HIV Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Study Design (Interventional, Expanded Access), By Sponsor, By Region,- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2034

HIV Clinical Trials Market Size and Research

The HIV clinical trials market size was exhibited at USD 1.30 billion in 2024 and is projected to hit around USD 2.42 billion by 2034, growing at a CAGR of 6.4% during the forecast period 2024 to 2034.

HIV Clinical Trials Market Key Takeaways:

• Phase I held the largest revenue share of over 30.0% in 2024.
• The Phase II segment is expected to register the second-fastest CAGR of 6.4% over the forecast period.
• The pharmaceutical and biopharmaceutical companies dominated the market and held a revenue share of over 70.0% in 2024.
• The non-profit organizations' segment is expected to register the second-highest CAGR of 5.5% during the forecast period.
• The interventional studies segment held the largest revenue share of over 46.0% in 2024.
• The expanded access studies segment is expected to expand at the fastest CAGR of 6.4% over the forecast period.
• North America dominated the market with a revenue share of over 45.0% in 2024 and is expected to exhibit a significant CAGR over the forecast period.
• The Asia Pacific region is anticipated to register the fastest CAGR of 8.7% during the forecast period.

Report Scope of HIV Clinical Trials Market

The market growth is due to a rise in R&D investment in HIV clinical trials by pharmaceutical and biotechnology companies, increasing drug approvals for HIV, and increasing incidence of HIV in the population. This growth was halted due to the COVID-19 pandemic as the sudden surge in the pandemic resulted in the slow enrollment of trials and a sudden shift in the COVID-19 drug trials.

The government announced stay-at-home orders due to the COVID-19 pandemic that caused disruption and restricted HIV testing and diagnosis, which led to a steep slowdown in referral and treatment for HIV and AIDS. However, from the start of 2024, the increasing prevalence of HIV among people and their inability to be treated due to staying at home will create a large patient pool and lead to the development of new treatment methods to prevent HIV infection. This will lead to the growth of the market.

A large number of non-profit organizations and pharmaceutical and biotechnology companies are investing in HIV clinical research industry for its treatment therapies. For instance, in April 2024, non-profit organizations: IAVI and Scripps Research announced that they had completed a phase I clinical trial for a novel vaccine against HIV. In addition, Excision has announced that the FDA has approved its Investigational New Drug (IND) as a treatment to cure chronic HIV, which is called EBT-101.

Numerous drug improvements have occurred in recent years as a result of the increased expenditure on HIV drug research and development. For instance, in December 2024, ViiV Healthcare announced the use of a Food and Drug Administration (FDA) accepted treatment to prevent HIV-1 infection that is acquired sexually, namely Apretude. It is a long-acting injectable pre-exposure prophylaxis (PrEP) for the treatment of the disease.

HIV Clinical Trials Market By Phase Insights

Phase I held the largest revenue share of over 30.0% in 2024. This segment is also anticipated to register the fastest CAGR during the forecast period. Phase I studies assess the safety of HIV drugs and involve the evaluation of tolerability and pharmacokinetics of molecules. It determines the effect of HIV drugs on humans including the way it is absorbed, metabolized, and excreted. It also examines the side effects of the drug in case of the increased dosage level. The stage includes 20 to 100 healthy volunteers or people with the disease.

The Phase II segment is expected to register the second-fastest CAGR of 6.4% over the forecast period. This is due to the increasing investments in the R&D of HIV clinical trials by industry and non-industry sponsors. The growing number of industry-sponsored and non-industry-sponsored clinical trials in phase II, the complexity associated with phase II clinical trials, and the globalization of clinical trials are factors expected to drive the market.

HIV Clinical Trials Market By Sponsor Insights

The pharmaceutical and biopharmaceutical companies dominated the market and held a revenue share of over 70.0% in 2024. It is also expected to register the fastest CAGR during the forecast period. This can be largely attributed to the rising R&D investments and the introduction of new drugs for HIV prevention, which have increased in the past two decades. Based on sponsors, this segment is segmented into pharmaceutical and biopharmaceutical companies, non-profit organizations, and others. Others include government institutes, academics, and research centers.

The non-profit organizations' segment is expected to register the second-highest CAGR of 5.5% during the forecast period. This growth is due to the increasing staff, reinvesting the revenue generated for new drug discovery for HIV treatment, and improving service. They are also searching for new ways to conduct trials for treating HIV infection.

HIV Clinical Trials Market By Study Design Insights

The interventional studies segment held the largest revenue share of over 46.0% in 2024 and it is expected to register the second-fastest CAGR during the forecast period. Intervention studies help in determining cost-effective, scalable, and preventive measures to treat HIV infection. It is also used to determine the weaknesses and strengths of a trial, estimate the impact of the treatment on individuals, and minimize limitations at the initial stage.

Based on study design, the market is segmented into interventional studies, observational studies, and expanded access studies. The expanded access studies segment is expected to expand at the fastest CAGR of 6.4% over the forecast period. The main driver is increasing innovation for HIV treatment. Expanded access is expected to be a good approach for patients with serious, life-threatening HIV conditions. In this, the patient is allowed to have treatment outside of a clinical trial when the result of the trial is not satisfactory or no improvement is shown.

HIV Clinical Trials Market By Regional Insights

North America dominated the market with a revenue share of over 45.0% in 2024 and is expected to exhibit a significant CAGR over the forecast period. This market is likely to grow due to the high number of HIV clinical trials being conducted in the region. Major R&D investments and government support for HIV clinical trials are further promoting the market growth.

The Asia Pacific region is anticipated to register the fastest CAGR of 8.7% during the forecast period. Developed clinical research infrastructure, a strong hospital network, and the availability of skilled medical practitioners for HIV prevention are factors supporting the growth of the Asia Pacific market. In addition, the large and diverse patient pools that are infected with HIV in these countries lead to market growth.

Some of the prominent players in the HIV clinical trials market include:

• PPD Inc.
• IQVIA Inc.
• Parexel International Corporation
• ICON plc
• Syneos Health
• WuXi AppTec 
• Janssen Global Services, LLC
• Gilead Sciences, Inc.
• Bionor Holding AS
• Charles River Laboratories
• GSK plc.
• SGS SA

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2024 to 2034. For this study, Nova one advisor, Inc. has segmented the HIV clinical trials market

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 Regional

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)