Landscape of ex vivo gene therapies: Technological trends and future prospects

<i>Ex vivo</i> gene therapy, a revolutionary approach involving extraction, genetic modification, and infusion of cells, is rapidly evolving, making it difficult to track its advancements. Strategic foresight methodologies play a crucial role in understanding the future of technology, anticipating trends, and making informed decisions. This study pioneers the use of strategic foresight methodology to understand technological trends of <i>ex vivo</i> gene therapies, leveraging data mining to generate and analyze a database of 1,491 products. Notably, 79.78% of <i>ex vivo</i> gene therapies target neoplasms, with T cells as the primary cell type (75.26%) and chimeric antigen receptor (CAR) as the most common genetic modification (83.19%). Although stem cells constitute a relatively small proportion (2.41%), they have demonstrated significant clinical promise. It was also observed that CD19 and BCMA (B-cell maturation antigen) are consolidated targets, although new targets (GPC3 [Glypican-3], mesothelin, CLDN18 [Claudin-18], KRAS [Kirsten rat sarcoma viral oncogene homolog], and others) as well as multispecific products are emerging. Vector analysis indicates that CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)-based modifications are expanding (25.66%), although lentivirus vector (40.12%) remains the dominant platform. Significantly, 22 products have advanced to the pre-registration or registration phase, underscoring their potential as viable treatments. This study provides a comprehensive overview of the current landscape and future directions in <i>ex vivo</i> gene therapy.