Report Highlights

COVID-19 Testing in the U.S.: Market Overview

The U.S. COVID-19 diagnostics market was valued at USD 5.4 billion in 2024, down sharply from its 2021 peak as demand shifted from emergency mass testing to routine respiratory screening. Unlike most global markets, U.S. volume splits between commercial reference laboratories such as Quest Diagnostics and Labcorp, which process most molecular testing, and over-the-counter antigen kits sold through CVS, Walgreens, and Amazon, which account for a growing share of units.

Regulation sets the U.S. apart from peer markets. Tests reach the market through FDA 510(k), De Novo, or Emergency Use Authorization pathways, and laboratories must hold CLIA certification administered by CMS before patient testing. Pricing is shaped by Medicare reimbursement and commercial payer coverage rather than open competition, so reimbursement status often determines commercial viability more than technical performance.

Growth Drivers in U.S. COVID-19 Testing

Respiratory co-testing is the first demand driver. CDC surveillance guidance covering influenza, COVID-19, and RSV, combined with FDA clearance of multiplex assays such as Cepheid's Xpert Xpress CoV-2/Flu/RSV plus test, sustains demand for panels that capture three pathogens in one visit. Emergency departments and urgent care networks now order these combined panels in place of standalone COVID tests, raising value per order.

Second, public surveillance funding has shifted toward wastewater and genomic monitoring. The CDC's National Wastewater Surveillance System and state-level sequencing contracts draw on residual American Rescue Plan Act testing appropriations of USD 47.8 billion. Third, BARDA's Project NextGen, launched with approximately USD 1.4 billion, funds next-generation point-of-care and at-home platforms, keeping manufacturer pipelines active despite falling consumer demand.

Market Restraints and Entry Barriers

The FDA authorization and CLIA categorization process is the first barrier. A new molecular assay requires separate CLIA complexity classification, and waived status for home or pharmacy use requires a 510(k) or De Novo submission supported by multisite clinical performance data. Manufacturers without an existing authorization face timelines well beyond twelve months before revenue begins.

Price erosion and incumbent lock-in follow. Commercial and government payers have reset reimbursement downward, while retail channels favor brands with established shelf placement. Abbott and Roche hold installed-base advantages in hospital laboratories, and Cue Health's 2024 bankruptcy demonstrated how thin margins become once federal purchase volumes decline.

Market Opportunities in U.S. COVID-19 Testing

Multiplex respiratory panels for pharmacies and employer clinics represent the nearest addressable pool. With roughly 340 million U.S. residents and clinical guidance favoring combined respiratory testing for symptomatic patients, a CLIA-waived flu, COVID, and RSV point-of-care test priced under USD 50 targets tens of millions of symptomatic encounters annually.

Retail pharmacy partnerships offer the second entry route. CVS and Walgreens operate in-store testing services, and Medicare Part B coverage for qualifying point-of-care tests gives pharmacists a billable service. Telehealth platforms, including Amazon One Medical, route at-home kits to members, creating a subscription channel for manufacturers holding CLIA-waived products.

Market at a Glance

Leading Market Participants

• Abbott Laboratories
• Roche Diagnostics
• Hologic
• QuidelOrtho
• Cepheid
• Becton Dickinson
• Thermo Fisher Scientific
• Quest Diagnostics
• Labcorp
• iHealth Labs

Regulatory and Policy Environment

Diagnostics are governed by the Federal Food, Drug, and Cosmetic Act, with FDA's Center for Devices and Radiological Health authorizing tests through 510(k), De Novo, and Emergency Use Authorization under Section 564. CMS administers the Clinical Laboratory Improvement Amendments under 42 CFR Part 493, requiring laboratories to hold a certificate of waiver, accreditation, or compliance before patient testing. The public health emergency declaration expired in May 2023, and FDA is moving EUA-only products toward full marketing authorization.

Reimbursement and funding rules complete the framework. CMS sets baseline rates through the Clinical Laboratory Fee Schedule, and CARES Act Section 3202 shaped commercial no-cost coverage for FDA-authorized tests during the emergency period. Project NextGen under BARDA, with its approximately USD 1.4 billion commitment, and remaining American Rescue Plan Act testing funds remain the largest federal sources, though Congress has not renewed bulk allocations.

Long-Term Outlook for COVID-19 Testing in the U.S.

By 2032 the U.S. market will be smaller and more concentrated in purchasing value. Revenue is forecast to decline to USD 3.9 billion, but point-of-care multiplex panels and home-use molecular kits will form a larger share, while standalone antigen products continue to commoditize through retail channels.

Winners will hold dual CLIA and FDA authorizations alongside integrated retail distribution. Laboratory consolidation among Quest Diagnostics and Labcorp, along with surveillance contracts tied to CDC wastewater programs, will shape demand. Manufacturers lacking a multiplex platform by 2028 will consolidate or exit the segment.