Prepping For Commercialization Through Supply Chain Logistics

Cell and gene therapies (CGTs) are bringing new hope to patients experiencing rare and serious diseases, and they are disrupting the biopharma market in new and challenging ways. Patients experiencing rare and serious diseases have seen a steady increase in possibilities for treatment as nearly 1,308 developers (as of 2021) were investigating regenerative medicine and advanced therapies (RMAT) in over 2,400 clinical trials globally. The RMAT sector included $22.7 billion of investments in 2021, a 14% increase from its $19.9 billion record in 2020.

US regulators are responding to this growth and the tremendous patient need by establishing new guidance and procedures including expedited programs for regenerative medicines. Because there is no reason to believe that demand and market growth will slow any time soon, the CGT space must recognize and prepare to mitigate supply chain challenges that result from and further limit current capacity. Here, we discuss several industry challenges and pain points as clients prepare for commercialization of CGT products.