Published: July 2021
Given the consistent increase in number of cell therapies being developed and launched, this upcoming therapeutic segment is on its way to becoming one of the highest valued markets within the biopharmaceutical industry
Owing to the complex manufacturing processes, requirement of advanced production facilities and the growing demand for cell therapy products, developers are actively outsourcing certain manufacturing operations, in addition to expanding their in-house capabilities.
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Around 200 organizations claim to be engaged in cell therapy manufacturing
The market landscape is dominated by industry players, which constitute 65% of the total number of stakeholders. Amongst these, over 25% companies are large firms.
280+ production facilities dedicated to cell therapies have been established worldwide
North America has emerged as the manufacturing hub for cell therapies, with the presence of nearly 45% of the manufacturing facilities; this is followed by Europe (31%). Other emerging regions include China, Japan, South Korea and Australia.
90 cell therapy manufacturers 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 the stem cell therapy manufacturers are primarily engaged in the production of adult stem cells and mesenchymal stem cell therapies
Presently, more than 70 companies carry out manufacturing at all scales of operation.
Nearly 45% players have the required capabilities for commercial scale manufacturing. It is worth noting that all the industry players manufacture cell therapies required for clinical purposes.
35+ companies offer automated and closed systems to cell therapy developers
More than 60 automated and closed systems are being used for cell therapy manufacturing. Organizations that are presently offering customized automated solutions for cell therapy processes / manufacturing are Fraunhofer Institute for Manufacturing Engineering and Automation IPA (Germany), KMC Systems (US), RoosterBio (US) and Mayo Clinic Center for Regenerative Medicine (US).
Several partnerships were established in this domain, during the period 2016-2021
More than 180 deals have been inked during the given time period. A large proportion (34%) of the partnerships were related to manufacturing of cell therapies, followed by acquisitions (17%) and licensing agreements (14%).
Expansion activity in this domain has grown at a CAGR of 59%, between 2016 and 2021
More than 75 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 (17%).
Role of big pharma players in this industry has evolved over the last few years; their initiatives increased at a CAGR of 41% during the period 2016-2020
Several big pharma players have undertaken various initiatives focused on cell therapy manufacturing. Gilead sciences, Takeda Pharmaceutical and Novartis are some of the prominent big pharma players in this domain.
The currently available global cell therapy manufacturing capacity is estimated to be over 1.88 billion sq. ft. of dedicated cleanroom area
The maximum (48%) installed capacity (in terms of cleanroom area) belongs to companies based in North America (48%); the region has higher number of players having multiple production facilities. This is followed by Asia Pacific (29%) and Europe (23%).
The demand for cell therapies is anticipated to grow at a CAGR of 22%, during 2021-2030
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 tumor cell, NK cell and dendritic cell therapies is expected to grow at a relatively faster pace, over the next decade.
By 2030, the market for commercial scale cell therapy manufacturing is likely to grow at an annualized rate of 31.5%
Currently, North America and Europe capture more than 70% 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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The USD 14.5 billion (by 2030) financial opportunity associated with cell therapy manufacturing market has been analyzed across the following segments:
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:
The research includes profiles of key players (industry and non-industry; listed below), featuring a brief overview company / organization, information on its manufacturing facilities, service portfolio, recent partnerships and an informed future outlook.
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