Lowest Price Guaranteed From USD 4,899
Published
January 2020
Pages
502
View Count
10315
The cost of cell-based therapies depends on various factors, such as duration of manufacturing, vector-based cell transfection and extent of gene modification. Price of such products has been observed to vary between USD 2,000 (for cartilage implants) to USD 50,000-60,000 (for cell and gene therapies).
-- CEO, a small-sized cell therapies manufacturer
Till date, more than 20 cell-based therapies have been approved (recent examples include Zynteglo® (2019), Alofisel® (2018), YESCARTA® (2017) and Kymriah® (2017)), while over 500 product candidates are under development. In fact, there are over 1,000 active clinical studies of cell therapies, worldwide. Over the last few years, such therapies have garnered significant attention within the biopharmaceutical industry. Several companies and venture capital funds / investors have already invested a lot of capital towards the development and commercialization of this emerging class of therapeutics. Despite the optimism, the growth in this domain is still hindered by various development and manufacturing related challenges, primarily due to the limited availability of expertise and infrastructure to produce cell-based therapies, such as CAR-T cell therapies. The growing number of product development initiatives in this domain, coupled to the fact that there are multiple marketed products, have led to a substantial rise in the overall cell therapy manufacturing demand. As a result, developers have turned to contract manufacturing organizations (CMOs) to fulfil their cell therapy development and production requirements.
A wide array of industry players, including well-established companies, mid-sized firms and start-ups, as well as academic institutes, are contributing towards fulfilling the aforementioned demand, offering GMP grade manufacturing services for cell therapies. In addition to cell therapy manufacturing companies, there are several other players that claim to have developed novel technology solutions, aimed at improving the existing cell therapy manufacturing process. Many CMOs are also actively expanding their cell therapy manufacturing capacity either through collaborations or acquisitions, in order to offer a wide range of services to their respective clients. As a result of the ongoing efforts aimed at mitigating the existing challenges in this domain, the cell therapy manufacturing market is expected to witness significant growth in mid-long term.
The “Cell Therapy Manufacturing Market (3rd Edition), 2019-2030” features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing. It focuses on both contract manufacturers, as well as developers with in-house manufacturing facilities, offering in-depth analyses of the various business entities that are engaged in this domain, across different global regions. Amongst other elements, the report includes:
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the cell therapy manufacturing market. Based on parameters, such as number of ongoing / planned clinical studies, cell therapy manufacturing costs, target patient population, and anticipated adoption of such products, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2019-2030. In addition, to account for the uncertainties associated with the manufacturing of cell-based therapies and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.
The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with the following individuals:
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high-level view on the likely evolution of the cell-based therapy manufacturing market in the short to mid-term, and long term.
Chapter 3 provides a general introduction to cell-based therapies and ATMPs. It includes a detailed discussion on the manufacturing process of cell-based therapies, and associated challenges and applications of currently available cell therapies. It also provides information on the different manufacturing models (centralized and decentralized) that are being used for the production of cell-based therapies, along with a discussion on their respective advantages and disadvantages. Further, it features details related to the scalability of cell-based therapies. The chapter also includes a brief overview on the role of automation and the need for effective supply chain management for cell-based therapies.
Chapter 4 features a detailed list of all the industry, as well as non-industry players that are actively involved in the manufacturing of cell-based therapies. It provides information on the location of their manufacturing facilities, scale of manufacturing, type of cells manufactured (immune cells (such as T cells, dendritic cells, NK cells), stem cells (such as adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), purpose of production (fulfilling in-house requirements / as a contract service provider), source of cells (autologous / allogeneic), manufacturing capabilities / services offered (such as R&D, cell culture development, testing, packaging, labelling, cell banking, cryopreservation, fill/ finish services, regulatory services).
Chapter 5 features a detailed discussion on the regulatory landscape related to cell therapies across various geographies, such as the US, Europe and Japan. Further, it presents an analysis of the manufacturing facilities on basis of the certifications awarded (for manufacturing cell-based therapies) to individual sites by various regulatory bodies across the globe.
Chapter 6 describes the strategies that are likely to be adopted to accelerate the translation of cell-based therapies from laboratory to clinics. It provides details on roadmaps published by different organizations located across various geographies, specifically in the US.
Chapter 7 discusses the role of automation technologies in optimization of current manufacturing practices with the use of closed and single use systems. Further, it features a roadmap that provides information on the steps to develop automation devices, supported by two case studies. It also presents a qualitive analysis on the cost incurred while manufacturing cell-based therapies using manual versus automated manufacturing approaches. In addition, it features a list of organizations that offer automated technologies for manufacturing operations or provide services to therapy developers to automate their production processes.
Chapter 8 features detailed profiles of industry players that offer contract manufacturing services for cell therapies at the clinical and / or commercial scales. Each profile provides a brief overview of the company, details on its manufacturing capabilities and facilities, recent partnerships and an informed future outlook.
Chapter 9 features profiles of non-industry players that offer contract manufacturing services for cell therapies. Each profile provides a brief overview of the organization, and details on its service portfolio and manufacturing facilities.
Chapter 10 discusses the role of non-profit organizations in this domain. It provides a list of organizations that are actively involved in the development and production of cell-based therapies, across different global regions. Further, it includes profiles of organizations that provide financial and / or technological support to cell therapy manufacturers and developers. Additionally, the chapter provides information on various international / national societies that help in disseminating knowledge about the advancement of these therapies to the general community.
Chapter 11 features an analysis of the various partnerships and collaborations that have been inked amongst players engaged in this domain, between 2014-2019. It includes a brief description on the various types of partnership models (which include manufacturing agreements, manufacturing process development agreements, licensing agreements, additional services agreements, acquisitions, joint ventures, service alliances and others) that are employed by stakeholders in this market, and an analysis on the trend of partnerships inked since 2014. It also includes analyses based on year of agreement, type of partnership, scale of operation, types of services offered and types of cells manufactured. Further, the chapter features a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.
Chapter 12 presents detailed analysis on the expansions that have taken place in the cell therapy manufacturing industry, since 2014. It includes information on expansions carried out for increasing existing capabilities, as well as those intended for setting-up of new facilities by manufacturers engaged in this domain. The expansion instances that we came across were analyzed based on various parameters, including year of expansion, type of expansion (capacity expansion and new facility), geographical location of the facility, scale of operation (as mentioned in the expansion terms), type of capability (research and manufacturing), type of cells (CAR-T cells, TCR cells, TIL cells, NK cells, dendritic cells and stem cells).
Chapter 13 features a comprehensive analysis of the overall installed capacity of cell-based therapy manufacturers. The analysis is based on meticulous data collection of reported capacities, via both secondary and primary research, of various small, mid-sized and large companies, and non-industry players distributed across their respective facilities. The results of this analysis were used to establish an informed opinion on the cell-based therapy production capabilities of organizations across different types of organization (industry and non-industry), scale of operation (clinical and commercial), geographies (North America, EU, Asia Pacific and the rest of the world) and size of the organization (small, mid-sized and large organizations).
Chapter 14 features a detailed analysis of the annual demand for cell therapies (in terms of number of cells produced and area dedicated to manufacturing), considering various relevant parameters, such as target patient population, dosing frequency and dose strength of the approved cell therapies, as well as those therapies that are currently being evaluated in clinical trials. The demand analysis has been segmented across different types of cell therapies (including CAR-T cells, TCR cells, TIL cells, NK cells, dendritic cells and stem cells), scales of operation (clinical and commercial) and regions (North America, Europe and Asia Pacific).
Chapter 15 highlights our views on the various factors, including manufacturing costs, that may be taken into consideration while pricing cell-based therapies. It features discussions on different pricing models / approaches, which a manufacturer may choose to adopt to decide the price of its proprietary products.
Chapter 16 presents a qualitative analysis that highlights the various factors that need to be taken into consideration by cell therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMOs.
Chapter 17 presents a comprehensive market forecast analysis, highlighting the likely growth of the cell therapy manufacturing market till the year 2030. We have segregated the opportunity by type of cell therapy (T-cell immunotherapies, dendritic cell-based therapies, NK cell therapies, stem cell therapies and other ATMPs), scale of operation (clinical and commercial), source of cells (autologous and allogeneic), purpose of production (in-house and contract services) and geography (North America, EU and Asia Pacific).
Chapter 18 presents a collection of key insights derived from the study. It includes a grid analysis, highlighting the distribution of cell-based therapy manufacturers on the basis of type of cells manufactured, scale of production and purpose of manufacturing (fulfilling in-house requirement / contract service provider). In addition, it consists of two logo landscapes, representing the distribution of cell-based therapy manufacturers based on the type of cells manufactured (immune cells and stem cells), geographical regions (North America, EU and Asia Pacific) and the type / size of organization (non-industry, small, mid-sized and large companies). The chapter also comprises of two schematic world map representations to highlight the locations of various cell-based therapy manufacturing facilities across different continents.
Chapter 19 provides a discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall industry.
Chapter 20 summarizes the entire report. It provides the key takeaways and presents our independent opinion of the cell therapy manufacturing market, based on the research and analysis described in the previous chapters.
Chapter 21 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development and / or manufacturing of different types of cell therapies. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.
Chapter 22 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR), Tim Oldham (Chief Executive Officer, Cell Therapies), Gerard MJ Bos (Chief Executive Officer, CiMaas), Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies), Arik Hasson (Executive VP Research and Development, Kadimastem), Gilles Devillers (General Manager, Bio Elpida), Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing), Fiona Bellot (Business Development Manager, Roslin CT), Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, Yposkesi) and David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota).
Chapter 23 is an appendix that contains tabulated data and numbers for all the figures provided in the report.
Chapter 24 is an appendix that provides the list of companies and organizations mentioned in the report.
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
12.2.3. 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 (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
Production
17.5.5. 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
21.7. 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
22.7. 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, Department 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 Cross Chair in Transfusion Medicine
23. APPENDIX 1: TABULATED DATA
24. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
Figure 3.1. Classification of Advanced Therapy Medicinal Products
Figure 3.2. Decentralized Manufacturing Process Model
Figure 3.3. Types of Cell Therapy Manufacturers
Figure 3.4. Cell Therapies: Challenges and Drivers
Figure 3.5. Cell Therapies: Potency as a Critical Quality Attribute
Figure 3.6. Cell Therapy Manufacturing Supply Chain Model
Figure 4.1. Cell Therapy Manufacturers (Industry Players): Distribution by Location of
Figure 4.2. Cell Therapy Manufacturers (Industry Players): Distribution by Location of
Figure 4.3. Cell Therapy Manufacturers (Industry Players): Distribution by Location of
Figure 4.4. Cell Therapy Manufacturers (Industry Players): Distribution by Type of Cells
Figure 4.5. Cell Therapy Manufacturers (Industry Players): Distribution by Immune Cells
Figure 4.6. Cell Therapy Manufacturers (Industry Players): Distribution by Stem Cells
Figure 4.7. Cell Therapy Manufacturers (Industry Players): Distribution by Source of Cells
Figure 4.8. Cell Therapy Manufacturers (Industry Players): Distribution by Scale of Operation
Figure 4.9. Cell Therapy Manufacturers (Industry Players): Distribution by Type of Cell Culture
Figure 4.10. Cell Therapy Manufacturers (Industry Players): Distribution by Purpose of Production
Figure 4.11. Cell Therapy Manufacturers (Industry Players): Distribution by Manufacturing
Figure 4.12. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Location of Headquarters
Figure 4.13. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Location of Manufacturing Facility (Region-wise)
Figure 4.14. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Location of Manufacturing Facility (Country-wise)
Figure 4.15. Cell Therapy Non-Industry Manufacturers: Distribution by Type of Cells
Figure 4.16. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Immune Cells
Figure 4.17. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Stem Cells
Figure 4.18. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Source of Cells
Figure 4.19. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Scale of Operation
Figure 4.20. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Type of Cell Culture
Figure 4.21. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Purpose of
Figure 4.22. Cell Therapy Manufacturers (Non-Industry Players): Distribution by Manufacturing Capabilities / Services
Figure 5.1. Number of Facilities Authorized to Manufacture Cell Therapies by Different
Figure 6.1. Cell Therapy Manufacturing: Roadmap for the US
Figure 6.2. Cell Therapy Manufacturing: Roadmap for the Asia Pacific Economic
Figure 7.1. Requirements to Implement Closed Systems in Cell Therapy Manufacturing
Figure 7.2. Advantages and Disadvantages of Single-Use Systems
Figure 7.3. Cell Therapy Manufacturing: Roadmap for Developing an Automated Device
Figure 7.4. Cell Therapy Manufacturing: Comparison of Manual and Automated
Figure 7.5. Cell Therapy Manufacturing: Comparison Analysis of Manual and
Figure 7.6. Cell Therapy Manufacturing: Comparison of Manual and Automated Processes Based on Annual Cost of Manufacturing
Figure 8.1. Cognate BioServices: Service Portfolio
Figure 8.2. FUJIFILM Cellular Dynamics: Service Portfolio
Figure 8.3. KBI Biopharma: Service Portfolio
Figure 8.4. Hitachi Chemical Advanced Therapeutics Solutions: Company Structure
Figure 8.5. Hitachi Chemical Advanced Therapeutics Solutions: Service Portfolio
Figure 8.6. Waisman Biomanufacturing: Service Portfolio
Figure 8.7. Waisman Biomanufacturing: Clinical Products Portfolio
Figure 8.8. Waisman Biomanufacturing: Quality Assurance and Control
Figure 8.9. Waisman Biomanufacturing: Manufacturing Suites
Figure 8.10. Waisman Biomanufacturing: Overview of Manufacturing Services
Figure 8.11. BioNTech Innovative Manufacturing Services: Service Portfolio
Figure 8.12. Cell and Gene Therapy Catapult: Service Portfolio
Figure 8.13. Lonza: Historical Timeline
Figure 8.14. Lonza: Important Business Divisions
Figure 8.15. Lonza Pharma and Biotech: Service Portfolio
Figure 8.16. Lonza: Biological Manufacturing Services
Figure 8.17. Lonza: Cell-based Products
Figure 8.18. Lonza Netherlands: Service Portfolio
Figure 8.19. MaSTherCell: Service Portfolio
Figure 8.20. Roslin Cell Therapies: Service Portfolio
Figure 8.21. Cell Therapies: Service Portfolio
Figure 8.22. Japan Tissue Engineering: Service Portfolio
Figure 8.23. MEDINET: Service Portfolio
Figure 8.24. Nikon CeLL innovation: Service Portfolio
Figure 9.1. Center for Cell and Gene Therapy: Operating Segments
Figure 9.2. Center for Cell and Gene Therapy: Service Portfolio
Figure 9.3. Center for Cell Manufacturing Ireland: Service Portfolio
Figure 9.4. Molecular and Cellular Therapeutics: Service Portfolio
Figure 9.5. Newcastle Cellular Therapies Facility: Service Portfolio
Figure 11.1. Partnerships: Cumulative Trend by Year (2014-2019)
Figure 11.2. Partnerships: Distribution by Type of Partnership Model
Figure 11.3. Partnerships: Distribution by Year and Type of Partnership Model (2014-2019)
Figure 11.4. Partnerships: Distribution by Type of Cells
Figure 11.5. Partnerships: Distribution by Immune Cells
Figure 11.6. Partnerships: Distribution by Stem Cells
Figure 11.7. Partnerships: Distribution by Scale of Operation
Figure 11.8. Partnerships: Distribution by Scale of Operation and Type of Cells
Figure 11.9. Partnerships: Continent-wise Distribution
Figure 11.10. Partnerships: Country-wise Distribution
Figure 11.11. Most Active Players: Distribution by Number of Partnerships
Figure 11.12. Heat Map Analysis: Distribution by Most Active Players and Type of Cells
Figure 11.13. Acquisitions: Distribution by Year and Type of Cells
Figure 11.14. Acquisitions: Continent-wise Distribution
Figure 11.15. Acquisitions: Country-wise Distribution
Figure 11.16. Acquisitions: Ownership Change Matrix
Figure 12.1. Expansions: Cumulative Year-wise Trend, 2014-2019
Figure 12.2. Expansions: Distribution by Type of Cells
Figure 12.3. Expansions: Distribution by Scale of Operation
Figure 12.4. Expansions: Distribution by Purpose of Expansion
Figure 12.5. Expansions: Distribution by Location of Facility (Region-wise)
Figure 12.6. Expansions: Distribution by Location of Facility (Country-wise)
Figure 12.7. Expansions: Distribution by Region and Purpose of Expansion
Figure 13.1. Cell Therapy Manufacturing: Installed Global Capacity of Industry Players
Figure 13.2. Cell Therapy Manufacturing: Installed Global Capacity of Industry Players
Figure 13.3. Cell Therapy Manufacturing Capacity (Industry Players): Distribution by Size
Figure 13.4. Cell Therapy Manufacturing Capacity (Industry Players): Distribution by Scale
Figure 13.5. Cell Therapy Manufacturing Capacity (Industry Players): Distribution by
Figure 13.6. Cell Therapy Manufacturing Capacity (Industry Players): Distribution by Size of Manufacturer (Cleanroom Area)
Figure 13.7. Cell Therapy Manufacturing Capacity (Industry Players): Distribution by Scale of Operation (Cleanroom Area)
Figure 13.8. Cell Therapy Manufacturing Capacity (Industry Players): Distribution by Location of Manufacturing Facility (Cleanroom Area)
Figure 13.9. Cell Therapy Manufacturing: Installed Global Capacity of Non-Industry Players (Number of Cleanrooms)
Figure 13.10. Cell Therapy Manufacturing Capacity (Non-Industry Players): Distribution by Scale of Operation (Number of Cleanrooms)
Figure 13.11. Cell Therapy Manufacturing Capacity (Non-Industry Players): Distribution by Location of Manufacturing Facility (Number of Cleanrooms)
Figure 13.12. Cell Therapy Manufacturing: Installed Global Capacity of Non-Industry Players (Cleanroom Area)
Figure 13.13. Cell Therapy Manufacturing Capacity (Non-Industry Players): Distribution by Scale of Operation (Cleanroom Area)
Figure 13.14. Cell Therapy Manufacturing Capacity (Non-Industry Players): Distribution by Location of Manufacturing Facility (Cleanroom Area)
Figure 14.1. Demand Analysis: Overall Annual Demand for Cell Therapies
Figure 14.2. Demand Analysis: Annual Demand for T-cells
Figure 14.3. Demand Analysis: Annual Demand for Dendritic and Tumor Cells
Figure 14.4. Demand Analysis: Annual Demand for NK Cells
Figure 14.5. Demand Analysis: Annual Demand for Stem Cells
Figure 14.6. Demand Analysis: Annual Demand for Clinical Scale Operations
Figure 14.7. Demand Analysis: Annual Demand for Commercial Scale Operations
Figure 14.8. Demand Analysis: Annual Demand for North America
Figure 14.9. Demand Analysis: Annual Demand for Europe
Figure 14.10. Demand Analysis: Annual Demand for Asia Pacific
Figure 15.1. Targeted Therapies: Pricing Model Based on Patient Segment
Figure 16.1. Parameters to Assess Complexity of Outsourcing Manufacturing Operations
Figure 16.2. Make versus Buy: Decision Making Framework
Figure 17.1. Overall Cell Therapy Manufacturing Market, Base Scenario, 2019-2030 (USD
Figure 17.2. Cell Therapy Manufacturing Market: Distribution by Type of Cell Therapy,
Figure 17.3. Cell Therapy Manufacturing Market: Distribution by Source of Cells, 2019-
Figure 17.4. Cell Therapy Manufacturing Market: Distribution by Scale of Operation, 2019-2030 (USD Million)
Figure 17.5. Cell Therapy Manufacturing Market: Distribution by Purpose of Production, 2019-2030 (USD Million)
Figure 17.6. Cell Therapy Manufacturing Market: Geographical Distribution, 2019 and 2030
Figure 17.7. Overall Commercial Scale Manufacturing Market for T-cell Therapies, Base Scenario, 2019-2030 (USD Million)
Figure 17.8. Commercial Scale Manufacturing Market for T-cell Therapies, Base Scenario, 2019-2030: Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy, TIL Therapy) (USD Million)
Figure 17.9. Commercial Scale Manufacturing Market for T-cell Therapies, Base Scenario, 2019-2030: Distribution by Source of Cells (USD Million)
Figure 17.10. Commercial Scale Manufacturing Market for T-cell Therapies, Base Scenario, 2019-2030: Distribution by Regions (USD Million)
Figure 17.11. Overall Commercial Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Base Scenario, 2019-2030 (USD Million)
Figure 17.12. Commercial Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Base Scenario, 2019-2030: Distribution by Type of Therapy (Dendritic Cell Therapy, Tumor Cell Therapy) (USD Million)
Figure 17.13. Commercial Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Base Scenario, 2019-2030: Distribution by Source of Cells (USD Million)
Figure 17.14. Commercial Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Base Scenario, 2019-2030: Geographical Distribution (USD Million)
Figure 17.15. Overall Commercial Scale Manufacturing Market for NK Cell Therapies, Base Scenario, 2019-2030 (USD Million)
Figure 17.16. Commercial Scale Manufacturing Market for NK Cell Therapies, Base Scenario, 2019-2030: Distribution by Source of Cells (USD Million)
Figure 17.17. Commercial Scale Manufacturing Market for NK Cell Therapies, Base Scenario, 2019-2030: Geographical Distribution (USD Million)
Figure 17.18. Overall Commercial Scale Manufacturing Market for Stem Cell Therapies, Base Scenario, 2019-2030 (USD Million)
Figure 17.19. Commercial Scale Manufacturing Market for Stem Cell Therapies, Base Scenario, 2019-2030: Distribution by Source of Cells (USD Million)
Figure 17.20. Commercial Scale Manufacturing Market for Stem Cell Therapies, Base Scenario, 2019-2030: Geographical Distribution (USD Million)
Figure 17.21. Overall Clinical Scale Manufacturing Market for T-cell Therapies, Base Scenario, 2019-2030 (USD Million)
Figure 17.22. Clinical Scale Manufacturing Market for T-cell Therapies, Base Scenario, 2019-2030: Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy, TIL Therapy) (USD Million)
Figure 17.23. Clinical Scale Manufacturing Market for T-cell Therapies, Base Scenario, 2019-2030: Distribution by Source of Cells (USD Million)
Figure 17.24. Clinical Scale Manufacturing Market for T-cell Therapies, Base Scenario, 2019-2030: Geographical Distribution (USD Million)
Figure 17.25. Overall Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Base Scenario, 2019-2030 (USD Million)
Figure 17.26. Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Base Scenario, 2019-2030: Distribution by Type of Therapy (Dendritic Cell Therapy, Tumor Cell Therapy) (USD Million)
Figure 17.27. Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Base Scenario, 2019-2030: Distribution by Source of Cells (USD Million)
Figure 17.28. Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Base Scenario, 2019-2030: Geographical Distribution (USD Million)
Figure 17.29. Overall Clinical Scale Manufacturing Market for NK Cell Therapies, Base Scenario, 2019-2030 (USD Million)
Figure 17.30. Clinical Scale Manufacturing Market for NK Cell Therapies, Base Scenario, 2019-2030: Distribution by Source of Cells (USD Million)
Figure 17.31. Clinical Scale Manufacturing Market for NK Cell Therapies, Base Scenario, 2019-2030: Geographical Distribution (USD Million)
Figure 17.32. Overall Clinical Scale Manufacturing Market for Stem Cell Therapies, Base Scenario, 2019-2030 (USD Million)
Figure 17.33. Clinical Scale Manufacturing Market for Stem Cell Therapies, Base Scenario, 2019-2030: Distribution by Source of Cells (USD Million)
Figure 17.34. Clinical Scale Manufacturing Market for Stem Cell Therapies, Base Scenario, 2019-2030: Distribution by Regions (USD Million)
Figure 18.1. Cell Therapy Manufacturers: Grid Analysis by Type of Manufacturer and Scale of Operation
Figure 18.2. Cell Therapy Manufacturers: Logo Landscape, Immune Cells
Figure 18.3. Cell Therapy Manufacturers: Logo Landscape, Stem Cells
Figure 18.4. Cell Therapy Manufacturers (Industry Players): Geographical Distribution by Location of Manufacturing Facility, World Map Representation
Figure 18.5. Cell Therapy Manufacturers (Non-Industry Players): Geographical Distribution by Location of Manufacturing Facility, World Map Representation
Figure 19.1. Cell Therapy Manufacturing: SWOT Analysis
Figure 19.2. Comparison of SWOT Factors: Harvey Ball Analysis
Figure 21.1. Survey Insights: Type of Organization
Figure 21.2. Survey Insights: Location of Manufacturing Facility
Figure 21.3. Survey Insights: Seniority Level of Respondents
Figure 21.4. Survey Insights: Type of Cell Therapy
Figure 21.5. Survey Insights: Scale of Manufacturing
Figure 21.6. Survey Insights: Source of Cells
Figure 21.7. Survey Insights: Cell Culture System
Figure 21.8. Survey Insights: Fill / Finish Service
Table 3.1. Applications of Cell-based Therapies
Table 3.2. Differences between Cell Therapies and Biotechnology Products
Table 3.3. Commercialized Cell-based Therapies
Table 3.4. Key Cell Therapy Manufacturing Steps
Table 3.5. Advantages and Disadvantages of Centralized and Decentralized Manufacturing Models
Table 4.1. Cell Therapy Manufacturers: List of Industry Players
Table 4.2. Cell Therapy Manufacturers: Information on Type of Cells Manufactured
Table 4.3. Cell Therapy Manufacturers: Information on Purpose of Production
Table 4.4. Cell Therapy Manufacturers: Information on Scale of Operation
Table 4.5. Cell Therapy Manufacturers: Information on Source of Cells
Table 4.6. Cell Therapy Manufacturers: Information on Type of Cell Culture
Table 4.7. Cell Therapy Manufacturers: Information on Type of Manufacturing Capabilities / Services
Table 4.8. Cell Therapy Manufacturers: List of Non-Industry Players
Table 4.9. Cell Therapy Manufacturers: Information on Type of Cells Manufactured
Table 4.10. Cell Therapy Manufacturers: Information on Purpose of Production
Table 4.11. Cell Therapy Manufacturers: Information on Scale of Operation
Table 4.12. Cell Therapy Manufacturers: Information on Source of Cells
Table 4.13. Cell Therapy Manufacturers: Information on Type of Cell Culture
Table 4.14. Cell Therapy Manufacturers: Information on Type of Manufacturing Capabilities / Services
Table 4.15. Logistics Service Providers for Cell-based Therapies
Table 5.1. List of Facilities Approved by Regulators to Manufacture Cell Therapies
Table 5.2. Cell Therapy Manufacturing: Regulatory Considerations
Table 6.1. Cell Processing: Challenges and Strategies
Table 6.2. Cell Preservation, Distribution and Handling: Challenges and Strategies
Table 6.3. Process Monitoring and Quality Control: Challenges and Strategies
Table 6.4. Standardization and Regulatory Support: Challenges and Strategies
Table 6.5. Workforce Development: Challenges and Strategies
Table 6.6. Supply Chain and Transport Logistics: Challenges and Strategies
Table 7.1. Cell Therapy Manufacturing: List of Service Providers for Automation of Manufacturing Process
Table 7.2. Scaling-up Cell Therapy Manufacturing: Switching from Manual to Automated Systems
Table 8.1. Cognate BioServices: Company Overview
Table 8.2. Cognate BioServices: Overview of Manufacturing Capabilities
Table 8.3. Cognate BioServices: Partnerships
Table 8.4. Cognate BioServices: Future Outlook
Table 8.5. FUJIFILM Cellular Dynamics: Company Overview
Table 8.6. FUJIFILM Cellular Dynamics: Overview of Manufacturing Capabilities
Table 8.7. FUJIFILM Cellular Dynamics: Partnerships
Table 8.8. FUJIFILM Cellular Dynamics: Future Outlook
Table 8.9. KBI Biopharma: Company Overview
Table 8.10. KBI Biopharma: Overview of Manufacturing Capabilities
Table 8.11. KBI Biopharma: Partnerships
Table 8.12. KBI Biopharma: Future Outlook
Table 8.13. Hitachi Chemical Advanced Therapeutics Solutions: Company Overview
Table 8.14. Hitachi Chemical Advanced Therapeutics Solutions: Overview of Manufacturing Capabilities
Table 8.15. Hitachi Chemical Advanced Therapeutics Solutions: Partnerships
Table 8.16. Hitachi Chemical Advanced Therapeutics Solutions: Future Outlook
Table 8.17. Waisman Biomanufacturing: Company Overview
Table 8.18. Waisman Biomanufacturing: Overview of Manufacturing Capabilities
Table 8.19. Waisman Biomanufacturing: Partnerships
Table 8.20. Waisman Biomanufacturing: Future Outlook
Table 8.21. BioNTech Innovative Manufacturing Services: Company Overview
Table 8.22. BioNTech Innovative Manufacturing Services: Overview of Manufacturing Capabilities
Table 8.23. BioNTech Innovative Manufacturing Services: Partnerships
Table 8.24. BioNTech Innovative Manufacturing Services: Future Outlook
Table 8.25. Cell and Gene Therapy Catapult: Company Overview
Table 8.26. Cell and Gene Therapy Catapult: Overview of Manufacturing Capabilities
Table 8.27. Cell and Gene Therapy Catapult: Partnerships
Table 8.28. Cell and Gene Therapy Catapult: Future Outlook
Table 8.29. Lonza: Company Overview
Table 8.30. Lonza: Global Manufacturing Sites
Table 8.31. Lonza: Overview of Manufacturing Capabilities
Table 8.32. Lonza: Partnerships
Table 8.33. Lonza: Future Outlook
Table 8.34. MaSTherCell: Company Overview
Table 8.35. MaSTherCell: Overview of Manufacturing Capabilities
Table 8.36. MaSTherCell: Partnerships
Table 8.37. MaSTherCell: Future Outlook
Table 8.38. Roslin Cell Therapies: Company Overview
Table 8.39. Roslin Cell Therapies: Overview of Manufacturing Capabilities
Table 8.40. Roslin Cell Therapies: Partnerships
Table 8.41. Roslin Cell Therapies: Future Outlook
Table 8.42. Cell Therapies: Company Overview
Table 8.43. Cell Therapies: Overview of Manufacturing Capabilities
Table 8.44. Cell Therapies: Partnerships
Table 8.45. Cell Therapies: Future Outlook
Table 8.46. Japan Tissue Engineering: Company Overview
Table 8.47. Japan Tissue Engineering: Overview of Manufacturing Capabilities
Table 8.48. Japan Tissue Engineering: Partnerships
Table 8.49. Japan Tissue Engineering: Future Outlook
Table 8.50. MEDINET: Company Overview
Table 8.51. MEDINET: Overview of Manufacturing Capabilities
Table 8.52. MEDINET: Partnerships
Table 8.53. MEDINET: Future Outlook
Table 8.54. Nikon CeLL innovation: Company Overview
Table 8.55. Nikon CeLL innovation: Overview of Manufacturing Capabilities
Table 8.56. Nikon CeLL innovation: Partnerships
Table 8.57. Nikon CeLL innovation: Future Outlook
Table 8.58. WuXi Advanced Therapies: Company Overview
Table 8.59. WuXi Advanced Therapies: Overview of Manufacturing Capabilities
Table 8.60. WuXi Advanced Therapies: Partnerships
Table 8.61. WuXi Advanced Therapies: Future Outlook
Table 9.1. Center for Cell and Gene Therapy: Overview of Manufacturing Facilities and Capabilities
Table 9.2. Center for Cell Manufacturing Ireland: Overview of Manufacturing Facilities and Capabilities
Table 9.3. Clinical Cell and Vaccine Production Facility: Overview of Manufacturing Facilities and Capabilities
Table 9.4. Guy’s and St. Thomas GMP Facility: Overview of Manufacturing Facilities and Capabilities
Table 9.5. Laboratory of Cell and Gene Medicine: Overview of Manufacturing Facilities and Capabilities
Table 9.6. Molecular and Cellular Therapeutics: Overview of Manufacturing Facilities and Capabilities
Table 9.7. Newcastle Cellular Therapies Facility: Overview of Manufacturing Facilities and Capabilities
Table 9.8. Rayne Cell Therapy Suite: Overview of Manufacturing Facilities and Capabilities
Table 9.9. Scottish National Blood Transfusion Services: Overview of Manufacturing Services and Capabilities
Table 9.10. Sydney Cell and Gene Therapy: Overview of Manufacturing Facilities and Capabilities
Table 10.1. Cell Therapy Manufacturing: List of Non-Profit Organizations
Table 10.2. CellCAN: Overview
Table 10.3. Cell Therapy Manufacturing Cooperative Research Center: Overview
Table 10.4. National Cell Manufacturing Consortium: Overview
Table 10.5. California Institute of Regenerative Medicine: Overview
Table 10.6. Cell Therapy Manufacturing: List of Gene and Cell Therapy Societies
Table 11.1. Cell Therapy Manufacturing: List of Partnerships
Table 11.2. Cell Therapy Manufacturing Partnerships: Distribution by Type of Cells
Table 11.3. Cell Therapy Manufacturing Partnerships: Distribution by Scale of Operation
Table 11.4. Cell Therapy Manufacturing: List of Acquistions
Table 12.1. Cell Therapy Manufacturing: List of Expansions
Table 12.2. Cell Therapy Manufacturing Expansions: Distribution by Type of Cells
Table 12.3. Cell Therapy Manufacturing Expansions: Distribution by Scale of Operation
Table 13.1. Cell Therapy Manufacturing Capacity (Sample Data Set for Industry Players): Average Capacity by Size of Manufacturer (Number of Cleanrooms)
Table 13.2. Cell Therapy Manufacturing Capacity (Industry Players): Distribution by Size of Manufacturers (Number of Cleanrooms)
Table 13.3. Cell Therapy Manufacturing Capacity (Sample Data Set for Industry Players): Average Capacity by Size of Manufacturer (Cleanroom Area)
Table 13.4. Cell Therapy Manufacturing Capacity (Industry Players): Distribution by Size of Manufacturer (Cleanroom Area)
Table 13.5. Cell Therapy Manufacturing Capacity for Non-Industry Players: Average Capacity (Number of Cleanrooms)
Table 13.6. Cell Therapy Manufacturing Capacity for Non-Industry Players: Average Capacity (Cleanroom Area)
Table 15.1. Costs Associated with Manufacturing Stem Cell Therapies
Table 15.2. Price of Marketed Gene / Cell Therapies
Table 15.3. Price of Marketed Targeted Drugs
Table 15.4. T-cell Immunotherapies: Expert Opinions on Pricing
Table 15.5. CAR-T Cell Therapies: Reimbursement Landscape
Table 17.1. Active Clinical Studies for Autologous Cell Therapies
Table 17.2. Active Clinical Studies for Allogeneic Cell Therapies
Table 17.3. Active Clinical Studies for Autologous Cell Therapies: Distribution by Patients Enrolled
Table 17.4. Active Clinical Studies for Allogeneic Cell Therapies: Distribution by Patients Enrolled
Table 20.1. Cell Therapy Manufacturing: Key Takeaways
Table 21.1. Survey Insights: Overview of the Participating Organizations
Table 21.2. Survey Insights: Seniority Level of Respondents
Table 21.3. Survey Insights: Type of Cell Therapy
Table 21.4. Survey Insights: Scale of Operation
Table 21.5. Survey Insights: Source of Cells
Table 21.6. Survey Insights: Cell Culture System
Table 21.7. Survey Insights: Fill / Finish Service
Table 22.1. Lion TCR: Company Snapshot
Table 22.2. Cell Therapies: Company Snapshot
Table 22.3. CiMaas: Company Snapshot
Table 22.4. Gracell Biotechnologies: Company Snapshot
Table 22.5. Glycostem Therapeutics: Company Snapshot
Table 22.6. Kadimastem: Company Snapshot
Table 22.7. Bio Elpida: Company Snapshot
Table 22.8. Center for Commercialization of Cancer Immunotherapy / C3i: Company Snapshot
Table 22.9. Waisman Biomanufacturing: Company Snapshot
Table 22.10. RoslinCT: Company Snapshot
Table 22.11. Yposkesi: Company Snapshot
Table 22.12. University of Minnesota: Organization SnapshotTable 23.1 Cell Therapy Manufacturers (Industry Players): Distribution by Location of Headquarters
Table 23.2 Cell Therapy Manufacturers (Industry Players): Distribution by Location of Headquarters (Country-wise)
Table 23.3 Cell Therapy Manufacturers (Industry Players): Distribution by Year of Establishment
Table 23.4 Cell Therapy Manufacturers (Industry Players): Distribution by Company Size
Table 23.5 Cell Therapy Manufacturers (Industry Players): Distribution by Location of Manufacturing Facility (Region-wise)
Table 23.6 Cell Therapy Manufacturers (Industry Players): Distribution by Location of Manufacturing Facility (Country-wise)
Table 23.7 Cell Therapy Manufacturers (Industry Players): Distribution by Type of Cells
Table 23.8 Cell Therapy Manufacturers (Industry Players): Distribution by Type of Immune Cells
Table 23.9 Cell Therapy Manufacturers (Industry Players): Distribution by Type of Stem Cells
Table 23.10 Cell Therapy Manufacturers (Industry Players): Distribution by Type of Manufacturers
Table 23.11 Cell Therapy Manufacturers (Industry Players): Distribution by Source of Cells
Table 23.12 Cell Therapy Manufacturers (Industry Players): Distribution by Scale of Operation
Table 23.13 Cell Therapy Manufacturers (Industry Players): Distribution by Type of Cell Culture
Table 23.14 Cell Therapy Manufacturers (Industry Players): Distribution by Manufacturing Capabilities / Services
Table 23.15 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Location of Headquarters
Table 23.16 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Location of Headquarters (Country-wise)
Table 23.17 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Location of Manufacturing Facility (Region-wise)
Table 23.18 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Location of Manufacturing Facility (Country-wise)
Table 23.19 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Type of Cells
Table 23.20 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Type of Stem and T-Cells
Table 23.21 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Source of Cells
Table 23.22 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Type of Manufacturers
Table 23.23 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Scale of Operation
Table 23.24 Cell Therapy Manufacturers (Non-Industry Players): Distribution by Manufacturing Capabilities / Services
Table 23.25 Cell Therapy Manufacturing (Industry Players): Distribution of Manufacturing Facilities by Regulatory Authorities
Table 23.26 Cell Therapy Manufacturing (Non-Industry Players): Distribution of Manufacturing Facilities by Regulatory Authorities
Table 23.27 Partnerships: Cumulative Trend by Year (2014-2019)
Table 23.28 Partnerships: Distribution by Type of Partnership
Table 23.29 Partnerships: Distribution by Year and Type of Partnership Model (2014-2018)
Table 23.30 Partnerships: Distribution by Type of Cells
Table 23.31 Partnerships: Distribution by Type of Stem Cells
Table 23.32 Partnerships: Distribution by Type of T Cells
Table 23.33 Partnerships: Distribution by Scale of Manufacturing
Table 23.34 Partnerships: Distribution by Scale of Manufacturing and Type of Cells
Table 23.35 Partnerships: Country-wise Distribution
Table 23.36 Partnerships: Intercontinental and Intracontinental Distribution
Table 23.37 Most Active Players: Distribution by Number of Partnerships
Table 23.38 Acquisitions: Cumulative Trend by Year (2015-2019)
Table 23.39 Cell Therapy Manufacturing Acquisitions: Year-wise Distribution along with Type of Cells Involved
Table 23.40 Acquisitions: Intercontinental and Intracontinental Distribution
Table 23.41 Acquisitions: Country-wise Distribution
Table 23.42 Acquisitions: Ownership Change Matrix
Table 23.43 Expansions: Cumulative Trend by Year (2015-2019)
Table 23.44 Expansions: Distribution by Purpose of Expansion
Table 23.45 Expansions: Distribution by Type of Cells Manufactured
Table 23.46 Expansions: Distribution by Type of Cells and Type of Expansion
Table 23.47 Expansions: Distribution by Scale of Operation
Table 23.48 Expansions: Distribution by Location of Facility (Region-wise)
Table 23.49 Expansions: Distribution by Location of Facility (Country-wise)
Table 23.50 Expansions: Distribution by Region and Purpose of Expansion
Table 23.51 Expansions: Most Active Players
Table 23.52 Expansions: Most Active Players Based on Area of Expansion
Table 23.53 Cell Therapy Installed Manufacturing Global Capacity in Terms of Number of Cleanrooms (Industry): Distribution by Size of Manufacturers
Table 23.54 Cell Therapy Installed Manufacturing Global Capacity in Terms of Number of Cleanrooms (Industry): Distribution by Scale of Operation
Table 23.55 Cell Therapy Installed Manufacturing Global Capacity in Terms of Number of Cleanrooms (Industry): Distribution by Location of Manufacturing Facility
Table 23.56 Cell Therapy Installed Manufacturing Global Capacity in Terms of Number of Cleanrooms (Industry): Distribution by Location of Manufacturing Facility and Scale of Operation
Table 23.57 Cell Therapy Installed Manufacturing Global Capacity in Terms of Number of Cleanrooms (Industry): Distribution by Location of Manufacturing Facility and Company Size
Table 23.58 Cell Therapy Installed Manufacturing Global Capacity in Terms of Cleanroom Area (Industry): Distribution by Company Size
Table 23.59 Cell Therapy Installed Manufacturing Global Capacity in Terms of Cleanroom Area (Industry): Distribution by Scale of Operation
Table 23.60 Cell Therapy Installed Manufacturing Global Capacity in Terms of Cleanroom Area (Industry): Distribution by Location of Manufacturing Facility
Table 23.61 Cell Therapy Installed Manufacturing Global Capacity in Terms of Cleanroom Area (Industry): Distribution by Geography and Scale of Manufacturing
Table 23.62 Cell Therapy Installed Manufacturing Global Capacity in Terms of Cleanroom Area (Industry): Distribution by Location of Manufacturing Facility and Company Size
Table 23.63 Cell Therapy Installed Manufacturing Global Capacity in Terms of Number of Cleanrooms (Non-Industry): Distribution by Scale of Operation
Table 23.64 Cell Therapy Installed Manufacturing Global Capacity in Terms of Number of Cleanrooms (Non-Industry): Distribution by Location of Manufacturing Facility
Table 23.65 Cell Therapy Installed Manufacturing Global Capacity in Terms of Cleanroom Area (Non-Industry): Distribution by Scale of Operation
Table 23.66 Cell Therapy Installed Manufacturing Global Capacity in Terms of Cleanroom Area (Non-Industry): Distribution by Location of Manufacturing Facility
Table 23.67 Global Demand for Cell Therapies, 2019-2030 (Number of Patients)
Table 23.68 Global Demand for Cell Therapies, 2019-2030 (Billion Cells)
Table 23.69 Global Clinical Demand for Cell Therapies, 2019-2030 (Number of Patients)
Table 23.70 Global Clinical Demand for Cell Therapies, 2019-2030: Distribution by Type of Cell Therapies (Number of Patients)
Table 23.71 Global Clinical Demand for Cell Therapies, 2019-2030: Distribution by Geographical Location (Number of Patients)
Table 23.72 Global Commercial Demand for Cell Therapies, 2019-2030 (Number of Patients)
Table 23.73 Global Commercial Demand for Cell Therapies, 2019-2030: Distribution by Type of Cell Therapies (Number of Patients)
Table 23.74 Global Commercial Demand for Cell Therapies, 2019-2030: Distribution by Geographical Location (Number of Patients)
Table 23.75 Overall Cell Therapy Manufacturing Market, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030 (USD Million)
Table 23.76 Cell Therapy Manufacturing Market: Distribution by Type of Cell Therapy, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030 (USD Million)
Table 23.77 Cell Therapy Manufacturing Market: Distribution by Source of Cells, Conservative Scenario, Base Scenario, Optimistic Scenario,2 020-2030 (USD Million)
Table 23.78 Cell Therapy Manufacturing Market: Distribution by Scale of Operation, Conservative Scenario, Base Scenario, Optimistic Scenario,2 020-2030 (USD Million)
Table 23.79 Cell Therapy Manufacturing Market: Distribution by Purpose of Manufacturing, Conservative Scenario, Base Scenario, Optimistic Scenario,2 020-2030 (USD Million)
Table 23.80 Cell Therapy Manufacturing Market, 2020-2030: Distribution by Regions, 2020 and 2030
Table 23.81 Overall Commercial Scale Manufacturing Market for T-cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030 (USD Million)
Table 23.82 Commercial Scale Manufacturing Market for T-cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy, TIL Therapy) (USD Million)
Table 23.83 Commercial Scale Manufacturing Market for T-cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Source of Cells (USD Million)
Table 23.84 Commercial Scale Manufacturing Market for T-cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Regions (USD Million)
Table 23.85 Overall Commercial Scale Manufacturing Market for NK cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2022-2030 (USD Million)
Table 23.86 Commercial Scale Manufacturing Market for NK Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2022-2030: Distribution by Source of Cells (USD Million)
Table 23.87 Commercial Scale Manufacturing Market for NK cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Regions (USD Million)
Table 23.88 Overall Commercial Scale Manufacturing Market for Dendritic cell and Tumor Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030 (USD Million)
Table 23.89 Commercial Scale Manufacturing Market for Dendritic and Tumor cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Type of Therapy (USD Million)
Table 23.90 Commercial Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Conservative scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Regions (USD Million)
Table 23.91 Overall Commercial Scale Manufacturing Market for Stem Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030 (USD Million)
Table 23.92 Commercial Scale Manufacturing Market for Stem Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Source of Cells (USD Million)
Table 23.93 Commercial Scale Manufacturing Market for Stem Cell Therapies, Conservative scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Regions (USD Million)
Table 23.94 Overall Clinical Scale Manufacturing Market for T-cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy, TIL Therapy) (USD Million)
Table 23.95 Clinical Scale Manufacturing Market for T-cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Type of Therapy (CAR-T Therapy, TCR Therapy, TIL Therapy) (USD Million)
Table 23.96 Clinical Scale Manufacturing Market for T-cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Source of Cells (USD Million)
Table 23.97 Clinical Scale Manufacturing Market for T-cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Regions (USD Million)
Table 23.98 Overall Clinical Scale Manufacturing Market for NK Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030 (USD Million)
Table 23.99 Clinical Scale Manufacturing Market for NK Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Source of Cells (USD Million)
Table 23.100 Clinical Scale Manufacturing Market for NK Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Regions (USD Million)
Table 23.101 Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Type of Therapy (Dendritic Cell Therapy, Tumor Cell Therapy) (USD Million)
Table 23.102 Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Source of Cells (USD Million)
Table 23.103 Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Regions (USD Million)
Table 23.104 Overall Clinical Scale Manufacturing Market for Stem Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030 (USD Million)
Table 23.105 Clinical Scale Manufacturing Market for Stem Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Source of Cells (USD Million)
Table 23.106 Clinical Scale Manufacturing Market for Stem Cell Therapies, Conservative Scenario, Base Scenario, Optimistic Scenario, 2020-2030: Distribution by Regions (USD Million)
Table 23.107 Survey Insights: Distribution by Type of Organization
Table 23.108 Survey Insights: Distribution by Location of Manufacturing Facility
Table 23.109 Survey Insights: Distribution by Designation and Seniority Level
Table 23.110 Survey Insights: Distribution by Type of Cell Therapy
Table 23.111 Survey Insights: Distribution by Scale of Operation
Table 23.112 Survey Insights: Distribution by Source of Cells
Table 23.113 Survey Insights: Distribution by Cell Culture System
Table 23.114 Survey Insights: Distribution by Fill / Finish Service
The following companies / institutes / government bodies and organizations have been mentioned in this report.
The USD 10+ billion (by 2030) financial opportunity within the cell therapy manufacturing market has been analyzed across the following segments: