Hello and welcome to our next deep dive. Today, it's all about QIAcuity digital PCR. We're going to answer questions around what is digital PCR, how does it compare with quantitative PCR, and how does sequencing fit in. Before we begin, a quick legal note. As with any investor event, this presentation includes a safe harbor statement. You're likely familiar with this from our other presentations, so I won't read it in full. Please remember that we will be making forward-looking statements. Actual results may differ materially from those projected, and the factors driving those are detailed in our most recent Form 20-F filed with the Securities and Exchange Commission. A copy is also available on our webpage. Let's now have a closer look into how dPCR, qPCR, and NGS differ and why it matters.
Huw Rickards, our Head of Global Digital PCR, and Francesca Di Pasquale, our Head of Digital PCR R&D, are going to take us on this journey. Huw, what are we doing here by the lake? I thought we were going to talk about digital PCR.
I know we are. I thought this would be a great location to talk about it. Earlier, I collected this water sample from the lake here. Don't worry, German waterways are generally pretty clean. This water sample could still contain traces of wastewater.
Now I see where you're going. Let's assume we want to analyze this sample for traces of norovirus for early signs of an outbreak, similar to how wastewater was analyzed during the COVID pandemic.
Right. Good point. It was used in the COVID pandemic. This is the kind of sample where digital PCR can be really valuable. It's a complex sample. In this sample, there contains millions of different components. Could be bacterial DNA, could be viruses, could be human DNA, could be environmental material.
How do we find a very small amount of genetic material from virus particles in all of that? There's different ways to approach it, right?
Exactly. An option number 1, next-generation sequencing. We don't look for one specific target like norovirus. We look for the unknown. We sequence or analyze all the genetic material in here. At the end, we have a comprehensive overview of exactly what's in the sample and in what quantities, like norovirus, bacteria, human DNA, and more.
With that, at the end, we have a very broad overview of what's in the sample.
Yes.
If I know what I'm looking for, I could simply go with, for example, qPCR.
Yes. With qPCR, we don't analyze everything. We look for one known sequence.
How does that work?
We specifically look for norovirus. We make many copies of it, then we detect the signal and monitor that over time as it increases. The stronger the signal, the more norovirus is in it. We rely on a reference standard. We compare our sample to a sample where we know how much of the target is in there. We use that comparison to make a calculation of how much norovirus was in the sample.
What about doing that in a complex sample like that?
That's when it becomes more challenging. Substances in the sample can interfere with the reaction. If our target is of low concentration, it's difficult to detect the signal accurately and precisely.
This is where digital PCR comes in, right?
Yes. Instead of looking at the whole sample at once, we divide the sample into thousands of different reaction chambers, the so-called partitions.
Even with a very complex sample like this and at very low concentrations, we're able to get clear results.
This is particularly important in surveillance, where we want to detect very low levels of target over time. For example, during the COVID pandemic, when we were looking at small changes in virus in the community, we want to be able to detect those signals early and with high confidence.
How does this work in practice?
Detection, quantification, and confidence.
Okay, good. Let's go to the lab.
Let's do it.
Hi, Francesca.
Hi, Francesca.
Here you are.
Hi.
Huw and I, we just took a walk, and we used this water sample to explore the difference between next-generation sequencing qPCR and dPCR. Now we need your help to go one step further and have a closer look into QIAcuity digital PCR and how it works in practice.
Sure. What is really interesting is that what you have been exploring now does not only apply to wastewater. In both environmental and clinical samples, we are really interested in finding a tiny amount of signal within a very large background. In wastewater, it could be a trace of a virus. In blood, indeed, we could be interested in finding cancer cells or very few amounts of cancer DNA within a large background. Both applications are very different, but the principle remains indeed the same. In this blood tube, we have millions of healthy cells, and the key question is: Do we also have cancer cells in it, and if so, how many?
Where would we start to find that out?
The first step is always sample preparation. We extract the DNA from the sample. We load the DNA together with the required reagents onto the plate, we seal it. The plate is put into the QIAcuity instrument, and the run is started.
What happens inside the QIAcuity?
The sample is partitioned into thousands of single reaction chambers, the so-called partitions. In every partition, a PCR takes place, targeting the cancer markers that we are interested in.
That's right. Each individual partition gives a clear answer.
This is also the reason why it is called digital PCR. Every single partition gives a yes or no answer, like the one and the zero in a computer logic. By counting these, the software uses statistics to calculate how many cancer cells were present in the original blood sample.
How long does it take?
The whole process takes about two hours. Everything happens in only one instrument, fully automated and plate-based. Actually, you can also detect more than one target at once, up to 12 in parallel. This is multiplexing. No reference standards, no complex setup. Simple.
Scalable
Highly reproducible.
We've seen how digital PCR works and why it delivers precise and reliable results. In real-world applications, it's not about measuring once. It's about generating consistent results across labs, across studies, and over time. What does it mean for our customers, and why are more and more switching from qPCR to dPCR? Let's take a closer look. Let's talk about our customers and their applications. Huw, why do customers switch from qPCR to dPCR?
It's all about confidence in your data. Customers are facing increasingly complex samples and demanding applications. They need to be confident they're producing reproducible data across different labs, across different operators, and at different times.
Our customers get more out of their samples, they generate higher confidence data, and all that at a very similar price point per experiment. What makes the QIAcuity really stand out?
It starts with simplicity. The QIAcuity is a fully integrated all-in-one system that reduces hands-on time and reduces complexity.
It is also why it is one of the most user-friendly digital PCR instrument available. It really enables our customers to implement it easily and also scale it across different labs. It also fits seamlessly into the QIAGEN ecosystem, starting from the sample technologies.
Beyond simplicity and integration?
Flexibility and scalability. Whether you're running a few samples or thousands, we have a one-plate system for low-throughput users to a multi-plate system for the high-throughput environments, and that's with all the same technology.
What else?
Speed at scale. QIAcuity is very accurate and highly reproducible across all different throughput levels. A good example is in biopharma, where you may have an R&D facility running many samples, screening many samples, and then in the same system can be used in the manufacturing, where quality control measurements need to be made at much lower throughput.
One system, different needs, right?
That's right. One system across all those different applications. All in all, QIAcuity combines performance with simplicity, ease of use, flexibility, and scalability.
What about QIAcuity digital PCR in clinical and diagnostics?
Well, we have already shown that digital PCR brings a lot of value in research, but we do not stop there. With QIAcuityDx, we bring digital PCR to the clinical and diagnostic space.
It forms a strong alternative where sequencing can be too slow or complex, and where quantitative PCR is really coming to its limits.
This opens up important applications, doesn't it?
Yeah. For example, in oncology, the QIAcuityDx is used to monitor minimal residual disease, where you're looking for very small signals to help guide treatment decisions. This is where digital PCR can really make a difference, to make fast, high-quality measurements that support decision-making.
This is how QIAcuity digital PCR is used today across research and clinical applications. Thank you, Huw. Thank you, Francesca.
Thank you.
Thank you.
QIAcuity digital PCR combines precision, reproducibility, and ease of use across a broad range of applications. What does it mean in a real clinical setting? Let's hear from our customer, Sean Monaghan, from Brown University Health, who is tackling one of the most critical challenges in healthcare, sepsis. He's going to tell us more about how QIAcuity digital PCR is supporting decision-making in a clinical environment.
As a trauma and critical care surgeon at Rhode Island Hospital, I spend much of my clinical work caring for very, very ill patients. My research is devoted to understanding sepsis. A definitive diagnosis of that infection can take days, and you have this period where you think the patient may have sepsis, but you don't know for sure, so you give them broad-spectrum antibiotics and hope that they improve. The issue is that with every delay in appropriate antibiotics for those patients, we have an increase in their mortality rate. In my research lab, we have been studying RNA sequencing data from sepsis patients for about seven to eight years. We identified a method where we could identify RNA from pathogens of interest that are causing the infections.
We knew we couldn't wait the days to weeks it takes for RNA sequencing data to come back for this to happen. We decided to translate or transition to a digital PCR machine, and that's where we decided to use the QIAcuityDx. With the QIAcuityDx, or digital PCR in general, is that we're able to get this level of copies per microliter for those pathogen. With this level, it's no longer just a yes/no. Instead, we have a level that can correlate with the patient's outcomes. When we get a sample from the patient, we can go from sample to result in about five hours. We know that with the QIAcuityDx, we have a very high sensitivity, down to five copies per microliter, which is a very small amount.
I would have to say the most beneficial aspect of the QIAcuityDx for us is having this level of the result for the PCR that's very different from qPCR or any other really molecular techniques that are out there. In our research, we're able to show that those copies from microliter have correlated with different clinical outcomes, such as whether the patient can be discharged from the ER to go home, or the patient needs to go to the ICU, or even if the treatment is working. The QIAcuityDx has allowed us to make our process from sample to actionable event much quicker. With the QIAcuityDx, we have a process where there are a few touch points.
With a faster diagnosis, we'll be able to tailor those antibiotics directly to those patients so that we don't have to use multiple antibiotics, we can narrow it down to one and see if that antibiotics are working.
We've explored the QIAcuity technology, some applications, and customer use cases. Now let's have a closer look into the business perspective. With that, let me hand over to Nitin Sood, our Head of Product Portfolio & Innovation, and Fernando Beils, our Head of Global Commercial Operations.
Digital PCR is one of the fastest-growing areas of molecular testing. QIAGEN's QIAcuity is designed to make this technology more accessible. QIAcuity bridges the gap between traditional qPCR and NGS. It has the sensitivity and accuracy of NGS and combines it with the speed and simplicity of qPCR. The digital PCR market itself is $600 million and growing robustly at 15% CAGR through 2028. In addition, there are opportunities to convert selected applications out of the NGS market, applications that require less number of targets. On top of that, we have the qPCR market and applications in there that can be converted to digital PCR that require more sensitivity and more accuracy.
We're executing against our growth strategies and seeing strong momentum across the business. In 2025, we did $89 million in revenue and are expecting to do about $100 million in revenue in 2026. We're winning because we are the easiest platform to use on the market. QIAcuity's workflow is as simple as that of traditional qPCR workflows. We also win because we cover low throughput labs and high throughput labs, and we cover a wide variety of applications in life sciences as well as in diagnostics. Lastly, we're making inroads into gene expression, the single largest application for traditional qPCR.
Since we launched QIAcuity in 2020, we have focused on serving a broad range of customers and applications. For our academic customers or customers that are just starting out with digital PCR, we have QIAcuity One, which serves one plate. As our customers scale their applications, particularly in translational research or in biopharma or in clinical diagnostic labs, we have QIAcuity Four and QIAcuity Eight, serving four and eight plates. To support a wide variety of applications, we provide more than 2,700 QIAcuity digital PCR assays. In addition, if customers have need for novel applications or assays, we provide GeneGlobe where they can easily design new assays. All these applications have resulted in over 1,100 publications that reference QIAcuity in 2025.
Our momentum in digital PCR is clearly driven by differentiation. With an installed base of more than 3,200 systems, which is a CAGR of 75%, and also as a result, we had a revenue CAGR of 55%, this differentiation is clearly visible. One of the attractive unique selling points in our digital PCR solution is the throughput per day. 1,500 samples per day we can process thanks to the variety and the scalability of our platform. At the same time, our multiplexing capabilities are continuing to increase so that we're able to test up to 12 targets in one single reaction. Differentiation is not only about performance metrics. What also matters is the feedback of our customers. From food testing to biopharma to wastewater testing, digital PCR represents, and this is a customer feedback, the next generation of PCR testing.
What we achieved with all our engineers across these years with the breadth of a portfolio was to make it as easy as qPCR. QIAcuity is part of a larger ecosystem which serves from R&D down to quality control, and I had the opportunity to meet a large biopharma customer who was using our QIAcuity dPCR solution in viral vector analysis, and this enabled them to apply our digital PCR solution, QIAcuity, from sample to insight. This is where we come in as QIAGEN, and this is also our offering, how we can enable our customer to grow, and we can customize the solutions for their needs from quality control down to research and development. This is another example on how QIAGEN expands and grows customer relationships across applications and workflows.
One of the biggest opportunities for QIAcuity is gene expression, the single largest application within the $2.7 billion qPCR market. What is gene expression? Gene expression is a foundational tool in disease biology that measures what genes are on and what genes are off. QIAcuity builds on the strengths of qPCR, and the fact that it's easy to use and it's fast, but it overcomes the limitations of qPCR by being more sensitive, by being more accurate and more reproducible, allowing researchers to uncover disease-specific gene expression signals that qPCR may miss. In 2025, there were over 17,000 publications in gene expression, and this number is growing by 35% annually. To serve this very important market, we're launching a series of products.
First, we're launching assays in mouse, rat, and human. In addition, we're launching the high multiplex mix that allows our customers to interrogate 12 targets in one reaction. Our new solutions will enable researchers to detect subtle changes in gene expression, and their high sensitivity will enable researchers to find the needle in a haystack. When customers work with QIAcuity, they get access to the breadth and flexibility of our assay ecosystem. Customers can go to GeneGlobe, our assay design platform, where they can gain access to 10 million pre-designed assays and unlimited customization abilities.
We, as QIAGEN, achieved to bring the simplicity, the control into digital PCR, and the ease of use, the adoption, the scalability, the capability of multiplexing, you get this all in that platform. Furthermore, expanding into gene expression, furthermore into expanding into other applications, be it in the clinical field, be it in life science, be it in applied, be it in translational, QIAcuity digital PCR solution is covering this breadth of a field. It is designed with the customer in mind across all these segments. Furthermore, we are stepping into companion diagnostics.
We at QIAGEN believe in digital PCR, one of the fastest-growing markets in molecular testing. Our QIAcuity platform is leading this market. QIAcuity's ease of use and performance wins the customer. Its scale keeps them. Our continuous innovation expands our customer base. With the QIAcuity ecosystem, we're well-positioned for future growth.
Thank you, Nitin and Fernando. We now know what QIAcuity's all about, there is one important aspect of our QIAcuity story that we haven't touched today, this is our pharma partnerships. Before my colleague, Huw, went into his digital PCR role, he was part of the companion diagnostics team, he had the chance to talk to Jonathan Arnold, Head of Partnering for Precision Diagnostics, and Richard Woods from the Business Development for Companion Diagnostics Team. Over to you.
Okay. Thank you, Domenica. Jonathan, let's start simply. For those who are not familiar with the topic, what is a companion diagnostic, why is it needed?
Sure. No, thanks, Huw. Great question, let's take it from a patient-clinician perspective. At the most basic level, what I consider a companion diagnostic is essentially a patient has been diagnosed with cancer, typically. Physician has assessed that patient, is making a determination about therapies, essentially needs the diagnostic to determine if the patient is eligible for the therapy. To me, this is the perfect example of precision medicine, finding the right patient with the right drug at the right time. From a pharma perspective, they're running a therapeutic program. They've developed a drug. The clinician is making a determination about what drug is right for the patient, ultimately. Essentially, the pharmaceutical partner is going to have to invest in the diagnostic to ensure that we are selecting the right patients.
The pharmaceutical company really needs a partner that they can trust, that has the competency capabilities to develop the diagnostic, because without the diagnostic, there is no drug prescription.
Where does QIAGEN come in, and what's your role in the process?
QIAGEN really acts as that trusted partner, and we are that partner because of our competencies across the requirements that pharma needs. If you think about our leadership in PCR technologies, both qPCR and dPCR, the QIAcuityDx is really resonating with pharma. We also have more than 30 master collaboration agreements with global pharmaceutical companies, and this is important because it really establishes us as repeat customers, and this is what I take most pride in. Not just the absolute number, but it signifies that these partners trust us and they want to do repeat business with us.
I think when people first look at companion diagnostics, they often think about developing the test as you've described there, and just getting paid for that from pharmaceutical companies, is that really the right way to be thinking about it?
It's true that essentially we are a commercial contract development business. They are paying us to develop the diagnostics, which is great. It's a very important business to us. That's not really what I think about the strategic value of our precision diagnostics business is to QIAGEN. The strategic value of our precision diagnostics business is developing innovative, differentiated content for QIAGEN platforms. The pharmaceutical companies are engaging with us to develop these novel, innovative diagnostics. We own the diagnostic, we then launch it onto QIAGEN platforms, especially the QIAcuityDx. This, in turn, makes those platforms more attractive. It's a very virtuous cycle. We're launching novel content that no other company typically has access to, which then makes our instruments more attractive to our customers.
It sounds like you're working with a broad range of pharma partners. How should we think about QIAGEN's position within the space today?
I think of it, we really have a leadership position. We've been doing this for a long time. As I mentioned, those 14 PMAs over roughly the last decade is testimony to that. Companion diagnostics is a tough business. If you think about these programs that we're supporting for our pharmaceutical partners, they're often billion-dollar programs, really that concept of our risk is their risk and vice versa, we take very seriously. We execute on time. Where we make commitments to these partners, we deliver.
I guess there's been recent interest in the field of ESR1, for example, as a biomarker, a companion diagnostic biomarker. Richard, could you explain why that is?
Yeah, sure, Huw. In breast cancer, ESR1 is a mutation in the estrogen receptor. Endocrine therapy is a key therapy that delays the progression of disease. Endocrine therapy is treatments such as aromatase inhibitors. Those aromatase inhibitors do a great job, but over time, patients start to develop resistance and progress the disease. With ESR1 mutations progressing the disease, the biology isn't detectable in the image, and so ESR1 mutation status needs to be characterized at the molecular level.
How does this play out in the patient journey? Explain a little bit.
If a patient is diagnosed, as I mentioned, with HR-positive, ER-positive breast cancer, then that patient is given endocrine therapy, and then the patient is then monitored on a 6- 12 month basis. It's when that patient starts to progress, when we start to see the disease developing resistance, that we need to check to see if the ESR1 mutation is present or not. That's where QIAGEN can step in with decentralized testing at the local level to help the oncologists make treatment decisions based upon analyzing blood samples taken from patients to determine if the ESR1 mutation is present.
How could QIAcuity digital PCR be good for ESR1 blood testing?
The QIAcuityDx and the application of digital PCR is really a magnifying glass to the molecular pathology world. It really allows us to go exquisitely sensitive into the analysis of the circulating tumor DNA that could be present in that patient's blood sample.
That's how it works today, how CDx is working today. Where do you see this evolving going forward?
Well, the analysis of circulating tumor DNA is really a paradigm shift in oncology and treatment decision making. We're looking for the detection of what we call minimal residual disease. The application of digital PCR is being applied in conjunction with next-generation sequencing, towards MRD detection, generally speaking. It's a paradigm shift that's opening a new form of treatment that can be given to patients, to extend their life.
Going back to you, Jonathan, beyond oncology, how far do you think this model could extend?
Sure. Great question, and it's one thing that I think of our companion diagnostic business at QIAGEN as somewhat of a platform. It allows us a look into the future. I often say we don't have to be smart, we just have to follow the money. We're able to see where pharma is investing, biomarkers, technologies, and if you think about how we apply that, this is what I mean by innovative testing. We're always ahead of the curve because pharma's looking across the horizon as well. In partnership with them, we see these things, they basically contract with QIAGEN to develop them, and then we launch them on these platforms. I really think of our CDx business as a platform enabling QIAGEN instruments and consumables.
Fantastic. Thanks very much, Jonathan. Thanks, Richard.
Thank you, Jonathan and Richard. This is clearly an exciting opportunity for our QIAcuity digital PCR. Let's hear from our CEO, Thierry Bernard, on how QIAcuity is positioned for future growth.
Thank you, Domenica, and good afternoon to everybody. I have two key messages. You have seen Nitin and Fernando presenting the value of our solution, QIAcuity. You have seen multiple testimonies from customers, research, companion diagnostic, but also clinical customers. My two key messages are very simple. First, digital PCR at QIAGEN or digital PCR by QIAGEN is not just a technology anymore. It's a full ecosystem, a sustainable ecosystem where QIAGEN fully masters the instrumentation, the consumable, the reagents, applications menu, and the bioinformatics.
Second, we are just at the beginning of what we believe to be a revolution in molecular biology, digital PCR. We believe that QIAGEN is already a leader, but we want to continue that leadership and continue to invest to provide every day more solutions to our customers, be them research, academia, pharmaceutical companies, or clinical labs. If you think about it, what do customer want today? First, they want reproducibility. Second, they want scalability.
Third, they want to be able to detect more pathogens into one single sample simultaneously. Many companies are able to provide customers with reproducibility, with scalability, with multiplexing. There is something also very important that customer want. It's simplicity. I think it's fair to say that QIAGEN is the only company to be able to offer and provide customers with reproducibility, scalability, multiplexing, but also simplicity. Digital PCR by QIAGEN, as you have heard from Nitin, from our customers, from Fernando, it's one sample in and the result out. It's a fully integrated box. This unique feature of digital PCR by QIAGEN, of QIAcuity translate in numbers today. Look at it. We launched it roughly 4 years ago.
In 4 years, we took more than 12% of an estimated market already at $ 600 million. More than 3,200 system placed since we launched that solution. 1,100 publication to support the value of QIAcuity. This is probably unprecedented. We are already the number 2 on this market, and we are on our way to become the clear number 1. There is no way we are going to stand still, and we want to continue to invest to enhance that leadership. I see three ways or three priorities for those investment. First, obviously, continue to increase the potential applications available for customers. We started with a lot of application at the beginning for research and academia. We extended it to pharma companies. We want to move also to new fields. Think about human identifications, forensics.
Second, companion diagnostic is probably one of the major growth field for QIAcuity and digital PCR. We are extremely well-placed at QIAGEN because we already can leverage more than 30 pharma partnerships to push that solution to our pharma partners. The third major investment for our company in the month, the weeks, the years to come is to be the leader converting the gene expression market into digital PCR. Gene expression is probably one of the major application in qPCR today all over the world.
Think about it. Customer will continue to look for more targets, for speed, for accuracy, but in a simple workflow. QIAcuity is ideally positioned to answer those needs. I'm not saying that tomorrow digital PCR will fully replace qPCR. That's not the point. By the way, digital PCR will not fully replace next-generation sequencing either. See it that way.
Digital PCR is allowing our customers to find more targets in one samples in a fast way than traditional qPCR, but, and this is very important, without the complexity of next-generation sequencing. When I think about QIAcuity for the future, I see a double-digit growth potential for our company. I see QIAGEN clearly taking the lead in this market. I see QIAGEN clearly converting more and more qPCR application into digital PCR. I see QIAGEN leading the move of PCR in gene expression for qPCR to digital PCR, and I see it as a very major investment for our company. Now back to you, Domenica.
Thank you, Thierry. Before moving on to the Q&A, we're happy to share more customer voices and their experiences with the QIAcuity.
My name is Gopal Ramachandran, and I'm the CSO and co-founder of Tracer Bio. For decades, imaging has been the mainstay of how we monitor cancer patients. Minimal residual disease is an attempt to go beyond that and measure microscopic amounts of disease in a patient's blood that are not detectable by imaging. This allows us to more quickly assess whether a patient is responding to therapy, when we need to switch therapies, and catch recurrence much, much earlier. At the logical extreme of MRD, we want to be able to detect a single molecule from the tumor in a blood sample from a patient. This requires every step in the process to be perfect, from sample collection to DNA extraction, and then ultimately detection of that single molecule using digital PCR.
When we first started working with the QIAcuity, we, I think like many others, saw QIAGEN as the maker of kits that come in blue boxes and reagents. When we started at Tracer, it would take one technician a ton of manual work. What that meant was it would take them approximately one day to build an assay for a single mutation for a single patient. With the simplicity of the QIAcuity workflow, we've been able to automate all of the pieces around this. Now, the technician doesn't have to do any of the work. It's all done robotically, and the robot can build assays for 10 different mutations in 20 minutes. This has yielded a greater than 100x speedup in our workflow.
I'm an associate professor at Florida State University. My lab works on developing methods which can reliably test for presence of Salmonella in poultry, presence of E. coli in red meat samples, so that the companies can reproducibly test their food and protect people. I started working on digital PCR assays in 2023, was having a conversation with the stakeholders that we don't need to only do presence/absence testing of Salmonella. We also need to count how many Salmonella cells are present in the food sample.
If they have a higher Salmonella load in the food sample, that product should be also eliminated or stopped from entering the commerce. Working on food samples for last 10, 15 years, I know that relative quantification will be always challenging with food samples because food samples are high in protein, high in fat, and high in all PCR inhibitors you can think of. That's why I chose dPCR for quantifying Salmonella in beef and poultry samples. What I value most about QIAcuity digital PCR platform, the one unit does everything from partitioning the plates, doing the PCR, and also imaging the plate. Everything done in one box. Second part, it quantifies this presence of target DNA. I also very much appreciate its ability to detect two or more targets within one cell of bacteria.
Thanks, Gopal and Prashant. You've seen today three customer voices, we've prepared three more for you, which you can see after the deep dive on our webpage coming from Novartis, Berliner Wasserbetriebe, and Cellares. Now we come to the last point of our session today, which is the Q&A. If you haven't done so, please type in your questions into the Q&A box in the web portal, we are happy to take them just in a minute. Today, together joining the Q&A session with me in the studio are Daniel Wendorff and Huw Rickards. Welcome.
Hi, Domenica.
We also have more speakers for today's Q&A that you can see on the screen, which are Thierry Bernard, Nitin Sood, Fernando Beils, and Jonathan Arnold. Welcome.
Thank you.
Thank you.
Perfect. Thanks a lot. I think we're ready with the first question. Daniel, please.
Yes. The first question is, what differentiates QIAcuity most strongly when customers evaluate competing digital PCR platforms?
Well, I think we can be, several of us. When we launched QIAcuity four years ago, the main differentiation was coming from the simplicity. It was the first time that a company was launching a digital PCR system, fully integrated. One box sampling, result out, and this for three kinds of different throughputs. Clearly, in the recent years, some competitors have tried to also integrate their solution. Our plate-based technology makes it simpler and much more cost-efficient than any other competitive solution at the moment on the market. This is why, notably on the American market, any time we are faced with competition, our hit rate is above 70%. That's quite remarkable. Perhaps, Nitin or Huw, you want to complete that differentiation.
Yeah, I think I'd add a couple of points to that, Thierry. In addition to being much easier to use, it's one platform that scales from one plate to eight. When a user gets used to our software, our ecosystem, they can very easily scale. The second is that scalability extends from research all the way to diagnostics. They can start out on our research use platforms, and as they move into the diagnostic application, they can use the Dx platform. Again, the same underlying technology platform, same software. Then lastly, we have the GeneGlobe ecosystem, where there are tens of millions of assays to choose from, lots of customizability available to our customers, and then 2,700 validated assays for them to pick from. Anything to add, Huw?
No, I think you've captured everything there, Thierry, in it. I think I can't add anything else. It's perfect.
Perfect. Let's go to the next one, which is, you mentioned that customers are increasingly switching to digital PCR. Where in that transition curve are we? Do we expect the majority of our qPCR install base to switch to digital PCR? Will we have customers that use both qPCR and dPCR?
I think we need to be very clear here. QIAGEN, in many different situation, has repeatedly said cannibalization is not what is going to happen. Digital PCR is not going to fully cannibalize qPCR. Digital PCR is not going to fully cannibalize next-generation sequencing either. By combining the fact that we are giving more answers with digital PCR than with qPCR, without the complexity of next-generation sequencing and the time to result of next-generation sequencing, we have created a new need. We are also opening new frontiers for our customers, be they pharma company, clinical lab, research, or academia. There will be some conversion, obviously, on both sides, both from qPCR and also from NGS, but it's not purely cannibalization. For us, as we said in that presentation, one of the major potential for conversion will be around gene expression.
We all know that gene expression is one of the key markets currently in qPCR. With that, all the market for gene expression will move to digital PCR? No. Clearly no. We want to convert a big part of it. As for the transition from our own portfolio to digital PCR, it's very fair to say that in the coming years, QIAGEN will invest much more in digital PCR than in qPCR itself. What is important is that being a leader in molecular biology, as of today, QIAGEN is the only company on the market to offer valid solutions in qPCR, in digital PCR, and in next-generation sequencing, and to offer those solutions both to research, academia, clinical customers, pharma, and many others application.
Perfect. Let's take one on clinical, and then we move on to gene expression. Can you speak about some more of the applications in the clinical setting that we see our customers moving to digital PCR, and what are the fastest-growing areas of the clinical market, and which applications do we think provide the biggest opportunity for us?
It's a market in the making, Huw, you might want to take this one, what we presented today in companion diagnostic is a good answer to that as well.
Thank you very much, Thierry. Absolutely. It's a great question, we do see an expansion in clinical applications. Anything where you may want to take repeated time points, samples over repeated time points, for example, the ESR1 example that Richard talked to us about, that's classically strong for digital PCR. You get the precision in the measurements between time points is a critical point. Anything in that oncology space is going to be important for clinical applications. Something like transplant. We're seeing quite a lot of opportunities in transplant monitoring of patients who have had a transplant.
Perfect. Daniel, do you want to continue with gene expression?
One question which came quite often is, how important really is gene expression as a future growth driver for the QIAcuity platform?
I think Nitin could give some indications here.
Yes. Gene expression is a really important market. As you heard in the presentation, 17,000 publications in gene expression, growing at 35% year-over-year. Continues to be an extremely important tool in analysis of diseases. Where QIAcuity will shine is finding the needle in the haystack, finding the gene expression signals that traditional qPCR will miss. That's going to uncover more disease biology, help us to develop better diagnostics and better drugs. Today, 10% of our instruments go into gene expression, with the launch of our new kits that we just announced, we expect that to increase. Then we're not just stopping there. You've heard us say we're working on our second-generation platform, that'll further accelerate the penetration into the gene expression market, it's a very important market.
Perfect. We have one on the EUR 600 million total addressable market in 2025. How much of that was clinical versus our research? Also similarly for our growth outlook through 2028, how is the break between clinical and research?
Well, the majority of the market is still in research and academia. As we said, the clinical market is in the making, the QIAGEN strategy is to boost that evolution via our pharmaceutical company partners and our companion diagnostic. It also, for us, the strategy is to put that technology in the hand as many application and customers as possible. You saw the example of Sean Monaghan, for example. He's developing his sepsis approach in Rhode Island thanks to our technology. He's developing it. We are supporting, obviously. There are many applications like this where we want to push customers in HID, in forensic, in agribusiness, in food control, for example, to try that technology because we know it brings values.
It's fair to say that the market is probably at the moment still 60%-70% research academia, but the clinical application are moving fast.
Thanks. Daniel?
Yeah. We have one more question. What are the biggest barriers preventing broader conversion from quantitative PCR to digital PCR today?
Huw, as Head of Marketing, would you want to take that one?
A pleasure. Thanks, Thierry. I think in the past, many customers were, let's say, fearful of digital PCR because of the difficulty with the workflow. It's a challenging workflow. With the QIAcuity, that's gone now. It's an ease of use. It's just like qPCR. You're using a plate-based system. You're setting up basically a qPCR reaction using digital PCR. I expect customers will adopt this because of the ease of use.
Okay, perfect. I would say let's move to companion diagnostics and what's the real status of the three partnerships for the QIAcuityDx?
Jonathan?
Sure. I can't comment directly on any individual program. These are highly confidential for our partners. I can confidently say they're on track. We're expecting launches in the next 12-24 months. It's always hard to precise a timeline because essentially we're married to the clinical timelines as well for the therapeutic. I'm also very bullish on our pipeline as I see the progression of digital PCR into our pipeline with pharmas. In the medium term, it will be the primary technology for our companion diagnostic business. Things are going very well on the companion diagnostic side. Pharma understands and appreciates the value proposition of the QIAcuityDx.
As we look at those monitoring applications, we see it as that nice complement to NGS. NGS will always be the primary diagnostic in my mind for oncology, there's other applications where it's not the best, and we see that's where dPCR is resonating right now. Things are good.
That's good. Daniel, do you have one more?
Yeah, I have one more. Where within the approximately $2.7 billion PCR market do you see the greatest opportunity for digital PCR conversion?
Fernando or Nitin, you want to come back to this one perhaps?
Yeah, I think we talked about this. We expect, again, the gene expression market, which is about 50% of that $2.7 billion market, to be the most exciting opportunity. Broadly, wherever you require high sensitivity, accuracy, precision, and you want to do repeat monitoring, we expect digital PCR to make inroads into the qPCR market. Fernando, anything to add?
Easy for our future customers for regards to reproducibility, easiness, multiplex, you heard up to 12 targets, which is coming up, and on top of this, more than 2,700 assays available and a large reliability of customization opportunities. We want to make it easy for our customers and future customers to convert pretty easily.
Perfect. Let's give additional color on the revenue mix across different applications, gene expression, cell and gene therapy, liquid biopsies, mention quality control, and so on, but also on end customers, academia, the clinical field. Where are we with that conversion?
Well, I think the first thing I'm going to highlight is that digital PCR QIAcuity is clearly one of our pillars in growth. As a result, it basically also receive one of our highest investment into research and development. We have dedicated people on the field who are sitting on digital PCR. We have a dedicated team for companion diagnostic, who is focusing also on pushing this technology to our pharma. You know the numbers. Nitin has given you the numbers for 2025, the target for 2026 as well. We are not splitting those numbers into clinical or research academia or into gene expression, QC, and so on. What is clear, the key messages are the following. Since we launched digital PCR We have developed the number of application to fuel that growth.
We started for research and academia, then move also to, cell and gene therapy, and move to also QC control. We are now moving into gene expression in the second half of 2026. Since the launch of QIAcuity, again, at the beginning, research and academia, we brought that solution to regulatory authorities, IVDR, FDA. We brought that solution to our pharma partners. That's how we invite you to see. We have a target, which is to become the number 1 on this growing market. We see digital PCR as a double-digit growth product in our portfolio. This market is growing. We have a good solution. We have a differentiated solution. We have a cost-efficient solution.
We have people dedicated to market it and sell it. Nearly as I said many, we will be number one in digital PCR, and if we don't, it won't be because of the solution. It's because of management, I would say. It's just a matter of execution at the moment.
Perfect. We have a couple of questions on conversion NGS to digital PCR. Can we talk more about digital PCR, when digital PCR would be used over a next-generation sequencing, particularly as in the oncology space? When you can get more genetic information from NGS alone by going with digital PCR, and if not completely used over NGS, specifically, how is this used in a tandem with NGS?
Insisting again on the fact that it's not about cannibalization, but providing customers with a new added-value solution, I will invite Huw and Nitin to take that question. Again, it's not about cannibalization. It's basically bringing value compared to what NGS brings to clinician and patient and compared to what qPCR brings to clinician and patients.
Absolutely. Thanks, Thierry. You heard from Jonathan as well. In oncology, NGS is going to be the primary diagnostic most of the time. Where we see, as Thierry said, digital PCR as a complement to NGS, and actually, often they're combined together, to give more information. In oncohematology, we see a lot of digital PCR being used, because often oncohematology is defined by a small subset of genomic alterations. You don't necessarily always need NGS, and you might need speed. These patients are extremely sick. You need an answer quickly, digital PCR fits very nicely there.
Perfect. On the Hamilton integration, what percentage of customers would benefit from Hamilton integration? What are good examples of potential use cases?
Nitin, you want to take this one?
Yes. One of the primary applications we're targeting with this integration is really in the cell and gene therapy QC space. As our customers are moving from method development and moving digital PCR from that space into QC of released drugs, they need higher throughput. As a result, they will benefit from automation and higher scale. Likewise, as we scale out, our customers are scaling out in applied testing as well as in clinical diagnostics. Those are another category of customers that would benefit from more automation.
We have time for one more, I guess. What products are you launching to target gene expression in the second half of 2026 and already 10% of instruments today, what's changing?
Nitin, on the assays that we are going to launch t he second half of this year.
We're launching two categories of assays. First, as you heard, we are launching panels that target various pathways in mouse, rat, and human. These are mouse and rat being model organisms, and of course, human being a very important category. We're launching the one-step, 12 or multiplex in kit in gene expression. One step meaning you'll be able to do a generation of cDNA from RNA and amplification in one step in the instrument itself, just making the workflow simpler. I just want to remind everyone that at QIAGEN, we also have our bioinformatics solutions, our Ingenuity Pathway Analysis, which does pathway analysis, which also contains the latest, greatest information about the new pathways that are being discovered. We'll continuously add new pathway-specific gene expression panels. That's going to drive our growth.
As I've mentioned, we continue to innovate, and we have more things in the pipeline that'll help us accelerate penetration of gene expression.
Thank you. With that, we are almost at the end. Before closing the session, I would like to hand over for some final remarks.
Well, thanks again, all of you, for your attention. I continue to believe, I hope, that you appreciate this format of one-hour investor relation and deep dive. I would like to thank Domenica and the team for the preparation of this event. Obviously, we remain open to your questions if you have any question by emails. The final message for me would be very simple. For a molecular biology company like QIAGEN, moving into digital PCR was clearly a natural step. What we have executed and achieved over the last four years is nothing short of remarkable. It's probably the fastest growth of an installed base in tools, life science, and diagnostics.
Clearly, achieving more than 3,200 systems in such a quick time is remarkable. As Nitin said, as Jonathan and Huw said, we don't want to stand still. Already in our pipeline is a new instrument. We call it at the moment QIAcuity version 2 or generation 2. Obviously, we will update you as we go, see that investment as a clear proof that, one, QIAGEN is definitely a digital PCR company, and two, that we are going to fuel our ambition to convert the market of qPCR, and any time we can, also the market of NGS to this new technology. Thank you and talk to you soon. Thank you.
Thank you. With that, we are at the end of this QIAcuity deep dive session. Thanks for your participation and for all the questions that we received. With that, have a great day. If you have any further questions, always feel free to reach out to us. Happy to help, and see you then. Bye-bye.