Cell therapy manufacturing market is projected to grow at an annualized rate of >16.5% / till 2030

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

 

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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. Compan