Molecular Diagnostics for Infectious Disease Markets: Market Forecast, Competitive Landscape, Company Revenue Estimates, Technology and Policy Outlook, 2027-2031

Molecular testing for infectious disease has worked through the COVID-19 collapse and is growing again on a much larger installed base. This report estimates the global market at $17,830 million in 2026, growing 6.5% a year to $24,400 million in 2031 and adding $6,570 million. Respiratory testing is the largest disease area at $6,151.3 million, but bloodstream and sepsis testing grows fastest at 9.2% a year, followed by STI and women's health at 8.0%. Syndromic panels grow 11.0% a year, sample-to-answer PCR 9.0%, sequencing 18.6% and point-of-care testing 10.9%, while batch laboratory PCR grows 2.7% a year. China is the fastest-growing country at 8.8% a year, and the USA is the largest market at $7,447.9 million.

The past year reshaped the industry. Waters took over BD's diagnostics business, Blackstone and TPG took Hologic private, Abbott completed its acquisition of Exact Sciences, and EQT agreed to take QIAGEN private. A mild respiratory season cut sales at Cepheid, bioMerieux and Roche, while new FDA clearances for gastrointestinal, bloodstream infection and vaginitis panels from Cepheid, QIAGEN, DiaSorin and Roche widened the syndromic market. COVID-19 emergency use authorisations end on 26 December 2026, PEPFAR cuts reduced HIV viral load testing, and the report profiles 38 companies with forecasts for 14 countries and regions.

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Product Code: IDMDx 1126

List of Tables

List of Figures

1. Executive Summary

1.1 Situation Analysis
1.2 Market Snapshot
1.3 Key Findings
1.4 Investment & Strategic Thesis

2. Research Methodology & Scope

2.1 Research Approach
2.2 Sources
2.3 Scope & Definitions
2.4 Overlap with Sister Reports
2.5 Author
2.6 Limitations

3. Introduction to Infectious Disease Molecular Diagnostics

3.1 Why Molecular Testing for Infection?
3.2 How the Methods Work
3.3 The Pandemic Boom and Normalisation
3.4 The Installed Base
3.5 The Industry and Its Players

4. The Global Market for Molecular Diagnostics for Infectious Disease

4.1 Global Market Overview by Country
4.2 Global Market by Disease Area – Overview
4.3 Global Market by Plex – Overview
4.4 Global Market by Technology – Overview
4.5 Global Market by Setting – Overview
4.6 Global Market by Product – Overview

5. Respiratory & Syndromic Testing

5.1 Market Overview
5.2 Combination Tests and the Low-plex Battleground
5.3 Syndromic Panel Economics
5.4 Reimbursement and MolDX Coverage Limits
5.5 Seasonality and the Mild 2025–26 Season
5.6 COVID-19 Testing After the Emergency Use Authorisations
5.7 Outlook

6. STI & Women's Health

6.1 Market Overview
6.2 Chlamydia, Gonorrhoea, Trichomonas and Mycoplasma genitalium
6.3 Vaginitis Panels and HSV
6.4 HPV and Cervical Screening
6.5 Point-of-Care and At-Home STI Testing
6.6 Screening Guidelines and Competitive Position
6.7 Outlook

7. Blood-Borne Viruses, Viral Load & Blood Screening

7.1 A Large, Mature and Slower-Growing Segment
7.2 HIV, HBV and HCV Viral Load and Diagnosis
7.3 Point-of-Care and Near-Patient Viral Load
7.4 WHO Prequalification and Global Health Procurement
7.5 PEPFAR and Global Fund Funding Changes, 2025–2026
7.6 HCV Elimination Programmes
7.7 Donor-Blood NAT Screening
7.8 Outlook

8. Gastrointestinal, Sepsis, Transplant & CNS Testing

8.1 Four Hospital-Centred Segments
8.2 Gastrointestinal Panels
8.3 Bloodstream Infection and Sepsis
8.4 Metagenomics and Karius
8.5 Transplant and Opportunistic Infection Monitoring
8.6 Meningitis and Encephalitis Panels
8.7 Outlook

9. Technology Landscape

9.1 Batch Real-time PCR Platforms
9.2 Sample-to-Answer Cartridge Systems
9.3 Isothermal and Other Technologies
9.4 Sequencing, Metagenomics and Nanopore
9.5 Automation, Artificial Intelligence and Connectivity

10. Regulation, Reimbursement & Policy

10.1 US FDA Pathways and the End of COVID-19 EUAs
10.2 Laboratory-Developed Tests After the Vacated Rule
10.3 EU IVDR
10.4 US Reimbursement: CMS, PAMA and MolDX
10.5 China: NMPA, Volume-Based Procurement and Pricing Reform
10.6 Global Health Funding

11. China, Asia-Pacific & Emerging Markets

11.1 Regional Overview
11.2 China
11.3 Japan and South Korea
11.4 India, Southeast Asia and Rest of Asia-Pacific
11.5 Latin America, Middle East and Africa
11.6 Outlook and Strategy for Suppliers

12. Recent Developments

12.1 Recent Developments – Importance and How to Use This Section
12.2 EQT Agrees to Take QIAGEN Private
12.3 FDA Clears QIAstat-Dx Bloodstream Infection Panels with Resistance Markers
12.4 FDA Clears Cepheid’s Xpert GI Panel
12.5 FDA Clears Roche’s cobas BV/CV Assay
12.6 Donor Funding Cuts Reduce HIV Viral-Load Testing
12.7 FDA Clears DiaSorin’s LIAISON PLEX Gastrointestinal Flex Assay
12.8 OraSure’s Home STI Programme: Collection Kit Cleared, Self-Test Withdrawn
12.9 Roche Adds a Bordetella Test to cobas liat as Point-of-Care Sales Slow
12.10 Visby’s At-Home STI PCR Test Sold Through Quest and Labcorp
12.11 FDA Approval Letter for Grifols’ Procleix Blood Screening Assays

13. Operations, Manufacturing & Supply Chain

13.1 The Operating Model of a Molecular Diagnostics Company
13.2 Key Inputs and Critical Suppliers
13.3 Manufacturing Capacity After the Pandemic
13.4 Trade, Tariffs and Localisation
13.5 Quality Systems and Regulatory Operations
13.6 Distribution, Service and the Installed Base
13.7 Operational Outlook

14. Competitive Landscape

14.1 Market Structure
14.2 Leaders by Technology and Disease Area
14.3 Asian and Emerging Players
14.4 Outlook for Competition

15. SWOT, Porter's Five Forces & Investment Risk Analysis

15.1 SWOT Analysis
15.2 Porter's Five Forces
15.3 Investment Risk Analysis

16. Strategic Recommendations

16.1 Guidance for Executives, Marketing, Sales and Business Development
16.2 Guidance for Consultants and Investment Advisors

17. Market Forecast by Disease Area, 2026–2031

17.1 Respiratory
17.2 STI & Women's Health
17.3 Blood-Borne Viruses & Screening
17.4 Gastrointestinal
17.5 Bloodstream & Sepsis
17.6 Transplant & Opportunistic
17.7 Meningitis & Encephalitis
17.8 Other

18. Market Forecast by Plex, 2026–2031

18.1 Singleplex
18.2 Low-plex (2–5 targets)
18.3 Syndromic Panels (6+ targets)
18.4 NGS & Metagenomics

19. Market Forecast by Technology, 2026–2031

19.1 Batch Real-time PCR
19.2 Sample-to-Answer PCR
19.3 Isothermal
19.4 Sequencing
19.5 Other Technology

20. Market Forecast by Setting, 2026–2031

20.1 Hospital Lab
20.2 Reference & Independent Lab
20.3 Point of Care
20.4 Home & Other

21. Market Forecast by Product, 2026–2031

21.1 Reagents & Kits
21.2 Instruments
21.3 Software & Services

22. Company Profiles

22.1 Abbott Laboratories
22.2 altona Diagnostics
22.3 Aptitude Medical Systems
22.4 BGI Genomics
22.5 Biocartis
22.6 bioMerieux
22.7 Bio-Rad Laboratories
22.8 Cepheid (Danaher)
22.9 Copan Diagnostics
22.10 Daan Gene
22.11 DiaSorin (Luminex)
22.12 Eurofins Scientific
22.13 Genetic Signatures
22.14 Grifols
22.15 Hologic
22.16 Illumina
22.17 Karius
22.18 Labcorp
22.19 Meridian Bioscience
22.20 Molbio Diagnostics
22.21 Mylab Discovery Solutions
22.22 OraSure Technologies
22.23 Oxford Nanopore Technologies
22.24 Qiagen
22.25 Quest Diagnostics
22.26 QuidelOrtho
22.27 R-Biopharm
22.28 Revvity
22.29 Roche Diagnostics
22.30 Sansure Biotech
22.31 SD Biosensor
22.32 Seegene
22.33 Siemens Healthineers
22.34 SpeeDx
22.35 Sysmex
22.36 Thermo Fisher Scientific
22.37 Visby Medical
22.38 Waters Corporation (formerly BD Diagnostic Solutions)

23. Appendix

23.1 Abbreviations
23.2 Developments Archive
23.3 Report Limitations Restated

Product Code: IDMDx 1126

List of Tables

Table 1 Key Market Indicators (constant 2026 US$)
Table 2 Global Market by Segment, 2026 and 2031 (US$ millions, constant 2026 dollars)
Table 3 Leading Infectious Disease Molecular Platforms and Tests, October 2026
Table 4 Overlap Between This Report and Related Howe Sound Research Reports
Table 5 Main Molecular Technologies for Infectious Disease
Table 6 Global Market by Country
Table 7 Global Market by Disease Area
Table 8 Global Market by Plex
Table 9 Global Market by Technology
Table 10 Global Market by Setting
Table 11 Global Market by Product
Table 12 Respiratory Testing and Related Segments, 2026 and 2031
Table 13 Leading Respiratory Molecular Systems
Table 14 STI & Women's Health: Key Market Indicators
Table 15 Main Suppliers in STI & Women's Health Molecular Testing
Table 16 Blood-Borne Viruses & Screening Market, 2026–2031 (constant 2026 US$ millions)
Table 17 Leading Molecular Platforms for Blood-Borne Viruses and Blood Screening
Table 18 Gastrointestinal, Sepsis, Transplant and CNS Testing Markets, 2026 and 2031 (constant 2026 US$ millions)
Table 19 Global Molecular Infectious Disease Market by Technology, 2026 and 2031
Table 20 Leading Sample-to-Answer Molecular Platforms
Table 21 Key Regulatory and Policy Changes
Table 22 Asia-Pacific and Emerging Markets, 2026 and 2031
Table 23 Recent Developments in This Edition, Summary
Table 24 Operating Models in Infectious Disease Molecular Diagnostics
Table 25 Critical Inputs for Molecular Infectious Disease Tests
Table 26 Competitive Structure by Technology
Table 27 Tiers of Molecular Infectious Disease Suppliers
Table 28 Leading Suppliers by Technology
Table 29 Leading Suppliers by Disease Area
Table 30 Selected Asian and Emerging Molecular Diagnostics Companies
Table 31 SWOT Analysis – Strengths and Weaknesses
Table 32 SWOT Analysis – Opportunities and Threats
Table 33 Porter's Five Forces Ratings
Table 34 Investment Risk Matrix
Table 35 Selected Growth Opportunities
Table 36 Respiratory by Country
Table 37 STI & Women's Health by Country
Table 38 Blood-Borne Viruses & Screening by Country
Table 39 Gastrointestinal by Country
Table 40 Bloodstream & Sepsis by Country
Table 41 Transplant & Opportunistic by Country
Table 42 Meningitis & Encephalitis by Country
Table 43 Other by Country
Table 44 Singleplex by Country
Table 45 Low-plex (2–5 targets) by Country
Table 46 Syndromic Panels (6+ targets) by Country
Table 47 NGS & Metagenomics by Country
Table 48 Batch Real-time PCR by Country
Table 49 Sample-to-Answer PCR by Country
Table 50 Isothermal by Country
Table 51 Sequencing by Country
Table 52 Other Technology by Country
Table 53 Hospital Lab by Country
Table 54 Reference & Independent Lab by Country
Table 55 Point of Care by Country
Table 56 Home & Other by Country
Table 57 Reagents & Kits by Country
Table 58 Instruments by Country
Table 59 Software & Services by Country

List of Figures

Figure 1 Key Graphic – Multiplex Testing Takes Share: Molecular Diagnostics for Infectious Disease Market by Plex, 2026 vs 2031
Figure 2 Global Market Pareto Chart
Figure 3 Global Market by Disease Area - Base vs. Final
Figure 4 Global Market by Disease Area Base Year
Figure 5 Global Market by Disease Area End Year
Figure 6 Disease Area Share by Year
Figure 7 Disease Area Segments Growth
Figure 8 Global Market by Plex - Base vs. Final
Figure 9 Global Market by Plex Base Year
Figure 10 Global Market by Plex End Year
Figure 11 Plex Share by Year
Figure 12 Plex Segments Growth
Figure 13 Global Market by Technology - Base vs. Final
Figure 14 Global Market by Technology Base Year
Figure 15 Global Market by Technology End Year
Figure 16 Technology Share by Year
Figure 17 Technology Segments Growth
Figure 18 Global Market by Setting - Base vs. Final
Figure 19 Global Market by Setting Base Year
Figure 20 Global Market by Setting End Year
Figure 21 Setting Share by Year
Figure 22 Setting Segments Growth
Figure 23 Global Market by Product - Base vs. Final
Figure 24 Global Market by Product Base Year
Figure 25 Global Market by Product End Year
Figure 26 Product Share by Year
Figure 27 Product Segments Growth
Figure 28 Respiratory Growth
Figure 29 STI & Women's Health Growth
Figure 30 Blood-Borne Viruses & Screening Growth
Figure 31 Gastrointestinal Growth
Figure 32 Bloodstream & Sepsis Growth
Figure 33 Transplant & Opportunistic Growth
Figure 34 Meningitis & Encephalitis Growth
Figure 35 Other Growth
Figure 36 Singleplex Growth
Figure 37 Low-plex (2–5 targets) Growth
Figure 38 Syndromic Panels (6+ targets) Growth
Figure 39 NGS & Metagenomics Growth
Figure 40 Batch Real-time PCR Growth
Figure 41 Sample-to-Answer PCR Growth
Figure 42 Isothermal Growth
Figure 43 Sequencing Growth
Figure 44 Other Technology Growth
Figure 45 Hospital Lab Growth
Figure 46 Reference & Independent Lab Growth
Figure 47 Point of Care Growth
Figure 48 Home & Other Growth
Figure 49 Reagents & Kits Growth
Figure 50 Instruments Growth
Figure 51 Software & Services Growth

Molecular Diagnostics for Infectious Disease Markets: Market Forecast, Competitive Landscape, Company Revenue Estimates, Technology and Policy Outlook, 2027-2031

Description

Table of Contents

List of Tables

Report Overview:

Table of Contents

List of Tables

List of Figures

1. Executive Summary

2. Research Methodology & Scope

3. Introduction to Infectious Disease Molecular Diagnostics

4. The Global Market for Molecular Diagnostics for Infectious Disease

5. Respiratory & Syndromic Testing

6. STI & Women's Health

7. Blood-Borne Viruses, Viral Load & Blood Screening

8. Gastrointestinal, Sepsis, Transplant & CNS Testing

9. Technology Landscape

10. Regulation, Reimbursement & Policy

11. China, Asia-Pacific & Emerging Markets

12. Recent Developments

13. Operations, Manufacturing & Supply Chain

14. Competitive Landscape

15. SWOT, Porter's Five Forces & Investment Risk Analysis

16. Strategic Recommendations

17. Market Forecast by Disease Area, 2026–2031

18. Market Forecast by Plex, 2026–2031

19. Market Forecast by Technology, 2026–2031

20. Market Forecast by Setting, 2026–2031

21. Market Forecast by Product, 2026–2031

22. Company Profiles

23. Appendix

List of Tables

List of Figures