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
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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
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