Valued at USD 2,600.09 million in 2024, the HIV diagnostics market is projected to reach USD 2,791.20 million in 2025 and USD 5,396.32 million by 2034, growing at a CAGR of 7.6% during the forecast period 2025–2034. The market covers technologies used for the detection, monitoring, and management of HIV infections, including rapid diagnostic tests, nucleic acid amplification tests, immunoassays, and self-testing kits serving healthcare facilities and point-of-care settings. North America was the largest market in 2024.

By mode, the report distinguishes self-test from lab-based testing, and by test type it covers antibody tests, viral load tests, CD4 tests, and others. Expanding screening programs, early detection techniques, and advances in molecular diagnostics underpin growth.

Rising Prevalence and Public Health Investment in the HIV Diagnostics Market

Rising HIV infection rates, particularly in low- and middle-income countries, drive demand for early detection, routine screening, and confirmatory testing. In 2022, approximately 31,800 individuals were newly infected with HIV in the US, and total HIV diagnoses among people aged 13 and older reached 37,981.

Governments, WHO, UNAIDS, and non-profit organizations are increasing access to low-cost, high-quality testing in resource-limited settings. The FY 2025 US budget proposal allocates USD 593 million to the CDC, HRSA, IHS, and NIH for the Ending the HIV Epidemic initiative, a USD 20 million increase over FY23 levels. Public health mandates advocating nationwide HIV screening programs are driving adoption of advanced, cost-effective testing across diverse healthcare infrastructures.

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HIV Self-Testing Kits and Decentralized Models

The shift toward decentralized, rapid testing enables immediate results, faster clinical decisions, and better patient management, especially in resource-limited settings. Rising consumer preference for home-based HIV self-testing kits, supported by mobile health solutions and telemedicine, promotes early detection and privacy-conscious screening.

Recent initiatives illustrate the trend. In March 2023, Emory University initiated a program to distribute one million rapid HIV self-testing kits across the US. In April 2023, Abbott collaborated with Population Services International and Unitaid to improve the affordability and accessibility of self-test kits in low- and middle-income countries. In July 2022, Abbott launched the Panbio HIV Self-Test for use in approved markets outside the US.

Rapid Diagnostic Tests, Point-of-Care Testing, and NAATs

The consumables segment held the largest product share in 2024, reflecting high demand for reagents, test kits, and assay consumables. Growing adoption of nucleic acid amplification tests, ELISAs, and rapid diagnostic tests has contributed to this leadership. Hospitals and clinics are expected to grow significantly as inpatient and outpatient testing volumes rise, increasing demand for point-of-care testing and bedside diagnostics. In March 2025, bioLytical launched the INSTI Multiplex HIV-1/2 and Syphilis Antibody Test in Australia, delivering results in one minute.

Regional Analysis: North America Leads, Asia Pacific Grows Fastest

North America accounted for the largest share in 2024, supported by high testing rates, well-established healthcare infrastructure, and strong government-backed screening initiatives. Funding from the CDC and NIH, the presence of leading manufacturers, rising PrEP adoption, and favorable reimbursement policies further support the region.

Asia Pacific is expected to record the highest CAGR, driven by rising HIV prevalence, government-led testing programs, and investments in healthcare infrastructure. In August 2022, ICAP at Columbia University, with the Almaty AIDS Center and local NGOs, launched a free, anonymous online HIV diagnostic  testing service in Almaty, Kazakhstan. Mobile diagnostic units and low-cost rapid test kits are also expanding access.

Key Players in the HIV Diagnostics Market

Key players include Abbott; Apogee Flow Systems; BD; Beckman Coulter, Inc.; Bristol-Myers Squibb Company; F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Janssen Global Services, LLC; Merck & Co. Inc.; Mylan N.V.; QIAGEN; Siemens Healthcare GmbH; Sysmex Europe SE; and VIIV Healthcare. In December 2024, Abbott partnered with Siemens Healthineers AG, Tanit Medical Engineering, and Abbott Laboratories GmbH to improve healthcare access across Nigeria. High cost remains a restraint.

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