Cell therapy commercialisation

Abstract

‘Cells as therapies’ is a major step change in healthcare. Living cells offer solutions for a range of currently incurable medical conditions; however, both the technology and its essential infrastructure are far from market ready. Despite the limitations of any fledgling technology, the global cell therapy industry (CTI) has already achieved a billion-dollar annual revenue. This is only the beginning; identifying the bottlenecks and efficiently resolving them will result in a new healthcare sector on a par with pharmaceutical, biotechnological and medical devices. Thus, it is critical that the CTI focuses on the translation of the biologically plausible through clinical feasibility into real products and services. This chapter provides an introduction to the field and its development to date including a comprehensive timeline, identifies key barriers to commercialisation and potential business models, and considers the value of autologous and allogeneic cells for advanced therapeutics. The authors then delve deeper into the need for translational funding, robust clinical trials, marketing and reimbursement. The chapter concludes with an overview of the practical challenges to cell therapy bioprocessing, including principal cost bottlenecks, and suggestions of future trends for the industry.