Adoption of novel technologies like virtual and decentralized trials, artificial intelligence (AI), and real-world data are reshaping the India’s clinical trials landscape, said Sanjay Vyas, executive vice president and managing director, Parexel.
Decentralized trials are leveraging digital technologies to enhance patient access and participation, enabling remote monitoring, telemedicine consultations, and electronic consent processes, he added. There is an increasing focus on oncology clinical trials due to rising cancer prevalence and the need for innovative therapies. Also private hospital networks are diversifying into tier 2/3 cities, providing broad access to patients, he said.
The geopolitical landscape is shifting in a way that could make India an increasingly attractive destination for pharmaceutical companies and researchers worldwide. Government initiatives like the Foreign Direct Investment (FDI) and production linked incentive (PLI) plan are creating opportunities for India, Vyas told Pharmabiz in an email.
India has emerged as a significant player in the global clinical trials landscape, with its market valued at US$ 2.05 billion in 2024 and projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. This growth is fuelled by several factors that make India an attractive destination for pharmaceutical companies and researchers worldwide. The vast and diverse patient population provides an ideal environment for clinical research. The demographic diversity allows for more comprehensive and representative studies, improving the generalizability of results. Additionally, the country's cost-effective operational environment and large pool of skilled medical professionals contribute significantly to its appeal. The pool of potential participants also makes India an attractive destination for various therapeutic areas, particularly oncology, diabetes, and infectious diseases, he noted.
There is significant growth in phase 2 and 3 trials which are growing 15-18% annually. There is also a growing prevalence of lifestyle diseases like diabetes and cardiovascular diseases driving demand for clinical trials. Regulatory advancements through amendments to the New Drugs and Clinical Trials (NDCT) Rules in 2019 are streamlining approval processes and introducing compensation provisions.
Ensuring ethical concerns and patient safety, particularly regarding informed consent and the protection of vulnerable populations, is critical for maintaining public trust and research integrity. Here we are seeing that India’s clinical trials industry faces several interconnected challenges that impact its growth and effectiveness.
A significant lack of public awareness about clinical trials hampers recruitment; many potential participants are unaware of their rights or the benefits of participation in India. Educational initiatives are essential to enhance understanding and encourage involvement, said Vyas.
Furthermore, certain regions suffer from infrastructure and skill deficits, necessitating strategic investments in healthcare facilities and capacity-building programs. While regulatory improvements have been made, consistent compliance across diverse research settings remains a challenge. As a final point, maintaining high standards of data quality and integrity across various trial sites is crucial for the credibility of research outcomes. Addressing these challenges holistically will be vital for the advancement of clinical trials in India, said the Parexel India chief.
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