HIV Clinical Trials Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Phase (Phase I, Phase II, Phase III, Phase IV), By Study Design (Interventional Studies, Observational Studies, Expanded Access Studies), By Sponsor (Pharmaceutical & Biopharmaceutical Companies, Non-Profit Organizations, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.67 Billion
CAGR (2026-2031)	5.63%
Fastest Growing Segment	Phase 2
Largest Market	North America
Market Size (2031)	USD 2.32 Billion

Market Overview

The Global HIV Clinical Trials Market will grow from USD 1.67 Billion in 2025 to USD 2.32 Billion by 2031 at a 5.63% CAGR. HIV clinical trials consist of systematic research studies designed to evaluate the safety and efficacy of pharmaceutical and behavioral interventions intended to prevent or treat the Human Immunodeficiency Virus. The market is fundamentally driven by the persistent global prevalence of the infection which necessitates continuous innovation in antiretroviral therapies and the development of potential vaccines. This demand is reinforced by substantial financial commitment from government bodies and international health organizations aiming to achieve viral suppression targets. According to UNAIDS, in 2024, approximately 40.8 million people were living with HIV globally which underscores the critical need for sustained therapeutic advancements and accessible treatment options.

However, the sector encounters a significant challenge regarding the complexity of patient recruitment and retention within regions possessing limited healthcare infrastructure. The logistical difficulties inherent in maintaining consistent participant engagement over extended periods often lead to operational delays and increased costs which can impede the efficient progression of essential clinical studies.

Key Market Drivers

The development of long-acting injectable antiretroviral therapies is fundamentally reshaping the sector by addressing critical challenges associated with daily oral pill adherence. Pharmaceutical companies are aggressively prioritizing extended-release formulations that offer convenient dosing schedules, thereby improving patient retention in clinical studies and real-world treatment. A pivotal advancement in this domain occurred when, according to Gilead Sciences, July 2024, in the 'Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir' press release, the Phase 3 PURPOSE 1 trial demonstrated that lenacapavir achieved 100% efficacy with zero infections observed among cisgender women. This shift towards infrequent dosing regimens not only enhances therapeutic outcomes but also stimulates the clinical pipeline as competitors strive to develop formulations with dosing intervals spanning several months.

Simultaneously, the market is experiencing an accelerated investigation of functional cures and gene therapies designed to induce sustained viral remission. Research efforts are increasingly concentrating on novel modalities such as broadly neutralizing antibodies, supported by robust investment in early-stage protocols. According to Treatment Action Group, July 2024, in the '2024 Pipeline Report', the research landscape expanded with the initiation of an AbbVie Phase II study recruiting 140 participants, distinguishing it as the largest HIV cure-related interventional trial involving an analytical treatment interruption to date. Despite these scientific strides, the persistence of transmission underscores the urgency of these studies; according to UNAIDS, in 2024, approximately 1.3 million individuals became newly infected with HIV globally, reinforcing the imperative for continued innovation in preventative and curative clinical research.

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Key Market Challenges

The complexity of patient recruitment and retention within regions possessing limited healthcare infrastructure stands as a formidable barrier to the Global HIV Clinical Trials Market. Conducting rigorous studies requires sites with reliable medical equipment, consistent supply chains, and trained personnel to ensure participant safety and data integrity. In many high-prevalence areas, these foundational elements are frequently absent or unreliable. This lack of infrastructure complicates the logistical management of trials, leading to high participant dropout rates and extended study timelines. Consequently, pharmaceutical companies face increased operational costs and significant delays in bringing new therapies to market, which directly hampers the sector's growth potential.

This operational instability is fundamentally underpinned by severe resource constraints that prevent necessary infrastructural upgrades. According to UNAIDS, in 2024, a funding gap of nearly USD 9.5 billion existed between the resources available for HIV responses in low- and middle-income countries and the targets required for effective disease management. This financial shortfall limits the ability of local health systems to support the demanding requirements of clinical research. Without adequate investment to bolster these healthcare frameworks, the market struggles to execute the large-scale, diverse trials necessary for the next generation of HIV treatments.

Key Market Trends

The Utilization of Artificial Intelligence for Patient Stratification and Retention is emerging as a transformative trend, addressing the sector's chronic inefficiencies in participant management. Advanced machine learning algorithms are now being deployed to analyze vast datasets, enabling researchers to predict patient adherence profiles and optimize cohort selection with unprecedented precision. This technological integration directly mitigates the high dropout rates common in long-term studies by identifying at-risk individuals early in the process. According to the National Institutes of Health, February 2025, in the 'AI applications in HIV research: advances and future directions' review, a meta-analysis involving 401,389 people living with HIV demonstrated the potential of these models to significantly enhance clinical decision-making and predictive accuracy in large-scale trials.

Simultaneously, the market is witnessing a distinct Focus on Pediatric and Adolescent Specific Formulation Trials to close the therapeutic gap for younger populations historically excluded from primary research. Stakeholders are increasingly directing capital toward developing age-appropriate interventions, such as vaccines and long-acting regimens tailored for developing immune systems. This shift is driven by the urgent need to provide equitable care standards for infants and children who require lifelong management strategies. According to Weill Cornell Medicine, September 2025, in the 'NIH Grant Aims for Childhood Vaccine Against HIV' news release, a multi-institutional team was awarded a $20.8 million grant to advance the preclinical development and optimization of an experimental HIV vaccine specifically designed for pediatric clinical trials.

Segmental Insights

The Phase 2 segment is positioned as the fastest-growing category within the Global HIV Clinical Trials Market due to a significant influx of novel therapeutic candidates progressing from early safety testing to preliminary efficacy evaluations. This rapid expansion is primarily driven by the industry shift toward long-acting injectables and broadly neutralizing antibodies, which require rigorous dose-ranging studies to establish optimal regimens. Furthermore, stringent requirements from regulatory authorities such as the U.S. Food and Drug Administration regarding proof-of-concept data encourage pharmaceutical sponsors to increase investment in these mid-stage trials to mitigate risks before large-scale confirmatory studies.

Regional Insights

North America maintains a dominant position in the Global HIV Clinical Trials market, driven by a developed healthcare infrastructure and significant investments in research and development. The region hosts several major pharmaceutical companies focused on antiretroviral therapies, ensuring a steady pipeline of new studies. This leadership is supported by favorable government initiatives and funding from institutions like the National Institutes of Health (NIH). Furthermore, the U.S. Food and Drug Administration (FDA) provides structured regulatory pathways that encourage continuous clinical evaluation, ensuring North America remains the primary hub for HIV treatment advancements.

Recent Developments

• In July 2025, Merck announced the initiation of the EXPrESSIVE Phase 3 clinical trial program to evaluate the safety and efficacy of MK-8527, an investigational once-monthly oral agent for HIV pre-exposure prophylaxis. The program included a large-scale study enrolling participants across 16 countries and a specific trial focused on women and adolescent girls in sub-Saharan Africa. This advancement to Phase 3 followed positive Phase 2 results that supported the drug's profile as a convenient monthly oral option. The Senior Vice President of Global Clinical Development at Merck emphasized that developing diverse prevention options is critical to reducing the global burden of HIV infection.
• In June 2025, Gilead Sciences received approval from the U.S. Food and Drug Administration for its injectable HIV-1 capsid inhibitor, marketed as Yeztugo, for pre-exposure prophylaxis. This regulatory decision established the drug as the first twice-yearly injectable option for HIV prevention in the United States. The approval was supported by results from the Phase 3 PURPOSE 1 and PURPOSE 2 trials, which demonstrated the drug's superior efficacy in preventing HIV acquisition compared to daily oral Truvada. The company highlighted that this twice-yearly injection offers a significant new tool to improve adherence and reduce new infections across diverse populations.
• In October 2024, Gilead Sciences and Merck announced promising data from a Phase 2 clinical study evaluating an investigational once-weekly oral combination of islatravir and lenacapavir. Presented at IDWeek 2024, the findings showed that the novel regimen maintained high rates of viral suppression in adults who were previously virologically suppressed on a daily antiretroviral therapy. At the 48-week mark, 94.2% of participants treated with the weekly combination maintained viral suppression, comparable to those continuing their daily regimen. This collaboration aimed to provide a less frequent oral dosing option to help address adherence challenges and reduce the pill burden for patients.
• In July 2024, ViiV Healthcare presented results from the PASO-DOBLE clinical trial at the 25th International AIDS Conference in Munich. The study was the largest head-to-head randomized clinical trial comparing the two-drug regimen dolutegravir/lamivudine against the three-drug regimen bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed adults. The data, which evaluated treatment efficacy, safety, and weight gain, demonstrated that the two-drug regimen was non-inferior to the three-drug standard of care. The Chief Medical Officer of ViiV Healthcare noted that these findings reinforced the company’s strategy of developing optimized, long-acting, and simplified treatment options for people living with HIV.

Key Market Players

• 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

By Phase	By Study Design	By Sponsor	By Region
Phase I Phase II Phase III Phase IV	Interventional Studies Observational Studies Expanded Access Studies	Pharmaceutical & Biopharmaceutical Companies Non-Profit Organizations Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global HIV Clinical Trials Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• 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
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE