Breaking Ground in Clinical Trials: India’s Innovation Imperative

Home to nearly 1.46 billion people in 2025, or 18 per cent of the global population, India bears a proportionately high share of the world’s disease burden. In recent years, the country recorded 212 million diabetics, nearly 25 per cent of the global diabetic population, accounted for a quarter of global DALYs due to ischemic heart disease, 28 per cent of all TB cases, and 1.46 million new cancer cases (representing 4 per cent of global incidence), according to WHO data. These numbers underscore the urgent need for robust clinical research, both to meet domestic healthcare challenges and to contribute meaningfully to global drug development.

The Current State of Play

Despite its demographic and disease burden , India’s clinical trial market was valued at only $1.5–1.6 billion in 2022, according to Frost & Sullivan, just 2–3 per cent of the global market. Most of this activity is concentrated in Phase 2 and 3 trials, where India’s ability to enroll large patient cohorts is an advantage. Early-phase trials, critical for cutting-edge drug innovation, remain underdeveloped.

Momentum is building, however. Frost & Sullivan projects a 14–15 per cent CAGR over the next decade, supported by cost competitiveness, with trials 30–50 per cent cheaper than in Western markets, and a strong base of scientific talent trained in international standards. Yet cost arbitrage alone will not secure India’s future. Drug development today is more complex than ever, with attrition-adjusted R&D costs exceeding $2.8 billion per novel drug. The industry is under immense pressure to reduce failure rates, improve trial efficiency, and accelerate access without compromising ethics or patient safety.

Global Innovations Reshaping Clinical Trials

Around the world, the clinical trials industry is being reshaped along four dimensions: technology, regulation, business models, and value chain architecture.

1. Technology innovation has opened new possibilities. Wearables now capture real-time patient biometrics, artificial intelligence accelerates recruitment and trial design, and genomics enables precision medicine with therapies tailored to smaller, genetically defined populations. In the United States, in some cases, AI-driven recruitment has reduced enrollment times by nearly 30 per cent, while wearable monitoring has improved remote oversight efficiency by 40 per cent. Real-world evidence has also become a cornerstone of trial design, and blockchain is enhancing data integrity.  
2. Regulatory innovation is accelerating trial speed and transparency. For example, the FDAAA 801 Final Rule, the US’ Diversity Action Plans for pivotal clinical trials, China’s Circular 53, the EU Clinical Trials Regulation, and Japan’s PMD Act revision aim to accelerate trial timelines, expand site access (beyond tier-1 cities), increase data transparency, and create more predictable approval pathways. Regulators globally are moving toward harmonisation, stricter reporting, and more predictable pathways for sponsors.
3. Business model innovation is broadening trial reach. Decentralised clinical trials (DCTs), powered by telehealth, home-based diagnostics, and remote monitoring, are reducing costs and improving accessibility. In the United States, across some studies, DCTs have cut trial expenses by up to 25 per cent and improved retention by 20 per cent. 
4. Value chain innovation is reconfiguring who participates in the clinical trial industry. Non-traditional players such as Apple, through its Research app, and Walgreens are integrating trial participation into everyday consumer interactions. In China, digital ecosystems built by Tencent and JD Health integrate recruitment, monitoring, and data management in a seamless, patient-centered model.

These global trends illustrate that clinical trials are no longer just about recruiting faster or cheaper, but about being smarter, more inclusive, and more data-driven.

India’s Path to Adoption

India is uniquely positioned to adopt and adapt these innovations, but doing so requires addressing local realities and leveraging its own strengths.

• On technology, India’s extraordinary genetic diversity and vast treatment-naive patient population make it a natural destination for precision medicine research. The rapid expansion of digital health infrastructure and smartphone usage in Tier 1 to Tier 3 cities provides fertile ground for AI-driven site selection and intelligent patient recruitment. 
• Clinical research is increasingly as much about data generation and analysis as it is about patient recruitment. Wearables, electronic health records, and real-world evidence are already shaping regulatory decisions worldwide. India has an underappreciated advantage here: it generates a vast amount of health data through government programmes like Ayushman Bharat, disease registries under NPCDCS, and the growing use of health apps. The challenge is fragmentation. If India can establish interoperable health data platforms, it could leapfrog other countries in producing population-scale insights. The innovation pathway does not lie in importing Western trial models but in leveraging India’s own digital public infrastructure, perhaps even the same architecture that powers UPI, Aadhaar, and CoWIN, as the blueprint for a national clinical data spine. This could position India as a global laboratory for data-driven trial innovation.
• On regulation, India has made important progress. The 2019 Clinical Trial Rules shortened approval timelines to about 90 days. More recently, the New Drugs and Clinical Trials (Amendment) Rules, 2024, effective April 2025, introduced faster test licenses, waiver of local clinical trials in certain cases, simplified BA/BE studies, mandatory CRO registration, and digital submissions. These are steps toward a more predictable and investor-friendly environment. The next step could be more towards harmonisation, which will allow companies to use results generated in India for global approvals.
• Around the world, patients and regulators are increasingly skeptical of trial conduct, data integrity scandals, underreporting, and pharma mistrust have made transparency a priority. Technologies like blockchain and mandatory reporting platforms are emerging as solutions. For India, this challenge is even more urgent. Past controversies around informed consent and adverse event reporting in the early 2010s continue to cast a shadow. The real innovation opportunity can be harnessed by rebuilding trust through patient engagement platforms, open-access registries, and community advisory boards. If India embeds trust-by-design into its trial ecosystem, it can shift perceptions from being a low-cost destination only to a credible and ethical global partner.
• On business models, decentralised trials are a natural fit for India’s geography and healthcare disparities. DCTs are usually described in terms of virtual visits and telehealth. But in India, decentralisation must mean more than replacing site visits with video calls. The deeper innovation lies in meeting patients where they are-  physically, digitally, and socially. Connectivity gaps, affordability barriers, and literacy challenges require protocols tailored for India’s landscape. Trials that integrate ASHA workers (community health workers), local pharmacies, or mobile diagnostic vans could unlock participation at scale- beyond urban centers and ensure participation from Tier 2 and Tier 3 cities and rural areas, making trial cohorts more representative of their population. The scope of innovation does not stop here, but can definitely serve as a starting point.

The Road Ahead

India has already proven its ability to transform global health by becoming the pharmacy of the world through generics and vaccines. The next frontier is to become the laboratory of the world for clinical research.

The opportunity is not simply to increase trial volumes with undeniable cost advantages, but to reposition India as a trusted, innovative, and indispensable partner in solving the global R&D productivity challenge. By embracing global innovations, adapting them to local realities, and embedding ethics and transparency, India can help bring therapies to patients faster, more efficiently, and more inclusively.

Khushbu Jain – Associate Director, Healthcare & Life Sciences Growth Advisory, Frost & Sullivan