Molecular Diagnostics - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2025 - 2030)

Molecular Diagnostics Market Analysis

The molecular diagnostics market is valued at USD 17.94 billion in 2025 and is forecast to reach USD 28.49 billion by 2030, advancing at a 9.68% CAGR through the period. Growth is underpinned by wider adoption of rapid multiplex testing in emergency and outpatient settings, stronger reimbursement for precision oncology assays, and sustained investments in national genome initiatives that improve reference databases. North America keeps a leading position because of established payer frameworks and accelerated retail-pharmacy testing, while Asia Pacific posts the quickest revenue climb on the back of ambitious population-genomics projects and expanding laboratory infrastructure. Technology suppliers are prioritizing integrated platforms that combine PCR, isothermal and sequencing-based workflows, a strategy that shortens turnaround and lowers per-test costs. At the same time, retailers and primary-care networks are capitalizing on streamlined CLIA rules that enable molecular testing at the consumer’s first point of contact, shifting volumes away from traditional laboratories.

Global Molecular Diagnostics Market Trends and Insights

Syndromic respiratory panels accelerating point-of-care PCR demand

Multiplex respiratory panels simultaneously detect multiple pathogens and now deliver results in 45-90 minutes, a shift that improves early therapy and isolation decisions in intensive-care units. Clinical adoption has lowered unnecessary antibiotic prescriptions by 20-30%, reinforcing stewardship initiatives. Because these assays also uncover co-infections in roughly 20% of respiratory cases, they reduce diagnostic blind spots that are common with single-pathogen tests. Hospital networks are codifying panel use within infection-control protocols, ensuring year-round volumes instead of seasonal peaks. As a result, suppliers of cartridge-based systems report sustained reagent demand, a trend that lifts recurring revenue and underlines the molecular diagnostics market’s focus on decentralization.

CLIA-waived molecular devices entering retail pharmacies

Revisions to U.S. CLIA rules effective December 2024 simplified personnel requirements and fee structures, enabling pharmacies to run moderate-complexity molecular assays. CVS Health introduced a three-in-one combo PCR for influenza A/B and COVID-19 across 1,600 outlets, giving customers testing and prescription consultation in a single visit. Kroger followed with cholesterol and glucose molecular testing across 2,100 sites, shrinking screening time to 90 seconds. The move repositions pharmacies as first-line diagnostic hubs, broadening access for underserved communities and redirecting sample flow away from central laboratories. Manufacturers of portable platforms benefit from higher test frequency and consumer visibility, supporting long-term revenue streams in the molecular diagnostics market.

Enzyme supply chain constraints causing cost spikes

Medical device makers have watched logistics and raw-material expenses climb to nearly 20% of revenue as geopolitical tensions disrupt trade lanes. High-purity enzymes are particularly exposed, with PTFE shortages forcing contract manufacturers to insource capabilities. Smaller assay developers struggle to secure buffer components and stabilizers, prompting production delays, higher list prices and slower entry into new markets. In emerging economies, where price sensitivity is acute, the resulting unit-cost escalation inhibits test adoption, capping near-term expansion of the molecular diagnostics market.

Other drivers and restraints analyzed in the detailed report include:

1. EMA-approved companion diagnostics boosting oncology test volumes
2. Population genomics initiatives driving NGS test uptake
3. EU IVDR backlog delaying new assay commercialization

For complete list of drivers and restraints, kindly check the Table Of Contents.

List of Companies Covered in this Report:

1. Roche
2. Abbott Laboratories
3. Thermo Fisher Scientific
4. Danaher
5. Hologic
6. Illumina
7. QIAGEN
8. Beckton Dickinson
9. bioMérieux
10. Agilent Technologies
11. Bio-Rad Laboratories
12. Sysmex
13. Siemens Healthineers
14. DiaSorin
15. Seegene
16. Guardant Health
17. LabCorp
18. Exact Sciences
19. 10x Genomics
20. DNA Genotek, Inc.
21. PathoNostics B.V.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support