South Africa is a well-established player in Africa’s clinical trial industry and is gaining recognition in the FIH Clinical Trial segment due to its genetically diverse population, high disease burden, and experienced research institutions. Regulatory oversight by the South African Health Products Regulatory Authority (SAHPRA) has improved significantly, with faster timelines and better alignment with international standards. South Africa offers cost-effective trial operations and strong capabilities in infectious disease research, particularly HIV, tuberculosis, and vaccines. However, the limited number of fully accredited Phase I units remains a constraint. Trends suggest increasing collaboration with international sponsors and greater investment in clinical infrastructure and workforce development. With ongoing reforms and a growing digital health ecosystem, South Africa presents strong potential for growth in the FIH market, especially in translational and exploratory drug development.
TABLE - South Africa 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 - South Africa 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 - South Africa 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