A Global View: CAR-T cell in resource-limited regions Open Access

Chimeric antigen receptor (CAR) T-cell therapy has significantly improved outcomes for patients with hematologic neoplasms, with expanding indications and increasing global use. However, access remains highly unequal across countries. This review outlines the main barriers to CAR-T implementation in resource-limited regions, structured into four domains: cost and reimbursement, regulatory frameworks, manufacturing logistics, and clinical infrastructure. The high cost of commercial CAR-T products remains a major limitation, especially in settings where public reimbursement is unavailable and private coverage is inconsistent. Academic programs have emerged as alternatives in countries such as Brazil, India, Turkey, and Spain, demonstrating the feasibility of lower-cost, non-commercial production models. Regulatory gaps also contribute to limited access. While high-income countries have developed specific frameworks for advanced therapy medicinal products (ATMPs), many resource-limited regions still lack clear pathways for clinical trials, product approval, or post-marketing surveillance. Brazil stands out for its recent regulatory innovations, including a dedicated resolution for ATMPs and integration with public health goals. Logistical challenges related to manufacturing capacity, reagent supply, and product-release testing further constrain local implementation. Clinical infrastructure is also insufficient in many resource-limited regions, especially regarding intensive care support, multidisciplinary teams, and access to key medications such as tocilizumab. Ongoing national and regional efforts point to possible strategies for expanding access. These include decentralization of manufacturing, investment in public infrastructure, and regulatory adaptations to support context-specific solutions.