Cell Therapy Manufacturing Market (3rd Edition), 2020 - 2030

Cell Therapy Manufacturing Market (3rd Edition), 2020 - 2030

  • January 2020 •
  • 570 pages •
  • Report ID: 5492737 •
  • Format: PDF
INTRODUCTION
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.

SCOPE OF THE REPORT
The “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. 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 (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 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.

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.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The study includes detailed transcripts of discussions held with the following individuals:
• Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR)
• Tim Oldham (Chief Executive Officer, Cell Therapies)
• Gerard MJ Bos (Chief Executive Officer, CiMaas)
• Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies)
• Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics)
• Arik Hasson (Executive VP Research and Development, Kadimastem)
• Gilles Devillers (General Manager, Bio Elpida)
• Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy)
• Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
• Fiona Bellot (Business Development Manager, Roslin CT)
• Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, Yposkesi)
• David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts’ views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various emerging trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high-level view on the likely evolution of the cell-based therapy manufacturing market in the short to mid-term, and long term.

Chapter 3 provides a general introduction to cell-based therapies and ATMPs. It includes a detailed discussion on the manufacturing process of cell-based therapies, and associated challenges and applications of currently available cell therapies. It also provides information on the different manufacturing models (centralized and decentralized) that are being used for the production of cell-based therapies, along with a discussion on their respective advantages and disadvantages. Further, it features details related to the scalability of cell-based therapies. The chapter also includes a brief overview on the role of automation and the need for effective supply chain management for cell-based therapies.

Chapter 4 features a detailed list of all the industry, as well as non-industry players that are actively involved in the manufacturing of cell-based therapies. It provides information on the location of their manufacturing facilities, scale of manufacturing, type of cells manufactured (immune cells (such as T cells, dendritic cells, NK cells), stem cells (such as adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), purpose of production (fulfilling in-house requirements / as a contract service provider), source of cells (autologous / allogeneic), manufacturing capabilities / services offered (such as R&D, cell culture development, testing, packaging, labelling, cell banking, cryopreservation, fill/ finish services, regulatory services).

Chapter 5 features a detailed discussion on the regulatory landscape related to cell therapies across various geographies, such as the US, Europe and Japan. Further, it presents an analysis of the manufacturing facilities on basis of the certifications awarded (for manufacturing cell-based therapies) to individual sites by various regulatory bodies across the globe.

Chapter 6 describes the strategies that are likely to be adopted to accelerate the translation of cell-based therapies from laboratory to clinics. It provides details on roadmaps published by different organizations located across various geographies, specifically in the US.

Chapter 7 discusses the role of automation technologies in optimization of current manufacturing practices with the use of closed and single use systems. Further, it features a roadmap that provides information on the steps to develop automation devices, supported by two case studies. It also presents a qualitive analysis on the cost incurred while manufacturing cell-based therapies using manual versus automated manufacturing approaches. In addition, it features a list of organizations that offer automated technologies for manufacturing operations or provide services to therapy developers to automate their production processes.

Chapter 8 features detailed profiles of industry players that offer contract manufacturing services for cell therapies at the clinical and / or commercial scales. Each profile provides a brief overview of the company, details on its manufacturing capabilities and facilities, recent partnerships and an informed future outlook.

Chapter 9 features profiles of non-industry players that offer contract manufacturing services for cell therapies. Each profile provides a brief overview of the organization, and details on its service portfolio and manufacturing facilities.

Chapter 10 discusses the role of non-profit organizations in this domain. It provides a list of organizations that are actively involved in the development and production of cell-based therapies, across different global regions. Further, it includes profiles of organizations that provide financial and / or technological support to cell therapy manufacturers and developers. Additionally, the chapter provides information on various international / national societies that help in disseminating knowledge about the advancement of these therapies to the general community.

Chapter 11 features an analysis of the various partnerships and collaborations that have been inked amongst players engaged in this domain, between 2014-2019. It includes a brief description on the various types of partnership models (which include manufacturing agreements, manufacturing process development agreements, licensing agreements, additional services agreements, acquisitions, joint ventures, service alliances and others) that are employed by stakeholders in this market, and an analysis on the trend of partnerships inked since 2014. It also includes analyses based on year of agreement, type of partnership, scale of operation, types of services offered and types of cells manufactured. Further, the chapter features a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 12 presents detailed analysis on the expansions that have taken place in the cell therapy manufacturing industry, since 2014. It includes information on expansions carried out for increasing existing capabilities, as well as those intended for setting-up of new facilities by manufacturers engaged in this domain. The expansion instances that we came across were analyzed based on various parameters, including year of expansion, type of expansion (capacity expansion and new facility), geographical location of the facility, scale of operation (as mentioned in the expansion terms), type of capability (research and manufacturing), type of cells (CAR-T cells, TCR cells, TIL cells, NK cells, dendritic cells and stem cells).

Chapter 13 features a comprehensive analysis of the overall installed capacity of cell-based therapy manufacturers. The analysis is based on meticulous data collection of reported capacities, via both secondary and primary research, of various small, mid-sized and large companies, and non-industry players distributed across their respective facilities. The results of this analysis were used to establish an informed opinion on the cell-based therapy production capabilities of organizations across different types of organization (industry and non-industry), scale of operation (clinical and commercial), geographies (North America, EU, Asia Pacific and the rest of the world) and size of the organization (small, mid-sized and large organizations).

Chapter 14 features a detailed analysis of the annual demand for cell therapies (in terms of number of cells produced and area dedicated to manufacturing), considering various relevant parameters, such as target patient population, dosing frequency and dose strength of the approved cell therapies, as well as those therapies that are currently being evaluated in clinical trials. The demand analysis has been segmented across different types of cell therapies (including CAR-T cells, TCR cells, TIL cells, NK cells, dendritic cells and stem cells), scales of operation (clinical and commercial) and regions (North America, Europe and Asia Pacific).

Chapter 15 highlights our views on the various factors, including manufacturing costs, that may be taken into consideration while pricing cell-based therapies. It features discussions on different pricing models / approaches, which a manufacturer may choose to adopt to decide the price of its proprietary products.

Chapter 16 presents a qualitative analysis that highlights 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 CMOs.

Chapter 17 presents a comprehensive market forecast analysis, highlighting the likely growth of the cell therapy manufacturing market till the year 2030. We have segregated the opportunity by type of cell therapy (T-cell immunotherapies, dendritic cell-based therapies, NK cell therapies, stem cell therapies and other ATMPs), scale of operation (clinical and commercial), source of cells (autologous and allogeneic), purpose of production (in-house and contract services) and geography (North America, EU and Asia Pacific).

Chapter 18 presents a collection of key insights derived from the study. It includes a grid analysis, highlighting the distribution of cell-based therapy manufacturers on the basis of type of cells manufactured, scale of production and purpose of manufacturing (fulfilling in-house requirement / contract service provider). In addition, it consists of two logo landscapes, representing the distribution of cell-based therapy manufacturers based on the type of cells manufactured (immune cells and stem cells), geographical regions (North America, EU and Asia Pacific) and the type / size of organization (non-industry, small, mid-sized and large companies). The chapter also comprises of two schematic world map representations to highlight the locations of various cell-based therapy manufacturing facilities across different continents.

Chapter 19 provides a discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall industry.

Chapter 20 summarizes the entire report. It provides the key takeaways and presents our independent opinion of the cell therapy manufacturing market, based on the research and analysis described in the previous chapters.

Chapter 21 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development and / or manufacturing of different types of cell therapies. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 22 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR), Tim Oldham (Chief Executive Officer, Cell Therapies), Gerard MJ Bos (Chief Executive Officer, CiMaas), Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies), Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics), Arik Hasson (Executive VP Research and Development, Kadimastem), Gilles Devillers (General Manager, Bio Elpida), Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing), Fiona Bellot (Business Development Manager, Roslin CT), Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, Yposkesi) and David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota).

Chapter 23 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 24 is an appendix that provides the list of companies and organizations mentioned in the report.