South America and Mexico's cell and gene therapy landscape: accelerating growth and persistent challenges

Cell and gene therapies (CGTs) are expanding globally, and South America and Mexico are gaining tangible momentum. This review maps the region's CGT landscape across four axes that together highlight regional progress: (i) patent activity as a signal of innovation and market pull; (ii) clinical trial activity and sponsorship patterns; (iii) manufacturing capabilities, including GMP (good manufacturing pratices) sites, platform maturity, vector/plasmid access, and QC/QA (quality control/quality assurance) readiness; and (iv) regulatory evolution. Although Central America was included in the search strategy, measurable CGT activity is currently concentrated in South America and Mexico. The emerging picture is of a region moving from isolated initiatives toward an integrated, capability-based ecosystem. We observe steady growth in early-phase trials across modalities, thereby establishing a robust translational pipeline. Brazil leads in volume and scope, while Argentina, Chile, and Mexico contribute specific programs, highlighting the existence of distributed centers of specialization. Industry-driven sponsorship indicates rising market confidence, and temporal trends in patent filings by public institutions and multinational assignees align with the recent acceleration in activity. On the policy front, regulatory frameworks are evolving and moving closer to international benchmarks, creating better conditions for multicenter studies. Based on these advances, a practical plan can transform momentum into lasting capacity and access: maintaining consistent public–private investment to expand GMP-compliant manufacturing capacity; aligning local standards with international ones (FDA/EMA/FACT) and improving consistency of requirements across countries; and structuring regional collaboration to share experiences, coordinate early-stage clinical trials, and establish reference laboratories and training centers. Together, these measures can reduce cell collection time, lower costs, and convert pilot programs into reliable clinical supply, positioning South America and Mexico as growing contributors to global innovation in gene and cell therapy and to equitable access.