The global HIV clinical trials market size was estimated at USD 1.56 billion in 2024 and is projected to reach USD 2.11 billion by 2030, growing at a compound annual growth rate (CAGR) of 5.8% from 2025 to 2030. The market holds substantial growth potential, largely driven by an increasing number of drug approvals for HIV treatment, higher investment in research and development by pharmaceutical and biotechnology companies, and the steadily growing incidence of HIV infections globally. These factors are collectively pushing forward the need for more efficient, accessible, and targeted treatment options.

In addition to facilitating drug approvals, clinical trials are also vital for advancing innovative therapies, including precision medicine and novel HIV vaccines. These initiatives are not only improving clinical outcomes for patients but are also helping to lower global infection rates. The HIV clinical trial ecosystem is undergoing continuous transformation as stakeholders strive to address multiple unmet needs, such as treatment adherence and drug resistance. The growing interest in long-acting injectables, potential curative therapies, and inclusive trials that serve diverse global populations further amplifies market momentum.

A key focus area is improving access to treatment and ensuring broader participation in trials from underrepresented regions and communities. This strategic expansion aligns with global health goals aimed at ending the HIV epidemic. Increasing government support and favorable regulatory frameworks in both developed and emerging countries have also strengthened the clinical trial infrastructure, contributing to the market’s upward trajectory. These advancements are creating a favorable environment for sponsors and researchers to accelerate drug development while ensuring safety and efficacy.

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Key Market Trends & Insights

1) By trial phase, the phase III segment led the HIV clinical trials market in 2024, accounting for a revenue share of 30.0%. Phase III trials are critical in evaluating the safety and efficacy of drugs at a larger scale before regulatory approval. These trials often involve diverse patient populations and aim to establish definitive evidence on therapeutic effectiveness, ultimately supporting marketing authorization.

2) The interventional studies segment was the dominant study design type in 2024, capturing a revenue share of 69.8%. This segment's growth can be attributed to its ability to provide actionable outcomes, cost-effectiveness, and its rising application in preventive HIV treatments. Interventional trials help identify benefits and limitations of treatment strategies early on and play a key role in shaping clinical guidelines and public health policies.

3) In terms of sponsor type, pharmaceutical and biopharmaceutical companies led the market in 2024. This dominance can be traced to increased R&D investments, rising demand for advanced and effective treatment options, and the introduction of new drugs targeting both prevention and management of HIV. These companies are also exploring partnerships and licensing deals to accelerate clinical development pipelines.