Breaking Ground in Clinical Trials: India's Innovation Imperative

For decades, India has been a global powerhouse in pharmaceutical manufacturing. Yet in clinical trials, the crucial bridge between laboratory discoveries and patient access, the country’s performance has lagged behind its industrial capabilities.

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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 cuttingedge 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 attritionadjusted 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.