Figure 1.
Key barriers to CAR-T therapy implementation in resource-limited settings. This diagram illustrates 4 major systemic challenges limiting access to CAR-T therapy in low- and middle-income countries. These include: (1) cost and reimbursement, marked by unaffordable commercial pricing, absence of public coverage, and the need for scalable low-cost alternatives; (2) regulatory framework, characterized by the lack of ATMP pathways, prolonged drug-style approvals, and the need for country-specific regulation; (3) manufacturing logistics, characterized by reliance on centralized systems, transport delays, and limited local production capacity; and (4) clinical infrastructure, involving a shortage of certified treatment centers, insufficient ICU/apheresis support, and critical training gaps for toxicity management (eg, CRS, ICANS).

Key barriers to CAR-T therapy implementation in resource-limited settings. This diagram illustrates 4 major systemic challenges limiting access to CAR-T therapy in low- and middle-income countries. These include: (1) cost and reimbursement, marked by unaffordable commercial pricing, absence of public coverage, and the need for scalable low-cost alternatives; (2) regulatory framework, characterized by the lack of ATMP pathways, prolonged drug-style approvals, and the need for country-specific regulation; (3) manufacturing logistics, characterized by reliance on centralized systems, transport delays, and limited local production capacity; and (4) clinical infrastructure, involving a shortage of certified treatment centers, insufficient ICU/apheresis support, and critical training gaps for toxicity management (eg, CRS, ICANS).

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