Very good. So welcome to our IR Diagnostics Day 2024. I think the last one we held back in 2021. I am happy to see a lot of familiar faces here. Happy you made it over from Cambridge. Not sure, actually, we can promise you CHF 80 billion by 2030, but maybe we also have some good stuff in the pipeline. On the diagnostic side, there's definitely this division is set up for growth. Let me have some opening remarks, and quickly take you through today's agenda. Starting here, we have nine speakers and experts with us today, and they will take you through all of our business segments and also highlight some of the key products which are actually entering now the launch phase.
I would also like to use the occasion to excuse our CFO, Alan Hippe. Due to some other obligations for Roche, he had to, unfortunately, to cancel last minute. But I think many of you had the opportunity to see him last week, Friday, at the Sell-Side Breakfast and then also on the UK roadshows. So today we will have two one-hour sessions for the presentations, and each of these sessions will be followed by always 20 minutes of Q&A. The first session is starting right now, and following my opening remarks, we will have Matt Sause, our CEO, Roche Diagnostics, on stage, who will present an overall update for the diagnostics strategy, and also provide an update on our future ambitions.
The second speaker, Palani Kumaresan, our Global Head of Roche Diagnostic Solutions, will take you through the late-stage assay menu development at Roche Diagnostic Solutions, focusing on the pipeline for cardiometabolic diseases, oncology, neurology, and infectious diseases. And finally, the first session will close with Benjamin Lilienfeld, Lifecycle Lead, Serum Work Area Systems, who will talk about the future of the clinical laboratory, including the launch of the first-ever mass spectrometer for routine use in the clinic. After these presentations and after the curtain has been raised over there, we will have our first 20-minute Q&A session with the speakers of the first session joining, followed by a 10-minute bio break. The second 1-hour session then starts at 2:25 P.M.
The first speaker of the second session will be Jochen Berchtold, Lifecycle Leader of Continuous Monitoring, who will introduce our novel CGM solution, the Accu-Chek SmartGuide, to be launched later this year. The second speaker, Ildikó Aradi, our Head of Research and Development, Roche Diagnostic Solutions. She's the Head of Research and Development, Roche Diagnostic Solutions. She will highlight our point-of-care solutions, allowing for rapid and decentralized responses, especially in the areas of cardiometabolic and infectious diseases. The third speaker is Nico Michel, Lifecycle Leader for Infectious Diseases for the molecular lab, will provide us an update on new platform offerings and assay development in this space.
Then we have again on stage, Palani Kumaresan, providing us an update on our next-generation sequencing efforts and the platform, where we have made significant progress in recent years, combining the original nanopore technology, which we acquired some time ago from Genia Technologies, which then was combined with a novel chemistry, which we acquired in 2019 through the Stratos Genomics acquisition. Next, in the row will be Jill German, our Head of Pathology Lab. Jill will provide an update on our leading pathology lab offerings and on how we build more end-to-end solutions for our customers. And finally, we will close the second session with Olivier Gilliaron, Lifecycle Leader for Cardiometabolic and Neurology, with an update on our neurology strategy and pipeline.
I think this is also an area to watch, where we might have an increasing overlap with the pharma division in the future if certain pipeline projects, for example, trontinemab in Alzheimer's disease, would work out. So overall, we have scheduled 2 hours for the presentations. We have 40 minutes for the Q&A sessions. Participants on-site will also have the opportunity to meet all our senior management and the experts at the closing apéro, which will be immediately following the broadcasted part of today's event. On the next slide, I just wanted to summarize some of the latest adjustments which have been made to the diagnostics division and also lay a bit the foundation, you know, for the diagnostics ambitions, which Matt will talk about later on in his presentation.
What you see here is on the left side, we have been looking recently for opportunities to realize synergies in the diagnostics business. We have made recently two adjustments to our diagnostics division, making sure that we take full advantage of the synergies within the organization. Firstly, you see here, as previously announced, FMI will move from pharma to diagnostics, where we see better opportunities to combine the expertise and leverage our next-generation sequencing technology. That's something you will also hear more about by Palani. And secondly, we have made the decision to integrate point of care and diabetes care into a new business segment, which is called Near Patient Care, and this will allow us to take advantage of the com...
You know, of the complementary patient segments and technologies, particularly with the upcoming launch of our CGM solution, something you will learn more about today, with Jochen. On the right side, you see here how the diagnostics division has performed over the last five years, and I think that's quite an impressive track record. From 2019 to 2023, you see the division has achieved a five-year CAGR of +7% at constant exchange rates and has been constantly outgrowing the overall market. What you also see is the temporary sales uplift due to the COVID-19-related testing sales from 2020 to 2022, which has also contributed, of course, to the core operating profit margin increase, which then peaked at 25% in 2022.
In 2023, COVID-related sales started to wash out, and this will be done in 2024, and we will see now in 2024, really the strength, the momentum of the underlying base business coming through. To complement the picture here, let me also highlight two other one-time changes, which had an impact on the margin. In 2022, the core operating profit margin increased by 4.6 percentage points, as we stopped the allocation of global costs to the divisions. This has included, for example, costs for procurement or for IT or for people and culture. And then the second one-time event was in 2023, where due to what I mentioned before, the integration of FMI, we saw a drop of the core operating profit margin by minus 2.2 percentage points.
So we are left now with a margin of 16.5%, and that's basically the new base to start from. On this slide, I also wanted to not only quickly here to sum up, you know, there's a lot of change ongoing within Roche, so the change is happening on the DIA side, the change is happening on the pharma side, and I just thought it might be useful to wrap up a bit what has happened on the pharma side with respect to the pharma portfolio. So you see here, we had put some significant efforts behind improving our pharma portfolio. This slide summarizes what we have achieved over the last 3 quarters in terms of strengthening and also diversifying our portfolio.
Over the last three quarters, we have terminated 20% of our pipeline NMEs by really focusing on high impact projects and also considering new early clinical data, which became available in that time. At the same time, you know, we did a couple of internal projects progressed, but we also had, like, several external molecules acquired, which are more de-risked, more late-stage, ready assets through business development or M&A. Overall, we expect this higher than usual portfolio turnover to continue for another two quarters before the portfolio rejuvenation is probably more or less done. Then we'll go back to the normal run rate.
This is here to use the occasion, which you know already, I think from the recent results calls, and it summarizes the 2024, 2025 key pipeline items for both divisions, for pharma and for DIA. I will not talk about the DIA part, as we will touch on all of these upcoming 2024 launches, 2024, 2025 launches in detail in the presentations. But let me quickly make a couple of comments on the pharma side so that we are all on the same page. Of the molecules listed here, I think you know tiragolumab, the SKYSCRAPER-01 data. I just can confirm this will come in the second half. Then I think we have two events now scheduled, IR events for the oncology portfolio.
We will have at the end of the month, we will have an ASCO IR-related call. Here, we will run you through the late-stage pipeline, summarizing the programs, eventually announcing a couple of new trials to fill gaps in the development programs. In terms of time, you know, Vabysmo you have seen is just moving ahead nicely. We just had the press release out on the breakthrough therapy designation. This is expected to be launched later this year. Giredestrant, you know, the first line, hormone receptor, hormone, hormone receptor-positive breast cancer data are to come next year for 2025. If we move down, Elevidys, we have announced, is will be filed in the EU. This is, I think, moving ahead as expected.
prasinezumab, we will have phase II data in Q4. This is a larger phase II study here, PADOVA, which will tell us whether there is something to be achieved in Parkinson's disease. For Evrysdi and GYM329, the combination data available also in the fourth quarter. And in parallel, we have mentioned we have a GYM329 study ongoing in obese, healthy patients just for dose finding purposes. So this study has now started, will also deliver us a dose finding data, you know, around maybe end 2024, beginning of 2025. Trontinemab, you know, the data we have presented the update at ADPD. We are still excited about this molecule.
The timelines hold up, so we are targeting somewhere between data for 200-250 patients by year-end, beginning of next year. These data should be then sufficient to take the next step here, and the decision whether we take trontinemab into late stage development. From a timeline perspective, we are doing now, really speeding this up, getting everything ready, that we could have a pivotal phase III opening in 2025, which then would probably read out in the 2028 timeframe. Fenebrutinib, next year, we have the final readouts. There might be... There will be, for sure, additional data in the second half. We will have the 48 follow-up data from the phase II study. This will be shared sometime in phase II, maybe something to watch out.
In immunology, Gazyva lupus, scheduled for the fourth quarter. Anti-TL1A, I think we are on track, as announced, to have the phase IIIs initiated in 2024, with expected readout 2027. And then also, I think, at year-end, beginning of next year, you will see additional trials opening up in other indications outside of IBD. Astegolumab COPD is scheduled for next year. Vamikibart, our IL-6 in ophthalmology, two studies here to read out in the second half. There's a monotherapy study, there's a combination study with Lucentis. They will be informative, but we have a wider development program that not only includes vamikibart, we also have bispecifics, tri-specifics in development with an IL-6 component. So we will, based on the data we see here, also then take a decision on how the development program as in total will move ahead.
ASO Factor B, also scheduled for the second half in geographic atrophy. Zilebesiran, we just have the KARDIA-2 data out. The third Phase II, KARDIA-3, started. We'll read out next year, then we expect to open the pivotal studies here. And then CT-388, we just had the news of last week. You saw the top-line release. I think we had a lively debate on this one. I think nothing here to add right now from my side. The diagnostics updates we will cover. And maybe then we had this as a final slide here from my part.
I've just thought, you know, maybe for all the participants who are not that familiar with the diagnostics division, this should help you a bit to, for the updates, to place the updates of today in the right customer areas. We have four customer areas, as you know. So there is Core Lab, which accounts for roughly 40%-55% of the revenues, of the Q1 revenues. Molecular Lab here is with 18% of the Q1 revenues, and then the new division, the new segment, Near Patient Care, with 16%, and Pathology Lab with 11%. And on the right side, you see, and we've mapped for you, for your convenience, today's key updates, so you can always see which customer area they will play. For example, mass spectrometry would be a part of Core Lab.
Let me also use this occasion here to thank all the speakers for their time and commitment, and also the IRT members who have worked on the overall organization of the event and the end of the slide decks. Let me call out first Birgit Masjost, I think, many of you will know her. I think she's covering Diagnostics within the IR team. Birgit had the overall lead of the event, and she will also moderate the two Q&A sessions. In addition, let me thank, from the IR team, Alina Levchuk, for managing the master deck, Alina Yonbayar, Anita Tang, and Andres Linas for speaker support.
And last but not least, I have to say a big thanks to Eva Losert, who was responsible for the overall event organization. And Eva and the technical team of Matthew Wyer were finally able to end the odyssey of finding a place suitable for our mass spectrometer, which weighs no less than 1.8 tons. So I can tell you this was a bigger exercise, but I think we have it now all here. And with that, I would like to hand over to Matt for providing us with a strategy update for the diagnostics division. Matt, please.
Thanks very much, Bruno. So on behalf of the entire Roche team, welcome to our 2024 Diagnostics Investor Day, and it's really gonna be my pleasure to be able to walk you through our strategy, our rich pipeline, and the plans we have to take this to the market and to patients going forward. And so with that, what I'd like to start with is we are proud, as Roche Diagnostics, to be the global leader in in vitro diagnostics. And there's a number of facts on this slide, and what I'll do is I'll walk you through each of them and why they're important. So starting on the far left, we are, as I just said, the number one in terms of market share, but we're also the number one in terms of market share growth of any of the large diagnostics players.
And what that meant in 2023 was sales of CHF 14.1 billion. You heard a little bit from Bruno about our trajectory. In the first quarter this year, we had overall sales growth of 2%, which absorbed significant sales from last year in COVID, and our base business, which grew 8%. And this is momentum we see carrying forward. How did we do this? Our 39,000 employees worldwide in 150 different countries, this gives us the commercial muscle and mass to really be able to take innovation the last mile to patients. And speaking of innovation, we're also the number one investor in R&D in diagnostics, and you'll see this over the course of today, reflected in the rich pipeline. And what this meant, again, in 2023, was 29 billion tests performed for patients across the world.
And so taking a step back, we have had a consistent strategy in diagnostics for the last five years, and that strategy really has three pillars. The first is we are gonna develop innovative, high medical value diagnostics, test the change clinical practice. And the second is we will build clinical decision support tools that enable physicians and patients to be able to better navigate their illness. The third leg is where we put these together, combine high medical value diagnostics, clinical decision support tools, and really enable patients and caregivers to navigate their illness and live healthier and better lives. And so I think then, let's talk about how that reflects itself in our goals. And what you see at the bottom is a key, a very clear link between our strategy and the goals that we have as an organization.
But if you think about what's been going on in healthcare after the COVID-19 pandemic, healthcare systems across the world have been under pressure to decrease costs, to be able to do more with less. And so that leads to two key dynamics that I would call out here. The first is centralized healthcare has to get better at being more efficient. They have to be able to do more with less resources. They have to be able to deliver healthcare in a constrained environment. But healthcare systems are also pushing health and care to a more decentralized setting, to the home, closer to, closer to the patient. And how that reflects itself in our goals is we wanna continue to be the number one player in the in vitro diagnostics laboratory and continue to grow our share, doubling down on that efficiency play.
Second, we really want to invest to become a leader in the decentralized testing environment. We will accomplish this, again, by delivering differentiated, high medical value diagnostics and by combining those with clinical decision support to deliver comprehensive disease management solutions. This is something you'll hear about over the course of today. If we achieve these goals, this is what really puts our financial ambition within reach. That is, we want to continue our strong on-market portfolio. We want to continue to expand our business in major markets as well as growing markets, and we want to continue to deliver on this rich pipeline. I also don't want to be remiss in not mentioning the focus on operational excellence. We will continue to make sure that every Swiss franc is optimally invested to deliver the best return for patients and for the company.
If we do so, for the foreseeable future, we will deliver mid- to high single-digit sales growth and faster-than-sales growth of our profit. I look forward to explaining how we're going to get there in the coming slides. First, I'll explain how we plan to maintain and expand our number one position in the clinical lab. Second, I'll explain how we plan to be a leader in decentralized testing. I think a great place to start with that is talking a little bit about our rich pipeline. I'll move on this slide from left to right. So really starting on the far left, what you see is we absolutely understand where the engine of our growth has been, and we will continue to invest in our areas of strength.
Those are the areas where we have shown strong growth, such as the core clinical laboratory, where you're going to hear more about our cobas c 703, which is our next-generation system for clinical chemistry, which will have twice the throughput of the previous generation. As well, our cobas 6800, 8800 version 2, and some of the next-generation applications that are coming with it. Nico is going to speak to that a little bit later. But then if you move to the center block, I'd like to talk also about some of the disruptive solutions that we plan to bring to market. The first, which you see under this under this tarp, is our mass spec, the first fully automated core lab ready with a comprehensive menu mass spec system. And the second is our high throughput, highly flexible nanopore sequencer, which is under development.
You'll hear more about this later from Palani Kumaresan. But then moving to the far right, you also see what we're doing to become a leader in decentralized testing. And here I would call out a couple of the solutions. First, our cobas Sense, which is going to be a point-of-care immunoassay instrument that able to deliver cardiac disease results with the same level of performance you'd expect from a core lab analyzer at the point of care. And our cobas Liat, which will do the same for PCR, deliver rapid PCR quality results at the point of care and really expand the ability of physicians to diagnose disease when it's most important. And then I would be remiss not to mention our Accu-Chek SmartGuide CGM. Jochen and, Ildikó are going to take you through these set of solutions later in the presentation.
But then, coming back to that, that comment about efficiency, I don't want to miss the bottom, which is our automation and efficiency row. We are also going to deliver the next generation of laboratory automation to ensure that laboratory services are able to optimally deliver care to the healthcare systems they support. And here, I would maybe just call it our Nexus solution, which is under development, that will fully integrate the analytic and pre-analytic components in the lab, delivering the next level of automation. But then continuing with this theme of efficiency, I think it's also quite important that I talk about our digital lab solutions pipeline. Here, we have a rich number of products on the market. We have five new solutions launching in the next three years.
Here I would call out, if you see all of our solutions are branded with Navify. Navify is what calls out these digital products as a Roche product and is a strong brand that could be connotated with our qual- level of quality. I would first call out our Navify Analytics product. So Navify Analytics provides actionable operational insights to laboratory managers that help them manage staffing, workflow, and lab setup, and helps them, again, deliver better efficiency to the healthcare systems they serve. I would also call out our Navify Sample Tracker. The Navify Sample Tracker is like an Amazon packages software product that lets you track a sample from the time that it's drawn in phlebotomy all the way through the analytical workflow until reporting.
Over 60% of errors in the clinical lab happen at the pre-analytic stage, and this is a product that can significantly address that. What I would also call out as important is the need to have that same level of digital connectivity in the decentralized setting. Ildikó will go into more depth on that in her presentation. Now I'd like to pivot and talk a little bit about that differentiated high medical value diagnostic portfolio that we have in development. With that, I think I'll start by talking about the disease areas where we are focused. On the left, you see, in ascending order of societal burden, the diseases where we have a focus. Infectious disease, which, as you know, with global warming, is becoming a larger topic in terms of the burden of healthcare strain.
Neurology, over 80 million people will be living with Alzheimer's disease by 2030. This is going to be a huge burden on societies worldwide. Oncology, 18 million people are diagnosed with cancer every year. And then cardiometabolic disease, implicating over 31% of deaths worldwide, and there's over 500 million people living with diabetes. These are our areas of focus. On the right, you see our portfolio strategy. We recognize in diagnostics, it's critical to have a full portfolio and able to secure or win a large tender within a healthcare system. So we are working to ensure we don't have any gaps in our portfolio that would disadvantage us when it comes to this. But then on top of that, we're developing these high medical value tests that you can only get from Roche that set us apart from the competition.
And so what I would call out at a high level, and Palani is going to go into some depth on this as well, we will launch 125 new tests in the next three years. And starting at the top in the cardiometabolic, I would maybe just first call out that you may have seen today we received breakthrough device designation from the FDA for our Lp(a) Tina-quant assay, that we're working together with Amgen, where they have a targeted therapeutic. Above that, you see a new biomarker we have under development for coronary artery disease. This can be combined with high-sensitivity troponin to improve the interval for the rule-out 1-hour rule-out for myocardial infarction. This could fundamentally change how this condition is managed in the ER. Moving on to oncology, we will have 24 tests launching in the next three years.
You saw yesterday we launched our FoundationOne RNA test. Another one I would call out is the great work being done by Jill and her team in Tucson in cervical cancer, where last week we received FDA approval for self-collection of cervical cancer specimens. And I would call out that one of the biggest challenges to effective cervical cancer screening programs worldwide is the ability to obtain a sample. By allowing women to collect their own sample, this has the potential to greatly improve access and the effectiveness of these screening programs. Neurology, I would also call out at a high level, we have five FDA Breakthrough Device Designations in neurology, and you'll hear more about this from Olivier later.
Two that I would call out is our amyloid plasma panel, which is a blood-based rule out test for Alzheimer's disease, and p-tau 217, which is a blood-based rule in. When you think about 80 million people potentially living with Alzheimer's by 2030, the challenge to healthcare systems worldwide is a very large portion that is going to come from the burden of diagnosis. Blood-based tests really have the potential to significantly address this challenge. Infectious disease, 32 new solutions. Here, one I would call out is our test for latent tuberculosis, our TB IGRA test, and you'll hear more about this a little bit later. But we know that across the world, as many as 25% of the world's population could be living with latent tuberculosis.
A scalable immunoassay test for this on our, on our highly installed platform base, has the potential to really address this. Now, I would also call out the conspicuous other category at the bottom, where we have 67 tests. Now this is... You, you might ask, why is this not in those four buckets of, of disease area focus? Well, this is the menu for the mass spec. Here, what we did was we made sure that when we launched this menu, we're launching the most important assays to go forward with in, in mass spec. That includes things like steroids, that includes things like immunosuppressives, vitamin D, and Benjamin's going to get into more depth on this in, in his presentation. But I also really want to take the moment to talk about our clinical decision support portfolio.
Here, we are going to launch 10 new solutions in the next 3 years, and I'll start with cardiometabolic. We have our Accu-Chek portfolio, which is going to be integrated with our continuous glucose monitoring solution and our Accu-Chek SmartGuide Predict app, which you're going to hear more about from Jochen. Fully integrating clinical decision support with a device that provides continuous disease monitoring. But also call out, and you may have heard me speak about this in the past, our Navify AlgoSuite. These are going to be algorithms that you can get through our AlgoSuite application, which basically allows information collected throughout the course of a healthcare visit, combined with information coming off our laboratory systems, to be integrated together to improve clinical decision-making for critical conditions. And I'll start with maybe mentioning a couple of the applications in cardiac care.
Our CADone chest pain triage test, our AFib cardio algorithm. Now, I think it goes without saying, by combining a strong presence in the laboratory together with these algorithms, we become even more helpful to healthcare systems and more sticky with our customers. I think this is a key point of differentiation for us in the future. We're also carrying this into oncology, where we have our GAD algorithm for hepatocellular carcinoma, as well as our Colon flag algorithm for colorectal cancer. Jill's going to speak a little bit later about digital pathology and the intersection between immunohistochemistry and digital interpretation software, and how that also has the potential to improve access and the quality of diagnosis.
So I think this, you know, clinical decision support slide is a great transition to come to the fourth goal, which is the culmination of all three pillars of our strategy, which is enabling disease management for better patient outcomes. Here, I think a picture says a thousand words. You see here, a photograph of our Accu-Chek's CGM SmartGuide solution. On the left, you see the applicator, in the center, you see our sensor, and on the right, you see the typical output that a user would see while managing their glucose levels using our application. I think one of the important features of the SmartGuide is going to be the Accu-Chek Predict app. This has key applications for things like two-hour glucose prediction and also an overnight glucose prediction application.
I think this addresses some of the critical challenges for people living with diabetes. One of them is, you know, the ability to plan into the future. You don't just get in your car and go for a drive when you have diabetes. I think knowing what your glucose is going to be like in a couple of hours gives you insight into how you plan your life, and I'll let Jochen speak more about this in his session. But really to bring it home, Roche Diagnostics is setting new standards for IVD and healthcare. We are the industry leader in IVD, with a clear strategy to grow above the market. We are delivering innovative solutions to the largest challenges in healthcare and society, and we're doing this by building solutions integrated with clinical decision support and utilizing artificial intelligence.
But most important is the team, and I'm really looking forward to the presentations that are yet to come and all the engagement with you all over the course of the day. So thank you very much. And with that, I'll hand it over to our Head of Roche Diagnostic Solutions, Palani Kumaresan. Thank you.
Thank you, Matt. Good afternoon, and a warm welcome in the room, as well as those joining virtually from my side as well. My name is Palani Kumaresan. I'm the Global Head of Roche Diagnostic Solutions, and I'll spend the next few minutes giving you a glimpse of our assay menu and late-stage development. Now, before I dive in, some macro numbers. On the left-hand side, you can see that in the coming decades, the percent of the world population that's going to be over sixty years old, and as this grows, the four important disease areas that Matt highlighted, the disease burden and the mortality from these four disease areas is only going to increase. And you can also see the huge economic impact to our society. So how does this then feature into our strategy?
When we think about our strategy around menu expansion, quite frankly, it's quite simple. We want to have a very broad installed base of our instruments around the world, and on these instruments, we want to have the broadest menu in the industry. On one hand, having high medical value, innovative solutions across the four disease areas, and on the other hand, smart gap fills, so that our customers can have the broadest menu on the instrument that they buy from us. So to give you a couple of numbers, the total number of tests that we have on our instruments is over 600 today in the market. And if you look at this year and the next couple of years, we are looking to launch over 40 new tests every year.
Now, this does not include things like claim extensions, new sample types, which also bring tremendous value, and we can capture value from those. If you layer those on top of these 40 tests, you're looking well over 50 new solutions per year over the next three years. You see some examples here on the right-hand side across the four disease areas. I'm not going to go into the details here, but I have one slide for each of the four disease areas, and I'll walk you through some of the highlights. Let's start with cardiometabolic. Now, in cardiometabolic, our goal is to maintain our IVD leadership and work towards better disease management. You can see four important focus indications for us: heart failure, coronary artery disease, chronic kidney disease, and diabetes.
Now, in coronary artery disease, you can see we have a very good asset set coming to the market. These are assays not only improving on existing assays, but also new biomarkers, particularly in myocardial infarction, which has a huge disease burden. Now, in diabetes, Matt already called out CGM, continuous glucose monitoring, and I will leave it to Jochen to talk more about it. The main point here is, once you have a patch that is continuously accessing data, it's very important what you do with that data, and this is where the predictive algorithms come into play, to really help patients better manage their disease. I also wanted to have a quick call-out on cobas Sense, which Ildikó will talk about more.
And Matt was mentioning about this, is ultimately it's bringing lab-like performance for critical cardiac markers, like high-sensitive troponin in an emergency room or even in an ambulance setting. But timely and accurate measurement of these biomarkers are important and can mean life or death for patients. I want to close this slide talking about STRONG-HF. This is a study that we did and was primarily looking at how do we manage patients after they have been discharged from the hospital after an acute event. And the bottom line here is that by doing frequent measurement of key cardiac biomarkers, like NT-proBNP, you can really titrate patients' treatment outside of the hospital setting and better manage them, and as a result, have less number of them returning to the hospital.
And that's what we mean also by disease management, and these are the kind of solutions we want to continue to work more on in the future. Now, turning to neurology, this is an exciting and dynamic field, particularly in Alzheimer's disease. We have important assets in the market today, tests for cerebrospinal fluid, looking at both amyloid and tau pathology. Now, with disease-modifying therapies that you guys know very well coming to market, like aducanumab, donanemab, it's really important that we have easily accessible testing modalities, simple blood-based tests coming to the market. And here, Matt already called out our Elecsys Amyloid Plasma Panel, which looks at two biomarkers, phospho-tau 181 and APOE4, as well as phospho-tau 217. These are important biomarkers, and Olivier will talk more about these. In MS, I'm very excited about neurofilament light.
This is an important assay not only for multiple sclerosis management, but because this is a biomarker for general neuronal damage, it can play an important role in other neurological disorders as well. Other indications, we have some early research going on in Parkinson's disease, and we continue our work in traumatic brain injury. The last bit I wanted to call out on this slide is the Neuro Toolkit. Because this is a new and dynamic field, we have several promising biomarkers, close to 30 or so, and what we do is we make them available as research-use only to translational researchers and allow them to generate evidence. And as we see promising evidence coming out for any of these biomarkers, then we can take a decision whether we want to take it into the IVD space or not. Now, I want to then pivot to infectious diseases.
Here you can see it's a comprehensive pipeline of tests across multiple indications. We continue to focus on the big indications like hepatitis, HIV, and upper respiratory infection. When we talk about upper respiratory infection post-pandemic, we are making sure we have a slew of solutions like singleplex test, low-level multiplexing, high-level multiplexing in different care settings, and we will have Nico and Ildikó talk a little bit more about it, and share with you guys. Now, looking at lower respiratory infection, Matt already called out tuberculosis. Today, we have solutions in the market for diagnosing active TB through our molecular solution, but there is close to a quarter of the world's population... I'm not making this number, it's close to a quarter of the world's population that's a carrier of latent TB.
For this, our interferon-gamma release assay test that we will be bringing on our broadly available Elecsys platform will play an extremely important role in the future. Quick comment on sepsis. Very complex, host-driven complication, and has very high mortality. Here, we do have solutions in the market, as you know, like procalcitonin, PCT. Prenosis is an important collaboration we are driving, which is looking at making use of machine learning, combining information from important markers like PCT, also other biomarkers and vital signs, to allow for better and faster diagnosis of sepsis in a healthcare setting. Under others, a couple of quick call-outs, gastrointestinal panel that we are looking to bring on a couple of different platforms. Also, sexually transmitted infections in a point-of-care setting, which is extremely important. And then vector or tick-borne diseases.
Matt was calling out dengue panel, malaria, Lyme panel. With climate change, we are seeing more of these vectors and ticks showing up in temperate parts of the world, and it's really important that we have these assets in our portfolio. Now, I want to talk briefly about oncology. This is a busy slide. I don't mean for you to read through all of this. The important points are, you can see we are bringing solutions across multiple modalities or technologies, which is what is shown by these different colors. Immunohistochemistry in pathology, molecular, AKA also PCR in sequencing, immunochemistry in blood-based tests, and algorithms. A couple of important points.
When we look at diagnosis today, immunohistochemistry still plays an extremely important role, and here we are clearly the market leaders, which also makes us a very attractive partner of choice for pharma partners, which is a very attractive and growing business for us. Within immunohistochemistry, I wanted to quickly call out a recent launch that we had, Kappa Lambda dual in situ hybridization mRNA test. This is for expanding the addressable population, particularly for B-cell lymphomas, so we are really excited about that. There are also very exciting algorithms here. Now, I won't go into the details here for the sake of time, but if you have questions later on during the Q&A or in the break, I'll be happy to talk to you about some of these algorithms.
The last point I would make on this slide is, beyond diagnosis, we are really expanding into screening and monitoring, because if you look at the patient population in the screening setting and the number of testing you would perform in a monitoring setting, where you are doing repeat testing, these are really attractive markets for us. At the same time, it's really valuable for patients as well if you're able to diagnose cancer earlier and/or how are you looking at disease recurrence in the monitoring phase. So that's why you can see we are really covering the entire continuum of the disease. We are keeping in line with how we are thinking about these different important disease areas now and into the future. So to close out, I want to give you two proof points.
The first one is the number of breakthrough device designations we have received in the past 5-6 years. This is not a complete list, because some of the breakthrough device designations, for competitive reasons, we haven't included here. You can see, on average, we are getting 2-3 breakthrough device designations from the FDA. What this means is, we can go through faster review cycle with the FDA to drive and bring these assays to the market. What's really important, the proof in the pudding, is really how many approvals are we getting? For this, if you look at the number of PMAs, pre-market approval, or the BLAs, biologics license application, that the FDA gives out, which is the highest bar that they set for innovative solutions in the diagnostic space. If you look at the past 5 years-...
Of the total number of PMAs or BLAs that the FDA has given out, over 50% have been given out to Roche. This is a testament of our commitment to innovation, and I hope I've been able to transmit to you the amazing, we think it's amazing, the pipeline that we have ahead of us and the solutions that we are looking to bring to the market. With that said, let me hand it over to Benjamin to tell you a little bit about our Serum Work Area instruments that are coming to market, and then we'll of course, do our very exciting unveiling of our mass spectrometry solution. So thank you for your attention, and over to you, Benjamin.
Good afternoon, everyone, and a very warm welcome also from my side. My name is Benjamin Lilienfeld, and I'm responsible for our clinical chemistry, immunochemistry, and mass spectrometry instruments, what we call Serum Work Area at Roche. Let's first have a look at the market from a revenue perspective. The total IVD market size 2023 was CHF 68 billion, still including approximately CHF 8 billion of COVID sales, which is dramatically declining. Out of the CHF 68 billion total market size, we have CHF 28 billion Serum Work Area market, which consists of clinical chemistry and immunochemistry sales, and grows at 7%, outperformed by the Roche growth of 10%. Roche Serum Work Area sales for the full year, 2023, was at CHF 7 billion, placing us as clear number one with 25% market share.
The same market share as number two and number three combined. The CHF 7 billion Serum Work Area sales for the year 2023 consisted of CHF 5 billion immunochemistry, and CHF 2 billion clinical chemistry sales, of which more than 50% is derived from our high-volume platforms. Now, let's switch gear from revenue to installations. Our large installed base grew again, significantly, also in the year 2023, as you can see, across all different areas. This includes a 14% growth for our pre-analytical solutions, 20% for our cobas 5800, 6800, and 8800 molecular diagnostic solutions, 6% for cobas Liat, 2% for our lab software solutions, and between 10% and almost 30% for our pathology instruments.
Of note is the huge growth of almost 80% for our new generation Serum Work Area solutions, cobas pro integrated solutions and cobas pure integrated solutions. Consequently, and in line with our plan, the older generation Serum Work Area systems, cobas 4000, 6000, and 8000 placements declined, which led to a total growth of Serum Work Area analytics of 3%. Our Serum Work Area placements hit an all-time high in 2023. The cobas pure integrated solutions are offering for small to medium volume labs, reached more than 2,100 installations, with 3,600 analytical units at the end of last year. That's a growth of more than 120% compared to 2022.
cobas pro integrated solutions are offering for medium to high volume labs, reached more than 3,100 installations with 8,300 analytical units. That's a growth of 60% compared to 2022. Together, cobas pro and cobas pure integrated solutions form a so-called system family and provide full standardization and fully standardized results and operations. They deliver a seamless experience and the highest level of standardization using the same reagents and assay menu, delivering consistent results and operation, and therefore allowing for flexible staff allocation and minimal training needs. This makes these systems ideal candidates for integrated health networks and laboratory chains alike. Our total installed base for ISE, clinical chemistry, and immunochemistry analytical units, reached approximately 90,000 installations worldwide at the end of 2023.
Now, this year, we will have a number of important launches, including the introduction of our high volume clinical chemistry and ISE testing to cobas pro integrated solutions with our new analytical units, cobas ISE neo and cobas c 703. These new units will become available in CE markets in the middle of this year, so it's really just around the corner, and in 2025 in the U.S. These new units will double the throughput on cobas pro integrated solutions, with cobas c 703, offering up to 2,000 tests per hour and thus deliver more patient results faster. They minimize hands-on time through automated maintenance, which means only monthly maintenance needs to be done by the operator, really addressing the severe shortage of qualified lab staff we see all around the world, and therefore, increasing overall efficiency for laboratories.
As mentioned before, our goal is to transition to this latest, fully standardized instrument generation over the coming years, which will help us streamlining operations and achieving cost efficiencies. It will help us to protect and expand our installed base, and ultimately, it will help laboratories accomplish more with less.... Another highlight this year will be the launch of our revolutionary cobas Mass Spec solution. Therefore, let's have a brief look at the Mass Spec technology in general. Mass spectrometry is a powerful and well-known technology. It has a number of benefits, including the ability to accurately measure complex analytes and a higher sensitivity than conventional technologies. This makes it the gold standard technology in specific critical situations.
And therefore, on top of the high volume routine testing done by clinical chemistry and immunochemistry, really forming the basis of diagnosis, additional layers of information to address diverse patient cohorts and clinical situations are sometimes needed, and this can be delivered by mass spectrometry. So how does the Mass Spec technology work? First, sample preparation is needed to purify the analytes and get rid of interfering substances. Next, separation is done via liquid chromatography, based on the size and/or the polarity of the molecules. Afterwards, the molecules will be ionized and sent to the mass spectrometer, where the actual detection of the molecule happens based on the molecular mass. This results in chromatograms that you can see on the right side of the slides, and enable a very sensitive and specific detection and quantification of the molecules of interest.
So why is such a powerful technology as mass spectrometry largely underutilized today? The answer is illustrated in this picture here. As you can see, this is a typical setup of a mass spectrometry lab today, and it does not look anything like a routine diagnostics laboratory. Therefore, it has numerous limitations, such as high operational complexity, no integration, automation, or standardization, and the need for highly skilled labor with expert training and special education. Furthermore, most Mass Spec labs today are using so-called laboratory-developed tests, which are tests they developed by themselves, which are very labor-intensive. As a consequence, 66% of users find current mass spectrometry systems not suitable for routine testing. This is what we want to change with cobas Mass Spec. This will be the future of mass spectrometry.
This will be the first standardized, fully automated, fully integrated, and easy-to-use solution for clinical Mass Spec testing. This is cobas Mass Spec, and this will allow us to tap into a completely new business segment. cobas Mass Spec is not just another Mass Spec solution. cobas Mass Spec will revolutionize the way Mass Spec is done in the future. The analytical unit itself is called the cobas i 601, and it will be part of our well-established cobas pro integrated solutions. It will allow for full integration into clinical chemistry and immunochemistry, as well as laboratory automation and IT, through the cobas pro sample supply unit you can see here, where you load the samples. Everything will be automated. Everything on the system will be automated.
The complete process, from sample input, to sample preparation and purification using paramagnetic beads, to sample separation on liquid chromatography, to mass spectrometry, all the way to result interpretation. That's what we call sample in, result out. Everything will be standardized and fully IVD compliant. This includes our ready-to-use reagent packs containing the analytes, similar to our reagent packs we use or on our immunochemistry systems. It also includes standard buffers. These standard buffers will be mixed according to the specific needs of the various analytes, and they're included in the system. And it includes one of the most innovative concepts on cobas Mass Spec, which are our proprietary liquid chromatography cartridges that you can see here. Today, one of the most time-consuming and critical points is the exchange of the liquid chromatography columns. Tomorrow... This will be as simple as pressing this button here.
This will bring down a complex process that takes sometimes more than an hour to literally 20-30 seconds. Overall, the full automation, integration, and simplification of the whole mass spec process will greatly increase patient access to standardized mass spec testing, and therefore, to a powerful diagnostic technology. We will launch the cobas i 601 instrument, together with a broad assay menu of high medical value analytes, expanding our already large serum work area assay portfolio to approximately 300 tests, further differentiating ourselves from competition. We will launch a total of more than 60 analytes in two launch waves over the next several years under the analyte brand Ionify. In launch wave 1, we will focus on steroid panel, vitamin D, immunosuppressive drugs, therapeutic drug monitoring. In launch wave 2, we will add additional vitamin D subclasses, more therapeutic drug monitoring analytes, and a drug of abuse panel.
Of course, there are plenty of opportunities for more and additional assays in the future. Now, the clinical utility of these mass spec assays is immense. To name just one example, many breast cancer patients today are treated with endocrine therapies, suppressing estradiol production for years. However, the suppression is not always 100% effective, which leads to increased risk for reoccurrence of the cancer and increased mortality. To monitor that the suppression is, in fact, working efficiently, it's important to measure the estradiol level in these patients regularly, so that the doctor can see if there is an increase in estradiol levels. In case this happens, the doctor needs to switch to an alternative therapy. And in order to detect small amounts of estradiol and see small changes in estradiol level, it's important to use a highly sensitive methodology as mass spectrometry.
The launch of the cobas Mass Spec solution is foreseen for the end of this year in CE markets and for the year 2025 in the US. With this launch, we intend to establish and shape the IVD market for automated, simplified, end-to-end mass spectrometry testing, which will open up a completely new business segment and sales opportunity for us, with an addressable market at launch of CHF 3 billion, growing at 5%. Our ambition is to reach 25% market share by the year 2031. This corresponds to more than 150 million tests per year. Such a footprint in the market will, in turn, greatly increase patient access to mass spectrometry and advance mass spec from a specialized testing to a routine testing discipline. Thank you very much for your attention and interest.
I'm happy to answer your questions during the Q&A session, which will commence now. I'm also happy to invite you to join me here at the instrument during the break, have a closer look at it, and of course, ask more questions. Thank you very much.
Good afternoon, good morning, everybody, and a very, very warm welcome from my side as well. My name is Birgit Masjost, I'm the diagnostics investor relations officer, and I'm very happy to moderate the Q&A today. Just a few instructions. So for everybody in the room, I would like you to raise your hands if you have a question, and then wait for the microphone, state your name and the company you're working for, and then please limit your questions to two at the moment to make sure that everybody gets a chance. With regard to the people from the joining through the webinar, I would like you to enter your questions through the Q&A, and we might also then take those.
In the panel here on stage, I have with me, on top of the speakers during the first session, Ildikó Aradi, who is our new Head of R&D, and will also be available to take your questions. Please raise your hands now. Okay, I think the first one was Odysseas over there.
Hi, this is from Berenberg. Thank you, Mike, for taking my questions. One for Benjamin first. On the mass spec side, given that, as you said, the fair share of mass spec testing is marked as LDTs, does the recent FDA ruling on LDTs raise your expectations of the success of this franchise, given the IVD compliant mainly, and was your 25% market share ambition by 2031 decided prior to that ruling?
So, I mean, we've always been, you know, looking at the mass spectrometry market in a way that we wanna bring it and advance it from an LDT market to an IVD market. And we believe that you have seen my picture before, right? How the labs look today, that we can really advance these labs now to a higher standard in terms of mass spectrometry testing, and like this, make it available to a broader patient population.
... here, and one more for Matt. So you've been working on a latent tuberculosis assay for a while. Why has development been challenging for you here? And is the earlier half of the within three-year period more likely for a product launch, given the time you've been working on this?
I think you saw the proof of principle with our IGRA test for SARS-CoV-2. So I think for us, the technology is something that we have well characterized. And it's really just a matter of executing the project. So we haven't found it to be any more technically challenging than historical. But maybe Ildikó or Palani, do you wanna comment on the specific development?
I mean, I can quickly comment. Look, I mean, I would say, to Matt's point, there's not fundamentally something technologically challenging. We are measuring interferon gamma release, and we have a good way of measuring that in our Elecsys platform. We need to have the right stimulating peptides, targeting tuberculosis like we have had in the past for SARS-CoV-2, and for that, we are partnering. We have a very good, reliable partner for that, for the stimulating peptides. So quite honestly, we don't see any major technical challenges here, and quite excited, quite honestly, to Benjamin's point, to bring this assay to a very large installed base of our Elecsys instruments.
Yeah. But I would just double down on what Palani said, Odysseas. I mean, we've shown the technical proof of principle for our platform to do this kind of testing, and as Palani said, just getting the peptides and, and moving it through our development process.
Okay. Maybe Emily, right here.
Hi, thanks. Emily Field from Barclays. Maybe the first one, just for Matt, just on the, you know, broader segment, financial ambition, if you could give a little bit more granularity, just how, you know, how you expect that margin progression to evolve. Is that gonna be sort of just a steady expansion year over year? And then just, on the, mass spec sales ambition, if you could also give some details just in terms of, you know, how many new installs, machine installs that would require, just so we can kind of get an idea on how that ramp will look from a sales perspective.
Thank you. So I would say our financial guidance for the year is, as I've stated in the investor call, which is mid- to high-single-digit growth of our base business. And I would say that our financial ambition is inclusive of the launch of mass spec, specifically. And the second part of your question again, please?
If you could give us some guidance on how we should expect that to evolve?
Exactly. So on the development of the COP, again, we expect that to be a year-over-year effect, where we expect it to grow faster than our sales growth. But we're not guiding with a specific number there. It's just more that you can—if you expect mid- to high-single-digit growth of our sales, you can expect profit to grow at a faster rate. And that's something that we're gonna work on every year. Again, what we talked about with our focus on operational excellence as well.
Okay, great. I can see Matthew has his hands up.
Excuse me. Thank you. It's Matthew Weston from UBS. Two questions, please. The first on mass spec. I mean, there are other players who've tried mass spec automation in the past with, arguably limited success, Thermo Cascadion, most recently. I'd love to understand what lessons you've learned from essentially their failure, that means that you're confident that you will have success. So as I understand it, people previously complained that having the fully automated route actually took away a lot of the power of mass spec as to what it could bring. And also, is there any cannibalization that we should expect that mass spec will take from your current portfolio?
Mm-hmm.
Then the second question is more for Matt, and it's a broader one. It's around China and China stimulus. There are a lot of equipment manufacturers who are excited about the new China stimulus, and there seems to really be two messages out there. One is, it's really big and therefore really exciting, and some people who may be a little bit more cautious, but it is really big, but it's over multiple years and therefore may take time to build versus previous stimulus packages. I'd love to understand what your view is for China.
Sure.
Good. Let me take that first one. So obviously, I'm an employee of Roche and not of Thermo Fisher, so I don't really know why they failed. I can just tell you that we have vast experience in bringing technologies that used to be lab developed to the market and make it IVD, fully automated, fully integrated. We've done that with radio immunoassays, we've done that with PCR, and we're doing it again with mass spectrometry, and I'm convinced that we do it in a successful way. Talking to a lot of laboratories, doing mass spectrometry today, all around the world, I've hardly ever seen such a pull from the market and such an expectation, so I'm confident that we will reach our ambitions there.
Yeah. And so I'll take the second half of that question, but I would also just double down. I mean, in the customer interactions I've had, and they have experience with multiple platforms, but the level of enthusiasm for this is really palpable, especially with some of the staff shortages that are really challenging the industry at the moment. But on to China. So I'll address this more at a high level. I hope, and I hope this addresses your question. China is a major focus for us. We've worked to really make sure that we have our entire value chain based in China. Some of those oncology assays that Palani presented, some of those are being researched and developed in China. We've moved manufacturing to China, and for us, it's a very critical geography for us.
I won't comment on that specific legislation beyond the fact that we're continuing to invest, and it's gonna continue to be a priority for us going forward, and certainly an area of focus for myself. Thank you.
Okay. Yeah, maybe the woman behind Matthew.
Thank you. Victoria Schroeder from Intello. This question is for Palani, but I know others can join in. I have a data question related to your algo suite products. And I suppose more broadly, what are the models trained on, and how do you ascertain improved data quality in terms of sort of a diverse population, complication of epigenetic factors that might change the profiles? But then also, what are the obstacles in terms of confidence and changing clinical pathways in terms of how that's instructed?
Yeah, no, I mean, it's a, it's a great question, and it really depends on the algorithm, quite honestly, because some of these algorithms are quite simplistic. You don't always have to have a machine learning-based multiparametric. So there are certain algorithms that are just two parameters based or so on and so forth. And here, we obviously make sure that we are looking at the right patient population, and we are generating the right proof points, and then we'll of course continue to generate more data once it's launched. And then there are others where, to your point, we have to look more broadly.
In those cases, especially if you're looking at algorithms that goes more in a screening setting or so on and so forth, where you have to have the right classifiers, there, we absolutely make sure that we are appropriately looking at the right data sets. In many of those cases, we will continue to then also improve those post-launch as well, in the real-world setting. So it's quite multifactorial, and it really depends on the nature of the algorithm that we are looking at. Not everything has to be very complex and has to involve machine learning.
And I would just add to what Palani said, and I would agree with everything he said, but clinical trial equity in ensuring representative patient populations in patient cohorts is a commitment for ourselves, you know, because it's the right thing to do, but also it's what regulators expect of us in the current environment. And so that's something that we have a focus on.
Okay, the gentleman right here.
Thank you. Simon Baker from Redburn Atlantic. Two, if I may, please. Just going back to the question on the LDT final rule. There's been some debate as to whether the final rule is actually final, so what are your expectations for it actually being implemented between 2024 and May 2028? And then going back to mass spec, you gave us an illustration of the first wave of assays. I wonder if you could give us a flavor of the overall capabilities of the mass spec engine in there in terms of other more advanced analyses. I was thinking of receptor quantification, receptor expression quantification. I've got one obviously in mind in particular, which is HER2. How far can this mass spec platform be pushed to these slightly more exotic analyses?
Thank you.
You can do the first.
Sure. So on the LDT rule, I think it would be really impossible for us to comment on when we feel that would become fully into effect, because there have been numerous challenges in the public sphere on that. What I would say is we'll be prepared independent of the outcome. And for us, that's also why I want to talk about some of the prospective trials we're running and our rate of approval of PMAs and BLAs. We are able to develop fully regulated, high quality diagnostics, and so irrespective of the outcome, we'll be ready. And then, maybe hand it to you.
Sure. So, I mean, you rightly so pointed out, we have, let's call them the usual suspects for mass spectrometry, and, that is on purpose. We're bringing here, something completely new to the market, so we wanted to really focus on those high volume parameters that are currently run by mass spec labs around the world. This covers for many mass spec labs, about 80% of their throughput. Throughput, not different analytes, right? So we really wanted to focus on those. We, on the other hand, have a list with literally hundreds of candidates for the future, which I obviously can't go into details right now, but there are plenty of opportunities. There's plenty of space for reactions there, because it's always a multi, multi-channels, right?
There's several analytes in one reaction pack, so there is more to be expected. Last point, it's an liquid chromatography triple quad mass spectrometer, so they are the best for kind of peptide mass spectrometry. If you go to larger proteins, it would be challenging, but anything that is smaller, that is peptides.
Yeah
drugs and so on, it's perfectly suitable for this instrument.
Yeah. No, I mean, I just wanted to quickly supplement what Benjamin was saying. We could very well... I mean, post-translational modifications can be very interesting as well to look at in the future. As Benjamin said, you'll have to basically look at peptides and reconstruct and so on. So we think this is a generational technology, again, that we can continue to drive forward in the coming years.
Okay. The woman here in the front row. Yes.
Thank you. Jo Walton, UBS. When you were launching your COVID tests, and you amazingly priced it everywhere to try and drive your acceptance in the US, you were hoping that this would increase your market share. But looking at the sales, particularly in core labs in the first quarter of this year, the US is still a really small proportion of that market. So could you tell us a little bit about whether you have gained market share and where you feel you are in that core lab market in terms of market share, maybe how you're going to change it? And my second question is about the TB. I'll just use the TB one as an example, but you talk about 25% of the global population with latent TB, but who's gonna pay for this sort of test?
Are you going to be getting governments to-
... forcibly test asylum seekers? I mean, I just don't know where the commercial drive for that is coming, and perhaps you can tell us when it's actually going to be on the market. Thank you.
Sure. So would you like to talk about this, or do you want me to?
Whatever you want. I can talk about Core Lab.
You can start, and then-
Okay.
We'll tag team.
We tag team. Okay, very good. So on your Core Lab question, the COVID sales was really pushing our market share in molecular diagnostics, as this is PCR business. We did have only very limited COVID sales on our Core Lab, what we call the serum work area business, the clinical chemistry and immunochemistry. So we didn't see an increase, really, in market share in Core Lab from COVID. However, we've been installing, and you've seen that on one of my slides, that we've been installing many, many instruments, specifically in Core Lab, in the last year, and we see that continue this year as well, which brings more instruments out in the market, which will then enable more reagent sales, and which you will be seeing reflected in our overall sales.
Yeah. And I would say that the growth in the U.S. has been quite strong, and I think, as Benjamin knows, that that is a region within the Core Lab business. We have seen strong growth of market share, and I think that is something we feel very, very comfortable with the momentum about that.
Absolutely.
We're excited about the momentum. So maybe on your question about latent tuberculosis. So just today, this is a large market. And not talking about even growing the pie. The existing pie is quite significant for this parameter, and we are coming again with a very automated test for this. But we also have a very large install global, you know, global install base, and I think this is something that we can leverage in countries across the world as they have tuberculosis elimination programs. There are also a large number of NGOs that have sig—very significant interest in these programs, where we have the opportunity to partner. So the existing market, the existing opportunity, is significant, but then the potential to scale it is also something that we're very excited about, would be my characterization of it. Well, anything you'd like to add?
I mean, you've captured very nicely, and we have good experience with these kind of programs in the past.
Yes
... when we have looked at HIV or HCV and other elimination programs, so you're absolutely right. It's not like suddenly funds will become massively available, so you have to work with the different governments, and to Matt's point, wherever there is a desire to go after this, then we can certainly partner and work on the right pricing, right model in those settings. So it will be an important work, but we feel like with the kind of install base that we will have this available, it really puts us in a better place than anyone else to really drive this forward.
The gentleman over there on the far right.
All right. Good afternoon, this is Doug Schenkel from Wolfe Research. Actually, I'm gonna stick with two of the topics that I think all of us are focused on. Why don't I start with latent TB? Maybe to be really direct about it, what is the timeline for the launch, and how do you intend to differentiate specifically? And what I'm trying to get at is what is gonna be different about your offering versus the existing solutions, and is the opportunity, as you see it, largely about still converting folks from skin testing, or is there actually a focus on converting folks, converting labs, away from the existing IGRA players?
Do you want to talk about the technical piece? I can talk about the other piece.
I mean, yeah. Look, I mean, the program is coming along very nicely, and it's progressing, but we won't give out the timelines at this point in time. In terms of what's different, I mean, to your point, it's not that an interferon-gamma release assay test is a new test, particularly. I mean, it's well established. The important thing is making it really broadly available. No one else has the test available in that kind of broad install base. That's what is going to be an important differentiator, and it's a combination of both. Even labs which already have a test, as we were saying, I mean, labs always are looking to consolidate their tests onto the same platform. So if we can bring that test into an existing platform the lab has, that's an important advantage.
And then skin test, of course, has its own limitations. I mean, it is done in very low-resource setting, but if a lab can't really afford to do an interferon gamma release, it would absolutely make sense to switch to that or sustain with the skin test.
Okay. Thank you for that, and if I can ask a mass spec question, and maybe this is just dumbing it down for myself, but you know, if I think about it, mass spec and liquid chromatography, listen, these are complex technologies, and they're areas I think in part because of that, that have been dominated by four or five players, really forever, for decades. So that's really the first thought. The second is, you know, the complexity of these technologies have really limited broad adoption of these tools in the clinical setting, I think for some of the reasons I mentioned. So if I think of—if I'm thinking about it the right way, is the approach annual year, not that we're gonna have the best chemistry or the best columns, not that we're gonna necessarily have the best mass spec.
Again, I'm not trying to knock the technologies, but it's not about whether you have a better column than Waters or a better mass spec than Thermo. It's about a mass spec that sort of demystifies this for a broader array of customers using Roche's proven IVD development approach and back-end informatics. Is that the right way to think about this?
Yeah, absolutely. So you you know, you asked the question, and you answered the question.
But I still want...
I mean, go ahead.
Why don't you finish, and then I'll add one more point.
We're gonna be absolutely state-of-the-art when it comes to sensitivity, specificity, quality, and everything.
... But what is the difference is you don't need to be a specialist anymore to run this. A normal lab technician running the core lab, the base business, is also able to run mass spectrometry in the future, and it makes it just much more broadly available. But it has been challenging. I mean, no doubt, right? We've been developing this since 10 years with our partner, Hitachi High-Tech, who we partner with for also our clinical chemistry and immunochemistry since more than 45 years. So this has been a huge undertaking, and, you know, we're very close to bringing that to the market, and we're extremely excited about that.
Actually, what is the timeline? Sorry, and I know that's three questions, and I don't want to get in trouble for it.
No, no worries, because we also shown it before. It's end of 2024 for CE markets and in 2025 for the US.
Yeah. And maybe I just wanted to add one point, because Benjamin really brought a nice example where you can use mass spec as well, and it is not yet used, for example, in patients with breast cancer that get anti-hormone therapy, where you don't measure routinely this kind of biomarkers. Now, having such a automated solution, bringing the right clinical trials also to the scientific community, this will be done much more often, right? At this point in time, it's super cumbersome for those analytes to be measured. But in the future, if it's so easy, you will see much more of that. So what I'm trying to say here is, obviously, the full potential of the mass spectrometry is not yet completely elaborated, and it will be done once it's so easy as we can see it here.
Now, it's a very good point that Ildikó made, and I do have to emphasize a point that Benjamin earlier made, because today it's really in the LDT space. What happens is every lab does its own standardization.
Mm-hmm.
You cannot—you don't really get cross-lab standardization. To Ildikó's point, if you're also going to run clinical trials across different labs-
Mm
... and so on and so forth, you really need a way to standardize your results across multiple labs, and this will be the first time we will have cross-lab standardization. And we are actually working with the FDA to even think, to help guide how to think about this, because this hasn't existed in mass spec in the past. So-
Yeah.
I mean, look, you can clearly see that we are a very strong believer in how this is going to change.
And I would maybe put a punctuation on it. I know we're deep in trouble with you, but I'm gonna take a risk here. The level of meticulous planning that went into even the standard development in our group in Pennsburg is really outstanding. And taking it, you know, really one step forward, the feedback from some of the early laboratories that have done some of the early evaluations, who are experts in this field, has been very positive.
Mm.
So, you know, I think these are people who do mass spec day in, day out, and they've been very impressed with the quality of the results on top of all the things Benjamin mentioned.
Okay, thank you very much. So what you don't see is that the timer for the Q&A session actually turned red. So I think we need to close the first Q&A session. However, there's an opportunity in the second Q&A session, and then there's also an opportunity in the, in the upper row at the end to ask more questions. And I can see there's a large interest around mass spec, so please take a look at the instrument. Although, I would like to keep the break rather short, so I would be happy if we can reconvene here around 2:30 P.M. for the second set of presentations. Thank you very much.
...
相遇，不知你是人还是仅是暴雨。啊，只有十几分钟的暴雨，过后只有泥土的气息，最终还是没有等到你。这场雨来得太容易，我和你就像一场闹剧，分离就这么地容易。爱情像是暴雨，昨晚下一场雨，看着行人在雨中游戏，每个人都疯狂地躲避着暴雨。我像迷失在这场雨里，期待着一刻与你相遇，不知你是人还是仅是暴雨。啊，只有十几分钟的暴雨，过后只有泥土的气息，最终还是没等到你。这场雨来得太容易，我和你就像一场闹剧，分离就这么地容易。爱情像是暴雨，只有十几分钟的暴雨，过后只有泥土的气息，最终还是没有等到你。这场雨来得太容易，我和你就像一场闹剧，分离就这么地容易。爱情像是暴雨，昨晚下一场雨，看着行人在雨中游戏，每个人都疯狂地躲避着暴雨。
Have you seen the well-to-do, up and down Park Avenue? On a famous thoroughfare, with their music in the air. High hats and arrow collars. White spats and lots of dollars. Spending every dime, for a wonderful time. Now if you're blue and you don't know where to go to, why don't you go where fashion sits? Putting on the Ritz. Different types who wear a day coat, pants with stripes, and cut away coat, perfect fits. Putting on the Ritz. Dressed up like a million dollar trooper. Trying hard to look like Gary Cooper. Super-duper! Come, let's mix where Rockefellers walk with sticks or umbrellas in their mitts. Putting on the Ritz. Now if you're blue and you don't know where to go to, why don't you go where fashion sits? Putting on the Ritz.
Different types who wear a day coat, pants with stripes, and cut away coat, perfect fits. Putting on the Ritz. Dressed up like a million dollar trooper... Trying mighty hard to look like super duper, Mr. Cooper. Come, let's mix where Rockefellers walk with sticks or umbrellas in their mitts. Putting on the Ritz.
Are you gonna share your secret? Or will you leave me guessing for days? Is it up to me to read you? Figure out a pattern in your ways. Are you just cold to me because you are afraid to be another shipwreck in my way? Maybe. Are we gonna share our excitement, or do we simply have to let it die? All you do is scold me with your silence. All I do is suffer and fight. This bubbling feeling whenever you're appearing, whenever I'm alone with you, I hide. I think about you day and night, girl. I think about you night and day. I think about you all the time, girl. And I can keep my hands off you. If only I would know that you are also having sleepless nights. If I would make a choice now, I would only lose now.
Better keep calm and keep my dream alive.
My mic. Yes. Hello. I think it's great to see that high level of interest in the mass spec. There will be more time to take a closer look and engage with Benjamin and his team during the apéro. I think now we need to start the second session of the presentations, and I'm happy to take it over to Jochen Berchtold.
Thank you, Birgit.
Welcome, everyone, and also welcome everyone in the virtual setting. My name is Jochen Berchtold. I'm the lifecycle leader for continuous monitoring, and I'm super excited to be here to share more information around the Accu-Chek SmartGuide CGM solution. I know it's going to be a tough cookie to top this one. I'll give it a try, but before we go into the details of the solution itself, I would like to give you an overview about the worldwide epidemic situation around diabetes. Matt, Matt mentioned it beforehand, we have around 500 million people on this planet that are suffering from diabetes. What is also important to note is that we have around 300 million people that are actually being diagnosed, and interestingly, only half of them are receiving care.
Which means there is a lot of accountability for healthcare organizations as well as companies in that space to provide access to care. And we as Roche, we already are in that space, active since decades, and we are providing to around 30 million people worldwide, solutions like test strips, like BGM meters and also insulin pumps, to provide access to care. What you see on the right-hand side is the interesting part around CGM. And that means there are around 8 million people that are already using a CGM, and I would like to dive more into that market because that's the topic around Accu-Chek SmartGuide CGM. So how does the market look like in detail? The market size in 2023 was around CHF 9 billion, and it is expected to grow up to CHF 20 billion by the end of the decade.
That translates into a CAGR of 13%, which is remarkable and super attractive for us to be in. What you see on the right-hand side of that picture is the utilization of the CGM technology based on the therapy. So you see that 50% of users are on a so-called multiple daily insulin injection therapy. That means those people have to use an insulin pen, for example, to inject insulin before every meal, for example. And for those users, it's super important to have continuous glucose data available to do the therapy in the right way. The other half of that population are using three different types of therapies. One is a fixed insulin dosing. The second one is the oral antidiabetic drug delivery, and the third one is the pump business. It's called continuous subcutaneous insulin infusion.
All in all, what I want to say with this slide is that there is a very strong growth in the market, and there are only three major competitors, and we see that there is room for a fourth one, which we want to be in the next future, right? So how would we like to get into that space? We want to get into that space with our Accu-Chek SmartGuide CGM solution. I have one that is far smaller than our mass spec, but this is how it looks like. That's the package that we are delivering to the end user. That's the package that the Type 2's and Type 1 diabetics are using, and it includes everything that you need to really use our CGM solution. I would like to demonstrate to you how it's actually working.
So within that pouch, you find a one-step applicator, and that one-step applicator includes the sensor, and it is used very simply by opening the inserter. For demonstration purposes, there is no sensor in there, but what you would do is not throw it away, to gently put it onto your arm, press the inserter, and then it's automatically injected to your body. And that is a one-step application system, so that means you don't need to build the system by combining different technologies. This sensor that is inside of this is that one. So you see here, our Accu-Chek SmartGuide CGM sensor. It is durable for 14 days after initial calibration. You can also swim with it, so you can use it for a bath or if you go to a shower or if you want to go swimming, that's all good.
It is also meant to use it in combination with our Accu-Chek SmartGuide Predict. The predictions are a key element of the solution because we're providing, for example, a two-hour glucose prediction and the nighttime hyper prediction, and I show later on a bit more details why those really matter. The other aspect of it is that the connection to the doctor is super important because we all know that the doctor has about five to seven minutes for the doctor's visit. So you can seamlessly transfer the data to the doctor's office before you are at the doctor, yeah? So in the combination, you see that it is more than just a sensor, it is actually a solution, and that's a combination of the digital assets as well as the sensor itself.
So with that, we have the first predictive CGM solution that helps people with diabetes to proactively act before a problem occurs. And I will show you later on why that works. So how are we going to position that product? We are going to position the product for Type 1s and Type 2 diabetics on an MDI therapy that are new to a CGM. The value proposition that we have is that we really want to enable the people with diabetes to take an action before problem occurs. And we do that with the Accu-Chek SmartGuide Predict app. And that prediction app includes a 30-minute prediction for lows, a 2-hour glucose prediction, a nighttime hyper prediction, as well as a pattern recognition. So this is the overall set that we have.
So now you could ask yourself, "Well, why the predictions?" The reason is simple, because for people with diabetes, there are still a lot of unmet medical needs, and I've got two examples with me. So one example is that people do not know where the glucose is heading, right? So imagine you are sitting in a room like this and in a meeting like this, and you would want to focus on the meeting. You don't want to screen for your glucose level all the time. So having a two-hour glucose prediction helps you to understand where the glucose is heading, and we try to remedy that situation. The second example, and I think, Matthew alluded to that, is if you want to go for a car ride. For me, this is super simple. I grab my key, I jump into a car, and I drive.
If you do have diabetes, you need to consider that you might run into a low, and if you run into a low glucose situation, you might get dizzy, and that means you could cause an accident or have a high risk of that, and you don't want to be in that position. So therefore, being aware of the situation is super crucial. The second, unmet need that I have got with me is nighttime hypos. So what is a nighttime hypo? A hypoglycemic event is an event where you fall into a very low glucose situation, and if that happens during the night, you might end up in a situation that you fall into a coma, or in the worst case, you could even die from it.
And when we talk to diabetes people, those people tell us that they sometimes even have severe fear of falling asleep and not waking up. And in the next two slides, I would like to show you how we want to help those people and to address those unmet medical needs. The first one that you see here on the screen is the two hours glucose prediction. And in the middle, you see the graph, how it's illustrated in the app. You see in a green area. The green area is actually the area where you want to be. That's the green zone. That's good. You see a solid line, and that solid line illustrates the historical glucose values. Then you have a green dot, that's your current glucose value. And then you see the dotted line, which is the prediction for the next two hours.
And with that prediction, we have three steps. Step one is we are generating the awareness as to where the glucose is heading in the next couple of hours. Secondly, it provides the opportunity to the patient to be prepared, so taking insulin with him or take a carb snack with him or her. And the last step is taking an action before you run into a high or into a low, in order to stay as long as possible in the green area. So and this is how we want to help people with diabetes to optimize and take their own decisions, to be prepared and take an action before the problem occurs. The second example is the app that we built for high nighttime hypoglycemic events, so it's a nighttime hypo prediction. You see on the left-hand side of that picture how it looks in the app.
So you see here in this particular case, you have a patient who has a high risk of falling into a nighttime hypo. And the app even illustrates during what period of the night it would happen. So in this case, it's between 10:30 and 2:00 in the morning, and you see in the lower end, a section on what I can do. And if you click on that, you get recommendations how to reduce the risk based on medical guidelines that are available. So in this particular case, the person could, for example, take in complex carbs to lower the risk and reduce the risk to not falling into a nighttime hypo. So I hope I could explain to you the two apps, and, we have prepared a video to show more in real life how that could look like, yeah.
If you could play the video, please. Thank you. So the SmartGuide Predict app is obviously based on CGM data, right? So what you see here is that the CGM sensor sends the data to the app via Bluetooth Low Energy, and then it displays the glucose ranges and the glucose values. What you see on the top right corner of the app is a button, which the lady is pressing now, which actually toggles to the predictions. So now you see a prediction that illustrates, okay, you run soon in the low, and that informs the patient before you run into the low, so she can counteract and, for example, drink something sugary, in this case, maybe an orange juice, right?
So there is another example where you see a lady also using the predictions, where the predictions show in two hours, I might be in a high glucose situation, so she is aware about the situation and can prepare, which means taking an insulin pen before she leaves the house, right? And with that, then can take an action later on. So the last example I have is with this gentleman here, who is sitting in his living room, obviously, and he's getting a notification of the app, that during the night, he might run into a high risk of a nighttime hypo. In this case, it's a very high risk, and he understands it now, so he can take an action and eat complex carbs before he goes to bed, right, in order to reduce the risk level for him or herself. So... And it seems to work.
He looks quite happy, so hopefully, surprise, surprise, he has a good night of sleep. And I hope I could generate for you an overview about what the combination of bringing together a strong CGM with predictive algorithms can do to help to address unmet medical needs, right? But this is not where we are stopping. That's actually our starting point, yeah, and I thought I'd bring also a couple of informations on what are the next steps for us. I said already that we will focus the launch on the MDI segment, right? So this is our starting point, and we also will expand into all other segments in the diabetes management space.
So which means we also want to go into the pump therapy, we want to address the insulin dosing on fixed insulin dosing patients, and last but not least, certainly also talk about the OAD patient group, which is the largest population. And we will combine that with future developments. So what we will do is we are working on, for example, the integration of the CGM into mySugr. That is super important because it would enable the user also to take the assets from mySugr, like the mySugr Logbook or the Bolus Calculator. So we are combining our assets. We also work on factory calibration and on the expansion of the algorithms suite....
That is super important because when we address new market segments, there will be other medical, unmet medical needs, and with the expansion in the algorithm suite, we want to address all those unmet medical needs as well. Last but not least, what you see is that we certainly also want to look into new sensors, to round up the picture. So I hope you got now a good overview about the CGM activities that we do, including an outlook. And with that, I would like to thank you for your audience and, hand it over to Ildikó. She has now another set of exciting news for you. Thank you so much.
Yeah, thank you very much, Jochen. I really can't wait to see that in the hands of our diabetes patients. Also, a warm welcome from my side. My name is Ildikó Aradi. I'm heading the research and development department, and today I would like to tell--talk a little bit about the point of care market as such. Well, when we talk about point of care market, we have to confess that this is a very segmented market with very distinct customer needs. And in the recent past, as Matt said, we saw a strong trend towards decentralization. And because of this market trend, we at Roche have developed a very cohesive point of care strategy, and this is what I'm going to talk about. We will focus on two indications, which are, are in alignment with our overarching strategy, and these two indications are cardiometabolic and infectious disease. Why?
Because in these indications, a very rapid diagnosis is needed for the initiation of the right treatment. The segments we would like to serve span from the hospital segment, with the emergency room and the intensive care units, through the general practitioners, the pharmacies, and the home care setting. All these are combined via digital connectivity and solutions in order to have a seamless data flow, that the data are really utilized. Now, for the emergency room setting and the indication of cardiometabolic, I'm super excited to introduce the cobas Sense system, which you have heard already a couple of times. For the infectious disease area, we will enlarge our menu on our well-established cobas Liat system. On the other end of a spectrum, you have just heard that we will launch the Accu-Chek SmartGuide CGM solution. This is our commitment for the home care setting.
Now, starting with the cobas Sense. What is that? That is an immunochemistry platform that will provide lab-like performance for our customers in the emergency room setting. It will mainly use for the detection of myocardial infarction. And why is that important? Imagine for a moment, you are a patient that is admitted to the emergency room because of chest pain. What do you need? You need a rapid diagnosis because you want to know what's ongoing. You need to have an accurate diagnosis because there should be no doubt. And you want to have a diagnosis out of a sample type that is readily available. And I'm super proud to say that the cobas Sense will combine all of these advantages. We will provide a high sensitive troponin T assay out of whole blood.
The results will be available in just 12 minutes, and we will have comparability and the same cutoff as our Elecsys system. That is really important for any monitoring and comparability of the results. We won't stop there. Obviously, we will broaden our menu for the differential diagnosis of cardiovascular diseases. The high sensitive troponin T will be followed by NT-proBNP and the launch of D-dimer. Now, again, why is that important? You have already heard, but I want to reiterate that cardiovascular diseases are the leading cause of death globally. In 2020, 15 million patients died because of cardiovascular diseases, and that is one third of all patients that died. This is substantial, and this is also why the market really demands such a high sensitive cardiovascular biomarker panel with an easy workflow in the emergency room.
Emergency room is a very stressful situation and the workflow should be as easy as possible, and cobas Sense will deliver that. We expect that this market potential is CHF 1 billion, a sizable market we definitely would like to serve. Switching gears a little bit to infectious disease and our cobas Liat system. This cobas Liat system has gained really a high and good foothold during the COVID time. We have now 13,000 cobas Liat analyzers installed globally. It is a system that primarily is used for respiratory diseases and to distinguish between the pathogens. It is quick. Just in 20 minutes, our customers will have an answer. It is confident because it's really based on our well-known PCR technology. And again, it is part of our point of care ecosystem, our digital ecosystem, so the laboratory still maintains the control over the data.
Again, this is a highly competitive market, the molecular point of care market, but it's also a super attractive market. Just in the last five years, this has grown sixfold. It has reached a market size of $3 billion. And we, during the COVID times and also today, we have substantially increased our market shares. But we won't we won't stop there. Just recently, we have submitted the so-called four-plex assay to, as an EUA, to the FDA. And this four-plex assay means that within 20 minutes, the customer can distinguish between the four most important viruses, for example, in the emergency room or also in the primary care setting, for flu-A, flu-B, SARS-CoV-2, and RSV.
This prompt diagnosis is super important for the initiation of the right treatment, and the early diagnosis can really also reduce further complications through the use of either antibiotics, if the test is negative, or antivirus. So combining all of that, the point of care strategy that we have developed is really centered around the diverse needs of our different customers. We will focus on two indications, cardiovascular and infectious disease, because in this indications, we need a rapid diagnosis for the right treatment. We aim to deliver lab-like performance and the reliable results. In conjunction with our lab system, we have comparability of the, of the data, and we really invest, as Matt said already, to become a leader in this highly attractive, decentralized testing. We want to be really the main choice of healthcare providers globally.
With that, I'm happy to answer any questions later, but first, I will hand over to Nico, who will explain a little bit further on infectious disease. Thank you very much.
Thanks a lot, Ildikó, and welcome to our next session that is covering our upcoming launches and innovations in the molecular lab. My name is Nico Michel. I'm Lifecycle Leader for the molecular infectious disease portfolio at Roche. Our solutions offering in the molecular lab covers the complete continuum of care. We are committed to streamline molecular testing and bring continuous innovation to our large installed base of instruments around the globe. Our solutions are versatile and easy to use for the point of care, for syndromic panel testing, and for high volume testing, and with the option to fully automate and create maximum routine efficiency. Today, I'm going to present you our upcoming launches, both for the systems as well as assay portfolio.
Let me first start with the unveiling of the cobas 6800, 8800 version 2.0 update, which we will be launching by the end of the year. This update introduces increased testing flexibility and greater automation of molecular workflows. As you may remember, these instruments brought high volume COVID-19 testing to labs from the beginning of the pandemic in 2022, when we introduced the first molecular SARS-CoV-2 PCR test. Accelerated by the pandemic, and together with the later introduction of the cobas 5800 platform, we were able to reach more than 3,000 placements of this powerful platform in the market. This drives our leading position in the centralized molecular testing market. The update is retrofittable, which means that also all our existing customers will gain access to the many new features and benefits we are now introducing. Let me give you some examples.
Our customers can now consolidate an even broader menu of assays. They can now run up to 6 tests per run, and together with a customizable quality control concept, this significantly reduces run costs. In addition, with the optional second thermocycler for the cobas 6800 system, customers can now increase their active testing time coming from 384 results to now 576 results per 8-hour shift. And the full and broad assay menu will be available for this version 2.0 update. This brings me to news around our assay menu. It's the upcoming cobas Malaria test for the cobas 5800, 6800, and 8800 system. This assay addresses an unmet medical need for patient blood safety and supply. And malaria is mainly transmitted via mosquitoes in tropical and subtropical regions.
However, it can also be transmitted via blood transfusion, causing serious complications in transfusion recipients and is potentially fatal. Therefore, the introduction of the malaria parasite into the blood supply must be prevented, and this is a risk that needs to be thoroughly managed, in particular in endemic countries with a high prevalence. But even in non-endemic countries, you do not want to defer your valuable donors from donations due to recent history of travel or residency in an endemic country. Current ELISA-based assays often provide inconsistent sensitivity and specificity. The introduction of a molecular malaria test will create greater certainty around the presence of this dangerous pathogen, and improve safety of the world's blood supply. The cobas Malaria test is designed to detect the five major species causing human malaria infection, enabling a broad coverage and a high certainty around the detection of this pathogen.
It is approved by USFDA for use on the cobas 6800 and 8800 system, and since last Friday, so perfect timing for this event, it's approved for by CE-IVDR for use on the cobas 800 instrument family. We're now leaving the space of molecular donor screening and entering a space, a spot in the continuum of care, where syndromic panel testing becomes more and more important in many healthcare systems worldwide. As you may recall, Roche has acquired GenMark in 2021 to expand its portfolio towards syndromic panel testing. Why is syndromic panel testing so important, and how does it create value for patients with severe infections? It's because it enables the detection of multiple pathogens from a single sample and a single test within a very short time.
And this, again, enables clinicians to determine the true cause of an infection, and then confirm or adjust the targeted therapy against this pathogen within hours. In these critical care settings, this can often make a difference between life and death. Now, we're introducing an updated cobas ePlex system that has been built with intensive feedback and collaboration with our customers, and brings many features that they-- and requirements that they currently have, and they will in the future need. Some examples. First, we have stabilized and scaled up the supply of the instrument and the consumables by further integrating the production in the Roche manufacturing environment. This also creates new synergies and unlocks economies of scale.
We've also improved the stability of the instrument itself, and simplified field service repairs, which leads to a high uptime of this instrument for our customers. Which is super important, again, in these critical care settings, where syndromic panel testing takes place. We are also introducing new software features that introduce even more improved and intuitive user workflows, and flexible ordering and reporting of results. With this, we will create a high customer satisfaction, and this instrument is launched to all healthcare markets worldwide. And with this, I'm also coming to a new assay, the gastrointestinal infection panel, which we're planning to launch in 2025. This assay was also designed in intensive collaboration with customers and key opinion leaders from the industry.
What we found is that the requirements for such a panel differ wildly between healthcare systems, but also between individual customers within one healthcare system. We took advantage of the new flexibility and the new features of the updated cobas ePlex, and advanced it even further by introducing dynamic panel ordering, or short, DPO. DPO will enable clinicians and the lab to collaborate and develop their own specific subpanels that best meet their hospital needs or needs of the individual patient populations. The complete panel targets 19 bacteria, parasites, and viruses, and you can see some of the key features and differentiators of this assays here on this slide. This assay provides access to the second biggest syndromic testing market.
Together with the existing respiratory panel and with the existing blood culture identification panel, as well as the new features of the ePlex systems, we are very confident to now accelerate placements of the system and growth of revenue in this dynamically growing syndromic panel testing market. We've touched now a number of times this afternoon, respiratory testing, so let's shine more light on the centralized respiratory testing market, which is projected to remain one of the biggest revenue drivers in molecular diagnostics. Even after its pandemic peak, it is expected to grow from CHF 0.6 billion in 2019 to CHF 1.7 billion in 2027. This offers a great growth opportunity for Roche, since we will be uniquely positioned across the continuum of care with our solutions for respiratory testing.
Now, with Roche's novel TAGS technology, we can boost growth in this segment by introducing flexible syndromic testing on the cobas x 800 instrument platform with the new cobas Respiratory Flex assay. This assay completes our offering for upper respiratory testing. As you can see here, this is built of immunoassays on the Elecsys platform, as well as gold standard PCR concepts for different care settings, with simple single-target multiplex or syndromic panel testing solutions. Now, with cobas Respiratory Flex, we bring respiratory panel testing on the cobas x 800 instrument platform, and with this, to the high volume molecular lab. It is the first of several future assays using Roche's novel and proprietary TAGS technology. And TAGS is the acronym for temperature-activated generation of signal. It's a technology that enables the detection of up to 15 individual targets within one PCR sample.
With the introduction of TAGS, all the existing more than 3,000 platforms in the market immediately have a threefold increase of their maximum target number within one PCR sample, from 5 to now 15 targets. If you combine this with the earlier presented version 2.0 update, you may realize that we now offer unique and powerful new features for our existing and future customers for centralized testing. This strengthens Roche as a partner of choice for centralized molecular testing. With this first TAGS assay shown here, we make respiratory infection testing fully automated, and we enable our customers to easily scale and tackle seasonal high demand. We are also introducing an innovative pricing strategy with the possibility to order flexibly and use digital reflexing in a cost-efficient approach.
The assay is launched in 2024 for CE mark-accepting markets, and this will be followed by U.S. IVD registration. With this, I'm handing back to my colleague, Palani, for an update on the sequencing solutions, and we'll be happy to take your questions later. Thanks.
Thank you, Nico. Next, I want to provide you an update on sequencing. In the break and earlier, a lot of you clearly have a lot of interest in this platform. Now, I have to preface by saying that today I won't be sharing a lot of the details, performance metrics, and so on and so forth. I'll give you a high-level overview of the chemistry, how we are thinking about this market, and how we want to bring solutions into the market, purely because we are still in stealth mode. We see that we have something really consequential in our hand. We are making good progress, but you also know that this is a competitive market, and we want to be sure that we have dotted our I's and crossed our T's before we start coming out with further details.
So let me start by talking a little bit about how we are thinking about our offering. Simply put, we are not just thinking about the sequencer itself, but an end-to-end workflow. Many of you know the end-to-end workflow of sequencing very well. So it's not only nucleic acid extraction but also library preparation. If you are doing targeted panels, then it's target enrichment, followed by sequencing. Then there is the primary analysis, where accurate base calling, secondary analysis, which is the variant calling, and then tertiary analysis, which is really linking the variant to clinical relevance. Now, what you can see here is, for many of these steps, we already have solutions in the market for the sequencing by synthesis, current technology that exists in the market.
Now, as we develop our Nanopore sequencer, we are also working to make sure all these other components will work seamlessly with our Nanopore sequencer to offer an end-to-end solution. And this is really important because some of the fastest-growing subsegments of the sequencing market, the clinical sequencing, the biopharma segment, they really need this end-to-end solution. So let me now zoom in a little bit on the Nanopore sequencer, because I know there is very high interest in that. There are two key elements of that sequencer. One is the chemistry, and other is the semiconductor sequencing chip. The chip came to us from the Genia acquisition, and we have been steadily working to improve that. But the real pivotal moment for us is really the acquisition of Stratos Genomics, through which we got the sequencing by expansion chemistry.
To give you a little feel for how this chemistry works, I would like to show you a conceptual video for this chemistry, and then talk a little bit about the advantages of the chemistry and why it sets this apart from other single-molecule Nanopore sequencing chemistries that are in the market. Can we play the video, please?
DNA bases are separated by only 3.4 angstroms, the width of a few atoms. DNA sequencing methods cannot easily resolve this dimension. Roche sequencing by expansion technology, or SBX for short, overcomes this limitation by creating a surrogate molecule called an Expandamer. This molecule is more than 50 times longer than its target DNA and encodes the DNA sequence information in large, high signal-to-noise reporters. The building blocks for the Expandamer are novel nucleotides called XNTPs. Expandamers are formed in a modified DNA replication process, where XNTPs sequentially link along a target DNA template using a proprietary enzymatic process. This forms a double-stranded helix. Each of the four XNTP types, depicted as A, C, G, and T, has a tether that is linked between the base and the alpha phosphate. The tether supports a high signal-to-noise reporter that mirrors the base sequence identity.
As the extension proceeds, only an xNTP that correctly complements the next base on the DNA template will be incorporated. The sequence information of the DNA is now expressed in the reporter sequence of the xNTP. This cycle of linking xNTPs is continued sequentially and extends along the entire length of the DNA. After synthesis, a reagent is added, which degrades the DNA template and breaks the cleavable bond between each of the xNTP bases, allowing the backbone to expand. This product is called the Expandamer. By scaling up the size and signal of the original base sequence using Expandamers, SBX technology enables high accuracy, short-read, nanopore-based DNA sequencing. The Expandamer chain is threaded electrically through a biological nanopore. As each reporter passes sequentially through the pore, the electrical resistance of the pore changes, providing one of four signals that uniquely identifies the corresponding base in the original DNA sequence.
A single CMOS array chip can measure millions of nanopores, leading to sequencing rates in the hundreds of millions of bases per second.
So now you can clearly see this is different from the nanopore sequencers that are available in the market today, and the data that we are seeing is extremely promising. So first of all, as it was highlighted in the video, we have a much higher signal-to-noise ratio, which improves the accuracy of the nanopore sequencer. Secondly, compared to sequencing by synthesis, which is really batch processing, that you guys are all well aware of, here, it's real-time data generation and analysis, so it allows for more flexible run conditions. So it also allows for very versatile throughput, low throughput to ultra-high throughput, and also for faster turnaround times, which is really important in clinical sequencing. And all of this adds up to a very attractive cost position.
Now, when we marry this chemistry with our semiconductor chip, which is an 8 million microwell chips to start out with, we are doing essentially simultaneous sequencing of Expandamers through 8 million wells in this chip. And it is because it's optical-free, it is a much more simplified instrument. It has smaller footprint, and again, allows for an attractive cost structure. And the very important part is we think not only will this be competitive at launch, it provides us a very long runway to really scale further as we kind of scale the chip and so on and so forth. So we have a very long runway ahead of us to make sure that we can continue building on this technology in the years to come. Now, that's what I wanted to share with you today. Again, as I said, I'm not able to share specific details.
I just wanted to convey to you that we feel very confident about what we have in our hand, the progress we are making with the chemistry, with the chip, also the data path. It's coming along in a really nice way, and I really look forward to coming and sharing more with you in the future. So with that said, let me pivot to our pathology labs. So we'll have Jill German providing you an update on pathology and also the exciting stuff we are doing in digital pathology. Thank you.
Thanks, Palani, and thank you all for being here today. It's been a pleasure chatting with some of you in the breaks. I'm Jill German. I'm head of the pathology customer area, and if you or anyone you know has ever had a biopsy, there's a really high likelihood that your result was read on a Roche instrument using a Roche test. And in fact, if you got a second opinion, there's a possibility that it used digital pathology. In 2023, in fact, 38 million patients around the world were provided diagnostic certainty through Roche Solutions. So let's take a minute and look at this market. Whoops! Yep, there I am. This tissue diagnostics market achieved 4.8 billion Swiss francs in 2023, growing in high single digits, very steadily.
We didn't see the COVID ups and downs that many of the other markets saw. As a market leader, we've continued to maintain our leadership position around the world, actually growing faster than market and maintaining our number one position in key markets, including the U.S. and China. One of the things that is also very important is that we have relationships with more than 85 pharma partners around the world, and what we see from them is a continued need for meaningful diagnostics as we go forward. We have a strong presence in more than 50% of the pathology labs around the world, which really gives us a stronghold there as well.
As we see this evolving need for pathology around the world, we see that access continues to be an opportunity. Only 10%-15% of the pathology labs around the world are fully digitized. That might be a surprise, but that's a real opportunity for us and for patients. So we see digital pathology as the opportunity to really expand this access. Imagine now, I have digital pathology here. I don't have the large instrument here, but imagine there's digital smoke going around my solution here. We start with scanners, both low throughput and high throughput, to really manage all the laboratories around the world. This is then anchored by what we call our Navify Digital Pathology Platform. This is a robust and scalable software solution that is providing an open ecosystem.
We think that's tremendously important, so that the third part of our strategy can be enabled, which is delivering meaningful algorithms that are either developed internally or externally. That's really an important point about the entire digital pathology ecosystem. As we look at accelerating digital pathology, there are two key things that will happen this year. One is, we expect regulatory approval for primary diagnosis on both the DP 200 and the DP 600. And because we see continued, increased need for digital solutions from our pharma partners, we need to enhance and really amplify our own internal algorithm development, and we've done that through a partnership with PathAI. So let's look at the whole picture. On the left-hand side of your screen, you can see everything that's on the market today.
So, the recent launch of the DP 600 really rounded out the scanner offering for Roche, and that enabled then the continued launch of algorithms. If you look at 2024, what you can see is, I've already mentioned primary diagnosis. We have partnered with two companies to really start the external content on our platform, and that's Ibex and PathAI. Those are already being marketed today, and there are roughly 12 others in the pipeline for this year, as well as a couple of other internally developed algorithms that you can see on here. In the future, in addition to our HER2 DISH 510K, you can see that we have...
I won't go into the specifics because I can't, but we have a significant CDx PHC pipeline of algorithms, both internally and externally developed, as well as multiplexing algorithms that are being developed, allowing the pathologist to actually retrieve a result for stains that will go beyond what their eye can visually see. When you have multiple biomarkers that we'll now call a result, it becomes more and more difficult for a pathologist to actually visualize that, and these algorithms enable that. So you can see from the expanding portfolio, that this really will enable great access across the world.
So with the solutions that we already have in this marketplace, with the pipeline that we have, and with the consistent delivery of innovation, I think you can see that our ability to reach beyond 38 million patients is easily done, and I'm really proud to be part of that. So I thank you for this. I welcome questions when we get up here later, and I pass it off to my good colleague, Olivier. Thank you.
Thank you. Thanks so much, Jill. It's really inspiring to see what we're doing for patients in oncology. My name is Olivier Gilliaron. I'm the Lifecycle Leader, Cardiometabolic and Neurology, and I'm pleased to provide an overview of our neurology strategy and pipeline in diagnostics. I would like to kick it off with a couple of figures. The world population, aged 65 years and above, is expected to grow up to 1.6 billion by 2050, which you can see on the left side. If we take the example of Alzheimer's disease, this translates into a disease prevalence of 150 million patients in the same year, which you can see on the right side. And as Alzheimer's disease patients,
These diseases do not only impact individuals, but actually entire families and society in general. The total amount of cost, both direct and indirect, is expected to grow up to $17 trillion by 2050. Hence, neurological conditions constitute a significant health and socioeconomic burden. At the same time, the neurology space is extremely dynamic. Significant advances have been made, both in science and technology, which will have an impact on patient care. On the treatment side, new drug delivery technologies and gene therapy approaches have been developed, and pharmaceutical companies have established broad pipelines of disease-modifying therapies in neurology. When it comes to diagnostic procedures, improvements have been made, both in in vitro diagnostics and in imaging, and at the same time, new digital solutions are emerging, which will optimize patient care.
At Roche, we currently have 12 new molecular entities in our pipeline in neurology on the pharma side and in diagnostics, and I'm really excited about that. Solely in the next 2 years, we plan to launch 5 new diagnostic solutions in neurology. Our vision is to make an impact on patient care by developing integrated diagnostic solutions across the patient journey. This vision is anchored in 3 fundamental pillars. First, we want to drive biomarker discovery by closely collaborating with academic centers and pharmaceutical companies. Secondly, we want to clinically validate our in vitro diagnostic solutions so that they can be implemented in clinical routine. And thirdly, we want to scale these solutions into the markets by leveraging our strong global presence and our instrument base. I will focus on each of these pillars in the next few slides.
In early research, we are closely collaborating with academic centers and pharmaceutical companies to drive our biomarker discovery. Once we have identified a novel biomarker, we are developing a so-called robust prototype assay. These assays are then made available to our partners through our neural toolkit approach for further validation. The benefits are actually twofold. For us, it means that we are able to de-risk and accelerate our biomarker development, and for our partners, it means that we are informing the clinical trial design and potentially de-risk the drug development. As of today, we have 30 robust prototype assays in our portfolio, and over the past years, we have been able to establish more than 10 strategic partnerships with pharmaceutical companies in this early research and development space. Now, let's take a closer look at the patient journey.
Here, I would like to refer back to what Palani has shared earlier, how we actually develop solutions to address problems across the care continuum, both in oncology or in cardiometabolic. Our ambition in neurology is the same. We're anchoring in a solution of strength, which is usually the aid in diagnosis, intended use. From there, we expand our solutions towards the left, into early diagnosis and screening, and to the right into risk stratification and patient monitoring. In the example of Alzheimer's disease, we leverage our on-market cerebrospinal fluid solutions and expand into blood-based biomarkers and digital biomarkers for the early diagnosis of Alzheimer's disease, as well as into genetic risk profiling solutions and patient management solutions, again, by combining digital and fluid biomarkers. At the same time, we are also expanding into new diseases such as multiple sclerosis and Parkinson's disease.
Now, let me focus on Alzheimer's disease. Here, I think it's important to highlight that all of our solutions are co-developed with multiple pharmaceutical partners, and at the same time, as mentioned earlier, all of the solutions displayed here have received Breakthrough Device Designation by the FDA. As new disease-modifying therapies have been approved, both in the U.S. and in China, the early diagnosis of Alzheimer's disease is fundamental. We currently have our cerebrospinal fluid solutions on market, which you can see on the left side. These are the tests, total tau, phospho-tau 181, and amyloid beta 42. The ratios of this test are used for the confirmatory diagnosis of Alzheimer's disease.
However, they come with a limitation, which is the sample material, as the sample has to be taken through an invasive procedure, and it can only be conducted by trained personnel in a specialized care setting. Hence, we're moving into blood-based biomarkers within the blue box you can see. Our first solution is the Elecsys Amyloid Plasma Panel. The panel consists of the two biomarkers, phospho-tau 181 and APOE4 in blood. The goal of this solution is to minimize false negatives. What does this mean? A patient with symptoms comes in and is tested. A negative test result translates into the rule-out of Alzheimer's disease, whereas a positive test result means that the patient needs, still needs to be referred into confirmatory testing, either through CSF tests or through a PET scan.
Now, I'm excited to share that we have also started the development of our Elecsys pTau217 test. The test is developed in close collaboration with Eli Lilly and has just received FDA Breakthrough Device Designation back in April this year. The goal of this solution is to minimize both false negatives and false positives. So what does this mean? Again, a negative test result translates into the rule-out of Alzheimer's disease, whereas a positive test result above the second cutoff means a direct confirmatory diagnosis of Alzheimer's disease. Between the two cutoffs, there is a gray zone where patients still need to be referred to confirmatory testing. One thing which is really important to highlight here is that we are validating these solutions in a global prospective trial, which is currently ongoing.
In this trial, we are mirroring the real-world patient population, and we believe this will be fundamental as we generate the evidence to successfully register the solutions, and in addition to that, also be able to educate healthcare professionals how to properly use these tests. Now, let me shift gears and move into multiple sclerosis. In MS, we are closely collaborating with Roche Pharma. We are market leaders with Ocrevus on market and with a strong pipeline in neuroimmunology.... In diagnostics, we are developing our Elecsys Neurofilament Light Chain test, which can be used for the aid in detection of disease activity. The test will help clinicians to guide treatment decisions and better manage patients moving forward. And as NFL is a biomarker of general neural damage, we are also exploring further intended uses in other diseases, such as Alzheimer's disease and Huntington's disease.
Now, how do we take all these innovations to patients and healthcare professionals around the world? We truly believe that we are well-positioned to be successful moving forward, as we are market leaders in diagnostics, and we are market leaders in neurology in pharma. We can leverage our direct presence in more than 150 countries and our huge installed base of more than 47,000 Elecsys instruments around the world. This is really unique, as many of the other neurology players are rather small players, and these players cannot rely on such a footprint. The neurology franchise is an attractive business opportunity for us in diagnostics, and we do also believe that the franchise will help differentiating our overarching core lab offering, as we are the only big in vitro diagnostic player really doubling down in neurology.
And finally, I also truly believe that we will differentiate through our integrated approach with Roche Pharma, as I showcased in the multiple sclerosis example, and as we are working closely together in Alzheimer's disease and in Parkinson's disease. With that, I truly believe that we'll make an impact on patient care and on the 150 million patients with Alzheimer's, as I mentioned in the beginning. Thank you. So with that, I will ask my colleagues to come on stage.
Thank you very much, Olivier. We are now happy to take the questions on the second set of presentations. I think the first question I would like to take from the webinar. So Urban Fritsche has a question: Has Roche liquid biopsy efforts, and if so, when could we expect more details? Maybe, Matt, do you want to take the question?
Yeah, absolutely. And I think I'll start by maybe just saying this is very much a key part of why we made the decision to bring FMI into diagnostics. What's really critical in the sequencing space is content. By having the close adjacency of our sequencing unit together with FMI, we really have a clear pipeline to develop new tests for the market in advance of our sequencer launch, but then as we bring our Nanopore sequencer to market, to also have additional pipelines. I think this is a critical element. This is going to be one of the projects that we bring over. Swati, do you want to expand on this?
No, absolutely. I mean, and, look, liquid biopsy is going to be, will be absolutely important. It is important to us, will continue to be important to us, as Matt said, across FMI and as we kit it on the diagnostic side as a decentralized test. Especially, I was also telling you about monitoring setting. So you're talking about residual disease monitoring. In those cases, it has to be a liquid biopsy at that point in time. So we absolutely are looking at this very carefully. We already have solutions, and then we will continue to work on additional solutions in the future.
Absolutely. Because we feel one of the important things is access. Access requires decentralization, which means it's important for us that we develop these tests into kits, and that's part of our roadmap for the future here.
Great. I saw Veronika has a question.
Hi, good afternoon, Veronika from Citigroup. Two questions for me. First, on the sequencing side of things, and appreciate you don't want to give a timeline, but maybe if you can talk through what are the hurdles that you have left? Is it manufacturing? Is it R&D? Sort of, what are the final things that you need to nail down before you can come into market? And, and then just related to that, you know, why short read? Is it because the long read market is not interesting or attractive enough, or is it - are there technological hurdles that prevent you from looking at long read, not just short read? So that's my first question.
Then my second question is on the CGM, and just your broader picture thoughts on entering as a fourth player versus being one of the existing three, and how do you think about the commercialization hurdles and building out that business as you expand into that space? Thank you.
Maybe we start with your second question first, because that's closer to market.
Yeah.
Yes.
Please.
Yeah. So, I mean, if I, if I understand your question correctly, the question was, we want to be the fourth player in the market and how we want to go into that space. As I illustrated on my last slide, we are starting in the MDI segment because there we see the highest need for people living with diabetes to really offer a different solution in combination with the predictive analytics, right? And our algorithms. But we also want to expand into all other segments. So we want to go into the space where we talk about fixed insulin dosing patients, where we talk about people that are on oral antidiabetic drug therapy and also the pump usage. So it's today, the starting point when we go through the launch, but then we want to expand into further segments as well.
Maybe I'll just add one thing before you bring on the second question. We have currently 31 million users worldwide for our blood glucose monitoring solutions. We have over 5 million users of our mySugr digital platform. We have a very strong commercial infrastructure globally. And as Jochen pointed out, this is a market growing at 13% per year. We feel there is room for another player here, and we have-
For sure
... I think, a strong right to play in the diabetes space.
Yeah. Now, coming to the sequencing part, I would say, as I said earlier, too, I mean, I won't go into the details, but things are coming along really well. When you're talking about a completely new chemistry, it's really important that you are past that-
... you know, that you are really kind of confident on the chemistry, on the chip, and we are absolutely moving forward in a really good way there. So we feel very confident on how things are developing. Now, in terms of long read versus short read, again, I won't go into the specifics there. The only thing I would say is, for us, the clinical sequencing market is extremely important. Also, the biopharma market is extremely important, and we want to make sure we have the right solutions to address the needs of those customers, and also beyond that as well. But at the end of the day, it's really important, it's driven by applications and what's needed for those applications.
Right. And I think, you know, kind of what you said, which is this technology has a lot of runway. So while, yes, we're focused on clinical, other segments are not ruled out at all. And I think that's something-
Yeah
We're exploring as we, we continue to progress.
Okay. Other question from Matthew?
Thank you. It's a big picture question for you, Matt, if that's okay.
Sure.
I'm taking advantage of the fact that Alan's not here. You're embedded into a larger company.
Right.
And if I think back into recent years, we've had experience of other business divisions that are embedded in larger companies that have been allowed some freedom. And in every case, when they are independent, they've said that they can grow faster 'cause there was underinvestment. So I guess my question to you is, firstly, do you feel underinvested in at Roche? Secondly, if you were unconstrained, what new market could you grow into? And then, I guess the final one, do you think we'll ever see a Roche Diagnostics target which calls for low double-digit revenue growth, not mid to high single digits?
So I appreciate the softball question, Matt. But I think starting from the top, I think it's important to say, you know, my predecessor obviously was the CEO of Roche Diagnostics and has a very strong and intimate understanding of the business. So I feel really, there's a strong appreciation for the growth, the potential of diagnostics, so I feel the investment is really where setting us up to continue to grow, and I'm absolutely confident in that. And then the other question about low double digit, appreciate it. I think we've been very clear about what our financial ambition is. There are levers for future growth, potentially in the future, as some of these things make their way to market. I think we can address that when that moment comes.
But I think we've been pretty clear about how the financial ambition is for the foreseeable future, given the near-term pipeline. But I think we'll continue to engage in this dialogue and, you know, make sure that you're aware of how we see the business as some of this, new, these new products come to market. But a very fair question. Thank you.
Great. One from Jo?
Over here.
Up here. Front row.
Front row.
Always the same.
Thank you. I'm Jo Walton from UBS. I've got a couple of big picture and a more niche question, I guess. In terms of the big picture, could you give us a help on how much R&D you think you're going to need going forwards? You're obviously accelerating some of your product development. Obviously, you've got more sales growth as well, but the sort of 1.7%-11.5% of sales of R&D, is that an appropriate rate going forwards? Or do you think the opportunity is such that you could actually accelerate that level of R&D? And I think I'm thinking of it really because of that move from the top line to the bottom line and seeing what the elements are that are going to allow your operating profit to grow faster than your sales growth-
Yeah
-going forwards.
So I'll be very clear that the growth in profit faster than sales isn't gonna be at the expense of our R&D line. I mean, we're absolutely committed to continue to invest significantly there to drive the portfolio. So I'm not gonna break it out individually, but what I would say is this growth of core operating profit faster than sales is gonna be inclusive of adequate investment in R&D, and also adequate investment in M&D as we enter into very competitive spaces, such as sequencing, such as CGM.
Why is 11.5% of sales the right level of R&D? Couldn't it be higher?
So, you know, and I would say we have a very disciplined project approach, where we have a long-term roadmap for instrumentation, looking at the instrumentation that we have today and what's needed for tomorrow. And then we layer on that the different assays, and specifically, the focus disease areas. And that's how we really assess what our needs are in R&D, specifically with some of these projects that we have coming in the pipeline. So I think the way we do our planning process is to ensure adequacy for the key projects that we have under development. So again, like I said, we'll contribute profit faster than sales, but we are not gonna compromise the R&D line as we grow. Do you wanna-
I mean, just a quick one I'll add.
Yeah.
I mean, to Matt's point, prioritization is extremely important-
Yeah
and that we do in a very systematic way. But also, we are continuously looking at productivity. So as I was the head of R&D, I was driving that very systematically, and Ildikó will continue driving that as well, to make sure, as Matt presented at the very beginning, that we are getting the most out of our money. So we feel very good at this point in time where we are. I mean, that's what I would say.
Yeah. Absolutely, and I think we've really looked at, from a systematic perspective, all the way from research, you know, manufacturing, quality and regulatory, all the areas where we have potential to improve our processes, because we're not just focused on R&D productivity, we're focused on product development productivity end to end, and I think that's also giving us the capital to invest back into the R&D line.
My other question was about the ePlex system that you got from GenMark. Can you give us an idea of what the installed base is now? And is it right to assume that you've effectively revamped it with the better flexibility and all the other bits and pieces that you were talking about earlier, and that we should see that really accelerate? And where's the market? Is it mid-size? You know, where do you see that growth coming from? Thank you.
I'll hand that to Nico.
Thanks a lot. Yes. Thanks for the question. So since it's a rather smaller segment, we are not currently commenting on the installed base that we have due to competitive reasons. However, I mean, your questions, again, gives me the opportunity to state we've improved the instrument, saying scalability, stability of supply, bringing important differentiators like the blood culture identification panel, and being state-of-the-art when it comes to easiness of the workflow, simplicity of use. And these are important differentiators that can now unlock growth since we are able to supply in the future going on.
Yeah.
The market, respiratory syndromic panel testing market, is projected to grow in the low double-digit numbers globally, and especially in gastrointestinal testing, respiratory testing, and then some additional niches that I've presented. Thanks.
Okay. Hugo?
Hi. Hello. Thanks for taking my questions. Maybe first, back on the margin guide. Given the strong launch phase ahead of you, and, as you mentioned, Matthew, not willing to cut back on R&D, to what extent, if you have bigger growth opportunity, you'll be willing to invest a bit more at the expense of margin? And, second, maybe Nico, on the ePlex, you mentioned the DPO availability. Should we understand that as a flexible pricing model in multiplexing? Is it just something, as you mentioned on the side, that will be available, or will you actively push for flexible pricing in multiplexing?
So for the cobas Respiratory Flex assay on the cobas x800 systems, there we will be introducing different pricing models for customers, and this will be actually available once launched.
Oh, that was on the ePlex. Sorry.
No, that's for the cobas Respiratory Flex on the x800. If you ask for the ePlex system, there we have the digital panel ordering, and the flexibility here is around ordering, reporting, and not about the pricing.
Yeah. May you repeat, please, the first part?
It's just, you are—you have a lot of product that you will launch now, obviously, markets end markets such as multiplexing that is growing double digits. So, to what extent you'll be willing to invest a bit more not to stop future top, future top-line growth, I guess?
Yeah, absolutely. So we're always already planning for the, the second generation of these products. So when you're talking about investing more in top line... I'm sorry, I still maybe perhaps didn't hear it.
I guess to what extent we can see margin more back and loaded, given that-
Yeah.
You will invest a lot into it.
Back end.
Back and loaded. So I think the margin, we can expect to see grow on, on a steady basis going forward, and of course, at the end it will also increase. I think, again, this isn't something where we expect to see the margin growth later because of the—If you're saying because of the R&D investment now, will the margin growth come later? No, the margin growth will also come now, but it will continue to expand later. And I'm sorry for making you repeat your question. Thank you.
Okay. Yeah, maybe we have a question from the gentleman over here in the middle.
Thank you. Peter Welford at Jefferies. Two questions. Firstly, just coming back to the ePlex, just to understand this dynamic panel ordering, if we can. So this is, to be clear, an IT-driven thing. The panels themselves, the actual consumables, are consistent in every case. Is that right? And if you can try to explain, is this directly applicable only to the GI panel, this sub-panel ordering, or is this also gonna be for respiratory? And I guess it's sort of similar to Hugo's question, what is it that drove this? Is this presumably the... It's not clinician-driven, because it's the same price of every panel, you've said. So is this payer-driven, as far as unlocking from a payer perspective? Or what's the rationale for the DPO?
Then the second question, I guess, is bigger picture, to some extent following on from Matthew, in that when you think about capital allocation, you've told us about a lot of different systems that you're rolling out with a lot of different types of consumables. To what extent do you need to be more capital-intensive, building out manufacturing over the next few years to make sure you've got, you know, a robust system for this? And I guess in a similar vein, FTC obviously has got stricter, but are there any areas where you still could look outside with Roche Diagnostics? Or at this point, you know, do you think you're basically too big to really do anything from an FTC point of view?
So I take-
You can take the flexible panning-
First one. Yes.
I can maybe do after that. We tagged it.
Okay. Thanks. So again, around the dynamic panel ordering, this will be introduced with gastrointestinal infection panel as the first assay here. So as we showed you, we've updated the ePlex system, as well designed these new assays in intensive collaboration with customers, and we received a lot of feedback. So specifically for syndromic panel testing, the feedback was, "Listen, when we are in this critical care setting, we want, in the short term, the complete panel of results." So there wasn't such a high demand for flexible pricing at this point. However, there was still a need to, at some point, exclude certain results for certain pathogens due to other reasons. That might be regulatory reasons or specific monitoring. So this triggered the introduction of DPO here at this point.
Yeah. And then I'll just talk a little bit about the manufacturing and maybe, Ildikó and Claus, if you want to jump in. We focused quite a bit the last couple of years on the manufacturing of the GenMark ePlex, and I think there, we've really made sure that we have the right parts of our value chain contributing the right way to manufacturing. For example, in Branchburg, where we're a world leader in oligonucleotide synthesis, that's where we're doing the oligo synthesis and bringing it into our broader supply chain to get the scale and the quality we need to improve. And we're doing the same across the board.
So I think we planned that very meticulously, and you can see that also it's gonna allow us to be even better positioned to capture share into the future. And then your second question on FTC. I think it's a very well-known fact, given our market share position across the different segments, that we'd be prohibited from looking at certain acquisitions. But we're always looking for innovation where it makes sense to add to our portfolio.
And as I'm sure you're aware, we did, pending regulatory review and approval, make the decision to acquire LumiraDx, which I think really helps us even more back to what you heard from Ildikó about our expansion in the near patient care testing, because that really is gonna also contribute significantly to our ability to move into low and middle income countries, where you have basically a room temperature stable product. You have multiple modalities on a single device. And I think you have, with its reel-to-reel manufacturing, a fantastic manufacturing process that allows you to iterate assays very quickly. So when we see the opportunity to go after innovation that adds, we're absolutely interested.
Okay, may-
Do you have anything to add, by the way?
No.
Very good. Cool. All right. Sorry.
So yeah, maybe we take one from the gentleman over there. I think you had your hand up for a long time. Yeah.
Rajesh Kumar from HSBC. If you could help us understand, you know, how the returns profile of your business will evolve as you launch all these instruments. I'm assuming that the margin on the instruments are lower. You often would have, reagent rental models involved. The buildup of consumables will happen over a period of time. So PNL operating margins are interesting, but in terms of the return on capital employed, and how long does it take to, you know, make these launches return accretive over a period of time? In that context, you are... You know, you've got a mass spec coming, you've got an NGS, next gen, coming. So, you know, just, how many different, platforms do you think you can, keep adding wi- without diluting your returns in the short term?
It would be very helpful to understand. Also, you know, I'm sorry, I'm going back to the previous session. I didn't get a question there, but on the TB testing side, obviously, it's a large market at the moment, but that's because it's on smaller devices at a higher price point. And you are obviously a, you know, larger device, and your prices tend to be lower. So without disclosing your price point, if you can help us understand, what is the threshold of revenue you would sort of need for it to start featuring at a CMD, for you to be talking about a new product or technology, that it becomes relevant? So it sort of gives us some idea as to whether it's important for us to model or not.
So, I was going to ask Benjamin to talk about our low volume immunoassay analyzer. Maybe, do you want to talk about that, Palani, and how that potentially plays into TB or-
I mean, I can play a little, talk about TB, but maybe we start with the-
I can start with the capital question.
Yeah.
I mean, I think we talked about our financial ambition. Clearly, our ambition, and that is from now going forward, is to grow core operating profit faster than sales. That's our ambition, if we're able to be successful. So understanding your point about the assets on the balance sheet, if we do reagent rentals, we always have a broad mixture of the different ways that our customers acquire our capital. But I think independent of what you see with these new launches, we still intend to grow profit at a faster rate than sales. And I think we didn't get into the specific acquisition model that we'll have for the mass spec, but this is something that we've taken into account as we build our long-term financial projections.
I think we can have perhaps a deeper discussion on that afterwards, but I think we feel quite confident. I know our diagnostic CFO, Richard, is here, and I think he can also perhaps engage on that question as well. So-
Yeah.
Maybe turn to you for TB.
And on that, the TB one, but also, I mean, I would say when we are developing instruments, we do it internally, but we also have a very strong partnership with, for example, Hitachi, and we have specific business models there, where we can really work around how the capital expenses happening up front or later or so on. So there are different ways we can address it. On the TB side, I know, Rajesh, you asked me earlier as well. I just want to make sure I understand your question correctly. I mean, you're not asking for us to, of course, reveal our prices, but you're saying that, how are we going-- are we going to price it lower than what's today, or, or?
The question is, what is the threshold?
So I think what, you know, the way I understand it is you're saying, because it's right now highly distributed and it happens at some low volumes, at what point are you going to need critical mass to be able to justify an instrument? Right? Is that...
I'm just saying, if you show me a new test or technology, it's 5% of total revenue significant, 2% of your profit.
Okay.
Mm.
Look, I mean, it's hard to say it that way, quite honestly, because we have a whole range-
Yeah
... Like, across our 600 tests, we have some which are low volume, but very high contributors to our revenue share, and others are maybe low contributors. But nevertheless, the idea is that when a customer invests in a platform, they really want to have the breadth of tests available to them.
Mm.
It depends on the setting as well. In a point-of-care setting, they may not need that many tests, depending on which point-of-care setting we are talking about... But then if it's a central lab testing, they would want to have, because the capital investment in the instrument is much higher, so they would want to have as many more tests as possible on the instrument. So it's a little different from the pharma model that they are really kind of interconnected in a way, and you can't quite assign saying that, "Hey," there are of course, we have tests which contribute quite meaningfully to the overall revenue, but it's very hard to kind of make that kind of distinction.
Yeah, and I think that's why you saw with our triangle strategy, we wanna be able to be a one-stop shop. And on top of the one-stop shop, we offer these highly differentiated tests. And we will be the, you know, with—as Benjamin pointed out, we'll have close to 300 tests, and that's gonna make us really indispensable if you're planning to run a clinical laboratory, because we will offer everything you need to run the lab, plus things you can't get anywhere else.
Okay. I think we have time for one final question, and I think it will go to the lady over there, who also had her hand up for a long time.
Thank you for taking my question. I'm Subbu Nambi from Guggenheim. You have been working to move into sequencing for clinical purposes for some time now. Is there an argument that you would be better served to acquire a more established platform rather than continuing your organic investment into early-stage acquired assets?
I mean, I can, of course, take it. Look, I mean, what I see it, what we see, we clearly see that we have something that is really has a very long runway, is going to be the next-generation sequencing. Because at the end of the day, if you were to go after what's established right now, which is largely a sequencing by synthesis chemistry, you guys can see it's starting to plateau out in the market. Because of the investments we are making, it's not just about when we launch, how competitive we are, it has to be a generational technology, like Elexys for us, like Mass Spec for us. So that's why we truly believe what we have right now is a combination of those acquisitions we have made.
You're absolutely right, we have spent a lot of time and energy to get it to a place where it is today. But again, when you're looking, talking about a single molecule sequencing technology, this is not easy. It is very hard, but we feel very good about the runway that we have ahead of us.
Got it. Thank you. And my second question was, for, on pathology. Do you believe in spatial proteomics? And if you do, how are you positioning that with the Ventana systems that's out there, and how do you leverage that?
Yeah, that's a great question. You guys can tap into this, too. It's. That's very important, actually, across really all modalities, whether it's pharma, diet, et cetera. I would say that today, that's still in research. You know, that's not in. You don't see clinical use of that, but that is absolutely not only on our radar, but something that we, of course, are very much looking at. I don't know, Palani, you want to add anything from other conversations?
I mean, what was that part?
Spatial.
Oh, spatial. I mean, it's still in translational research right now, so we continue to follow the space very carefully. But if it's going to come into the clinical space, then we will, of course, pay very close attention to it. But right now, it's not in the near future. We don't—We are not seeing it in the clinical space, so I'm sorry, Jill, I didn't-
But we haven't forgotten about it, and it is very much on, like many other technologies, by the way, that in pathology, we continue to-
Yeah
... really monitor and work with. So thank you for asking.
Yeah.
Okay, unfortunately, time is up, so I think we need to close the Q&A for today. I hope that you will have the opportunity to engage with the speakers during the appro, which will follow this. And at this point, I would really like to thank all speakers and the whole team, basically, for this amazing level of engagement throughout the preparation. And then I would also really like to thank everybody here in the room and in the webinar for their interest in our diagnostics business. Thank you very much. Matt, and the final word goes to you.
Hard to follow that closing. I just want to thank you all for your interest in the Roche Diagnostics business, for the great questions. I'm looking forward to the engagement at the appro, and I want to thank all the Roche participants for the outstanding job and presentation. So thanks again, and look forward.