Dublin, Aug. 11, 2021 (GLOBE NEWSWIRE) -- The "Cell Therapy Manufacturing Market by Type of Cell Manufactured, Source of Cell, Scale of Operation, Purpose of Manufacturing and Key Geographical Regions - Industry Trends and Global Forecasts, 2021-2030" report has been added to ResearchAndMarkets.com's offering.
Thisreport features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing, along with information on both contract manufacturers, as well as developers having in-house production capabilities, offering in-depth analyses of the various business entities engaged in this domain, across key global regions.
Given the consistent increase in number of cell therapies being developed and launched, this upcoming therapeutic segment is on its way to becoming one of the highest valued markets within the biopharmaceutical industry. In fact, in February 2021, the USFDA approved Breyanzi, a CAR-T cell-based therapy, developed by Bristol Myers Squibb, which is designed to treat relapsed or refractory large B-cell lymphoma. According to a recent report (published by The Alliance for Regenerative Medicine), over 1,200 clinical trials, focused on the evaluation of cell therapies, gene therapies and tissue-based therapies, are currently being conducted by over 1,000 organizations (including academic institutions), worldwide.
Further growth of the market is primarily hindered by the limited availability of expertise, lack of specialized infrastructure to produce cell therapies, and several product development and manufacturing related challenges. With a sufficient body of evidence, validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, the focus of stakeholders in this industry segment has now shifted to optimizing the cell therapy manufacturing process. Moreover, as more big pharma players enter this field of research, there is likely to be a substantial rise in the cell therapy manufacturing demand, as the proprietary product candidates of these large companies mature and need to be mass produced. In order to address the concerns related to manufacturing, several cell therapy developers (including the larger companies) have turned to contract manufacturing organizations (CMOs).
The cell therapy manufacturing service landscape features a mix of industry players (including well-established companies, mid-sized firms and start-ups / small companies), as well as several academic institutes. It is worth highlighting that innovator companies that have the required capabilities and facilities to produce cell therapies for in-house requirements, also offer contract services (primarily to ensure the optimum use of their resources and open up additional revenue generation opportunities).
Further, in order to make cell therapies more affordable, several stakeholders are integrating various degrees of automation to cut down on labor costs and also improve process scalability. This specialty services industry has witnessed significant partnership activity over the past few years, with several companies being acquired by the larger firms, in efforts to grow and consolidate their capabilities in this space. As stakeholders strive to mitigate existing challenges and focus on innovation to improve the cell production process, we believe that the market will witness significant growth in mid-long term.
Amongst other elements, the report includes:
- A detailed review of the overall landscape of players engaged in the manufacturing of cell-based therapies, along with information on type of cell manufactured (including immune cells (including T cells, dendritic cells, NK cells), stem cells (including adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), source of cell (autologous and allogeneic), scale of operation (preclinical, clinical and commercial), purpose of production (fulfilling in-house requirements and contract services), manufacturing capabilities / services offered (including R&D, cell culture development, quality testing, packaging, cell banking, supply chain management services, and regulatory services), as well as location of headquarters and their respective manufacturing facilities.
- An analysis of the various expansion initiatives undertaken by service providers engaged in this domain in order to augment their respective cell therapy manufacturing capabilities, during the period 2016-2021, based on several relevant parameters, such as year of expansion, type of cell manufactured, scale of operation, purpose of expansion (facility expansion and new facility), location of expanded manufacturing facility, and most active players (in terms of number of expansion initiatives undertaken).
- An analysis of the recent partnerships focused on the manufacturing of cell-based therapies, which have been established during the period 2016-2021, based on several relevant parameters, such as the year of agreement, type of partnership model adopted, type of cell and scale of operation.
- A review of the various cell therapy manufacturing initiatives undertaken by big pharma players engaged in this domain, 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.
- 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 estimate of the overall, installed capacity for the manufacturing of cell-based therapies, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity on the basis of scale of operation (clinical and commercial), company size (small, mid-sized and large firms) and key geographical regions (North America, Europe and Asia Pacific).
- An in-depth analysis of cell therapy manufacturers using three versatile representations, namely [A] a three dimensional grid analysis, presenting the distribution of companies on the basis of type of cell manufactured, scale of operation and purpose of production, [B] a logo landscape, based on the type of cell manufactured, geographical location of manufacturer (North America, Europe and Asia Pacific), and type and size of organization (non-industry players, and small, mid-sized and large companies), and [C] a schematic world map representation, highlighting the geographical location of cell therapy manufacturing facilities of both industry and non-industry stakeholders.
- A detailed analysis of various factors that are likely to influence the price of cell-based therapies, featuring different models / approaches adopted by manufacturers while determining the price of their proprietary offerings.
- An elaborate discussion on the role of automation technologies in improving the current manufacturing methods, along with a comparative (qualitive) analysis of cost differences between manual and automated processes.
- A qualitative analysis, highlighting 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 discussion on cell therapy manufacturing regulations across various geographies, including North America (focusing on the US), Europe and Asia (focusing on Japan and China), featuring an analysis of the diverse certifications / accreditations awarded to manufacturing facilities by important regulatory bodies across the globe.
- Elaborate profiles of key players (industry and non-industry) that offer contract manufacturing services for cell-based therapies; each profile includes an overview of the company / organization, information on its manufacturing facilities, service portfolio, recent partnerships and an informed future outlook.
- A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry's evolution, under an elaborate SWOT framework, along with a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall market dynamics.
- Insights generated in a market-wide survey, featuring inputs solicited from experts who are directly / indirectly involved in the development and / or manufacturing of cell-based therapies.
Key Questions Answered
- What is the current, annual, global demand for cell-based therapies? How is the demand for such products likely to evolve over the next decade?
- What is the current, installed contract manufacturing capacity for cell therapies?
- What are the key parameters governing the price of cell therapies?
- What are the key recent developments (such as partnerships and expansions) in this industry?
- What kind of partnership models are commonly adopted by stakeholders engaged in this domain?
- What are the different initiatives undertaken by big pharma players for the manufacturing of cell therapies in the recent past?
- What different types of automated technology platforms available for the development and manufacturing of cell therapies?
- Who are the key players (industry / non-industry) engaged in the manufacturing of cell-based therapies across the world?
- What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision related to cell therapies?
- How is the current and future market opportunity likely to be distributed across key market segments?
Key Topics Covered:
1. PREFACE
2. EXECUTIVE SUMMARY
3. INTRODUCTION
4. MARKET OVERVIEW
5. REGULATORY LANDSCAPE
6. ROADMAPS FOR OVERCOMING CHALLENGES
7. AUTOMATION TECHNOLOGIES FOR CELL THERAPY MANUFACTURING
8. PROFILES: INDUSTRY PLAYERS
8.1. Chapter Overview
8.2. Service Providers in North America
8.2.1 Cognate BioServices
8.2.1.1. Company Overview
8.2.1.2. Service Portfolio
8.2.1.3. Manufacturing Facilities and Capabilities
8.2.1.4. Partnerships
8.2.1.5. Future Outlook
8.2.2. KBI Biopharma
8.2.2.1. Company Overview
8.2.2.2. Service Portfolio
8.2.2.3. Manufacturing Facilities and Capabilities
8.2.2.4. Partnerships
8.2.2.5. Future Outlook
8.2.3. Waisman Biomanufacturing
8.2.3.1. Company Overview
8.2.3.2. Service Portfolio
8.2.3.3. Manufacturing Facilities and Capabilities
8.2.3.4. Partnerships
8.2.3.5. Future Outlook
8.3. Service Providers in Europe
8.3.1. BioNTech Innovative Manufacturing Services
8.3.2. Cell and Gene Therapy Catapult
8.3.3. Lonza
8.3.4. Roslin Cell Therapies
8.4. Service Providers in Asia Pacific
8.4.1. Cell Therapies
8.4.2. FUJIFILM Cellular Dynamics
8.4.3. Minaris Regenerative Medicine
8.4.4. MEDINET
8.4.5. Nikon CeLL Innovation
8.4.6. WuXi AppTec
9. PROFILES: 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 Advanced Therapies, Newcastle University
9.9. Rayne Cell Therapy Suite, King's College London
9.10. Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for 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 (NCMC)
10.2.4. California Institute of Regenerative Medicine (CIRM)
10.3. Cell Therapy Manufacturing: International Societies
11. PARTNERSHIPS
12. FACILITY EXPANSIONS
13. BIG PHARMA INITIATIVES
14. CAPACITY ANALYSIS
15. DEMAND ANALYSIS
16. COST PRICE ANALYSIS
17. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
18. MARKET SIZING AND OPPORTUNITY ANALYSIS
19. KEY INSIGHTS
20. SWOT ANALYSIS
21. CONCLUDING REMARKS
22. SURVEY ANALYSIS
23. INTERVIEW TRANSCRIPTS
24. APPENDIX 1: TABULATED DATA
25. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
For more information about this report visit https://www.researchandmarkets.com/r/bw5s48
