s the global landscape of clinical trials shifts, China and India have emerged as the next frontiers of opportunity for pharmaceutical and biotech companies. Representing over 28% of all global clinical trials in 2023–2024, these two countries are rapidly becoming innovation hubs. Yet, many Western sponsors struggle to enter these markets effectively. This white paper outlines why China and India should be prioritized in your clinical development strategy and how partnering with regional CROs and technology platforms like DISTILL EDC and ePRO can help you unlock their full potential at a fraction of the cost.

1. Global Trends Point to China and India

According to recent data from the WHO ICTRP and EFPIA, the distribution of global clinical trials in 2023–2024 shows a clear shift:

• United States: ~24%

• China: ~18%

• India: ~10%

China and India together now host over a quarter of all global trials, rivalling the traditional dominance of North America and Europe. This growth is driven by regulatory reform, government investment, improved infrastructure, and large, treatment-naïve patient populations.

2. Strategic Advantages of Conducting Trials in China and India

• Large, Diverse Populations: Access to genetically and ethnically diverse patient groups accelerates recruitment and improves the generalizability of results.

• Cost Efficiency: Trial costs in India and China can be 40–60% lower than in the US or EU.

• Rapid Recruitment: High population density and centralized healthcare systems enable faster enrolment.

• Regulatory Evolution: Authorities like the NMPA (China) and CDSCO (India) are streamlining trial approvals and aligning with ICH-GCP standards.

3. Challenges for Traditional Western CROs

Global CROs headquartered in the US and EU often face challenges when operating in China and India:

• Cost Barriers: High overheads make them less competitive in cost-sensitive markets.

• Limited Local Presence: Regulatory, linguistic, and cultural gaps hinder smooth execution.

• Rigid Technology Platforms: Most Western EDC/ePRO solutions are too expensive or inflexible for use in local Phase II and III studies.

  
  

4. Local Partnerships

To succeed in China and India, Western sponsors must collaborate with experienced regional partners. That means:

• Working with Local CROs: They understand regional regulatory nuances, investigator networks, and site dynamics.

• Leveraging Local Tech Platforms like DISTILL EDC and ePRO:

  • Developed in India, DISTILL offers a powerful yet intuitive platform tailored for emerging markets.

  • Fully compliant with GDPR, HIPAA, and 21 CFR Part 11.

  • Enables study teams to self-design and manage trials affordably, without relying on costly programming support.

Conclusion

China and India are no longer peripheral options—they are central to the future of clinical research. However, unlocking their full potential requires the right partners. Western sponsors must rethink outdated models and embrace cost-effective, agile partnerships with local CROs and tech innovators like DISTILL EDC and ePRO.

For further information, please contact jay@distill.biz