The Cell Therapy Manufacturing Market is projected to grow at an annualized rate of >16.5%, till 2030
Roots Analysis has done a detailed study on Cell Therapy Manufacturing Market (3rd Edition), 2019 - 2030, covering various important aspects of the industry and identifying key future growth opportunities.
Key Market Insights
· More than 100 industry players and over 60 non-industry players currently claim to manufacture different types of cell therapies, either for in-house requirements or on contract basis
· The market is fragmented, featuring both established players and new entrants, which claim to operate at various scales and manufacture a diverse range of cell therapies
· In order to cater to the growing needs of clients / sponsors, companies have established presence across different regions; presently, the US, the UK and China are the key hubs for cell therapy manufacturing
· In recent years, a significant increase in partnership activity has been observed in this domain; in fact, therapy developers have already inked manufacturing deals with both indigenous and international experts
· In order to enhance core competencies related to the domain, both drug developers and CMOs are actively investing in expanding their existing infrastructure and capabilities
· Cell therapy manufacturers are also gradually opting to automate various operations in the supply chain; the primary objective is to achieve favorable bench-to-clinic timelines and cut down on production related losses
· Currently, the installed global capacity for cell therapy manufacturing is estimated to be spread across 1.2+ million square feet of dedicated cleanroom area distributed across various scales of operation
· More than 70,000 patients were estimated to have been enrolled in cell therapy related clinical trials; the demand for cell therapies is anticipated to grow significantly over the next decade
· Revenues from manufacturing operations of T-cell therapies are anticipated to capture higher market share; the benefit will be realized by both autologous and allogeneic therapies across different regions the world
· Clinical scale manufacturing operations are likely to drive the future market size, taking into consideration both in-house and contract service requirements
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A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
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 Other Biotechnology Products
3.2.2. Classification of Advanced Therapy Medicinal Products (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 (Industry Players): Overall Market Landscape
4.2.1. Analysis by Location of Headquarters
4.2.2. Analysis by Location of Manufacturing Facility
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-Industry Players): Overall Market Landscape
4.3.1. Analysis by Location of Headquarters
4.3.2. Analysis by Location of Manufacturing Facility
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 of Logistics 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 Cell Therapy Manufacturing
5.3.1. Facilities Approved by Regulators to Manufacture Cell Therapies
5.4. Summary of Guidelines for Clinical-Stage Manufacturing of Cell Therapies
5.5. Existing Challenges to Clinical-Stage Manufacturing
5.5.1. Variability in Regulatory Guidelines across Different Geographies
5.6. Conclusion
6. ROADMAPS FOR OVERCOMING EXISTING CHALLENGES
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 CELL THERAPY MANUFACTURING
7.1. Chapter Overview
7.2. Automation of Cell Therapy Manufacturing Processes
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 Cell Manufacturing / 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 and Automated 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 Therapeutics Solutions
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, Baylor College 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 Production Facility, 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’s Hospital
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 College London
9.9.1. Overview
9.9.2. Manufacturing Facilities and Capabilities
9.10. Scottish National Blood Transfusion Services 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 Service Providers: Non-Profit Organizations
10.2.1. CellCAN
10.2.2. Cell Therapy Manufacturing Cooperative Research 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: Affiliated International Societies
11.PARTNERSHIPS
11.1. Chapter Overview
11.2. Partnership Models
11.3. Cell Therapy Manufacturing: List of Partnerships
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 of Partnerships
11.8. Cell Therapy Manufacturing: List of Acquisitions
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 of Expansions
12.2.1. Cumulative Year-wise Distribution
12.2.2. Analysis by Type of Cells
12.2.3. Analysis by Scale of Operation
12.2.4. Analysis by Purpose of Expansion
12.2.5. Analysis by Location of Manufacturing Facility
12.2.6. Analysis by Region and Purpose of Expansion
13.CAPACITY ANALYSIS
13.1. Chapter Overview
13.2. Key Assumptions and Methodology (Industry Players)
13.2.1 Cell Therapy Manufacturing: Installed Global Capacity (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 Global Capacity (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 Global Capacity (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 Annual Demand
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 of Cell 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 Cell Therapies
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 Manufacturing Organizations
15.5. Reimbursement-related Considerations for Cell Therapies
15.5.1. Case Study: The National Institute for Health and Care Excellence’s (NICE) Appraisal of CAR-T Therapies
16.MAKE VERSUS BUY DECISION MAKING FRAMEWORK
16.1. Chapter Overview
16.2. Make versus Buy Decision Making: Analytical Output
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
17.5.5. Production
17.5.6. Cell Therapy Manufacturing Market, 2019-2030: Geographical Distribution
17.6. Market Opportunity in Commercial Scale Manufacturing of Cell-based Therapies
17.6.1. Overall Commercial Scale Manufacturing Market for 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 Market for Dendritic Cell and Tumor Cell Therapies, 2019-2030
17.6.2.1. Distribution by Type of Therapy (Dendritic Cell Therapy, and Tumor Cell Therapy)
17.6.2.2. Distribution by Source of Cells
17.6.2.3. Geographical Distribution
17.6.3. Overall Commercial Scale Manufacturing Market for 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 Market for 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 Scale Manufacturing of Cell-based Therapies
17.7.1. Overall Clinical Scale Manufacturing Market for 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 Market for 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 Market for 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 Market for 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 Landscape by 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 Map Representation 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-Founder and Chief Executive Officer
22.3. Cell Therapies
22.3.1. Company Overview
22.3.2. Interview Transcript: Tim Oldham, Chief Executive Officer
22.4. CiMaas
22.4.1. Company Overview
22.4.2. Interview Transcript: Gerard MJ Bos, Chief Executive 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, Chief Executive Officer
22.7. Kadimastem
22.7.1. Company Overview
22.7.2. Interview Transcript: Arik Hasson, Executive VP 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 Cancer Immunotherapy / 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 Transfusion Medicine
23.APPENDIX 1: TABULATED DATA
24.APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
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