The 2025 outlook for India’s clinical trials industry
Sanjay Vyas, President and Managing Director, Parexel India, highlights that as India strengthens its position in global pharmaceutical research, several key trends are expected to drive growth and evolution in the clinical trials sector
India’s clinical trials landscape is poised for significant transformation in 2025, with technological innovation and patient-guided approaches reshaping the industry. As the country strengthens its position in global pharmaceutical research, several key trends are expected to drive growth and evolution in the clinical trials sector.
Increase in Phase 1 Clinical Trials
India is set to emerge as a powerhouse in early-phase clinical research, particularly in Phase 1 trials. The Indian Council of Medical Research’s (ICMR) strategic initiative to establish a dedicated Network for Phase 1 Clinical Trials marks a significant milestone in India’s clinical research capabilities. This network will facilitate crucial collaborations for advancing cutting-edge therapies, including CAR-T cell treatments and vaccines, while simultaneously promoting the development of indigenous molecules.
Accelerating innovation in therapeutic development
The Indian clinical trials sector is poised for remarkable growth in 2025, with breakthroughs across multiple therapeutic areas. Cell and gene therapies are making significant strides, particularly in treating genetic disorders and certain types of cancer. On the other hand, mRNA-based treatments are also gaining significant momentum.
A critical focus area emerging in 2025 is the battle against Antimicrobial Resistance (AMR), which poses a significant global health threat. India’s pharma and clinical trials ecosystem supports global antibiotic development with advanced screening, novel drug delivery, narrow-spectrum antibiotics, and combination therapies. Its growing focus on AMR research and cost-efficient capabilities will make India a key partner for global pharma.
Digital transformation redefining patient recruitment
AI integration in clinical trials is improving patient recruitment by analysing electronic health records (EHRs) with greater efficiency. This helps speed up participant selection, potentially reducing recruitment timelines by up to 50 per cent, while ensuring more accurate matching to study criteria, thus enhancing trial reliability and results. Beyond recruitment, digital transformation also automates data collection and analysis from diverse sources like EHRs and patient-reported outcomes. It further optimises protocols using historical data, improves scientific integrity, reduces costs, and streamlines trial operations, all of which lead to better data quality.
Expanding access and inclusion using decentralised clinical trials
Traditional clinical trial models have historically concentrated on urban medical centers, creating an opportunity to enhance access for a more diverse range of participants. Decentralised clinical trials (DCTs) continue to be a transformative solution that broaden access to groups previously excluded, including rural populations, the elderly with mobility challenges, children, pregnant women needing specialised care, and individuals with rare or terminal conditions.
Wearable technology is central to this shift, allowing continuous remote monitoring of patient health metrics. By transmitting real-time data, wearable devices reduce the need for frequent site visits and provide researchers with more comprehensive insights into patient conditions.
Opportunities and challenges
India’s clinical trials sector in 2025 presents opportunities like enhanced global competitiveness, wider patient access, cost-effective drug development, and accelerated innovation. However, challenges include ensuring data security in digital trials, maintaining regulatory compliance with new technologies, building infrastructure for decentralised trials, training healthcare professionals, and standardising processes across regions.
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