HIV CLINICAL TRIALS MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

HIV Clinical Trials Market Size and Trends

Global HIV clinical trials market is estimated to be valued at USD 1.48 Bn in 2024 and is expected to reach USD 2.19 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 5.7% from 2024 to 2031.

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The market can witness positive growth during the forecast period due to factors such as rising number of people suffering from HIV/AIDS globally, increasing R&D investment in drug development by key pharmaceutical players, and growing government support for conducting clinical trials. Moreover, increasing demand for effective and highly innovative drugs for treatment of HIV/AIDS can also drive the market growth in the near future. However, high costs associated with clinical trial material and lengthy U.S. FDA approval process could hamper the market growth during the forecast period.

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Insights, By Phase- Clinical advancement drives phase I contributions

In terms of phase, phase I segment is estimated to contribute the highest share of the HIV clinical trials market with 32.1% in 2024, owing to its critical role in testing experimental treatments. Phase I trials lay the groundwork for subsequent research by evaluating a new drug's safety, determining a safe dosage range, and identifying possible side effects. Given the exploratory nature of Phase I, a high level of uncertainty exists around both clinical efficacy and commercial viability.

Insights, By Study Design - Interventional research shapes Interventional dominance

In terms of study design, the interventional studies segment is estimated to contribute the highest market share of 43.1% in 2024, owing to their ability to directly assess clinical effectiveness. Interventional trials test the impact of an experimental treatment compared to standard care or placebo in a prospective, controlled manner. This provides robust evidence for regulatory approval and physician adoption. However, their expansive scope requires sizable resources. Interventional studies take advantage of existing subject pools and real-world settings to generate complementary insights with lower costs.

Insights, By Sponsor Type - Academic research drives government involvement

In terms of sponsor type, the pharmaceutical & biotechnology companies segment dominates the global HIV clinical trials market with 41.3% in 2024 due to their significant investment in the development of HIV treatments, including antiretroviral therapies and vaccines. These companies have the largest financial resources, enabling them to conduct large-scale trials. Their focus on innovation and market demand for effective HIV solutions further drives their leadership.

Regional Insights

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Dominating Region- North America

North America dominates the HIV clinical trials market with an estimated market share of 39.2% in 2024, due to presence of major pharmaceutical companies like AbbVie Inc. and Johnson & Johnson and contract research organizations (CROs) in the region. The region also has a supportive regulatory environment and high healthcare expenditure which promotes clinical research activities.

Fastest-Growing Region- Asia Pacific

Asia Pacific region exhibits the fastest growth and is emerging as a key market for HIV clinical trials. This can be attributed to rising investment by international players to leverage low-cost opportunities and growing patient population in countries like China and India. Regional governments are also encouraging clinical research to improve medical capabilities.

HIV Clinical Trials Market Outlook for Key Countries

U.S.- Leading Hub for HIV Clinical Trials and Innovation

The U.S. HIV clinical trials market leads due to top sponsors and trial sites. For instance, in September 2023, a Phase 1 trial for the novel HIV vaccine VIR-1388 began in the U.S. and South Africa. Funded by the National Institute of Allergy and Infectious Diseases (NIAID) and sponsored by Vir Biotechnology, the trial aims to test the safety and immune response of the vaccine, enrolling 95 HIV-negative participants.

Canada- Growing Healthcare Infrastructure Drives HIV Clinical Trials

The HIV clinical trials market in Canada is driven by increasing number of clinical trials and sites, along with the country’s robust healthcare infrastructure for conducting these trials. Furthermore, ongoing research and development, product innovation, and approvals are anticipated to boost the market growth. For instance, in April 2022, according to the government of Canada, approximately 77% of biopharmaceutical products are in the early stages of research and development (from research to phase I/II) In Canada, while 23% are in the mid- to late-stage of development (late-stage clinical trials). These government initiatives are expected to drive market expansion.

India- Cost-Effective and Diverse Patient Pool Boosting HIV Clinical Trials

The HIV clinical trials market in India is fueled by cost-effectiveness, a diverse patient population that makes it an appealing location for clinical trials, and growing research activities by organizations. For instance, in October 2023, Roche Pharma launched the Clinical Trial Excellence Project in India. The project aims to enhance the capabilities of public health institutions to conduct clinical trials and drug research. It will transform government hospitals into centers of excellence for clinical research, further, boosting the market.

Market Concentration and Competitive Landscape

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Top Strategies Followed by Global HIV Clinical Trials Market Players

• Established Players- Companies are focusing on novel therapies to enhance patient outcomes. For instance, Gilead Sciences spends over 20% of its annual revenues on R&D activities focused on developing new drug formulations and testing trials. Its recent pipeline includes long-acting therapies that only need to be administered monthly.
• Mid-Level Players- Mid-sized companies in the HIV clinical trials market focus on delivering high-quality and affordable treatment solutions. For example, Merck Sharp & Dohme invests in robust manufacturing infrastructure in low-cost regions. This helps reduce production expenses and enables them to price drugs competitively. Boehringer Ingelheim runs clinical trials in developing nations where patient recruitment and site costs are lower.
• Small-Scale Players- New entrants often target specific segments left untapped by larger firms. Anthropic focuses only on pediatric It engineers AI-powered chatbots educate children about self-management of the condition. Altoida Biosciences concentrates on developing user-friendly rapid testing kits ideal for point-of-care diagnosis in remote areas.

Emerging Startups in the Global HIV Clinical Trials Market

Innovative Technologies- Recent startups are introducing innovative technologies, such as Dexcom, which is developing implantable continuous glucose monitors integrated with AI. These sensors help optimize drug dosages in patients by providing real-time blood monitoring to prevent virus mutations. Additionally, SynSense is creating wireless smart patches that non-invasively track vital signs, monitor medication adherence, and alert healthcare providers to potential health deteriorations.

Sustainable Solutions- Startups like TerraCycle focus on sustainability by converting clinical waste like used syringes, vials, and others into reusable plastics using unique recycling technologies. Its solutions help reduce environmental pollution from medical kits. Poett manufactures medicines using plant-based packaging that can decompose without harming the ecosystem.

HIV Clinical Trials Industry News

• In October 2024, Gilead Sciences, a biopharmaceutical company, and Merck, a global healthcare company, announced Phase 2 data on October 19, 2024, showing that a once-weekly oral combination of islatravir and lenacapavir maintained viral suppression in HIV-1 patients for 48 weeks. The investigational regimen achieved a 94.2% viral suppression rate, with no participants experiencing a viral load above 50 copies/mL. This novel combination, advancing to Phase 3, could become the first weekly oral HIV treatment, offering a new option in personalized HIV care.
• In July 2024, Gilead Sciences, a biopharmaceutical company, launched two clinical trials to assess the effectiveness of lenacapavir, a long-acting HIV prevention injection, in underrepresented populations, including cisgender women and people who inject drugs. The trials, part of the HIV Prevention Trials Network (HPTN), aim to evaluate the safety, acceptability, and pharmacokinetics of the drug, which is already FDA-approved for HIV treatment. The studies will provide crucial data on how these populations respond to the treatment, helping improve HIV prevention strategies.
• In July 2024, ViiV Healthcare, a global leader in HIV treatment, announced positive results from the PASO DOBLE study, the largest Phase IV clinical trial comparing the 2-drug regimen Dovato (dolutegravir/lamivudine) with the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for maintenance therapy in HIV-1 patients

Key Takeaways from Analyst

• Global HIV clinical trials market growth is driven by increasing prevalence of HIV/AIDS worldwide. The market growth is driven by rising investments from governments and non-profit organizations to develop improved treatment options for HIV patients. Growing demand for newer drug formulations such as long-acting antiretrovirals which require less frequent dosing can support market expansion.
• Stringent regulations for drug approval and long approval timelines pose challenges for growth of HIV clinical trials. Conducting international multi-center trials also involve substantial investments pertaining to participant recruitment and retention. 
• North America dominates the market due to presence of majority of global pharmaceutical vendors and clinical research organizations. However, Asia Pacific is likely to gain significant market share, owing to large patient pools and lower costs for clinical trials. Improving healthcare infrastructure and regulatory framework in many Asian countries attracts several pharmaceutical companies to conduct late phase trials.
• Ongoing research for HIV cure and vaccine presents tremendous opportunities for market players. Partnerships between drug makers, research institutes and non-profit organizations should help in faster clinical development. Furthermore, growing emergence of biosimilars will augment the clinical trial testing needs in the future.

Market Report Scope

Market Dynamics

Market Driver- Increasing incidence of HIV infections

The prevalence of HIV infections has increased in recent years. According to WHO data published in July 2024, by 2023, approximately 39.9 million people, including 1.4 million children, were living with HIV. In 2023, there were 1.3 million new HIV infections, reflecting a 39% reduction since 2010. HIV-related deaths also decreased by 51% since 2010, with 630,000 deaths reported in 2023. By 2023, 86% of people living with HIV were aware of their status, leaving 3.4 million individuals still to be tested.

Market Challenge- High costs associated with conducting clinical trials

Conducting clinical trials for HIV therapies and vaccines is an extremely costly process. Various phases of clinical trials require recruiting thousands of human participants and carrying out complex research studies over long periods of time. Moreover, standard therapies and diagnostics need to undergo rigorous testing to prove their safety and efficacy as per regulatory guidelines. This involves setting up proper clinical infrastructure at trial sites, hiring and training clinical research personnel, developing investigational drugs and products, monitoring trials and collecting and analyzing vast amounts of clinical data.

Market Opportunity- Growing demand for innovative therapies and vaccines

There has been growing global demand for more effective, safer and affordable innovative therapies and vaccines for the treatment and prevention of HIV/AIDS. While current antiretroviral treatments have increased lifespan of HIV patients, these regimens still face issues of drug resistance, toxicities, requirement of lifelong adherence and socioeconomic inaccessibility in developing countries. No vaccine has been proven to completely prevent HIV infection even after decades of research.

Key Stakeholders of Market

What does growth in the global HIV clinical trials market mean for different stakeholders?

Global HIV clinical trials market has multiple players with varied designations and offers multiple opportunities based on their scope of operations.

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Market Segmentation

•  Phase Insights (Revenue, USD Bn, 2019 - 2031)
• • Phase I
  • Phase II
  • Phase III
  • Phase IV
  • Preclinical
•  Study Design Insights (Revenue, USD Bn, 2019 - 2031)
• • Interventional Studies
  • Observational Studies
  • Expanded Access Studies
•  Sponsor Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Pharmaceutical & Biotechnology Companies
  • Academic Research Institutes
  • Government & Private Research Organizations
  • Contract Research Organizations (CROs)
• Indication Insights (Revenue, USD Bn, 2019 - 2031)
• • HIV-1
  • HIV-2
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
• • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Gilead Sciences, Inc.
  • Johnson & Johnson
  • Merck & Co., Inc.
  • AbbVie Inc.
  • Bristol-Myers Squibb Company
  • GlaxoSmithKline plc
  • Pfizer Inc.
  • Roche Holding AG
  • Sanofi S.A.
  • Novartis AG
  • Astellas Pharma Inc.
  • Boehringer Ingelheim GmbH
  • Vertex Pharmaceuticals Incorporated
  • Amgen Inc.
  • Takeda Pharmaceutical Company Limited