Abstract
Unlike haematopoietic stem-cell transplantation and donor lymphocyte infusion, approved gene therapies are drug products protected by intellectual property rights, which has driven commercial investment into a market sector with a current value of US$2·7 billion, and a forecasted value of $12·9 billion by 2026. Each approved gene therapy candidate began as an investigator-initiated clinical trial in an academic institution where drug products were manufactured and administered at place-of-care. However, further development to support regulatory approvals of these treatments required substantial commercial investment to show the safety and efficacy of the product, as well as reproducibility of the manufacturing process.
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