Home Diagnostics Markets 2027–2031

Home Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Channel Outlook, 2027–2031

Global forecasts by application, format, channel, payer and product, for 14 countries and regions, with 37 company profiles. Values are retail: what consumers, insurers, health accounts, employers and public programmes spend.

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Our Take

Home testing has become a permanent part of healthcare, and the pandemic chapter is closing. The centre of the market is no longer the COVID-19 swab but cancer screening collected at home and mailed to a laboratory, alongside STI and HIV self-tests, fertility monitors and a second generation of home molecular tests. Measured at retail, the market grows from $8,140 million in 2026 to $11,500 million in 2031, at 7.2% a year, with colorectal and cancer screening adding $1,504.2 million, about 45% of all growth.

Market Size 2026: USD $8.14B Market Size 2031: USD $11.5B CAGR: 7.2%

Situation Analysis: what is really happening

• Cancer screening moves home. Colorectal & Cancer Screening is the largest application at $2,808.3 million, and Abbott completed its acquisition of Exact Sciences, the maker of Cologuard, on 23 March 2026.
• Cervical screening follows. Waters' Onclarity HPV Self-Collection Kit was cleared for home use on 8 April 2026, and HRSA guidelines require no-cost coverage of HPV self-collection for plan years from 1 January 2027.
• The pandemic chapter closes. Device COVID-19 EUAs end on 26 December 2026, and combination self-tests such as ACON's Flowflex Plus four-in-one COVID-19, flu and RSV test are now the standard.
• Laboratory-quality tests at home. Home Molecular grows fastest of the formats, at 18.7% a year, from $366.3 million to $862.5 million, led by Visby Medical and Aptitude's Metrix, cleared on 7 August 2026.
• Sexual health grows fastest. STI & HIV self-tests grow 11.3% a year, from $773.3 million to $1,322.5 million, and Wisp and Visby launched at-home STI test-to-treat on 16 April 2026.
• Buying moves online. Online & DTC and Telehealth & Test-to-Treat rise from 29% of spending (18.5% + 10.5%) to 36% (22.0% + 14.0%), while CMS's preliminary 2027 lab rates, about 16% below 2026, put pressure on mail-in screening.

Company Analysis: who is positioned, who is exposed

• Exact Sciences (Abbott), Geneoscopy, Polymedco, Eiken Chemical and Mainz Biomed: Mail-in colorectal cancer screening, from stool DNA and RNA tests to FIT.
• Teal Health and Waters (formerly BD Diagnostic Solutions): At-home HPV self-collection for cervical screening.
• Abbott, OraSure, QuidelOrtho, iHealth, ACON, Healgen and SD Biosensor: Rapid self-tests for respiratory infections, HIV and other infections.
• Visby Medical and Aptitude Medical Systems: Home molecular tests with full FDA marketing authorisation.
• Swiss Precision Diagnostics, Church & Dwight, Mira, Inito, MFB Fertility (Proov) and Oova: Pregnancy tests and connected fertility monitors.
• LetsGetChecked, Everlywell, Labcorp, Quest Diagnostics, Wisp and Nurx: Mail-in kits, direct-to-consumer sales and telehealth test-to-treat.

In all, 37 company profiles, each one to two pages with a fact box covering website, headquarters, ownership, revenue, employees and key products.

Questions this report answers

• How large is the home diagnostics market at retail, and which applications grow fastest?
• How will at-home colorectal and cervical screening change the market after Abbott's purchase of Exact Sciences and the 2027 HPV self-collection coverage rule?
• What happens to home respiratory testing after COVID-19 EUAs end on 26 December 2026?
• Can home molecular tests be made cheaply enough to replace lateral flow?
• How fast are online, direct-to-consumer and telehealth channels taking share from pharmacies?
• How large is each country market, and where is growth fastest?

What's inside

• 303 pages, 23 chapters, 71 tables and 56 figures
• Forecasts for 2027–2031 from a 2026 base year, by application, format, channel, payer and product, for 14 countries and regions
• Infectious disease self-tests, pregnancy, ovulation and fertility, and colorectal and cancer screening at home
• Test formats and technology, channels, payers and pricing, regulation and reimbursement, and China, Asia-Pacific and emerging markets
• IVD – The Big Picture: healthcare and IVD spending, the four large IVD segments, the road to diagnostics and lab fee trends
• 10 market-moving developments from 2025 and 2026, SWOT, Porter's Five Forces and strategic recommendations
• 37 company profiles
• Download the Table of Contents (PDF)

Who buys this report

• Diagnostic and consumer health companies: plan home tests, formats and channels as the market moves beyond COVID-19.
• Retailers, telehealth and DTC platforms: choose which home tests to sell and how to link results to care.
• Investors and analysts: model a retail market reshaped by cancer screening, home molecular tests and new payment rules.
• Payers, employers and public health programmes: plan coverage for home screening and self-testing.

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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.