The Latin American (LATAM) region is increasingly gaining attention in the First-in-Human (FIH) Clinical Trial market due to its large, treatment-naïve population, rising healthcare investment, and improving regulatory environments. Countries such as Brazil, Mexico, Argentina, Chile, and Colombia are at the forefront of this growth, offering cost-effective trial operations and high patient enrollment rates. While historically the region has been more active in Phase II–IV studies, recent reforms and investments are making it more attractive for early-phase trials. Key restraints include variability in regulatory timelines across countries, bureaucratic delays, and underdeveloped Phase I infrastructure in some areas. However, a strong trend is emerging around centralized ethics approvals, digitalization of trial management, and greater international collaboration. Opportunities lie in oncology, infectious diseases, and biologics, especially as governments and CROs work together to improve trial quality and compliance with global standards.
TABLE - LATAM LATAM First-in-Human Clinical Trial Market Size & Forecast 2021 – 2033
LATAM | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | CAGR (2024-2033) |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Brazil | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
Mexico | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
Argentina | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
Chile | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
Colombia | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX | XX |
Rest of LATAM | 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 - LATAM 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 - LATAM 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 - LATAM 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