The cell therapy manufacturing market is anticipated to grow at an annualized rate of over 12%, claims Roots Analysis
Given the consistent research efforts and continuous growth of the cell therapies development pipeline, this upcoming therapeutic segment is expected to represent one of the highest valued segments of the biopharmaceutical industry in the foreseen future
London, Nov. 22, 2022 (GLOBE NEWSWIRE) — Roots Analysis has announced the addition of “Cell Therapy Manufacturing Market (5th Edition), 2022-2035” report to its list of offerings.
Owing to the intricacies associated with the manufacturing processes, requirement for advanced production facilities and the growing demand for cell therapy products, developers are actively outsourcing certain production operations, in addition to expanding their in-house capabilities.
To order this 649 page report, which features 245+ figures and 285+ tables, please visit https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html
Key Market Insights
Around 243 organizations claim to be engaged in cell therapy manufacturing (outsourced)
The current market landscape is dominated by industry players, which constitute 70% of the total number of stakeholders. It is worth mentioning that, amongst these, over 39% companies are small firms.
340+ facilities dedicated to cell therapy manufacturing have been established worldwide
North America has emerged as a key manufacturing hub for cell therapies, featuring the presence of nearly 46% manufacturing facilities; this is followed by Europe (28%). Other emerging regions include China, Japan, Singapore and Australia.
65+ cell therapy manufacturing companies are focused on immune cell and stem cell therapies
Most of the players in this domain are focused on manufacturing of T cell therapies, primarily CAR-T therapies, while stem cell therapy manufacturers are primarily engaged in the production of adult stem cells and mesenchymal stem cell therapies
Presently, more than 108 companies carry out cell therapy manufacturing at all scales of operation.
Nearly 54% players have the required capabilities for commercial scale manufacturing. It is worth noting that all industry and non-industry players manufacture cell therapies required for clinical purposes.
45+ companies offer automated and closed systems to cell therapy developers
More than 70 automated and closed systems are being used for cell therapy manufacturing. Nearly 60% automation technologies have been developed for processing and manufacturing adult stem cells, followed by those focused on T cells (53%).
1,038+ clinical trials evaluating cell therapies have been registered post 2019, worldwide
The clinical research activity (in terms of number of trials registered) increased at a CAGR of 73%, during the period 2019-2022. Of the total number of trials, close to 94% studies are presently active. Amongst the active trials, 76% were observed to be currently recruiting.
Over 260 partnerships were established in this domain, during the period 2016-2022
A large proportion (28%) of the partnerships were related to cell therapy manufacuring, followed by mergers and acquisitions (19%), and product development and commercialization agreements (9%).
Expansion activity cell therapy manufacturing market has grown at a CAGR of 70%, between 2017 and 2022
More than 110 facility expansions were reported during the given time period. Over 80% instances were related to the establishment of new facilities, followed by those involving the expansion of existing facilities (19%).
Initiatives undertaken by big pharma players have increased at a CAGR of 58%, during 2017-2022
Several big pharma players have carried out initiatives focused on cell therapy manufacturing. Gilead sciences, Takeda Pharmaceutical and Novartis are some of the prominent big pharma players in this domain.
Currently available global cell therapy manufacturing capacity is estimated to be over 5.44 billion sq. ft. of dedicated cleanroom area
The maximum (48%) installed capacity (in terms of cleanroom area) belongs to companies based in North America; the region has a higher number of players, which have multiple production facilities. This is followed by Asia Pacific (41%) and Europe (12%).
The demand for cell therapies is anticipated to grow at a CAGR of 16%, during 2022-2035
Presently, the clinical demand for stem cell and CAR-T cell-based products is the highest; this trend is unlikely to change in the foreseen future as well. On the other hand, the demand for NK cell and dendritic cell therapies is expected to grow at a relatively faster pace, over the next decade.
By 2035, the commercial scale cell therapy manufacturing market is likely to grow at an annualized rate of 19%
Currently, North America and Europe capture more than 55% share of the overall market. Specifically, the cell therapy manufacturing market in Asia Pacific is driven by countries, such as China, Japan, South Korea, India and Singapore. It is worth noting that the current market in Asia Pacific is primarily driven by the clinical demand for cell therapies.
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Frequently Asked Questions
- 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 cell therapy manufacturing capacity?
- What are the key parameters governing the price of cell therapies?
- What are the key recent developments (such as partnerships and expansions) that have been undertaken in the field of cell therapies?
- What kind of partnership models are commonly adopted by stakeholders engaged in the cell therapy manufacturing domain?
- What are the different types of initiatives undertaken by big pharma players for the cell therapy manufacturing in the recent past?
- What are the different types of automated technology platforms that are available to be adopted for the cell therapy development and manufacturing?
- Who are the key players (industry / non-industry) engaged in the cell therapy manufacturing across the world?
- What is the estimated total capital expenditure required to set up a cell therapy manufacturing facility?
- What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision related to cell therapies?
- What is the current cell therapy manufacturing market?
- What is the future cell therapy manufacturing market?
The financial opportunity associated with the cell therapy manufacturing market has been analyzed across the following segments:
Type of Cell Therapy
- T cell therapies
- Dendritic cell therapies
- NK cell therapies
- Stem cell therapies
Source of Cell
Scale of Operation
Purpose of Manufacturing
- In-house Manufacturing
- Contract Manufacturing
- North America
- Asia Pacific
- Rest of the World
The report also 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:
- Peter Coleman (Chief Executive Officer, RoslinCT)
- Dominic Clarke (Chief Technical Officer, Cell and Gene Therapy, Discovery Life Sciences)
- 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, RoslinCT)
- 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)
The research includes profiles of key players (industry and non-industry; listed below), featuring a brief overview of the company / organization, along with details related to its manufacturing facilities, service portfolio, recent developments and an informed future outlook.
- AGC Biologics
- BioNTech Innovative Manufacturing Services
- Cell and Gene Therapy Catapult
- Cell Therapies
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Center for Cell Manufacturing Ireland, National University of Ireland
- Charles River Laboratories
- Clinical Cell and Vaccine Production Facility, University of Pennsylvania
- FUJIFILM Cellular Dynamics
- Guy’s and St. Thomas GMP Facility, Guy’s Hospital
- KBI Biopharma
- Laboratory for Cell and Gene Medicine, Stanford University
- Minaris Regenerative Medicine
- Molecular and Cellular Therapeutics, University of Minnesota
- Newcastle Cellular Therapies Facility, Newcastle University
- Nikon CeLL innovation
- Rayne Cell Therapy Suite, King’s College London
- Scottish National Blood Transfusion Service, Scottish Centre of Regenerative Medicine
- Sydney Cell and Gene Therapy
- Thermofisher Scientific
- WuXi AppTec
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