HIV Clinical Trials Market Size to Surpass USD 2.42 Billion by 2030

According to Report Study, the global HIV clinical trials market was estimated at USD 1.25 billion in 2021 and it is expected to surpass around USD 2.42 billion by 2030, poised to grow at a CAGR of 7.62% from 2022 to 2030

Report Highlights

• Phase I held the largest revenue share of over 30.06% in 2021.
• The Phase II segment is expected to register the second-fastest CAGR of 6.62% over the forecast period.
• The pharmaceutical and biopharmaceutical companies dominated the market and held a revenue share of over 70.36% in 2021. It is also expected to register the fastest CAGR during the forecast period.
• The non-profit organizations’ segment is expected to register the second-highest CAGR of 5.62% during the forecast period.
• The interventional studies segment held the largest revenue share of over 45.17% in 2021 and it is expected to register the second-fastest CAGR during the forecast period.
• The expanded access studies segment is expected to expand at the fastest CAGR of 6.5% over the forecast period.
• North America dominated the market with a revenue share of over 45.03% in 2021 and is expected to exhibit a significant CAGR over the forecast period.
• The Asia Pacific region is anticipated to register the fastest CAGR of 8.76% during the forecast period.

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The main drivers of this market are increasing HIV vaccine trials, increased R&D activities for HIV clinical trials, and rising HIV infection awareness, which leads to a large number of patients enrolling in clinical trials. During the COVID-19 pandemic, there was a halt in the market growth.

This decrease in HIV and AIDS clinical trials is due to stay-at-home orders by the government to prevent COVID-19 that led to canceled and delayed trials. It also includes disruption in patient recruitment, hurdles in the conduction of clinical trials, and rapid study for the development of vaccines and medical products for the prevention of COVID-19 that lead to detrimental effects in HIV clinical trial studies. However, these impacts were significantly reduced by adopting strategic measures taken by the clinical trial conducting organization, regulatory authorities, and government bodies.

According to the WHO, in 2020, there were around 37.7 million people infected with HIV infection. To reduce this number, increasing funding and partnerships by biotechnology and pharmaceutical firms have been observed. Moreover, increasing initiatives are being taken by the government to find treatment and spread awareness regarding this disease. For instance, in October 2021, Samsung BioLogics collaborated with Enzolytics Inc. This partnership aims to manufacture Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapies.

However, a lack of awareness regarding HIV clinical research trials and the availability of treatments for preventing it are factors that are hindering the growth of this market. According to a report by BioMed Central Ltd. in Europe, out of 467 participants, about one-third of them were not aware of the HIV infection. As a result, ignorance and unawareness regarding the disease will prevent admission to an HIV clinical trial.

Scope of The Report

Phase Insights

Phase I held the largest revenue share of over 30.06% in 2021. 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 6.62% 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.

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Sponsor Insights

The pharmaceutical and biopharmaceutical companies dominated the market and held a revenue share of over 70.36% in 2021. 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 5.62% 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.

Study Design Insights

The interventional studies segment held the largest revenue share of over 45.17% in 2021 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 6.5% 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.

Regional Insights

North America dominated the market with a revenue share of over 45.03% in 2021 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 8.76% 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.

Key Players

• 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

Market Segmentation

• By Phase Outlook
  • Phase I
  • Phase II
  • Phase III
  • Phase IV
• By Study Design Outlook
  • Interventional Studies
  • Observational Studies
  • Expanded Access Studies
• By Sponsor Outlook
  • Pharmaceutical & Biopharmaceutical Companies
  • Non Profit Organizations
  • Others
• By Regional Outlook
  • North America

• • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

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