COVID-19 Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Policy Outlook, 2027-2031

COVID-19 testing is now a large, seasonal market, and the value is moving from tests that look only for SARS-CoV-2 to tests that also find flu and RSV. This report estimates the global COVID-19 diagnostics market at $6,930 million in 2026, growing 1.3% a year to $7,400 million in 2031 and adding $470 million of annual spending. SARS-CoV-2-only tests fall 4.8% a year, from $3,361.0 million to $2,627.0 million, while combination tests (COVID + flu, COVID + flu + RSV and broader respiratory panels) grow from $3,569.0 million to $4,773.0 million, and COVID + flu + RSV is the fastest-growing panel at 7.2% a year. Multiplex PCR grows 7.0% a year to $2,331.0 million and overtakes rapid antigen, at $2,035.0 million in 2031, while point-of-care molecular testing grows 6.5% a year. The full value of any combination test that includes SARS-CoV-2 is counted in this market.

The past year reset the rules. HHS ended the COVID-19 emergency declaration behind test authorisations, so emergency use authorisations for COVID tests end on 26 December 2026 unless the FDA has accepted a full submission. The FDA cleared Visby Medical's at-home flu and COVID-19 PCR test and Aptitude's Metrix COVID test, QuidelOrtho bought LEX Diagnostics for its fast point-of-care PCR system, and respiratory testing sales fell at Danaher, bioMerieux, Abbott and QuidelOrtho after a mild season. The BA.3.2 variant was found in wastewater before clinical cases, just as US wastewater surveillance faced a funding cliff. The report covers 23 chapters, 63 tables and 51 figures, with forecasts by technology, test panel, setting, product and sample type for 14 countries and regions, and profiles of 37 companies.

Product Code: IDCOVID 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 Scope & Market Definition
2.2 Overlap with Other HSR Reports
2.3 Value Basis
2.4 Market Segments
2.5 Geographic Coverage
2.6 Forecast Approach
2.7 Sources
2.8 Author
2.9 Limitations

3. Introduction to COVID-19 & SARS-CoV-2 Testing

3.1 The Virus
3.2 Variants to Date
3.3 How the Tests Work
3.4 The Pandemic Boom and the Bust
3.5 Endemic COVID-19 and Seasonality
3.6 Who Tests Now and Why
3.7 The Industry and Its Players

4. The Global Market for COVID-19 Diagnostics

4.1 Global Market Overview by Country
4.2 Global Market by Technology – Overview
4.3 Global Market by Test Panel – Overview
4.4 Global Market by Setting – Overview
4.5 Global Market by Product – Overview
4.6 Global Market by Sample Type – Overview

5. Laboratory Molecular Testing: Lab PCR & Multiplex Respiratory Panels

5.1 The Laboratory Core of the Market
5.2 High-Throughput PCR Platforms
5.3 Syndromic and Multiplex Respiratory Panels
5.4 From Single-Plex to Combination Testing
5.5 Reimbursement Limits on Large Panels
5.6 The End of the EUA Era in the Laboratory
5.7 Laboratory Volumes and Outlook

6. Point-of-Care & Home Testing: POC Molecular, Rapid Antigen & OTC

6.1 Testing Outside the Laboratory
6.2 Point-of-Care Molecular Platforms
6.3 Regulation: EUAs End and Tests Become Class II Devices
6.4 Rapid Antigen Tests: Professional and OTC
6.5 Home Molecular Testing
6.6 Pharmacy Test-to-Treat and the Antiviral Link
6.7 Consumer Behaviour and Pricing

7. Combination Respiratory Testing: COVID, Flu & RSV

7.1 From Single-Target Tests to Combination Panels
7.2 Seasonality and the Respiratory Calendar
7.3 Why Combination Tests Win
7.4 Leading Combination Products
7.5 Antiviral Treatment Decisions
7.6 RSV Vaccines, Monoclonals and Their Effect on Testing
7.7 The Payer View
7.8 Outlook for Combination Testing

8. Surveillance, Sequencing & Serology

8.1 Overview: Testing Populations Rather Than Patients
8.2 Genomic Surveillance
8.3 Sequencing Technologies and Suppliers
8.4 Wastewater Surveillance
8.5 Traveller Surveillance
8.6 Antibody and Serology Testing Today
8.7 Outlook for Surveillance, Sequencing and Serology

9. Regulation, Reimbursement & Policy

9.1 From Emergency to Ordinary Regulation
9.2 United States: The End of COVID-19 Test EUAs
9.3 Reimbursement After the Public Health Emergency
9.4 Free-Test Programmes and Federal Stockpiles
9.5 US Vaccine and Public Health Policy, 2025–2026
9.6 Europe: IVDR and National Policy
9.7 China and Other Regulators
9.8 Outlook for Regulation and Policy

10. Channels, Pricing & Demand Drivers

10.1 A Seasonal, Endemic Market
10.2 Demand by Setting
10.3 Channel Economics
10.4 Price Erosion in Antigen Tests
10.5 Government Stockpiles and Their Unwinding
10.6 Demand Drivers and Restraints

11. China, Asia-Pacific & Emerging Markets

11.1 Regional Overview
11.2 China After Zero-COVID
11.3 Korea: SD Biosensor and Seegene
11.4 Japan
11.5 India and Southeast Asia
11.6 Latin America, the Middle East and Africa
11.7 Pricing Across Emerging Markets
11.8 Outlook

12. Recent Developments

12.1 Recent Developments – Importance and How to Use This Section
12.2 HHS Ends the COVID-19 Emergency Declaration Behind Device EUAs
12.3 FDA Classifies Point-of-Care SARS-CoV-2 Antigen Tests as Class II
12.4 FDA Clears Visby Medical’s At-Home Flu & COVID-19 PCR Test
12.5 Aptitude’s Next-Generation Metrix COVID Test Receives 510(k) Clearance
12.6 QuidelOrtho Completes Its Acquisition of LEX Diagnostics
12.7 Danaher’s Q3 2026 Respiratory Testing Sales Fall About 30%
12.8 bioMerieux Cuts 2026 Guidance as BIOFIRE Respiratory Panels Fall 23%
12.9 Abbott’s 2025 COVID Testing Sales Fall to $297 Million as It Stops Reporting COVID Separately
12.10 CDC MMWR Reports the BA.3.2 Variant, Detected in Wastewater Before Clinical Cases
12.11 CDC Wastewater Surveillance (NWSS) Faces a Funding Cliff

13. Operations, Manufacturing & Supply Chain

13.1 From Shortage to Overcapacity
13.2 Plant Closures, Write-Downs and Restructuring
13.3 Collection, Swabs and Transport Media
13.4 Lateral Flow Manufacturing in Asia
13.5 Molecular Cartridges, Reagents and Contract Manufacturing
13.6 Cost Reduction and Operating Strategies

14. Competitive Landscape

14.1 Market Structure
14.2 Leaders by Technology and Setting
14.3 Asian and Emerging Players
14.4 Outlook

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 Management Consultants and Investment Advisors

17. Market Forecast by Technology, 2026–2031

17.1 Lab PCR
17.2 Multiplex PCR
17.3 POC Molecular
17.4 Rapid Antigen
17.5 Antibody & Serology
17.6 Sequencing & Surveillance

18. Market Forecast by Test Panel, 2026–2031

18.1 SARS-CoV-2 Only
18.2 COVID + Flu A/B
18.3 COVID + Flu + RSV
18.4 Broader Respiratory Panels

19. Market Forecast by Setting, 2026–2031

19.1 Hospital & Reference Lab
19.2 Physician Office & Urgent Care
19.3 Pharmacy & Retail Clinic
19.4 Home / OTC
19.5 Public Health & Surveillance
19.6 Workplace, Travel & Other

20. Market Forecast by Product, 2026–2031

20.1 Instruments
20.2 Reagents & Kits
20.3 Sample Prep & Extraction
20.4 Collection & Transport

21. Market Forecast by Sample Type, 2026–2031

21.1 Anterior Nasal Swab
21.2 Nasopharyngeal Swab
21.3 Saliva & Oral Fluid
21.4 Blood / Serum

22. Company Profiles

22.1 Abbott Laboratories
22.2 Access Bio
22.3 ACON Laboratories (Flowflex)
22.4 Aptitude Medical Systems
22.5 Beijing Hotgen Biotech
22.6 BGI Genomics
22.7 bioMerieux
22.8 Bio-Rad Laboratories
22.9 Cepheid (Danaher)
22.10 Copan Diagnostics
22.11 Daan Gene
22.12 DiaSorin (Luminex)
22.13 Everlywell
22.14 Ginkgo Biosecurity (Ginkgo Bioworks)
22.15 Guangzhou Wondfo Biotech
22.16 Hangzhou AllTest Biotech
22.17 Hologic
22.18 iHealth Labs
22.19 Illumina
22.20 Labcorp
22.21 OraSure Technologies
22.22 Oxford Nanopore Technologies
22.23 Puritan Medical Products
22.24 Qiagen
22.25 Quest Diagnostics
22.26 QuidelOrtho
22.27 Revvity
22.28 Roche Diagnostics
22.29 Sansure Biotech
22.30 SD Biosensor
22.31 Seegene
22.32 Siemens Healthineers
22.33 Sugentech
22.34 Thermo Fisher Scientific
22.35 Verily (WastewaterSCAN laboratory partner)
22.36 Visby Medical
22.37 Waters Corporation (formerly BD Diagnostic Solutions)

23. Appendix

23.1 Abbreviations
23.2 Developments Archive
23.3 Report Limitations Restated

Product Code: IDCOVID 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 COVID-19 Test Products, October 2026
Table 4 SARS-CoV-2 Variants and Testing, 2020–2026
Table 5 COVID-19 Test Types Compared
Table 6 Global Market by Country
Table 7 Global Market by Technology
Table 8 Global Market by Test Panel
Table 9 Global Market by Setting
Table 10 Global Market by Product
Table 11 Global Market by Sample Type
Table 12 Laboratory Molecular Testing, Global Market 2026–2031 (US$ millions, constant 2026 dollars)
Table 13 Main Laboratory PCR Platforms Used for SARS-CoV-2 Testing
Table 14 Selected Multiplex Respiratory Panels That Include SARS-CoV-2
Table 15 Point-of-Care and Rapid Testing by Technology, Global Market 2026–2031 (US$ millions, constant 2026 dollars)
Table 16 Decentralised Testing Settings, Global Market 2026–2031 (US$ millions)
Table 17 Selected Point-of-Care and Home Molecular Platforms for COVID-19 Testing
Table 18 Global COVID-19 Diagnostics Market by Test Panel, 2026 and 2031
Table 19 Examples of Combination Respiratory Tests Including SARS-CoV-2
Table 20 Antiviral Treatment and the Value of a Specific Diagnosis
Table 21 Surveillance and Serology Segments, 2026 and 2031
Table 22 COVID-19 Test Reimbursement Before and After the Emergency
Table 23 COVID-19 Test Regulatory Routes by Market
Table 24 Global COVID-19 Diagnostics Market by Setting, 2026 and 2031
Table 25 COVID-19 Testing Channels and Their Economics
Table 26 COVID-19 Diagnostics Market in Asia-Pacific and Emerging Regions, 2026 and 2031
Table 27 Leading Chinese COVID-19 Test Makers
Table 28 Recent Developments in This Edition, Summary
Table 29 Main Forms of Post-Pandemic Restructuring
Table 30 Competitive Structure by Technology
Table 31 Tiers of COVID-19 Test Suppliers
Table 32 Leading Suppliers in Laboratory Molecular Testing
Table 33 Leading Supplier Tiers by Setting
Table 34 Selected Asian and Emerging Market Suppliers
Table 35 SWOT Analysis – Strengths and Weaknesses
Table 36 SWOT Analysis – Opportunities and Threats
Table 37 Porter's Five Forces Ratings
Table 38 Investment Risk Matrix
Table 39 Selected Growth Opportunities
Table 40 Lab PCR by Country
Table 41 Multiplex PCR by Country
Table 42 POC Molecular by Country
Table 43 Rapid Antigen by Country
Table 44 Antibody & Serology by Country
Table 45 Sequencing & Surveillance by Country
Table 46 SARS-CoV-2 Only by Country
Table 47 COVID + Flu A/B by Country
Table 48 COVID + Flu + RSV by Country
Table 49 Broader Respiratory Panels by Country
Table 50 Hospital & Reference Lab by Country
Table 51 Physician Office & Urgent Care by Country
Table 52 Pharmacy & Retail Clinic by Country
Table 53 Home / OTC by Country
Table 54 Public Health & Surveillance by Country
Table 55 Workplace, Travel & Other by Country
Table 56 Instruments by Country
Table 57 Reagents & Kits by Country
Table 58 Sample Prep & Extraction by Country
Table 59 Collection & Transport by Country
Table 60 Anterior Nasal Swab by Country
Table 61 Nasopharyngeal Swab by Country
Table 62 Saliva & Oral Fluid by Country
Table 63 Blood / Serum by Country

List of Figures

Figure 1 Key Graphic – Combination Tests Take Over: COVID-19 Diagnostics Market by Test
Panel, 2026 vs 2031
Figure 2 Global Market Pareto Chart
Figure 3 Global Market by Technology - Base vs. Final
Figure 4 Global Market by Technology Base Year
Figure 5 Global Market by Technology End Year
Figure 6 Technology Share by Year
Figure 7 Technology Segments Growth
Figure 8 Global Market by Test Panel - Base vs. Final
Figure 9 Global Market by Test Panel Base Year
Figure 10 Global Market by Test Panel End Year
Figure 11 Test Panel Share by Year
Figure 12 Test Panel Segments Growth
Figure 13 Global Market by Setting - Base vs. Final
Figure 14 Global Market by Setting Base Year
Figure 15 Global Market by Setting End Year
Figure 16 Setting Share by Year
Figure 17 Setting Segments Growth
Figure 18 Global Market by Product - Base vs. Final
Figure 19 Global Market by Product Base Year
Figure 20 Global Market by Product End Year
Figure 21 Product Share by Year
Figure 22 Product Segments Growth
Figure 23 Global Market by Sample Type - Base vs. Final
Figure 24 Global Market by Sample Type Base Year
Figure 25 Global Market by Sample Type End Year
Figure 26 Sample Type Share by Year
Figure 27 Sample Type Segments Growth
Figure 28 Lab PCR Growth
Figure 29 Multiplex PCR Growth
Figure 30 POC Molecular Growth
Figure 31 Rapid Antigen Growth
Figure 32 Antibody & Serology Growth
Figure 33 Sequencing & Surveillance Growth
Figure 34 SARS-CoV-2 Only Growth
Figure 35 COVID + Flu A/B Growth
Figure 36 COVID + Flu + RSV Growth
Figure 37 Broader Respiratory Panels Growth
Figure 38 Hospital & Reference Lab Growth
Figure 39 Physician Office & Urgent Care Growth
Figure 40 Pharmacy & Retail Clinic Growth
Figure 41 Home / OTC Growth
Figure 42 Public Health & Surveillance Growth
Figure 43 Workplace, Travel & Other Growth
Figure 44 Instruments Growth
Figure 45 Reagents & Kits Growth
Figure 46 Sample Prep & Extraction Growth
Figure 47 Collection & Transport Growth
Figure 48 Anterior Nasal Swab Growth
Figure 49 Nasopharyngeal Swab Growth
Figure 50 Saliva & Oral Fluid Growth
Figure 51 Blood / Serum Growth

COVID-19 Diagnostics Markets: Market Forecast, Competitive Landscape, 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 COVID-19 & SARS-CoV-2 Testing

4. The Global Market for COVID-19 Diagnostics

5. Laboratory Molecular Testing: Lab PCR & Multiplex Respiratory Panels

6. Point-of-Care & Home Testing: POC Molecular, Rapid Antigen & OTC

7. Combination Respiratory Testing: COVID, Flu & RSV

8. Surveillance, Sequencing & Serology

9. Regulation, Reimbursement & Policy

10. Channels, Pricing & Demand Drivers

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 Technology, 2026–2031

18. Market Forecast by Test Panel, 2026–2031

19. Market Forecast by Setting, 2026–2031

20. Market Forecast by Product, 2026–2031

21. Market Forecast by Sample Type, 2026–2031

22. Company Profiles

23. Appendix

List of Tables

List of Figures