The intricacies associated with cell therapy manufacturing have paved the way for novel automation technologies

Roots Analysis is pleased to announce the publication of its recent study, titled, “Cell Therapy Manufacturing Market, 2021-2030.”

Manufacturing cell therapies is technically and financially demanding; as a result, despite therapy developers gradually strengthening their in-house expertise, they are also becoming increasingly reliant on contract service providers

Over the years, several advanced and innovative automation tools and technologies have been developed; these have been demonstrated to hold the potential for significant reduction in the cost associated with the manufacturing of advanced therapy medicinal products, thereby, making such products more affordable.

One such emerging concept, namely GMP-In-A Box, offers several advantages, including increased throughput, decreased idle time between batch runs and reduced manual labor. However, the delicate nature of steps involved in the cell therapy production process is known to hinder the overall automation process. Further, the lack of specialized infrastructure and limited expertise available in this domain are some of the known challenges impacting the growth of this segment.

Despite the challenges associated with the development and production of such therapies, we believe, that the benefits offered by them outweigh the hurdles. They are likely to serve as important drivers of the industry’s growth. Efforts to introduce automation technologies in cell therapy manufacturing are underway, and if implemented successfully, can significantly help in the elimination of human intervention and reduce the risk of contamination. As a consequence, it is likely to result in a marked increase in product consistency, ensure the maintenance of sterility, and decrease the production time and cost. In a nutshell, cell therapies are expected to soon represent one of the prominent therapeutic options within the mainstream healthcare. 

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The report features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing. It focuses on both contract manufacturers, as well as developers with in-house manufacturing facilities, offering in-depth analyses of the various business entities that are engaged in this domain, across different global regions. Amongst other elements, the report includes:

• An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective cell therapy manufacturing capabilities, over the period 2015-2019.


• An analysis of the recent partnerships focused on the manufacturing of cell-based therapies, which have been established in the period 2014-2019.


• Informed estimates of the annual commercial and clinical demand for cell therapies, in terms of number of cells produced and area dedicated to manufacturing.


• An estimate of the overall, installed capacity for manufacturing cell-based therapies based on information reported by industry stakeholders in the public domain A competitiveness analysis of biological targets, featuring insightful pictorial summaries and representations.


• A detailed analysis of the various factors that are likely to influence the pricing of cell-based therapies, featuring different models / approaches that may be adopted by manufacturers while deciding the prices of their proprietary offerings.


• A qualitative analysis, highlighting the various factors that need to be taken into consideration by cell therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.


• An elaborate discussion on the role of automation technologies in improving current manufacturing methods.


• A discussion on cell therapy manufacturing regulations across various geographies, including North America, Europe, and Asia Pacific.


• Elaborate profiles of key players (industry and non-industry) that offer contract manufacturing services.


• A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry’s evolution, under a comprehensive SWOT framework.

A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

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

• 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

Key companies covered in the report

• 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 

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Table of Contents

1. Preface

2. Executive Summary

3. Introduction

4. Market Overview

5. Regulatory Landscape

6. Roadmaps for Overcoming Existing Challenges

7. Automation Technologies for Cell Therapy Manufacturing

8. Profiles: Industry Players

9. Profiles: Non-Industry Players

10. Role of Non-Profit Organizations

11. Partnerships

12. Facility Expansions

13. Capacity Analysis

14. Demand Analysis

15. Cost Price Analysis

16. Make Versus Buy Decision Making Framework

17. Market Sizing and Opportunity Analysis

18. Key Insights

19. SWOT Analysis

20. Conclusion

21. Survey Analysis

22. Interview Transcripts

23. Appendix 1: Tabulated Data

24. Appendix 2: List of Companies and Organizations

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