The cell therapy manufacturing market is projected to reach close to USD 11 Billion by 2030, growing at an annualized rate of 14.9%, claims Roots Analysis

Published: August 2019

Having demonstrated the ability to offer improved treatment related outcomes and also enhance the quality of lives of patients suffering from a diverse range of clinical conditions, the demand for cell therapies is anticipated to increase in the near future

Roots Analysis has announced the addition of Cell Therapy Manufacturing Market report to its list of offerings. 

Given the commercial success of multiple cell therapies, such as RECELL® (Avita Medical) and YESCARTA® (Gilead Sciences), and an evolving clinical pipeline, the opportunity for contract development and manufacturing organizations (CDMOs) is anticipated to grow significantly. Over the years, many service providers have begun automating their operations, in order to eliminate chances of human error during manufacturing.

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Key Market Insights 

Over 145 companies / organizations are actively involved in manufacturing cell-based therapies 
The market landscape is currently dominated by the presence of industry players, which represent more than 55% of the total number of players. Amongst these, over 45 are large or mid-sized firms (having more than 50 employees). It is also worth noting that this field has witnessed the entry of several start-ups.

50+ organizations claim to possess commercial manufacturing capabilities for cell therapies 
As most of the cell therapy products are under clinical evaluation, majority of the manufacturing facilities currently have the capacity to support clinical scale production requirements. At the same time, it is worth noting that several players (over 35%) have already developed / are developing commercial scale capacity for cell therapies. 

Europe has emerged as a key region for the production of cell therapies with more than 40% of manufacturing facilities
Globally, 195 facilities have been established by various players for the manufacturing of the cell therapies; of these, 41% are located in Europe, followed by those based in North America (38%). Other emerging regions include Australia, China, Japan, Singapore, South Korea and Israel. 

Close to 15 companies are presently offering automated solutions to cell therapy developers 
Over the years, automation has emerged as a key enabler of cell therapy manufacturing. Players that claim to offer consultancy services related to automation include (in alphabetical order) these include (in alphabetical order) Berkeley Lights, Cesca Therapeutics, Ferrologix, FluDesign Sonics, GE Healthcare and Terumo BCT. Further, we identified five 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. 

150+ partnerships were inked between 2014 and 2018 
Of these, 32% were observed to be focused on the supply of cell-based therapy products for clinical trials. Other popular types of collaboration models implemented in this domain include additional services agreements (24%), joint ventures (9%) and acquisitions (3%).

North America anticipated to capture 50% of the cell therapy manufacturing market by 2030
Owing to high venture capital funding and drug development activity, North America is anticipated to capture close to 50% of the total market share 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 to grow at a CAGR of over 18%. 

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Key Questions Answered
  • Which are the key CMOs (industry / non-industry), across different geographies, that you can reach out to for your manufacturing requirements?
  • What is the global, installed contract manufacturing capacity available for cell therapies?
  • How is the current and future market opportunity likely to be distributed across key market segments?
  • What kind of partnership models (research agreements, product / technology licensing, technology upgrade, manufacturing process development and testing, manufacturing agreements, acquisitions, clinical trial collaborations and others) are commonly adopted by industry stakeholders? 
  • What are the factors that are likely to influence the prices of cell therapy manufacturing?
  • What are the prevalent trends related to cell therapy manufacturing?
  • What are the key drivers and challenges that are likely to have an impact on the industry (SWOT analysis)?

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 cell therapies
    • Allogeneic cell therapies
  • Scale of operation
    • Clinical scale of manufacturing
    • Commercial scale of manufacturing
  • 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 manufacturing of cell therapies is largely being outsourced due to the exorbitant costs associated with setting-up in-house facilities. The report includes detailed transcripts of discussions held with the following experts:

  • Tim Oldham (Chief Executive Officer, Cell Therapies)
  • Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, Center of Excellence for Cellular Therapy / C3i)
  • Gerard MJ Bos (Chief Executive Officer, CiMaas)
  • Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR)
  • Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
  • Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi)

The research covers profiles of key players (industry and non-industry) that offer contract manufacturing services for cell-based therapies, featuring an overview of the company, information on its manufacturing facilities, and recent collaborations. 

  • BioNTech Innovative Manufacturing Services
  • Brammer Bio
  • Cell and Gene Therapy Catapult
  • Cell Therapies
  • 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
  • Cryosite
  • FUJIFILM Cellular Dynamics
  • Guy’s and St. Thomas’ GMP Facility, Guy’s Hospital
  • Japan Tissue Engineering (J-TEC)
  • KBI Biopharma
  • Laboratory for Cell and Gene Medicine, Stanford University
  • Lonza
  • MaSTherCell
  • Molecular and Cellular Therapeutics, University of Minnesota
  • Newcastle Cellular Therapies Facility, Newcastle University
  • Nikon CeLL innovation
  • PCT, a Hitachi Group Company
  • Rayne Cell Therapy Suite, King’s College London
  • Roslin Cell Therapies
  • Scottish Centre of Regenerative Medicine
  • Sydney Cell and Gene Therapy
  • Waisman Biomanufacturing
  • WuXi Advanced Therapies, a subsidiary of WuXi AppTec

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You may also be interested in the following titles: 

  1. Global T-Cell (CAR-T, TCR, and TIL) Therapy Market
  2. Global Stem Cell Therapy Market
  3. Cell and Gene Therapy CROs Market
  4. Biopharma Contract Manufacturing Market

Gaurav Chaudhary
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