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Key Inclusions
- 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.
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Key Questions Answered
- What is the global demand for cell-based therapies?
- Who are the key manufacturers (industry / non-industry) of cell-based therapies, across the world?
- What are the major recent developments (such as partnerships and expansions) in this industry?
- What kind of partnership models are commonly adopted by stakeholders in this domain?
- What is the current, installed contract manufacturing capacity for cell therapies?
- What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision related to cell therapies?
- What are the key parameters governing the cost of cell therapy manufacturing?
- What are important technology platforms (available / under development) for cell therapy development and manufacturing?
- What are the key drivers and growth constraints in cell therapy manufacturing market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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About Roots Analysis
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