Growing at an Annualized Rate of Over 20%, The Cell Therapy Manufacturing Market is Estimated to Reach Close to USD 10 Billion by 2030, Claims Roots Analysis

The approval of KYMRIAH®, 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

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Roots Analysis

Nov 21, 2019, 11:00 ET

LONDON, Nov. 21, 2019 /PRNewswire/ -- Roots Analysis has announced the addition of "Cell Therapy Manufacturing Market (3^rd Edition), 2019 - 2030" report to its list of offerings.

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 10+ 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
Stem cell therapies

Source of cells

Autologous
Allogeneic

Scale of operation

Clinical
Commercial

Purpose of manufacturing

Contract manufacturing
In-house manufacturing

Key geographical regions

North America
Europe
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
FUJIFILM
Guy's and St. Thomas' GMP Facility, Guy's Hospital
Hitachi Chemical
KBI Biopharma
Laboratory for Cell and Gene Medicine, Stanford University
Lonza
MaSTherCell
MEDINET
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