Molecular Diagnostics Market Size (2025 – 2030)

The Molecular Diagnostics Market was valued at USD 19.4 billion in 2024 and is expected to grow at a CAGR of 7.8% from 2025 to 2030, reaching a market value of USD 30.44 billion by the end of 2030.

The Molecular Diagnostics Market can be characterized as a rapidly developing branch of the healthcare market, which utilizes molecular biology to study genetic material and provide precise, rapid, and reliable information for the detection, diagnosis, and treatment of diseases. As opposed to previous diagnostic techniques, molecular diagnostics is aimed at the identification of DNA, RNA, proteins, and biomarkers in specific cases, thus allowing clinicians to identify conditions at the earliest stages and tailor treatment options even more precisely. The market has had incredible momentum due to the increase in prevalence of infectious diseases, cancer, genetic disorders, and the increased need for personalized medicine. The scope and applications of this have been expanded greatly by technological advances like real-time PCR, next-generation sequencing, and advanced microarray platforms. Also, the growing awareness about the importance of detecting diseases at an early stage, rising health care spending, and strategic alliances between biotech firms and medical delivery organizations are contributing to its growth. The COVID-19 pandemic served as the triggering factor, demonstrating the invaluable nature of molecular diagnostics to mass testing and worldwide monitoring. Having become part of the precision medicine and companion diagnostics, the market is not only transforming patient care, but also provides stakeholders in the global scene with lucrative opportunities. Moving forward with the development of healthcare, molecular diagnostics is in the vanguard, which reconciles innovation with enhanced clinical results.

Key Market Insights:

Molecular diagnostics is shifting from centralized labs to decentralized settings. Point-of-care and near-patient testing contribute ~52.6% of total revenues in developed markets, showing a structural preference for fast, location-flexible testing.  

McKinsey notes that molecular diagnostics tests often generate a high gross margin (50-70%) compared with typical diagnostics (which have ~30-50%).

National health systems are adopting liquid biopsy (ctDNA) as routine practice. In one pilot, over 2,000 cancer patients benefited, cutting decision-making time by ~16 days. Annually, ~20,000 patients in oncology could see improved treatment pathways.

In next-generation sequencing (NGS) workflows, the sequencing stage alone accounts for ~63.9% share of laboratory costs and activities. This underscores heavy capital and consumable demand for sequencing platforms in clinical diagnostics.

Despite rising adoption of sequencing, PCR still leads clinical and POC diagnostics, holding ~65.7% revenue share in POC molecular tests. PCR’s dominance reflects its affordability, scalability, and speed for infectious disease detection.

AI-driven analytics and automation are revolutionizing molecular workflows. Recent surveys show ~66% of physicians use health AI tools to support diagnostics, and labs rank automation & AI among the top trends shaping 2025. These tools improve speed in NGS data analysis and precision diagnostics.

Market Drivers:

The Rising Burden of Infectious and Chronic Diseases is Driving Molecular Diagnostics Adoption.

The market is highly motivated by the increasing rate of infectious diseases and chronic conditions, which require accuracy, early and reliable detection. With new viral outbreaks and long-standing infections such as tuberculosis and cancer, healthcare organizations face pressure to implement molecular diagnostics that would provide fast and high-quality information. The need is further accelerated by the increasing global awareness of early diagnosis and preventive care, which makes molecular testing one of the frontline instruments in the process of protecting the health of the population.

Advancements in Technology and AI Integration are Accelerating Molecular Diagnostics Growth.

The other major driving force is the ongoing innovation wave defining the molecular platforms. New technologies like real-time PCR, next-generation sequencing, and liquid biopsy are currently being paired with automation and artificial intelligence to give them faster analysis and improved interpretation. These technologies are able not only to improve clinical results but also to simplify the functioning of operations, making molecular diagnostics easier to achieve in decentralized and point-of-care environments. Such a combination of accuracy and velocity continues to take the industry to new frontiers.

Market Restraints and Challenges:

Although the molecular diagnostics market has witnessed a high level of improvement, it has significant limitations that question its smooth development. The challenge of the high cost of sophisticated diagnostic technologies is also among the main obstacles because such complex tools as next-generation sequencing (NGS) platforms and automated PCR systems require significant investments in the purchase, maintenance, and use. This economic cost not only discourages uptake in cost-sensitive healthcare institutions, but also the accessibility of patients in low- and middle-income areas, where affordability is a critical issue. The market is also struggling with regulatory complexities and the problem of standardization, in addition to cost barriers. The differences in approval requirements within the different geographies, combined with the lack of testing standards internationally, delay the commercialization of products and introduce ambiguity concerning the reliability of tests. To smaller players within the industry, these complex regulations are especially challenging and can slow innovation and competitive strength. Collectively, these issues are tremendous inhibitors that limit the market's ability to gain mass penetration across the world.

Market Opportunities:

The opportunities in the molecular diagnostics market are abundant, specifically, with its growing presence in personalized medicine and the increased use of point-of-care testing. The industry is making it possible to offer precision treatments based on individualized genetic profiles, with the field of next-generation sequencing and biomarker discovery, which opens the doors to massive value in oncology and rare diseases. Meanwhile, the need to be fast, portable, and cost-effective in diagnostic testing is driving point-of-care testing into the limelight, particularly in underserved and resource-restricted areas. With these trends combined, molecular diagnostics companies can be set to transform healthcare delivery by integrating both accuracy and accessibility to ultimately create a more patient-centric and inclusive healthcare environment.

MOLECULAR DIAGNOSTICS MARKET REPORT COVERAGE:

Molecular Diagnostics Market Segmentation:

Molecular Diagnostics Market Segmentation by Type:

• PCR-based tests
• Microarray-based tests
• Next-generation sequencing
• Isothermal amplification-based tests

The largest portion of the molecular diagnostics market is occupied by Polymerase Chain Reaction (PCR)-based tests, which are mainly characterized by the fact that they are the most sensitive, fast, and accurate in the process of detecting genetic material. These tests continue to be the gold standard of infectious disease diagnostics, especially after the outbreaks that occurred globally, where quick detection is paramount. Their superiority is upheld by their prevalence in clinical practice, standardization of procedures, and real-time PCR platforms that are present in the developed and developing healthcare systems. The PCR technologies are also proving to be indispensable in routine diagnostics, oncology testing, and the identification of genetic disorders due to their reliability and scalability, and so the company will remain the leader in this segment.

The fastest-paced sub-segment is Next-Generation Sequencing (NGS), which is growing due to the escalating need for precision medicine and the comprehensive genomic study. Its multiple-gene analysis using a high-throughput capability is transforming the way cancer is diagnosed, rare diseases are identified, and treatment models are personalized. Declining sequencing prices and the development of bioinformatics are further facilitating its usage, and it can now be used in non-research organizations and in general clinical laboratories. With healthcare providers becoming more and more dependent on genomics to personalize treatment, NGS is changing the face of molecular diagnostics faster and faster, and it is the most active driver of growth in the market.

Molecular Diagnostics Market Segmentation by Application:

• Infectious disease diagnostics
• Oncology diagnostics
• Genetic testing
• Cardiovascular disease diagnostics

The most prevalent use of molecular diagnostics in the market is infectious disease diagnostics, which is mainly driven by the need to identify bacterial, viral, and parasitic infections in a fast and precise way all over the world. An increased load of diseases and disorders like HIV, hepatitis, and tuberculosis, along with the ongoing development of new agents, has increased the need to use molecular platforms. The development of sophisticated PCR-based tests and next-generation sequencing is providing opportunities to diagnose early, treat more efficiently, and implement effective strategies of infection control. Moreover, the experience of the recent world health disasters has strengthened the investments in large-scale testing of infectious diseases, which makes this segment of the market firmly established as the foundation of the molecular diagnostics adoption globally.

Oncology diagnostics is rapidly becoming the fastest-growing field of application due to the increasing incidence of cancer and the desperate need to find a solution to personalized medicine. Ventures in liquid biopsy, companion diagnostics, and biomarker-guided assays are helping clinicians to detect cancers at an earlier stage and provide precise therapy. Molecular diagnostics is also entering the mainstream of cancer screening and surveillance, and is being encouraged by healthcare policy and payer acceptance. With patients becoming more and more convinced of the need to have minimally invasive testing modalities that are at the same time highly precise, there is an unprecedented boom in oncology diagnostics, which is revolutionizing the face of cancer care and taking the lead as the most dynamic growth driver in the field of molecular diagnostics.

Market Segmentation: Regional Analysis:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa

Asia-Pacific is the largest segment of the market in molecular diagnostics, which is backed by the strong expansion of healthcare infrastructure, an increasing number of patients, and a higher rate of adoption of high-level diagnostic solutions. Countries like China, India, and Japan are experiencing an upsurge in demand for molecular testing, a fact that is attributed to the increase in the prevalence of infectious diseases, cancer, and genetic disorders. Moreover, more government funding of precision medicine, prevalent clinical research programs, and the infiltration of affordable diagnosis technology have catapulted the Asia-Pacific into a leadership role. The young population in the region, the high rate of urbanization, and the increasing spending on health care funds still enhance its status as the major centre of the market growth.

Conversely, the North American region is the fastest-growing one, which is driven by its developed biotechnology ecosystem, a high level of usage of innovative testing platforms, and positive guidelines on precision diagnostics. The area has an agglomeration of major diagnostic firms and large investments in R&D, and the high-speed adoption of both next-generation sequencing (NGS), point-of-care testing, and companion diagnostics into clinical care. North America is the best growth engine in view of the increased growth rates in personalized medicine and heightened awareness of early disease detection. As the focus on preventive medical care and electronic health integration grows, the adoption of molecular diagnostics is bound to accelerate in the region in the next few years.

Molecular Diagnostics Market COVID-19 Impact Analysis:

COVID-19 transformed the market of molecular diagnostics, causing an unparalleled increase in demand for PCR-based testing. With the pandemic events, molecular diagnostics became an important resource in the detection of the SARS-CoV-2 virus, with governments worldwide directing much of their resources to diagnostic testing in order to limit the spread of the virus. This huge investment resulted in a spectacular growth in the revenue and the output of molecular tests. The acuteness of the case predetermined the rapid evolution of diagnostic technology, and companies were interested in creating and gaining the approval of new, more rapid, and more accurate testing methods, which would be able to satisfy the continuously growing demands of the healthcare system. Not only did the pandemic increase the growth of the market, but it also enhanced innovation in the sector, which was reflected in an increase in the number of diagnostic technologies launched in the market, and faster. Even though the first wave of the crisis has been mitigated, the fear of new variants and the necessity to perform regular tests are likely to remain key factors in the growth of molecular diagnostics requirements. This long-term demand is also expected to make the market lively, with the healthcare systems and governments being careful in their endeavours to control and keep a check on the virus. The pandemic has therefore changed the landscape of molecular diagnostics as it has proven to be indispensable to the well-being of the population and has set the stage for further development in testing technology.

Latest Market News:

• In April 2025, Illumina and Tempus announced a strategic collaboration to accelerate clinical adoption of next-generation sequencing and AI-driven molecular profiling; the release highlights Illumina’s automated proteomics solution that detects and quantifies 9,500 human proteins in 2.5 days, and frames the tie-up as a move to build evidence packages that standardize comprehensive genomic profiling across disease areas.

• In June 2025, Illumina agreed to acquire SomaLogic (a leader in data-driven proteomics) for $350 million in cash plus up to $75 million in near-term performance-based milestones, a buy intended to accelerate Illumina’s multi-omics strategy and broaden molecular profiling capabilities beyond DNA sequencing.
   
• June 2025, QIAGEN launched its Acuity Partnering Program with GENCURIX as the inaugural partner to develop multiplex IVD oncology assays for tissue and liquid biopsy; QIAGEN noted the installed QI Acuity research/diagnostic base reached more than 2,700 cumulative placements by end-2024, and said it added 130+ new QI Acuity research assays in 2024, metrics cited to show platform traction that underpins this partner ecosystem.
   
• July 2025, Waters Corporation and Becton Dickinson agreed to combine BD’s Biosciences & Diagnostic Solutions business with Waters in a Reverse Morris Trust transaction valued at about $17.5 billion, creating a life-sciences/diagnostics leader projected to generate ~$6.5 billion in combined revenue in 2025 and target $345 million of annual cost synergies by 2030, a deal that reshapes scale and distribution in high-volume clinical and molecular testing tools.
   

Latest Trends and Developments:

The sphere of molecular diagnostics is developing very fast, with a number of trends. Among the developments that have been noted is the emergence of point-of-care molecular diagnostics that satisfy the increasing demand to have rapid, reliable testing that does not require special laboratory equipment. Such handheld diagnostic platforms are being adopted not only in hospital facilities but also in remote or underserved locations so that medical action can be taken in time. At the same time, the incorporation of artificial intelligence (AI) is changing the field of molecular diagnostics and providing unprecedented accuracy and speed in the analysis of complex genomic data. Machine learning algorithms that are being driven by AI can enhance the speed and quality of diagnostic decisions made by healthcare providers, thereby enhancing patient outcomes. Furthermore, innovation in genomic medicine is also driving change in the sphere. Developments in sequencing technologies are turning the analysis of whole genomes into an increasingly affordable process, and thus, molecular diagnostics are becoming increasingly broad-based, especially in the fields of oncology and personalized medicine. The resulting increasing potential enables more tailored and precise treatment methodologies, which represent a major shift towards precision medicine. All of these trends are transforming the environment of molecular diagnostics, making it more available, more precise, and more a part of general health care plans.

Key Players in the Market:

1. Roche Diagnostics
2. Abbott Laboratories
3. Thermon Fisher Scientific
4. Siemens Healthiness
5. Bio-Rad Laboratories
6. Qiagen N.V.
7. Hologic, Inc.
8. Danaher Corporation
9. Agilent Technologies

10. Cepheid