Good morning, everybody. I guess good afternoon. We just turned to 12:00 here. Thank you all for coming here. Got a full crowd here. I'm sure we have a full crowd on the webcast here. It's been three years since we've been in person, so we're really excited here to welcome you all to Cytiva and learn a little bit more about our bioprocessing business. Rainer will be up here to make some opening remarks shortly as well. Before we get started, I have to read this. Today's presentation may include forward-looking statements, and actual results may differ materially from these statements. Please refer to the slideshow and in our website for more information here.
With that, again, have a really great day here for you. We're gonna start. Rainer's gonna come up and make some opening remarks, certainly comment a little bit on the news from last night. We'll then go to Biotechnology Group here, where Emmanuel Ligner and team will really give you a little bit more look under the hood of the great businesses that we have here with Pall and Cytiva. Gonna get a chance to hear from some customers. We'll go to Q&A session before we go to see some live demos here on the Gemba walks. Without further ado, I'll invite Rainer up here.
Thanks, John. Well, good day, everybody. Welcome to Marlborough, Massachusetts, the North American headquarters of Cytiva. It's great to see so many of you in person, right? After all these virtual conferences that we've had, it's great to have you here in person and also to see so many familiar faces. That's really great. Also, I'd like to welcome all of those that are joining us via the webcast. Thanks for being here today. We have, as John just showed us, an agenda that is chock-full of important information, and so we hope you have a good day here. With that, as John mentioned, clearly we've had some news here the last 24 hours. Before I jump into sort of the heart of the agenda, allow me to give you just a brief current update.
Our strong momentum of the first half of the year is continuing into the third quarter. Our end markets are healthy, and we expect high single-digit base business core growth for the third quarter, and that is consistent with our Q3 guidance as well as the first half. Our respiratory testing at Cepheid is tracking well ahead of expectations. In fact, the respiratory testing demand at the point of care where Cepheid has its advantage solutions is robust, it's resilient, and of course, we also see a tailwind here from additional respiratory outbreaks. We anticipate our respiratory testing revenue to be in excess of $500 million in Q3 versus the $325 million that we had originally guided to.
Now, at the same time, yesterday, we announced our intention to separate the Environmental and Applied Solutions segment into really what is a premium industrial growth company. Of course, that'll be separated to be an independent, publicly traded company. I'll say more about that in just a minute. Today, we really do wanna focus on our colleagues here at the Biotechnology Group, and we'll see much more of that in just a minute. I'll speak to you today more about the EAS separation, but also about what Danaher 2024 and beyond will look like post the separation.
We'll set up the life science evolution, which is important not just because of our repositioning, our enhanced growth and earnings trajectory, but also because it provides the context and the framework in which the Biotechnology Group will share the progress that they're making. Let's go ahead and jump right in. Now, the separation of EAS really allows both Danaher and EAS to realize their full potential, and we expect that transaction to complete here by about Q4 of 2023. Both companies will be more focused, and they'll be able to execute their respective strategies with greater clarity than ever. Now, we're excited for both the team as well as Jennifer Honeycutt, who will be the president and CEO of the new entity. You know, Jennifer has been with us for over 20 years.
In fact, she joined the business via the acquisition of Hach and has tremendous experience through three out of our four platforms with increasing business leadership responsibility throughout the years, international experience, a strong DBS leader, and of course, tremendous experience in mergers and acquisitions. We're really pleased that Jennifer Honeycutt will be guiding us here through that transition until we complete the transaction when she takes over then the public company president and CEO role. Now, if we look to the left, you can see here that we've dialed that portfolio into the most attractive areas of both the water quality and the product identification markets. These are the best franchises in the marketplace. They have differentiated business models. Think razor blade, keyed-in consumables, outstanding financial profile, and a really attractive sustainability and ESG profile as well.
If you look to the right, you can see that mid-single-digit growth, over 55% recurring revenue, and adjusted EBITDA margins of 25%. Now importantly, of course, for EAS, the Danaher Business System, DBS, is foundational, and their commitment to continuous improvement, strong execution, and market share gain will continue as it has for the last 10+ years. Now importantly, EAS will also have the opportunity to meaningfully deploy capital to execute its strategy with a bias towards M&A. That is a real important change here for the EAS team as they continue then to pursue their strategy. When you bring all this together, outstanding end markets with secular growth drivers, think of protecting the water and the food supply as being critical aspects of the near term, but also, the long term.
Think of these outstanding differentiated business models, a great financial profile, the ability to deploy capital. We see all this coming together to drive tremendous shareholder value creation. Now let's fast-forward to 2024 and beyond. What you see there is Danaher, a $25 billion focused science and technology leader that profoundly and positively impacts human health. As you look at the franchises at the bottom of the chart here, you can see that once again, we've dialed ourselves into the most attractive end markets, buffeted by strong secular growth drivers for the long term, and in aggregate, have a growth profile here that is balanced at high single digits for both segments. Now, I'll be talking to you about the life science segment to see the exciting growth franchises and brands that we have there.
As we look at the diagnostics franchise, you can see that it is $10 billion. It was 2019, to give you a sense, of the development there. It is once again dialed into the most attractive secular growth opportunities in diagnostics. For example, the under-penetration of molecular testing at the point of care where Cepheid is positioned as the gold standard, advantaged with the largest installed base and largest menu in the world. Secondly, the decentralization of care, the automation of workflows because it's so hard to get skilled labor these days, and likely in the future, that's a problem set that the value propositions of our entire diagnostic portfolio addresses head on, but particularly Beckman Coulter diagnostics.
When you bring all this together, what you have is a $25 billion, faster-growing science and technology powerhouse that is having a profound and positive impact on human health. Now let's talk about the power of our portfolio, and it's united by these common business models. For example, we have enormous installed bases. I just spoke about Cepheid. It's the same for Beckman Coulter, the same for Leica Biosystems, and of course, the same for Radiometer as well. These are very large installed bases that have cued in or specced in consumable flows that are incredibly sticky, and they are serving high-value mission-critical applications. We're talking about doctors being able to get the right answer faster and making a prognosis or certainly a diagnosis in order to help a patient.
We are also helping pharma, whether large or small biotech, to help develop their molecules, get them through the approvals more quickly, and ultimately commercialize them successfully in order to, once again, profoundly impact human health. Now, you see on the right side the dramatic change in recurring revenues. 2015, 45%. 2024 and beyond, 80%. Of course, in the first instance, you conclude, well, that gives much lower revenue volatility. Of course, in the short term, as we think about the choppiness that we see in the global marketplace, that feels incredibly important. It is also in the long term, and that's because this recurring revenue gives us more touch points and more customer intimacy and more insights into the pain points and the unmet needs of our customers and fuels our innovation engine.
That fuel allows us then to develop proprietary higher-margin solutions in order to win additional market share. The flywheel is evident at all levels of this opportunity. Now, you bring all that together. I spoke about these attractive end markets, the secular growth drivers, the incredible franchises with their differentiated business models, the power of the Danaher Business System, and you can see the sustained leverage we bring to our growth and earnings trajectory for the long term. We think that our growth re-rates higher for the long term. You say, "Well, why do you think that?" Well, let's have a look at the left here, where you see Cytiva and Pall together representing a $7.5 billion bioprocessing franchise growing high single digits% for the long term.
You see Cepheid, more than 10% of our future portfolio growing low double digits. You see our differentiated genomics franchise consisting of IDT and Aldevron at $1 billion plus growing well into the low double digits. You see our life science instruments and clinical diagnostics businesses in which we have invested aggressively to accelerate growth through innovation and improve commercial execution growing at mid-single digits and plus. All that comes together to rerate our long-term growth, core growth to high single digits. Now, when you combine that with our discipline and the power of the Danaher Business System and our bias to deploy capital towards M&A, you see the leverage that provides to double digits earnings growth. Simply stated, our outstanding portfolio, combined with the power of DBS, really accelerates our growth and earnings trajectory for the long term.
Now, underpinning all of this is the Danaher Business System. That's the case for Danaher as a whole. That's the case for EAS as well. The Danaher Business System, that's the way we run our businesses. That is how we execute. It's really on the basis of those core values and our shared purpose, helping realize life's potential, that DBS is our sustained long-term competitive advantage. It pulses through all of our processes in all of our operating companies and delivers real value, and I'll show you that real value here in some concrete examples. DBS is not just a collection of tools, it's a culture. It's who we are, it's how we identify, and it's how we do what we do. Now, sustainability is so important today. As you can imagine, it's a priority at Danaher as well.
In fact, we will be publishing our 2022 sustainability report here in just a couple of weeks. The team has allowed me to share some facts with you before the actual report publishes. The way we organize our activities at Danaher around sustainability is along three dimensions. The first one is building the best team. The second is innovating products that improve lives and our planet, as well as protecting our environment. Okay, well, what progress have we made there? Well, let's start with building the best team, where among many things, we're looking to improve the representation of diverse populations. In 2021, 75% of our new hires were diverse. 75%. Of course, under innovating products, we are investing significantly more in research and development. 30% is nothing to sneeze at.
In addition to that, we are also including sustainable design processes in our innovation engine, so that what we design is great for the long term, not just the short term, and of course, helping our customers with their challenges. As it relates to protecting the environment, we've committed to reducing our greenhouse gas emissions by over 50%. When we go on our tour here of the facility, you will see sustainability coming to life in concrete terms with Cytiva. Important progress here on the sustainability front at Danaher as well. Now let's switch gears and talk about the evolution of the life. The organic work that we have done with the Danaher playbook and deploying the DBS tools and driving growth and earnings improvement organically was every bit as much fun as the acquisitions.
Having said that, let's look at that, the acquisitions a bit. The way we enter a new adjacency is usually by acquiring an anchor asset, an asset that brings new capability and scale to us, in a new end market. Then we tend to round that out, both organically with new capabilities, as well as inorganically with bolt-on acquisitions to improve that positioning. As you think about the Danaher playbook, what do we do? Well, we tend to remove waste. We tend to identify underperforming processes, remove process steps to shorten those processes, and then to accelerate those processes so that we have more resources available to reinvest in innovation and commercial execution for growth. You can literally feel the flywheel starting to turn as you make progress in applying the DBS tool set to that end.
Let's have a look at some of the results after all of that work. On the right at first, you'll notice that the platform is repositioned from 15% of biopharma sales as an example, to roughly 60%. Of course, our colleagues from the Biotechnology Group will be talking at length about our progress there. At the same time, you see the scale from $3+ billion in 2015 to $15 billion in 2021. The growth rate re-rated from low single digits, here it says to 25%+. Of course, that was the 2021 growth rate. Let's say high single digits long term, from low single digits to high single digits re-rating that growth. The recurring revenue goes from 45% to 70% and over 1,000 basis points of operating margin improvement.
I want you to imagine the effect of the compounding at a higher growth and higher margin with that scale difference over time to see the long-term value creation of not only our M&A capabilities, but also the organic capabilities that we deploy via the Danaher playbook for long-term value creation. Okay. So how do we do that? Well, let's look at how we accelerate growth through innovation in the life science portfolio. What we've done here is we've picked the three largest life science instrument group operating companies, and if you focus with me on the right here for just a minute, you'll see SCIEX, Beckman Coulter Life Sciences, and Leica Microsystems, all of which in that period from 2012 - 2016, you know, grew in aggregate low single-digit %.
Now, you fast-forward to 2017- 2021, and in aggregate, you see them growing at high single digits. How'd you do that? Well, let's have a look here at the left. First of all, of course, we talked about the playbook, which allows us to free up the resources to increase investment in innovation. Removing muda, waste, shortening processes and accelerating them, and then reinvesting in the business in these examples to have the resources to accelerate innovation. What do we see? The use of the Problem to Portfolio tool, which not only allows us to identify customer pain points and unmet needs more quickly, it allows us to do it more precisely. Why is that so important?
If you look at the adoption rate of new technologies in the life science market, if you're off just a little bit with the design of your product, it will materially affect the success of your innovation in the marketplace. SCIEX has done wonders here with the 7500 Triple Quad as a case in point, the most sensitive triple quad in the world. The ZenoTOF 7600 allows scientists to see more proteins than any other mass spec platform in the world. You can see that 40% of the 2021 revenue at SCIEX is attributed to new products. Now, if we look at the accelerated product development tool, this is intuitive.
If you're able to reduce your development times, not only do you get to market first to set the new standard, but of course, in the same period of time, you can do more products because you're using less of your development capacity. What you see Beckman Coulter has done is they have launched over 30 new products in the last 3 years. That compares to 3 products in the 3 years prior to the acquisition. An order of magnitude improvement in the number of products launched. Look at the impact on the right. Beckman Coulter goes from low singles to high singles, low double-digit growth. Very material. Now let's look at product launch excellence. You do all that hard work finding what that unmet need is, and you dial it in just right, and you do it with shorter cycle times.
If you blow your launch, you leave a lot of value on the table. Of course, we have a launch excellence tool, and Leica is a great example for that, where Leica has combined the power of wide field and confocal microscopy at a price point that allows principal investigators to have their own high-resolution microscopy solution. There are many more principal investigators than there are core labs. Now these investigators can have their own solution in their own lab to look at live cells and understand biologic mechanisms and disease pathways, rather than having to send fragile cells through FedEx to a core lab. It's a huge change, and you can see the impact this type of launch excellence has had at Leica, a 40%+ increase from new product revenue in the last three years.
You can see here how the Danaher playbook frees up the resources to reinvest in innovation and is coupled with the D-DBS tool set to allow us to accelerate our growth to improve our growth and earnings trajectory. We have a great example here with Pall of the Danaher playbook in action over the longer term. Now, for those of you who don't recall, we acquired Pall in 2015, and it was about a low single-digit% grower, and the operating margins were, you know, in the high teens%. Of course, we apply the Danaher playbook, which is tailored to the needs of each individual acquisition. We reduced G&A, we reduced the COGS of goods sold, and we reinvested in innovation through R&D as well as improved commercial execution in sales and marketing.
I think the results on the right speak for themselves, going from low single-digit to high single-digit growth. In fact, it was double-digit in 2021 and over 1,000 basis points of operating margin expansion. As you look to the left and you think about the power of compounding higher margins with higher growth rates, we show you here the impact on cumulative operating margin and ROIC. Now, the lower dashed line is what Pall would have performed at with cumulative operating margin, with a margin improvement, but only low single-digit growth. The solid line is the actual result, the higher margin at the high single-digit growth. You can see the leverage of compounding higher margins at higher growth rates over the long term with more than $1 billion of additional operating margin.
Yes, it's important to get it right early in acquisitions. You've got to get out of the gates quickly, and you've got to do really well in value creation in the first 2-3 years. At Danaher, Kaizen is our way of life. Continuous improvement is our way of life for the long term, and you can see the power of that long-term value creation here. Now let's have a look at Cytiva's progress since acquisition. The fact that we are here speaks to the degree of pride that we have in our team that has joined us. The performance that they have shown over the last two and a half years since they have been part of Danaher is nothing short of extraordinary. Nothing short of extraordinary.
That's why we're here, and we wanna show to you what has been achieved with Cytiva and the Biotechnology Group. Now, this was a three-phase process for us. This was a complex deal. Phase one, carve it out. We had, you see this, over 200 transition service agreements which were completed successfully, and GE was a fantastic partner for us in this effort. We had over 3,000 new associates join us, get trained, and deliver value during a pandemic and in a virtual world. Not an easy thing to do. Already, in unaided awareness, our new brand, Cytiva, is the number two brand in the entire space 2.5 years in. Carving out has been a resounding success. Phase two, operate, take care of your customers, and succeed as an independent operating company within Danaher.
You see here, embracing DBS, over 400 Kaizens in our manufacturing plants to unlock capacity, improve productivity, to be able to supply our customers in the middle of a pandemic. Also improving the on-time delivery of our R&D projects by a factor of two. If you look to the right, and you see the financial results, we've more than doubled the sales of Cytiva. We've re-rated the long-term growth from what we initially expected to be 6%-7%, really for the long term here. Not talking about year one, two, or three, but talking about the next seven to 10 years, high single-digit growth. Then beyond all of our expectations, double-digit return on invested capital 2.5 years in. Of course, we're reinvesting in the business.
$1.5 billion here of cash going into expanding our capacities, yes, to help with the supply constraints of the day, but also to be able to supply for the long term, and as importantly, provide the industry and our customers with the best supply security in the industry. That manifests itself in over 2x, you know, the capacity for single-use technologies as just one of several examples which we'll go into in quite a bit more depth. Okay, phase one and two. Phase one, carve out. Phase two, stand up and be a successful company. Phase three, create the Biotechnology Group. This is new.
We're bringing together Cytiva and that $6 billion franchise with Pall Life Sciences, the $2.5 billion franchise, to give you an $8.5 billion growth juggernaut, with $7.5 billion of that revenue being in bioprocessing. Now, you bring these two activities together under the Biotechnology Group, and you have not only the broadest product portfolio in bioprocessing, but also the deepest. When I say the broadest, you can get any point solution that you need in the context of a bioprocessing workflow, or you can get the entire end-to-end workflow, an entire factory, including the clean rooms, the shell, the building, the attachments, everything from the combination of Cytiva and Pall Life Sciences.
When I talk about depth of the portfolio, this combination can do that not just for monoclonal antibodies, but for cell and gene therapies, for mRNA, for oligonucleotides, for CRISPR-Cas9. You name your therapeutic biologic modality, and this combination can deliver it for you, either a point solution or end to end. At the same time, we have brought together the largest global commercial, technical, and service team in the industry, and not by a little bit. This is a team that can deliver those solutions and support our customers with the value proposition, I'll call it zero headaches.
Best-in-class customer experience, helping you whether you're still in the development phase of your biologic molecule or whether you're working that molecule through the entire journey, the clinical trial phases, all the way through to commercialization. We can go that walk with our customers, and they're doing it increasingly every day. Last thing I'll mention here, with the insight that we have gained through this combination, we're able to focus our innovation on what matters most to our customers: quality. Quality means purity. Purity means less side effects. Yield means more productivity and lower cost for our customers in producing the molecule. We also focus on total cost of ownership to ensure that uptime contributes significantly to that total cost of ownership. This is unrivaled in the industry, and this combination is truly unique.
I can't wait to see, quite frankly, what else the biotechnology group has in store for us. We're gonna see some of that here in just a couple minutes. What I'd like to do now is introduce my colleague, Emmanuel Ligner, who is the Danaher Vice President and Group Executive of the Biotechnology Group. Emmanuel.
Thank you. Thank you, Rainer. Thank you very much. Good afternoon, everybody. Good evening, good morning if you're on the Webex. We're going to go deep into the biotechnology group. I will not be alone presenting. I will tell you a bit more about the biotechnology group, but I have also three of my colleagues here today with me. We will talk about how do we differentiate our commercial, our services, our technical capabilities. That will be presented by our Vice President for Commercial and Bioprocess, Amanda Halford. We will move on. I will come back on stage again and talk to you more in depth about our leadership position in monoclonal antibody. I will ask Emmanuel Abate, our Vice President for the Genomic Medicine, to speak about what are we doing for the new modalities.
We will have Conor McKechnie, our Chief Commercial Marketing Officer, CMO, getting confused now with this title, presenting to you a panel of customers. We will have two customers, a very large pharma and a biotech, just discussing with you about how do we serve them. We'll come back, we'll have a small break, and then we'll go into some Q&A. Let's go deep about why we're creating the Biotechnology Group and what we're doing. Just a quick reminder about Cytiva first. Cytiva is definitely a leader in bioprocessing, $6 billion revenue, with an extreme talent.
Talent on the field, PhDs, masters, that are very intimate with the customers, but also a lot of field service engineers which are at the customers days in, days out. They are very well-recognized in the industry and are a leading expert. We have scale. We'll talk a bit more about that. We have a differentiated business and differentiated portfolio. What Rainer was explaining is very important. We start at the very early on development of a product, in university, in a startup, in a translational academy, at picogram level of protein, and then we help the customers step by step to scale up to metric ton through research, development, and manufacturing. I think as Rainer has explained, Cytiva was a transformational addition to the life science platform.
Pall Life Sciences is also very similar to Cytiva, a leader in filtration and in single-use technology with extreme talent, expert in material science and leading around membranes and filtration technology. They have a differentiated product portfolio. They have scale, global manufacturing, and depth of expert to also serve the customers. It has been an outstanding business in and a very attractive business model. This is new. We're taking those two outstanding company and putting them together. We're creating an undisputed leaders in the bioprocessing. $8.5 billion of revenue, anticipating long-term performance of high single digits%. I'd like to spend the rest of the day on the bioprocessing $7.5 billion franchise that we have. We are an outstanding reach to customers around the world.
We're focusing on innovation to bring to customers what they need, products that are going to help the customers to increase productivity and to bring those life-changing therapy faster to the market. Let's talk about which market we are playing into. We're playing into the biologic markets with a market that I'm sure you're very familiar with, but we wanted to give you a bit of overview before we go a bit deeper. Medicine starting early in the 20th century with small molecules like aspirin or proton pump inhibitors, which are actually manufacturing through a chemical reaction. But we are absolutely not in that segment. A bit, but very, very not. What we have been doing for the last 60 years in Cytiva and more for Pall, actually, we are really working with medicines which are coming from a cell, biologics. It started with recombinant protein.
It started bioreplacement therapy. Diabetes patients who don't have enough insulin. Patients who are hemophilic, that need factor eight, factor nine coming from plasma, blood plasma fragmentation. We've been there from the very, very beginning, and we are still in that segment. More and more, the market has evolved to monoclonal antibody, and we'll talk about this. New modalities, new therapies, new tools, oligo, cell and gene therapies, mRNAs, which of course you've heard with COVID vaccine. The industry is constantly evolving, and we also are evolving with our customers to make sure that we continue to serve them in that biologic market. This market is a fast-growing market. As you can see, if we look over, today, if we look at the pipeline, 60% of the total medicines are biologics, compared to only 20% just 20 years ago.
There's an incremental spend from our customers, from the industry into biologics. There's more than 20,000 compounds today in development. Now, of course, not all of them will make it to market, but it is our role, and you will see that during the Gemba walk, to make sure that we track every single of those molecule, where they are around the world, and that we serve the customers to make sure that we help them to go faster at incredible yield, at very productive way to produce those compound. The genomic medicines, those new modalities that Emmanuel Abate will talk to you more in detail, look ten times more in pipeline today versus 2015. On the right, you have the approval.
You have the products that are coming to market for treating the patients, and as you can see that there's an acceleration of approval. Now, this is only the U.S. data. Think about it, other markets, as well, maybe other biologics, China, Europe, India and so on. You can see that really the biologics and genetic medicines are still at the very, very beginning of what is coming over the long-term period. How do we win in this market? Well, as Rainer said, putting Pall and Cytiva together bring to our customers a broader portfolio, not only on the workflow for monoclonal antibody, and we will go a bit more in details later, but also in other workflow like mRNA, CAR T cell therapies that you will be able to see upstairs later in the gemba walk, gene therapy using viral vectors, et cetera.
We have a leading position in upstream, a leading position in downstream. Just to give you a bit of reference, we'll talk a bit about the single-use technology, which is really the way, the modern way of producing those biologics. Our revenue in 2021 was in excess of $1 billion. It's not only about the portfolio, it's not only about the breadth of the portfolio. We are wrapping up those high technology product with an incredible team, an incredible service, scientific service that help the customers to do more, to go faster, and it's a global scale. Our commercial team, and again, you will hear that more in details, are really capable of helping the customers all around the world. This is a global business.
You can have molecules which have been developed and found in California, which is moving here to the East Coast and then which is moving to Europe. You can have a molecule studied in China which gets produced in Korea or actually gets produced in multiple centers around the world, not only in Korea, but in Switzerland or on the East Coast. You need to be able to serve the customers with the same level of quality products and technical support all around the world, and you will see that we have the scale. We not only have the commercial scale, but we also have the production scale. We'll talk about security of supply, something which is extremely important for the industry today, and I will explain to you why a bit in a few more slides.
As Rainer said, we are constantly investing in organic, in new product, in new technology, working with our customers, having collaboration, and you will hear with our customer panel some of the collaboration that we are doing and why we cannot do it alone, they cannot do it alone, and therefore collaboration is important. We have the scale to do this. We're investing more in R&D every year. We also have an incredible capabilities of doing inorganic investment. This is something which has been really fantastic for us joining Danaher, is to be able to invest capacity when we need to, is to be able to make the acquisition when we need to, and we'll talk a bit about that later.
Really, our day-to-day life and our day-to-day mission is to really advance and accelerate those life-changing therapeutics with our customers to go faster to market, but also to reach more patients around the world. Let's go through an example of a workflow for molecules. This is a workflow of a monoclonal antibody. I'm going to quickly explain to you a bit of what we are showing here, but you will have an opportunity to go a bit deeper later, but actually seeing all the different products one behind the others. To manufacture a monoclonal antibody, you take one cell. You genetically modify this cell. To make a biologic, actually, your cell is your factory. Your cell is going to produce the protein you want. You take that cell and you grow it.
What you need to provide to the cell is food, cell culture media. You need to grow into bioreactors. When the cell is ready, and when you change the chemical environment of the cell, the cells start to express your protein or to produce your protein. You end up with plenty of things that you don't need and the protein you need. You are going to go into clarification steps where you separate all those different bits. You need to capture the protein that you want. It's your capture steps. What you do right after is you make sure that you have no contamination, so you do a viral inactivation. You filter, basically, to remove virus. You cannot sterilize a protein. You cannot heat it. It will die or disappear or degrade.
From there, you move into an intermediate, and you're only 95% pure at that point of time, so you want to continue to purify your protein. You go into what we call polishing steps. That's chromatography steps. Two steps most of the time. You do another viral filtration, and then you go into formulation, which going to be your final formulation. At that point of time, most of the times the product is what we call an API, an active pharmaceutical ingredient, and you freeze it here, or you go straight to fill and finish. To be able to fill and finish, you need machines and some consumable called bag filter, and then you introduce your product into vial or into your final injectables, like prefilled syringes.
Look at where Pall is in that workflow. Clarification, viral inactivation, viral filtration, formulation, and sterile filtration. At acquisition, Pall was about, like science was about $1 billion and a single-use revenue about $200 million with leading position in filtration. Now, when you put Pall and Cytiva together, this is what happened. I'm going to do it again because I like it. A complete solution to the customers. From the very, very beginning, from the cell to the vial. From an idea to a drug delivery. This type of complete workflow is not only available in monoclonal antibody. We'll see latter are kind of slightly different but the same similar complementary of Pall and Cytiva for other workflow such as viral vectors and mRNA.
Today, our bioprocessing business is $7.5 billion, of which the single-use technology is in excess of $1 billion, and we really anticipate a long-term growth rate of high single-digit %. Cytiva and Pall together is an incredible offering to the customer, and therefore in an incredible position. We are so much stronger together, and this is why we're doing it, because for the customers, it matters to have a complete solution. Our customers do not want to take time to take a machine from one company, a machine for another company, a consumable for this company, and try to put it together. It is easier, it is faster to work with a complete solution provider, but not only on the tools, on the consumables, and also on the service and the deep scientific experience, and experts that goes with it. Now, we don't have only those product.
We need to wrap it up with an incredible service for our customers. On the left you have two services, one called Fast Trak in Cytiva and Pall has quite very similar services, but I'm going to explain you how those service fit together. What are we talking about when we talk about services? Basically, we are working with customers on their process to optimize their process. From cell line development, optimization of the cell line, optimization of the production of the protein at the cell line level to make sure that the yield is improved, increase productivity in downstream, making sure that the customer is choosing the right chromatography resin that given the maximum yield, working together to scale up.
As Rainer said, as I explained earlier, we are capable of helping the customers with the complete workflow, not only at manufacturing scale but at lab scale, from picogram of protein to metric ton of protein. Fast Trak has been around for 30+ years, and in China more than 15 years. You will go through the labs there. This is one of the labs that we have around the world, where really the customers bring their processes and our scientists, our PhDs are working with them hand in hand to make sure that we get the best and most robust processes which can be transferred to other places around the world.
We have Fast Trak unit in Shanghai, in Seoul, Korea, in Tokyo, Japan, in Mumbai, in India, in Europe, and here in the United States, and Pall is adding on services in Germany and in the U.K. with more than 400 experts in filtration to make sure that we help the customers to validate those filters for those incredibly important molecules. We also have more than 1,000 field service engineers everywhere around the world, which are here to make sure that they can help the customers with a bit of education on the machines or on the equipment, or just to make sure that those equipment are up to date with the latest software, which are working absolutely perfectly, especially when you are in a GMP environment. Again, an incredible scale to serve the customers from R&D, development, to commercialization of those compounds.
Now, talking about scale, I think it's always good to give numbers when we talk about scale. Pall and Cytiva together, it is 16,000 associates located in more than 41 country, I think, if my memory is correct. Yeah, actually it's written there, so I should just read. 110 country where our product are available. We are selling our product in more than 110 countries. We have 36 manufacturing sites all around the world, and we have more than 20 R&D and innovation centers. Something maybe which is more, and which have been more exciting since we joined Danaher, is our ability to invest in capacity of production, our ability to reduce lead time to our customers by adding more capacity. We've committed to $1.5 billion of capacity expansion.
We've shared that last year across 2021-2025. As you can see, we are really investing in every single important product line, cell culture media, the food for the cells, single-use technology, which are those disposable products that we will talk a bit more later, chromatography resin and membrane and filtration. Those investments are ongoing, but as you can see, we are doubling at a minimum the capacity of production in many of those products, and we have a commitment to reduce lead time for our customers up to 85% versus where we are today. This has been a game changer for us. Not only this, we have used and leveraged the DBS tools to make sure that we deploy those capacity of production in a record speed.
By leveraging DBS tools like Visual Project Management, Daily Management, and Kaizen when we face problems, PSPs, we've been able to deploy in Cardiff, in Wales, in the U.K., 120,000 sq ft single-use manufacturing plant in 15 months, which is 30% faster than when we used to do it in the past. This is just demonstrate where the DBS is an incredible power tool for a company like Cytiva, which is just joining a bit more than 2.5 years ago. This has helped us to double the capacity in 15 months. We have also leveraging the DBS in our organic, R&D. We have invested in excess of $100 million of incremental annual R&D spend. When we deployed those capitals, we have only one thing in mind, customer needs. Today, customers want speed and productivity.
It is about accelerating time to market, it is about improving yield, and it is, of course, about operating cost reduction for our customers. Those are example of recent launch that we have. From Cytiva, the ÄKTA oligosynt. We are the leading companies in the oligosynthesis equipment. Pall have launched modular bulk fill system, which I show in the workflow, which is at the end just before fill and finish. Then an example that you will be able to see live upstairs when we talk about cell therapies, it's a Chronicle digital tool, which is the first GMP manufacturing automation software for tracking the CAR T cell therapy. Since 2020, we have increased by 2 times the revenue from our new product as a contribution.
Again, something that is really great for us now that we are part of the Danaher house. Not only we've been busy with capacity, with incremental R&D, we've been also capable of making some strategic M&A and strategic acquisition, not only in workflow differentiation, but also sometimes just in capacity. Intermountain, for example, has been one where we have added capacity for high purity water, for buffer, but also brought new capacity for new special liquid for cell culture media, but also for the genomic medicines. Precision NanoSystems, very important acquisition for us. Emmanuel Abate will give you a bit more details, but when you inject an mRNA, when you create an mRNA, it's incredibly fragile. You need to protect the mRNA, and what you do is you encapsulate the mRNA into a lipid nanoparticle.
You put a little fat around it, if you want, to protect it and to be able to inject into the human body as a delivery system. Well, Precision NanoSystems is a leading company of microfluidic technology to encapsulate mRNA into LNP. Not only they have that incredible machines that you can see, a bit later behind and upstairs as well, which can be used at research scales, development scale or GMP manufacturing scale, but they have also an incredible library of those LNP which are so critical because they are going to work with the customers in a service relationship to develop and to try and to test those unique LNP for the customers. GoSilico is a completely different acquisition.
We are moving into a digital world, and our customers can gain a tremendous amount of time if they do in silico simulation of their processes, in particular in downstream. How I'm going to capture, how I'm going to polish my monoclonal antibody. This is a very interesting software which help the customers to reduce their development time and bring modern tools, I will say, to their development. Robust simulation in silico, and then that they can try at the bench. Finally, from Canada, from Vancouver, the leading provider of robotic aseptic filling, which is very important for the last part of the process that I show, not only for monoclonal antibody, but very important for gene therapy and mRNA and personalized medicine, and I think Emmanuel will talk about this.
We've deployed more than $500 million of bioprocessing M&A since Cytiva acquisition. Again, something that we are super proud about, and we have been able to do this because of Danaher business model. Now in summary, I hope you feel that I am super excited that this is a dream come true for me. I've been in this industry for 18 years, and the combination of Pall and Cytiva is incredible. We have created an undisputed leaders in bioprocessing with global reach, with long-term growth opportunity because the market is solid, because our product are unique, and because our talent are phenomenal. We've differentiated. We're comprehensive comprehensive portfolio. We have a commercial reach which is undisputed, incredible, and I want to take a bit more time about this, but I'm going to ask our VP of Commercial and Bioprocesses, Amanda, to do so.
Amanda, the floor is yours.
Thank you, Emmanuel. Good morning, everyone. Emmanuel has talked you through our technologies, our market, and our future. I want to take some time to talk about how this impacts our customers, how bringing Cytiva and Pall together will be better for our customers, enable us to drive an enhanced customer experience, and get better outcomes, positive outcomes, for our customers of the Biotechnology Group. I'll touch on our commercial strategy, a strategy of following the molecule to really drive our commercial action. How by adopting DBS, we really drive competitive advantage by continually challenging ourselves, so how we can improve our commercial processes and improve that customer experience. How we do that through our team of scientists and engineers to deliver best-in-class service and problem-solving.
Emmanuel talked you through the evolution of the biologics industry, how it's gone from a few molecules in the 1980s to, you know, a multitude of modalities and molecules today. What does that mean for our customers? In the 1980s, we had a few global biopharma customers. Today, we've seen an explosion of customers through academic translational centers through to biotech. We've gone from a few global customers to thousands of customers, and that gives us a fantastic opportunity to nurture those customers through the development process. What do our customers do? No matter who they are or what molecule they're working on, whether they are a small biotech or an academic lab or a large biopharma, they're all working through the same development process.
Starting out in preclinical, where they have an interesting molecule, wanna test in non-humans, through to phase one, where we start to look at patient safety in human clinical trials, all the way through to commercial launch. It's always the same process. You can see that the majority of our revenues today come from the later phases, so looking at phase three and commercial manufacturing. This is when our customers are scaling up for large scale trials and moving into commercial manufacturing, which is repeat manufacturing. Today, our revenues come from those commercialized biologics. The heart of our work starts early in the phase, at that preclinical and phase one stage. There you can see there are thousands of molecules in those phases and all of those many customers working to develop them through that process as effectively as possible.
For us, it's important to engage in those early phases because that's where we partner with our customers to help them develop and improve their processes, and in doing so, design in our products, help them choose the best resin or media or filtration product for their process. That's what will guarantee us our future revenue streams. If we look at our customers, from academia through to the CDMOs, we see different customer segments. While they're all doing the same thing in the development process for the pharmaceuticals, they actually have very different needs at the same sort of phase. If you take, say, phase one, preparing a molecule for your first in human trial, and you'll need some CGMP material to put into the patient.
You know, if you're looking at a biotech company, small company, maybe it's the first time they've sort of achieved this step, they may not have all the in-house knowledge to know how to do that. They may not have all the talent they need to be able to progress in that phase. That's why they would partner with somebody like us to provide help, knowledge, advice as to how to do that. We'd engage a service in process development to help them determine that process. If you look at, say, a large biopharma company, they probably have a lot of expertise in that area. They will have developed many molecules, and they're more likely to come to us to work with us in partnership, say, develop or choose the best product for their particular process.
We may work with them on customizing a product to really optimize their manufacturing process. Customers have different needs. As we follow the molecules through the phases, we organize our sales teams around the customer segments, and that enables us to deliver our products and our services in the best way to a specific customer. To have differentiated customer value propositions and really deliver that locally at the customer. There, where the customer is. We have an organization which has this global infrastructure, a global framework, and by that I mean process, systems, and knowledge, but we deliver it locally to the customer. This is where the scale of Pall Life Sciences and Cytiva coming together will really enhance that customer experience as we increase our coverage in the market.
With over 4,000 associates who are in customer-facing roles, and if you remember earlier, Emmanuel saying we have 16,000 associates, that's a quarter of our associates in customer-facing roles working locally with the customers to really understand their needs and provide that relevant solution. The 4,000 associates in over 100 countries, we're very local. We're working with our customers. We drive a real customer intimacy through those relationships. We're able to understand the need at any phase of the process for a customer segment, and we're able to bring in the right scientists and technical resources to solve that problem, to work on that need. We know this works. We know it works well because the feedback from our customers tell us that we have a 96% customer satisfaction for our service. That's a fantastic achievement.
I'm very privileged to lead a team that are able to deliver that day in, day out across so many different customers globally. While that is good, we know we can do better. What's important, we know we have to continually innovate and evolve to stay ahead of the game. That's where really we can leverage DBS. DBS, the philosophy and tool, and toolbox that we use, really challenges every day to improve and to question how we work, how efficient we are, how we can get better. I can give you a couple of examples. By deploying standard work for the lead generation process, we were able to increase the quality of our leads by 20%. That meant that our leads were more relevant, more timely in the way in which they were delivered to our sales force.
It's through a process that we've developed the screening globally, we're able to drive those leads out to our sales force in a timely way through our CRM. That has resulted in us acquiring over 1,000 new customers, 1,000 new biotech customers over the last 18 months. We can really see DBS in action as we improve those commercial processes. It brings a rigor that you would usually find in a manufacturing environment into a sales environment. We combine that with our scientists and our engineers, and it really enables us to differentiate our customer approach and experience. We've also used DBS in terms of visual and daily management to track molecules through that development process. We are able to visualize globally a molecule track it through every phase of the funnel.
We're also able to track it globally. Our customers move their projects around. Maybe they do their research in California, their development on the East Coast, and then send the manufacturing of a commercial molecule to Ireland, for example. We're able to track over time, over the process, geographically where these molecules are going, so we don't drop the ball. We're able to make sure we can continually track that, and that gives us that great opportunity to design in, follow the molecule, and really achieve the revenues in those phase three and commercial stages of manufacturing. I've talked about how it's important to, you know, continually improve processes, but we also have to focus on, you know, evolving our services. Services are important because they really create that intimacy with the customer.
It takes your relationship from transactional to more of a partner relationship. As we engage with the customer to improve and add value to their process, and by that I mean helping to increase their yield, reduce the time, or reduce the cost through any step of the process, that's where we can really develop that long-term relationship that's needed to take a molecule from early phase, work with the customer from early phase through to late phase. Here we've got some really good examples. Emmanuel referred to earlier Fast Trak and process development. This is something in Cytiva we've done for over 30 years, helping customers optimize upstream and downstream processes.
The last 15 years, we've been doing that in China. As we combine with Pall, we now have more of a global footprint to do this. We're able to do this across the filtration process as well. We're also able to expand across more modalities, so not just mAbs, but gene therapy, viral vectors and such. It could be as simple as providing training and education services. Talent is scarce in the biotech industry, and the ability to train and bring people like our operators at a customer's manufacturing site to a point where they are able to go into the manufacturing facility and be effective in their work. We have ways of doing that in a virtual way.
We're able to do that with speed, and we're able to do that with efficiency and really help our customers gain in productivity in their manufacturing suites. By having this range of services which we can apply at different points in that development cycle, we really are able to drive a really close customer relationship, enhance the customer experience, and build that relationship over time across the development cycle. Really, having a differentiated commercial model, it's about having the local resources supported by the global infrastructure that enables us to work with our customers from lab to commercial manufacturing. DBS is really helping us drive our improvement philosophy, really keeping us challenged and sharp to enhance our competitive advantage.
Most of all, it's our teams of scientists and engineers who are out in the field every day working with our customers and bringing those services and bringing those solutions to help them get their therapeutics to market faster. With that, I'll hand back over to Emmanuel, who'll take you through the monoclonal antibody process.
Indeed. Thank you very much, Amanda. Thank you. I will see you back for the Q&A session. We're going to go a bit more deeper in the portfolio and more portfolio specific to some of those biologics, and we will start with the monoclonal antibody. We'll talk about our leadership position in the monoclonal antibody. We'll talk about why the monoclonal antibody is so important today, our portfolio differentiation, and probably more important, we'll give very clear example on how we help our customer to really accelerate their molecule to market through flexible manufacturing solution. Remember this slide? Now we are in monoclonal antibody. Emmanuel Abate, which will follow my second presentation, will take care of the cell and gene therapy. Why monoclonal antibody? I think Rainer shared the slide earlier about the Danaher revenue is around 60% coming from monoclonal antibody.
It's over the last five years, the fastest growing segments of the market with more than 50% of molecules in development. Biosimilars have increased significantly as well. Biosimilars are actually very good because biosimilars bring those life-changing therapies to more patients, to people that could not access and could not afford the originator. We're supporting as well biosimilars, but biosimilars are also boosting the monoclonal antibody market. If we look at high-growth markets, places like China, it's a bit behind around monoclonal antibodies, but they have accelerated dramatically their spend on the biologics. If we look at the data over the last 10 years, it's an increment of 25% spend on biologics, and this is really a market which is catching up and a market where we are very well positioned as well.
If we look at the monoclonal antibody pipeline, we're expecting growth at double-digit over the next five years. What is our offering in this? Do you remember our Pall and Cytiva combined portfolio? You can see below circle that shared with you our vision about our own product completeness, the comprehensiveness of the portfolio, if you want, for every single path. We're leading in the cell culture and single-use paths. We are leading in downstream chromatography, and we are very strong in filtration. I want to go a bit more in detail about this. Today, this incredible portfolio, this incredible combined portfolio is used in more than 90% of all approved monoclonal antibody. This give us the annuity that we were talking earlier, the 80% annual annuity which is coming. Now, how do we have a differentiated portfolio?
We'll go through cell culture media, single-use technology, chromatography, and filtration. Let's start with cell culture media, which is, you remember, the food for the cell and how have we grown market share over the last 5 years. Well, first of all, security of supply. We talk about those global molecules that are made in many different sites. We talk about the fact that the customers want a service which is impeccable. Well, we have manufacturing site in the U.S., in Europe, and in Asia, and which have the same quality, the same tools, the same quality system, the same product line. So we can serve multiple customers at different places in their own network. This is a huge differentiation. Our production also has a unique control system of the media purity, which give profile of every batch at really small parts per billion of data.
We are capable of differentiating our offering with an incredible control system of impurity. Then we have services. We talk about Fast Trak services, we talk about the SLS services from Pall, those two combined services. Amanda just gave you a bit more details about it. Well, we also offer that services in cell culture media. Cell line development, cell culture media optimization, feed optimization. Again, working with the customers to improve their productivity. All this are giving us the opportunity to grow faster than our peer in this segment and gain market share. Let's talk about single-use technology. Before we go about our portfolio and our offering, maybe I should explain a bit of the history of the industry.
To go back to the recombinant protein, the insulin, for example, this was manufacturing at the very beginning and still today in a very large biomanufacturing plants, which were stainless steel. Very complex, all in stainless steel, very inflexible, very expensive to build. With the evolution of science, the cell, which is your production plant, if you want, the cell have evolved and the technology has evolved around the cell, and the cell can produce more protein. The size could be reduced. Then company like Pall or us in Sartorius, brought new technology to the customers, technology which are much more flexible. You don't need a stainless steel complex plant anymore. You just need a workflow, as I show earlier, that you will see later with silicone tube, with aseptic connectors, with bioreactor bag, which are for one batch.
You have your equipment, you make your batch, you take your entire flow path, your entire bioreactor bags, pre-packed column that you will see as well in chromatography in downstream, and then you move them away, and you can make another batch. This has been a revolution for the industry because it bring cost of goods sold reduction up to 30% in average. It bring plant which are much more smaller footprint, so cheaper to build, 40% cheaper investment cost. It bring also extreme flexibility. In one plant, you can do different molecules. You can do a campaign in one molecules and do a campaign with another molecules.
It reduce the turnaround time because you don't have to clean the stainless steel plant with a lot of water, a lot of chemicals, and therefore it reduce your carbon footprint, it reduce the use of water, it reduce the use of energy. Today, 90% of the biomolecule being developed are developed using single-use technology. This is where we are leading the pack with revenue with more than $1 billion in 2021. How do we differentiate ourselves? Well, first of all, a very complementary and comprehensive portfolio.
Not only we have single-use technology for small volumes, but for also large volume, not only in upstream, in the cell culture media and the cell growth area, but also in the purification area, in the downstream, as you can see in the second graph there, where we provide flow paths and pre-packed column, which give a lot of flexibility, a lot of speed to the customers. We are the leaders in the fastest-growing category of tools for bioprocessing monitoring, bioprocessing manufacturing. Again, from the R&D development to manufacturing. Now chromatography. Well, chromatography, this is something that we've been doing for more than six decades. The first chromatography resin was launched in 1959. I'll tell you a story in the next slide.
We have an incredible expert team with the largest R&D team around the world focused on purification, focused on those unique steps of capture and polishing steps. We have an incredible portfolio, more than 80 different resin, but resin that you can find in very different format, from 1 ml, very small column, pre-packed column, to 60-liter pack. We have also the equipment that goes with it, which is also so important. We have the largest capacity of manufacturing of more than 1 million liters as installed capacity. You may have heard that we are building a second site in Michigan, in the U.S., to increase our capacity further and to be able to have an incredible security of supply for the industry. We want to maintain the leadership in chromatography. This is really an area where we have an incredible strength.
The reason is we started extremely early on. Let me tell you the story about the first chromatography resin launched in 1959, called Sephadex. 60+ years later, this product is still growing. It is still used in more than 50 approved biologics today. Not longer than two months ago, I opened a brand new site for manufacturing more of those products because the demand is still there and it was part of the capacity expansion that we've done in Uppsala, Sweden. The reason that it really matters is that our customers today, which are investing billions of dollars in their compounds, want to make sure that they are partnering with a supplier which is going to be here for the next 60 years.
The trust has been built up by us continuously manufacturing product to the same quality with the right quantity to be delivered on time for all those customers along all those decades. When I joined the company about 18 years ago, our capture step product and the best product we had was MabSelect. We launched MabSelect SuRe, MabSelect SuRe LX, and four years ago, we launched PrismA, which is today the golden standard in that capture steps. During that time, if we compare the product, we've increased productivity to customers in terms of how much protein you can capture when you do that chromatography steps by more than 2x. This is the golden standard today, and we will continue to invest to bring to the customers better chromatography resin. It's based on innovation.
It's based on relationship and intimacy that we have with customers, as Amanda explained. Now, let's move to filtration. Pall is an incredible leader in filtration. It has decades as well of experience on membrane technology, on encapsulation of those membrane into filters. More than 10,000 patents around filtration, around separation. All the innovation that we are doing is about higher yield, higher flow speed, and longer life of those cartridges, those filters. We have an incredible portfolio, but I think what is more important is we have scale. Global manufacturing footprint, technical services, support capabilities. I just want you to remember one number around filtration. In 2021, we delivered to customers more than 5 million units of Pall filters in the life science industry.
When there is a problem for filtration, when we have customers with a challenge on separation needs, this is the place to go. Pall is well-known for solving those customers' problem. Now, we spoke about speed. We spoke about the customers that wants to have this one solution. Let's go a bit more in details about this. About 10 years ago, we launched FlexFactory and KUBio. You may have heard about this in the industry. What it is basically when a customers is looking for capacity of production, they can come to Cytiva, and we will work with tzem to deploy that capacity of production in record time. We will take on the project. We will work with them on the design of the factory. We will work with them on the planning of the delivery of the product.
We'll plan with them on the automation because we will provide a fully automated factory for them in a record time. If the customers have a building, this is a FlexFactory. If the customer do not have a building, just a greenfield, we will build the factory for them using the KUBio technology, which is a modular facilities. We've done that for very large customers such as Pfizer or Lonza in China. The benefit for the customers is a reduction of operating expenses, a reduction of capital expenditure up to 50%, and more importantly, a reduction in time to market up to 50%. One-stop shop, turnkey project, one point of contact, multiple parallel track, which give us the ability to really go fast for the customers. This is proven. We've done that in more than 100x .
Well, 127x to be precise. In the last 18 months, we sold 27 more FlexFactory around the world. We are doing this not only in monoclonal antibody, but also for viral vectors and also for mRNA, for vaccine production. I think maybe you'll be a bit tired about listening to my French accent. What I'll propose is that we watch a short video, and then we will wrap up the monoclonal antibody, and I will pass the microphone to Emmanuel Abate. Can you play the video, please? Cytiva's FlexFactory is a manufacturing platform for key biologics. The end-to-end integrated solution helps biopharma establish agile manufacturing capacity in a new or existing facility, maximizing throughput and efficiency, no matter the space.
Manufacturing processes are automated from cell culture to fill of the final product. Our single-use technology and modular design allows our customers to modify their workflow efficiently, reducing downtime during runs and between batches. For biomanufacturers who are quickly evolving to meet the demands of smaller batch, personalized medicines, the FlexFactory platform delivers the agility and speed they need to bring future therapeutics to patients around the world.
In summary, we have a leading position in monoclonal antibody, which is today the largest class of biologics. We have scaled and differentiated portfolio with leadership across the bioprocessing workflow, and we have this incredible differentiated solution of flexible manufacturing solution to help our customers to be more efficient, to reduce costs, and accelerate time to market. We have that not only monoclonal antibody, and I think it's time to speak about the genomic medicines. I apologize in advance, Emmanuel, with another French accent. Thank you, Emmanuel. Yes, more French accent indeed. It's a pleasure being here and have the opportunity to share with you our progress and plans for genomic medicine. mRNA needs no introduction, of course, and I'm sure you've heard or are familiar with cell and gene therapy. They have the potential to bring transformative change to healthcare.
They also come with significant manufacturing challenges. What I'm gonna share with you is how we see that as an opportunity for us to make a difference by solving big problems, as we do that by setting standards for this new wave of biologics and build a long-term sustained business franchise. I'm gonna talk about the basics of genomic medicine, give you an overview, and talk about the manufacturing challenges that come with these new therapeutics. I will then take you through the positions we've developed over the past 10 years in genomic medicine and how we continue to innovate and partner to make this space progress.
By now you're very familiar with this page, but really, you know, what we've done over the past 50 or 60 years is really fundamental, and we see that as the enabler to the future. The expertise we've developed in biomanufacturing, the scale we have, our ability to invest, and our business model of installing factories and then generating annuities. This is how we are tackling genomic medicine. You might now wonder what we mean by stimulate, modify, harness. Here's what we mean. When monoclonal antibodies do a fine job, a great job at managing, moderating a disease, genomic medicine have actually the potential to cure the disease. How? Well, monoclonal antibodies, you mass produce proteins, you inject them to the patient.
That doesn't have a permanent effect, and so you need to keep repeating the treatment over the length of the disease. With genomic medicine, we inject the patient with genomic information, and we turn the body into the factory. By doing so, we induce a permanent cure or permanent effect. There's different ways to do this, okay? I'm trying to simplify and bring up four workflows here. The first one is gene therapy. Gene therapy, we take a piece of genetic information, we put it into a virus, inject the virus, the virus goes in the cells, it infects the cells, and once it's in there, start producing the protein of interest. As you, I'm sure know, there is already a couple of commercially available drugs targeting rare disease.
No later than a couple of weeks ago, hemophilia A, a treatment against hemophilia was approved in Europe, opening the door for broader population type disease management. Gene editing therapy. In this case, same viral vector, but we use techniques such as CRISPR to come and modify the genome of the patient, and that's how you induce a permanent treatment. mRNA therapy, of course, no introduction needed. As you've heard from Emmanuel, in this case, we encapsulate a little piece of mRNA in a lipid. The lipid is delivered to the cells, express the proteins, the famous spike protein in the case of COVID. Lastly, cell therapy, which is a bit of a different workflow and manufacturing process.
In this case, we take the cells of the patient, we take them to the lab, we modify them, we educate the immune system to go and target cancer in general, and reinject them into the patient. Now, the manufacturing challenges associated with those therapies. For monoclonal antibodies, you mass produce those proteins, you inject them, it's the same treatment for every patient. In this case, these are very personalized treatments. We're looking at much smaller scale equipment. In this case, where the cell was the factory in the case of monoclonal antibody, in this case, the cell is the therapy, and the virus is part of the therapy. Virus and cells are extremely fragile. Some people compare manipulating virus as manipulating snowflakes. They need to be handled with extra care, and that requires new consumables, new hardware.
In fact, we're at the very early stage of those therapies. We are at a point where by innovating, we have the opportunity to set the standards of how those therapies are gonna be manufactured in the future. Genomic medicine for the Biotechnology Group is still a very relatively small part of our activities, the fastest growing part of our business. Huge investments going into the space over the past 10 years. The announcement from President Biden earlier this week, a lot of this cancer money is actually gonna go into genomic medicine. Thousands of clinical trials, hundreds of them in late stage. This is really a space that is maturing.
The disease, you know, started with rare disease, going into cancer and going into broader, chronic disease and of course, vaccine expanding the opportunity for patients. Now, before I go into how we serve this industry, I'd like you to hear the story of a patient, and we're gonna invite Emily Whitehead to tell you her story.
You know, I wake up blessed every day to still be Emily's father. My wife Carrie, who works in research, noticed that Emily had blood on her gums twice when she was brushing her teeth. Something's wrong, and I googled it. I was like, you know, "Holy cow." We had Emily admitted to Hershey Medical Center on a morphine pump, and she had cancer.
One of the things I love about life sciences is the impact we have on people. We make a difference, right? Twenty years ago, we used to measure success with how many more months can a patient live without the cancer progressing. Today, we're able to use the word cure.
We knew standard treatment, chemotherapy, radiation or surgery wasn't gonna fix her. One of the best moves we did is enter her as the first child in the world to have her T-cells trained to recognize and kill her cancer.
What is cell therapy? At a very high level, it's empowering the body's own immune system to attack and fight cancer. We do that by taking the patient's own T-cells out of their body and genetically reprogramming it. When put back into the body, the T-cell docks with the cancer cell. It sends its normal signaling to the body's immune system to attack the cancer just like it would any other disease that the body gets. Basically, that's in a nutshell is cell therapy.
This is the workflow for CAR T. In fact, those are pretty much the instruments that were used to develop the therapy for Emily. We've started investing in that space about 10 years ago. Really, at the very beginning, we partnered with leading science institutions, tweaking our bioprocessing equipment and thereafter developing bespoke dedicated equipment. You'll get to see the workflow and all the equipment upstairs during the Gemba visit. I'm not gonna take you step by step, but you'll see, you'll get to see it all. The results of these 10 years of work is that we are now designing most of cell therapy available commercially.
We're designing in every of the five CAR T therapy that are available commercially, and we're the only one that is actually able to do back to the FlexFactory to do an enterprise sale and sell the complete workflow end-to-end to customers. Another workflow is the mRNA workflow, and this is how you make the COVID vaccine. All right. It starts with DNA, then RNA, then it gets encapsulated into a lipid using our PNI instruments. Emmanuel talked about them. Then it finishes with aseptic filling, which we also incorporated through the acquisition of Vanrx last year. We're now one of the very few that are able to serve this workflow truly end-to-end. Very close to this workflow is the viral vector workflow. We are bringing the Cytiva downstream chromatography with the Pall filtration and bioreactor.
We are now also able to serve this workflow end-to-end. As a result, over the past 18-24 months, where there was truly a surge in capacity and demand for both viral vector and mRNA, we've been able to install 25 FlexFactory that thereafter will generate consumables and reagents annuities. Now, this innovation story is just starting, and there are still significant barriers to the adoption of those therapies. One of them is cost. Still very costly to manufacture. Customers continue to need help to make sure that we help them improve the potency while maintaining the safety of these treatments. Four areas among others that we work on. The first one is digitization.
One patient, one batch, hundreds of pages of manual records that we're moving, enabling customers to move to a digital platform, helping them to reduce costs, helping them to improve and guarantee compliance of the batch record. Cost. You'll see upstairs the process is still very scattered. We're bringing all these instruments together, automating the process with the ambition to reduce the labor cost by up to 50%. Production. We're developing bespoke dedicated viral vector bioreactor. The iCELLis adherent bioreactor from Pall is an industry standard and our platform for development of bioreactor going forward. Finally, because this is not only about manufacturing the therapy, but it's actually bringing it and protecting those cells from the patient and back to the patient, we have the full suite of dedicated cold chain management equipment just for the cell therapy workflow.
Now, we don't do this alone. This space is buoyant with innovations. There is new things coming out every day, and at the heart of our innovation strategy is partnership. In fact, this business was built around partnerships and acquisition that we scaled up. A couple of examples here. CCRM up in Toronto, Canada, we work with them. We co-locate scientists, and we work with them on the automation and the scaling of the CAR T workflow. ATCC is a partner in the U.K., where we work with them on our cold chain equipment portfolio development. Nucleus Biologics in California, we work with them on cell culture media development.
There is still a lot of work that needs to happen, and that can happen to enable the growth of these cells in the best possible way, and we work on Nucleus Biologics on this. Lastly, Caring Cross. Caring Cross will be here for our panel later, and you'll hear how they work on addressing the cost barrier of cell therapy, and we work with them in that endeavor. The last example of partnership, a very important one, is the partnership we recently announced with Bayer, and here again, you'll get to hear from Bayer in a little while. This process that you saw that cured Emily, one patient, one treatment, back to the patient. What if we could use healthy donor cells, and from one batch serving multiple patients?
That's what we call the allogeneic cell therapy workflow. The program we have with Bayer, multimillion-dollar co-investments, is about developing scalable end-to-end manufacturing solutions for allogeneic cell therapy manufacturing. Before I conclude, I'd like to bring back Emily so you can hear the second part of her story.
It was a great day when we finally gave her her T cells back, her own T cells that were trained. They checked her bone marrow again, so that's just 23 days after her first dose of T cells, and she had no cancer. They couldn't find any leukemia in her system. She's nine years cancer-free and coming up on nine years since she spent a night in the hospital.
When we develop a cell therapy product, we change the way medicine is practiced in the hospital, and that's innovation. We're creating and influencing a support structure of raw material suppliers, of technology partners, to help us create a piece of our process that we ourselves don't have and doesn't exist off the shelf because we're pioneering in the cell therapy space. It hasn't been done before. Working with companies like Cytiva are essential for us to be able to advance the forefront of cell therapy.
We have seen what cell therapy really can do for patients, and really not only take away the symptoms, but actually to cure diseases. What Cytiva is doing is helping the science to be produced in a standardized and industrialized manner. I think that is, you could say, what we are experts in. We are experts in taking science into industrialization.
This is what brings us to work every day, helping cure the incurable, developing the technology that really are gonna enable those fantastic therapies. It plays to our strength, our 50 or 60 years of expertise in biotechnology development, our scale, our servicing, our ability to invest and partner. Since we are still at a very early stage of those therapies, we think we have the ability to set manufacturing standards, and in doing so, really building a long-term sustainable business franchise. Thank you very much. I think handing it back to John.
Thank you, Emmanuel. Okay. We are right at about the time we're gonna take a break, but before we do, one of the traditions here when we put on Investor Day is to donate to causes that are very near and dear to us here, and for Cytiva that's via Biomedical Science Careers Program charity, really helping underrepresented and create more diversity in the biomedical field here. You can see today we've helped 2,000 people along that career path at Cytiva with a goal to actually increase that to 10,000 annually. In the honor of the day that we are here, we're gonna make a donation there as a corporation to really support that.
Couple things before we go to break. We got a lot of folks here, so in order to make sure that when we go on the Gemba tour that it's in an orderly fashion, there's some cubbies and tables over to the side. So if you have extra things you're carrying, now is a good time to put it over there, you know, when we do go to break. That'll just help things progress in an orderly fashion, when we do go on the Gemba tours a little bit later here. We've got about 15 minutes, so there's some refreshments also kinda back over there on the left and restrooms in the back of the room. So thank you. We'll see you in 15.
Ladies and gentlemen, if you wouldn't mind coming back into the room, making your way back into the room. We know we have a couple people over there standing in line, but we're gonna start in about two minutes, please. In about two minutes.
Good evening, everybody. I'd like to say hello to my father.
Ladies and gentlemen, we're about to begin. Please take your seats. We're about to begin.
1, 2, 3.
Hello, folks, and welcome back. Hope you've got a chance to stretch your legs a little bit. We're gonna be about half an hour, and then you'll be on to the Gemba Walks. My name's Conor McKechnie. I lead marketing for the combined Pall and Cytiva organizations in the biotechnology group. You've heard from a lot of executives today in the group. We thought it would be a good idea for you to hear from people who are at the really pointy end of the development of new therapies, some of our customers. I'm extremely honored and really pleased that you were both able to come. We have Dr. Jens Vogel, who is the Senior Vice President and the Global Head of Biotech at Bayer's Pharmaceuticals and Product Supply organization, large biopharmaceutical company.
We have Dr. Boro Dropulić, who is the founder of Caring Cross, which is a CAR T cell therapy-focused nonprofit organization focused on expanding access to cell therapies to lower and middle income countries. Gentlemen, thank you very much. Boro, if I can ask you to maybe introduce yourself a little bit, and we'll go on to explore where we are today and what the future of these therapies look like.
Yeah, thank you for that kind introduction. Yeah, I've been in this space for, you know, since the late 1980s. I was a Fogarty fellow down at Johns Hopkins. Started my first company. We were the first group in the world to put lentiviral vectors into human clinical trials and establish their safety with Carl June and the University of Pennsylvania team. Later, I started a company called Lentigen. There we continued the collaboration with Carl and developed a vector that eventually, under Novartis, became Kymriah. After that, Lentigen was acquired by Miltenyi Biotec. We're very interested in local manufacturing, decreasing the costs, and we were very successful in developing a number of candidates and developing this place of care model. I started Caring Cross to address the issues with my co-founder, to address the issues of access.
These therapies, although very quite transformative, do cost a lot. Our goal is to really try to improve access by lowering the cost of goods, improving the technologies, and developing what is called a place of care manufacturing paradigm.
Jens?
Yeah, thanks. A pleasure to be here and actually not just look into a camera zone, but being physically present and have faces looking back at me. So I'm in the industry for about 23 years now, mostly in large molecules, mostly at Bayer and at Boehringer Ingelheim for many years, in development and manufacturing of large molecules. Worked on over 60 INDs and about 8 products that we commercialized. I'm really passionate now actually about transforming Bayer's biotech organization into an organization that actually also works on the industrialization of these new therapeutic modalities that we already heard something about today. I think that's, you know, we are on the verge of a revolution really in medicine, and we're gonna talk more about this in this panel.
It really requires partnering between, you know, us, innovators, companies like Danaher, Cytiva to bring this forward. Happy to talk a bit more about that.
Thank you, Jens. It really characterizes the nature of the industry to have the two of you from very different parts of the ecosystem of people who are developing these therapies. We have a very small innovative company, and then we have Bayer's history of industrialization and bringing those therapies into access. Of course, you have very different needs as organizations, and partnership is one of those things. Boro, can you talk about a little bit through your career the change in the innovation landscape that you've seen and what that requires of the industry in terms of partnership?
Yeah, absolutely. Being through the highs and lows of the cell and gene therapy field to a point where one would think that the field wouldn't go forward. Today, you know, six approved products. You know, we can use the word cure, transformative medicines. It's a very exciting time and a lot of interest and investment in the space. The manufacturing issues remain complex, as we heard about this morning. That's why partnership with expertise is very, very key for success. Companies try to build their own infrastructure, and it's too complex. Being able to rely on partners that have that expertise to bring things forward, I think is a very important idea and concept to keep in mind.
As a company like Boro, Jens, develops a new and emerging CAR T or gene therapy, what's the role then of a large organization like Bayer, and how do you get involved in that and then sort of drive it towards access to patients?
Yeah, I think that's a crucial piece because when you look at it, we have about 1,300 or so cell and gene therapies in pipelines globally. Most of this innovation comes from small startups, small companies, academia. I think those are very agile and fast moving this innovation also into the clinic. However, you know, you start with small clinical trials. You make a couple of batches for a handful of patients to get started. Even going into late-stage clinical trials, where you go for larger patient populations already poses an extreme challenge.
Mm.
Basically, we need to use the lessons learned from, you know, 30 years ago, from the very beginning of the biotech industry when everybody saw the potential of protein therapeutics, but nobody really knew exactly how to develop and to manufacture them. For cells, it starts also at the fundamental product understanding. For a cell, what even are the critical quality attributes? We are constantly learning about that. Then again, how do we manufacture them? This is something that we are really good at. As a large company, we want to partner with the innovators that allow us in an open innovation approach to enter the space faster.
What we bring and what we want to leverage is the ability to make difficult-to-make products, and then use a global footprint to really bring it to patients on a global scale.
It's fascinating because the developments process and cycle, it hasn't changed. We're still going through the phases of clinical trials and so on and so forth, but the actors in those spaces have changed, and the relationships.
Mm-hmm
Between them have changed. Boro, can you? You talked a little bit about the manufacturing challenges and so on, but can you expand a little bit more? What's really difficult about these therapies? We know that they're complex, but what is it that you and your scientists in the lab are facing as you try to, you know, essentially design them for manufacturing later and making them, you know, easy to get out to patients?
It depends on which track you're taking, where you're taking a track on with these personalized medicines to make them one patient at a time. You have to think about an idea on scaling out rather than scaling up.
Mm.
If you take the other alternative is to do allogeneic approaches, then you're thinking about scaling up and producing that final product out. We are. Our focus has really been on the scaling out of the personalized therapies, taking cells out and very quickly manipulating them and putting them back in. Now, the challenge is creating very inexpensive workflows that are very robust. Those are the challenges, and so that's what we are as a field trying to tackle. That involves not only on the cell side, it involves also on the vector manufacturing side, and it also involves on the analytical side, and that all relates to the critical quality attributes.
Mm-hmm
As Jen mentioned.
Mm.
Mm-hmm.
You talked there about the need for sort of robust manufacturing. Jens, your focus is on the allogeneic side.
Mm-hmm.
Maybe we should just quickly do a little bit of an intro in terms of, like, the difference between autologous and allogeneic cell therapies. The workflows are the same, in many ways, but just characterize for the audience who may not have heard this before.
Sure. There are fundamental differences, and Boro alluded to those already. For autologous, it is basically the ultimate personalized therapy, where you basically take the cells from the actual patient, and then you basically train those cells, engineer those cells to fight the cancer. Then you expand these cells ex vivo and transfuse them as an army to basically kill cancer cells. In the example of cancer.
That was the example that we had in the video earlier.
Yes, exactly. Emily Whitehead is a perfect example of what these therapies can do.
Mm.
You know, I worked in pharma all my life and, you know, a lot of times we're working on therapies which ultimately, you know, were successful but might have increased median survival by a couple of months.
True.
Now for the first time, you have something like this where you see Emily Whitehead. We just celebrated the 10-year anniversary. She was under the, amongst the first CAR T patients, ever, and 10 years later, she's still cancer-free. That's as close to a cure as you possibly can be. That shows the potential. Now, for allogeneic, you can imagine if it's so personalized, it's very difficult to manufacture because you can only scale out. One batch is one patient.
Mm-hmm.
You have these farms, basically, of small bioreactors, all parallel operation. You will try to automate as much as possible. That's where the future there lies. Allogeneic is basically trying to take healthy donor cells, and then basically engineer those so that you are not triggering graft versus host or host versus graft disease, so that basically you can use these cells for many, many patients. One batch might be able to ultimately treat hundreds of patients.
It's important to realize that it's not an either/or, right? It's not like allogeneic is gonna be the future or autologous is gonna be the future. It's not a VHS, Betamax challenge.
Yes. Yes.
We're looking out there, and the audience is maybe too young.
Yeah
to realize the analogy. In terms of the sort of manufacturing challenge and that smaller footprint then.
Mm-hmm
Jens, could you talk a little bit about how important the development of single-use capabilities, single-use biomanufacturing and adapting that for cell therapies has been in the last, what, five or 10 years?
No, absolutely. I mean, again, for allogeneic, a lot of the platforms that we need to truly industrialize it don't exist yet. Now our vision is to basically create something akin to a consensus platform. This was also if you've maybe observed the biotech industry. What made the industrialization, the true industrialization of antibodies possible was that the industry converged onto a consensus platform with fed-batch bioreactors, Protein A, and so on. Cytiva plays an important role in this and others. Now that allows you basically to transfer processes and translate from a lab into manufacturing from one site to another site and so on, true industrialization. We don't have that for cell therapy. Again, we focus on allogeneic, but even there you have many different cell types that have specific needs.
The vision is to create a platform that is modular and flexible, where you then have a roadmap and you look at, okay, I need for that particular cell type, I need that module, that module, that module, and that module. They're all using single-use components. They all operate on the same operating system, and you can flex them together, and it's sort of plug and play. You have the basic element of a platform to produce very rapidly.
Mm.
That's what we are trying to build, and that's why we, as Bayer, are partnering now with Cytiva because we need a partner with the deep expertise and manufacturing capabilities in both the equipment and then very important, the consumables.
Mm.
Because again, all of that will be based on single-use technology. We combine that with our expertise in product development, science and technology development.
It's very-
Together we can really set, hopefully, a new industry standard in that space.
Yeah. It's really interesting listening to you speak. It's almost the language of software development, right? You're talking about plug and play, you're talking about platforms and so on, and this combination of biology and engineering and.
Digital.
Digital.
Mm-hmm.
Boro, could you talk a little bit about how that's sort of going to enable the future of these therapies, bringing those multiple disciplines together?
Oh, that's essential even in autologous therapies, and it's the same kind of platform. What we envision is that instead of scaling up, having very, very short processes, right? Then working with partners, we've got a partnership with Cytiva, is to try to really reduce the time, because reducing the time really reduces the cost, right? When you have a personalized therapy, it becomes very, very straightforward to do it at the place of care, right? Either in a modular clean room. The big advantage of this is that you can do fresh in and fresh out manufacturing. What we have learned is that fresh product manufactured is more potent than frozen product. These are some of the advantages.
There are caveats and advantages in all these approaches, and I think we just have to go down this path and figure it out. These modular systems, I think are common. A lot of them are common to both platforms.
Mm.
Mm-hmm.
You know, as somebody who's a newcomer to the space or is just getting up to speed, it can seem very, very confusing. There's sort of mRNA, there's lipids, there's viral vectors, there's viral gene therapies, there's CAR T-cell therapies and so on. There's so many different things going on, but is there something that underlies all of it that you could say is, "Well, if you take a systemic approach, these are the core characteristics-
Mm-hmm
of what you're going to see. You've talked a little bit about the challenges in manufacturing. You've talked a little bit about sort of the platform approach that's being taken. Is there anything else that really kind of unites these therapies in the way that people ought to be thinking about them in the future, Boro?
Yeah. Particularly the quality systems that surround the manufacturing of the product. I think that's very, very key and that's very, very common.
Mm.
That's very good. The analytics, right? Even some of the platforms in terms of sharing, even some of the bioreactor processes can also be common.
We need to be able to see what's going on inside the bioreactor.
Yeah
as the cells are being grown or as the proteins are being developed.
Absolutely.
Yeah. Jens?
Yeah, I think it's, you know, automation, digitalization, and above all, really, really sound product understanding.
Mm.
That's required for all these new modalities.
Mm
because, again, it's still in its infancy. From a technology perspective, of course, you said it earlier, a lot of these will coexist for many, many, many years and decades to come.
Mm.
I think there will be a certain amount of shakeout ultimately perhaps with the cell types.
Mm-hmm
You know, a lot of these technologies also work in tandem and approaches.
Mm.
For example, advances in gene editing, of course, help us in cell therapies. They help us in gene therapy. Vectors or also vector-less gene editing helps us with the cell therapy. It's basically all not completely converging, but it's inspiring each other.
Mm
in the different modalities.
Can we turn a little bit to sort of the future technology needs? I mean, we've talked about the need for automation and closing systems or bringing the cost down, but what could you see happening in the next sort of 10-15 years in this space? What should we be excited about from a technology point of view rather than the biology? From a manufacturing standpoint, where are things possibly going, and what would that mean actually for the end patient?
My bias is that, you know, localized manufacturing. That, that's my personal bias. That we're moving more and more towards very short processes and making it localized just because the reduced cost of goods, of avoiding that whole.
Infrastructure logistical aspect of transporting from centralized manufacturing facilities and back. I think that certainly it really depends upon the science and which therapies prove to be durable, right? Whether it's allogeneic or autologous, it's the best therapy that we really need to be aiming for, and then build those systems around that to make those therapies really distributed correctly for an affordable cost.
Affordability is key to expanding it beyond the U.S. And Europe, right?
Absolutely. I mean, the current pricing of, you know, $370,000, $400,000, over $1 million is really not even sustainable in the US, let alone in low- and middle-income countries. By focusing on decreasing the cost of goods and innovations to decrease the manufacturing time and cost, we can actually create value and create products that can be reimbursed and sustainably reimbursed in the U.S., and also then create space for cost plus pricing, say, in low- and middle-income countries.
Mm-hmm. Jens, cost, absolutely key, and cost is coming down, and we're seeing that year on year, and that's very exciting. What else in terms of, like, technologically, in the future, what as a large pharma do you see being most exciting?
Well, I think there are so many aspects. Again, autologous, I totally agree with Boro. I'm really excited about the ability to control stemness, for example, better understand how important that is, avoid exhaustion, and then basically be able to reduce the expansion time in the factory as much as possible. What I find fascinating is, and I'm discussing a lot about that also with colleagues and peers, is can we ultimately get to the point where we skip the ex vivo expansion completely?
Sure
We basically have truly a point of care. Yeah, maybe you can still call it local manufacturing, but you have to envision it almost like a dialysis clinic in the major hospitals and treatment centers. That's something that I'm excited about. On the other end, with allogeneic approaches, still the ability to, like in the traditional drug model, to have centralized manufacturing and then you basically have a universal cell bank, and you're able to ship this anywhere on the globe.
Mm
infuse it. I mean, that, of course, would solve a lot of the challenges.
Yeah. It seems just incredibly exciting that something like a curative CAR T-cell therapy could be maybe not necessarily as simple, but as efficiently administered as dialysis.
Mm-hmm
has been developed over the last sort of 30-
As an infusion of an allogeneic.
As an infusion.
Yeah.
Exactly. Absolutely.
There's also the other possibility of using the vector directly.
Mm.
Right? Although there is a high bar because you're now putting the vector in a more uncontrolled environment rather than isolating your target cell type, having that as your final product. There are a number of companies working in this area to actually use vectors directly as a final product. In that case, you don't need to take out the cells at all. Again, I think there is a relatively high threshold there to make that really work.
Mm.
Yeah.
If you remember, Emmanuel talked about the fact that you need to put the DNA or the RNA, the coding, into something to get it to the patient into the vector. Using the vector directly as a therapeutic that then is targeted at the right place, for the patient.
In vivo gene editing is something that.
Yeah
that I think eventually will come.
Mm-hmm.
I think the bar is high. We have a collaboration with Mammoth Biosciences.
Yeah
... and programs that could eventually lead us there. I do believe we get there in certain indications at some point.
Yes.
But-
Mm.
Totally.
I mean, you know, Emily Whitehead had the example. It's spine-chilling because 10 years ago when she was first diagnosed and, you know, we had the honor of being sort of part of the development of that therapeutic process, just to see that actually happening, it felt a little bit science fiction-y, and now it's not. It's fact. It's happening. When you talk about these innovations as things that are, you know, potentially a long way off, they are going to come.
Yeah.
Yeah.
There are some things that, I think will come very soon, which we haven't talked about. We focus really very much on cancer here right now. Now, one area is that it's very close to my heart, and we are working a lot on that, is using induced pluripotent stem cells for regenerative therapies. That is a form of sort of next generation cell therapy, which sometimes still to me also sounds a bit like science fiction. We basically take cells from a healthy donor. We actually engineer them to become pluripotent. Then you can differentiate them into any kind of cell type a human body has. Our first program that's already in the clinic that comes from our BlueRock partners is in Parkinson's.
We basically take these cells, we differentiate them into healthy brain cells that are producing dopamine, which Parkinson's patients don't have anymore. Then we can basically transplant them into somebody's brain to hopefully cure them.
Mm.
The next program that I just have to mention because it is really exciting, is the heart failure program, just to show you where we can go. You basically differentiate these iPSCs into heart cells. You grow them in a bioreactor. I can tell you, one of the most exciting moments of my life was seeing in the lab suddenly these heart cells start to beat in sync.
Mm.
The idea is that you can basically then transplant them into a damaged heart.
Mm.
They will basically associate with the damaged heart, repair the damage, and start to synchronize with the cell, with the heart cells, so they can basically mend a broken heart.
That's extraordinary. Maybe spiritually as well. You know, we get very excited about this. Could you talk a little bit, I mean, I'm not asking you to shill for Cytiva and Danaher and so on, but could you talk a little bit about what prompted you to choose to work with this organization? The experience, the technology, the people, what is it that
It's a combination of all of those factors. We've worked with Cytiva for a long time, and it was still GE Healthcare and even before. You know, of course we again need somebody who understands the technology, who has the manufacturing capabilities, the know-how, very importantly, shares the same vision.
Mm.
I think this, in this current partnership, this was one of the decisive factors. I mean, we started talking about allogeneic cell therapy, it became very clear that our teams shares a vision of where we need to go together.
Mm.
The capabilities are all there, and that's why we're gonna be successful.
Boro, yourself, very different needs as an organization.
Mm.
There are many places you could have gone. Why partner with Cytiva?
Well, it's the same reason. You have a deep expertise in this space. Again, I wanna stress and underline the importance of that in this space, 'cause if you work with a group that hasn't got that level of expertise, you are bound to hit the rocks at some point.
Mm.
That was one of the main reasons. Also you've picked the right platforms. You know, when you look at the single-use disposable kind of platforms.
Mm
That's clearly the way of the future.
Mm.
Knowing that, you'll be behind those platforms for the longer term.
Mm
which we're investing in, that is very important for us. It builds confidence in our partnership that you'll be there and helping us as we evolve in making these processes the way that we think they need to be made for this, for our place of care manufacturing model.
Irrespective of the number of patients, the number of bags.
Yeah
The number of transfer sets that are required, the cell culture media and so on, it's all it's always gonna be there as you develop. As we move towards the close of this session, just one last question. Everyone here has made a real effort to get here, and we want to thank them for that. What can we give them in terms of a sort of nugget of information that perhaps they should know about the industry that people who missed the session won't know, so they can go on their way with a little bit of, you know, extra knowledge? Jens.
I mean, first of all, I'm not gonna give out any investment advice here. You know, I think one thing that most of you, I think will already know, I mean, we talked about a lot of revolutionary approaches. One thing, of course, always in pharma, if you look at any individual asset, any individual therapy that someone is working on, the risk of failure is very high, right? That's always the case. The concept can be as brilliant as, you know, you want, but you might still encounter unanticipated things in the clinic, and so it might fail. The trick is platforms, having platforms that can generate many assets.
That's, you know, what we are trying to do as Bayer working with someone like BlueRock or AskBio, who basically create platforms that can then generate asset after asset after asset, because some of these absolutely will be successful.
Mm.
The same in the technology space. The platforms ultimately will help us to get to the revolution that we are after.
Whether you're talking about the actual biology, look for the biology platform, or the manufacturing technology, look for the manufacturing technology.
Mm
platform. Boro, what would you say?
Yeah. It's partnering with a group that not only has solutions, but has a vision for the end-to-end solution. We've heard a lot about that today, and that's very important, and not every company does this. Having that vision that you're tackling every aspect of that workflow, every aspect of that analytic, is important and it builds real confidence in any partnership. I just wanted to leave you that. That's important for us in any partner, I think.
Okay. Well, listen, thank you both very much. It's been a joy getting to know you and your organizations and your work a little bit more. I would ask Emmanuel to come back to the stage.
Okay.
Is that right?
Absolutely.
We'll head off.
Thank you very much.
Thank you.
Jens, thank you so much.
Thank you.
Conal, thank you.
Again, huge thank you for our guests, Jens from Bayer and Boro from Caring Cross, and I hope it gave you a sense of the partnership. I'm just going to very quickly wrap up and summarize before we move to our Q&A session. We're creating an absolute leader in the bioprocessing industry. Partnering Cytiva together, it is a stronger offering for our customers. I think you heard Boro saying that one of the most important things for him is a partner which is going to look at end-to-end, and I hope you understand that this is what we're doing with our product portfolio, with our talent, with our services. The Biotechnology Group is now a leader across all modalities, including monoclonal antibody, cell and gene therapy, and mRNA.
We have a strong secular driver in biologics, which creates significant long-term growth opportunity, and a long-term prediction of high single digit. Uniquely positioned for the most comprehensive offering, best-in-class services, support, and scale. Scale of manufacturing, scale of talent, scale of commercial, scale of organic, and the ability with the Danaher Business System to continuously improve our service to customers. I hope you enjoy the talk. You will have an opportunity after the Q&A session to go in the Gemba to listen about what we're doing in sustainability, to see the work for monoclonal antibody, to see the CAR T workflow that Jens and Boro and how we win commercially. I think now it's time for inviting Rainer, Amanda, and Emmanuel back on stage for some Q&A. Thank you very much.
Raise your hand. Just raise your hand if you have a question.
My lights and...
We'll start with Dan. No worries. Too many Dans.
Well, he was pointing at Dan Leonard, but this is Dan Brennan from TD Cowen. Thanks for doing the day. I thought I would just kick it off just with a high-level question, just as you kinda raised the Danaher growth rate here as EAS kinda separates out to kinda. You know, as we look across the different buckets of businesses, you know, obviously the genomics business, 30%+ today before we even get to a broader commercial stage in the market, if you will, and the mAbs at mid-teens. It just. You know, it appears to us as we look at it, well, high single digits is attractive.
Just wondering, you know, where the conservatism is baked in there 'cause if you just do the simple math, you would imply something certainly north of that, even if you look out over the next five or 10 years, I think, just given what we're seeing on the stage today and the proliferation of all these new modalities. Maybe you can just maybe focus in on the Biotechnology Group high single maybe as a proxy and a little more color about, you know, how we should think about that growth rate.
When we start, as we're talking about biotechnology, I think when we join Danaher, we talk a lot about, you know, 5%-7% growth. I think when we really look at the trajectory where we can go on the prediction, you know, high single-digit, I think is the right number.
I would just add, as we look forward and we look at our own models, you know, I do think that there's some degree of prudence and conservatism that we build into these models because as I have mentioned here, offline, you know, we do think about the 7-10-year model and not just the 1-3-year model. When you project growth rates, you know, pick a number well into the double digits for 10 years off of large bases, you know, it potentiates.
From some of the early experiences and your ability to maintain the share, from all these new players that maybe could look to maybe some cheaper alternatives or, you know, other alternatives, versus Danaher.
That's a very good question. I mean, biosimilar is a good thing. All right. It's a good thing because it's bring those life-changing therapy to many more patient around the world. It's interesting to think that biosimilar company is going to work with us to make their process more efficient, and they are 20 years later the originator. Different cell line, different cell culture media, you know, different processes, sometimes single-use technology, which as I said, is more productive than the other. But we still work with the originator because the originator may go into a second generation or a third generation of processes, and we do that with them as well. I think both give us opportunity, originator into the next generation or biosimilar across the world.
Great. You got the other.
Oh. Thanks for taking the question.
We can't hear you, Dan. Do a test.
Testing.
All right, you're good.
All right, perfect.
There we go.
Thanks for taking the question. Thank you for the deep dive, Rainer and team. Dan Leonard here, the other Dan. A question on the integration and creation of the biotech division. You typically don't integrate opcos at Danaher, so I'm wondering or curious about what was the tipping point to drive the integration here, and how might that apply to decisions to do something similar elsewhere in the portfolio?
That's a great question, and there's a couple factors here that intersect to us making that decision. First of all, we are really looking at the same customers here for Pall and Cytiva. We're not in the same parking lot. We're in the same building and office with the same really procurement and scientific personas that are looking at these particular solutions. That's, you know, that's certainly a factor that's important to us. Also the customer requests that we've gotten over time to ensure that we have seamless not only interfaces, but technologies and collaborations and services, which they just see as such a huge benefit as the team has been talking about. That's really a key factor here. There's another key factor as to the timing, you know, why now.
While we talked about the complex process of acquiring the business during a pandemic, so carving it out first phase one, right? Standing it up and operating it as an independent company to ensure that we deliver and fire on all cylinders. Then lastly, now taking that step and being able to bring these businesses together, for the benefit of all the stakeholders. That's really been driving the thinking and the decision-making there. Now, first of all, we never say never in terms of, will you do this again? We never say never. I wouldn't say that this is going to be, you know, the new mantra.
We look at each situation individually, and we make a call, that's based really on what the marketplace and our customers are looking for and need from us, and then we'll make the necessary adjustments.
This is Vijay Kumar from Evercore.
Vijay.
All the way in the back, Rainer.
Where are you? There you are.
There we are. Just one on following on the last question from Dan. Has your go-to-market strategy changed now that Pall and Cytiva are together? Maybe talk about your competitive win rates and what's changed in the marketplace.
Can you just repeat go-to-market and then?
Your go-to-market strategy.
Yeah
Now that these two assets are together, how has it changed versus two years ago, and are you winning more competitive wins?
I'll start and then maybe.
Okay.
You pick up the pieces. Thank you, Vijay. Sorry, it was a bit hard to hear you. Go-to-market is very important, but you have to see that we have an opportunity to deploy more resources to a broader range, okay? To cover maybe some segments that in the past we could not cover really much the same way. Really putting the two teams together gave us an opportunity to cover much broader customers. If you want to add anything.
Yeah, I think that was really the remit. I mean, we have fantastic scale now bringing the two commercial organizations together. We really wanted to bring our biotech, but really, you know, maintaining the focus on our big revenue-generating customers in CDMOs.
CDMOs.
biopharma. So that it just allows us to really enhance that approach globally.
I think, Vijay, just one thing. In the Gemba Walk, you will have an opportunity to see the process that we put behind the commercial team, which is a process which is standard, which has been enhanced with the DBS. You will have an opportunity to see the go-to-market the way that we are doing it now.
Again, the Pall Life Sciences sales team will come into that process. Again, we'll see that advantage as we bring the two teams together.
That's helpful. Rainer, maybe one for you. I would be remiss if I didn't ask you on M&A. The last time we had a spin, we had Cytiva, now we had EAS. I mean, just talk about broadly what you see out there, what areas interest you. You know, you mentioned 7-10 years outlook. You know, when you put that 7-10-year hat, what kind of assets do you see out there which are interesting?
Well, I'll tell you, we first of all have to come back to the portfolio that we have. The EAS announcement is 12 hours or so, twenty-
Yes.
Just about 24 hours or so old. It's gonna take us to, you know, the end of next year really to complete that transaction. But having said that, as you rightly point out, we're very active in the field of M&A. Our funnels are as full as ever, and we will continue with our strategy to look at the white spaces of scale, always focusing on, you know, strategy and market first, then identifying the company, and then ultimately ensuring that the business case works. If all those three turn green, as we say in DBS, you know, then we'll pull the trigger. We're currently in an environment which we have historically performed very well from an M&A perspective. It
In times of dislocation, the number of opportunities increase, and we have several assets today in our portfolio. SCIEX comes to mind of scale, and there are others that we precisely were able to acquire in this kind of time period. Expect us to continue to prioritize our capital deployment towards M&A, and that will happen at all scale levels, from large to small.
Thank you.
Hey, Rainer. Patrick Donnelly with Citi.
Patrick.
Thanks for the time. Maybe on the guidance, back to the guidance. On the core bioproduction side, you know, you guys have been growing. I think you grew 20%+ in 2Q, you know, guiding a little more high single. Some of the peers are talking more low double even in the go forward. Can you just talk about, I guess, the near-term drivers that are enabling that growth, and then how durable, how sustainable those are, and kind of when we transition to more of the high single? Just trying to think about that guidance versus what we're seeing here recently, and obviously, again, all these growth drivers you guys are talking about.
Sure. A couple things. First of all, it's very clear that we're coming with a tailwind that is based on, you know, COVID therapeutics as well as vaccines. As those wane, and we have, you know, called that out pretty clearly, right? $2 billion in 2021, $1 billion here in 2022, and we'd expect, you know, $500 million or so in 2023. At the same time, we have the non-COVID applications, you know, growing at very fast rates and, you know, we've talked about those being in the mid-teens% plus here. That's what we're currently seeing, and that's what our order book shows here going forward.
You know, when we come to the high single digits, it's once again a perspective that is not tied to any single year and the dynamics of any single year, but to say, you know, this is the kind of very positive scaled market growth that we see, and there aren't that many markets in the world of this scale that be so high. Once again, as we
Growth versus maybe some of those legacy Danaher deals where you bought things that maybe weren't necessarily growth accretive immediately, but there were big synergies and you were able to drive the growth higher pretty quickly.
It's a great question. Let's start off, we never say problems about everything we saw. We say challenges or issues, because we view them as being fixable, right? That aside, once again, we look at markets first, then we look at the assets that have either the opportunity or the potential that come with that type of growth and potential for earnings improvement, and then we look at our business case. There's a bunch of decisions that we're making along that continuum. We believe that a premium asset with an outstanding brand, perhaps that is struggling with the one or the other issues, sometimes companies stub their toes, Beckman Coulter back in 2011, and that suddenly creates an opportunity for us.
I think we look at each one of these individually, and we measure our own capabilities to influence the dynamic of that particular asset. As long as we feel that we're in a market where we're swimming with the current as opposed to against the current.
Maybe one more here.
Thank you. Jack Meehan.
Yeah.
Nephron Research. Recently, the Biden administration has had some updates related to strengthening our biomanufacturing footprint. I was wondering if you've thought about what that could mean for Danaher and some of the services that you provide.
Sure. First of all, we're thrilled to see that this has become a part of the national priorities. In fact, I'm part of a working group on supply chain security here in the U.S., which is chaired by Secretary Raimondo. These kinds of discussions are not entirely new to us. I will say this, that you know, the bioeconomy is a huge opportunity for our generation and the next several in order to solve all kinds of challenges, whether they be environmental, health-related, food security, you name it. This effort, which you know, we believe makes a lot of sense, is one that we feel that our portfolio can add value to.
It's a bit early days to understand how that all plays out. Still a little bit early, but clearly we're part of the mix there. Okay, well, I think that concludes our Q&A session, and our formal comments here. We wanna thank all of you here in Marlborough. We're gonna now go on our Gemba walk. Gemba is the Japanese word for where the action is. For those of you who joined us on the webcast, thank you for being with us here today virtually. We ask you all to stay safe and healthy, and we hope to see you again soon. Thank you.
Thank you, everybody.