Cell therapy manufacturing market is projected to grow at an annualized rate of >16.5%, By Roots Knowpia

Roots Analysis has done a detailed study on Cell Therapy Manufacturing Market (3^rd Edition), 2019 - 2030, covering various important aspects of the industry and identifying key future growth opportunities.

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Key Market Insights

§ More than 100 industry players and over 60 non-industry players currently claim to manufacture different types of cell therapies, either for in-house requirements or on contract basis

§ The market is fragmented, featuring both established players and new entrants, which claim to operate at various scales and manufacture a diverse range of cell therapies

§ In order to cater to the growing needs of clients / sponsors, companies have established presence across different regions; presently, the US, the UK and China are the key hubs for cell therapy manufacturing

§ In recent years, a significant increase in partnership activity has been observed in this domain; in fact, therapy developers have already inked manufacturing deals with both indigenous and international experts

§ In order to enhance core competencies related to the domain, both drug developers and CMOs are actively investing in expanding their existing infrastructure and capabilities

§ Cell therapy manufacturers are also gradually opting to automate various operations in the supply chain; the primary objective is to achieve favorable bench-to-clinic timelines and cut down on production related losses

§ Currently, the installed global capacity for cell therapy manufacturing is estimated to be spread across 1.2+ million square feet of dedicated cleanroom area distributed across various scales of operation

§ More than 70,000 patients were estimated to have been enrolled in cell therapy related clinical trials; the demand for cell therapies is anticipated to grow significantly over the next decade

§ Revenues from manufacturing operations of T-cell therapies are anticipated to capture higher market share; the benefit will be realized by both autologous and allogeneic therapies across different regions the world

§ Clinical scale manufacturing operations are likely to drive the future market size, taking into consideration both in-house and contract service requirements

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Table of Contents

1. PREFACE

1.1. Scope of the Report

1.2. Research Methodology

1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Context and Background

3.2. Introduction to Cell Therapies

3.2.1. Comparison of Cell Therapies and Other Biotechnology Products

3.2.2. Classification of Advanced Therapy Medicinal Products (ATMPs)

3.2.3. Current Market Landscape of ATMPs

3.3. Overview of Cell Therapy Manufacturing

3.4. Cell Therapy Manufacturing Models

3.4.1. Centralized Manufacturing

3.4.2. Decentralized Manufacturing

3.5. Scalability of Cell Therapy Manufacturing

3.5.1. Scale-up

3.5.2. Scale-out

3.6. Types of Cell Therapy Manufacturers

3.7. Key Manufacturing-related Challenges

3.8. Factors Influencing Cell Therapy Manufacturing

3.9. Automating Cell Therapy Manufacturing

3.10. Cell Therapy Manufacturing Supply Chain

3.11. Future Perspectives

4. MARKET OVERVIEW

4.1. Chapter Overview

4.2. Cell Therapy Manufacturers (Industry Players): Overall Market Landscape

4.2.1. Analysis by Location of Headquarters

4.2.2. Analysis by Location of Manufacturing Facility

4.2.3. Analysis by Type of Cells Manufactured

4.2.4. Analysis by Source of Cells

4.2.5. Analysis by Scale of Operation

4.2.6. Analysis by Type of Cell Culture

4.2.7. Analysis by Purpose of Production

4.2.8. Analysis by Manufacturing Capabilities / Services

4.3. Cell Therapy Manufacturers (Non-Industry Players): Overall Market Landscape

4.3.1. Analysis by Location of Headquarters

4.3.2. Analysis by Location of Manufacturing Facility

4.3.3. Analysis by Type of Cells Manufactured

4.3.4. Analysis by Source of Cells

4.3.5. Analysis by Scale of Operation

4.3.6. Analysis by Type of Cell Culture

4.3.7. Analysis by Purpose of Production

4.3.8. Analysis by Manufacturing Capabilities / Services

4.4. Cell Therapy Manufacturing: Role of Logistics Service Providers

5. REGULATORY LANDSCAPE

5.1. Chapter Overview

5.2. Current Scenario

5.2.1. Regulatory Guidelines in the US

5.2.2. Regulatory Guidelines in Europe

5.2.3. Regulatory Guidelines in Japan

5.2.4. Conditional Approvals

5.3. Regulatory Accreditations for Cell Therapy Manufacturing

5.3.1. Facilities Approved by Regulators to Manufacture Cell Therapies

5.4. Summary of Guidelines for Clinical-Stage Manufacturing of Cell Therapies

5.5. Existing Challenges to Clinical-Stage Manufacturing

5.5.1. Variability in Regulatory Guidelines across Different Geographies

5.6. Conclusion

6. ROADMAPS FOR OVERCOMING EXISTING CHALLENGES

6.1. Chapter Overview

6.2. Roadmap for the US

6.2.1. Cell Processing

6.2.2. Cell Preservation, Distribution and Handling

6.2.3. Process Automation and Data Analytics

6.2.4. Process Monitoring and Quality Control

6.2.5. Standardization and Regulatory Support

6.2.6. Workforce Development

6.2.7. Supply Chain and Logistics

6.3. Roadmaps for Other Geographies

6.3.1. Europe

6.3.2. Asia Pacific

7. AUTOMATION TECHNOLOGIES FOR CELL THERAPY MANUFACTURING

7.1. Chapter Overview

7.2. Automation of Cell Therapy Manufacturing Processes

7.2.1. Closed Systems

7.2.2. Single-use Systems

7.2.3. Modular Systems

7.3. Case Studies

7.3.1. Roadmap to Developing an Automated Cell Manufacturing / Processing Device

7.3.2. Automating Cell Therapy Manufacturing

7.4. GMP-in-a-Box

7.5. List of Automation Service Providers

7.6. Comparative Analysis of Manual and Automated Processes

7.7. Concluding Remarks

8. PROFILES: INDUSTRY PLAYERS

8.1. Chapter Overview

8.2. Service Providers in the US

8.2.1 Cognate BioServices

8.2.1.1. Company Overview

8.2.1.2. Service Portfolio

8.2.1.3. Manufacturing Capabilities

8.2.1.4. Partnerships

8.2.1.5. Future Outlook

8.2.2. FUJIFILM Cellular Dynamics

8.2.2.1. Company Overview

8.2.2.2. Service Portfolio

8.2.2.3. Manufacturing Capabilities

8.2.2.4. Partnerships

8.2.2.5. Future Outlook

8.2.3. KBI Biopharma

8.2.3.1. Company Overview

8.2.3.2. Service Portfolio

8.2.3.3. Manufacturing Capabilities

8.2.3.4. Partnerships

8.2.3.5. Future Outlook

8.2.4. Hitachi Chemical Advanced Therapeutics Solutions

8.2.4.1. Company Overview

8.2.4.2. Service Portfolio

8.2.4.3. Manufacturing Capabilities

8.2.4.4. Partnerships

8.2.4.5. Future Outlook

8.2.5. Waisman Biomanufacturing

8.2.5.1. Company Overview

8.2.5.2. Service Portfolio

8.2.5.3. Manufacturing Capabilities

8.2.5.4. Partnerships

8.2.5.5. Future Outlook

8.3. Service Providers in Europe

8.3.1. BioNTech Innovative Manufacturing Services

8.3.1.1. Company Overview

8.3.1.2. Service Portfolio

8.3.1.3. Manufacturing Capabilities

8.3.1.4. Partnerships

8.3.1.5. Future Outlook

8.3.2. Cell and Gene Therapy Catapult

8.3.2.1. Company Overview

8.3.2.2. Service Portfolio

8.3.2.3. Manufacturing Capabilities

8.3.2.4. Partnerships

8.3.2.5. Future Outlook

8.3.3. Lonza

8.3.3.1. Company Overview

8.3.3.2. Service Portfolio

8.3.3.3. Manufacturing Capabilities

8.3.3.4. Partnerships

8.3.3.5. Future Outlook

8.3.4. MaSTherCell

8.3.4.1. Company Overview

8.3.4.2. Service Portfolio

8.3.4.3. Manufacturing Capabilities

8.3.4.4. Partnerships

8.3.4.5. Future Outlook

8.3.5. Roslin Cell Therapies

8.3.5.1. Company Overview

8.3.5.2. Service Portfolio

8.3.5.3. Manufacturing Capabilities

8.3.5.4. Partnerships

8.3.5.5. Future Outlook

8.4. Service Providers in Asia Pacific

8.4.1. Cell Therapies

8.4.1.1. Company Overview

8.4.1.2. Service Portfolio

8.4.1.3. Manufacturing Capabilities

8.4.1.4. Partnerships

8.4.1.5. Future Outlook

8.4.2. Japan Tissue Engineering (J-TEC)

8.4.2.1. Company Overview

8.4.2.2. Service Portfolio

8.4.2.3. Manufacturing Capabilities

8.4.2.4. Partnerships

8.4.2.5. Future Outlook

8.4.3. MEDINET

8.4.3.1. Company Overview

8.4.3.2. Service Portfolio

8.4.3.3. Manufacturing Capabilities

8.4.3.4. Partnerships

8.4.3.5. Future Outlook

8.4.4. Nikon CeLL innovation

8.4.4.1. Company Overview

8.4.4.2. Service Portfolio

8.4.4.3. Manufacturing Capabilities

8.4.4.4. Partnerships

8.4.4.5. Future Outlook

8.4.5. WuXi Advanced Therapies

8.4.5.1. Company Overview

8.4.5.2. Service Portfolio

8.4.5.3. Manufacturing Capabilities

8.4.5.4. Partnerships

8.4.5.5. Future Outlook

9. PROFILES: NON-INDUSTRY PLAYERS

9.1. Chapter Overview

9.2. Center for Cell and Gene Therapy, Baylor College of Medicine

9.2.1. Overview

9.2.2. Operating Segments

9.2.3. Service Portfolio

9.2.4. Manufacturing Facilities and Capabilities

9.3. Centre for Cell Manufacturing Ireland, National University of Ireland

9.3.1. Overview

9.3.2. Service Portfolio

9.3.3. Manufacturing Facilities and Capabilities

9.4. Clinical Cell and Vaccine Production Facility, University of Pennsylvania

9.4.1. Overview

9.4.2. Service Portfolio

9.4.3. Manufacturing Facilities and Capabilities

9.5. Guy’s and St. Thomas’ GMP Facility, Guy’s Hospital

9.5.1. Overview

9.5.2. Service Portfolio

9.5.3. Manufacturing Facilities and Capabilities

9.6. Laboratory for Cell and Gene Medicine, Stanford University

9.6.1. Overview

9.6.2. Service Portfolio

9.6.3. Manufacturing Facilities and Capabilities

9.7. Molecular and Cellular Therapeutics, University of Minnesota

9.7.1. Overview

9.7.2. Service Portfolio

9.7.3. Manufacturing Facilities and Capabilities

9.8. Newcastle Cellular Therapies Facility, Newcastle University

9.8.1. Overview

9.8.2. Service Portfolio

9.8.3. Manufacturing Facilities and Capabilities

9.9. Rayne Cell Therapy Suite, King’s College London

9.9.1. Overview

9.9.2. Manufacturing Facilities and Capabilities

9.10. Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine

9.10.1. Overview

9.10.2. Manufacturing Facilities and Capabilities

9.11. Sydney Cell and Gene Therapy

9.11.1. Overview

9.11.2. Manufacturing Facilities and Capabilities

10. ROLE OF NON-PROFIT ORGANIZATIONS

10.1. Chapter Overview

10.2. Cell Therapy Manufacturing Service Providers: Non-Profit Organizations

10.2.1. CellCAN

10.2.2. Cell Therapy Manufacturing Cooperative Research Center (CTM CRC)

10.2.3. National Cell Manufacturing Consortium (NCMC)

10.2.4. California Institute of Regenerative Medicine (CIRM)

10.3. Cell Therapy Manufacturing: Affiliated International Societies

11. PARTNERSHIPS

11.1. Chapter Overview

11.2. Partnership Models

11.3. Cell Therapy Manufacturing: List of Partnerships

11.3.1. Analysis by Year of Partnership

11.3.2. Analysis by Type of Partnership Model

11.3.3. Analysis by Year and Type of Partnership Model

11.4. Analysis by Type of Cells

11.5. Analysis by Scale of Operation

11.6. Geographical Analysis

11.6.1. Continent-wise Distribution

11.6.2. Country-wise Distribution

11.7. Most Active Players: Analysis by Number of Partnerships

11.8. Cell Therapy Manufacturing: List of Acquisitions

11.8.1. Analysis by Year and Type of Cells

11.8.2. Geographical Analysis

11.8.3. Ownership Change Matrix

12. FACILITY EXPANSIONS

12.1. Chapter Overview

12.2. Cell Therapy Manufacturing: List of Expansions

12.2.1. Cumulative Year-wise Distribution

12.2.2. Analysis by Type of Cells

12.2.3. Analysis by Scale of Operation

12.2.3. 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

22.7. Availability of Fill / Finish Services

22. INTERVIEW TRANSCRIPTS

22.1. Chapter Overview

22.2. Lion TCR

22.2.1. Company Overview

22.2.2. Interview Transcript: Victor Lietao Li, Co-Founder and Chief Executive Officer

22.3. Cell Therapies

22.3.1. Company Overview

22.3.2. Interview Transcript: Tim Oldham, Chief Executive Officer

22.4. CiMaas

22.4.1. Company Overview

22.4.2. Interview Transcript: Gerard MJ Bos, Chief Executive Officer

22.5. Gracell Biotechnologies

22.5.1. Company Overview

22.5.2. Interview Transcript: Wei (William) Cao, Chief Executive Officer

22.6. Glycostem Therapeutics

22.6.1. Company Overview

22.6.2. Interview Transcript: Troels Jordansen, Chief Executive Officer

22.7. Kadimastem

22.7.1. Company Overview

22.7.2. Interview Transcript: Arik Hasson, Executive VP Research and Development

22.8. Bio Elpida

22.8.1. Company Overview

22.8.2. Interview Transcript: Gilles Devillers, General Manager

22.9. Center for Commercialization of Cancer Immunotherapy / C3i

22.9.1. Company Overview

22.9.2. Interview Transcript: Arnaud Deladeriere, Manager, Business Development & Operations-cGMP Manufacturing Unit

22.10. Waisman Biomanufacturing

22.10.1. Company Overview

22.10.2. Interview Transcript: Brian Dattilo, Manager of Business Development

22.11. RoslinCT

22.11.1. Company Overview

22.11.2. Interview Transcript: Fiona Bellot, Business Development Manager

22.12. Yposkesi

22.12.1. Company Overview

22.12.2. Interview Transcript: Mathilde Girard, Leader, Cell Therapy Innovation and Development

22.13. University of Minnesota

22.13.1. Organization Overview

22.13.2. Interview Transcript: David Mckenna, Professor and American Red in Transfusion Medicine

23. APPENDIX 1: TABULATED DATA

24. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Cell therapy manufacturing market is projected to grow at an annualized rate of >16.5%, By Roots

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