According to Nova One Advisor, the global HIV clinical trials market size was estimated at USD 1.30 billion in 2024 and is expected to hit around USD 2.42 billion by 2034, poised to grow at a CAGR of 6.4% from 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.
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Factors such as increasing incidences of HIV infections, rise in R&D investments for conducting clinical trials by biopharmaceutical companies, drug approvals, increased HIV vaccine trials and the growing awareness about HIV infections among the population which is leading to enrolment of large number of patients in clinical trials eventually contributing towards the growth of market.
The HIV clinical trials market is propelling with the innovation and development of investigative studies outlined for the treatment of HIV infected population. The availability of numerous highly effective treatments such as antiretroviral therapy (ART) and the need for developing a functional cure for the treatment of HIV is fueling the growth of the clinical trials market.
Clinical trials are controlled research studies which are meticulously designed for evaluating the safety, efficacy and potential development of drugs, therapies and study the side effects of new or approved medicines, medical devices, treatments or procedures in humans. HIV clinical trials help researchers to develop innovative or better ways to prevent, detect and treat HIV and AIDS.
Initially the lack of safe and effective therapies spiraled the growth of HIV epidemic. According to the global HIV statistics by UNAIDS, 39.9 million people are living with HIV and about 1.3 million people were newly infected with HIV in 2023. AIDS-related illness caused 0.63 million deaths in 2023.
Moreover, lack of resources to reach the epidemiological targets and to access the treatments are factors declining the market growth. The intervention of COVID-19 led to decrease in clinical trials and disrupted the market causing a delay in the unending search for the HIV cure.
Why are HIV clinical trials and studies important?
HIV research studies are important because for new HIV or AIDS treatments to be approved, they need to first be rigorously tested in clinical trials. These trials examine the required dose of a potential HIV drug for it to produce a response (also known as efficacy), and its side effects to understand the drug's safety profile. Most clinical trials used for approval compare treatments against placebo (or an inactive drug) or other existing treatments. Because of the commitment and support of so many people who have taken part in clinical trials for HIV, society has witnessed significant progress in the fight against the epidemic.
The HIV epidemic initially lacked safe and effective therapies. However, today, numerous highly effective HIV treatments referred to as antiretroviral therapy (ART) are available. ART involves combining multiple antiretroviral (ARV) drugs. These treatments enable individuals living with HIV to suppress the virus to undetectable levels, preventing its transmission. In simpler terms, undetectable means untransmutable, which is often abbreviated as U=U.
HIV Clinical Trials Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 1.39 billion |
|
Revenue forecast in 2034 |
USD 2.42 billion |
|
Growth rate |
CAGR of 6.4% from 2024 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2019 - 2023 |
|
Forecast period |
2024 - 2034 |
|
Quantitative units |
Revenue in USD Million and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Phase, Study Design, Sponsor, Region |
|
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
|
Country scope |
U.S.; Canada; Mexico; UK; Germany; France; Italy; Spain; Sweden; Denmark; Norway; Japan; China; India; Thailand; South Korea; Australia; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
|
Key companies profiled |
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 among others. |
Recent Investments in the HIV Clinical Trials Market
· Gilead Sciences, one of the leading innovators in HIV has developed the PURPOSE clinical trials in partnership with communities affected across the globe. The PURPOSE trials are evaluating the safety & efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV also referred as pre-exposure prophylaxis (PrEP). In June 2024, the results of the Phase I trials showed 100% efficacy of investigational use for HIV prevention in cisgender woman.
· In July 2024, the Elton John AIDS Foundation in collaboration with Gilead Sciences announced the RADIAN 2.0 program which was extended for another five years since it’s launch in 2019. The program aims to provide access to quality HIV prevention, testing and treatment services with addressing structural barriers such as limited access to government service and stigma for refugees from Ukraine.
HIV Clinical Trials Market Trends
· The rising prevalence of HIV, need for finding a functional cure, growth in investments of clinical trials, collaborations between companies, non-profit organizations, government institutions and academia are driving the market expansion.
· The HIV clinical trials focus on prevention and early intervention of HIV, developing a cure by creating new antibody therapies, tailoring personalized medicine plans, using combination drug regimens, investigating elite controllers (a rare group of individuals with an ability to naturally suppress HIV without ART) with the ongoing research to develop a potential cure.
· Development of predictive models by utilizing genomic data and artificial intelligence (AI) for combating HIV drug resistance. Providing optimization strategies for approaching personalized care in HIV treatment with the integration of AI. Applying machine learning and predictive analysis, through which AI algorithms can identify patterns and trends in patient data which may not be noticed by clinicians leading to long term beneficial outcomes for patients.
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Segment Insights
By Phase Insights
Phase I held the largest revenue share of over 30.0% in 2024. This segment is anticipated to flourish during the forecast period. The Phase I clinical trials primarily focuses on evaluation of the drug’s safety, efficacy and toxicity levels at different dose levels and determining the pharmacokinetics and tolerability of the drug on humans. Also the drug is examined for side effects and adverse reactions in case of high dosage levels.
The Phase II segment is expected to register the second-fastest CAGR of 6.4% over the forecast period. The surge in investments for R&D of HIV clinical trials by biopharmaceutical industries and non-industry sponsors alongwith the involvement of government entities and academic researchers is expanding the market. Moreover, the difficulties involved in phase II clinical trials, the internationalization of clinical trials and the integration of AI and machine learning tools for genomic mapping of data and developing optimization strategies providing personalized care are driving market growth.
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. These studies help in assessment of providing adaptable, economical and prophylactic measures to treat HIV infections. They also assist in development of optimization strategies, estimate the impact of treatment on individuals and to determine the strengths and weakness of a trials further minimizing the restrictions at the beginning 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 globalization of clinical trials, increasing innovations for HIV treatment are driving the expanded access segment in the market. Expanded access provides treatment outside of a clinical trial for patients with serious and life-threatening HIV conditions when the results of a trial are not satisfactory or show no developments.
By Sponsor Insights
The pharmaceutical and biopharmaceutical companies dominated the market and held a revenue share of over 70.0% in 2024. with registering the fastest CAGR during the forecast period. The introduction of new treatments and therapies and rising investments in R&D are major contributors of this segment.
The non-profit organizations' segment is expected to register the second-highest CAGR of 5.5% during the forecast period. The growth is attributed to the increased staff assistance, reinvestment of the revenue generated for new drug discovery for HIV treatment, development of different ways to conduct clinical trials and improved service.
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. The market growth is boosted due to the multitude of HIV clinical trials conducted in the region and the increased awareness, support from government institutions and the rising investments in R&D by the various industries and non-profit organizations.
· For instance, pharmaceutical companies like Gilead Sciences, Janssen Pharmaceuticals (Johnson & Johnson) and ViiV Healthcare (a joint venture of GSK, Pfizer and Shionogi) are the principle investors and contributors for HIV clinical trials in North America.
· Furthermore, the substantial contributions of National Institutes of Health (NIH) through the funding research endeavors from National Institute of Allergy and Infectious Diseases (NIAID) to develop a functional cure for HIV.
The Asia Pacific region is anticipated to register the fastest CAGR of 8.7% during the forecast period. The aid for HIV received from the Global Fund, evolving clinical research infrastructure, the accessibility of skilled medical practitioners and a strong hospital network are the factors promoting the growth of the Asia Pacific market. The availability of large and diverse pools of patients infected with HIV in these countries is supporting the market growth.
Related Report
Pediatric Clinical Trials Market- The pediatric clinical trials market size was exhibited at USD 16.50 billion in 2023 and is projected to hit around USD 27.65 billion by 2033, growing at a CAGR of 5.3% during the forecast period 2024 to 2033.
Europe Clinical Trials Market- The Europe clinical trials market size was exhibited at USD 22.25 billion in 2024 and is projected to hit around USD 43.00 billion by 2034, growing at a CAGR of 6.81% during the forecast period 2024 to 2034.
Artificial Intelligence (AI) in Clinical Trials Market- The global AI in clinical trials market size was valued at USD 1.58 billion in 2023 and is anticipated to reach around USD 20.16 billion by 2033, growing at a CAGR of 29% from 2024 to 2033.
U.S. Clinical Trials Market- The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is projected to surpass around USD 41.57 billion by 2033, registering a CAGR of 4.88% over the forecast period of 2024 to 2033.
Clinical Trials Support Services Market- The global clinical trials support services market size was exhibited at USD 21.80 billion in 2023 and is projected to hit around USD 45.73 billion by 2033, growing at a CAGR of 7.69% during the forecast period 2024 to 2033.
Major Companies and Their Contributions to the Market
From preclinical and early-stage clinical trials to developing a functional cure, a large number of industries from the pharmaceutical and biotechnology field, non-profits organizations, government entities, researchers are involved in the HIV clinical trials market with the ultimatum of ending the HIV epidemic. The rising investments and technological advancements in research and development of meticulously designed trials, collaborations, approvals and phase launches are the major business strategies used by the market players to reach the global market.
HIV Clinical Trials Market Top Companies
· PPD Inc.
· Parexel International Corporation
· ICON plc
· WuXi AppTec
· Janssen Global Services, LLC
· Gilead Sciences, Inc.
· Bionor Holding AS
· Charles River Laboratories
· GSK plc.
· SGS SA
HIV Clinical Trials Market Recent Developments
· On 11 November 2024, the global specialist HIV company ViiV Healthcare majorly owned by GSK announced the 48-weeks findings of the DOLCE study (NCT04880395), showing that the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) accomplished similar results in comparison to a 3-drug regimen for viral suppression of advanced HIV in a population of adults
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)
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