HIV Clinical Trials Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global HIV Clinical Trials Market is projected to expand from USD 1.67 Billion in 2025 to USD 2.32 Billion by 2031, registering a CAGR of 5.63%. These trials involve systematic research aimed at assessing the safety and effectiveness of pharmaceutical and behavioral interventions designed to treat or prevent the Human Immunodeficiency Virus. The primary driver for this market is the enduring global prevalence of the infection, which creates a continuous need for innovative antiretroviral therapies and the development of viable vaccines. This demand is supported by significant financial backing from international health organizations and government bodies striving to reach viral suppression goals. As reported by UNAIDS in 2024, roughly 40.8 million individuals were living with HIV worldwide, highlighting the vital necessity for ongoing therapeutic progress and accessible treatment solutions.

However, the industry faces substantial hurdles related to the difficulties of recruiting and retaining patients in areas with inadequate healthcare infrastructure. The logistical challenges involved in ensuring consistent participant engagement over long durations frequently result in operational setbacks and escalating costs. These issues can hinder the efficient advancement of critical clinical studies, posing a barrier to the timely development of essential new interventions.

Market Drivers

The landscape of the sector is being transformed by the creation of long-acting injectable antiretroviral therapies, which solve key issues related to adhering to daily oral medication. Pharmaceutical firms are actively prioritizing extended-release options that provide more convenient dosing schedules, which in turn boosts patient retention in both clinical trials and actual treatment settings. A significant breakthrough in this area was highlighted in a July 2024 press release by Gilead Sciences regarding the 'Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir'; the Phase 3 PURPOSE 1 trial showed that lenacapavir reached 100% efficacy with no infections found among cisgender women. This move toward less frequent dosing not only improves treatment results but also energizes the clinical pipeline as rivals work to create formulations with dosing gaps of several months.

At the same time, there is a heightened focus on investigating functional cures and gene therapies aimed at achieving sustained viral remission. Research initiatives are increasingly centering on innovative approaches like broadly neutralizing antibodies, backed by strong funding for early-stage protocols. As noted by the Treatment Action Group in their '2024 Pipeline Report' from July 2024, the research field has broadened with the start of an AbbVie Phase II study enrolling 140 participants, marking it as the largest HIV cure-related interventional trial to date involving analytical treatment interruption. Even with these scientific advances, the ongoing transmission rates emphasize the critical need for such studies; UNAIDS reported that in 2024, about 1.3 million people were newly infected with HIV worldwide, confirming the necessity for persistent innovation in preventative and curative clinical research.

Market Challenges

A major obstacle facing the Global HIV Clinical Trials Market is the difficulty of recruiting and retaining patients in regions with insufficient healthcare infrastructure. Performing rigorous studies necessitates sites equipped with dependable medical tools, steady supply chains, and skilled staff to guarantee data integrity and participant safety. However, in many areas with high HIV prevalence, these essential components are often missing or inconsistent. This infrastructure deficit makes the logistical handling of trials more difficult, resulting in high rates of participant dropout and prolonged study durations. As a result, pharmaceutical companies encounter higher operational expenses and substantial delays in introducing new therapies, which directly impedes the growth potential of the sector.

Severe resource limitations that hinder essential infrastructural improvements are the root cause of this operational instability. UNAIDS reported in 2024 that there was a funding gap of approximately USD 9.5 billion between the available resources for HIV responses in low- and middle-income nations and the targets needed for effective disease management. This lack of funds restricts the capacity of local health systems to meet the rigorous demands of clinical research. Unless there is sufficient investment to strengthen these healthcare structures, the market will continue to face challenges in conducting the large-scale, diverse trials required to develop the next generation of HIV treatments.

Market Trends

The use of Artificial Intelligence for patient stratification and retention is becoming a pivotal trend, tackling long-standing inefficiencies in managing participants within the sector. Sophisticated machine learning algorithms are increasingly utilized to examine immense datasets, allowing researchers to forecast patient adherence patterns and refine cohort selection with remarkable accuracy. This integration of technology directly helps reduce the high dropout rates typical of long-term studies by detecting at-risk individuals early on. As highlighted in a February 2025 review by the National Institutes of Health titled 'AI applications in HIV research: advances and future directions', a meta-analysis of 401,389 people living with HIV showed that these models have the potential to vastly improve clinical decision-making and predictive precision in large-scale trials.

At the same time, the market is seeing a clear emphasis on trials for pediatric and adolescent-specific formulations, aiming to bridge the therapeutic gap for younger groups that have historically been left out of primary research. Investors and stakeholders are channeling more funds into creating age-appropriate interventions, including vaccines and long-acting treatments customized for developing immune systems. This trend is motivated by the critical necessity of offering equitable standards of care for infants and children needing lifelong management plans. According to a September 2025 news release from Weill Cornell Medicine regarding the 'NIH Grant Aims for Childhood Vaccine Against HIV', a multi-institutional group received a $20.8 million grant to further the preclinical development and refinement of an experimental HIV vaccine tailored specifically for pediatric clinical trials.

Key Players Profiled in the HIV Clinical Trials Market

• PPD Inc.
• IQVIA Inc.
• PAREXEL International Corp
• ICON PLC
• Syneos Health Inc.
• WuXi AppTec Co Ltd.
• Janssen Global Services LLC
• Gilead Sciences Inc.
• GSK PLC
• Charles River Laboratories Inc.

Report Scope

In this report, the Global HIV Clinical Trials Market has been segmented into the following categories:

HIV Clinical Trials Market, by Phase:

• Phase I
• Phase II
• Phase III
• Phase IV

HIV Clinical Trials Market, by Study Design:

• Interventional Studies
• Observational Studies
• Expanded Access Studies

HIV Clinical Trials Market, by Sponsor:

• Pharmaceutical & Biopharmaceutical Companies
• Non-Profit Organizations
• Others

HIV Clinical Trials Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global HIV Clinical Trials Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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