Indian Clinical Trials Market (By Phase: Phase I, Phase II, Phase III, Phase IV; By Study Design: Interventional Trials, Observational Trials; By Indication) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The Indian clinical trials market was valued at USD 2.25 billion in 2023 and it is predicted to surpass around USD 5.01 billion by 2033 with a CAGR of 8.34% from 2024 to 2033. The Indian clinical trials market stands as a dynamic and rapidly growing sector within the global landscape of medical research and development. India has emerged as a key player, offering a blend of diverse factors that make it an attractive destination for conducting clinical trials.

Key Pointers

• By Phase, the phase III segment led the market with the largest revenue share of 54% in 2023.
• By Phase, the phase I segment is anticipated to grow at the fastest CAGR of 10.05% over the forecast period.
• By Study Design, the interventional trials segment contributed the largest market share of 41% in 2023.
• By Study Design, the observational trials segment is expected to expand at the highest CAGR of 8.53% from 2024 to 2033.
• By Indication, the oncology segment generated the maximum market share of 25% in 2023.

Indian Clinical Trials Market Growth

The Indian clinical trials market is propelled by a confluence of factors contributing to its robust growth. A pivotal driver lies in the expanding pharmaceutical and biotechnology sectors, characterized by continuous innovation and a supportive regulatory environment. The vast and genetically diverse population of India serves as a valuable asset, offering researchers an extensive participant pool essential for comprehensive clinical trials. The market's competitiveness is underscored by a cost-effective structure, making India an economically favorable destination for both domestic and international research sponsors. Furthermore, the nation's wealth of skilled medical professionals ensures the successful execution of trials, upholding the highest standards of medical care. Strengthening regulatory frameworks, global collaborations, and a commitment to ethical research practices further bolster the market's growth trajectory. As India continues to address challenges and enhance its clinical research ecosystem, it stands poised as a key player in shaping the future of global healthcare innovation.

Report Scope of the Indian Clinical Trials Market

Indian Clinical Trials Market Dynamics

Drivers

• Pharmaceutical and Biotechnology Advancements: The continuous growth and innovation within India's pharmaceutical and biotechnology industries serve as a primary driver, attracting clinical trials and research activities.
• Genetically Diverse Population: India's large and genetically diverse population provides a substantial and varied participant pool, enabling researchers to generate comprehensive and globally relevant data.

Restraints

• Infrastructure Gaps: Despite advancements, infrastructure gaps in certain regions of India, particularly rural areas, can hinder the seamless execution of clinical trials and limit access to a broader participant pool.
• Economic and Regulatory Uncertainties: Fluctuations in the economic and regulatory landscape can create uncertainties for research sponsors, influencing decision-making and investment plans in the Indian Clinical Trials Market.

Opportunities

• Expanding Disease Demographics: The diverse disease demographics in India present an opportunity for researchers to conduct trials across a wide spectrum of diseases, addressing both prevalent and emerging healthcare challenges.
• Accelerated Regulatory Approvals: Streamlined regulatory processes and accelerated approvals for clinical trials can attract more research sponsors, fostering a conducive environment for timely and efficient research.

Phase Insights

Based on phase, the market is segmented into phases I, II, III, and IV. The phase III segment dominated the market with the largest revenue share of 54% in 2023, owing to the cost-intensive nature of this segment. Phase III trials require a large patient population, which is one of the prime reasons for the high cost of this trial. Moreover, the studies in the phase last for a longer time, compared to phase I and II, which further improves the trial's cost and the market's segment share.

The phase I segment is expected to grow at the fastest CAGR of 10.05% over the forecast period owing to significant R&D investments by global and local pharmaceutical and biotechnological firms. The country's demand for new treatments and biologics further contributes to the segment's growth.

Study Design Insights

The interventional trials segment held the largest revenue share of 41% in 2023 due to the large number of trials adopting this study design. This type of study design includes large randomized clinical trials and is considered one of the best study designs for detecting small to moderate effects of drugs. These studies also provide the best means of minimizing the confounding effect, thus improving their adoption compared to other clinical study designs.

The observational trials segment is expected to grow at the fastest CAGR of 8.53% during the forecast period due to its ease of conduct and level of control, making it a good option for countries like India, where the infrastructure for clinical trials may not be as well-developed. The increasing prevalence of chronic diseases, regulatory support from the government, and availability of the largest datasets for observational studies are driving the segment's growth.

The expanded access trials segment is anticipated to grow at a lucrative CAGR during the forecast period. Factors such as the growing incidence of serious diseases, demand for new innovative treatment options, and the country's high burden of chronic diseases are anticipated to fuel the segment’s growth. Moreover, owing to the COVID-19 pandemic, an expanded access study with convalescent plasma was used in India to treat patients with COVID-19. Such actions are further contributing to the segment growth.

Indication Insights

The oncology segment dominated the market with the largest revenue share of 25% in 2023 and is expected to grow at the fastest CAGR of 10.5% over the forecast period, owing to the increasing prevalence of cancer in the country and the growing demand for advanced medical devices and cancer treatments. Cancer is considered one of the major causes of death globally and is expected to affect approximately 2 million people in India by 2040, according to the Cancer Tomorrow estimates. Most treatments for cancer are ineffective in the last stages of the disease, which is a key reason for the growing demand for new treatment options for cancer in the country.

The various measures and launches are driving the oncology market growth. For instance, in November 2023, the International Association of Oncology (AIO) in partnership with BioLEAGUES announced the 5th Indo Oncology Summit, taking place in Bhubaneshwar, India, on the subject “Cancer Care: Era of Precision.” In January 2023, the Indian government announced the launch of its first made-in-India CERVAVAC vaccine, a “Quadrivalent Human Papillomavirus” (qHPV) vaccine that helps prevent cervical cancer. In March 2023, Dr. AV Cancer Institute of Personalized Cancer Therapy and Research, Gurugram, launched India’s first Precision Oncology treatment center to make precision oncology treatment affordable and easily accessible nationwide.

CNS conditions held a significant revenue share in 2022. Many people in India are affected by neurological disorders like stroke, epilepsy, tremors, and Parkinson’s disease; the trend is similar globally. This is expected to impact R&D investments for clinical trials in the country positively.

Indian Clinical Trials Market Key Companies

• IQVIA HOLDINGS INC.
• PAREXEL International Corporation
• Pharmaceutical Product Development (PPD) LLC
• Charles River Laboratory
• ICON PLC
• PRA Health Inc.
• Chiltern International LTD.
• Syneos Health Inc.
• SGS SA
• Syngene International Limited
• Aurigene Discovery Technologies Limited
• Aragen Life Sciences
• Abiogenesis Clinpharm Pvt Ltd
• Accelsiors
• Accutest Global.
• Clario
• Cliantha Research
• Cliniminds
• CliniRx
• JSS Medical Research

Indian Clinical Trials Market Report Segmentations:

By Phase

• Phase I
• Phase II
• Phase III
• Phase IV

By Study Design

• Interventional Trials
• Observational Trials
• Expanded Access Trials

By Indication

• Autoimmune/Inflammation
  • Rheumatoid Arthritis
  • Multiple Sclerosis
  • Osteoarthritis
  • Irritable Bowel Syndrome (IBS)
  • Others
• Pain Management
  • Chronic Pain
  • Acute Pain
• Oncology
  • Blood Cancer
  • Solid Tumors
  • Other
• CNS Condition
  • Epilepsy
  • Parkinson's Disease (PD)
  • Huntington's Disease
  • Stroke
  • Traumatic Brain Injury (TBI)
  • Amyotrophic Lateral Sclerosis (ALS)
  • Muscle Regeneration
  • Others
• Diabetes
• Obesity
• Cardiovascular
• Others