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India Poised to Become Major Hub for Early-Stage Clinical Trials Amid Global Shifts

With increasing geopolitical disruptions and shifting trial strategies, India emerges as an attractive destination for early-stage clinical trials, backed by CRO expansion and competitive cost advantages.

India is rapidly gaining ground as a key global center for early-stage clinical research. This push is being driven by ongoing disruptions—such as those in Eastern Europe—and global pharmaceutical firms’ growing desire to diversify away from China. These insights were shared by Sanjay Vyas, head of Parexel’s India operations, at the recent BioAsia conference.

Parexel is spearheading this shift. The Contract Research Organization (CRO) plans to bolster its Indian workforce by more than 2,000 new hires within the next three to five years, building on its current base of 6,000 staff. The firm currently operates 100 to 150 trial sites across key states including Maharashtra, Karnataka, Telangana, and Tamil Nadu.

Strategic Drivers and Challenges

  • Geopolitical Realignment: The fallout from the Russia–Ukraine conflict has disrupted trials in the region, prompting global sponsors to seek more stable partners. India’s emergence as an affordable and capable alternative is timely.
  • Cost Efficiency: Vyas emphasises that the “cost of failure in India is much less”, highlighting the economic appeal of conducting early-stage trials in the country.
  • Regulatory and Awareness Hurdles: Despite strong potential, India currently lacks standardized guidelines for early-phase trial conduct. Additionally, patient and physician awareness of experimental treatments remains low, with remote site establishment posing logistical challenges.

What This Means for Clinical Research Stakeholders

Pharma Sponsors  

India offers a lower-cost, high-capacity alternative for Phase I/II trials, especially when other regions are unpredictable.

CROs Companies like Parexel stand to benefit from increased trial volume, infrastructure development, and expanded footprint across Indian states.
Sites & Investigators There is a growth opportunity for new trial sites, provided regulatory frameworks and awareness catch up.
Policymakers & Regulators Intensified focus on standardizing protocols, training, and rural outreach is essential to support India’s clinical research ambitions.

Conclusion

India’s evolving role in global clinical research is a defining trend in 2025. As geopolitical factors and rising costs push sponsors to diversify trial locations, India’s low-cost capacity and expanding infrastructure position it as a viable early-stage trial leader—provided regulatory and educational gaps are addressed.

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