HIV/AIDS Diagnostics - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2025 - 2030)

HIV/AIDS Diagnostics Market Analysis

The HIV/AIDS diagnostics market is valued at USD 3.64 billion in 2025 and is forecast to reach USD 6.06 billion by 2030, translating to a CAGR of 10.73%. This pace reflects sustained funding, updated testing guidelines, and rapid technology diffusion that keep the HIV/AIDS diagnostics market well aligned with global 95-95-95 goals. Government-led self-testing programs, rising viral load monitoring volumes, and multi-disease molecular platforms collectively widen the addressable pool of users . At the same time, donor-backed price ceilings, assay sensitivity gaps for new recombinant strains, and the shift to syndromic panels impose competitive and margin pressures that shape product strategy. Platform consolidation by leading firms and AI-enabled result interpretation continue to define how the HIV/AIDS diagnostics market evolves while ensuring reliable access in both mature and resource-limited settings.

Global HIV/AIDS Diagnostics Market Trends and Insights

Growing HIV Prevalence & Incidence

High-burden regions record continued case growth that widens the screening pool and amplifies demand for new assays. China reported 1.3 million people living with HIV by 2023, virtually all from sexual transmission, which is shifting screening efforts to general adult populations . South Korea logged a 5.7% rise in new infections in 2023, with two-thirds occurring in adults aged 20-39. Novel recombinants such as CRF85_BC/CRF01_AE discovered in Ningxia, China, challenge assay sensitivity and spur continuous test optimization. India’s expanding PrEP programs also mandate periodic viral load checks to ensure prevention efficacy. These epidemiological shifts collectively enlarge the addressable HIV/AIDS diagnostics market.

Government Funding & Initiatives

Coordinated global and national funding accelerates test uptake. PEPFAR and the Global Fund are supporting lenacapavir access for 2 million individuals, requiring robust baseline screening and follow-up. The United Kingdom allocated GBP 20 million to expand opt-out HIV testing across 47 emergency departments, translating to immediate procurement needs . West Bengal’s “Triple Elimination” program pairs HIV, syphilis, and hepatitis B screening, creating bundled demand for multiplex test kits. South Africa’s plan to enroll an extra 1.1 million patients in antiretroviral therapy by 2025 further solidifies predictable test volumes. Such funding clarity strengthens the revenue baseline for the HIV/AIDS diagnostics market.

Limited Lab Infrastructure & Skilled Manpower in LICs

Infrastructure gaps hinder implementation of high-complexity assays. A regulatory landscape review in Zimbabwe highlighted shortages in equipment calibration services and trained biomedical engineers, delaying device approvals. Low-cost approaches such as India-ink cryptococcosis screening in Mozambique illustrate demand for ultra-simple diagnostics that may compete with advanced molecular systems. While point-of-care early infant diagnosis in Uganda cut result turnaround from 28 days to 1 day and boosted ART initiation to 95%, scaling similar models requires steady funding for maintenance and training. These structural hurdles temper the near-term expansion pace of the HIV/AIDS diagnostics market in low-income regions.

Other drivers and restraints analyzed in the detailed report include:

1. Expanding Adoption of HIV Self-Testing & At-Home Rapid Tests
2. Integration of HIV in Multiplex Molecular Respiratory/STD Panels
3. Price Erosion from Donor-Driven Bulk Tenders

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Consumables held 62.21% of the HIV/AIDS diagnostics market share in 2024 and generate steady repeat sales each time a test is performed. Volume predictability secures cash flow and funds R&D. Instruments contribute larger upfront revenue per unit and are forecast to expand at an 11.45% CAGR, reflecting health-system moves toward integrated analyzers that accept multiple assays. Software and service add-ons, including AI-based interpretation dashboards, start to differentiate vendor offerings.

Recurring reagent demand anchors margin sustainability in the HIV/AIDS diagnostics market. Meanwhile, platform acquisitions—such as Roche’s USD 350 million purchase of LumiraDx’s point-of-care technology—signal that incumbents aim to secure future instrument installed bases. Public research funding, exemplified by NIH’s USD 1.3 million grant to Florida Atlantic University for a USD 5 microchip test, underscores how innovation targets both cost containment and usability. Digital services that triage results and guide next steps grow in prominence as manufacturers compete beyond hardware.

Antibody assays led revenue at 48.34% in 2024 because they serve as gateway screening tools. Yet viral load testing is set for the highest 11.54% CAGR through 2030 as treatment monitoring drives routine usage. The WHO recommendation that viral load replace CD4 counts for monitoring more than 30 million individuals on therapy materially boosts this subsegment. CD4 and resistance tests remain important adjuncts but at lower growth trajectories.

High-throughput labs such as South Africa’s National Health Laboratory Service processed over 45 million viral load samples in 2022, proving scale economics. Innovations like pooled testing in Cameroon, which raised capacity by 80% while holding accuracy, and Bigtec Labs’ portable micro-PCR platforms illustrate how technology adapts to infrastructure realities. These factors cement the HIV/AIDS diagnostics market size for viral load assays as a prime growth driver.

The HIV/AIDS Diagnostics Market Report is Segmented by Product (Consumables, Instruments, Software & Services), Test Type (Antibody Tests, Viral Load Tests, CD4 Tests, Others), Technology (Immunoassay, Molecular Diagnostics, and More), End User (Hospitals, Diagnostic Laboratories, At-Home Settings, Others), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America held a 38.98% revenue lead in 2024 because of strong insurance coverage and proactive public health campaigns. Federal initiatives such as the Together TakeMeHome self-test distribution provide reliable procurement streams and keep the HIV/AIDS diagnostics market expanding steadily in mature settings. Europe sustains moderate growth through emergency-department opt-out programs and integrated care models.

Asia-Pacific is the definitive growth engine, advancing at an 11.78% CAGR to 2030. India’s National AIDS Control Programme conducted 60 million tests in 2023-24 and dispenses free treatment to more than 1.68 million patients. China’s 1.3 million-person HIV cohort and Japan’s 2024 PrEP approval build continuous demand for screening and monitoring. South Korea’s broader healthcare reforms, which include diagnostic capacity upgrades, further bolster market expansion.

Middle East & Africa and South America trail but still represent meaningful opportunities as infrastructure investments rise. PEPFAR and Global Fund financing channels continue to anchor procurement in Sub-Saharan Africa. In Latin America, modernization of public laboratories and the gradual inclusion of self-testing in national guidelines stimulate incremental volumes, rounding out the global HIV/AIDS diagnostics market landscape.

List of Companies Covered in this Report:

1. Siemens Healthineers
2. Roche
3. Abbott Laboratories
4. Danaher Corp. (Cepheid & Beckman Coulter)
5. Thermo Fisher Scientific
6. Merck KGaA (MilliporeSigma)
7. Beckton Dickinson
8. Hologic
9. Bio-Rad Laboratories
10. Orasure Technologies
11. Chembio Diagnostics Inc.
12. Omega Diagnostics Group
13. QIAGEN
14. bioMérieux
15. QuidelOrtho Corp.
16. Trinity Biotech
17. Sysmex Corp.
18. GenMark Diagnostics (Roche)
19. Seegene
20. DiaSorin
21. Guangzhou Wondfo Biotech
22. Access Bio

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support