DELRAY BEACH, Fla., Nov. 9, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Molecular Diagnostics Market is projected to reach USD 32.56 billion by 2031 from USD 21.68 billion in 2026, at a CAGR of 8.5% during the forecast period.

Browse 450 market data Tables and 150 Figures spread through 300 Pages and in-depth TOC on 'Molecular Diagnostics Market - Global Forecast to 2031'

Molecular Diagnostics Market Size & Forecast:

• Market Size Available for Years: 2026–2031
• 2026 Market Size: USD 21.68 billion
• 2031 Projected Market Size: USD 32.56 billion
• CAGR (2026–2031): 8.5%

Molecular Diagnostics Market Trends & Insights:

• Asia Pacific is anticipated to register the highest CAGR of 10.6% during the forecast period.
• By type, the lab tests segment led the molecular diagnostics market, with a share of 88.9% in 2025.
• By end user, diagnostics laboratories will grow at a CAGR of 10.1% in the molecular diagnostics market during the forecast period.

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Steady growth is driven primarily by the rising incidence of infectious diseases and cancer worldwide. These technologies are essential for early, accurate pathogen detection, supporting prompt clinical decisions and effective disease management. In cancer care, molecular diagnostics identify specific genetic mutations, enabling personalized treatment strategies and monitoring disease progression. The growing adoption of precision medicine and increasing demand for targeted therapies further increase the need for molecular testing. Consequently, the expanding role of molecular diagnostics in infectious disease detection and oncology is expected to remain a key driver of market growth.

Point-of-care (POC) testing is a fast-growing and potentially disruptive segment of the molecular diagnostics market. POC molecular platforms are compact, often cartridge-based systems that deliver lab-quality results at or near the patient, in settings such as clinics, emergency departments, pharmacies, and remote healthcare facilities. They typically use rapid PCR or isothermal amplification, which lets them return results in minutes to under an hour instead of the days needed when samples are sent to a central laboratory. This speeds up clinical decisions, especially for infectious diseases like influenza, COVID-19, RSV, and sexually transmitted infections, where timely treatment and infection control matter. Adoption accelerated during the COVID-19 pandemic and has continued as healthcare systems prioritize decentralized testing. POC systems are well suited to resource-limited settings because they are easy to use, need minimal training and sample handling, and reduce dependence on laboratory infrastructure. Regulatory pathways such as CLIA-waived designations have further supported their use outside traditional laboratories. Challenges remain, including higher cost per test, quality control across many testing sites, and data integration with health records. As the technology matures, advances in multiplex testing, connectivity, and automation are expected to widen the range of tests available at the point of care and strengthen its role in expanding global access to molecular diagnostics.

Lab Tests Led the Market in 2025 on the Strength of Centralized, High-Throughput Testing

By test type, the molecular diagnostics market is segmented into lab tests and PoC tests. Lab tests held the largest share in 2025, largely because molecular testing is widely performed in centralized laboratories that handle large patient volumes and rely on advanced, high-throughput platforms. These tests offer high accuracy and sensitivity, along with extensive assay menus, making them well suited to complex applications such as cancer diagnostics, genetic screening, and infectious disease detection. They also integrate smoothly into hospital and reference laboratory workflows, supported by trained staff and established quality control protocols. Ongoing advances in automated systems and multiplex technologies further improve lab testing efficiency. Together with their established infrastructure and proven clinical reliability, these strengths continue to sustain the segment's dominance.

Blood, Serum, and Plasma Are Expected to Be the Fastest-Growing Sample Type During the Forecast Period

By sample type, the molecular diagnostics market is segmented into blood, serum and plasma, urine, and other samples. The blood, serum, and plasma segment is expected to grow the fastest over the forecast period. This growth is driven by the broad clinical utility of these samples for detecting infectious diseases, genetic disorders, and cancer. These samples are widely accepted in clinical practice because they are reliable, easy to collect, and compatible with many molecular testing platforms. Advances in liquid biopsy and noninvasive testing methods further encourage the use of blood-based diagnostics. As the need for accurate, minimally invasive testing rises, the segment is likely to continue expanding rapidly.

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North America is the Largest Regional Market for Molecular Diagnostics

The molecular diagnostics market is divided into five geographic regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to be the largest regional market, supported by robust healthcare infrastructure and strong adoption of advanced testing technologies. The region bears a considerable burden of infectious diseases, cancer, and genetic disorders, driving demand for accurate and timely diagnostics. Supportive regulatory policies and steady investment in research and development also contribute to market growth. Leading diagnostic companies and well-equipped laboratories enable the deployment of molecular tests at scale across hospitals and diagnostic centers, improving patient access to timely and reliable results.

Key Players

Leading players in the Molecular Diagnostics companies include Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), Hologic, Inc. (US), Illumina, Inc. (US), Abbott (US), bioMérieux (France), Thermo Fisher Scientific Inc. (US), QIAGEN N.V. (Netherlands), Revvity, Inc. (US), Myriad Genetics, Inc. (US), Siemens Healthineers AG (Germany), Becton, Dickinson and Company (BD) (US), Grifols, S.A. (Spain), QuidelOrtho Corporation (US), DiaSorin S.p.A. (Italy), Exact Sciences Corporation (US), Genetic Signatures (Australia), Agilent Technologies, Inc. (US), MDxHealth (Belgium), Biocartis (Belgium), Bruker (US), TBG Diagnostics Limited (Australia), Amoy Diagnostics Co., Ltd. (China), Vela Diagnostics (Singapore), Molbio Diagnostics Limited (India), geneOmbio Technologies (India), Savyon Diagnostics (Israel), and Uniogen OY (Finland).

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Molecular Diagnostics Market- Investment and Funding Scenario

Investment Funding Context

The molecular diagnostics market is attracting growing investment as healthcare systems shift toward precision medicine, early disease detection, decentralized testing, and personalized treatment decisions. Funding interest is increasingly focused on scalable platforms spanning PCR, next-generation sequencing (NGS), liquid biopsy, molecular oncology, infectious-disease testing, and point-of-care diagnostics. The sector also benefits from recurring revenue from diagnostic assays, reagents, consumables, and testing services.

Revenue Shift Context

The market is shifting from conventional laboratory testing toward faster, more sensitive, multiplexed, and technology-enabled molecular testing solutions. Globally, the molecular diagnostics market is estimated at approximately USD 21.68 billion in 2026 and is projected to reach USD 32.56 billion by 2031, representing a CAGR of about 8.5%. Growth is supported by increasing adoption of PCR and NGS, oncology and genetic testing, infectious-disease diagnostics, liquid biopsy, and decentralized/point-of-care molecular testing.

Mergers and Acquisitions

Mergers and acquisitions in molecular diagnostics during 2025–26 reflected growing consolidation around precision medicine, cancer diagnostics, molecular testing platforms, and point-of-care technologies. Strategic buyers are targeting companies with proprietary assays, genomic technologies, recurring testing revenues, and differentiated molecular diagnostic capabilities. Diagnostics deal-making also rebounded strongly in 2025, with major transactions spanning molecular diagnostics and precision medicine.

Notable transactions included Abbott's acquisition of Exact Sciences for approximately USD 23 billion, TPG and Blackstone's acquisition of Hologic for up to USD 18.3 billion, and Natera's acquisition of Foresight Diagnostics to strengthen its molecular residual-disease testing capabilities. QuidelOrtho also announced plans to acquire LEX Diagnostics for approximately USD 100 million, subject to FDA clearance.

MOLECULAR DIAGNOSTICS MARKET: MERGERS AND ACQUISITIONS, JANUARY 2025–JUNE 2025

Company Revenue Share Details

The molecular diagnostics market is relatively fragmented, with the top five players—F. Hoffmann-La Roche, Abbott Laboratories, Danaher Corporation, Thermo Fisher Scientific, and QIAGEN—accounting for approximately 60% of the molecular diagnostics equipment and reagent market. The remaining share is held by established players such as Hologic, bioMérieux, Becton Dickinson, Bio-Rad Laboratories, Illumina, and Siemens Healthineers, as well as regional and specialized molecular diagnostics companies. The mix of large, diversified healthcare companies and specialized molecular diagnostics providers reflects the broad competitive landscape across PCR, sample preparation, syndromic testing, sequencing, oncology, and infectious-disease diagnostics. This fragmentation leaves room for continued competition, product innovation, partnerships, and consolidation across the market.

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