India First-in-Human Clinical Trial Market Size, Share & Trends Analysis Report By Phase Type (Phase 0 (Microdosing), Phase I (FIH Safety/Tolerability)), By Therapeutic Area (Oncology, Neurology, Rare and Orphan Diseases, Immunology & Infectious Diseases), By Sponsor Type (Pharmaceutical Companies, Biotech Firms, Academic/Governmental Institutes) and Forecasts, 2025-2033
USD 4500
India First-in-Human Clinical Trial Market Insights
India is emerging as a prominent destination for First-in-Human (FIH) Clinical Trials, driven by its vast treatment-naïve patient population, skilled medical professionals, and cost-effective clinical trial operations. The Central Drugs Standard Control Organization (CDSCO) has improved transparency and efficiency in trial approvals, supported by digital portals and tightened ethics guidelines. India’s growing biotech ecosystem and supportive government schemes such as "Make in India" and the Biotechnology Industry Research Assistance Council (BIRAC) are encouraging early-phase research, especially in oncology, infectious diseases, and metabolic disorders. However, concerns over past ethical controversies and regional disparities in trial oversight continue to act as restraints. Despite this, there is a clear trend toward adoption of electronic data capture (EDC) systems and decentralized trial models. Opportunities lie in leveraging India's digital health mission and telemedicine infrastructure to support hybrid and remote FIH trial formats, making it a highly promising market.
TABLE - India First-in-Human Clinical Trial Market Size & Forecast By Phase Type 2021-2033
| Phase Type | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | CAGR (2024-2033) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 0 (Microdosing) | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Phase I (FIH Safety/Tolerability) | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Total | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX |
Source: Company Publications, Primary Interviews, and SR Analysis
TABLE - India First-in-Human Clinical Trial Market Size & Forecast By Therapeutic Area 2021-2033
| Therapeutic Area | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | CAGR (2024-2033) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Oncology | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Neurology | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Rare and Orphan Diseases | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Immunology & Infectious Diseases | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Total | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX |
Source: Company Publications, Primary Interviews, and SR Analysis
TABLE - India First-in-Human Clinical Trial Market Size & Forecast By Sponsor Type 2021-2033
| Sponsor Type | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | CAGR (2024-2033) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmaceutical Companies | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Biotech Firms | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Academic/Governmental Institutes | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
| Total | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX |
Source: Company Publications, Primary Interviews, and SR Analysis
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