China is becoming a powerhouse in the FIH Clinical Trial space, supported by major regulatory reforms and growing domestic biopharma innovation. The National Medical Products Administration (NMPA) has shortened approval timelines and aligned more closely with ICH guidelines, making China more attractive for global sponsors. High prevalence of chronic diseases and the expansion of Phase I units are driving trial activity, especially in oncology, metabolic disorders, and novel biologics. However, challenges remain around data privacy laws, language barriers, and limited transparency in some regions. A strong trend includes the rise of local CROs and tech-driven trial solutions, helping companies streamline early-phase research. China also shows increasing interest in real-world data integration and AI-powered patient matching. These factors present vast opportunities for both domestic and international firms aiming to conduct efficient and scalable FIH trials.
TABLE - China 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 - China 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 - China 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