Delray Beach, FL, Nov. 13, 2025 (GLOBE NEWSWIRE) — Investments in precision medicine, expanding healthcare infrastructure, and rising infectious disease burden fuel market growth
The global molecular diagnostics market, valued at US$18.29 billion in 2024, stood at US$19.48 billion in 2025 and is projected to advance at a resilient CAGR of 9.6% from 2025 to 2030, culminating in a forecasted valuation of US$30.74 billion by the end of the period. This growth is driven by increasing government funding, expansion of precision medicine initiatives, rising infectious disease and cancer prevalence, and advancements that are making testing faster, more portable, and more accessible across care settings.
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Meeting Expanding Global Healthcare Demands
As healthcare systems worldwide confront a growing patient population and an elevated need for early and accurate disease detection, molecular diagnostics are emerging as a critical component of clinical decision-making. Governments are directing significant investments toward genomics and next-generation diagnostic platforms, accelerating adoption in both developed and emerging regions.
Strengthening Innovation Through R&D
Government-backed R&D incentives, public–private collaborations, and supportive regulatory initiatives are enabling companies to advance next-generation sequencing (NGS), digital PCR, multiplex assays, and automated molecular instruments. These investments enhance laboratory capabilities and expand the availability of reliable, high-sensitivity testing solutions. As a result, earlier disease detection, improved patient management, and expanded diagnostic reach are becoming more achievable across diverse healthcare environments.
Market Challenge: High Equipment and Operational Costs
Despite robust demand, the high cost of molecular diagnostic instruments continues to limit adoption, particularly among smaller clinics and resource-constrained facilities. Beyond initial acquisition costs, maintenance, consumable usage, and specialized training requirements create additional financial barriers. These constraints contribute to disparities in diagnostic access, particularly in rural and underserved regions.
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Emerging Market Momentum
Countries such as Brazil, India, South Korea, and Mexico represent high-growth markets for molecular diagnostics. Rising healthcare expenditure, growing awareness of preventive care, and the expansion of private healthcare networks support increased adoption. Medical tourism and ongoing investments in laboratory modernization further accelerate demand for advanced testing capabilities.
Regulatory Complexity Remains a Key Industry Challenge
The evolving regulatory environment requires manufacturers to continuously adapt product validation, documentation, and compliance processes. Variations in approval requirements across regions add time and cost to market entry, increasing complexity especially for smaller companies expanding internationally.
Market Structure and Segment Performance
The market ecosystem includes diagnostic laboratories, hospitals, clinics, and regulatory authorities, along with manufacturers providing instruments, reagents, and software.
- Reagents & Kits accounted for the largest product segment in 2024 due to recurring testing demand and ongoing improvements in ease-of-use and automation compatibility.
- Diagnostic Laboratories dominated among end users, supported by high testing volumes, advanced capabilities, and cost-effective outsourcing models.
- North America held the largest regional share in 2024, driven by advanced healthcare infrastructure, leading industry players, and strong R&D investment.
Key Industry Participants
Leading companies shaping the global molecular diagnostics landscape include:
Danaher Corporation, F. Hoffmann-La Roche Ltd., Illumina, Inc., bioMérieux, Hologic, Inc., QIAGEN N.V., Thermo Fisher Scientific Inc., Abbott, Siemens Healthineers AG, Revvity, Inc., Becton, Dickinson and Company, DiaSorin S.p.A., Myriad Genetics, Agilent Technologies, Exact Sciences Corporation, and others across the US, Europe, Asia Pacific, and emerging regions.
Recent Industry Developments
- June 2025: Health Canada granted Cepheid (Danaher) approval for the Xpert HIV-1 Viral Load XC test to support HIV treatment monitoring.
- May 2025: Illumina received Japan MHLW approval for TruSight™ Oncology Comprehensive, supporting precision oncology.
- March 2025: QIAGEN secured FDA clearance for the QIAstat-Dx Gastrointestinal Panel 2 Mini B.
- February 2025: bioMérieux received FDA clearance for its BIOFIRE FILMARRAY GI Panel Mid.
- January 2025: Roche received FDA 510(k) clearance and CLIA waiver for its cobas liat STI multiplex assay panels.
Why This Matters Now
The continued spread of infectious diseases, rising cancer incidence, and global prioritization of early diagnosis are intensifying the need for scalable and accurate molecular testing. At the same time, healthcare systems are under pressure to improve efficiency and reduce diagnostic uncertainty. Molecular diagnostics directly support these imperatives, enabling faster interventions, more personalized treatment planning, and improved patient outcomes.
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Discover Connected Healthcare Market Opportunities:
Point of Care Molecular Diagnostics Market
Molecular Infectious Disease Testing Market
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PCR Technologies Market
Next Generation Sequencing Market
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