StemCell Therapy

INTRODUCTION 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.

New York, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "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" - https://www.reportlinker.com/p06130492/?utm_source=GNW 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, gene 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-based 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-based 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.

SCOPE OF THE REPORT The Cell Therapy Manufacturing Market (4th Edition) by Type of Cell Manufactured (Immune Cells, Stem Cells and Others ), Source of Cell (Autologous and Allogeneic), Scale of Operation (Preclinical, Clinical and Commercial), Purpose of Manufacturing (In-house and Contract) and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America and MENA) - Industry Trends and Global Forecasts, 2021-2030 report 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. 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 industrys 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.

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 informed estimates on the evolution of the market in the short to mid-term and mid to long term, for the period 2021-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] type of cell therapy (T cell therapies, dendritic and tumor cell therapies, NK cell therapies, stem cell therapies and others), [B] source of cell (autologous and allogeneic), [C] scale of operation (clinical and commercial), [D] purpose of manufacturing (in-house and contract), and [E] key geographical regions (North America, Europe, Asia Pacific, Latin America and MENA). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industrys growth.

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

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.

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?

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 key insights captured in our research. It offers a high-level view on the current state of the cell-based therapy manufacturing market and its likely evolution in the short to mid-term, and long term.

Chapter 3 provides a general introduction to cell-based therapies and ATMPs. It further includes a detailed discussion on the manufacturing process of cell-based therapies, and associated challenges, along with highlighting the applications of currently approved products. Additionally, it highlights information on the different manufacturing models (centralized and decentralized) that are being used for the production of cell-based therapies, as well as their associated advantages and disadvantages. Furthermore, it features details related to the scalability of cell-based therapies. The chapter also includes a brief overview of 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 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.

Chapter 5 features a detailed discussion on the regulatory landscape related to cell therapies across various geographies, such as the US, Europe, Japan and China. 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 2016-2021 (till February). It includes a brief description on the various types of partnership models that are employed by stakeholders in this market, and an analysis on the trend of partnerships. It also includes analyses based on year of agreement, type of partnership, scale of operation, type of cell manufactured and most active players. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals. Further, the chapter features an analysis of the various acquisitions that have taken place in this domain, highlighting geographical activity. The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain.

Chapter 12 presents detailed analysis on the expansions that have taken place in the cell therapy manufacturing industry, since 2016. 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 were analyzed based on various parameters, including 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).

Chapter 13 provides a detailed analysis 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.

Chapter 14 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, Europe and Asia Pacific) and company size (small, mid-sized and large organizations).

Chapter 15 features a detailed analysis of the annual demand for cell therapies (in terms of number of patients), 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, tumor cells and stem cells), scale of operation (clinical and commercial) and regions (North America, Europe and Asia Pacific).

Chapter 16 highlights our views on various factors, including manufacturing costs, that may be taken into consideration while pricing cell-based therapies. It features discussions on different pricing models / approaches adopted by manufacturers to decide the price of its proprietary products.

Chapter 17 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 CMO.

Chapter 18 presents an elaborate market forecast analysis, highlighting the future potential of the market till the year 2030. The chapter presents a detailed market segmentation on the basis of [A] type of cell therapy (T cell therapies, dendritic and tumor cell therapies, NK cell therapies, stem cell therapies and others), [B] source of cell (autologous and allogeneic), [C] scale of operation (clinical and commercial), [D] purpose of manufacturing (in-house and contract), and [E] key geographical regions (North America, Europe, Asia Pacific and Latin America and MENA).

Chapter 19 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 cell manufactured, scale of operation and purpose of production (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 cell manufactured (immune cells and stem cells), geographical regions (North America, Europe 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 20 provides a discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall cell therapy manufacturing industry.

Chapter 21 summarizes the overall report, wherein we have mentioned all the key facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the cell therapy manufacturing market.

Chapter 22 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 23 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics), Gilles Devillers (General Manager, Bio Elpida), Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies), Arik Hasson (Executive VP Research and Development, Kadimastem), Fiona Bellot (Business Development Manager, Roslin CT), David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota), Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR), Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing), Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, Yposkesi), Tim Oldham (Chief Executive Officer, Cell Therapies) and Gerard MJ Bos (Chief Executive Officer, CiMaas).

Chapter 24 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 25 is an appendix, which contains a list of companies and organizations mentioned in this report.Read the full report: https://www.reportlinker.com/p06130492/?utm_source=GNW

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