next question goes to Dan Brennan from Cowen.
Terrific, thank you. Just on, maybe on AXELIOS, maybe a two-parter since you did mention orders. I would just ask you, can you share what you think a successful launch would look like in terms of year 1 placements? Then just on the clinical opportunity there, how will Roche seek to leverage your global diagnostic leadership position to help AXELIOS penetrate diagnostic labs? Kind of where do you see the best opportunity there, and what does early interest look like?
Sure. I would say for that, if you talk about our global network, we're present in over 100 countries. What we've seen is some of these early orders, again, like I said, are coming from those countries because we already have that channel in place. That really gives us a significant advantage in terms of infrastructure to drive the testing. What would a successful first year look like? I think we would ideally want to place 100 of these systems in the first year, you know, with, you know, thereabouts. I think what we've seen is a real tremendous positive reception from the market and we're gonna drive that.
Okay. Next question goes to, I think it's Graham, right? Yeah, from Citi.
Great, thanks. Graham Parry from Citi. Question on core lab 5-year CAGR on slide 38. I think that's now showing at 3%. It was 4% this time last year. See if you can help us understand what's driving the change there. Is that China or something else? Question for Thomas on pharma margins. You guide to at least stable core operating profit margin, can we dream a little bit more when we look at things like giredestrant, a wholly owned small molecule product with significant potential there? What's holding you back from being more optimistic there? Thirdly, what's with PathAI, how inhibited will PathAI be with third-party contracts with other pharma companies post-acquisition? Thank you.
Maybe I'll take the first part. I think definitely Thomas will take the second, and then maybe Andy.
Sure
can take the third. You hit it. I think you answered your question. China is probably the second biggest global market for immunoassay testing, and with the reduction in reimbursement and healthcare reform, that's dropped the size of that market, and that's the impact on the CAGR.
To your question, I mean, for the last 3 years, we always said the same. We said that, keep margins at least stable. Now, if I look back the last 3 years, we always grew margins faster than profit. Profit faster than sales, we increased margins. I guess what I'm saying is future looking, we will say in the long term that in terms of guidance, if we change the guidance for that year like we did this year, this year again, we say we grow core EPS faster than sales, we will say that in the beginning of the year.
That gives us, A, the flexibility to make the right investments that we need to make, and B, you know, it also gives us the flexibility to be a positive in terms of guidance and not already give out a guidance like that right now.
Sure. On the pharma question, Roche has tremendo us history with PHCS as well as FMI for building strong relationships with pharma and really driving value for pharma partners. So far we've been operating as an independent company, but also building a strong portfolio of projects and partners within pharma. In 2024, we signed a AI-powered CDX agreement with Ventana. Each side has tremendous experience supporting pharma, and I would expect that putting us together would even increase the ability of us to drive value with pharma partners.
Okay. Next question goes to Urban Fritsche from ZKB.
Yes. Thanks a lot. A question on Alzheimer p-tau217. How do you envision the implementation of the testing in primary care? Will this become a routine test which patients will do? Like, annually with their health check, or will it be more on when you suspect some symptoms already?
I mean, I can give a quick a nswer, but of course, after the break, Olivier will go into more details. Look, right now it's still indicated in symptomatic patients, so patients who are showing up with signs and symptoms of dementia. Typically they show up in a primary care setting before they are then sent over to a secondary care setting. This is where one of the key strengths of the data that later on Olivier will be showing is we have shown very good performance for both rule in and rule out, not only in a secondary care setting, which is where many of the others are starting, but also in a primary care setting. To your point, to have an annual kind of test, that's in a more preclinical, asymptomatic population.
That is not the case at this point in time. No one has a solution for that. That's a pretty tough problem, but that is something that we'll absolutely continue to work towards. Right now it's individuals who are coming in with signs and symptoms of dementia, and here, using a simple blood test, you can triage them instead of going through a cerebrospinal fluid test or a PET CT scan or so on.
Okay. Next question goes to David Westenberg from Piper.
Thank you for the question. First, just for Matt, you talked about growing faster than the overall market. I just kind of was curious about the, how you're benchmarking that. You know, there's a life science tools growth rate. There's diagnostics growth rate. You're all over the entire diagnostic market. Can you just give us a flavor for how it's benchmarked? Is that just?
Yeah
1 growth rate overall, or just versus all the other ones? Second one for Palani, I love to see all that innovation. Can you talk about maybe the trade-off between getting things perfect and getting things out on time? New innovation's always hard. There's always software, other kinds of things that you know, get in the hands of customers, and they go, "Oh, you know what? Here's a fix," and whatnot. Just how you're thinking about that dynamic. Thank you.
Yeah. Starting with your quest ion, the overall IVD market, I mean IVD, we're not talking about life science tools, is growing at a little bit above 3%. If you say we're growing mid to high single digit, that could be as much as double the market rate or 5% at least, you know, 60%-66% above the market rate. I think we're significantly outgrowing the market, and I would say, yes, that is challenging, but it's something that we've done and we will continue to do. Again, I'm referring to the clinical IVD marketplace, not the broader life science tools market.
It's a great question. This is something that we think about all the time. I was just wondering, maybe I'll give you the two examples how we try to balance this. Let's take the example of Alzheimer's disease. Here there are some key assets where we feel we absolutely have to take the lead and generate the clinical evidence, and that's what we are doing with pTau217, pTau181, and so on and so forth. We also have the Ineuro toolkit, where we have a range of early biomarkers that haven't been validated yet. These are research use only. Here we make them available to many of our customers who then can use them to do their own research. They can use that to do research with their biopharma partners and so on and so forth.
We are striking that balance. On certain assets, we feel we absolutely have to take the lead and drive it because that's how we bring medical value, and in other cases where there is not enough evidence, we work with our customers for them to allow them to generate the evidence. The second example will be with AXELIOS as well. I mean, there are so many different workflows that we can be looking at, and as we are having conversations with customers, they are coming up with their own ideas because now their gears are turning around a completely new chemistry and a new technology. We will introduce many of the application notes and workflows, but there will be many more that customers will develop.
We will hand it over to them, and we will of course support them on the library prep side as well as on the bioinformatics side. That's how we are trying to strike the balance in many of these cases where we feel like, okay, certain things we have to own and drive to capture the value, and in other cases, we feel there will be other brilliant minds who will be able to essentially generate value.
Okay. Thank you very much. I think we have to close the first Q&A session now. There will be an opportunity to ask more questions in the second Q&A session after the second set of presentations. For now, we are doing a break, and I would like to ask everybody to reconvene here at about 5 minutes to 3. Thank you very much for your attention so far.
If everyone could take their seats, we'll get started. That's a lot of light.
Yes, it is.
It's not gonna stay this bright the whole time, is it?
It is.
Okay. Are we good to go? All right. Welcome back, everyone, from the break. I hope you managed to squeeze in some coffee and bio breaks. My name is Josh Lauer, and I'm the Global Head of the molecular labs customer area. Today, I'll be very exc ited to give you a brief overview of our strategic priorities in PCR, but then, of course, I'll spend most of my time expanding on our recent upcoming or our upcoming launch with AXELIOS. As Palani mentioned, our strength and leadership in PCR really stems from our core position in higher volume, automated platforms that sit in the central lab. This is where our leadership position exists in infectious diseases and in blood screening. That's only part of our broader PCR ecosystem. Our platform portfolio extends beyond these automated platforms and into syndromic testing, digital PCR, and open molecular systems.
This broad portfolio helps us cover the entire continuum of testing and enables us to deliver the right assays to the right platform for the right use case. Speaking of those assays, we are continually investing to expand our menu across this portfolio, with over 16 assays planned for launch over the next three years. These assays not only generate value for patients, they accrue increasing value to our lab customers who are able to consolidate testing onto single platforms over time. To highlight a few assays, I would say this year we will extend our leadership in the blood screening franchise with the launch of a multiplex assay that includes hepatitis E. We will also gain increasing share in the fastest-growing segment of sexually transmitted diseases with the launch of our BV/CV assay.
Over the next couple of years, we will launch a variety of products, including completing our syndromic testing menu, completing our STI testing menu, launching panels in gastrointestinal diseases and respiratory, and offering new solutions for self-sampling or home sampling, which can expand the market for PCR into decentralized settings. One assay in particular that I'd like to dive a little deeper on in the next couple of months, will be our hepatitis D assay. Hepatitis D is an important disease that affects over 12 million people around the world, and unfortunately, the chronic forms of hepatitis D lead to liver cirrhosis and liver cancer, which are two horrible diseases. We're excited about this assay because it's the first fully automated test to diagnose hepatitis D infections via RNA, and it fits into a very clear diagnostic pathway.
We have two forms of testing for this that we envision. The first is, of course, existing guidelines to test patients who have chronic hepatitis B infections for hepatitis D. The second is a growing opportunity to monitor the effectiveness of new therapies for hepatitis D. We see this as a growing opportunity over time, and we think it's a great example of extending our leadership position in virology to gain increasing share in PCR. Of course, while we're excited to continue investing in PCR leadership, most of what we want to talk about today is how we're expanding into a new category of sequencing with the AXELIOS platform. As mentioned before, this is a generational technology, and we couldn't be more excited about the positive reception we're hearing from the market about this.
We don't have the instruments here today, so we just have them on screens everywhere. If you weren't here last year, I hope you've had the opportunity to watch some of the webinars or conferences where we've explained the SBX technology in more detail. At a high level, I would say there are 3 components of this system, each which highlight the differentiation of our architecture. The first is the synthesis instrument, which turns a DNA molecule into an Xpandomer. This makes single molecule sequencing at scale possible for the first time because it improves the signal-to-noise ratio. The second instrument is the sequencing instrument, which runs those Xpandomers through an 8 million well reusable CMOS array, which provides incredible data rates. The third is the analysis module, which while we don't talk about it as much, is a critical component of this end-to-end architecture.
It is essentially a high-performance compute stack, which is able to keep up with the data rates of the sensor module, processing all this sequencing data in real time. Before I jump into more on the workflow, we've recently held workshops with hundreds of customers in the U.S. and Europe, and I'd love to show you a brief video to hear what they have to say about AXELIOS. Please cue.
In one word, I would describe AXELIOS 1 as exciting. I find AXELIOS 1 innovative because of this combination of the Nanopore sequencer platform combined with the Xpandomer technology that really reduces the cost of sequencing and greatly increases the throughput we can achieve. My first impression was, wow, this works, right? Because the chemistry is so intricate and it's single molecule sequencing. To see the data as advertised as they had talked about, it was beyond expectation. Really the amount of thought and care that went into the system from the Xpandomer chemistry to the Genia technology, and then how that was all put together, really on all fronts it's seamless, high scale and beautiful data quality.
I think we've already shown with the data we presented on our RNA isoform work that there's a whole lot of biology in transcript isoforms that aren't captured by current workflows and that could be transformative. We don't know yet, but, you know, it enables us to do something new, to embark on a new frontier, which is great. Compared to my current sequencing solution, AXELIOS 1 offers a much faster turnaround time at a much more attractive per million read price
Okay, I love it. One of the themes you often hear customers talk about, and you will hear us talk about, is speed. That's not the only attribute of this platform, but it is a compelling attribute. Let's look a little bit at how that speed manifests in an end-to-end workflow, just to orient us. I'll walk through some of the steps, the first thing to be aware is the speed is actually flexible. Because customers have the ability to load anywhere from 1 to 4 pools onto this instrument, they can tailor the throughput to what they need, that unlocks economics for different classes of users. Mid-throughput users can actually access the same economics as high-throughput users, the workflows themselves are flexible. If we start at the left-hand side, library prep is pretty similar to traditional methods.
The important thing here is that we've already shown that you can automate this library prep, not only on Roche platforms, but on other leading platforms from Beckman, Hamilton, et cetera. This is pretty easy. It makes it possible for users to walk away and not worry about the steps here. Where the speed really comes in is when you look at the Xpandomer synthesis and the actual sequencing times. These turnaround times are simply much faster than traditional methods. If you want a benchmark, you can say that if you wanted to load this thing up fully with four queued runs, you can generate 64 genomes in less than two days, when traditional technologies take significantly more than two days. Two days just for the onboard sequencing time alone. Obviously, we have shown the ability to go much faster.
We have amplification-free workflows, such as the one used in the world record run, for NICU testing, to generate a full VCF file from a sample in less than 4 hours. The platform is fast no matter how you run it, and as we mentioned before, the unsung hero of this is also the high-performance compute, keeping up with all this processing in real time. This is actually a unique aspect of the architecture as well. Because we don't have to wait for every flowing cycle of nucleotides to complete a read, our reads are read in real time, and we can immediately start processing those on the compute module, so that by the time the sequencing run is done, the data processing is almost complete.
One thing that shocked the market a little bit when it comes to the flexibility of our architecture is the fact that we can reuse this sensor module up to 20 times. This is really impressive because it's part of how we unlock the flexible economics for users. It doesn't matter whether you're running or queuing 1 run because you only have a certain amount of genomes available, or you wanna queue up 4 runs because you're a very high-throughput lab. Both labs can access the same economics. Obviously, as a leader in clinical diagnostics, we're keenly aware of the importance of carryover whenever you're reusing a component like a sensor module. We've already done experiments that show carryover on the AXELIOS system is actually lower than traditional systems. You might wonder why that is.
There are several reasons. 1 obvious technical reason is that we're not sequencing DNA. DNA is a very robust molecule, and if it's stuck in fluidic systems, it's very easy for carryover to occur. We, on the other hand, are sequencing Xpandomers. These are more delicate molecules, and they're easily cleaned out via our system cleaning cycle. Carryover is not something we are worried about. One of the top things I hear other than speed, speed, is customers are really impressed that a new technology comes right out of the gate matching or exceeding the accuracy, cost, and performance of traditional platforms. That's a rare thing for a new technology to do. A lot of that performance data that you're seeing is driven by the duplex workflows that we've described.
One underappreciated attribute of the platform that we're just beginning to explore with the community, and you saw Michael Quail talk about that, you saw Graham Wylie talk about that, is people are starting to think about new use cases, things they've never been able to do before. This essentially is leveraging the fact that SBX has longer reads than traditional short read platforms. If you want SBS-style performance and accuracy, simply fold those in half, and you get duplex for high intermolecular consensus quality. If that's not your focus, what if you want longer reads? We can easily generate 500 to 1,000 base pairs at a scale no other platform can do. This is useful for things like novel isoform detection. What if you only want cheap reads?
We can tune the system down so that if you're only going for short reads, we can generate output that no one has ever seen before on a sequencing platform. These different use cases will unlock new types of applications, and we're only at the beginning of understanding what the community will do with this new technology. Some stats that we showed at AGBT, which kind of help customers understand what to expect when we launch this summer. On duplex, you're looking at a roughly a couple of terabases. This is sufficient to always generate 16 genomes or more at a very high quality, Q38 or higher. Note that those insert sizes are longer than the traditional paired-end 150 as well. This is part of the quality that we're driving. It's not just Q scores, it's also read length for mappability.
On the simplex side, it's just staggering the amount of data that can come here. On the short read side, over 40 billion reads in four hours. Just think about that. That's over 10 billion reads an hour. The sequencing world has never seen output like this. If you want the longer reads, you can still get over 10 billion reads in four hours. Still unheard of. These statistics are what we use to communicate pricing expectations to the market. We said that SPX and AXELIOS would be competitive with high throughput platforms, and we delivered that with a list price of CHF 150 per genome. This doesn't require any volume-based discounting. Everyone can achieve this pricing. While it sounds competitive with high throughput platforms, it's actually way more than competitive if you're running smaller throughput.
Remember, lower throughput users don't get the headline number economics that other sequencing platforms enable. They have to pay a lot more per genome. If they're able to access these economics, it's not just competitive, it's transformative for them. We already talked about how simplex offers economics that we've just never seen before in sequencing. CHF 0.06 per million reads is multiples lower than the nearest competing technology. We also gave some examples of how you can turn these reads into different application economics. Pa nels all vary, so it's hard to baseline. We can't just come up with CHF per genome or CHF per million reads. We took a commonly used 1.1 megabase panel, sequenced at normal depths to achieve the kind of clinical grade accuracy that liquid biopsy requires, and we found that you could do that for CHF 25 a sample.
This is multiples lower than what you can achieve with other technologies. That breeds certain questions. After AGBT, we got some questions from the analyst community asking, "Hold on, how does target enrichment really work?" Previously, we only showed data on target enrichment using simplex, there's a good reason for this. In liquid biopsy, the standard practice is to stack up multiple reads with UMIs, or unique molecular identifiers. All technologies form consensus for these needle-in-a-haystack applications. Here, you want more than 2 reads. You want several reads. We used UMIs and our ability to generate cheap simplex reads, cheaper than anyone else, to show this. This is also useful because the error profile of SBX is largely dominated by random errors. As you stack up more reads, you can push beyond Q 38.
We've shown Q 50, we don't even know yet where that ceiling is. We're very confident that these simplex reads can deliver the kind of accuracy liquid biopsy requires. This is not the only way to do target enrichment. It's just the only way we had presented so far. The answer to the question many of you have asked is, yes, it is possible to do target enrichment with duplex. Because of the way the molecular biology works, it will be a different workflow. Essentially, what this will be is a traditional workflow, which uses some PCR-mediated steps at the end to extend, add a hairpin, and make a duplex construct. This will still enable high intramolecular consensus accuracy for applications where 2 reads are sufficient. We'll be interested to see how the market adapts these for different clinical-level accuracy workflows.
Stepping back, this is our first-gen RUO platform. We are very honored that the community has been embracing this platform to demonstrate how it can work across all of the highest volume workflows in sequencing, including some new small ones that we hope will expand to be high volume. For SBXD, we've already talked about how high accuracy has been demonstrated in germline and oncology. We've shown fresh frozen tissue, we've shown FFPE, and our partners at Foundation Medicine have shown MRD. This is all great. We also showed the unique capabilities of duplex and the speed with the world record, as we mentioned before. We think this can be transformative in NICU settings, where ultra-fast typically means a few days, and the Broad and Boston Children showed that it's possible to do this same day.
I won't go through all of the other applications, as I mentioned, simplex is there's a long tail of applications that we want to explore with the community. Some of the ones we all hear about, single-cell, Perturb-seq, CRISPR screens, that's all great. There's a lot of things beyond spatial, proteomics, novel isoform detection that we look forward to expanding on in conferences over time. A few examples in this vein that we showed at AGBT were the partners with proteomic vendors. Olink has been the largest vendor in this field. We were happy to collaborate with them and show the ability of this platform to generate the kind of data they expect. This was also done with Pixelgen and Alamar. This is only the beginning of our engaging with the sequencing ecosystem.
That's part of our strategy with this open platform. It's not only going to be Roche solutions. We've showed data with Watchmaker and other vendors. We have a partnership with 10x. We will engage with the NGS ecosystem to make sure AXELIOS is usable across all of the solutions that are predominant in the market. We also see the potential for DNA to be a technology beyond DNA and to power multi-omics, not just methylation, but proteomics, spatial transcriptomics, et cetera. Because it's not only important for research, but for our longer term ambitions for AXELIOS to be a clinical platform, we will focus on end-to-end workflows and bringing our expertise in automation, library prep, et cetera, into the AXELIOS ecosystem. We also said this is a generational technology, so it's not enough to just invest in it being an open platform.
We intend to invest in the next 20 years of improvements on SBX in the same way the traditional platforms have been optimizing over the last 20 years. I won't go into all of these in great detail, but suffice to say, we have the ability to scale this platform up and down, not only deal with short reads, but extend read lengths. We intend to continue optimizing the chemistry for accuracy, to extend reuse of the sensor module, and to proliferate AXELIOS into a wide variety of applications. You know, as a leader in clinical diagnostics, that we've been investing in sequencing heavily because we believe sequencing will be a very significant platform in clinical diagnostics. It's already becoming one, but we think this is only the beginning of an ongoing trend.
We were very honored that our partners at Foundation Medicine looked at AXELIOS and demonstrated what it can do in one of the largest high accuracy applications out there in liquid biopsy, minimal residual disease. This was presented at AACR, essentially what it shows is that AXELIOS was actually able to detect more MRD positive cases than a competing technology, and it actually showed that it was better at doing this in earlier stage disease as well. As I mentioned earlier, Q-38 is not a limit here. We're seeing Q-50 and higher, our limits of detection should be very competitive in this space. Obviously, MRD is not the only large liquid biopsy opportunity out there.
We've already talked several times in this meeting about the partnership with Freenome, we're very excited to work with them to show what AXELIOS can do with their multi-cancer early detection platform and to enable decentralized testing with AXELIOS. These are examples of our strategic intention to make sure we're partnering with the leading labs around the world to make sure that AXELIOS has the content to be a leading clinical genomics platform over time. With that, I think it's a great opportunity to hand it over to Daniel Malarek, the CEO of Foundation Medicine, and I look forward to answering your questions at the Q&A.
Thank you, Josh. I'm excited to be here to share how Foundation Medicine is gonna continue shaping the oncology market moving forward. When we talk about oncology care, what we're essentially talking about is a sequence of often irreversible decisions. What therapy to give, when to change course, how aggressively to treat, when to monitor, and even how to monitor, and when to intervene again. Every one of those decisions depends entirely on how quickly and how confidently we can turn complex biology into insight for oncologists. This is exactly where Foundation Medicine operates. What excites me the most is that actually we're only at the beginning of this era. Let's zoom out a bit. Josh just ended speaking about screening and early detection, and I'm gonna focus on what comes next.
Those critical steps where molecular insights really guides therapy selection, therapy management, monitoring, and ongoi ng care. Let me start by grounding us in who is Foundation Medicine and what have we built. Foundation Medicine was founded in 2010 out of the Broad Institute with a core belief that cancer is a disease of the genome. If we can get those genomic insights into the hands of drug developers, if we can get those genomic insights into the hands of oncologists, that ultimately, that will lead to better outcomes for patients. That's exactly what has happened. Over the past 15 years, we've helped define the field of personalized medicine in oncology.
We were the first to launch a comprehensive genomic profiling assay, pioneers in linking genomic data with clinical outcomes at scale, leveraging advanced machine learning early on in genomics, and we continue to invest heavily in AI. We paved the regulatory path for companion diagnostics, all in parallel to paving the path to reimbursement. These milestones didn't just matter for us. They actually shaped the entire industry. In the process, on the clinical side, we've delivered more than 1.5 million comprehensive genomic profiles to patients. One thing I wanna highlight is our commercial reach. We've built a platform where over the last 12 months, over 40% of oncologists in the U.S. have ordered from us. That is via our portal, and that is via our EMR integrations. That will be a springboard for all our future launches.
That pioneering work has also resulted in extremely valuable data assets, AI solutions, and industry-leading number of publications. Now, on the biopharma side, we're fully embedded in the biopharma drug development ecosystem with more than 100 approved companion diagnostics, and that represents more than the entire rest of the industry combined. When we talk about Foundation Medicine, what we're talking about is a scaled, clinically embedded, biopharma-connected platform that has shown to create value across the entire oncology ecosystem. How does our business work? Well, our business model actually has 2 aspects to it, so the clinical business and the biopharma business. In the clinical setting, it's our multimodal portfolio that supports decision-making across the entire patient journey, making us a one-stop shop for oncologists. Our customers range from major academic medical centers all the way to the community oncology practices.
What we consistently see is that adoption is still far from where it needs to be. For example, I was recently speaking with one of the largest community oncology practices in the U.S., where they treat around 20% of all cancer patients. They said that in the metastatic setting, only around 50% of their patients are getting a comprehensive genomic profile. That is unacceptable. We agreed that that number needs to be north of 90%, so there's huge opportunity there. On the biopharma side, we work with the top 80 biopharma companies and are currently supporting over 300 active clinical trials to date. Our partners not only value our scientific capabilities, but also our regulatory strength. What do I mean by regulatory strength?
Well, it's our ability to execute complex companion diagnostic programs, align with regulators, and ensure that their launches and commercialization goes smoothly. Importantly, these two businesses actually reinforce each other. Insights from clinical practice feed in to drug development, and advances in drug development then in turn, feed back into clinical care. Like I said, we're still at the beginning of this journey. If we look at the market, the oncology testing market is one of the fastest-growing markets in diagnostics. If we look across biopharma, clinical therapy selection, and clinical monitoring, we expect the market to essentially double over the next five years. This is due to three factors. The first one is we are seeing an explosion of new targeted therapies and actually new targeted modalities being developed that require genomic insights.
Everything from bispecifics, trispecifics, ADCs, cyclic peptides, even molecular glues, individual neoantigen therapies, all of these require those genomic insights. The second reason is CGP adoption is going up, especially as these new therapies are being launched that require genomic insights. The third is around molecular monitoring. As clinical evidence builds showing that molecular monitoring is superior to traditional PET and CT scan monitoring, that market is expected to grow rapidly. There are approximately 50 million people currently living with cancer, and that number is expected to almost double in the next 10 years. For any cancer survivor, there are 2 questions that dominate. The first one is my therapy working? The second one is, when might my cancer return?
Being able to answer those questions via simple blood test has profound implications for patients and for healthcare systems. Overall, we're moving from the narrow question of what therapy do I give my patient to how do I manage my patient over time? This is central to where Foundation Medicine is going. Three core differentiators position Foundation Medicine for the next era of growth: quality, innovation across the patient journey, and being Roche-powered. I'm gonna now double-click into each of these. I'm gonna start with quality. I'm gonna say that not all cancer tests are made equal. If assays are not engineered to detect and capture difficult alterations, patients will be missed. Copy number loss is an example of a difficult-to-detect alteration, and a powerful example that I would like to use is a copy number loss called MTAP loss.
Why is MTAP loss so important? It is actually present in around 10% of all cancers and is a critical biomarker in trials that are evaluating MAT2A and PRMT5 inhibitors, which are showing great promise. In a recent publication by Sarah Cannon Research Institute, when they looked at their own real-world data comparing 3 major testing laboratories, they actually found that Foundation Medicine detected MTAP loss at rates consistent with published incidents. The other labs showed detection rates between 40%-60% lower. That difference matters. Missed calls means missed trial enrollment, delayed drug development, and patients who never receive potentially life-changing therapies. Our biopharma partners have also recognized this material difference, and that's why we are the clinical trial enrollment assay currently for 15 different MTAP trials.
With another copy number loss, PTEN loss, FoundationOne CDx is the only FDA-approved tissue NGS test validated to detect a copy number loss. This is why quality matters. It matters for patients, and this is why we believe that every patient doesn't just deserve a CGP test, they deserve a Foundation Medicine CGP test. The second differentiator is innovation. We talked about how molecular monitoring is rapidly expanding. Let me talk about 2 exciting new products that we have. First, let me talk about F1 Monitor. F1 Monitor is a liquid only, so no tissue needed, assay used in the metastatic setting to answer a simple question: Is this therapy working? In studies, we detected progression at roughly half the lead time of traditional CT/PET scan imaging. That means earlier decisions.
That means whether to stop an ineffective therapy, or it also means that confidence that the therapy is working. Another differentiator of F1 Monitor relative to other common tests is that F1 Monitor also provides resistance mutations. If a therapy is not working, the next question the oncologist will have is, why isn't it working? F1 Monitor also provides that information. To PathLight MRD. Obviously, you've heard around our acquisition of Saga, once that closes, we're excited to welcome the PathLight MRD assay into our portfolio. I'm excited about this. I'm excited about it for a number of reasons. From a clinical perspective, patient impact perspective, PathLight has demonstrated the ability to detect recurrence over 13 months before traditional CT PET scan imaging in early-stage breast. That's the first reason. The second reason, PathLight is already Medicare approved.
It's Medicare covered for early-stage breast, stage 2 and 3, across all subtypes over 6 years of a patient's journey and 12 time points. The third reason, it's a best-in-class assay. By best in class, what I mean, ultra-sensitivity and disruptive turnaround time. Just as exciting as the assay itself is our plans to decentralize testing. We have the AXELIOS platform where we can do the whole genome sequencing tissue baseline, and we have our Digital LightCycler platform from which we can do the multi-time point testing. By decentralizing using our own platforms, we can provide access to patients in all settings. With this portfolio, Foundation Medicine is exceptionally well-positioned to scale and become a leader in monitoring.
The second thing I wanted to talk about on an innovation standpoint is as our biopharma partners develop increasingly complex therapies, we're expanding how we interrogate disease biology. We have built a platform to understand disease and operationalize insights at scale. This is our Flexomics platform. Essentially, just how we were integral in turning oncology into the poster child of precision medicine, our aim is to take those same capabilities and apply it to other disease areas, neurodegenerative, metabolic, and autoimmune diseases. This is what our Flexomics lab will bring. For biopharma, this means better target discovery, better patient selection, and also de-risked development. Innovation alone cannot make an impact. You have to have delivery at scale, and this is what being powered by Roche actually means. We operate actually three different models.
The first model is our centralized testing model, where samples come from over 50 countries into our labs, based in the U.S. and based in Germany. Outside the U.S., it's Roche Diagnostics that are commercializing our products, and in Japan, it's Chugai. The second model that we operate is our installation and services model. This is where we essentially build our lab at our partner sites, and they run the wet lab workflow. The data goes into the cloud. We collect the data. We run it through our analysis pipeline. We generate the report, which essentially means they get FMI quality in their own lab. They get all the latest complex biomarkers that we run all in their lab. We have INS sites in the U.K. where we won 50% of the NHS liquid biopsy tender.
We have it at the Gustave Roussy Institute in Paris, where they become a hub for liquid biopsy testing in France. We also have it at the University of Zurich Hospital. The last model that we operate is our completely decentralized model, which is based on the Roche AVENIO kits. These kits have been co-developed with us, and they run and are powered by our analysis pipeline. We believe that the future will be always a combination of centralized and decentralized testing. Our focus is to kit our solutions, which enables us to win overall. With these models, it allows us to scale globally while also not compromising on quality. Being part of Roche goes beyond just the scalability.
We are, as you heard, we're an early access site for the AXELIOS sequencer, and implementing the AXELIOS sequencer in our clinical workflows has the potential to shorten our turnaround time and improve our cost basis. Over time, once we embed that in our clinical workflows, our plan is also to onboard our installation and services sites, the sites I just mentioned in the U.K. and France and so forth. It's exciting to see how Foundation Medicine and Roche together can accelerate the adoption of the AXELIOS platform in the clinical sequencing market. Secondly, we also leverage Ventana IHC to aid in treatment selection, and we're gonna continue expanding our portfolio to be the one-stop shop for multimodal insights.
The third area and partnership is with our navify colleagues, where I'm very excited to be launching navify Clinical Hub decision support applications within our Foundation Medicine portal. We talked about the community oncologists. They're treating 20 to 30 patients every single day. They need to be making decisions and have all the insights at their fingertips. With the applications around clinical trial matching, dynamic NCCN guidelines, which essentially allows them to see where their patient is in the decision-making tree, dynamic publication search and AI patient education, we actually make it easy for them. We bring those insights straight to them so that they can make the right decision for their patients. This is how precision medicine becomes routine practice. Our product roadmap reflects a deliberate strategy from single tests to platforms, from snapshots to longitudinal insights, from information to decision support.
Each initiative essentially builds on assets that we already have, data, scale, regulatory credibility, and extends us into new value pools, and that is our approach to disciplined growth. In summary, let me close with 3 points. The oncology testing market is poised for strong growth. Foundation Medicine is evolving from helping decide what therapy to give to helping manage patients over time. Together with Roche, we have an unmatched ability to scale. Foundation Medicine is going to continue shaping the market by turning complex biology into better decisions, and better decisions mean better outcomes for patients, better outcomes for healthcare systems. Thank you very much.
Tha nk you, Dan. Good afternoon, everyone. I'm Laura Apitz. I'm the head of pathology lab, and I'm going to be sharing with you the most impactful developments that we have going on in pathology. Palani already mentioned our three focus areas is all about automating our core business. It's about digitization, and it's about growing our high medical value menu. We're a strong leader, number one leader in pathology lab, and you can see we've had double-digit growth, 14%. It's driven by our advanced staining business, our personalized healthcare business, as well as our IHC and ISH systems, our over 13,000 install base globally.
I want to call your attention to the innovation section of this slide because I'm just going to be going through our next generation systems that we have in development, a little bit more on our personalized healthcare business, digital pathology, and how that's helping there. Also, we cover the cervical cancer disease state in pathology as a holistic disease state. First, our vision for transforming the pathology lab is really about bringing end-to-end automation to the lab. Pathology is not very automated today, and it really needs a way to integrate patient workflows and make the lab more efficient. We're going to be doing this with our partners, Hitachi High-Tech, to bring out our next generation advanced staining system. Also, within the next 18 months, we'll bring out task-targeted automation with some AI-driven tools that will help labs go to digitization overall.
These are some of the ways we'll be bringing more automation and digitization to the lab. When I turn to our multiplexing portfolio, we've been doing multiplexing for some time. You can see that in our pipeline here. What we're going to bring out uniquely now next year, starting with some duplexes, is our new translucent chromogens. This allows easy access to doing multiplexing. The 2 I want to highlight is P40 and TTF-1. This is in the lung cancer space where we'll differentiate non-small cell lung cancer. 1 of them is SOX10 and Ki-67, where you can tell between a melanoma and a benign lymph node. This is just a first of many multiplexes that we'll bring out in the companion diagnostic space, in the companion digital pathology space, as well as some non-gyne cytology space as well.
Turning to a little bit more to our Personalised Healthcare business. This is a growing business. We've been in it for 25 years. We really have a strong footprint here to grow even more. What's growing even more importance is these computational pathology algorithms. You can see we have over 25 projects in our pipeline for these computational algorithms. This will be significantly enhanced. You've heard a lot today about PathAI. This will really help us grow this area of digital pathology even more. I want to call your attention to our Trop2 franchise, and it really is going to be a franchise. It will be the very first computational pathology companion diagnostic that we'll launch in the lung space next year.
Right now with the RUO Trop2, we're really growing that footprint globally, so it sets us up really nicely for those companion diagnostics algorithms. Digital pathology, I'm hugely excited that we have a complete end-to-end offering here. You've heard about the best-in-class image management system that we're going to be bringing into the fold. Pathology-centric collaboration is really what this is all about with some AI-driven tools as well. We also have our DP200 and DP600 scanners, and we're going to be bringing out improvements next year to these scanners, faster scan speed, as well as improving cytology workflows as well. You can see we're really rounding out our digital pathology platforms to be able to fuel this growth in the future. Now I'm going to turn to our cervical cancer solutions.
We're on a mission to eliminate cervical cancer. You know that HPV infection causes most cervical cancers. It's really about getting access to the important testing. The first test I want to highlight is our HPV genotyping test, detecting 14 individual high-risk genotypes. This is important for screening programs around the world so they can really customize in an evidence-based way how they want to manage their patient populations all over the world. With our large install base of cobas 8800 molecular platforms, we're really able to bring this test everywhere, and we plan to launch this in CE mark next year. The other area of cervical cancer I want to highlight is really our self collection. Again, it's all about accessing people for testing and getting closer and closer to their homes so we can get those samples.
We're going to do that for HPV. You can see our kit design here that we're going to launch next year. What's also really unique is we're adding our STI testing. All in one, we'll have HPV, STI testing, and actually a really seamless workflow to bring it into the laboratories for testing with not a lot of manipulation needed. We're really excited about both the genotyping and of course, the self collection to bring access to this important type of testing. With that, you see we've have a really strong pipeline in pathology. Still growing stronger. You know, what we're super passionate about is making sure we're reaching beyond the 44 million patients that we reached last year. Thank you very much for your time. I'm going to hand it over to Ildiko to talk about near patient testing.
Yeah. Thank yo u very much, Laura. It's always impressive to see the many patients that are positively impacted by our pathology solution. A warm welcome also from my side. My name is Ildiko Ammann-Zalan. I am heading the Research and Development department in RDS, and I am here today to talk about the highlights in near patient care, our updates of our products, and any upcoming launch. As Palani already said, we are up and we want to establish near patient care as a leader in this space, and we have 3 priorities to do that. 1 is building a leading portfolio in clinical chemistry and in immunoassays. We want to strengthen our position in molecular point of care through systematic menu expansion, and we want to deliver a competitive CGM solution. You have heard about that a couple of times.
I would like to dig deeper into our strategy and how we want to achieve that. First of all, I want to concentrate on the disease areas. We are convinced that testing in proximity of patients that are affected by infectious disease, cardiometabolic or diabetes will improve the outcome of these patients, and this is why we do point of care in these 3 prioritized disease areas. Now, we want to serve these patients across the whole spectrum of decentralized setting. As you appreciate from this slide, these settings are very diverse. We have emergency room and intensive care settings, we have GP settings, we have pharmacies, and we have consumer patients. To understanding the needs in these different settings is of essential importance, and we will provide tailor-made solutions for each of these settings in order to become a leader in near patient care.
For my presentation, I would like to start on the very right side, on the consumer and patient area, and then work backwards to the emergency room. You have already heard about Accu-Chek SmartGuide, our CGM solution, a couple of times. In the last year, we have made substantial progress with our controlled launch strategy. We are now available in 45 markets. Last time when we spoke, we were around 4-5 markets. This year we are available in 45 markets. We have launched across EU, Middle East, APAC and Latin America. In the first half of this year, we have also achieved very important milestones. We continued to ramp up our manufacturing facilities, and we had a full roll out of mySugr as part of the Accu-Chek SmartGuide CGM solution. I will talk about both of these points in a minute.
In the next half of the year, we aim for regulatory approval for factory calibration to avoid the first finger prick and first use, and we will broaden our geographical market deployment. Now, it's very important that the foundation of our market penetration are our 11 state-of-the-art manufacturing facilities that we have built up over the last couple of months and years. These are highly automated, state-of-the-art manufacturing centers. We have built here on our long-lasting know-how that we have in diabetes care. For more than 30, 40 years, we are in this field. In order to give you an impression how these manufacturing lines are built up and what they do every day for us, I would like to show you a short video.
With this, we really want to highlight that we are focused on investing in a solid base for our CGM solution and making it available globally. The other highlight and milestone we have achieved over the last couple of months was really the combination of the ArcoCheck MyGuide Predict app, where we have AI-enabled algorithm, for example, for the two-hour glucose forecasting or the night low prediction, together with our mySugr ecosystem, where we have a download of more than 7 million users. This combination really provides a scalable digital ecosystem for our diabetes customers. We can with that accelerate BGM to CGM conversion, and we will also improve clinical outcome. For the future, this means that we integrate data and insights from multiple smart devices and health platforms. Moving over to our customers.
Up to now, we have focused very much on the multiple daily injection patients. As a matter of fact, diabetes care, in Roche has a legacy. We have already more than 30 million BGM users that use our blood glucose monitoring platform. 11 of them in insulin users and 20 million of them in non-insulin users. Our strategy will be to upgrade those Roche customer base from BGM to CGM by leveraging reimbursement availability. We will also partner with third-party systems, and integrate their devices. For the non-insulin users, we will offer intermittent use of BGM and CGM via mySugr together and learn new user insights. This is very important because most of the customers that today are not yet on insulin will earlier or later end up as an insulin users.
To give them already the opportunity to use the CGM early on will helps them to learn how their exercise, how diet is impacting their blood sugars. Last but not least, we also connect our portfolio with Roche Pharma, and this is really also a nice synergy between the two divisions. Now, as you already heard, we are constantly improving our device and we are also listening to our customers. We have also an evolution in our pipeline from a first generation to a next generation. As you can see here, the next generation, the inserter will be much smaller. We will exchange the battery. We will have also less manufacturing step. Most importantly, if you look at the current size of the CGM solution today, it is like that, and the new one will be like that.
I hope you appreciate the difference in the size. That all will actually improve the wearing comfort for our customers. With that, I can say that all over we are absolutely on our way to provide our patients our strategic intent of a very competitive CGM solution. Moving on to our next segment, that is the GP setting. You heard from Thomas that primary care gets more and more important because more of the healthcare will be decentralized. Here in 2024, we made a very important acquisition with LumiraDx, and that platform is really remarkable. We have shown it last year. It's a portable platform that has less than 1 kilogram, and the technology as such provides multimodality. You can measure immuno assays, clinical chemistry assays, coagulation assays, and potentially in the future, also molecular assays.
It provides multiplexing capabilities, so 3 assays can be done at the same time. It also, in addition, comes at room temperature. As you can see, I like to wear these parts here in my pocket because it's always nice to have point of care tests with you. It also has finger pricking capability, so you only need 1 drop of blood for this platform. Last but not least, it's really tailor-made for the GP setting. Since we acquired LumiraDx, we have made commercially available this platform in more than 43 countries, and we have approval in more than 75 countries. I also want to highlight a couple of commercial wins that we have. For example, in Wales.
In Wales, we have a pilot currently running with CRP testing to fight against AMR, and that is government-backed. We have a pharma partnership in India, where we test NT-proBNP for cardiac risk screening, and here the main differentiator was really the finger pricking capability for NT-proBNP on this device. Really a remarkable platform. We are also investing heavily in alignment with our disease area strategy. We will make it IVD compliant, and we also have an update for our HbA1c. From 2020 on, 2028 onwards, we will add further tests like the lipid panel and also further tests in infectious disease and inflammation. Moving on to the next big segment. This is a molecular point of care segment, which has a market size of CHF 2.65 million.
We are participating in this market segment with our cobas LIAT platform, which is well-established and which provides lab-like PCR quality at the point of care. As you can see here, we have already a pretty broad spectrum and menu there. We are adding now sexually transmitted disease assays, like we have last year with the CTng or the cobas LIAT lesion panel. What I would like to point out that we address with these platforms always gaps that are existing in care where this rapid diagnosis is essential. For example, we will now or have already launched the Bordetella test, the pertussis test, which is super important for newborns, for small babies and elderly. Here the decision if an antibiotic is necessary or not is a very important one and needs to be taken rapidly.
Again, the LIAT platform helps in this regard. Talking about lab-like performance, I'm super pleased and happy and privileged to announce the launch of the cobas Sense instrument and the high sensitive troponin T in 2027. We have talked about this platform a couple of times. Today, I would like to provide you the correlation between the cobas Sense high sensitive troponin T assay and our 6th generation. This is the newest generation of our CorLab platform, the Elecsys platform. As you will appreciate, this is an almost perfect curve. There is an correlation curve of 0.995 between these two assays. This means it's really lab-like performance.
It's not only true that this is across a whole curve, but it's in particular in this very low range where you need this high sensitivity in order to make this important decision if a patient has a myocardial infarction or not. This supports the standardization and enables interoperability between lab and point of care. It also overcomes the barriers that we have in the emergency room, because up to now it was always perceived that point of care is not sensitive enough. With that, we can help our customers and our physicians to reduce the amount of patients in the emergency room because these decisions of if a patient has a myocardial infarction or not can be done with certainty.
We will also add additional assays, additional cardiac assays on the cobas Sense like NT-proBNP and D-dimer for patients that present in the emergency room with shortness of breath or chest pain. A very nice and comprehensive platform that we will bring on the market in 2027 with lab-like performance. Talking about lab-like performance, it's my pleasure to introduce Olivier to you, who will talk about the exciting portfolio that we have in CorLab. Thank you very much for your attention.
Yeah, thanks, Silke. It's indeed great to see the lab-like performance at the point of care. My name is Olivier Gilliéron. I'm the Lifecycle Leader Cardiometabolic and Neurology, and I'm pleased to be here to provide the overview of the CorLab assay highlights. In CorLab, our goal is to continuously expand our menu across our four key disease states, which are oncology, neurology, cardiometabolic, and infectious diseases. Within 24 months, we have actually been able to deliver 10 new solutions to the market, which is peaking literally in this quarter with the introduction of the NfL test and the phospho-tau 217 test in neurology, as well as our IGRA TB solution in infectious diseases.
I will focus on these three solutions in my presentation today. Let's start with infectious diseases. As mentioned by Palani earlier, our goal is really to provide a high-quality comprehensive testing menu in infectious diseases. End of last year, we launched our dengue an antigen test, followed by the IgM test earlier this year and the IgG coming later this year. In 2027, we plan to launch the Lyme IgG and IgM assays with more menu coming further down the road, as you can see on the right side.
The highlight for this year is indeed our IGRA TB assay. Before I get into specifics, let me give you a bit of disease context. Tuberculosis is the deadliest infectious disease around the world. As you can see on the left side, there are more than 10 million new active cases globally in 2024. At the same time, if we move to the right, up to 25% of the global population may have a latent tuberculosis infection. This is why it is important to test for latent TB, not only in high-prevalence countries, but especially in high-risk populations. This is where both the tuberculin skin test and the interferon-gamma release assay, blood-based, are established in clinical routine. As of today, there are approximately 30 million tests of IGRA TB which are run on an annual basis globally.
Now, I'm excited to share that next month we plan to launch our LXIS IGRA TB assay in countries accepting CE mark. We have validated the test in close to 2,000 patients, and we plan to present the results at the ESM Congress in Verona next month. As there is no gold standard in IGRA TB testing, we compared our solution to the current standard of care. I'm happy to share that we have reached our endpoint, and we have a strong performance which is on par with the standard of care, and you see the PPA of 91.1% and the NPA of 94.6%. We will offer our IGRA TB test on all our second-generation LXIS platforms. I think Palani nicely elaborated on it.
If we look at our E-801, which is our high-throughput platform, this will enable a throughput of up to 400 IGRA TB samples per hour. The test will also be available on the E-402 and on the Smart E, which is our solution for more decentralized settings, as presented by Palani earlier today. We do plan to further differentiate our solution by automating the pre-analytical steps, and we will do this on our next generation cobas ultra automation platform. With that, we're in a strong position to scale testing into the markets. As you can see on the left, we can leverage more than 48,000 LXIS instruments, as well as our direct presence in more than 150 countries to drive access to latent TB testing.
As you can see on the right, the market will evolve into a highly attractive above CHF 1 billion segment by 2034. Our goal is clearly to capture a significant share and become a leader in IGRA TB testing. Let's shift gears and move into neurology. Neurological conditions constitute a significant health and socioeconomic challenge around the world. In Alzheimer's disease, 75% of the patients are undiagnosed. It takes three and a half years to get a formal diagnosis of the disease. At the same time, 98% of the patients are untreated. If we move into multiple sclerosis, 40% of patients are untreated. Still 45% are on low-efficacy treatments, despite the availability of highly potent anti-CD20 treatments.
Clearly, there is a significant opportunity to leverage diagnostic solutions to shape care pathways and drive access to these novel disease-modifying therapies. Let me start with multiple sclerosis. I'm happy to share that we have obtained CE mark for our Elecsys Neurofilament Light Chain. NfL reflects neuroinflammation in patients with relapsing-remitting multiple sclerosis. It is important to highlight that we have established age-specific NfL healthy reference ranges to support clinical interpretation as NfL values increase with age. In combination with MRI and other clinical data, NfL supports clinicians to monitor disease activity and guide treatment decisions towards high-efficacy treatments such as OCREVUS and fenebrutinib moving forward. Moving to Alzheimer's disease, our goal is to drive the early detection of amyloid pathology and therefore, again, access to treatments. In the meantime, we have a total of 7 diagnostic solutions along the patient journey.
We have our CSF ratios, which are used for the confirmatory diagnosis of amyloid pathology. Last year, we introduced our pTau181 solution, which is the first blood-based biomarker specifically approved in the primary care setting, which is ruling out amyloid pathology. Early this year, we introduced our APOE4 test, which is a test which is able to discriminate between APOE4 carriers and non-carriers. Now, the highlight is clearly our pTau217 solution. As we have shared earlier today, we have obtained the CE mark, I will speak to it on our next slide. We are also further expanding our solutions along the patient journey.
We're looking at digital cognitive screener solutions on the left side of the patient journey, at the role of p-tau217, also in the cognitively unimpaired population, and we are also developing new biomarkers for other pathologies and disease mechanisms, as well as treatment monitoring. Let's speak about p-tau217. I'm really excited about the launch of this test. It has the potential to redefine the standard of care. We have validated the solution in a real-world cohort spanning across care settings, so both primary care and secondary care, but also different clinical stages. Let me guide you through the results on the right side. In the middle, you can see that illustration. You can see that we have established two cutoffs, and it's important to highlight these cutoffs are consistent and valid in both primary care and secondary care.
The two cutoffs classify patients into positive, high likelihood of amyloid pathology, negative, low likelihood of amyloid pathology, and intermediate, where patients should be considered for further testing. Let's double-click on the performance. I'm really excited about the sensitivities and specificities in both secondary care and primary care. They're all above 93%. If we look at the performance in secondary care, you can see that both MPV and PPV are above 90%. Moving into primary care, the MPV is at 98.6%, and the PPV, despite low prevalence, is at a remarkable close to 80%. Finally, looking at the patients in the intermediate zone, we have less than 20% in basically that specific zone. With this performance, we're actually ticking off all performance criteria of the COO guidelines for blood-based biomarkers, both in secondary care and in primary care.
With that, we really believe that we have a robust, best-in-class phospho-tau 217 assay, which will enable clinicians to rapidly and safely triage and diagnose patients with signs and symptoms of cognitive decline. Now, with the addition of NfL and phospho-tau 217, we have the broadest on-market IVD portfolio. We are also further expanding our early pipeline by closely collaborating with academic centers and pharmaceutical companies and by leveraging our Ineuro toolkit. Our goal is to add 5 to 10 new robust prototype assays or researchers-only tests in specific diseases where we focus on, which are Alzheimer's disease, Parkinson's disease, and multiple sclerosis. Let me close with our ambition. On one hand, we continue to drive the early biomarker innovation. At the same time, we continue to collaborate closely with pharma companies to drive that innovation.
We're really ready now to scale these tests into the geographies. We have the broadest menu on market. We can leverage our large installed base. As you can see on the right side, specifically for the Alzheimer's disease market, this market is expected to quadruple in the next 10 years. Our clear ambition is to be the global leader in this field, shaping care pathways and making an impact on patients, families, and society. Thanks a lot for your attention. With this, I would like to hand over to Birgit for the 2nd Q&A and my colleagues on stage.
Super. Okay. Thank you very much, Olivier. I would like to ask the speakers from the second set of presentations to join me here on stage for the Q&A, including Matt, Palani, and Moritz. Okay, happy to take your questions now. First question goes to Richard Vosser from J.P. Morgan.
Thanks, Birgit. Where do you want to be?
Does it work?
Not sure. Now it is.
Yeah, it works, I think.
Thanks for taking my question. One question on the adoption of molecular testing. There was an ODAC about 1 or 2 weeks ago, which was trying to adopt earlier molecular testing rather than radiographic progression testing, and the regulators pretty much didn't like it. Didn't have enough, you know, clinical data of the proof. Pharma companies are probably not gonna do the trials that the regulators seem to want. How do you get adoption of earlier testing, particularly in the metastatic space? Just your thoughts there. Secondly, on Trop-2 testing, you know, what evidence have you seen that the integration of the QCS is better able to differentiate between patients allowing better treatment algorithms? Just thoughts there. Thanks very much.
Yeah. I can start on the first one. The importance of designing your studies in a way that will resonate also with regulators is incredibly important. I think that's one aspect of it where we feel that it was a setback in a specific case, but not a setba ck overall. Molecular-guided MRD testing is something that will continue to evolve, and that evidence will continue to build. I think a second point is that pharma companies are also looking for surrogate endpoints to their studies, and this is where ultrasensitive MRD assays will provide that for them. That evidence is gonna build with time. We just have to also work very closely with our pharma partners in developing that evidence. You want to take this?
I can take the Trop-2.
Yeah.
Thanks for the question. You know, I think it's very similar to what Dan just said. I mean, evidence is gonna build on how these computational pathology algorithms can really help differentiate and detect therapy for Trop-2. Obviously there's evidence, early evidence that it can do that, but we're really waiting for next year and those important first readouts to see what the true impact is gonna be.
Okay. Cool. Next question goes to Subunami from Guggenheim.
Thank you for taking my questions. I actually have 2 questions on Foundation. How has the growth profile of Foundation Medicine evolved relative to peers over the past few years, especially in therapy selection? It seems like you were lagging for a few years. First, do you agree? Is that improving as your focus and strategy have evolved? Second, how important is moving Foundation content to AXELIOS pursuant to generating above average growth relative to peers?
On the first question, even today when talking to clinicians, when talking to pharma companies, we are viewed as the best in class, and that's without doubt. You can go to any ASCO meeting, you can go to any ESMO meeting, you can talk to our biopharma partners, and that's something that we're confident in, and they see the quality that we provide. From that perspective, that quality differentiator still stands. I think the second aspect, which is incredibly important, is our ability to scale, and that is something that we have unprecedented reach with the Roche partnership. Our reputation has grown, especially outside the U.S. That's something that we're extremely happy with. The second question was around, correct me if I'm wrong, AXELIOS-
Yes
Inclusion in our clinical workflows. This is something that we're extremely excited about because the potential that AXELIOS provides us is better turnaround times and a lower cost base. With that, we also feel that the capabilities of the system will also enhance our offerings to our biopharma partners and enable us to further differentiate versus not only the competition, but also further enhance our own internal developments and what we're able to provide in terms of services for our biopharma partners. Overall, we're very excited about the platform.
Thank you.
Okay. Next question goes to Davi d Evans from Kepler Cheuvreux.
Thanks. Yeah, maybe for Matt, but just of all of the product launches and innovations and assays we've heard about, which ones do you hope may have the biggest, most visible impact on total Roche diagnostic sales growth? I mean, I assume that AXELIOS would be the biggest single one, but is that by quite a distance? You know, is there any uptick likely from gen two of the Accu-Chek or the next wave of mass spec launches, or equally assays like the Alzheimer's diagnostic seem to be, you know?
Very off the impact.
pretty big opportunity.
I would frame, again, back to our financial ambition of mid to high single digit. I think in order to see the kind of growth we expect, which is well above market, we need all of our launches to contribute. I think they're all extremely exciting, and I think each of them, if I'm being super direct, has a extremely exciting aspect to them. This AXELIOS is really gonna be the core of that backbone that we use to drive oncology, and it also gives us an opportunity, again, to really engage in the translational space. That's exciting. The cobas Mass Spec, again, is the first fully automated, fully standardized with an IVD menu mass spec system, and we see there as an opportunity to grow our biggest business unit, which is the core lab.
If you look at CGM, we had for several years decline in our blood glucose monitoring business. Now we have an opportunity to really revitalize that franchise, bring in a state-of-the-art technology, combine it with our AI capabilities, and return that to growth. All of those together, I think are gonna be what drives. It would be impossible for me to pick one from that group, but thank you for the question.
Okay, thanks.
Next question goes to Tycho Peterson from Jefferies.
Thanks. Maybe just to follow up on the content strategy for AXELIOS. You know, Saga had their own roadmap. Curious how you're thinking about some of their other indications, lung, head and neck, ovarian, some of the things they've talked about in their pipeline. Maybe timing on Freenome, you know, converting over, in your view. Lastly, you know, how are you thinking about the willingness of the community hospitals to embrace, you know, sequencing in-house? I mean, is this mainly for the academic medical centers for the next few years, or when do you see that, you know, transition on the community side?
Do you want to take the Saga part?
I'll take the Saga.
I'll take Freenome.
Yep.
Yeah.
From the Saga perspective, they have also launched their assay in CRC. We have both indications, breast, CRC right now. They have studies in ovarian. And we will further invest in driving clinical evidence in other indications. We're immediately looking into lung and so forth. More than that, I'm not gonna comment because the deal hasn't closed, so we need to wait for it to close, and then we will put a robust clinical development strategy in place for the Saga acquisition. We're really excited about the capabilities of the assay.
Okay. I'll just say for Freenome, that's an easy one. As we've publicly disclosed, they're gonna evaluate the AXELIOS sequencer. How that's go nna be incorpora ted in their workflows is gonna depend on how that shakes out.
Maybe I should-
The third part, you asked about community settings. Here, I think we have some surrogates for this. Obviously, Foundation Medicine has a lens into serving these different populations. There is, as Dan described, a lot of demand for some centers to want to bring testing in-house, and that can be for a variety of reasons. Often it's reimbursement and the ability of some of these community oncology practices to tap into that. The real question is, do you deliver a solution that's capable and economic for them to run and capitalize on that opportunity? We don't see any reason why we can't do that. Sure, AMCs and researchers might drive early momentum, but our view is over time, as Dan said, these can be both centralized and decentralized solutions.
Okay. Next question goes to Kyle Mikson from Canaccord.
Thank you. Couple questions. On the, some diagnostic growth drivers in Alzheimer's and neurology, any, like, interest or appetite to combine markers here like p-tau217 and NfL or maybe even more? In MCED, you kind of referenced this 35% CAGR. Is that international as well as U.S.? It's obviously different markets. We have this trial kind of read out recently. Just separately, just taking a step back, your thoughts on profitability in the NGS, the AXELIOS kind of segment. You know, obviously, if there is operating profit dilution, it's a smaller segment, not gonna really affect the full company, but You know, there's pricing headwinds in that industry. How do you think about going, you know, CHF 1 billion?
If it's a blockbuster product, could you get to that CHF 1 billion in revenue on CHF 1 billion in expenses, or could it take more? Thanks.
I will start with the neu rology questions. First of all, I mean, as of today, the standalone or single phospho-tau217 performs best. I think the field will indeed move into an approach where multiple biomarkers may be combined and where, you know, potentially, better evidence is generated. Maybe also for very specific use cases, because obviously NfL or also GFAP are inflammatory biomarkers which may add a certain component to the phospho-taus. I think moving forward and also thinking long term, we will see certainly combination of biomarkers, where again, we may integrate with more patient-related data into algorithms. That, that is probably the future. On, on the market potential per se, we outlined a global market potential, but you are absolutely right.
At the moment, it's certainly the U.S. market, which is the growing market based on the acceptance of disease-modifying therapies. Thinking about the future, we see the growth actually across all geographies, and it's clearly also our goal to have solutions, you know, basically for all geographies, including, for example, also China as an important future market.
I believe you also said MCED. Yeah. For MCED, yes, that's a global number. Again, it's early days, and I think the potential is that it could be higher, but I think that's a number we feel comfortable with. Josh, I think you can take the profitability too.
Yeah, for sequencing, I see no reason why even a blockbuster scale sequencing can't be massively profitable. Molecular diagnostics in general are high profit diagnostics. I think if you look at the field, you can look at public companies that are out there and their margins. We have every technical entitlement to be just as cost efficient, if not more, than all the solutions that are out there. I say that based on our technology today, let alone on where we can take it over time. Even if the sequencing costs tend to go down over time, we think 2 things will happen. One is our technology will scale, and we will remain competitive and profitable. 2 is the focus of cost is going to shift a bit.
We're already seeing potentially diminishing returns on if you get the cost per genome for a certain amount, the costs are elsewhere. They're in library prep, they're in sample collection, they're in other things. It's not obvious where this will go, but we'll be profitable no matter where it goes.
What Josh said is assuming we will also continue to maintain the same type of R&D investments as well.
Yeah.
Okay, next question will go to Dak Shenkel from Wolfe.
Thank you. You've done a really nice job today demonstrating progress across the portfolio and outlining strategic priorities for the next several years. A lot of this progress has come via organic efforts. It does feel like, and I haven't gone back and pressure tested this observation, but it does feel like there's more contributions that you're highlighting today from partnerships, investments, and acquisitions. You know, amongst those, I think of Saga and Foundation and Freenome amongst others. With that in mind, really, a three-part question. You know, one, over the next 5 to 10 years, what's your expectation for organic versus inorganic development? Two, what's the criteria we should expect you to use? You know, I'm thinking of things like size, growth profile, you know, when and why.
Maybe a little bit redundant, but the third part is, you know, does this criteria differ by diagnostic sub-sector or even geography based on, you know, the geopolitical regulatory and market backdrop? Thank you very much.
Yeah. That's a great question. What I would maybe start by saying is if you look at what we highlighted today, which is Foundation, which has been part of Roche for a while, but Saga and PathAI, these are two particular organizations that fulfill a very key part of our overarching strategy that we've had. That being the integration of high medical value diagnostics with clinical decision support tools, very on strategy, and in an area where it's very clear that these are gonna be growth drivers. What I would say, you know, when we look at, and we look at everything, we're the largest IVD company in the world, and that limits a lot of our optionality, you know, for inorganic growth.
In this case, what we saw was, and we showed our key areas of focus, these were key drivers. I mean, we know that MRD is gonna be one of the biggest drivers of the diagnostics industry in the years to come. We saw an optionality that very much fit with our technology stack and our strategy, so it was a smart bolt-on. With PathAI, the absolute complementary nature of that to our Ventana business also made sense, and the fact it was very much aligned with our strategy. That's the way we're gonna look at it. Again, we will be somewhat limited by our size and our scope, our scale, excuse me, because we are the biggest IVD company. I hope that answers your question. Thanks.
Okay. I think one more and then we need to close the Q&A session. Odysseus?
Odysseus again. Can't finish it without a PAMA question. Yes, thank you very much for the microphone as well. I mean, PAMA has been pushed for about 6 years now. I just wanted to get a feeling of whether you think PAMA or a version of it through the RESULTS Act gets enforced from next year. In general, I mean, the U.S. reimbursement environment, do you see it getting worse from here given what seemed like a 6-year break?
Yeah. I think, as you know, we're a member of ACLA, or associate member of ACLA. We're a member of AdvaMed, so we work through our industry association organizations to really advocate for reimbursement reform, and that's to see, you know, reimbursement levels and diagnostics accurately reflect, you know, the payments that are given, and I think that's, as you said, the RESULTS Act. The reason PAMA's been pushed out is because I think there's a reasonable level of understanding that this would be challenging for the industry, and I think that's why you see also a focus on reform. It's gonna be impossible to say what's gonna happen at the end of the year, but I think what you see is a lot of initiative and a lot of, I'd say groundswell support for seeing some reform.
We're gonna continue to advocate for that. Again, as we, I think we've had the question before, we don't expect that even if it didn't get extended, we wouldn't see this as really material to our business.
Got it. Thank you.
Great. Thank you. With that, I would like to hand it over to Matt Sause for the closing.
Sure. Thanks, Birgit. Thanks, everyone. Okay. First off, I just want to thank everyone from all the Roche side, all the speakers and everyone who worked on the presentations in the background, everyone who traveled here. I just want to say a big thank you. It's really been a wonderful team effort. Again, thanks to everyone who's here today and watching us online. What I would like to just say in summary, and I think you saw this from what we really highlighted today and the, you know, really, I'd say deliberate, intentional purpose behind our, our strategy, is we are the IVD leader, and we have a clear right to play and right to win to grow above the market and continue to stay in that position.
The second is I think you heard this from Josh and then the real clear synergy with Dan and the Foundation Medicine organization. AXELIOS has a differentiated value proposition in the sequencing space, and we feel it is positioned to change this industry. We have a leading end-to-end oncology portfolio, and this will have benefits from our dia business, but on to pharma. You know, the question that came specifically around the ODAC, I mean, if you think about it, surrogate endpoints and the ability with something like MRD, that enables a lot of clinical trials that can't be run today. I think there's across the entire Roche Group what you see is the synergies of our oncology portfolio to be additive for our growth in the future.
Finally, you saw from Andy and Moritz, we are fundamentally integrating digital and AI into our products. That is going to set them apart from the competition and really continue to make us differentiated. With that, I'd like to thank you all, and again, thank the Roche team, and thanks very much.