Description:

This paper explores the evolving landscape of cell and gene therapies (CGT), which are emerging as pivotal drivers of healthcare innovation and investment. Although CGT represents a small percentage of launched products in major pharmaceutical markets, its development is accelerating, as indicated by a rapid increase in FDA approvals—from the first therapy approved in 2017 to thirty-nine approvals as of 2025. The focus on therapeutic approaches, such as cell therapies using pluripotent and mesenchymal stem cells, exosomes, gene therapy, and mRNA technology, is complemented by the challenges of single-use technologies, scalable manufacturing, regulatory hurdles, and analytical characterization of these novel therapies. Furthermore, this document highlights the importance of sustainability in a rapidly changing industry, emphasizing the need for innovative solutions and cross-disciplinary collaboration for effective supply chain management. Ultimately, while promising, CGT in the single-use era continues to face significant obstacles requiring strategic attention to ensure its successful integration into mainstream medicine.