Global HIV Clinical Trials Market Size Grows at a CAGR of 5.78%

Introduction

Straits Research released its highly anticipated report, “Global HIV Clinical Trials Market Size & Outlook, 2026-2034”. According to the study, the market size is valued at USD 1.64 billion in 2025 and is projected to expand to USD 2.71 billion by 2034, registering a compound annual growth rate (CAGR) of 5.78%.

Market Dynamics

The growth of the global HIV clinical trials market is primarily driven by the rising prevalence of HIV infections worldwide, creating a continuous demand for novel and effective therapeutic solutions. According to UNAIDS, more than 39 million people are living with HIV globally, emphasizing the urgent need for innovative treatment options and preventive measures. This surge in disease burden led to an increase in government and private funding aimed at advancing HIV research and accelerating clinical development programs. Further, the rapid advancement in antiretroviral therapy formulations is significantly improving patient adherence, reducing viral load, and driving the progression of late-stage clinical trials across leading pharmaceutical firms.

However, the market faces restraints such as the high operational and recruitment costs associated with HIV clinical trials. Conducting long-term studies requires substantial financial investment, particularly due to stringent regulatory frameworks, complex trial designs, and the need for high-risk patient populations. This poses challenges for smaller biotech companies and limits the pace of innovation in developing regions with limited infrastructure and trial accessibility.

On the other hand, the growing focus on developing an effective HIV vaccine and curative therapies presents a significant opportunity for market players. Increasing collaborations between academic institutions, pharmaceutical companies, and global health organizations are fostering research initiatives, positioning the HIV clinical trials market for strong future growth and expanded therapeutic breakthroughs.

Market Highlights

• Phase: The phase II segment dominated the market with a revenue share of 31.67% in 2025.
• Study Design: The expanded access studies segment is estimated to grow at the fastest pace with a CAGR of 6.49%.
• Sponsor: The non-profit organizations segment is estimated to grow with the fastest CAGR, owing to increasing funding and a surge in global HIV research initiatives.
• Regional Insights: North America accounted for 45.84% market share in 2025, driven by strong R&D infrastructure and advanced clinical trial networks.

Competitive Players

1. Gilead Sciences
2. ViiV Healthcare
3. GSK plc
4. Johnson & Johnson
5. Merck & Co. Inc.
6. Pfizer Inc.
7. Bristol Myers Squibb
8. AbbVie Inc.
9. Sanofi
10. PPD Inc.
11. IQVIA Inc.
12. ICON plc
13. WuXi AppTec
14. Bionor Holding AS
15. Charles River Laboratories
16. Syneos Health
17. BioNTech SE
18. Sangamo Therapeutics
19. Parexel International Corporation
20. Others

Recent Developments

Segmentation

1. By Phase (2026-2034)
   1. Phase I
   2. Phase II
   3. Phase III
   4. Phase IV
2. By Study Design (2026-2034)
   1. Interventional Studies
   2. Observational Studies
   3. Expanded Access Studies
3. By Sponsor (2026-2034)
   1. Pharmaceutical & Biopharmaceutical Companies
   2. Non-Profit Organizations
   3. Others