The Market For Cell Therapy Manufacturing - Strategies for Pricing, Cost Control, Reimbursement, and Distribution
Traditionally, one of the major issues with commercializing cell therapy products has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing. Furthermore, much of cell therapy manufacturing now involves patient-specific cell therapies, where cells for an individual patient are processed one batch at a time.
While many factors contribute to high pricing associated with cell therapies, a critical factor affecting the pricing of a cell therapy product is the cost of continuously manufacturing the product. To keep a cell therapy product “on market,” manufacturing costs of must be covered and a profit margin achieved. Therefore, great consideration must be given to the variables affecting the costs of goods (COGs) associated with cell therapy manufacturing, as well as strategies for process optimization.
Currently, allogeneic cell therapy manufacturing dominates over autologous cell therapy manufacturing, although clinical data in support of patient-specific therapy is compelling. There are opportunities for the development of both autologous and allogeneic cell therapies, which vary greatly in their manufacturing requirements, routes for patient administration, and cost structures.
Among cell therapy companies, the pressure for manufacturing process innovation can incentivize them to seek third-party partners who possess technical, manufacturing, and regulatory expertise in cell therapy development and manufacturing, such as cell therapy contract and development manufacturing organizations (CDMOs). Currently, there are more than 20 cell therapy CDMO’s specializing in manufacturing and clinical trial support for cell therapy companies, including WuXi PharmaTech (and its subsidiary WuXi AppTec), Lonza Group, PCT (a Caladrius company), MEDINET, Cell and Gene Therapy Catapult, Brammer Bio, KBI Biopharmaceuticals, PharmaCell, Roslin Cell Therapies, apceth Biopharma, and more.
Benefits of partnering with a cell therapy CDMO include scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies. This report considers the role of cell therapy CDMOs, as well as the importance of in-house manufacturing at cell therapy companies worldwide.
This global strategic report provides detailed analysis of ten leading cell therapy companies worldwide, evaluating the strengths of each company, as well as identifying cell therapy products in development, manufacturing strategies, and partnerships. These companies include:
Astellas Pharma, and Subsidiary Ocata Therapeutics
Gamida Cell Ltd.
Organogenesis, Inc. & Novartis AG
Advanced Tissue Sciences
JCR Pharmaceuticals Co. Ltd. (Licensee of Mesoblast Ltd.)
MasTHerCell, Acquired by Orgenesis
PCT, a Caladrius Company (Previously Neostem)
WuXi PharmaTech, Including Subsidiary WuXi AppTech, Inc.
Cell and Gene Therapy Catapult
KBI Biopharma (Acquired Opexa Assets, February 2017)
Brammer Bio (Formed through Merger of Brammer Biopharmaceuticals and Florida Biologix)
Roslin Cell Therapies, a Subsidiary of Roslin Cells
Cognate Bioservices, Inc.
MEDINET Co. Ltd.
The Clinical Trial Company (TCTC)
Miltenyi Bioprocess, the Contract Manufacturing Business of Miltenyi Biotec
Lonza Group, Cell Therapy Manufacturing Unit
Cellular Therapeutics Ltd. (CTL)
CTI Clinical Trial and Consulting
CELL THERAPIES MENTIONED:
Apligraf (Organogenesis, Inc. & Novartis AG)
ChrondoCelect (TiGenix NV)
Dermagraft (Advanced Tissue Sciences)
Hearticellgram-AMI (FCB Pharmicell)
Holoclar (Chiesi Farmaceutici)
TEMCELL (JCR Pharmaceuticals Co. Ltd., Licensee of Mesoblast Ltd.)
Learn how to effectively navigate the market research process to help guide your organization on the journey to success.Download eBook