Global Cell Therapy Manufacturing Market Study, 2019-2030 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Cell Therapy Manufacturing Market (3rd Edition), 2019-2030” report has been added to ResearchAndMarkets.com’s offering.

Cell Therapy Manufacturing Market (3rd Edition), 2019-2030 features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing. It focuses on both contract manufacturers, as well as developers with in-house manufacturing facilities, offering in-depth analyses of the various business entities that are engaged in this domain, across different global regions.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the cell therapy manufacturing market. Based on parameters, such as number of ongoing/planned clinical studies, cell therapy manufacturing costs, target patient population, and anticipated adoption of such products, 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 2019-2030.

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.

Market Insights

Till date, more than 20 cell-based therapies have been approved (recent examples include Zynteglo (2019), Alofisel (2018), YESCARTA (2017) and Kymriah (2017)), while over 500 product candidates are under development. In fact, there are over 1,000 active clinical studies of cell therapies, worldwide. Over the last few years, such therapies have garnered significant attention within the biopharmaceutical industry. Several companies and venture capital funds/investors have already invested a lot of capital towards the development and commercialization of this emerging class of therapeutics.

Despite the optimism, the growth in this domain is still hindered by various development and manufacturing related challenges, primarily due to the limited availability of expertise and infrastructure to produce cell-based therapies, such as CAR-T cell therapies. The growing number of product development initiatives in this domain, coupled to the fact that there are multiple marketed products, have led to a substantial rise in the overall cell therapy manufacturing demand. As a result, developers have turned to contract manufacturing organizations (CMOs) to fulfil their cell therapy development and production requirements.

A wide array of industry players, including well-established companies, mid-sized firms and start-ups, as well as academic institutes, are contributing towards fulfilling the aforementioned demand, offering GMP grade manufacturing services for cell therapies. In addition to cell therapy manufacturing companies, there are several other players that claim to have developed novel technology solutions, aimed at improving the existing cell therapy manufacturing process.

Many CMOs are also actively expanding their cell therapy manufacturing capacity either through collaborations or acquisitions, in order to offer a wide range of services to their respective clients. As a result of the ongoing efforts aimed at mitigating the existing challenges in this domain, the cell therapy manufacturing market is expected to witness significant growth in mid-long term.

Amongst other elements, the report includes:

  • A detailed review of the overall landscape of companies that are engaged in the manufacturing of cell-based therapies, including information on the type of cells 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 cells (autologous and allogeneic), scale of manufacturing, type of cell cultures (adherent and suspension), purpose of production (fulfilling in-house requirements and contract services), manufacturing capabilities/services offered (including R&D, cell culture development, quality testing, packaging, labelling, cell banking, cryopreservation, fill/finish services, and regulatory affairs management), location of headquarters and location of their respective manufacturing facilities.
  • An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective cell therapy manufacturing capabilities, over the period 2015-2019 (till October), taking into consideration parameters, such as year of expansion, type of cells, scale of operation, purpose of expansion (facility expansion and new facility), location of 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 in the period 2014-2019 (till November), based on various relevant parameters, such as the year of agreement, type of partnership, type of cells, and scale of operation (preclinical, clinical and commercial).
  • Informed estimates of the annual commercial and clinical demand for cell therapies (in terms of number of cells produced and area dedicated to manufacturing), which were further analyzed based on type of cells.
  • An estimate of the overall, installed capacity for manufacturing cell-based therapies based on information reported by industry stakeholders in the public domain, highlighting the distribution of the available capacity on the basis of scale of operation (clinical and commercial), size of the organization (small, mid-sized and large firms) and key geographical regions (North America, EU 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 cells manufactured, scale of operation and purpose of production, [B] a logo landscape based on the type of cells 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 locations of cell therapy manufacturing facilities of both industry and non-industry stakeholders.
  • A detailed analysis of the various factors that are likely to influence the pricing of cell-based therapies, featuring different models/approaches that may be adopted by manufacturers while deciding the prices of their proprietary offerings.
  • An elaborate discussion on the role of automation technologies in improving current manufacturing methods, along with a comparative (qualitative) 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 the North America (focusing on the US), Europe and Asia (focusing on Japan), 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 details, 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 a comprehensive SWOT framework, which includes 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 and indirectly involved in the development and/or manufacturing of cell-based therapies.

Key Topics Covered

1. Preface

2. Executive Summary

3. Introduction

4. Market Overview

5. Regulatory Landscape

6. Roadmaps for Overcoming Existing Challenges

7. Automation Technologies for Cell Therapy Manufacturing

8. Profiles: Industry Players

9. Profiles: Non-Industry Players

10. Role of Non-Profit Organizations

11. Partnerships

12. Facility Expansions

13. Capacity Analysis

14. Demand Analysis

15. Cost Price Analysis

16. Make vs Buy Decision Making Framework

17. Market Sizing and Opportunity Analysis

18. Key Insights

19. SWOT Analysis

20. Conclusion

21. Survey Analysis

22. Interview Transcripts

Companies Mentioned

  • 3P Biopharmaceuticals
  • A2 Healthcare
  • Accellta
  • Acerta Pharma
  • Adaptimmune
  • Adva Biotechnology
  • Advanced Cell Therapy Laboratory, Yale School of Medicine
  • Advanced Regenerative Manufacturing Institute
  • Advent Bioservices
  • Agios Pharmaceuticals
  • Ajinomoto
  • Akron Biotech
  • Alberta Cell Therapy Manufacturing, University of Alberta
  • Allele Biotechnology & Pharmaceuticals
  • Alliance for Regenerative Medicine
  • AlloSource
  • Altor BioScience
  • American Productivity & Quality Center
  • American Society of Gene and Cell Therapy
  • American Society of Mechanical Engineers
  • Amgen
  • Amsterdam Biotherapeutics Unit
  • Andalusian Initiative for Advanced Therapies
  • Angiocrine Bioscience
  • Anterogen
  • Aokai (Suzhou) Biomedical
  • apceth Biopharma
  • Argos Therapeutics
  • ARIAD Pharmaceuticals
  • Asahi Glass Company
  • Asterias Biotherapeutics
  • AstraZeneca
  • Asymptote
  • Atara Biotherapeutics
  • Athersys
  • Atlantic Bio GMP
  • ATVIO Biotechnology
  • Australasian Gene and Cell Therapy Society
  • Austrian Network for Gene Therapy
  • Autolus
  • Azellon Cell Therapeutics
  • Bavarian Nordic
  • Bayer
  • Be The Match BioTherapies
  • Bellicum Pharmaceuticals
  • Berkeley Lights
  • Bio Elpida
  • BioCision
  • Bioinova
  • BioLife Solutions
  • and many, many more!

For more information about this report visit https://www.researchandmarkets.com/r/phglls

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900