Indian Clinical Trials Market Analysis Report By Indication (Oncology, Autoimmune), By Phase (I/II/III/IV), By Study Design (Interventional, Observational), Vendor Landscape, And Segment Forecasts, 2018 - 2025

Report Overview

The Indian clinical trials market size was estimated at USD 1.6 billion in 2017. It is anticipated to expand at a CAGR of 8.7% over the forecast period. Globalization of clinical trials and growing disease variation and prevalence are anticipated to be some of the primary market drivers. Moreover, adoption of new technology in clinical research and rise in R&D to promote outsourcing are estimated to drive the growth in the near future.

India accounts for nearly 16.0% of the population worldwide and nearly 20% of the disease burden across the globe, yet less than around 1.4% of total global clinical trials are conducted in the country. This can be attributed to lack of proper regulations. However, the recent amendments in regulations by the Central Drugs Standard Control Organization (CDSCO), such as reduced approval period and online registry, are anticipated to drive the market growth.

Digitalization of clinical trials is estimated to further propel the growth. Digitalization has enabled streamlining of several trial process such as data capture, regulatory compliance, logistics and supplies managements, and others. Furthermore, with the introduction of digital therapeutics; real-time data acquisition related to safety and toxicity is becoming increasingly easy thereby, promoting timely rectification in trial design and facilitating the market growth.

Owing to several financial and geographic reasons, a substantial percentage of Indians do not have access to advanced medicines and treatment, thus presenting a large pool of native patients for clinical trials. According to a report by the Institute for Studies in Industrial Development, India ranked second, following China, in terms of patient population for clinical trials. Furthermore, the cost of clinical trials in India is nearly half of that incurred in the U.S. and Europe. Thus, the cost efficiency and large treatment-naïve patient pool offered by the county are anticipated to drive the market growth.

Phase Insights

On the basis of phase, Indian clinical trials market has been categorized into phase I, phase II, phase III, and phase IV. Phase I is anticipated to witness a rapid growth owing to the increasing R&D investments by global and local pharmaceutical and biotechnological firms.

Phase III led the market in 2017 accounting for more than 50.0% of the revenue share. This can be attributed to the cost intensive nature of this segment. Sun Pharma is currently conducting two phase III trials for evaluating the efficacy and safety of tildrakizumab, for the treatment of psoriasis. This is funded by Sun pharma whereas completion of phase III process will be the responsibility of Merck. Such collaborative initiatives are anticipated to fuel growth in the forthcoming years.

Study Design Insights

Based on study design, the market is segmented into interventional, observational, and expanded access trials. Interventional segment held a substantial market share in 2017 due to the large number of trials adopting this study design.

Expanded access study design is anticipated to witness remunerative growth during the forecast period. Factors such as increasing innovation, evolution of treatment, greater disease variation are projected to drive the growth. Increasing pressure from social media on both regulatory authorities and drug companies is anticipated to further fuel the growth.

Indication Insights

On the basis of indication, the market is segmented into autoimmune/inflammation, pain management, oncology, CNS condition, cardiovascular, diabetes, obesity. Autoimmune/inflammation is sub-segmented into rheumatoid arthritis, osteoarthritis, multiple sclerosis, Irritable Bowel Syndrome (IBS), and others.

Oncology is further segmented into blood cancer, solid tumors, and others. Pain management is further divided into acute and chronic pain whereas the CNS conditions segment is sub-segmented into stroke, amyotrophic lateral Sclerosis, Parkinson's disease, muscle regeneration, Huntington's disease, traumatic brain injury, epilepsy, and others.

Oncology held the dominant market share in 2017 and is anticipated to witness the fastest CAGR during the forecast period. This can be attributed to high prevalence of the disease and increasing demand for quality and affordable therapies.

Indian Clinical Trials Market Share Insights

Some of the key companies present in this market are IQVIA, Inc.; ICON PLC; PRA Health Sciences; GVK Biosciences; PAREXEL International Corporation; Syneos Health; Charles River Laboratories; and Syngene International Ltd. Various strategies such as mergers, acquisitions, and collaborations are adopted by them to maintain their market share.

For instance, in June 2017, PAREXEL International Corporation announced collaboration with Sanofi, to advance the use of wearable devices in clinical data collection. The two companies are expected to leverage each other’s scientific, logistics, regulatory and technical expertise as well as expand their global footprint, as a part of this transaction.

Indian Clinical Trials Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the Indian clinical trials market report on the basis of phase, study design, and indication:

• Phase Outlook (Revenue, USD Million, 2014 - 2025)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Study Design Outlook (Revenue, USD Million, 2014 - 2025)

  • Interventional

  • Observational

  • Expanded Access

• Indication Outlook (Revenue, USD Million, 2014 - 2025)

  • Autoimmune/Inflammation

  • Pain Management

  • Oncology

  • CNS Condition

  • Diabetes

  • Obesity

  • Cardiovascular

  • Others