Product Code: RA100392
CELL THERAPY MANUFACTURING MARKET: OVERVIEW
As per Roots Analysis, the global cell therapy manufacturing market is estimated to grow from USD 4.90 billion in the current year to USD 13.83 billion by 2035, at a CAGR of 9.90% during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Cell Therapy
- T Cell Therapies
- NK Cell Therapies
- Dendritic Cell Therapies
- Stem Cell Therapies
Source of Cells
- Autologous
- Allogeneic
- Unspecified
Scale of Operation
Type of Manufacturer
- In-house Manufacturing
- Contract Manufacturing Organization
Key Geographical Regions
- North America
- Europe
- Asia-Pacific
- Rest of the World
CELL THERAPY MANUFACTURING MARKET: GROWTH AND TRENDS
Recent advancements in cellular therapies, along with several FDA-approved cell therapies, highlight the potential of these innovative therapies for treating cancer, rare diseases, and chronic illnesses. As a result, the healthcare sector is increasingly prioritizing this promising therapeutic approach. It is worth noting that more than 1,930 clinical trials are currently underway to investigate cell therapies for the treatment of a wide range of diseases, across different geographies. Moreover, several commercialized cell therapies have emerged as top selling drugs in the healthcare industry. For example, Gilead Sciences reported that Yescarta(R) has achieved annual sales surpassing USD 1.5 billion. Given the substantial evidence supporting the clinical advantages and therapeutic potential of cellular therapies, the focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. At present, over 260 industry and non-industry players are engaged in the cell therapy manufacturing industry. Notably, over 50% of the organizations in the cell therapy manufacturing industry are based in the US.
Given the continuous efforts of various stakeholders to ease the manufacturing related complexities, and a heightened emphasis on the advancement of such therapies, we anticipate a healthy growth in the cell therapy manufacturing market in the foreseen future. Owing to the relatively high efficacy of cell therapies, there is an increased interest and involvement of the big pharma players in this market. This has played a crucial role in the increasing adoption of cell therapies.
CELL THERAPY MANUFACTURING MARKET: KEY INSIGHTS
The report delves into the current state of the cell therapy manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:
1. Presently, over 265 industry and non-industry stakeholders are engaged in cell therapy manufacturing; more than 70% of these are industry players, with the required capability to manufacture various types of cells.
2. Immune cells and stem cells are the most prominent type of cells being manufactured by stakeholders in this industry; over 60% of the players operate at preclinical, clinical and commercial scales of operation.
3. More than 70 automation technologies are currently available for the manufacturing of cell therapies to minimize manual interventions; this is likely to attract the interest of stakeholders in the cell therapy domain.
4. In the past few years, the number of clinical studies has increased at an annualized rate of nearly 10% across the world; majority of the clinical studies are evaluating cell therapies in phase I studies.
5. The rise in partnership activity in this domain highlights the growing interest of players in the cell therapy manufacturing market; majority of the deals have been inked for the clinical manufacturing of T cell therapies.
6. To gain a competitive edge and establish themselves as one-stop shops, stakeholders are actively consolidating their capabilities related to cell therapy manufacturing through mergers and acquisitions.
7. 80% of the industry players have expanded their existing capacities and capabilities through the establishment of new facilities; among these more than 40% of facilities are dedicated to the manufacturing of T cells.
8. Nearly 50% of the big pharma initiatives have been undertaken for the purpose of expanding their portfolio and capabilities through partnerships and collaborations; among these, 70% initiatives were undertaken post-2019.
9. More than 70% of the current installed cell therapy manufacturing capacity (in terms of number of cleanrooms) is presently available with industry players; maximum capacity is installed in facilities based in North America.
10. In 2035, more than 45% of the clinical demand for cell therapies is likely to be generated by T cell therapies, including CAR-T, TCR and TIL therapies, for the treatment of patients suffering from various disorders.
11. Owing to the increased disease burden and shift in patient preferences towards tailored cell therapies, the market is poised to witness substantial growth in the next decade.
12. The cell therapy manufacturing domain is poised to grow at a CAGR of 10%; the opportunity is well distributed across different types of cell therapies, sources of cells, scale of operation, type of manufacturer and geography.
CELL THERAPY MANUFACTURING MARKET: KEY SEGMENTS
Currently, T Cell Therapy Holds Maximum Share of the Cell Therapy Manufacturing Market
Based on the type of cell therapy, the market is segmented into T cell therapies, NK cell therapies, dendritic cell therapies and stem cell therapies. It is worth highlighting that the market for dendritic cell therapies is likely to grow at a relatively faster pace (CAGR of 11.1%) in the next decade. This can be attributed to high effectiveness of dendritic cell therapies in treating oncological disorders.
At Present, Autologous Source of Cell Market Segment Captures the Largest Market Share of the Overall Cell Therapy Manufacturing Market
Based on the source of cell, the market is segmented into autologous, allogeneic, and unspecified sources. It is worth highlighting that autologous source of cell is likely to grow at an annualized rate of 9.8% in the next decade. This can be attributed to the fact that more than 90% of the FDA approved cell therapies are derived from the patients.
Cell Therapies Manufactured at Clinical Scale is Likely to Dominate the Cell Therapy Manufacturing Market During the Forecast Period
Based on scale of operation, the market is segmented into clinical and commercial. It is worth highlighting that the cell therapies manufactured at clinical scale capture the larger share of the market and is poised to capture 58% of the revenue share by 2035. This can be attributed to the increasing number of cell therapy pipeline candidates in clinical trial phases.
Contract Manufacturing is Likely to Dominate the Cell Therapy Manufacturing Market During the Forecast Period
Based on type of manufacturer, the market is segmented into contract manufacturing and in-house manufacturing. It is worth highlighting that, currently, contract manufacturing of cell therapies holds the larger share in the cell therapy manufacturing market. This trend is unlikely to change in the coming decade. This can be attributed to the fact that contract manufacturers offer scalability and flexibility, enabling them to quickly adapt to evolving manufacturing needs and accommodate increased production volumes. In addition, by outsourcing cell therapy manufacturing operations, the drug developers can prevent significant capital investments for the establishment of in-house manufacturing facilities
North America Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. It is worth highlighting that, over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.
Example Players in the Cell Therapy Manufacturing Market
- AGC Biologics
- BioNTech Innovative Manufacturing Services
- Cell and Gene Therapy Catapult
- Cell Therapies
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Centre for Cell Manufacturing Ireland, National University of Ireland
- Charles River Laboratories
- Clinical Cell and Vaccine Production Facility, University of Pennsylvania
- FUJIFILM Cellular Dynamics
- Guy's and St. Thomas' GMP Facility, Guy's Hospital
- KBI Biopharma
- Laboratory for Cell and Gene Medicine, Stanford University
- Lonza
- MEDINET
- Minaris Regenerative Medicine
- Molecular and Cellular Therapeutics, University of Minnesota
- Newcastle Cellular Therapies Facility, Newcastle University
- Nikon CeLL Innovation
- Rayne Cell Therapy Suite, King's College London
- RoslinCT
- Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
- Sydney Cell and Gene Therapy
- Thermo Fisher Scientific
- WuXi AppTec
Primary Research Overview
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:
- Marketing Manager, Cell Therapy, Invetech
- Director, Imperial College London
- Marketing Director, Cellistic
- Chief Commercial Officer and Executive Vice-President, FamiCord
- Senior Director of Sales Advanced Therapies, GenCure
- Business Administration Department Manager, Japan Tissue Engineering
- Chief Business Officer, Medace
- Director of Finance and Facility Operations, Laboratory for Cell and Gene Medicine, University of Stanford
- Senior Director, Sumitomo Pharma
- Chief Executive Officer, RoslinCT
- Chief Technical Officer, Cell and Gene Therapy, Discovery Life Sciences
- Chief Executive Officer, Glycostem Therapeutics
- General Manager, Bio Elpida
- Chief Executive Officer, Gracell Biotechnologies
- Executive VP Research and Development, Kadimastem
- Ex-Business Development Manager, Roslin CT
- Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota
- Ex- Co-Founder and Chief Executive Officer, Lion TCR
- Ex-Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy
- Manager of Business Development, Waisman Biomanufacturing
- Ex-Department Leader, Cell Therapy Innovation and Development, Yposkesi
- Ex-Chief Executive Officer, Cell Therapies
- Chief Executive Officer, CiMaas
CELL THERAPY MANUFACTURING MARKET: RESEARCH COVERAGE
- The report features an in-depth analysis of the cell therapy manufacturing market, focusing on key market segments, including type of cell therapy, source of cells, scale of operation, type of manufacturer and key geographical regions.
- The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting the market growth.
- A comprehensive evaluation of companies involved in cell therapy manufacturing, considering various parameters, such as company size, year of establishment, location of headquarters, location of manufacturing facilities, type of manufacturer (in-house manufacturers and contract manufacturing organizations), type of cell manufactured (immune cells, stem cells and others), source of cells (autologous and allogeneic), scale of operation (preclinical, clinical and commercial) and additional services offered (research and development, cell culture development, cell banking, documentation, testing, packaging, supply chain management and regulatory support).
- Thorough analysis of non-industry players involved in cell therapy manufacturing, detailing information on their year of establishment, location of headquarters, location of manufacturing facilities, type of manufacturer (in-house manufacturers and contract manufacturing organizations), type of cell manufactured (immune cells, stem cells and others), source of cells (autologous and allogeneic), scale of operation (preclinical, clinical and commercial) and additional services offered (research and development, cell culture development, cell banking, documentation, testing, packaging, supply chain management and regulatory support).
- A comprehensive discussion on regulations governing cell therapy manufacturing across different regions, specifically North America (with an emphasis on the US), Europe, and Asia (highlighting Japan and China). This analysis includes a review of the various certifications and accreditations granted to manufacturing facilities by key regulatory authorities worldwide.
- An overview of the diverse roadmaps released by various global agencies in order to advance the cell therapy manufacturing process.
- An in-depth analysis of the impact of technological automation on cell therapy manufacturing aims to enhance existing production methods by utilizing closed and single-use systems. The discussion includes a strategic roadmap outlining the necessary steps for developing automation devices, bolstered by two illustrative case studies. Additionally, it offers a qualitative assessment of the costs associated with manufacturing cell-based therapies through manual versus automated processes. Furthermore, it lists organizations that provide automated technologies for manufacturing operations or assist therapy developers in automating their cell therapy production processes.
- In-depth profiles of key industry players in cell therapy manufacturing market, focusing on company overviews, service portfolio, manufacturing capabilities and facilities, recent developments, and an informed future outlook.
- In-depth profiles of key non-industry players in cell therapy manufacturing market, focusing on organization overviews, service portfolio and manufacturing facilities.
- A comprehensive overview of non-profit organizations engaged in the manufacturing of cell therapies, including a list of organizations actively involved in the development and production of cell-based therapies across various regions. This discussion will also highlight different international and national societies dedicated to disseminating knowledge about advancements in these therapies to the broader community.
- Examination of completed, ongoing, and planned clinical studies based on parameters like trial registration year, enrolled patient population, trial status, trial phase, type of sponsor / collaborator, patient segment, study design, most active players (in terms of number of clinical trial conducted) and geographical distribution of trials.
- An analysis of partnerships established in this sector, since 2016, based on several relevant parameters, such as the year of partnership, type of partnership, type of cells manufactured, scale of operation, most active players (in terms of number of partnerships) and geographical distribution.
- An examination of the different expansion efforts made by service providers in this field to enhance their cell therapy manufacturing capabilities, since 2017. This analysis considers various factors, including the year of expansion, type of expansion, type of cells produced, scale of operations, location of the expanded manufacturing facilities and the most active companies based on the number of expansion initiatives undertaken.
- Assessment of the various cell therapy manufacturing focused initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of cell manufactured.
- Estimation of global cell-based therapies manufacturing capacity, derived from data provided by various industry and non-industry sources in the public domain. This analysis emphasizes the distribution of the available capacity (in terms of cleanroom area and number of cleanrooms) on the basis of scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia Pacific and Rest of the World).
- Informed estimates of the annual commercial and clinical demand for cell therapies (in terms of number of patients), based on type of cell therapy and key geographical regions.
- An in-depth examination of the various factors that may impact the pricing of cell-based therapies, highlights the different models and strategies used by manufacturers to establish the prices of their proprietary products.
- 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 CMO.
- A comprehensive total cost of ownership analysis for cell therapy manufacturing organizations, categorized by company size, spanning 20 years.
KEY QUESTIONS ANSWERED IN THIS REPORT
- How many companies are currently engaged in this market?
- Which are the leading CDMOs / CMOs in this market?
- What kind of partnership models are commonly adopted by industry stakeholders?
- What kinds of expansion initiatives have been undertaken by industry stakeholders?
- What are the factors that are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
REASONS TO BUY THIS REPORT
- The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
- Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
- The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
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TABLE OF CONTENTS
1. PREFACE
- 1.1. Introduction
- 1.2. Market Share Insights
- 1.3. Key Market Insights
- 1.4. Report Coverage
- 1.5. Key Questions Answered
- 1.6. Chapter Outlines
2. RESEARCH METHODOLOGY
- 2.1. Chapter Overview
- 2.2. Research Assumptions
- 2.3. Project Methodology
- 2.4. Forecast Methodology
- 2.5. Robust Quality Control
- 2.6. Key Market Segmentations
- 2.7. Key Considerations
- 2.7.1. Demographics
- 2.7.2. Economic Factors
- 2.7.3. Government Regulations
- 2.7.4. Supply Chain
- 2.7.5. COVID Impact / Related Factors
- 2.7.6. Market Access
- 2.7.7. Healthcare Policies
- 2.7.8. Industry Consolidation
3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
- 3.1. Chapter Overview
- 3.2. Market Dynamics
- 3.2.1. Time Period
- 3.2.1.1. Historical Trends
- 3.2.1.2. Current and Forecasted Estimates
- 3.2.2. Currency Coverage
- 3.2.2.1. Overview of Major Currencies Affecting the Market
- 3.2.2.2. Impact of Currency Fluctuations on the Industry
- 3.2.3. Foreign Exchange Impact
- 3.2.3.1. Evaluation of Foreign Exchange Rates and their Impact on Market
- 3.2.3.2. Strategies for Mitigating Foreign Exchange Risk
- 3.2.4. Recession
- 3.2.4.1. Historical Trends Analysis of Past Recessions and Lessons Learnt
- 3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
- 3.2.5. Inflation
- 3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
- 3.2.5.2. Potential Impact of Inflation on the Market Evolution
4. EXECUTIVE SUMMARY
5. INTRODUCTION
- 5.1. Chapter Overview
- 5.2. Introduction to Cell-based Therapies
- 5.2.1. Comparison of Cell-based Therapies and Other Biotechnological Products
- 5.2.2. Classification of Advanced Therapy Medicinal Products (ATMPs)
- 5.2.3. Current Market Landscape of ATMPs
- 5.3. Overview of Cell Therapy Manufacturing
- 5.4. Cell Therapy Manufacturing Models
- 5.4.1. Centralized Manufacturing
- 5.4.2. Decentralized Manufacturing
- 5.5. Scalability of Cell Therapy Manufacturing Processes
- 5.5.1. Scale-up
- 5.5.2. Scale-out
- 5.6. Types of Cell Therapy Manufacturers
- 5.7. Key Challenges for Manufacturing Cell Therapies
- 5.8. Key Factors Influencing Cell Therapy Manufacturing
- 5.8.1. Characterization
- 5.8.2. Cost of Goods
- 5.9. Automation of Cell Therapy Manufacturing Processes
- 5.10. Cell Therapy Manufacturing Supply Chain
- 5.11. Future Perspectives
6. CELL THERAPY MANUFACTURERS (INDUSTRY PLAYERS): MARKET LANDSCAPE
- 6.1. Chapter Overview
- 6.2. Industry Players: Overall Market Landscape
- 6.2.1. Analysis by Year of Establishment
- 6.2.2. Analysis by Company Size
- 6.2.3. Analysis by Location of Headquarters
- 6.2.4. Analysis by Company Size and Location of Headquarters
- 6.2.5. Analysis by Location of Manufacturing Facility
- 6.2.6. Analysis by Type of Manufacturer
- 6.2.7. Analysis by Location of Headquarters and Type of Manufacturer
- 6.2.8. Analysis by Type of Cell Manufactured
- 6.2.9. Analysis by Location of Headquarters and Type of Cell Manufactured
- 6.2.10. Analysis by Source of Cells
- 6.2.11. Analysis by Type of Cell Manufactured and Source of Cells
- 6.2.12. Analysis by Scale of Operation
- 6.2.13. Analysis by Additional Services Offered
- 6.2.14. Analysis by Company Size and Additional Services Offered
7. CELL THERAPY MANUFACTURERS (NON-INDUSTRY PLAYERS): MARKET LANDSCAPE
- 7.1. Chapter Overview
- 7.2. Non-Industry Players: Overall Market Landscape
- 7.2.1. Analysis by Year of Establishment
- 7.2.2. Analysis by Location of Headquarters
- 7.2.3. Analysis by Location of Manufacturing Facility
- 7.2.4. Analysis by Type of Manufacturer
- 7.2.5. Analysis by Location of Headquarters and Type of Manufacturer
- 7.2.6. Analysis by Type of Cell Manufactured
- 7.2.7. Analysis by Location of Headquarters and Type of Cell Manufactured
- 7.2.8. Analysis by Source of Cells
- 7.2.9. Analysis by Type of Cell Manufactured and Source of Cells
- 7.2.10. Analysis by Scale of Operation
- 7.2.11. Analysis by Additional Services Offered
8. REGULATORY LANDSCAPE
- 8.1. Chapter Overview
- 8.2. Current Scenario
- 8.2.1. Regulatory Guidelines in North America
- 8.2.2. Regulatory Guidelines in Europe
- 8.2.3. Regulatory Guidelines in Asia Pacific
- 8.2.3.1. Regulatory Guidelines in Japan
- 8.2.3.2. Regulatory Guidelines in China
- 8.2.4. Conditional Approvals
- 8.3. Regulatory Authorities for Cell Therapy Manufacturing
- 8.3.1. Cell Therapy Manufacturing (Industry Players): Regulatory Authorities
- 8.4. Summary of Guidelines for Early-Stage Manufacturing of Cell Therapies
- 8.5. Existing Challenges to Early-Stage Manufacturing of Cell Therapies
- 8.6. Variability in Regulatory Guidelines across Different Geographies
9. ROADMAPS FOR OVERCOMING CHALLENGES
- 9.1. Chapter Overview
- 9.2. Roadmap for the US
- 9.2.1. Cell Processing
- 9.2.2. Cell Preservation, Distribution and Handling
- 9.2.3. Process Automation and Data Analytics
- 9.2.4. Process Monitoring and Quality Control
- 9.2.5. Standardization and Regulatory Support
- 9.2.6. Workforce Development
- 9.2.7. Supply Chain and Logistics
- 9.3. Roadmaps for Other Geographies
- 9.3.1. Europe
- 9.3.2. Asia Pacific
10. AUTOMATION TECHNOLOGIES FOR CELL THERAPY MANUFACTURING
- 10.1. Chapter Overview
- 10.2. Automation of Cell Therapy Manufacturing Processes
- 10.2.1. Closed Systems
- 10.2.2. Single-use Systems
- 10.2.3. Modular Systems
- 10.3. Growth Drivers and Roadblocks
- 10.4. Case Studies
- 10.4.1. Roadmap to Develop an Automated Cell Manufacturing / Processing Device
- 10.4.2. Automating the Cell Therapy Manufacturing Process
- 10.5. GMP-in-a-Box
- 10.6. List of Automated and Closed Cell Therapy Processing Systems
- 10.7. Comparative Analysis of Manual and Automated Processes
11. COMPANY PROFILES: INDUSTRY PLAYERS
- 11.1. Chapter Overview
- 11.2. Service Providers in North America
- 11.2.1 AGC Biologics
- 11.2.1.1. Company Overview
- 11.2.1.2. Financial Information
- 11.2.1.3. Service Portfolio
- 11.2.1.4. Manufacturing Facilities and Capabilities
- 11.2.1.5. Recent Developments and Future Outlook
- 11.2.2. Charles River Laboratories
- 11.2.2.1. Company Overview
- 11.2.2.2 Financial Information
- 11.2.2.3. Service Portfolio
- 11.2.2.4. Manufacturing Facilities and Capabilities
- 11.2.2.5. Recent Developments and Future Outlook
- 11.2.3. FUJIFILM Cellular Dynamics
- 11.2.3.1. Company Overview
- 11.2.3.2. Service Portfolio
- 11.2.3.3. Manufacturing Facilities and Capabilities
- 11.2.3.4. Recent Developments and Future Outlook
- 11.2.4. KBI Biopharma
- 11.2.4.1. Company Overview
- 11.2.4.2. Financial Information
- 11.2.4.3. Service Portfolio
- 11.2.4.4. Manufacturing Facilities and Capabilities
- 11.2.4.5. Recent Developments and Future Outlook
- 11.2.5. Thermo Fisher Scientific
- 11.2.5.1. Company Overview
- 11.2.5.2. Financial Information
- 11.2.5.3. Service Portfolio
- 11.2.5.4. Manufacturing Facilities and Capabilities
- 11.2.5.5. Recent Developments and Future Outlook
- 11.2.6. WuXi Advanced Therapies
- 11.2.6.1. Company Overview
- 11.2.6.2. Service Portfolio
- 11.2.6.3. Manufacturing Facilities and Capabilities
- 11.2.6.4. Recent Developments and Future Outlook
- 11.3. Service Providers in Europe
- 11.3.1. BioNTech Innovative Manufacturing Services
- 11.3.1.1. Company Overview
- 11.3.1.2. Service Portfolio
- 11.3.1.3. Manufacturing Facilities and Capabilities
- 11.3.1.4. Recent Developments and Future Outlook
- 11.3.2. Cell and Gene Therapy Catapult
- 11.3.2.1. Company Overview
- 11.3.2.2. Service Portfolio
- 11.3.2.3. Manufacturing Facilities and Capabilities
- 11.3.2.4. Recent Developments and Future Outlook
- 11.3.3. Lonza
- 11.3.3.1. Company Overview
- 11.3.3.2. Financial Information
- 11.3.3.3. Service Portfolio
- 11.3.3.4. Manufacturing Facilities and Capabilities
- 11.3.3.5. Recent Developments and Future Outlook
- 11.3.4. RoslinCT
- 11.3.4.1. Company Overview
- 11.3.4.2. Service Portfolio
- 11.3.4.3. Manufacturing Facilities and Capabilities
- 11.3.4.4. Recent Developments and Future Outlook
- 11.4. Service Providers in Asia Pacific
- 11.4.1. Cell Therapies
- 11.4.1.1. Company Overview
- 11.4.1.2. Service Portfolio
- 11.4.1.3. Manufacturing Facilities and Capabilities
- 11.4.1.4. Recent Developments and Future Outlook
- 11.4.2. Minaris Regenerative Medicine
- 11.4.2.1. Company Overview
- 11.4.2.2. Service Portfolio
- 11.4.2.3. Manufacturing Facilities and Capabilities
- 11.4.2.4. Recent Developments and Future Outlook
- 11.4.3. MEDINET
- 11.4.3.1. Company Overview
- 11.4.3.2. Service Portfolio
- 11.4.3.3. Manufacturing Facilities and Capabilities
- 11.4.3.4. Recent Developments and Future Outlook
- 11.4.4. Nikon CeLL Innovation
- 11.4.4.1. Company Overview
- 11.4.4.2. Service Portfolio
- 11.4.4.3. Manufacturing Facilities and Capabilities
- 11.4.4.4. Recent Developments and Future Outlook
12. COMPANY PROFILES: NON-INDUSTRY PLAYERS
- 12.1. Chapter Overview
- 12.2. Center for Cell and Gene Therapy, Baylor College of Medicine
- 12.2.1. Overview
- 12.2.2. Service Portfolio
- 12.2.3. Manufacturing Facilities and Capabilities
- 12.3. Centre for Cell Manufacturing Ireland, National University of Ireland
- 12.3.1. Overview
- 12.3.2. Service Portfolio
- 12.3.3. Manufacturing Facilities and Capabilities
- 12.4. Clinical Cell and Vaccine Production Facility, University of Pennsylvania
- 12.4.1. Overview
- 12.4.2. Service Portfolio
- 12.4.3. Manufacturing Facilities and Capabilities
- 12.5. Guy's and St. Thomas' GMP Facility, Guy's Hospital
- 12.5.1. Overview
- 12.5.2. Service Portfolio
- 12.5.3. Manufacturing Facilities and Capabilities
- 12.6. Laboratory for Cell and Gene Medicine, Stanford University
- 12.6.1. Overview
- 12.6.2. Service Portfolio
- 12.6.3. Manufacturing Facilities and Capabilities
- 12.7. Molecular and Cellular Therapeutics, University of Minnesota
- 12.7.1. Overview
- 12.7.2. Service Portfolio
- 12.7.3. Manufacturing Facilities and Capabilities
- 12.8. Newcastle Cellular Therapies Facility, Newcastle University
- 12.8.1. Overview
- 12.8.2. Service Portfolio
- 12.8.3. Manufacturing Facilities and Capabilities
- 12.9. Rayne Cell Therapy Suite, King's College London
- 12.9.1. Overview
- 12.9.2. Service Portfolio
- 12.9.2. Manufacturing Facilities and Capabilities
- 12.10. Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
- 12.10.1. Overview
- 12.10.2. Service Portfolio
- 12.10.2. Manufacturing Facilities and Capabilities
- 12.11. Sydney Cell and Gene Therapy
- 12.11.1. Overview
- 12.11.2. Service Portfolio
- 12.11.3. Manufacturing Facilities and Capabilities
13. NON-PROFIT ORGANIZATIONS IN CELL THERAPY MANUFACTURING
- 13.1. Chapter Overview
- 13.2. Cell Therapy Manufacturing: Non-Profit Organizations
- 13.2.1. CellCAN
- 13.2.2. Cell Therapy Manufacturing Cooperative Research Center
- 13.2.3. National Cell Manufacturing Consortium (NCMC)
- 13.2.4. California Institute of Regenerative Medicine (CIRM)
- 13.3. Cell Therapy Manufacturing: International Societies
14. CLINICAL TRIAL ANALYSIS
- 14.1. Chapter Overview
- 14.2. Scope and Methodology
- 14.3. Cell Therapies: Clinical Trial Analysis
- 14.3.1. Analysis by Trial Registration Year
- 14.3.2. Analysis by Tria Registration Year and Enrolled Patient Population
- 14.3.3. Analysis by Trial Status
- 14.3.4. Analysis by Trial Registration Year and Trial Status
- 14.3.5. Analysis by Trial Phase
- 14.4.6. Analysis of Number of Clinical Trials and Enrolled Patient Population by Trial Phase
- 14.3.7. Analysis by Type of Sponsor / Collaborator
- 14.3.8. Analysis by Patient Segment
- 14.3.9. Analysis by Study Design
- 14.3.10. Most Active Players: Analysis by Number of Registered Trials
- 14.3.11. Analysis by Number of Trials and Geography
- 14.3.12. Analysis by Number of Trials, Trial Status and Geography
- 14.3.13. Analysis by Enrolled Patient Population, Trial Status and Geography
15. PARTNERSHIPS AND COLLABORATIONS
- 15.1. Chapter Overview
- 15.2. Partnership Models
- 15.3. Cell Therapy Manufacturing: List of Partnerships
- 15.3.1. Analysis by Year of Partnership
- 15.3.2. Analysis by Type of Partnership
- 15.3.3. Analysis by Year and Type of Partnership
- 15.4. Analysis by Type of Cells
- 15.5. Analysis by Scale of Operation
- 15.6. Analysis by Region
- 15.6.1. Country-wise Distribution
- 15.6.2. Continent-wise Distribution
- 15.7. Most Active Players: Analysis by Number of Partnerships
- 15.8. Cell Therapy Manufacturing: List of Mergers and Acquisitions
- 15.8.1. Analysis by Year of Agreement
- 15.8.2. Analysis by Type of Agreement
- 15.8.3. Analysis by Year of Acquisition and Type of Cells
- 15.8.4. Analysis by Region
- 15.8.4.1. Country-wise Distribution
- 15.8.4.2. Continent-wise Distribution
- 15.8.4.3. Intercontinental and Intracontinental Deals
- 15.8.5. Ownership Change Matrix
16. RECENT EXPANSIONS
- 16.1. Chapter Overview
- 16.2. Cell Therapy Manufacturing: List of Expansions
- 16.2.1. Analysis by Year of Expansion
- 16.2.2. Analysis by Type of Expansion
- 16.2.3. Analysis by Type of Cell Manufactured
- 16.2.4. Analysis by Scale of Operation
- 16.2.5. Analysis by Location of Manufacturing Facility
- 16.2.6. Analysis by Type of Expansion and Location of Manufacturing Facility
- 16.2.7. Most Active Players: Analysis by Number of Expansions
- 16.2.8. Most Active Players: Analysis by Area of Expansion
- 16.2.9. Analysis by Year and Location of Manufacturing Facility
17. BIG PHARMA INITIATIVES
- 17.1. Chapter Overview
- 17.2. List of Cell Therapy Manufacturing Focused Initiatives of Big Pharma Players
- 17.2.1. Analysis by Number of Initiatives
- 17.2.2. Analysis by Year of Initiative
- 17.2.3. Analysis by Type of Initiative
- 17.2.3.1. Analysis by Type of Partnership
- 17.2.3.2. Analysis by Type of Expansion
- 17.2.4. Analysis by Types of Cells Manufactured
- 17.2.5. Analysis by Scale of Operation
- 17.2.6. Analysis of Big Pharma Players by Year of Initiative
- 17.2.7. Analysis by Year and Type of Initiative
- 17.2.8. Analysis of Big Pharma Players by Types of Cells Manufactured
- 17.2.9. Analysis of Big Pharma Players by Scale of Operation
- 17.3. Competitive Benchmarking of Big Pharmaceutical Players
- 17.3.1. Harvey Ball Analysis: Big Pharma Initiatives Summary
- 17.3.2. Spider Web Analysis: Big Pharmaceutical Players
18. CAPACITY ANALYSIS
- 18.1. Chapter Overview
- 18.2. Industry Players: Key Assumptions and Methodology
- 18.2.1 Cell Therapy Manufacturing: Installed Global Capacity (Number of Cleanrooms)
- 18.2.1.1. Analysis by Company Size
- 18.2.1.2. Analysis by Scale of Operation
- 18.2.1.3. Analysis by Location of Manufacturing Facility
- 18.2.1.4. Analysis by Company Size and Location of Manufacturing Facility
- 18.2.1.5. Analysis by Scale of Operation and Location of Manufacturing Facility
- 18.2.2. Cell Therapy Manufacturing: Installed Global Capacity (Cleanroom Area)
- 18.2.2.1. Analysis by Company Size
- 18.2.2.2. Analysis by Scale of Operation
- 18.2.2.3. Analysis by Location of Manufacturing Facility
- 18.2.2.4. Analysis by Company Size and Location of Manufacturing Facility
- 18.2.2.5. Analysis by Scale of Operation and Location of Manufacturing Facility
- 18.3. Non- Industry Players: Key Assumptions and Methodology
- 18.3.1. Cell Therapy Manufacturing: Installed Global Capacity (Number of Cleanrooms)
- 18.3.1.1. Analysis by Scale of Operation
- 18.3.1.2. Analysis by Location of Manufacturing Facility
- 18.3.2. Cell Therapy Manufacturing: Installed Global Capacity (Cleanroom Area)
- 18.3.2.1. Analysis by Scale of Operation
- 18.3.2.2. Analysis by Location of Manufacturing Facility
- 18.4. Concluding Remarks
19. DEMAND ANALYSIS
- 19.1. Chapter Overview
- 19.2. Scope and Methodology
- 19.3. Global Demand for Cell Therapy Manufacturing
- 19.4. Global Clinical Demand for Cell Therapy Manufacturing
- 19.4.1. Analysis by Type of Cell Therapy
- 19.4.2. Analysis by Geography
- 19.5. Global Commercial Demand for Cell Therapy Manufacturing
- 19.5.1. Commercial Demand: Analysis by Type of Cell Therapy
- 19.5.2. Commercial Demand: Analysis by Geography
20. COST PRICE ANALYSIS
- 20.1. Chapter Overview
- 20.2. Factors Contributing to the High Price of Cell Therapies
- 20.3. Pricing Models for Cell Therapies
- 20.3.1. Based on Associated Costs for T-Cell Therapies
- 20.3.2. Based on Associated Costs for Stem Cell Therapies
- 20.3.3. Based on Availability of Competing Products
- 20.3.4. Based on Target Patient Segment
- 20.3.5. Based on the Opinions of Industry Experts
- 20.4. Cell Therapy Cost Optimization
- 20.4.1. Role of Cost of Goods Sold
- 20.4.2. Role of Automation
- 20.5. Role of Cell Therapy Contract Manufacturing Organizations
- 20.6. Reimbursement-related Considerations for Cell Therapies
- 20.6.1. Case Study: The National Institute for Health and Care Excellence's (NICE) Appraisal of CAR-T Therapies
21. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
- 21.1. Chapter Overview
- 21.2. Assumptions and Key Parameters
- 21.3. Cell Therapy Manufacturing: Make versus Buy Decision Making
- 21.3.1. Scenario 1
- 21.3.2. Scenario 2
- 21.3.3. Scenario 3
- 21.3.4. Scenario 4
- 21.4. Concluding Remarks
22. TOTAL COST OF OWNERSHIP FOR CELL THERAPY MANUFACTURING ORGANIZATIONS
- 22.1. Chapter Overview
- 22.2. Key Parameters
- 22.3. Assumptions and Methodology
- 22.4. Sample Dataset for the Estimation of Total Cost of Ownership
- 22.5. Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations, Y0-Y20
- 22.6. Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations: Analysis by CAPEX and OPEX, Y0 and Y20
- 22.6.1. Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations: Analysis by CAPEX, Y0
- 22.6.2. Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations: Analysis by OPEX, Y1-Y20
23. GLOBAL CELL THERAPY MANUFACTURING MARKET
- 23.1. Chapter Overview
- 23.2. Scope of the Forecast
- 23.3. Input Data and Key Assumptions
- 23.4. Forecast Methodology
- 23.5. Global Cell Therapy Manufacturing Market, Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 23.5.1. Scenario Analysis
- 23.5.1.1 Conservative Scenario
- 23.5.1.2. Optimistic Scenario
- 23.6. Key Market Segmentations
24. CELL THERAPY MANUFACTURING MARKET, BY TYPE OF CELL THERAPY
- 24.1. Chapter Overview
- 24.2. Key Assumptions and Methodology
- 24.3. Cell Therapy Manufacturing Market: Distribution by Type of Cell Therapy, 2022, 2024 and 2035
- 24.3.1. T Cell Therapies: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 24.3.1.1. CAR-T Cell Therapies: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 24.3.1.2. TCR Cell Therapies: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 24.3.1.3. TIL Cell Therapies: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 24.3.2 Stem Cell Therapies: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 24.3.3. Dendritic Cell Therapies: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 24.3.4. NK Cell Therapies: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 24.4. Data Triangulation and Validation
25. CELL THERAPY MANUFACTURING MARKET, BY SOURCE OF CELLS
- 25.1 Chapter Overview
- 25.2. Key Assumptions and Methodology
- 25.3. Cell Therapy Manufacturing Market: Distribution by Source of Cells, 2022, 2024 and 2035
- 25.3.1 Autologous Source of Cells: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 25.3.2 Allogeneic Source of Cells: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 25.3.3 Unspecified Source of Cells: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 25.4. Data Triangulation and Validation
26. CELL THERAPY MANUFACTURING MARKET, BY SCALE OF OPERATION
- 26.1. Chapter Overview
- 26.2. Key Assumptions and Methodology
- 26.3. Cell Therapy Manufacturing Market: Distribution by Scale of Operation, 2022, 2024 And 2035
- 26.3.1. Clinical Scale: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 26.4. Clinical Cell Therapy Manufacturing Market, by Type of Therapy
- 26.4.1. Clinical Scale Manufacturing Market for T Cell Therapies, till 2035
- 26.4.1.1. Clinical Scale Manufacturing Market for T Cell Therapies: Distribution by Type of Therapy, till 2035
- 26.4.1.2. Clinical Scale Manufacturing Market for T Cell Therapies: Distribution by Source of Cells, till 2035
- 26.4.1.3. Clinical Scale Manufacturing Market for T Cell Therapies: Distribution by Geography, till 2035
- 26.4.2. Clinical Scale Manufacturing Market for NK Cell Therapies, till 2035
- 26.4.2.1. Clinical Scale Manufacturing Market for NK Cell Therapies: Distribution by Source of Cells, till 2035
- 26.4.2.2. Clinical Scale Manufacturing Market for NK Cell Therapies: Distribution by Geography, till 2035
- 26.4.3. Clinical Scale Manufacturing Market for Dendritic Cell Therapies, till 2035
- 26.4.3.1. Clinical Scale Manufacturing Market for Dendritic Cell Therapies: Distribution by Source of Cells, till 2035
- 26.4.3.2. Clinical Scale Manufacturing Market for Dendritic Cell Therapies: Distribution by Geography, till 2035
- 26.4.4. Clinical Scale Manufacturing Market for Stem Cell Therapies, till 2035
- 26.4.4.1. Clinical Scale Manufacturing Market for Stem Cell Therapies: Distribution by Source of Cells, till 2035
- 26.4.4.2. Clinical Scale Manufacturing Market for Stem Cell Therapies: Distribution by Geography, till 2035
- 26.4.5. Commercial Scale: Historical Trends (since 2022) And Forecasted Estimates (till 2035)
- 26.5. Commercial Cell Therapy Manufacturing Market, by Type of Cell Therapy
- 26.5.1. Commercial Scale Manufacturing Market for T Cell Therapies, till 2035
- 26.5.1.1. Commercial Scale Manufacturing Market for T Cell Therapies: Distribution by Type of Therapy, till 2035
- 26.5.1.2. Commercial Scale Manufacturing Market for T Cell Therapies: Distribution by Source of Cells, till 2035
- 26.5.1.3. Commercial Scale Manufacturing Market for T Cell Therapies: Distribution by Geography, till 2035
- 26.5.2. Commercial Scale Manufacturing Market for Dendritic Cell Therapies, till 2035
- 26.5.2.1. Commercial Scale Manufacturing Market for Dendritic Cell Therapies: Distribution by Geography, till 2035
- 26.5.3. Commercial Scale Manufacturing Market for Stem Cell Therapies, till 2035
- 26.5.3.1. Commercial Scale Manufacturing Market for Stem Cell Therapies: Distribution by Source of Cells, till 2035
- 26.5.3.2. Commercial Scale Manufacturing Market for Stem Cell Therapies, till 2035: Distribution by Geography
- 26.6. Data Triangulation and Validation
27. CELL THERAPY MANUFACTURING MARKET, BY TYPE OF MANUFACTURER
- 27.1. Chapter Overview
- 27.2. Key Assumptions and Methodology
- 27.3. Cell Therapy Manufacturing Market: Distribution by Type of Manufacturer, 2022, 2024 And 2035
- 27.3.1. In-House Manufacturers: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 27.3.2. Contract Manufacturing Organizations: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 27.4. Data Triangulation and Validation
28. CELL THERAPY MANUFACTURING MARKET, BY GEOGRAPHY
- 28.1. Chapter Overview
- 28.2. Key Assumptions and Methodology
- 28.3. Cell Therapy Manufacturing Market: Distribution by Geography, 2022, 2024 And 2035
- 28.3.1. North America: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 28.3.2. Europe: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 28.3.3. Asia Pacific: Historical Trends (since 2022) and Forecasted Estimates (till 2035)
- 28.3.4. Rest of the World: Historical Trends (since 2022) And Forecasted Estimates (till 2035)
- 28.4. Data Triangulation and Validation
29. SWOT ANALYSIS
- 29.1. Chapter Overview
- 29.2. Strengths
- 29.3. Weaknesses
- 29.4. Opportunities
- 29.5. Threats
- 29.6. Comparison of SWOT Factors
30. SURVEY ANALYSIS
- 30.1. Chapter Overview
- 30.2. Analysis by Designation of Respondents
- 30.3. Analysis by Type of Cell Therapy
- 30.4. Analysis by Scale of Operation
- 30.5. Analysis by Source of Cells
- 30.6. Analysis by Type of Cell Culture System Used
- 30.7. Analysis by Availability of Fill / Finish Services
31. CONCLUDING REMARKS
32. EXECUTIVE INSIGHTS
- 32.1. Chapter Overview
- 32.2. Invetech
- 32.2.1. Company Snapshot
- 32.2.2. Interview Transcript: Kelly Pisarev Lord (Marketing Manager, Cell Therapy)
- 32.3. John Goldman Centre for Cellular Therapy, Imperial College London
- 32.3.1. Organization Snapshot
- 32.3.2. Interview Transcript: Sandra Loaiza (Director)
- 32.4. Cellistic
- 32.4.1. Company Snapshot
- 32.4.2. Interview Transcript: Rikke Lyngaa (Marketing Director)
- 32.5. Chapter Overview
- 32.5. FamiCord
- 32.5.1. Company Snapshot
- 32.5.2. Interview Transcript: Tomasz Baran (Management Board Vice-President)
- 32.6. GenCure
- 32.6.1. Company Snapshot
- 32.6.2. Interview Transcript: Christie Malone (Senior Director of Sales Advanced Therapies) and Sophie Bardy (Vice President of Marketing)
- 32.7. Japan Tissue Engineering
- 32.7.1. Company Snapshot
- 32.7.2. Interview Transcript: Azusa Kito (Business Administration Department Manager)
- 32.8. Medace
- 32.8.1. Company Snapshot
- 32.8.2. Interview Transcript: Kurt Gielen (Chief Business Officer)
- 32.9. Laboratory For Cell and Gene Medicine, University of Stanford
- 32.9.1. Company Snapshot
- 32.9.2. Interview Transcript: Kathryn Melsop (Director of Finance and Facility Operations)
- 32.10. Sumitomo Pharma
- 32.10.1. Company Snapshot
- 32.10.2. Interview Transcript: Takashi Yoshikawa (Senior Director)
- 32.11. RoslinCT
- 32.11.1. Company Snapshot
- 32.11.2. Interview Transcript: Peter Coleman (Chief Executive Officer)
- 32.12. Discovery Life Sciences
- 32.12.1. Company Snapshot
- 32.12.2. Interview Transcript: Dominic Clarke (Chief Technical Officer, Cell and Gene Therapy)
- 32.13. Glycostem Therapeutics
- 32.13.1. Company Snapshot
- 32.13.2. Interview Transcript: Troels Jordansen (Former Chief Executive Officer)
- 32.14. Bio Elpida
- 32.14.1. Company Snapshot
- 32.14.2. Interview Transcript: Gilles Devillers (President)
- 32.15. Gracell Biotechnologies
- 32.15.1. Company Snapshot
- 32.15.2. Interview Transcript: Wei (William) Cao (Chief Executive Officer)
- 32.16. Kadimastem
- 32.16.1. Company Snapshot
- 32.16.2. Interview Transcript: Arik Hasson (Executive Vice President Research and Development)
- 32.17. RoslinCT
- 32.17.1. Company Snapshot
- 32.17.2. Interview Transcript: Fiona Bellot (Former Business Development Manager)
- 32.18. University of Minnesota
- 32.18.1. Company Snapshot
- 32.18.2. Interview Transcript: David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine)
- 32.19. Lion TCR
- 32.19.1. Company Snapshot
- 32.19.2. Interview Transcript: Victor Lietao Li, (Former Co-Founder and Chief Executive Officer)
- 32.20. Center for Commercialization of Cancer Immunotherapy / C3i
- 32.20.1. Company Snapshot
- 32.20.2. Interview Transcript: Arnaud Deladeriere (Former Manager, Business Development and Operations-cGMP Manufacturing Unit)
- 32.21. Waisman Biomanufacturing
- 32.21.1. Company Snapshot
- 32.21.2. Interview Transcript: Brian Dattilo (Director of Business Development)
- 32.22. Yposkesi
- 32.22.1. Company Snapshot
- 32.22.2. Interview Transcript: Mathilde Girard (Former Department Leader, Cell Therapy Innovation and Development)
- 32.23. Cell Therapies
- 32.23.1. Company Snapshot
- 32.23.2. Interview Transcript: Tim Oldham (Former Chief Executive Officer)
- 32.24. CiMaas
- 32.24.1. Company Snapshot
- 32.24.2. Interview Transcript: Gerard MJ Bos (Chief Executive Officer)
33. APPENDIX 1: TABULATED DATA
34. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS