India has the potential to increase global clinical trials in the country by five times in the coming years, a report has said, with experts highlighting the significant opportunities for biopharma companies to leverage India’s rich diversity and robust healthcare infrastructure to develop innovative treatments.

The joint report by the USA India Chamber of Commerce & PwC India titled, “Clinical Trial opportunities in India” which will be released at the virtual edition of the 17th annual BioPharma & Healthcare Summit 2023 to be held on Wednesday in Boston also indicates that through several key drivers, India is emerging as a favourable destination to conduct clinical trials.

According to the report, the private sector is a well-suited channel for the top biopharma to conduct more efficient clinical trials with easier and faster access to investigators and patients.

According to the report, India has the potential to increase global clinical trials in the country by five times in the coming years.

Indian states with high disease prevalence (e.g., cancer) also have the most number of tier-1 cities, with advanced medical infrastructure and availability of investigators. Targeting these states can provide biopharma companies with faster access to patients, sites, and investigators.

The total number of investigators has increased by twice between 2015 and 2020, with the majority of the increase occurring in the internal medicine and oncology specialisations.

However, the growth in the number of investigators is largely restricted to tier-1 and 2 cities, the report said.While the top 20 pharma activity for the major therapy classes in India has remained largely constant in the last decade, growth opportunities exist across key diseases (e.g., pain, epilepsy, cervical cancer) and orphan diseases (ß-thalassemia, Duchenne Muscular Dystrophy), it said.

India has an overall clinical trial participation of three per cent but contributes upwards of 15 per cent to the global burden of most high prevalent diseases (e.g., respiratory infections, cardiovascular, diabetes, cervical cancer), representing an untapped potential for top pharma, the report said.

Top biopharma companies should align their strategy towards tier-1 cities (e.g., Mumbai, Delhi, Bengaluru, Chennai) where the higher bed capacity, number of doctors, and presence of tertiary care multi-city hospitals can support enablement efforts of running faster and more efficient clinical trials, it said.

“This year, with India on track to become the world’s most populous country, our responsibility to ensure its people benefit from the innovations that improve human health has never been greater,” said Andrew Plump, President of R&D, Takeda and Chair, USAIC BioPharma & Healthcare Summit.

A critical part of this will be addressing the gap in clinical trial activity in India and identifying opportunities to collectively promote clinical research and help build infrastructure to support clinical trials in the country, he added.

Karun Rishi, president of USAIC, said that the growing interest in clinical trials in India presents a significant opportunity for biopharma companies to leverage the country’s rich diversity and robust healthcare infrastructure.

With a large and diverse patient pool, streamlined regulatory processes, and a highly skilled workforce, India offers a favourable environment for biopharma companies to conduct efficient and cost-effective clinical trials.

By tapping into this opportunity, companies can accelerate their drug development timelines, increase the efficiency of their research, and bring innovative treatments to patients in need, ultimately advancing global healthcare, he said.

“It is painful to see India’s share in the ongoing global clinical trials is less than 3.2 per cent. The global BioPharma companies need to do more to correct this situation from the science and ethical point of view,” Rishi said.

He said that with key data in hand, USAIC over the past one year worked closely and engaged with the leadership of top BioPharma companies and CROs globally to brainstorm on this issue.

“Response from sponsors and CROs has been very encouraging. They are ready and want to do more in India. We see the potential to increase global trials in India by 5x in the coming years. This is India’s moment to capture this great opportunity. Three triggers which are under play in India’s favour are diversity, equity, access and inclusiveness in clinical trials; Russia-Ukraine conflict and China’s zero Covid policy,” Rishi said.

India, he said, has made good progress in streamlining the clinical trials regulatory processes.

“We encourage India to continue to focus on stable and transparent clinical trials regulations particularly involving clinical trial execution in India under International Council for Harmonisation (ICH) guidelines. India should enhance its clinical trial infrastructure including skills development and incentivize global BioPharma companies to conduct trials,” he said.

“Large-scale ethical clinical trials with high-quality data will lead to collaborations, investments, skill development, translational research, startups, employment generation of high paying jobs leading to GDP growth. Entire innovation ecosystem will be created in India and ultimately enhance Indian patients’ access to innovative medicines,” Rishi said.

Sujay Shetty, a partner and global health industries leader, at PwC, said that the clinical trial activity in India has been increasing steadily since 2014 due to several key regulatory reforms aimed towards global harmonisation, enabling open access to clinical trials in India.

The country’s diverse population, combined with its rapidly advancing healthcare infrastructure, provides a fertile ground for clinical trials to flourish.

This is an opportunity for top biopharma companies to develop a long-term strategy that focuses on the key enablers of innovation and strategic partnerships in India, he said.

Dr Naresh Trehan, CMD Medanta and USAIC advisory board member believes that India’s healthcare landscape is poised for transformation, with its vast and diverse population in need of innovative solutions to address a range of health challenges.

“The country’s potential for clinical trials presents a unique opportunity to leverage cutting-edge research and technology to drive meaningful improvements in patient outcomes and advance the frontiers of medical science. By fostering a collaborative and dynamic ecosystem, India can lead the way in shaping the future of healthcare for the benefit of all,” he said.