OTC/DTC Infectious Disease Diagnostics Markets 2027–2031

OTC/DTC Infectious Disease Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Policy Outlook, 2027–2031

Global forecasts of consumer spending by application, channel, test technology, product and payer, for 14 countries and regions, with 40 company profiles.

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Our Take

Testing yourself for an infection at home is now routine, and the habit is spreading from COVID-19 to flu, RSV, sexual health and urinary infections. Lateral flow antigen tests still dominate, but home PCR, send-in kits and telehealth-linked testing take most of the growth. Consumer spending grows from $3,260 million in 2026 to $4,600 million in 2031, at 7.1% a year. The end of COVID-19 emergency authorisations on 26 December 2026 will clear tests without FDA clearance off US shelves.

Market Size 2026: USD $3.26B Market Size 2031: USD $4.6B CAGR: 7.1%

Situation Analysis: what is really happening

• Emergency authorisations are ending. COVID-19 emergency use authorisations end on 26 December 2026, and the FDA has moved COVID-19 antigen tests to Class II, so only cleared home tests will stay on US shelves.
• Home PCR gets a second chance. The FDA cleared Visby Medical's at-home flu and COVID-19 PCR test and Aptitude's next-generation Metrix COVID test. Home Molecular grows 29.2% a year, from $146.7 million to $529.0 million.
• Combination home tests take over. ACON and iHealth home tests for COVID-19, flu A/B and RSV are cleared, replacing COVID-only tests.
• Sexual health moves home. Visby's sexual health PCR self-test is sold through Quest and Labcorp, OraSure's Colli-Pee home urine kit was cleared, and Sexually Transmitted is the fastest-growing application at 13.0% a year.
• Online channels overtake the pharmacy. Online, home-collection and telehealth-linked sales rise from $1,336.6 million to $2,208.0 million and pass retail pharmacy, at $1,771.0 million, by 2031.
• Donor-funded HIV self-testing is under pressure. PEPFAR cuts and the move to bilateral aid hold government and employer spending to 2.0% a year.

Company Analysis: who is positioned, who is exposed

• Abbott, QuidelOrtho, ACON and iHealth: Lead US home antigen testing; the cleared combination tests decide who keeps shelf space after the emergency authorisations end.
• Visby Medical and Aptitude: The new home PCR players, with cleared respiratory and sexual health tests.
• OraSure and NOWDiagnostics: HIV and syphilis self-testing and home sample collection; OraSure plans to resubmit its CT/NG self-test.
• Labcorp, Quest, Everlywell and LetsGetChecked: Send-in kits and consumer lab ordering, now also selling self-tests.
• Hims & Hers, Ro and Remedy Meds (Nurx): Telehealth services that turn a test into a prescription.
• CVS, Walgreens and Amazon: The shelves and websites where most tests are bought.

In all, 40 company profiles, each one to two pages with a fact box covering website, headquarters, ownership, revenue, employees and key products.

Questions this report answers

• Which home tests survive the end of COVID-19 emergency authorisations on 26 December 2026?
• How fast will home PCR grow now that cleared tests are on sale?
• How large are the markets for home STI, HIV, hepatitis, urinary and vaginal health tests?
• How much testing moves from the pharmacy shelf to online, home collection and telehealth?
• Who pays: consumers, insurers and FSA/HSA accounts, or governments and employers?
• How large is each country market, and how is donor-funded HIV self-testing changing?

What's inside

• 284 pages, 23 chapters, 63 tables and 49 figures
• Forecasts for 2027–2031 from a 2026 base year, by application, channel, test technology, product and payer, for 14 countries and regions
• Respiratory self-testing, sexual health, HIV and hepatitis self-testing, urinary tract and vaginal health tests, and retail, online, home collection and telehealth channels
• Technology, regulation, reimbursement and policy, and international markets
• 10 market-moving developments from 2025 and 2026, SWOT, Porter's Five Forces and strategic recommendations
• 40 company profiles
• Download the Table of Contents (PDF)

Who buys this report

• Diagnostic companies and business development teams: plan home tests for the post-EUA market.
• Retailers, telehealth and consumer health companies: size each application and channel.
• Investors and analysts: judge which home test makers and DTC services can reach scale.
• Public health programmes: plan self-testing for HIV, STIs and respiratory infections.

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ABOUT THE LEAD AUTHOR

Mr. Greg Powell, B.Sc., M.B.A., is the President of Howe Sound Research. His education includes:

Finance for Senior Executives - Harvard Business School

Market Research - Burke Institute

M.B.A. (Finance and Policy) - University of British Columbia

B.Sc. (Chemistry) - University of British Columbia

He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years.