Roots Analysis has done a detailed study on Cell Therapy Manufacturing Market (3rdEdition), 2019 - 2030, covering various important aspects of the industry andidentifying key future growth opportunities.
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Key Market Insights
§ More than 100 industry players and over 60 non-industryplayers currently claim to manufacture different types of cell therapies,either for in-house requirements or on contract basis
§ The market is fragmented, featuring both establishedplayers and new entrants, which claim to operate at various scales andmanufacture a diverse range of cell therapies
§ In order to cater tothe growing needs of clients / sponsors, companies have established presenceacross different regions; presently, the US, the UK and China are the key hubsfor cell therapy manufacturing
§ In recent years, asignificant increase in partnership activity has been observed in this domain;in fact, therapy developers have already inked manufacturing deals with bothindigenous and international experts
§ In order to enhancecore competencies related to the domain, both drug developers and CMOs areactively investing in expanding their existing infrastructure and capabilities
§ Cell therapymanufacturers are also gradually opting to automate various operations in thesupply chain; the primary objective is to achieve favorable bench-to-clinictimelines and cut down on production related losses
§ Currently, theinstalled global capacity for cell therapy manufacturing is estimated to bespread across 1.2+ million square feet ofdedicated cleanroom area distributed across various scales of operation
§ More than 70,000 patientswere estimated to have been enrolled in cell therapy related clinical trials;the demand for cell therapies is anticipated to grow significantly over thenext decade
§ Revenues frommanufacturing operations of T-cell therapies are anticipated to capture highermarket share; the benefit will be realized by both autologous and allogeneictherapies across different regions the world
§ Clinical scalemanufacturing operations are likely to drive the future market size, takinginto consideration both in-house and contract service requirements
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Table of Contents
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Context and Background
3.2. Introduction to Cell Therapies
3.2.1. Comparison of Cell Therapies and OtherBiotechnology Products
3.2.2. Classification of Advanced Therapy MedicinalProducts (ATMPs)
3.2.3. Current Market Landscape of ATMPs
3.3. Overview of Cell Therapy Manufacturing
3.4. Cell Therapy Manufacturing Models
3.4.1. Centralized Manufacturing
3.4.2. Decentralized Manufacturing
3.5. Scalability of Cell Therapy Manufacturing
3.5.1. Scale-up
3.5.2. Scale-out
3.6. Types of Cell Therapy Manufacturers
3.7. Key Manufacturing-related Challenges
3.8. Factors Influencing Cell Therapy Manufacturing
3.9. Automating Cell Therapy Manufacturing
3.10. Cell Therapy Manufacturing Supply Chain
3.11. Future Perspectives
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Cell Therapy Manufacturers (IndustryPlayers): Overall Market Landscape
4.2.1. Analysis by Location of Headquarters
4.2.2. Analysis by Location of ManufacturingFacility
4.2.3. Analysis by Type of Cells Manufactured
4.2.4. Analysis by Source of Cells
4.2.5. Analysis by Scale of Operation
4.2.6. Analysis by Type of Cell Culture
4.2.7. Analysis by Purpose of Production
4.2.8. Analysis by Manufacturing Capabilities /Services
4.3. Cell Therapy Manufacturers (Non-IndustryPlayers): Overall Market Landscape
4.3.1. Analysis by Location of Headquarters
4.3.2. Analysis by Location of ManufacturingFacility
4.3.3. Analysis by Type of Cells Manufactured
4.3.4. Analysis by Source of Cells
4.3.5. Analysis by Scale of Operation
4.3.6. Analysis by Type of Cell Culture
4.3.7. Analysis by Purpose of Production
4.3.8. Analysis by Manufacturing Capabilities /Services
4.4. Cell Therapy Manufacturing: Role ofLogistics Service Providers
5. REGULATORY LANDSCAPE
5.1. Chapter Overview
5.2. Current Scenario
5.2.1. Regulatory Guidelines in the US
5.2.2. Regulatory Guidelines in Europe
5.2.3. Regulatory Guidelines in Japan
5.2.4. Conditional Approvals
5.3. Regulatory Accreditations for CellTherapy Manufacturing
5.3.1. Facilities Approved by Regulators toManufacture Cell Therapies
5.4. Summary of Guidelines for Clinical-StageManufacturing of Cell Therapies
5.5. Existing Challenges to Clinical-StageManufacturing
5.5.1. Variability in Regulatory Guidelines acrossDifferent Geographies
5.6. Conclusion
6. ROADMAPS FOR OVERCOMING EXISTINGCHALLENGES
6.1. Chapter Overview
6.2. Roadmap for the US
6.2.1. Cell Processing
6.2.2. Cell Preservation, Distribution and Handling
6.2.3. Process Automation and Data Analytics
6.2.4. Process Monitoring and Quality Control
6.2.5. Standardization and Regulatory Support
6.2.6. Workforce Development
6.2.7. Supply Chain and Logistics
6.3. Roadmaps for Other Geographies
6.3.1. Europe
6.3.2. Asia Pacific
7. AUTOMATION TECHNOLOGIES FOR CELLTHERAPY MANUFACTURING
7.1. Chapter Overview
7.2. Automation of Cell Therapy ManufacturingProcesses
7.2.1. Closed Systems
7.2.2. Single-use Systems
7.2.3. Modular Systems
7.3. Case Studies
7.3.1. Roadmap to Developing an Automated CellManufacturing / Processing Device
7.3.2. Automating Cell Therapy Manufacturing
7.4. GMP-in-a-Box
7.5. List of Automation Service Providers
7.6. Comparative Analysis of Manual andAutomated Processes
7.7. Concluding Remarks
8. PROFILES: INDUSTRY PLAYERS
8.1. Chapter Overview
8.2. Service Providers in the US
8.2.1 Cognate BioServices
8.2.1.1. Company Overview
8.2.1.2. Service Portfolio
8.2.1.3. Manufacturing Capabilities
8.2.1.4. Partnerships
8.2.1.5. Future Outlook
8.2.2. FUJIFILM Cellular Dynamics
8.2.2.1. Company Overview
8.2.2.2. Service Portfolio
8.2.2.3. Manufacturing Capabilities
8.2.2.4. Partnerships
8.2.2.5. Future Outlook
8.2.3. KBI Biopharma
8.2.3.1. Company Overview
8.2.3.2. Service Portfolio
8.2.3.3. Manufacturing Capabilities
8.2.3.4. Partnerships
8.2.3.5. Future Outlook
8.2.4. Hitachi Chemical Advanced TherapeuticsSolutions
8.2.4.1. Company Overview
8.2.4.2. Service Portfolio
8.2.4.3. Manufacturing Capabilities
8.2.4.4. Partnerships
8.2.4.5. Future Outlook
8.2.5. Waisman Biomanufacturing
8.2.5.1. Company Overview
8.2.5.2. Service Portfolio
8.2.5.3. Manufacturing Capabilities
8.2.5.4. Partnerships
8.2.5.5. Future Outlook
8.3. Service Providers in Europe
8.3.1. BioNTech Innovative Manufacturing Services
8.3.1.1. Company Overview
8.3.1.2. Service Portfolio
8.3.1.3. Manufacturing Capabilities
8.3.1.4. Partnerships
8.3.1.5. Future Outlook
8.3.2. Cell and Gene Therapy Catapult
8.3.2.1. Company Overview
8.3.2.2. Service Portfolio
8.3.2.3. Manufacturing Capabilities
8.3.2.4. Partnerships
8.3.2.5. Future Outlook
8.3.3. Lonza
8.3.3.1. Company Overview
8.3.3.2. Service Portfolio
8.3.3.3. Manufacturing Capabilities
8.3.3.4. Partnerships
8.3.3.5. Future Outlook
8.3.4. MaSTherCell
8.3.4.1. Company Overview
8.3.4.2. Service Portfolio
8.3.4.3. Manufacturing Capabilities
8.3.4.4. Partnerships
8.3.4.5. Future Outlook
8.3.5. Roslin Cell Therapies
8.3.5.1. Company Overview
8.3.5.2. Service Portfolio
8.3.5.3. Manufacturing Capabilities
8.3.5.4. Partnerships
8.3.5.5. Future Outlook
8.4. Service Providers in Asia Pacific
8.4.1. Cell Therapies
8.4.1.1. Company Overview
8.4.1.2. Service Portfolio
8.4.1.3. Manufacturing Capabilities
8.4.1.4. Partnerships
8.4.1.5. Future Outlook
8.4.2. Japan Tissue Engineering (J-TEC)
8.4.2.1. Company Overview
8.4.2.2. Service Portfolio
8.4.2.3. Manufacturing Capabilities
8.4.2.4. Partnerships
8.4.2.5. Future Outlook
8.4.3. MEDINET
8.4.3.1. Company Overview
8.4.3.2. Service Portfolio
8.4.3.3. Manufacturing Capabilities
8.4.3.4. Partnerships
8.4.3.5. Future Outlook
8.4.4. Nikon CeLL innovation
8.4.4.1. Company Overview
8.4.4.2. Service Portfolio
8.4.4.3. Manufacturing Capabilities
8.4.4.4. Partnerships
8.4.4.5. Future Outlook
8.4.5. WuXi Advanced Therapies
8.4.5.1. Company Overview
8.4.5.2. Service Portfolio
8.4.5.3. Manufacturing Capabilities
8.4.5.4. Partnerships
8.4.5.5. Future Outlook
9. PROFILES: NON-INDUSTRY PLAYERS
9.1. Chapter Overview
9.2. Center for Cell and Gene Therapy, BaylorCollege of Medicine
9.2.1. Overview
9.2.2. Operating Segments
9.2.3. Service Portfolio
9.2.4. Manufacturing Facilities and Capabilities
9.3. Centre for Cell Manufacturing Ireland,National University of Ireland
9.3.1. Overview
9.3.2. Service Portfolio
9.3.3. Manufacturing Facilities and Capabilities
9.4. Clinical Cell and Vaccine ProductionFacility, University of Pennsylvania
9.4.1. Overview
9.4.2. Service Portfolio
9.4.3. Manufacturing Facilities and Capabilities
9.5. Guy’s and St. Thomas’ GMP Facility, Guy’sHospital
9.5.1. Overview
9.5.2. Service Portfolio
9.5.3. Manufacturing Facilities and Capabilities
9.6. Laboratory for Cell and Gene Medicine,Stanford University
9.6.1. Overview
9.6.2. Service Portfolio
9.6.3. Manufacturing Facilities and Capabilities
9.7. Molecular and Cellular Therapeutics,University of Minnesota
9.7.1. Overview
9.7.2. Service Portfolio
9.7.3. Manufacturing Facilities and Capabilities
9.8. Newcastle Cellular Therapies Facility,Newcastle University
9.8.1. Overview
9.8.2. Service Portfolio
9.8.3. Manufacturing Facilities and Capabilities
9.9. Rayne Cell Therapy Suite, King’s CollegeLondon
9.9.1. Overview
9.9.2. Manufacturing Facilities and Capabilities
9.10. Scottish National Blood TransfusionServices Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
9.10.1. Overview
9.10.2. Manufacturing Facilities and Capabilities
9.11. Sydney Cell and Gene Therapy
9.11.1. Overview
9.11.2. Manufacturing Facilities and Capabilities
10. ROLE OF NON-PROFIT ORGANIZATIONS
10.1. Chapter Overview
10.2. Cell Therapy Manufacturing ServiceProviders: Non-Profit Organizations
10.2.1. CellCAN
10.2.2. Cell Therapy Manufacturing CooperativeResearch Center (CTM CRC)
10.2.3. National Cell Manufacturing Consortium (NCMC)
10.2.4. California Institute of Regenerative Medicine(CIRM)
10.3. Cell Therapy Manufacturing: AffiliatedInternational Societies
11. PARTNERSHIPS
11.1. Chapter Overview
11.2. Partnership Models
11.3. Cell Therapy Manufacturing: List ofPartnerships
11.3.1. Analysis by Year of Partnership
11.3.2. Analysis by Type of Partnership Model
11.3.3. Analysis by Year and Type of Partnership Model
11.4. Analysis by Type of Cells
11.5. Analysis by Scale of Operation
11.6. Geographical Analysis
11.6.1. Continent-wise Distribution
11.6.2. Country-wise Distribution
11.7. Most Active Players: Analysis by Number ofPartnerships
11.8. Cell Therapy Manufacturing: List ofAcquisitions
11.8.1. Analysis by Year and Type of Cells
11.8.2. Geographical Analysis
11.8.3. Ownership Change Matrix
12. FACILITY EXPANSIONS
12.1. Chapter Overview
12.2. Cell Therapy Manufacturing: List ofExpansions
12.2.1. Cumulative Year-wise Distribution
12.2.2. Analysis by Type of Cells
12.2.3. Analysis by Scale of Operation
12.2.3. Analysis by Purpose of Expansion
12.2.4. Analysis by Location of Manufacturing Facility
12.2.5. Analysis by Region and Purpose of Expansion
13. CAPACITY ANALYSIS
13.1. Chapter Overview
13.2. Key Assumptions and Methodology (IndustryPlayers)
13.2.1 Cell Therapy Manufacturing: Installed GlobalCapacity (Number of Cleanrooms)
13.2.1.1.Analysis by Size of Manufacturer
13.2.1.2.Analysis by Scale of Operation
13.2.1.3.Analysis by Location of Manufacturing Facility
13.2.2. Cell Therapy Manufacturing: Installed GlobalCapacity (Cleanroom Area)
13.2.2.1.Analysis by Size of Manufacturer
13.2.2.2.Analysis by Scale of Operation
13.2.2.3.Analysis by Location of Manufacturing Facility
13.3. Key Assumptions and Methodology(Non-Industry Players)
13.3.1. Cell Therapy Manufacturing: Installed Global Capacity(Number of Cleanrooms)
13.3.1.1.Analysis by Scale of Operation
13.3.1.2.Analysis by Location of Manufacturing Facility
13.3.2. Cell Therapy Manufacturing: Installed GlobalCapacity (Cleanroom Area)
13.3.2.1.Analysis by Scale of Operation
13.3.2.2.Analysis by Location of Manufacturing Facility
13.4 Concluding Remarks
14. DEMAND ANALYSIS
14.1 Chapter Overview
14.2 Key Assumptions and Methodology
14.3 Cell Therapy Manufacturing: Overall AnnualDemand
14.3.1. Analysis by Type of Cells
14.3.2. Analysis by Scale of Operations
14.3.3. Analysis by Geography
15. COST PRICE ANALYSIS
15.1. Chapter Overview
15.2. Factors Contributing to the High Price ofCell Therapies
15.3. Pricing Models for Cell Therapies
15.3.1. Based on Associated Costs for T-cell Therapies
15.3.2. Based on Associated Costs for Stem CellTherapies
15.3.3. Based on Availability of Competing Products
15.3.4. Based on Target Patient Segment
15.3.5. Based on Opinions of Industry Experts
15.4. Cell Therapy Cost Optimization
15.4.1. Role of Cost of Goods Sold
15.4.2. Role of Automation
15.4.3. Role of Cell Therapy Contract ManufacturingOrganizations
15.5. Reimbursement-related Considerations forCell Therapies
15.5.1. Case Study: The National Institute for Healthand Care Excellence’s (NICE) Appraisal of CAR-T Therapies
16. MAKE VERSUS BUY DECISION MAKINGFRAMEWORK
16.1. Chapter Overview
16.2. Make versus Buy Decision Making: AnalyticalOutput
17. MARKET SIZING AND OPPORTUNITY ANALYSIS
17.1. Chapter Overview
17.2. Scope of the Forecast
17.3. Forecast Methodology
17.4. Input Tables and Key Assumptions
17.5. Overall Cell Therapy Manufacturing Market,2019-2030
17.5.1. Cell Therapy Manufacturing Market, 2019-2030:Distribution by Type of Cell Therapy
17.5.2. Cell Therapy Manufacturing Market, 2019-2030:Distribution by Source of Cells
17.5.3. Cell Therapy Manufacturing Market, 2019-2030:Distribution by Scale of Operation
17.5.4. Cell Therapy Manufacturing Market, 2019-2030:Distribution by Purpose of
Production
17.5.5. Cell Therapy Manufacturing Market, 2019-2030:Geographical Distribution
17.6. Market Opportunity in Commercial ScaleManufacturing of Cell-based Therapies
17.6.1. Overall Commercial Scale Manufacturing Marketfor T-cell Therapies, 2019-2030
17.6.1.1.Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy, and TIL Therapy)
17.6.1.2.Distribution by Source of Cells
17.6.1.3.Geographical Distribution
17.6.2. Overall Commercial Scale Manufacturing Marketfor Dendritic Cell and Tumor Cell Therapies, 2019-2030
17.6.2.1.Distribution by Type of Therapy (Dendritic Cell Therapy, and Tumor CellTherapy)
17.6.2.2.Distribution by Source of Cells
17.6.2.3.Geographical Distribution
17.6.3. Overall Commercial Scale Manufacturing Marketfor NK Cell Therapies, 2019-2030
17.6.3.1.Distribution by Source of Cells
17.6.3.2.Geographical Distribution
17.6.4. Overall Commercial Scale Manufacturing Marketfor Stem Cell Therapies, 2019-2030
17.6.4.1.Distribution by Source of Cells
17.6.4.2.Geographical Distribution
17.7. Market Opportunity in Clinical ScaleManufacturing of Cell-based Therapies
17.7.1. Overall Clinical Scale Manufacturing Marketfor T-cell Therapies, 2019-2030
17.7.1.1.Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy and TIL Therapy)
17.7.1.2.Distribution by Source of Cells
17.7.1.3.Geographical Distribution
17.7.2. Overall Clinical Scale Manufacturing Marketfor Dendritic Cell and Tumor Cell Therapies, 2019-2030
17.7.2.1.Distribution by Type of Therapy (Dendritic Cell Therapy, Tumor Cell Therapy)
17.7.2.2.Distribution by Source of Cells
17.7.2.3.Geographical Distribution
17.7.3. Overall Clinical Scale Manufacturing Marketfor NK Cell Therapies, 2019-2030
17.7.3.1.Distribution by Source of Cells
17.7.3.2.Geographical Distribution
17.7.4. Overall Clinical Scale Manufacturing Marketfor Stem Cell Therapies, 2019-2030
17.7.4.1.Distribution by Source of Cells
17.7.4.2.Geographical Distribution
18. KEY INSIGHTS
18.1. Chapter Overview
18.2. Cell Therapy Manufacturers: Grid Analysis
18.3. Cell Therapy Manufacturers: Logo Landscapeby Type of Cell Therapy
18.3.1. Logo Landscape: Immune Cell Manufacturers
18.3.2. Logo Landscape: Stem Cell Manufacturers
18.4. Cell Therapy Manufacturers: World MapRepresentation of Location of Manufacturing Facility
18.4.1. Industry Players
18.4.2. Non-Industry Players
19. SWOT ANALYSIS
19.1. Chapter Overview
19.2. Strengths
19.3. Weaknesses
19.4. Opportunities
19.5. Threats
19.6. Comparison of SWOT Factors
19.6.1. Concluding Remarks
20. CONCLUSION
20.1. Chapter Overview
20.2. Key Takeaways
21. SURVEY ANALYSIS
21.1. Chapter Overview
21.2. Seniority Level of Respondents
21.3. Type of Cell Therapy
21.4. Scale of Operation
21.5. Source of Cells
21.6. Type of Cell Culture System
22.7. Availability of Fill / Finish Services
22. INTERVIEW TRANSCRIPTS
22.1. Chapter Overview
22.2. Lion TCR
22.2.1. Company Overview
22.2.2. Interview Transcript: Victor Lietao Li, Co-Founderand Chief Executive Officer
22.3. Cell Therapies
22.3.1. Company Overview
22.3.2. Interview Transcript: Tim Oldham, ChiefExecutive Officer
22.4. CiMaas
22.4.1. Company Overview
22.4.2. Interview Transcript: Gerard MJ Bos, ChiefExecutive Officer
22.5. Gracell Biotechnologies
22.5.1. Company Overview
22.5.2. Interview Transcript: Wei (William) Cao, Chief Executive Officer
22.6. Glycostem Therapeutics
22.6.1. Company Overview
22.6.2. Interview Transcript: Troels Jordansen, ChiefExecutive Officer
22.7. Kadimastem
22.7.1. Company Overview
22.7.2. Interview Transcript: Arik Hasson, ExecutiveVP Research and Development
22.8. Bio Elpida
22.8.1. Company Overview
22.8.2. Interview Transcript: Gilles Devillers,General Manager
22.9. Center for Commercialization of CancerImmunotherapy / C3i
22.9.1. Company Overview
22.9.2. Interview Transcript: Arnaud Deladeriere,Manager, Business Development & Operations-cGMP Manufacturing Unit
22.10. Waisman Biomanufacturing
22.10.1.Company Overview
22.10.2.Interview Transcript: Brian Dattilo, Manager of Business Development
22.11. RoslinCT
22.11.1.Company Overview
22.11.2.Interview Transcript: Fiona Bellot, Business Development Manager
22.12. Yposkesi
22.12.1.Company Overview
22.12.2.Interview Transcript: Mathilde Girard, Leader, Cell Therapy Innovation and Development
22.13. University of Minnesota
22.13.1.Organization Overview
22.13.2.Interview Transcript: David Mckenna, Professor and American Red in TransfusionMedicine
23. APPENDIX 1: TABULATED DATA
24. APPENDIX 2: LIST OF COMPANIES ANDORGANIZATIONS
Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
