9.1.1 To gain a comprehensive understanding of the pricing dynamics for the outsourced development and manufacture of cell-based therapies, Nice Insight spoke one-on-one with industry key opinion leaders (KOLs) from therapeutic innovator companies, independent consultants, and cell therapy CDMOs who are all subject matter experts (SMEs) in the sector.
9.1.2 In total, Nice Insight obtained information on the cell therapy outsourcing market and associated pricing dynamics from discussions and inputs from seven different CDMOs, from a range of geographies (five in North America; two in UK/Europe; one in APAC), that provide cell therapy–based development and manufacturing services. Further information was obtained from two independent SMEs, who provided insight and validation on the pricing trends and dynamics for the current cell therapy outsourcing market.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
9.2.1 The manufacture of a cell-based therapeutic product does not follow the classic route employed by other biological medicines. Due to the “personalized” nature of autologous cell therapy it is not possible to leverage the economies of scale routinely used in the production of recombinant proteins, vaccines, and even gene therapies. For autologous therapies, the batch sizes required are very small, as one batch equates to a single patient. The only way to address this personalized batch constraint is to scale out, rather than scale up, production.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
9.3.1 We were able to obtain detailed pricing information from five CDMOs regarding the technology and process transfer, and subsequent GMP production, for a human mesenchymal stem cell (hMCS) therapy project (Table 22). Due to the level of pricing detail obtained it was not possible to directly compare the five pricing sets on all line items or project stages. When asked, the SMEs all agreed that CDMOs cost estimate projects in different ways, some including capacity reservation fees, some including new equipment costs, while all seemed to bundle stages and operations into different categories in their respective proposals, hampering any direct comparison. Again this reflects the nonstandardized approach to cell therapy development and production across the cell therapy sector. Therefore, it is interesting to note that there were significant variations on total project pricing, ranging from $1.5M at CDMO #1 to nearly $4.0M at CDMO #5. As all of these CDMOs are located in North America, the range is unlikely due solely to any large variation in FTE resource costs, but rather the difference in approach to process transfer and GMP readiness requirements between the various service providers.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
9.4.1 Due to the lack of standardization in cell therapy production processes, equipment used, cell type, and characterization, all linked to the inability to scale up autologous cell therapy production, CDMOs try to focus on identifying and implementing the most efficient approach for each project. CDMOs vary in facility design, manufacturing approaches, and client requirements, each balancing risk, efficiency, and cost in different ways. One SME informed us that “all of these different approaches tend to impact CDMO pricing ranges and strategies in the market.” He went on to explain that CDMOs all aim to ensure that their facilities are designed in a flexible manner in order to operate as efficiently as possible, while having the ability to deal with a wide variety of possible cell types and processes, but inevitably all CDMOs run different approaches to a similar project, which drives variation in pricing.
9.4.2 A recent article[225] from CRB Group compared and discussed the various alternative approaches and setups employed for the manufacture of cell therapies, exploring four different cell therapy manufacturing approaches: dedicated rooms, chasing workstations, segregated unit operations, and an emerging option called process-in-a-box systems. They state that no “two manufacturing strategies are the same. Each unique approach requires significant time and expertise to get right.” If this is applied to the CDMO perspective then it is no wonder that price ranges can be broadly different among CDMOs and between different processes.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.