The approval of KYMIRAH®, YESCARTA®, Alofisel® and Zyntelgo® has increased the interest of pharma stakeholders in cell therapies.

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Key Inclusions

§ A detailed review of the overall landscape of companiesthat are engaged in the manufacturing of cell-based therapies, including informationon the type of cells manufactured (including immune cells (including T cells,dendritic cells, NK cells), stem cells (including adult stem cells, humanembryonic stem cells and induced pluripotent stem cells) and others), source ofcells (autologous and allogeneic), scale of manufacturing, type of cellcultures (adherent and suspension), purpose of production (fulfilling in-houserequirements and contract services), manufacturing capabilities / servicesoffered (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 oftheir respective manufacturing facilities.

§ An analysis of the various expansion initiatives undertakenby service providers, in order to augment their respective cell therapymanufacturing capabilities, over the period 2015-2019 (till October), takinginto consideration parameters, such as year of expansion, type of cells, scaleof operation, purpose of expansion (facility expansion and new facility),location of manufacturing facility, and most active players (in terms of numberof expansion initiatives undertaken).

§ An analysis of the recent partnerships focused on themanufacturing of cell-based therapies, which have been established in theperiod 2014-2019 (till November), based on various relevant parameters, such asthe year of agreement, type of partnership, type of cells, and scale ofoperation (preclinical, clinical and commercial).

§ Informed estimates of the annual commercial and clinicaldemand for cell therapies (in terms of number of cells produced and areadedicated to manufacturing), which were further analyzed based on type ofcells.

§ An estimate of the overall, installed capacity formanufacturing cell-based therapies based on information reported by industrystakeholders in the public domain, highlighting the distribution of theavailable capacity on the basis of scale of operation (clinical andcommercial), size of the organization (small, mid-sized and large firms) andkey geographical regions (North America, EU and Asia Pacific).

§ An in-depth analysis of cell therapy manufacturers usingthree versatile representations, namely [A] a three dimensional grid analysis,presenting the distribution of companies on the basis of type of cellsmanufactured, scale of operation and purpose of production, [B] a logolandscape based on the type of cells manufactured, geographical location ofmanufacturer (North America, Europe and Asia Pacific) and type and size oforganization (non-industry players, and small, mid-sized and large companies),and [C] a schematic world map representation, highlighting the geographicallocations of cell therapy manufacturing facilities of both industry andnon-industry stakeholders.

§ A detailed analysis of the various factors that are likelyto influence the pricing of cell-based therapies, featuring different models /approaches that may be adopted by manufacturers while deciding the prices oftheir proprietary offerings.

§ An elaborate discussion on the role of automationtechnologies in improving current manufacturing methods, along with acomparative (qualitive) analysis of cost differences between manual andautomated processes.

§ A qualitative analysis, highlighting the various factorsthat need to be taken into consideration by cell therapy developers whiledeciding whether to manufacture their respective products in-house or engagethe services of a CMO.

§ A discussion on cell therapy manufacturing regulationsacross various geographies, including the North America (focusing on the US),Europe and Asia (focusing on Japan), featuring an analysis of the diversecertifications / accreditations awarded to manufacturing facilities byimportant regulatory bodies across the globe.

§ Elaborate profiles of key players (industry andnon-industry) that offer contract manufacturing services for cell-basedtherapies; each profile includes an overview of the company / organization,information on its manufacturing facilities, service portfolio details, recentpartnerships and an informed future outlook.

§ A discussion on affiliated trends, key drivers andchallenges, which are likely to impact the industry’s evolution, under acomprehensive SWOT framework, which includes a Harvey ball analysis,highlighting the relative effect of each SWOT parameter on the overall marketdynamics.

§ Insights generated in a market-wide survey, featuringinputs solicited from experts who are directly and indirectly involved in thedevelopment and / or manufacturing of cell-based therapies.

 

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KeyQuestions Answered

§ What is the global demand for cell-based therapies?

§ Who are the key manufacturers (industry / non-industry) ofcell-based therapies, across the world?

§ What are the major recent developments (such aspartnerships and expansions) in this industry?

§ What kind of partnership models are commonly adopted bystakeholders in this domain?

§ What is the current, installed contract manufacturingcapacity for cell therapies?

§ What are the key factors influencing the make(manufacture in-house) versus buy (outsource) decision related to celltherapies?

§ What are the key parameters governing the cost of celltherapy manufacturing?

§ What are important technology platforms (available / underdevelopment) for cell therapy development and manufacturing?

§  Whatare the key drivers and growth constraints in cell therapy manufacturing market?

§ How is the current and future market opportunity likely tobe distributed across key market segments?

 

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1.    Cell and AdvancedTherapies Supply Chain Management Market, 2019-2030

2.    RNAi TherapeuticsMarket (2nd Edition), 2019 – 2030

3.    Gene Therapy Market(3rd Edition), 2019 – 2030

4.    Stem Cell TherapyContract Manufacturing Market, 2019-2030

 

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Gaurav Chaudhary

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