Market Overview

Cell Therapy Manufacturing Market, 2030

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Dublin, Sept. 14, 2018 (GLOBE NEWSWIRE) -- The "Cell Therapy Manufacturing Market (2nd Edition), 2018-2030" report has been added to ResearchAndMarkets.com's offering.

The "Cell Therapy Manufacturing Market (2nd Edition), 2018-2030" report provides an extensive study of the rapidly growing market of cell therapy manufacturing, focusing on contract manufacturers, as well as cell therapy developers with in-house manufacturing facilities. The study presents an in-depth analysis of various organizations that are engaged in this domain across different regions of the globe.

Cell-based therapies have gained significant attention in the overall biopharmaceutical industry. The personalized nature of these treatment options render them highly specific and, according to a number of clinical studies, safe and efficacious. Such therapies are considered to possess the potential to address various unmet medical needs associated with the treatment of several types of physiological disorders and clinical conditions. A number of pharmaceutical companies and investors have already invested significant capital towards the development and commercialization of such products.

Around 20 such therapies have been approved; recent approvals include Baloise (2018), YESCARTA (2017) and Kymriah (2017). It is also worth highlighting that over 500 cell-based therapy candidates are in different stages of clinical development, and are being evaluated in more than 1,000 active clinical studies across various regions of the globe.

The growing number of cell therapy candidates, coupled to their rapid progression through various phases of clinical development, continues to create an increasing demand for facilities that offer manufacturing services for these complex therapies. There is a wide array of industry players, including well-established companies, mid-sized firms and start-ups, as well as academic institutes that are significantly contributing to the production of GMP grade cell therapies. In addition, several players offer novel technology solutions, aimed at improving and upgrading existing cell-based therapies and their manufacturing processes. Most of these players have signed multiple partnerships / collaborations with an aim to optimize, scale-up and expand the capabilities for the production of cell-based therapies.

Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums, to accelerate the transition of these therapies from laboratories to clinics. Looking at the evolutionary trend so far, we believe that the cell therapy manufacturing market is poised to steadily grow, driven by a robust pipeline of therapy candidates and technological advances aimed at mitigating challenges posed by the conventional methods of production.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as increase in number of clinical studies, target patient population, anticipated adoption of cell-based therapies and expected variation in manufacturing costs, 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 2018-2030. 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.

Key Topics Covered:

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. An Introduction to Cell-based Therapies
3.2.1. Comparison of Cell-based Therapies and Biotechnology Products
3.2.2. Classification of Advanced Therapy Medicinal Products (ATMPs)
3.2.3. Current Market Landscape
3.3. An Overview to Cell Therapy Manufacturing
3.4. Cell Therapy Manufacturing Models
3.4.1. Centralized Manufacturing Model
3.4.2. Decentralized Manufacturing Model
3.5. Scalability of Cell Therapy Manufacturing Processes
3.5.1. Scale-up
3.5.2. Scale-out
3.6. Types of Cell Therapy Manufacturers
3.7. Key Challenges for Manufacturing Cell Therapies
3.8. Important Factors for Cell Therapy Manufacturing
3.9. Automation of Cell Therapy Manufacturing Processes
3.10. Supply Chain for Cell Therapy Manufacturing

4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Cell Therapy Manufacturers: Overall Market Landscape
4.2.1. Distribution by Location of Headquarters
4.2.2. Distribution by Location of Manufacturing Facility
4.2.3. Distribution by Type of Cells Manufactured
4.2.4. Distribution by Purpose of Production
4.2.5. Distribution by Scale of Operation
4.2.6. Distribution by Source of Cells
4.2.7. Distribution by Type of Cell Cultures
4.3. Cell Therapy Manufacturing: Role of Logistics Service Providers

5. REGULATORY LANDSCAPE
5.1. Chapter Overview
5.2. Current Scenario
5.2.1. Regulatory System in the US
5.2.2. Regulatory System in Europe
5.2.3. Regulatory System in Japan
5.2.4. Conditional Approvals
5.3. Accreditations for Cell Therapy Manufacturing
5.3.1. Information on Facility Approvals Granted by Various Regulatory Authorities
5.4. Guidelines for Manufacturing Cell-based Therapies
5.5. Existing Challenges
5.5.1. Variability in Regulatory Guidelines across Different Geographies

6. ROADMAPS: POTENTIAL STRATEGIES TO OVERCOME 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 Transport 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 Processes
7.2.1. Closed Systems
7.2.2. Single-use Systems
7.2.3. Modular Systems
7.3. Roadmap for Developing an Automated Device
7.4. GMP-in-a-Box Concept
7.5. List of Service Providers for Automation of Manufacturing Processes
7.6. Comparative Analysis of Manual and Automated Processes

8. CELL THERAPY MANUFACTURING: INDUSTRY PLAYERS
8.1. Chapter Overview
8.2. Market Landscape in the US
8.2.1. Brammer Bio
8.2.2 Cognate BioServices
8.2.3. FUJIFILM Cellular Dynamics
8.2.4. KBI Biopharma
8.2.5 PCT, a Hitachi Group Company
8.2.6. Waisman Biomanufacturing
8.3. Market Landscape in Europe
8.3.1. BioNTech Innovative Manufacturing Services
8.3.2. Cell and Gene Therapy Catapult
8.3.3. CELLforCURE
8.3.4. Lonza
8.3.5. MaSTherCell
8.3.6. Roslin Cell Therapies
8.4. Market Landscape in Asia Pacific
8.4.1. Cell Therapies
8.4.2. Cryosite
8.4.3. Japan Tissue Engineering (J-TEC)
8.4.4. MEDINET
8.4.5. Nikon CeLL innovation
8.4.6. WuXi Advanced Therapies, a subsidiary of WuXi AppTec

9. CELL THERAPY MANUFACTURING: NON-INDUSTRY PLAYERS
9.1. Chapter Overview
9.2. Center for Cell and Gene Therapy, Baylor College of Medicine
9.3. Centre for Cell Manufacturing Ireland, National University of Ireland
9.4. Clinical Cell and Vaccine Production Facility, University of Pennsylvania
9.5. Guy's and St. Thomas' GMP Facility, Guy's Hospital
9.6. Laboratory for Cell and Gene Medicine, Stanford University
9.7. Molecular and Cellular Therapeutics, University of Minnesota
9.8. Newcastle Cellular Therapies Facility, Newcastle University
9.9. Rayne Cell Therapy Suite, King's College London
9.10. Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre of Regenerative Medicine
9.11. Sydney Cell and Gene Therapy

10. ROLE OF NON-PROFIT ORGANIZATIONS
10.1. Chapter Overview
10.2. Cell Therapy Manufacturing: Non-Profit Organizations
10.2.1. CellCAN
10.2.2. Cell Therapy Manufacturing Cooperative Research Center
10.2.3. National Cell Manufacturing Consortium
10.2.4. California Institute of Regenerative Medicine
10.3. Cell Therapy Manufacturing: International Societies

11. RECENT DEVELOPMENTS
11.1. Chapter Overview
11.2. Partnership / Collaboration Models
11.3. Cell Therapy Manufacturing: List of Partnerships

12. CAPACITY ANALYSIS
12.1. Chapter Overview
12.2. Key Assumptions and Methodology for Industry Players
12.2.1 Cell Therapy Manufacturing: Installed Global Capacity in Terms of Number of Cleanrooms
12.2.2. Cell Therapy Manufacturing: Installed Global Capacity in Terms of Cleanroom Area
12.3. Key Assumptions and Methodology for Non-Industry Players
12.3.1. Cell Therapy Manufacturing: Installed Global Capacity in Terms of Number of Cleanrooms
12.3.2. Cell Therapy Manufacturing: Installed Global Capacity in Terms of Cleanroom Area
12.4 Concluding Remarks

13. COST PRICE ANALYSIS
13.1. Chapter Overview
13.2. Factors Contributing Towards High Price Tags of Cell-based Therapies
13.3. Pricing Models for Cell-based Therapies
13.4. Cost Control for Cell Therapy Products
13.4.1. Cost of Goods Sold
13.4.2. Manufacturing Cost-Effective Therapies with Automation
13.4.3. Role of Cell Therapy Contract Manufacturing Organizations

14. MARKET SIZING AND FORECAST
14.1. Chapter Overview
14.2. Scope of the Forecast
14.3. Forecast Methodology
14.4. Input Tables and Key Assumptions
14.5. Overall Cell Therapy Manufacturing Market, 2018-2030
14.6. Market Opportunity for Commercial Scale Manufacturing of Cell-based Therapies
14.7. Market Opportunity for Clinical Scale Manufacturing of Cell-based Therapies

15. KEY INSIGHTS
15.1. Cell Therapy Manufacturers: World Map Representation by Location of Manufacturing Facility
15.1.1. Industry Players
15.1.2. Non- Industry Players
15.2. Cell Therapy Manufacturers: Grid Analysis
15.3. Cell Therapy Manufacturers: Logo Landscapes by Type of Cell Therapy
15.3.1. Immune Cells
15.3.2. Stem Cells

16. SWOT ANALYSIS
16.1. Chapter Overview
16.2. Strengths
16.3. Weaknesses
16.4. Opportunities
16.5. Threats
16.6. Comparison of SWOT Factors
16.7. Concluding Remarks

17. CONCLUSION
17.1. Owing to a Consistently Growing Pipeline, the Demand for Cell Therapy Manufacturing Services is Likely to Increase Steadily
17.2. The Market Features the Involvement of Several Industry, as well as Academic Players; we anticipate Trend to Persist in the Future as well
17.3. Stakeholders have Established their Presence across Different Regions; Presently, the US and UK are Considered as Prominent Hubs for Cell Therapy Manufacturing
17.4. Partnering Activity is on the Rise as Organizations Actively Collaborate to Develop Novel Technology Platforms and Improve Current Manufacturing Processes
17.5. Technical Advances Enabling Automation, Scale-up and Better Logistics Solutions are Expected to Act as Key Growth Drivers
17.6. Cell Therapy Manufacturing is Projected to become a Multi-billion Dollar Market over the Coming Decade

18. SURVEY ANALYSIS
18.1. Chapter Overview
18.2. Seniority Level of Respondents
18.3. Type of Cell Therapy
18.4. Scale of Operation
18.5. Source of Cells
18.6. Type of Cell Culture System
18.7. Availability of Fill / Finish Services

19. INTERVIEW TRANSCRIPTS
19.1. Chapter Overview
19.2. Cell Therapies
19.2.1. Company Overview
19.2.2. Interview Transcript: Tim Oldham, Chief Executive Officer
19.3. Center of Excellence for Cellular Therapy / C3i
19.3.1. Company Overview
19.3.2. Interview Transcript: Arnaud Deladeriere, Manager, Business Development & Operations-cGMP Manufacturing Unit
19.4. CiMaas
19.4.1. Company Overview
19.4.2. Interview Transcript: Gerard MJ Bos, Chief Executive Officer
19.5. Lion TCR
19.5.1. Company Overview
19.5.2. Interview Transcript: Victor Lietao Li, Co-Founder and Chief Executive Officer
19.6. Waisman Biomanufacturing
19.6.1. Company Overview
19.6.2. Interview Transcript: Brian Dattilo, Manager of Business Development
19.7. YposKesi
19.7.1. Company Overview
19.7.2. Interview Transcript: Mathilde Girard, Department Leader, Cell Therapy Innovation and Development

20. APPENDIX: TABULATED DATA

For more information about this report visit https://www.researchandmarkets.com/research/nh3ns2/cell_therapy?w=12

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Related Topics: Genomics

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