According to Coherent Market Insights, the global HIV Clinical Trials Market size was valued at US$ 1.48 billion in 2024 and is projected to reach US$ 2.19 billion by 2031, registering a CAGR of 5.8% from 2024 to 2031.
The rising prevalence of HIV across the globe is estimated propel the growth of the HIV clinical trials market over the forecast period. According to UNAIDS, around 38 million people were living with HIV worldwide in 2019. Furthermore, the increasing funding for clinical trials related to treatments and vaccine for HIV by government and non-government organizations is also expected to boost the market growth. For instance, in 2020, the U.S. government has allocated around US$ 31.1 billion for HIV/AIDS care, prevention and research through various U.S. government agencies.
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Key Market Trends:
Introduction of novel drugs for HIV treatment: Novel drugs such as Gene therapies and long acting therapies are being introduced which are more efficacious and has lesser side effects. For example, Cabenuva by ViiV Healthcare is the first long acting HIV treatment regimen approved in the U.S. and EU.
Growing clinical trial activities in emerging markets: Emerging markets such as Asia Pacific, Latin America and Africa are witnessing increase in clinical trial activities for HIV undertaken by global pharmaceutical companies owing to easy availability of patients and relatively lower cost of conducting trials.
HIV Clinical Trials Market Report Coverage
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Report Coverage |
Details |
|
Market Revenue in 2024 |
US$ 1.48 billion |
|
Estimated Value by 2031 |
US$ 2.19 billion |
|
Growth Rate |
Poised to grow at a CAGR of 5.8% |
|
Historical Data |
2019–2023 |
|
Forecast Period |
2024–2031 |
|
Forecast Units |
Value (USD Million/Billion) |
|
Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
|
Segments Covered |
Phase, Study Design, Sponsor Type, Indication |
|
Geographies Covered |
North America, Europe, Asia Pacific, and Rest of World |
|
Growth Drivers |
Increasing incidence of HIV infections Rising investments in research and development for HIV treatments |
|
Restraints & Challenges |
High costs associated with conducting clinical trials Limited access to clinical trial participation in low-resource settings |
Market Opportunities
Phase I clinical trials represents the first stage of testing in human subjects which mainly focuses on evaluating the safety and tolerability of a new drug or treatment. In 2024, the phase I clinical trials segment is estimated to account for nearly 25% share of the overall HIV clinical trials market. The growing number of new drug candidates and rising R&D investments by pharmaceutical companies for developing novel and effective treatment options for HIV are some of the major factors expected to drive the demand for phase I clinical trials during the forecast period.
Phase III clinical trials involves large participant groups, typically several hundred to several thousand people, and is intended to confirm the effectiveness of a drug or treatment, monitor side effects, compare it to commonly used treatments, and collect information that will allow the antiretroviral drug or treatment to be used safely. The phase III clinical trials segment is projected to witness the highest CAGR of over 6% during 2024-2031 owing to increasing focus on late stage clinical research for developing and commercializing drugs with high efficacy and safety.
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Key Market Takeaways
The global HIV clinical trials market size was valued at USD 1.48 Bn in 2024 and is anticipated to witness a CAGR of 5.8% during the forecast period 2024-2031. The market growth can be attributed to rising prevalence of HIV infections globally and increasing R&D investments by leading pharmaceutical companies for developing innovative treatment options.
By phase, phase III clinical trials segment is expected to hold a dominant position accounting for over 35% market share owing to growing number of late stage clinical studies for new drug candidates.
Based on study design, interventional studies segment currently dominates the market and is projected to maintain its lead, accumulating a market revenue of USD 1 Bn by 2031 due increased research focusing on evaluating therapeutic effectiveness.
Regionally, North America is anticipated to dominate the global HIV clinical trials market through 2031. This is majorly attributed to rising burden of HIV infections, presence of major industry players, and availability of public and private funding for clinical research activities in the region.
Competitor Insights:
Amgen Inc
Sanofi S.A
GlaxoSmithKline plc
Bristol-Myers Squibb Company
AbbVie Inc
Johnson & Johnson
Merck & Co., Inc
Recent Developments
In June 2023, researchers from Johns Hopkins University announced positive results from a Phase 3 clinical trial evaluating an investigational long-acting injectable two-drug regimen for HIV treatment and prevention. The trial involved over 3,000 participants across sixteen countries who received either the two-drug injection every eight weeks or a similar daily oral three-drug regimen. Preliminary results found the injectable regimen to be just as effective as daily oral pills in maintaining viral suppression. If approved, the long-acting injection could provide an important new option for managing HIV and help address adherence challenges with daily medication.
In July 2023, researchers from the University of Pennsylvania and the Children's Hospital of Philadelphia published results from an ongoing Phase 1 clinical trial investigating the safety and efficacy of a gene therapy approach for HIV. The trial involves using a modified lentiviral vector to deliver functional copies of the CCR5 gene into patients' own hematopoietic stem cells. Early signs indicate the gene-modified cells were able to engraft long-term and expression of CCR5 was detectable up to two years post-transplant. While the trial is not designed to assess efficacy, researchers observed declines in HIV reservoirs in some patients raising hope the approach may lead to remission. The trial continues to enroll more participants to gather additional long-term safety and efficacy data.
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