The approval of KYMIRAH®, YESCARTA®, Alofisel® and Zyntelgo® has increased the interest of pharma stakeholders in cell therapies; further, owing to the technical challenges in this field, outsourcing manufacturing operations has become a necessity
Owing to various reasons, the demand for cell therapies is anticipated to increase over the coming years. Therefore, both therapy developers and contract service providers may need to strengthen their capabilities and expand available capacity. In this context, automation is expected to be a key enabler within the cell therapy manufacturing and contract services industry.
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Key Market Insights
More than 160 organizations claim to be engaged in cell therapy manufacturing
The market landscape is dominated by industry players, representing more than 60% of the total number of stakeholders. Amongst these, over 55 are large or mid-sized firms (having more than 50 employees).
100+ players focused on T-cell and stem cell therapies
Most of these players are focused on manufacturing T-cell therapies, including CART, TCR or TILs. It is worth highlighting that more than 35 organizations claim to have necessary capabilities for the manufacturing of both types of therapies.
Presently, 70+ companies have commercial scale capacity
As majority of the cell therapy products are in clinical trials, the demand is high at this scale. However, it is worth noting that several players (~50%) have already developed commercial scale capacity for cell therapies.
Europe is currently considered a current hub for cell therapy production
More than 220 manufacturing facilities have been established by various players, worldwide; of these, 35% are in Europe, followed by those based in North America. Other emerging regions include Australia, China, Japan, Singapore, South Korea and Israel.
50+ facility expansions reported between 2015-2019
More than 85% of the expansions are related to setting up of new facilities across different regions. Maximum expansion activity was observed in the US and in certain countries within the Asia Pacific regions.
20+ companies offer automated solutions to cell therapy developers
Players that claim to offer consultancy services related to automation include (in alphabetical order) Berkeley Lights, Cesca Therapeutics, Ferrologix, FluDesign Sonics, GE Healthcare and Terumo BCT. Further, we identified players, namely (in alphabetical order) Fraunhofer Institute for Manufacturing Engineering and Automation IPA, Invetech, KMC Systems, Mayo Clinic Center for Regenerative Medicine and RoosterBio, that offer consultancy solutions related to automation.
Partnership activity has grown at an annualized rate of 16%, between 2014 and 2018
More than 200 agreements have been inked in the last 5 years; majority of these were focused on the supply of cell-based therapy products for clinical trials. Other popular types of collaboration models include manufacturing process development agreements (16%), services agreements (12%) and acquisitions (10%).
By 2030, developed geographies will capture over 60% of the market share
Asia Pacific is anticipated to capture the major share (~36%) of the market by 2030. It is also important to highlight that financial resources, technical expertise and established infrastructure is likely to drive cell therapy manufacturing market in Europe, which is estimated to grow at a CAGR of ~26%.
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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?
The USD 11 billion (by 2030) financial opportunity within the cell therapy manufacturing market has been analyzed across the following segments:
§ Type of therapy
§ T-cell therapies (CAR-T therapies, TCR therapies, TIL therapies)
§ Dendritic cell therapies
§ Tumor cell therapies
§ NK cell therapies
§ Stem cell therapies
§ Source of cells
§ Scale of operation
§ Purpose of manufacturing
§ Contract manufacturing
§ In-house manufacturing
§ Key geographical regions
§ North America
§ Asia Pacific
§ Rest of the world
The report features inputs from eminent industry stakeholders, according to whom the manufacturing of cell therapies is largely being outsourced due to exorbitant costs associated with the setting-up of in-house expertise. The report includes detailed transcripts of discussions held with the following experts:
§ 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, Center of Excellence for Cellular Therapy / C3i)
§ Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
§ Fiona Bellot (Business Development Manager, RoslinCT)
§ Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi)
§ David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota)
The research covers profiles of key players (industry and non-industry) that offer manufacturing services for cell-based therapies, featuring a company overview, information on manufacturing facilities, and recent collaborations.
§ BioNTech Innovative Manufacturing Services
§ Cell Therapies
§ Cell and Gene Therapy Catapult
§ Center for Cell and Gene Therapy, Baylor College of Medicine
§ Centre for Cell Manufacturing Ireland, National University of Ireland
§ Clinical Cell and Vaccine Production Facility, University of Pennsylvania
§ Cognate BioServices
§ Guy’s and St. Thomas’ GMP Facility, Guy’s Hospital
§ Hitachi Chemical
§ KBI Biopharma
§ Laboratory for Cell and Gene Medicine, Stanford University
§ Molecular and Cellular Therapeutics, University of Minnesota
§ Newcastle Cellular Therapies Facility, Newcastle University
§ Nikon CeLL innovation
§ Rayne Cell Therapy Suite, King’s College London
§ Roslin Cell Therapies
§ Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
§ Sydney Cell and Gene Therapy
§ WuXi Advanced Therapies
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