Global HIV Clinical Trials Market Size, Trend & Opportunity Analysis Report, by Phase (Phase I, Phase II, Phase III, Phase IV), Study Design (Interventional Studies, Observational Studies, Expanded Access Studies), and Forecast, 2024–2035

Market Definition and Introduction

The global HIV clinical trials market was valued at USD 1.56 billion in 2024 and is anticipated to reach USD 2.90 billion by 2035, expanding at a CAGR of 5.8% during the forecast period (2024–2035). HIV clinical trials are now tending to become globally more pivotal in establishing treatment paradigms, therapeutic combinations, and preventive strategies as it continues to evolve into the realm of precision medicine. HIV research stands as a testimony to how scientific perseverance and regulatory collaboration can alter the course of an unsolvable disease, a therapeutic area that, unlike most others, has much to show for the advancement of therapy, diagnosis, and prevention approaches. Boosted by vast amounts of R&D spending, bolstered by extensive partnerships between pharmaceutical giants and biotechnology firms, and in research institutes worldwide, the market for HIV clinical trials is now poised to enter a time of transformation.

The two decades have seen a gradual change from monotherapy and standard ART to long-acting injectables and vaccine development. Regimens have become highly individualised over time. This evolution has demanded a steady stream of clinical trials, with newer phases designed not only to test efficacy and safety but also to ensure patient adherence, drug tolerability, and compatibility with comorbid conditions. Clinical trial designs, particularly interventional studies, have increasingly focused on endpoints around the sustainability of viral suppression, reduced side effects, and better quality of life for patients.

From the supply end, sponsors and clinical research organisations have been boosting adaptive trial designs, decentralised methodologies, and patient recruitment via artificial intelligence. Increased agency guidance has also accelerated pathways through the FDA, EMA, and WHO. This has been linked with community engagement and patient advocacy networks that massively endorse recruitment and trial diversity in underrepresented geographic areas. All these are creating a dynamic architecture in which clinical trials for HIV will no longer adhere to traditional methods but will be astoundingly innovative within the larger field of infectious disease research.

Recent Developments in the Industry

Gilead Sciences advances long-acting injectable therapy into Phase III trials.

In April 2024, Gilead announced interim data from a Phase III trial of lenacapavir as a long-acting injectable with positive safety and efficacy outcomes, therefore further strengthening the confidence of commercial value.

ViiV Healthcare initiates global pediatric trial initiative supported by UNICEF.

In June 2024, ViiV Healthcare formed a landmark collaboration with UNICEF and academic centres across Africa to evaluate pediatric formulations of dolutegravir-based therapies. The trial aims to plug the unmet need for children living with HIV.

Johnson & Johnson ups ante for HIV vaccine development with mRNA platform

In September 2023, Johnson & Johnson formed a strategic alliance with Moderna to co-develop mRNA-based vaccines for HIV. First-in-human Phase I studies are already in progress with the goal of using mRNA technology to induce broadly neutralizing antibodies.

AbbVie obtains FDA fast-track designation for a novel HIV candidate

In February 2025, the U.S. FDA granted fast-track designation to AbbVie's novel protease inhibitor, currently in Phase II trials. This fast-track designation demonstrates the regulatory body's acknowledgment of its potential against resistant strains of HIV.

Cipla fosters a partnership with Indian research organizations to widen the generic HIV trial footprint.

In November 2024, Cipla formally entered into a collaboration with the Indian Council of Medical Research (ICMR) to conduct Phase IV observational studies over generic ART regimens; the focus was on strengthening the financial status to make the medicines more affordable and accessible.

Market Dynamics

The HIV clinical development is rapidly responding to a surge in pipeline activity and innovative trial designs.

Clinical trials for HIV are on a surge as long-acting formulations, mRNA-based vaccines, and personalised therapy regimens are developed. Pharmaceutical and biotech companies are ramping up their R&D pipelines, while adaptive and decentralised trial designs have begun to counter some 'old' roadblocks of recruitment and cost.

Intense market confidence across the globe due to regulatory support and accelerated approvals

The FDA and EMA have outlined an adaptive licensing framework and compassionate access schemes to accelerate promising therapies for HIV. In this regulatory eco-system, companies are pushed to bring their innovative products to market even quicker, thus additionally stimulating investment in interventional and expanded access studies.

High trial costs and recruitment challenges continue to impede advances

With challenges still existing, recruitment challenges remain strong in HIV clinical trials, especially in children, and in areas with weak health-care infrastructure. Scale-up remains hampered for small biotechnology firms due to high trial costs, convoluted inclusion criteria, and long timelines for studies.

Digital health solutions, AI integration, and community partnerships create openings.

The ingenious application of AI in patient identification and trial monitoring, along with decentralised trial models, is redefining operational efficiency. Patient advocacy and local health systems are, however, now much more involved in bridging gaps in trial participation. These are three trends that collectively present a great opportunity to fast-track time-to-market for new therapies for HIV.

Attractive Opportunities in the Market

Long-acting therapies surge – Growing demand for injectables driving trials in adherence-focused regimens
Paediatric formulations demand – Global focus on child-specific regimens accelerating paediatric trial investments
mRNA vaccine innovation – Partnerships in vaccine development reshaping prevention-focused HIV trial landscapes
Regulatory fast-track pathways – Agencies enabling accelerated approvals, driving expansion of late-stage trials
Decentralised trial adoption – Hybrid and remote models increasing participation across diverse geographies
Emerging market enrolments – Expanding trial sites in Asia and Africa, enhancing global population representation
Digital recruitment platforms – AI-enabled enrolment strategies reducing recruitment bottlenecks and drop-outs
Expanded access programmes – Compassionate use trials supporting therapy adoption in high-burden regions
Biotech–pharma collaborations – Joint ventures accelerating drug discovery and clinical trial progressions
Generic therapy validation – Post-marketing Phase IV studies strengthening global accessibility of proven treatments

Report Segmentation

By Phase: Phase I, Phase II, Phase III, Phase IV

By Study Design: Interventional Studies, Observational Studies, Expanded Access Studies

By Region: North America (U.S., Canada, Mexico), Europe (UK, Germany, France, Spain, Italy, Spain, Rest of Europe), Asia-Pacific (China, India, Japan, Australia, South Korea, Rest of Asia-Pacific), LAMEA (Brazil, Argentina, UAE, Saudi Arabia (KSA), Africa Rest of Latin America)

Key Market Players

Gilead Sciences, Inc., ViiV Healthcare, Johnson & Johnson, Merck & Co., Inc., AbbVie Inc., Cipla Limited, Theratechnologies Inc., Immunocore Holdings, Frontier Biotechnologies Inc., and Moderna, Inc.

Report Aspects

Base Year: 2024
Historic Years: 2022, 2023, 2024
Forecast Period: 2024-2035
Report Pages: 293

Dominating Segments

Phase III trials uniquely dominate the global HIV clinical trials landscape.

Phase III trials command a larger share of the HIV clinical trials market since they are quintessential in affirming safety, efficacy, and comparative effectiveness of antiretroviral therapies and innovative treatment modalities. These trials are often conducted in diverse patient populations in multiple geographies to allow for regulatory submission and commercialization. The increased investment of pharmaceutical giants in Phase III studies underlines their importance in finalizing treatment regimens designed for large populations.

Interventional studies rule, with their strong role in therapy development.

Interventional studies dominate HIV clinical trials in perspective. These trials provide the most credible evidence on the safety and efficacy of new regimens, vaccines, or their combinations by allocating interventions directly to the participants. Interventional trials are hence developing into adaptive designs integrating digital monitoring to achieve patient-centric endpoints with the objective of improving outcomes commensurate with the demand for precision therapy in HIV. They are the most widely undertaken; therefore, they are the very foundation of HIV clinical research.

Phase II trials stimulate innovation with the exploratory picture of efficacy and safety.

Phase II trials also hold considerable sway by delivering essential information about preliminary efficacy, dose-finding, and side-effect profiles. With the advancement of long-acting and mRNA-based therapies, Phase II studies have the potential to further broaden, particularly concerning the qualification of candidates for advancement to Phase III.

Expanded access studies build momentum as a bridge to critical therapies.

Access expanded studies, gaining greater significance despite small scale, as they render life-saving treatment to patients who, otherwise, have limited options in the interim, until such treatments can be registered, whilst gathering real-world data. Its relevance becomes pronounced in geographies of higher burden and resource limitations, wherein immediate access to therapy assumes utmost importance.

Observational studies complement interventional designs with real-world insights.

Observational studies, in rank second to interventional studies, assess long-term safety, adherence, and quality-of-life indicators, therefore ameliorating their relevance in the context of post-marketing surveillance and the tailoring of strategies for specific demographic groups.

Key Takeaways

Phase III dominance – Largest share driven by pivotal role in global regulatory approvals
Interventional trials lead – Direct therapy testing positions them as the backbone of HIV clinical development
Paediatric trial focus – Rising investments to address treatment gaps among children and adolescents
mRNA vaccines trend – Innovative platforms reshaping HIV prevention trial landscapes worldwide
Expanded access impact – Bridging gaps for high-burden geographies with limited therapy access
AI in recruitment – Digital enrolment systems mitigating traditional trial recruitment challenges
Long-acting injectables rise – Growing trial activity around adherence-friendly treatment options
Collaborative R&D growth – Strategic alliances boosting trial efficiency and innovation capacity
Post-marketing validation – Phase IV studies ensuring therapy safety and efficacy across populations
Global enrolment expansion – Increased trial activity in Asia-Pacific and Africa, boosting representation

Regional Insights

North America fosters innovation with solid infrastructure and a sound regulatory framework.

North America continues to lead the HIV clinical trials market because of strong academic research institutions, high prevalence of HIV patients, and excellent healthcare infrastructure. The expedited delivery of regulatory frameworks, such as the FDA fast-track designation, is a particular advantage for the U.S. in accelerating trials. Zu a large extent, heavy investments by Gilead, Johnson & Johnson, and ViiV Healthcare reinforce North America in the HIV domain.

Europe remains the home of collaborative initiatives in HIV research.

Europe continues to be a key center for HIV clinical trials due to the pan-European consortia, Horizon Europe funding programmes, and strict adherence to EMA regulatory standards. Countries such as Germany, the UK, and France are leading clinical trials on vaccination and long-acting injectable therapies. So far, strong emphasis on inclusivity and patient representation has greatly enhanced Europe’s profile in global HIV research.

Asia-Pacific has the fastest growth in the HIV clinical trial market.

The highest growth in HIV clinical trials has been observed in the Asia-Pacific countries, enhanced by increasing patient populations in China, India, and Thailand, and by the government's approach to enhancing the HIV treatment pipeline. The rapid industrial development of CROs and partnerships with global pharma players have turned the region into a preferred trial destination.

The LAMEA market is growing because of increased trial enrollment in high-prevalence regions

The LAMEA region, mainly Africa and Latin America, is increasingly playing a role in the global landscape of HIV clinical trials. With disproportionate HIV burden, these regions are fundamental for carrying out efficacy trials of new therapies. International funding, WHO's support, and the establishment of strong partnerships with local institutions are all driving forward new decentralized and community-based trial designs to ensure accessibility and representation.

Core Strategic Questions Answered in This Report

Q1: What is the expected growth trajectory of the HIV Clinical Trials Market from 2024 to 2035?

The global HIV clinical trials market is projected to grow from USD 1.56 billion in 2024 to USD 2.90 billion by 2035, registering a CAGR of 5.8%. This growth is driven by an increasing pipeline of innovative therapies, regulatory fast-track approvals, and the expansion of decentralised trial models across emerging regions.

Q2: Which key factors are fuelling the growth of the HIV Clinical Trials Market?

Several key factors are propelling market growth:

Rising investments in long-acting injectables, vaccines, and paediatric therapies
Regulatory support for accelerated approval and compassionate use programmes
Adoption of decentralised and adaptive trial designs
Expansion of CRO activity in Asia-Pacific and Africa
Strengthening collaborations between pharma giants and biotech innovators

Q3: What are the primary challenges hindering the growth of the HIV Clinical Trials Market?

Major challenges include:

High costs associated with large-scale interventional trials
Recruitment barriers in paediatric and underrepresented populations
Stringent trial inclusion criteria limiting enrolment diversity
Uncertain outcomes of vaccine trials despite high investments
Operational complexities in resource-limited geographies

Q4: Which regions currently lead the HIV Clinical Trials Market in terms of market share?

North America currently leads the HIV clinical trials market due to strong infrastructure, robust regulatory frameworks, and high industry investments. Europe closely follows with a leadership role in collaborative HIV vaccine and injectable therapy development.

Q5: What emerging opportunities are anticipated in the HIV Clinical Trials Market?

The market is ripe with new opportunities, including:

Expansion of decentralised and hybrid trial models
Growing reliance on AI and digital platforms for recruitment
Increased trial activity in paediatric formulations and adolescent populations
Emergence of mRNA-based vaccine platforms for prevention
Expanded access studies addressing therapy gaps in high-burden geographies

Key Benefits for Stakeholders

The report offers a quantitative assessment of market segments, emerging trends, projections, and market dynamics for the period 2024 to 2035.
The report presents comprehensive market research, including insights into key growth drivers, challenges, and potential opportunities.
Porter's Five Forces analysis evaluates the influence of buyers and suppliers, helping stakeholders make strategic, profit-driven decisions and strengthen their supplier-buyer relationships.
A detailed examination of market segmentation helps identify existing and emerging opportunities.
Key countries within each region are analysed based on their revenue contributions to the overall market.
The positioning of market players enables effective benchmarking and provides clarity on their current standing within the industry.
The report covers regional and global market trends, major players, key segments, application areas, and strategies for market expansion. Show more