Report Highlights

U.S. HIV Diagnosis and Treatment: Market Overview

The U.S. HIV diagnosis and treatment market reached USD 24.6 billion in 2024 and is organised around three revenue pools: branded antiretroviral therapy, long-acting injectables and pre-exposure prophylaxis (PrEP), and laboratory and point-of-care diagnostics. Therapeutics account for the large majority of value, with Gilead Sciences and ViiV Healthcare dominating single-tablet regimen sales. Diagnostics remain a smaller pool but expand steadily because the CDC's 2006 recommendation for routine opt-out testing of people aged 13 to 64 in healthcare settings still anchors test volumes across emergency departments and primary care clinics.

Government has dominated demand rather than manufacturing. Medicaid and Medicare fund the majority of treatment spend, while the Ryan White HIV/AIDS Program, administered by HRSA's HIV/AIDS Bureau, finances state AIDS Drug Assistance Programs (ADAPs) for uninsured and underinsured patients. Private firms have led on product innovation, including the FDA's 2012 approval of OraSure Technologies' OraQuick In-Home HIV Test, the first over-the-counter HIV test and still the category benchmark.

Policy-Driven Growth in U.S. HIV Testing and Treatment

The Ending the HIV Epidemic in the U.S. initiative, launched by HHS in 2019, sets targets of a 75% reduction in new infections by 2025 and 90% by 2030. Its diagnose, treat, prevent and respond pillars channel CDC and HRSA grants into rapid testing and linkage navigators, and the Ryan White HIV/AIDS Program supplies more than USD 2.5 billion a year. Each newly identified positive is routed into ADAP or Medicaid-funded therapy, converting federal testing spend into branded antiretroviral sales.

Section 2713 of the Affordable Care Act, enacted as Public Law 111-148, requires most private plans to cover USPSTF A- and B-graded preventive services without cost sharing. The USPSTF's 2019 Grade A recommendation for PrEP placed daily and long-acting PrEP inside that mandate, and the Supreme Court upheld the task force's structure in Kennedy v. Braidwood Management in June 2025. Medicare Part D has covered PrEP without cost sharing since 2024 under the Inflation Reduction Act, and FDA approval of Yeztugo in June 2025 adds a twice-yearly injectable to the covered prevention pipeline.

Regulatory Barriers and Compliance Costs

FDA regulates HIV test kits as in vitro diagnostics under the Federal Food, Drug, and Cosmetic Act, requiring 510(k) clearance or De Novo authorisation, with a statutory goal of 90 review days for 510(k) submissions. Laboratories performing testing must hold a Clinical Laboratory Improvement Amendments (CLIA) certificate administered by CMS, and waived point-of-care tests need a CLIA waiver before community clinics can deploy them. The FDA's laboratory-developed test rule was vacated by the Eastern District of Texas in March 2025 in ACLA v. FDA, leaving in-house assays under CLIA alone.

Pricing is the second barrier. Biktarvy, Gilead Sciences' single-tablet regimen, was selected in January 2025 for Medicare drug price negotiation under the Inflation Reduction Act, with the negotiated maximum fair price effective in 2027. ADAPs administered by state health departments apply formularies and prior authorisation, and the 340B Drug Pricing Program, administered by HRSA, requires covered entities to register and maintain auditable contract pharmacy arrangements, adding compliance overhead for community health centers.

Policy-Created Opportunities in the U.S.

Medicare Part B covers annual HIV screening for individuals aged 15 to 65 and for younger or older patients at increased risk, creating a reimbursed volume base for laboratory and rapid-test providers. Commercial laboratory suppliers such as Bio-Rad Laboratories and Cepheid can capture this flow through CLIA-certified sites, and the screening benefit reinforces demand under the ACA's preventive services mandate.

Long-acting PrEP creates a second opportunity. Plans subject to Section 2713 must cover Yeztugo at zero patient cost, which opens pharmacy-administered injection services to community pharmacies and health systems holding 340B contracts. Health departments in EHE jurisdictions also procure point-of-care rapid tests through HRSA and CDC grants, sustaining demand for Abbott Laboratories' and OraSure Technologies' platforms.

Market at a Glance

Leading Market Participants

• Gilead Sciences
• ViiV Healthcare
• Merck & Co.
• Janssen Pharmaceuticals
• Abbott Laboratories
• Roche Diagnostics
• OraSure Technologies
• Bio-Rad Laboratories
• bioMérieux
• Cepheid

Regulatory and Policy Environment

The primary legislation is the Ryan White HIV/AIDS Treatment Modernization Act of 2006 and its successor authority, the Ryan White HIV/AIDS Treatment Extension Act of 2009, which govern HRSA's Part A to Part D funding streams with compliance overseen by the HIV/AIDS Bureau. Diagnostics fall under the Federal Food, Drug, and Cosmetic Act through FDA, and under CLIA 1988 through CMS with CDC technical guidance. Public Law 111-148 Section 2713 sets preventive coverage obligations, while Public Law 117-169, the Inflation Reduction Act, sets Part D cost-sharing rules and Medicare negotiation.

Key compliance requirements include FDA premarket clearance and CLIA certification for testing, state-level HIV case reporting to health departments, and 340B registration with HRSA's Office of Pharmacy Affairs. Upcoming changes include negotiated Medicare prices for Biktarvy effective January 1, 2027, recurring FY2026 appropriations debates over CDC HIV prevention lines, and the review of EHE progress against the 2030 goal of a 90% reduction. Compared with regional peers, England has funded PrEP through NHS commissioning since 2020 and Canada operates through provincial formularies, whereas the U.S. runs a fragmented multi-payer system with more compliance layers.

Long-Term Policy Outlook for U.S. HIV Diagnosis and Treatment

By 2032, Medicare negotiation will extend to additional HIV regimens through successive selection cycles, pressuring net prices for branded antiretroviral therapy and steering payers toward long-acting formulations with lower administration burdens. Congress will continue to set CDC and HRSA appropriations annually, making prevention funding the largest policy variable for diagnostic demand in EHE jurisdictions.

The 2030 target of a 90% reduction in new infections will be assessed against CDC's National HIV Surveillance System data, and jurisdictions missing interim milestones will face tighter HRSA performance conditions. FDA will continue to review expansions of self-testing indications, and Medicare Part B will revisit screening payment rates as diagnostic volume shifts into pharmacies and community sites.