The Market For Cell Therapy Manufacturing - Strategies for Pricing, Cost Control, Reimbursement, and Distribution

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:
 ReNeuron
 Mesoblast Ltd.
 Asterias Biotherapeutics
 TiGenix NV
 Cellectis
 Cynata Therapeutics
 Cytori Therapeutics
 Astellas Pharma (and Subsidiary Ocata Therapeutics)
 Gamida Cell Ltd.
 Pluristem Therapeutics
 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.
 
 The 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.
 
 It 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)
 Pharmaceuticals and Medical Device (PMD) Act (Law No. 84/2013)
 Based in Washington, DC, BioInformant is first and only market research firm to specialize in the stem cell industry. Unlike other publishers that hire analysts from foreign countries, BioInformant is an American-based company with more than 10 years of experience with tracking the cell therapy market (2006 to present). BioInformant compiled this global strategic report using primary interviews with more than 50 participants from across the cell therapy manufacturing industry, including representatives from:
 Gamida Cell (Dr. Yael Margolin)
 Pluristem (Yaky Yanay)
 Cynata Therapeutics (Dr. Paul Wotton)
 Accellta (Dr. Itzchak Angel and Eran Cohen)
 Stem Cell Medicine Ltd. (Dr. Frida Grynspan)
 Minerva Biotechnologies (Dr. Cynthia Bamdad)
 RoosterBio (Dr. Jon Rowley)
 Universal Cells (Gregory Block)
 Many More
 It also incorporates secondary findings from SEC filings, company websites, press releases, investor presentations, and government policy documents (FDA / PMDA). Produced for companies involved with cell therapy product development, this global strategic report offers critical insights into strategies for optimizing modern cell therapy manufacturing.
 
 COMPANIES MENTIONED:
 
 ReNeuron
 Mesoblast Ltd.
 Asterias Biotherapeutics
 TiGenix NV
 Cellectis
 Cynata Therapeutics
 Cytori Therapeutics
 Astellas Pharma, and Subsidiary Ocata Therapeutics
 Gamida Cell Ltd.
 Pluristem Therapeutics
 Organogenesis, Inc. & Novartis AG
 Genzyme
 MEDIPOST
 TiGenix NV
 Anterogen
 Advanced Tissue Sciences
 Vericel
 FCB Pharmicell
 Chiesi Farmaceutici
 NuVasive
 GSK
 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
 apceth Biopharm
 Cognate Bioservices, Inc.
 MEDINET Co. Ltd.
 PharmaCell, B.V.
 The Clinical Trial Company (TCTC)
 Miltenyi Bioprocess, the Contract Manufacturing Business of Miltenyi Biotec
 Lonza Group, Cell Therapy Manufacturing Unit
 Praxis Pharmaceutical
 Cellular Therapeutics Ltd. (CTL)
 CTI Clinical Trial and Consulting
 Eufets GmbH
 Fraunhofer Gesellschaft
 Cellforcure SASU
 Molmed S.p.A.
 
 CELL THERAPIES MENTIONED:
 
 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 (Chiesi Farmaceutici)
 Osteocel (NuVasive)
 Prochymal (Mesoblast)
 Provenge
 Strimvelis (GSK)
 TEMCELL (JCR Pharmaceuticals Co. Ltd., Licensee of Mesoblast Ltd.)

 1. Introduction to Cell Therapy Manufacturing
 2. Leading Cell Therapy Companies
 2.1. List of Cell Therapy Companies Worldwide
 [Table] List of Cell Therapy Companies Worldwide by Location and Type
 2.2. Leading Cell Therapy Companies
 2.1.1. ReNeuron
 2.1.2. Mesoblast Ltd.
 2.1.3. Asterias Biotherapeutics
 2.1.4. TiGenix NV
 2.1.5. Cellectis
 2.1.6. Cynata Therapeutics
 2.1.7. Cytori Therapeutics
 2.1.8. Astellas Pharma, and Subsidiary Ocata Therapeutics
 2.1.9. Gamida Cell Ltd.
 2.1.10. Pluristem Therapeutics
 3. Approved Cell Therapy Products
 3.1. Apligraf (Organogenesis, Inc. & Novartis AG)
 3.2. Carticel (Genzyme)
 3.3. Cartistem (MEDIPOST)
 3.4. ChrondoCelect (TiGenix NV)
 3.5. Cupistem (Anterogen)
 3.6. Dermagraft (Advanced Tissue Sciences)
 3.7. Epicel (Vericel)
 3.8. Hearticellgram-AMI (FCB Pharmicell)
 3.9. Holoclar (Chiesi Farmaceutici)
 3.10. Osteocel (NuVasive)
 3.11. Prochymal (Mesoblast)
 3.12. Provenge
 3.13. Strimvelis (GSK)
 3.14. TEMCELL (JCR Pharmaceuticals Co. Ltd., Licensee of Mesoblast Ltd.)
 4. Pricing Analysis for Cell Therapy Products
 4.1. Pricing of Approved Cell Therapy Products
 [Table] Pricing of Approved Cell Therapies
 [Table] Pricing Scale for Approved Cell Therapies, by Type
 4.2. Reasons for High Cell Therapy Product Costs
 4.2.1. High Cost of Manufacturing
 4.2.2. Need to Recoup Developmental Costs
 4.2.3. Cash Flow and Quantity of Cash Reserves
 4.2.4. Need for Return on Investment (ROI)
 4.2.5. High Cost of Delivery
 4.2.6. Lack of Comparative Studies as Evidence for Reimbursement Scheme
 4.2.7. Lack of Competition
 4.2.8. Potential for High Utility Patient Outcomes (Cures)
 4.2.9. Small Market Size
 5. Cost-Control for Cell Therapy Products
 5.1. Cost of Goods (COGs) Components
 5.2. Automation as a Cost Control Measure
 [Table] Cost Per Million of Clinical-Grade MSCs Expanded by Different Methods
 5.3. Effect of Process Development and Process Change on COGs
 5.4. Managing Cash Flow
 5.5. Role of Cell Therapy CDMOs
 6. Time Frames for Cell Therapy Product Development
 6.1. Pre-Market Challenges
 6.2. Persevering Through Lengthy Developmental Timelines
 6.3. Navigating the Regulatory Environment
 6.4. Timeline from Phase I to Commercialization
 7. Reimbursement of Cell Therapy Products
 7.1. Securing Reasonable Reimbursement
 7.2. Encouraging Adoption
 8. Distribution Channels for Cell Therapy Products
 8.1. Addressing Distribution Logistics
 8.2. Allogeneic vs. Autologous Therapies
 9. Market Trend Analysis - Key Trends Impacting the Marketplace
 9.1. Regulatory Issues
 9.1.1. FDA Guidelines for HCT/Ps
 9.1.2. 21st Century Cures Act)
 9.2. Global Trends
 9.2.1. Accelerated Approval Pathway in Japan
 9.2.2. Prolific Partnering Between Cell Therapy Companies and Japanese Pharmaceutical Companies
 9.2.3. Cell Therapy Products (and Pricing) Resulting from the Japanese Regulatory Framework
 10. Technologies Impacting the Cell Therapy Manufacturing Market
 10.1. Closed-System Manufacturing
 10.2. Automation of Cell Therapy Manufacturing Processes
 10.3. Automation of Data Management
 10.4. Bioreactor Technologies
 11. Market Potential for Autologous vs. Allogeneic Manufacturing
 [Table] Allogeneic vs. Autologous Product Development Among Leading Cell Therapy
 12. Cell Therapy Manufacturing Challenges and Considerations
 13. Conclusions


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