Leica Biosystems Nussloch GmbH

HYDERABAD, India, Jan. 16, 2026 /PRNewswire/ -- According to Mordor Intelligence, the digital pathology market is valued at USD 2.01 billion in 2026, and is projected to surpass USD 3.2 billion by 2031, growing at a CAGR of 9.90% during the forecast period (2026-2031). The market is supported by rising cancer incidence, growing demand for faster and more accurate diagnostics, and increasing use of artificial intelligence and machine learning in pathology interpretation. Digital pathology solutions enable improved collaboration, remote case reviews, and enhanced diagnostic efficiency across healthcare systems globally. The transition from conventional microscopy to whole-slide imaging and digital platforms is reshaping pathology practices. Hospitals and laboratories are investing in digital pathology systems to streamline workflows, reduce turnaround times, and support precision medicine initiatives. Regional Market Insights North America remains a leading region in the digital pathology market due to early adoption of advanced diagnostic technologies, strong healthcare infrastructure, and favorable regulatory frameworks supporting digital pathology use in clinical diagnostics. The United States continues to play a central role, with increasing deployment of whole-slide imaging systems and AI-assisted diagnostic software across hospitals and reference laboratories. Europe represents another significant market, driven by growing acceptance of digital pathology in routine diagnostics, academic research, and pharmaceutical applications. Countries across Western Europe are adopting digital pathology platforms to improve efficiency and enable cross-border collaboration among pathologists. Emerging Key Trends Artificial Intelligence Integration Gains Momentum AI-powered image analysis tools are increasingly being integrated into digital pathology platforms to assist in disease detection, grading, and classification. These tools support pathologists by reducing manual workload, improving diagnostic consistency, and enabling early identification of complex conditions, particularly in oncology. Remote and Collaborative Pathology Workflows Expand Digital pathology is enabling remote diagnostics and real-time collaboration among pathologists across different locations. This trend is supporting telepathology applications, addressing workforce shortages, and improving access to expert opinions in underserved regions. Comprehensive Market Segmentation Overview By Product Whole Slide Imaging Systems Image Analysis & AI Software Communication & Storage Systems Slide Management Systems & Accessories By Imaging Technique Brightfield Fluorescence By Application Disease Diagnosis Drug Discovery & Companion Diagnostics Telepathology & Consultation Education & Training Quality Assurance & Archiving By End User Hospital & Reference Laboratories Pharmaceutical & Biotechnology Companies and CROs Diagnostic Centers Other End Users By Deployment Model On-premise Cloud-based / SaaS By Geography North America Europe Asia-Pacific Middle East & Africa South America For a full breakdown of market size, segmentation data, regional analysis, and competitive intelligence, access the details of the Mordor Intelligence report: Competitive Outlook The digital pathology market is moderately competitive, with established medical imaging companies, specialized digital pathology vendors, and emerging technology firms operating globally. Market participants are focusing on product innovation, AI integration, strategic collaborations, and regulatory approvals to strengthen their market presence. Investments in scalable software platforms and cloud-enabled solutions are key strategies shaping competition. Key Companies in the Digital Pathology Market Include: Koninklijke Philips N.V. Hamamatsu Photonics KK F. Hoffmann-La Roche Ltd 3DHistech Ltd Danaher Corporation (Leica Biosystems Nussloch GmbH) Check out related reports published by Mordor Intelligence: Long Term Care Software Market: The long term care software market report segments the industry into by product (electronic health records, e-prescribing, clinical decision support systems), by deployment (cloud-based, on-premise based), by end-user (home healthcare agencies, hospice care facilities, nursing homes and assisted living facilities), and geography (North America, Europe, Asia-Pacific). Clinical Workflow Solutions Market: The clinical workflow solutions market report is segmented by component (software and services), product type (data-integration solutions, real-time communication solutions), delivery mode (on-premise, cloud-based, and hybrid), organization size (large enterprises and SMEs), end-user (hospitals), and geography (North America, Europe). Healthcare Analytics Market: The healthcare analytics market is segmented by technology type (predictive analytics), component (hardware, software), delivery mode (on-premise model), application (clinical data analytics, financial data analytics), end user (healthcare providers), and geography (North America, Europe, Asia-Pacific). About Mordor Intelligence:  Mordor Intelligence is a trusted partner for businesses seeking comprehensive and actionable market intelligence. Our global reach, expert team, and tailored solutions empower organizations and individuals to make informed decisions, navigate complex markets, and achieve their strategic goals.  With a team of over 550 domain experts and on-ground specialists spanning 150+ countries, Mordor Intelligence possesses a unique understanding of the global business landscape. This expertise translates into comprehensive syndicated and custom research reports covering a wide spectrum of industries, including aerospace & defense, agriculture, animal nutrition and wellness, automation, automotive, chemicals & materials, consumer goods & services, electronics, energy & power, financial services, food & beverages, healthcare, hospitality & tourism, information & communications technology, investment opportunities, and logistics.  For any inquiries, please contact: [email protected]   Logo: SOURCE Mordor Intelligence Private Limited 21% more press release views with Request a Demo

In vitro diagnostics (IVDs) are a mainstay of modern medicine. People of all ages and their healthcare providers rely on these tests to determine the risk of a wide range of chronic and acute diseases, from cancer and diabetes to COVID-19. IVDs are indispensable tools for revealing and managing life’s milestones, from pregnancy to menopause. And they’re at the center of a budding interest in medical interventions aimed at optimizing lifespan. A growing and evolving global market within medical devices, IVDs range from reagent devices, such as urine dip-and-read sticks, to glucose monitors, to sophisticated genetic tests that are used to predict response to cancer therapies, according to the “Regulatory Knowledge Guide for In Vitro Diagnostics” published on the National Institutes of Health (NIH) website. About 3.3 billion IVDs are performed in the U.S. annually, according to the guide. A report by Grand View Research suggests the in vitro diagnostics market, which was more than $108 billion in 2024, would exceed $150 billion by 2030. North America led the IVD industry in 2024, with the Asia Pacific region emerging as the world’s fastest-growing IVD market. Based on product, the reagents segment held the lion’s share of the market in 2024. A reagent is a substance or mixture of substances (liquids or solids, like test strips) used to perform a laboratory test. Based on technology, the immunoassay segment accounted for the largest revenue share; and based on application, the infectious diseases segment dominated IVD options that year, according to the report. In 2024, the IVD sector continued to rebound from the decline in COVID-19-related sales, having already shown solid growth with a 6% increase in 2023. “… the core IVD market remains robust, with significant gains in core lab and point-of-care (POC) segments,” according to IQVIA. The IVD market, however, is transforming. The report, “ Navigating the Future of In Vitro Diagnostics, by IQVIA , suggests technological advances, shifting market dynamics, and evolving regulatory landscapes are driving the market’s evolution. To help guide medical device manufacturers who are developing IVDs or plan to enter the market, MD+DI takes an in-depth look at the complex IVD regulatory landscape, reimbursement challenges, and leading and emerging IVD companies. Understanding in vitro diagnostics IVD tests use samples, including bodily fluids and tissue, to detect diseases and other conditions, monitor a person's health, identify patients likely to benefit from specific treatments (by tracking biomarkers)—even scan a person’s DNA to detect genomic abnormalities, according to FDA. IVDs also play important roles in public health and epidemiology, in wide-scale screening for infectious disease surveillance (e.g., HIV, tuberculosis (TB)), blood safety, population health screening, and rapid response to outbreaks, according to IVD and medical device clinical research services company CovarsaDx. Las Vegas-based CovarsaDx responded to MD+DI by email for this article. IVDs differ from other diagnostic tools. “In vitro” means in glass (test tubes, for example) to describe tests that are conducted outside the body. That’s unlike in vivo diagnostics (imaging, endoscopy) or directly observational diagnostics (physical exam, biopsy imaging). The urine, saliva, blood, or tissue retrieved for IVDs provides biochemical, genetic, immunologic, or molecular data, often revealing diseases before noticeable symptoms or structural changes are detectable, according to CovarsaDx. While some test types are processed in a laboratory and done in a lab, hospital, or clinic setting, others can be done and interpreted at home by patients or users. IVD product types include reagent kits, instruments, and software. Techniques include immunoassay, molecular diagnostics, clinical chemistry, hematology, and microbiology. FDA regulates IVDs with regulations that differ from those for the general medical device category. stockbusters via iStock/Getty Images “Within FDA, the Center for Devices and Radiological Health (CDRH) and, for a subset of medical devices, the Center for Biologics Evaluation and Research (CBER) are responsible for ensuring the safety and effectiveness of IVDs. FDA lists all IVDs cleared or approved since November 2003 in a searchable database , according to the “Regulatory Knowledge Guide for In Vitro Diagnostics” report. “Non-IVD devices function primarily in or on an individual, whereas an IVD involves the collection or examination of human specimens that have been removed from the body.” Common IVDs IVDs include a broad ecosystem of routine tests, advanced molecular assays, and distributed testing systems. Common examples, according to CovarsaDx, include: Blood-based tests, such as complete blood count, basic and comprehensive metabolic panels, blood glucose, liver/kidney function panels, coagulation, cardiac biomarkers, hormone tests, and infectious disease serology. Molecular diagnostics, which are tests used for infectious diseases, genetic testing, oncology, and more. These include nucleic acids (DNA, RNA), such as Polymerase Chain Reaction (PCR) based assays, real-time PCR, nucleic acid amplification tests (NAAT), hybridization assays, and sequencing-based tests (such as next-generation sequencing (NGS)). Point-of-care testing (POCT)/rapid diagnostics are portable or near-patient devices, rapid antigen tests, bedside analyzers, small handheld instruments, and at-home testing kits. These include tests for COVID-19, flu, and RSV. High-throughput lab instruments and automation systems are automated immunoassay analyzers for large-volume clinical labs that process samples for chemistry, immunoassays, molecular panels, etc. These include thyroid hormone panels, prostate-specific antigen (PSA), Vitamin D, allergy testing, and autoimmune markers. Personalized medicine to public health IVDs are central to increasing demand for personalized medicine. Genetic tests, biomarker assays, molecular diagnostics, and companion diagnostics allow clinicians to tailor therapy to a patient’s biology (mutations, expression patterns, risk profile). In individualized treatment guidance and optimization, IVDs help monitor therapeutic responses and can offer early detection of relapse or the need to adjust dosing or treatment. As a result, patients might experience better health outcomes and minimal side effects while avoiding unnecessary interventions. On the opposite end of the spectrum, IVDs support mass screenings for such things as communicable diseases, early detection campaigns, blood-safety testing, and epidemiological surveillance. Point-of-care IVDs can fill critical gaps in resource-limited settings. And in the big picture of healthcare efficiency and cost, IVDs help enable early diagnoses; appropriate therapy selections and monitoring to help reduce downstream healthcare costs and improve resource utilization, according to CovarsaDx. Global regulatory landscape for IVD High development costs to meet regulatory standards may limit the IVD market’s growth. The need for extensive clinical validation, complexities of IVD platforms, stricter regulations, high research and development investment, and clinical trials can lead to high development costs, according to an industry report by Precedence Research . Global governments and health agencies, however, are increasing their support of the development and deployment of advanced IVD tools, according to another market research report by Exactitude Consultancy . “Regulatory bodies are also modernizing frameworks to accommodate breakthrough innovations in diagnostics, making it easier for new technologies to enter the market under clear guidance,” according to Exactitude Consultancy’s research. How FDA regulates IVDs There are special considerations for IVDs, and FDA created a distinct set of regulations that cover these types of products, says Benjamin M. Zegarelli, of counsel, at Mintz . Zegarelli provides regulatory compliance counsel to global clients developing and marketing FDA-regulated products. “[IVDs] have special types of testing that need to be done to make sure they’re validated,” Zegarelli told MD+DI. FDA 510(k) clearance is among the authorization methods for IVDs. Some IVDs are class I devices, meaning they don’t require any sort of clearance or approval. Class I devices may be available to the public as long as the manufacturer follows the appropriate quality system requirements and other general controls necessary to be able to ensure the proper safety and efficacy. Much more commonly, IVDs are class II devices, most of which are required to follow general and special controls that are defined by the specific 510(k) clearance. IVDs can also be class III requiring a PMA, or premarket approval. Regulatory requirements for many IVDs address reagent use, instructions for use, test interpretation, and more on labeling. “IVDs involve reagents,” Zegarelli said. “So, there are chemicals associated with this type of device use. If there are reagents involved, you have to name those reagents, just like you would for a drug or biologic. There are statements of warnings and precautions for use. And a lot of very specific reagent-based declarations that have to be on the label.” R egulatory challenges Depending on a manufacturer’s device classification, the costs to meet FDA requirements could be prohibitive. “A lot of smaller entities don’t really have the capital or the means to move forward with the highest possible classification. If you have to go with a PMA, typically you need a clinical evaluation of that test before it can actually be approved by FDA. That’s pretty prohibitive, especially in the device world,” Zegarelli said. “So, trying to get the classification down as low as possible is very helpful for these types of tests.” Another challenge is the fact that laboratory-developed tests (LDTs) are even less regulated by FDA than they were before FDA tried to make its final rule to regulate LDTs, according to Zegarelli. Laboratory-developed tests are a type of in vitro diagnostic test that are typically designed, manufactured, and performed all within one Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. “This was supposed to be a narrow exception, and that exception has burgeoned into a huge industry, where clinical labs are running lots of diagnostic tests,” he said. Still, in 2025, a federal court said FDA does not have the authority to regulate LDTs, and the U.S. administration did not appeal the ruling. “Today, LDTs are operating in kind of a vacuum. The laboratories that run and design them are regulated by CLIA, under CMS, but there is no other regulatory oversight over the tests themselves,” Zegarelli explained. “This is a huge problem for the IVD industry. Traditional manufacturers of IVDs have to fully compete with a sector of the industry that is technically less regulated (and they are).” In this case, there’s no easy solution for IVD manufacturers, he said. The one advantage that IVDs might have over LDTs is that FDA clearance of a device may lead to an easier path for U.S. coverage and reimbursement, according to Zegarelli. U.S. regulatory trends Like most sectors, IVD developers are trying to integrate generative artificial intelligence (AI), including large language model functions, like ChatGPT. Despite the momentum to use generative AI in clinical decision support software and IVD device sectors, FDA has not yet authorized any specific medical use of generative AI, Zegarelli says. “By contrast, there are many IVD products that incorporate algorithms and basic types of AI. … incorporating AI is an ongoing trend, and you can see this unfolding at FDA's website for AI-enabled medical devices,” according to Zegarelli. Another potential regulatory challenge isn’t new but is something many manufacturers might not consider. It’s that IVD accessories or devices that are ancillary to the actual diagnostic testing process (sample collection and kits that are needed to collect fluids and tissue) are considered medical devices. IVD and LDT kits, for example, are meant to collect biospecimens. “Each individual component of a kit is usually a medical device. The sharp used to prick the skin and collect blood is a medical device. The collector to collect the blood is a medical device. A swab to collect buccal samples from inside the mouth is a medical device. The saliva vial that you use for [genetic testing] or any sort of testing that would involve collecting DNA from saliva, that’s a medical device. And all of those components are regulated by FDA. They have specific device classifications, and some require 510(k)s,” Zegarelli said. European regulatory landscape “Globally, regulatory changes are reshaping the landscape. For example, in the European Union, the new In Vitro Diagnostic Regulation (IVDR) replaced the older directive,” according to CovarsaDx. The European Union refers to the IVDR for regulating IVDs. While there are many basic similarities, EU regulations, like IVD regulations in the Asia-Pacific region and South America, differ from the FDA’s system. Compared to the older directive, IVDR introduces stricter classification, increased conformity assessment requirements, more rigorous documentation of analytical and clinical performance, unique device identification (UDI), post-market surveillance, and supply-chain transparency, according to CovarsaDx. “As a result, many IVDs now require review by third-party ‘Notified Bodies,’ and only a subset of previously self-certified devices remain permissible,” CovarsaDx reported. The transition has been difficult, creating bottlenecks for manufacturers. This is especially the case for small and mid-sized companies. The lack of harmonization across jurisdictions and increasing regulatory burden challenges companies in the IVD space. “The increasing regulatory burden — while intended to improve safety, quality, and transparency — can slow innovation, raise development cost, and create market entry barriers …,” CovarsaDx wrote. [For more on the EU regulatory landscape for IVDs, see MD+DI ’s coverage Ensuring Continued Availability of In-Vitro Diagnostics in UK, EU . Asia and Pacific regulatory landscapes Asia and the Pacific economies differ significantly regarding the maturity level of their National Regulatory Authorities (NRAs), according to Development Asia . While Australia, Japan, and Singapore have well-established regulatory bodies, countries like India are evolving to meet the growing market’s demands. “At the other end of the spectrum, Brunei, Georgia, Mongolia, Timor-Leste, and other low- and middle-income countries (LMICs) either lack a national regulatory authority (in which case the Ministry of Health oversees regulation for medical devices) or have NRAs with limited capacity,” according to Development Asia. “In general, countries categorize medical devices based on risk to humans but with a varying number of levels or classes. Under a risk-based classification system, an increasing level of regulation is applied as the potential risk rises. Depending on the country, medical device regulations may include registration, licensing, and in-country testing, among others.” Zolnierek via iStock Getty Images Reimbursement in the IVD Industry Reimbursement policy variability and uncertainty in many countries remain an industry challenge. “…limited or unclear insurance coverage for new diagnostic tests discourages both providers and patients from adopting high-cost or novel solutions. Without standardized value assessment metrics, many IVD manufacturers struggle to demonstrate cost-effectiveness, which impedes market penetration and revenue generation,” according to the report by Exactitude Consultancy. In the United States, reimbursement for most IVD tests is mediated through CMS via the Clinical Laboratory Fee Schedule (CLFS), using established billing codes such as Current Procedural Terminology (CPT) codes (or Healthcare Common Procedure Coding System (HCPCS) where applicable), according to CovarsaDx. Among the challenges is that the CPT code-linked reimbursement schedule is typically linked to older or simpler tests. Introducing more complex or next-generation diagnostics, such as high-complexity molecular assays, NGS-based tests, and multiplex panels, often fails to translate into proportionally higher reimbursement. And there is no consistent process for value-based pricing of complex diagnostics in the U.S., CovarsaDx reports. “In infectious disease diagnostics, for example, reimbursement pressure is evident: some high-complexity molecular tests (e.g., certain multiplex PCR panels) may cost hospitals more to perform than the reimbursement allows,” the company writes. CovarsaDx describes IVD reimbursement in many European markets as even more fragmented, with payments being negotiated at times at regional or local levels. Pricing and uptake of advanced diagnostics often depend on local health-technology assessment (HTA) frameworks, which in many cases are underdeveloped and inconsistent for diagnostics. Key reimbursement challenges According to CovarsaDx, these are reimbursement challenges that manufacturers face: Value recognition lag. New, more sophisticated diagnostics may not be reimbursed at a level that reflects their clinical value or development cost, limiting commercial viability despite technical superiority. In the U.S., there is no formal, widely accepted mechanism for revaluing diagnostics based on improved outcomes, cost savings, or personalization benefits. Economic pressure on high-cost tests and panels. For example, labs running complex molecular tests or multiplex panels must balance the cost of reagents, labor, and equipment against fixed (possibly low) reimbursement rates, which may disincentivize adoption. Fragmentation of global access. In lower- and middle-income countries, the high cost of advanced IVD technologies, regulatory burdens, and less favorable reimbursement or healthcare financing constrain uptake. New technology roadblocks. The process to apply for and receive a new ICD-10-PCS procedure code can be lengthy and variable based on test complexity, requirements for clinical evidence, regulatory and administrative cycles, and substantial review time. Strategies for overcoming reimbursement hurdles in the U.S. CovarsaDx recommends that manufacturers take these steps to overcome reimbursement challenges in the U.S. Demonstrate the health and economic value of an IVD by performing and publishing real-world evidence and health-economic studies that document how advanced diagnostics reduce downstream costs. IVDs might reduce costs by enabling earlier diagnoses, preventing hospitalizations, avoiding ineffective therapies, or optimizing therapy via companion diagnostics. Manufacturers can use the data to negotiate with payers or influence guideline adoption. Engage with payers early to define value-based contracts or risk-sharing models (examples include: “pay-for-performance,” “outcome-based reimbursement,” or bundled-test plus therapy reimbursement for companion diagnostics). Seek new or revised CPT/HCPCS codes and coverage policies for novel diagnostics by working with professional societies, CMS, and commercial payers. This avoids being shoehorned into old coding and may better reflect test complexity and cost. Advocate for periodic re-evaluation of lab test reimbursement rates based on updated cost-of-labor, reagent, and instrument costs, and added value. Target sectors with favorable economics or unmet need , such as oncology companion diagnostics, rare disease genetic testing, or high-impact infectious-disease multiplex panels (where payers may acknowledge the value of precision diagnostics, making reimbursement more likely or acceptable). Offer bundled or integrated testing and diagnostic services (lab + interpretation + reporting), possibly via partnerships with payers or providers. This allows for a one-stop value proposition. Optimize cost and platform scalability with assays and platforms that lower test cost, improve throughput, and amortize instrument cost. Use automation, standardized workflows, and economies of scale to reduce labor and consumables costs. Leverage digital health, AI, and data-driven tools by using AI/ML-driven interpretation tools to reduce personnel time, decrease error rates, and improve consistency. Use data analytics to demonstrate improved outcomes, efficiency gains, and cost savings at the population level. Collaborate with payers, providers, and pharma . Partner with pharmaceutical companies to co-develop companion diagnostics. Tying tests to a specific therapy can accelerate payer acceptance. Work with large health systems to integrate diagnostics into care pathways. Top in vitro diagnostic companies Today’s leading IVD players (and their recent IVD-related announcements) include: Roche : Switzerland-based Roche, a global leader in in-vitro diagnostics, announced in December 2025 that it had received CE Mark approval for its mass spectrometry reagent pack for antibiotic drug monitoring. “This establishes Roche's in-vitro diagnostics (IVD) menu as the broadest available for any automated mass spectrometry platform, including already 39 of the most frequently tested targets,” according to Roche. Abbott Laboratories : Abbott stands out for innovative point-of-care testing and laboratory solutions. In November 2025, the U.S.-based company announced that it acquired Exact Sciences, maker of Cologuard noninvasive colorectal cancer screening, to “enter and lead in fast-growing cancer diagnostics segments….” Thermo Fisher Scientific : U.S.-based Thermo Fisher Scientific’s extensive diagnostics portfolio includes patient care solutions in oncology, infectious disease, women’s health, toxicology, allergy, and autoimmune diseases, and transplant and protein diagnostics. Among its IVD offerings, rapid next-generation sequencing (NGS) solutions for oncology research and routine patient testing, and biomarker prenatal screenings. The company offers the first immunoassays to receive FDA breakthrough designation and clearance for risk assessment and clinical management of preeclampsia. Siemens Healthineers : Siemens Healthineers offers IVD solutions for nearly every clinical environment. According to the company, it has differentiated its in vitro diagnostic test offerings with flexible, scalable, and integrated automation capabilities. In July 2025, Siemens Healthineers announced it earned My Green Lab ACT Ecolabel Certification for more than 150 immunoassay and clinical chemistry reagents used globally by medical laboratories for IVD testing, including its High-Sensitivity Troponin I assay, which helps with heart attack diagnosis and to identify future risk of death and cardiac events, as well as its Enhanced Liver Fibrosis (ELF) Test, the first prognostic test used to help assess the likelihood of disease progression in patients with advanced fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH). Danaher , a global life sciences and diagnostics company, operates subsidiaries including HemoCue point-of-care blood diagnostics; molecular diagnostics company Cephied; Leica Biosystems, a cancer diagnostics and workflow solutions company; Beckman Coulter, which develops, manufactures, and markets complex biomedical testing products and provides in vitro diagnostic systems and reproductive health products; as well as others. Among the industry’s promising startups Many IVD startups are looking to disrupt the industry. These are a few of the “top” IVD startups listed by VentureRadar . Founded in 2022, Detechgene is developing a rapid test procedure that combines PCR’s precision with the ease of use of a rapid antigen test to detect viral, bacterial, and fungal pathogens. The Germany-based company announced in July 2025 that it completed its second seed financing round, raising 3 million euros. U.S.-based TETmedical (Tethered Enzyme Technologies) is a clinical-stage platform nanomedicine company focused on in vitro diagnostics that enable insights for high-consequence disease decision making. The company’s TED nanobot is less than a hundredth the width of a human hair and is capable of performing chemical operations with high sensitivity, stability, and speed (thousands of times faster than antibody assays), according to TETmedical.com . Finland-based NADMED developed a technology to measure nicotinamide adenine dinucleotide (NAD) levels in the body from a drop of blood. NADs are coenzymes that are essential to metabolism. NADMED was selected to join the AMPlify program, a U.S. market entry initiative jointly organized by Mayo Clinic and Business Finland. The program combines world-class clinical expertise, valuable market knowledge, and extensive networks to support the growth of a select group of Finnish health tech companies, according to NADMED . Future trends in the in vitro diagnostics market Several market forces are driving IVD industry growth, according to CovarsaDx, including: The increasing prevalence of infectious diseases, such as COVID-19, HIV/AIDS, tuberculosis, hepatitis, and malaria, poses significant public health challenges. The rising burden of chronic, genetic, infectious, and other diseases — fueled by aging populations, increased prevalence of chronic diseases (cardiovascular, cancer, diabetes, etc.), and continuing infectious disease threats. Need for early disease detection and prevention. Growing adoption and rising demand for personalized, or precision, medicine. Technology advances and automation, including innovations in molecular diagnostics, multiplex assays, lab automation, point-of-care testing, and digital connectivity. Public health screening and surveillance for infectious diseases, population health, blood donation screening, etc. Impacts of AI/ML on the future of IVDs CovarsaDx points to digital health integration and AI-driven diagnostics impacting the industry and regulations. The industry’s technological evolution includes advances in molecular diagnostics (PCR, isothermal amplification, NGS), lab automation, high-throughput instruments, microfluidics (lab-on-a-chip), and point-of-care and at-home testing. “Increasingly, IVD is not just a standalone test: results feed into digital platforms, electronic health records, cloud-based systems, and telemedicine workflows. This enables remote diagnostics, population-level data aggregation, epidemiological surveillance, and longitudinal patient monitoring,” according to CovarsaDx. AI/machine learning (ML) is being used to interpret complex data: molecular profiles, multi-marker panels, genomics, proteomics, or multiplex assays; pattern recognition (e.g., disease signatures), predictive models, risk stratification, or prognostic biomarkers. And while these advances offer important benefits, such as faster turnarounds and standardized interpretation, as well as potentially predictive or prognostic and diagnostic capabilities, the traditional medical-device regulatory model will need upgrading, as it may not be sufficient for AI/ML systems that learn or update over time, according to CovarsaDx. Thapana Onphalai via iStock/Getty Images Other major IVD trends, innovations CovarsaDx notes the rise of molecular diagnostics, genomics, and proteomics. Use of advanced molecular diagnostics (PCR, real-time PCR, digital PCR), high-throughput sequencing (such as NGS), and genomic assays is expanding — especially for cancer diagnostics, rare diseases, and precision medicine. As costs decline (though still high), NGS-based tests are becoming more accessible — enabling liquid biopsy, non-invasive cancer detection, minimal residual disease (MRD) monitoring, pharmacogenomics, and companion diagnostics. Scientists are increasingly exploring proteomics for biomarker discovery. As novel biomarkers are identified, immunoassays and multiplex assays built around them become possible, expanding diagnostic coverage beyond genetics, according to CovarsaDx. In another innovative area, manufacturers are focusing on the development of multiplex testing, an advanced diagnostic approach that enables simultaneous detection of multiple targets from a single sample or reagent or test kit, according to Roche Diagnostics . In molecular diagnostics, multiplex PCR technology enables the detection of multiple targets in a single reaction. “Multiplex point of care testing for respiratory or sexually transmitted infections can provide rapid results for multiple analytes from a single patient sample, while the patient is still present with their healthcare provider,” according to Roche. There are notable shifts toward point-of-care testing (POCT), decentralization, and at-home diagnostics, including portable, rapid-result devices for use at the bedside, clinics, or at home, according to CovarsaDx. Major unmet needs Unmet needs remain in the industry. According to CovarsaDx, these include: Affordable access to advanced diagnostics in low-resource settings domestically and worldwide. Validated biomarkers for broader diseases. Neurodegenerative diseases, chronic inflammatory conditions, and complex diseases are a few examples of areas where few validated biomarkers exist, which limit diagnostic or companion assay development. Reimbursement frameworks lack consistent, standardized mechanisms to reimburse based on value rather than cost-of-goods. Interoperability and data integration: As diagnostics become more complex and data-driven, many labs and health systems struggle with integrating IVD data into existing IT/electronic health record (EHR) systems. Skilled workforces for advanced diagnostics often require trained personnel, bioinformatics support, and specialized lab infrastructure, which can create workforce challenges for smaller labs or resource-constrained settings. Regulatory and standardization hurdles for novel diagnostics and AI tools remain, even as more assays leverage complex algorithms, machine learning, or novel biomarkers. Forces that could slow IVD growth CovarsaDx writes that manufacturers should have their eyes open to these challenges to market launches and penetration: Saturation of some test categories — Routine testing (such as common immunoassays, standard panels) may be subject to market saturation, especially in developed markets with established infrastructure. Reimbursement pressure on high-cost tests -- If public or private payers resist paying more for complex diagnostics, adoption may stall despite clinical value, especially for multiplex panels or novel biomarker assays. Regulatory and validation bottlenecks — As diagnostics get more complex, regulatory approval becomes more challenging and can slow time-to-market and adoption. Competition from decentralized/self-testing/consumer diagnostics — As at-home/self-testing becomes more common, traditional centralized lab-based testing may decline for certain categories, particularly low-complexity or routine tests. A futuristic look at the IVD market Based on current trends, drivers, and structural dynamics, CovarsaDx anticipates: Continued growth of the IVD market, at a robust rate — Estimates from recent market research suggest that the global IVD market could grow from about $108 billion in 2024 to about $150 to $192 billion by 2030 to 2034 under conservative to optimistic growth scenarios. Acceleration of molecular, genomic, proteomic, and multiplex diagnostics adoption — As precision medicine, companion diagnostics, liquid biopsy, and personalized therapy become standard of care, demand for advanced diagnostics will expand, especially in oncology, rare diseases, and chronic disease management. Expansion of decentralized, point-of-care, and at-home diagnostics — This will be driven by patient demand, digital health adoption, telemedicine, and the need for rapid turnarounds. It will be particularly important in chronic disease monitoring, infectious disease outbreaks, remote care, and preventive screening. Wider integration of digital health, AI, and data-driven diagnostics — AI/ML-enabled IVD platforms, cloud-based analytics, automated workflows, and digital pathology will become mainstream, improving efficiency, reducing costs, enabling scalable diagnostics, and facilitating continuous improvement through data learning loops. Shift toward value-based diagnostics, outcome-based reimbursement, and healthcare economics orientation — As payers and health systems focus interest on cost-efficiency and health outcomes, diagnostics providers will increasingly need to demonstrate real-world value with early detection, prevention, reduced hospitalizations, therapy optimization, and long-term cost savings. This may lead to new reimbursement models, bundled payment + diagnostics + therapy, and commercial alignment with value-based care. Growing fragmentation and specialization — While large incumbent players will continue to dominate core lab and broad-market diagnostics, there will be increasing space for specialized niche players. These players will likely focus on such things as novel biomarkers, rare diseases, precision medicine, advanced multiplex assays, decentralized diagnostics, and data-driven tests. Finally, according to CovarsaDx, there will likely be global expansion and penetration into emerging markets. “As costs decline and infrastructure spreads, IVD adoption will grow significantly in emerging economies, fueled by rising chronic disease burden, increasing healthcare spending, and demand for early diagnosis. This will create new growth corridors worldwide,” wrote CovarsaDx.

FORT MYERS, Fla.--(BUSINESS WIRE)--NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced the appointment of diagnostics and lab services industry veteran John P. “Jack” Kenny to its Board of Directors. Mr. Kenny is filling the seat vacated by Alison Hannah, MD, who is rotating off the Board after more than ten years of dedicated service. Mr. Kenny brings to the NeoGenomics Board over three decades of diverse executive, commercial, and operational experience and a track record of success in the diagnostics and lab services businesses. He most recently served as President, Chief Executive Officer and Board Director of Meridian Bioscience, a fully integrated life science company that develops, manufactures and distributes a broad range of innovative diagnostic products and critical raw materials for immunoassay and molecular testing companies. Meridian, which formerly traded on the NASDAQ exchange under the ticker “VIVO,” was taken private in January 2023. “We are very excited to welcome Jack to the NeoGenomics Board,” said Lynn Tetrault, Chair of the Board of NeoGenomics. “His vast experience building winning cultures and leading high performance commercial teams will serve us well as we pursue significant emerging opportunities in the next generation of cancer testing, notably NGS and MRD. I look forward to his insights and guidance.” “I would also like to thank Dr. Hannah for her strategic guidance over the past decade and her unwavering commitment to NeoGenomics’ mission to save lives by improving patient care. Her contributions have been invaluable,” Ms. Tetrault concluded. Prior to joining Meridian Bioscience in 2017, Mr. Kenny served as SVP and General Manager of North America at Siemens Healthcare and, before that, as VP and General Manager of the U.S. region at Becton Dickinson. Earlier in his career, he held sales leadership positions at Leica Biosystems, Quest Diagnostics, Siemens Medical Solutions, and Abbott Laboratories. Mr. Kenny also serves on the Boards of OraSure Technologies, Inc., DCN Diagnostics, and Quantum-Si, Inc. He received a BS in management systems with a focus in marketing from Kettering University (formerly the GMI Engineering and Management Institute). “I have known NeoGenomics for many years, and I believe their leadership position in hematology cancer testing positions them well to deliver innovation to where it’s needed most – the community setting – improving patient outcomes while creating sustained value for shareholders,” said Mr. Kenny. “I look forward to working alongside my fellow Board members and the passionate NeoGenomics leadership team to help guide the Company through its next phase of growth.” About NeoGenomics NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom. Forward Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “can,” “could,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “guidance,” “potential” and other words of similar meaning, although not all forward-looking statements include these words. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Applicable risks and uncertainties include, among others, the risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and the Company's other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and in the “Investors” section of our website at ir.neogenomics.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.