Global Cell Therapy Manufacturing Market report analyzes time frames for cell therapy product development, distribution channels, key trends and technologies impacting cell therapy manufacturing, cost control measures, and challenges and considerations affecting with cell therapy manufacturing.
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Global Cell Therapy Manufacturing Market 2017 report spread across 123 pages provides an overview of the regulatory environment affecting cell therapy manufacturing in key countries worldwide, evaluating the importance of the recent FDA guidelines for Human Cell and Tissue-based Products (HCT/Ps) and the 21st Century Cures Act, as well as accelerated pathways for cell therapy approvals in Japan, including the: Act on the Safety of Regenerative Medicine (Law No. 85/2013) and Pharmaceuticals and Medical Device (PMD) Act (Law No.
“Cell Therapy Manufacturing Market 2017 Strategies for Pricing, Cost Control, Reimbursement, Distribution” report says, 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.
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There are 13 Chapters to deeply display the global Cell Therapy Manufacturing market.
- Introduction to Cell Therapy Manufacturing
- Leading Cell Therapy Companies
- Approved Cell Therapy Products
- Pricing Analysis for Cell Therapy Products
- Cost-Control for Cell Therapy Products
- Time Frames for Cell Therapy Product Development
- Reimbursement of Cell Therapy Products
- Distribution Channels for Cell Therapy Products
- Market Trend Analysis - Key Trends Impacting the Marketplace
- Technologies Impacting the Cell Therapy Manufacturing Market
- Market Potential for Autologous vs. Allogeneic Manufacturing
- Cell Therapy Manufacturing Challenges and Considerations
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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: WuXiPharmaTech (and its subsidiary WuXiAppTec), Lonza Group, PCT (a Caladrius company), MEDINET, Cell and Gene Therapy Catapult, Brammer Bio, KBI Biopharmaceuticals, PharmaCell, Roslin Cell Therapies, apceth Biopharma, and more.
Additionally, the report identifies cell therapy products that have been reviewed and approved by internationally-recognized regulatory agencies, as well as products brought to market in the U.S. with FDA approval. It also specifies which cell therapies have since been pulled from market, due to factors such as low adoption rates, unsuccessful reimbursement strategies, or high cost of manufacturing.
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Cell Therapies covered: Apligraf (Organogenesis, Inc. & Novartis AG), Carticel (Genzyme), Cartistem (MEDIPOST), ChrondoCelect (TiGenix NV), Cupistem (Anterogen), Dermagraft (Advanced Tissue Sciences), Epicel (Vericel), Hearticellgram-AMI (FCB Pharmicell), Holoclar (ChiesiFarmaceutici), Osteocel (NuVasive), Prochymal (Mesoblast), Provenge, Strimvelis (GSK), TEMCELL (JCR Pharmaceuticals Co.
Ltd., Licensee of Mesoblast Ltd.)
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