Cell Therapy Manufacturing Market (5th Edition), 2022-2035

Cell Therapy Manufacturing Market (5th Edition), 2022-2035

Driven by numerous developmental breakthroughs and results of studies demonstrating the vast potential of cellular therapies in the treatment of rare disorders, this therapeutic modality has garnered considerable attention of players engaged in the healthcare industry, in the past few years. In this context, it is worth noting that, since 2019, over 1,035 clinical studies focused on such cell therapy candidates have been initiated. Moreover, several commercialized cell therapies have emerged as top selling drugs in the healthcare industry. For instance, Kymriah® has registered sales worth over USD 1.5 billion since its launch in 2018. Considering the sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, the focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. 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.

At present, the market landscape for cell therapy manufacturing is fragmented, featuring a mix of in-house manufacturers and contract service providers. Further, in order to ensure the optimum use of their resources and enable additional revenue generation opportunities, a number of innovator companies engaged in this market also offer contract services, in addition to their in-house manufacturing capabilities. Considering the growing demand for cell therapies, players engaged in this industry are undertaking several initiatives to ensure that they are able to cater to the requirements of their clients. Since 2020, a considerable increase in both partnership and expansion activity has been observed within the overall cell therapy domain. It is also worth highlighting that the increasing interest and involvement of big pharma players in this market has been instrumental in escalation of the adoption of such therapies. In recent years, several big pharma players have undertaken initiatives, including establishing strategic partnerships with other industry players and carrying out expansion projects, in order to enhance their cell therapy manufacturing capabilities. Considering the ongoing efforts of stakeholders to mitigate the manufacturing associated complications and an enhanced emphasis on the advancement of such therapies, the cell therapy manufacturing market is anticipated to witness significant growth in the foreseen future.

SCOPE OF THE REPORT

The “Cell Therapy Manufacturing Market (5th Edition) by Type of Cell Manufactured (Immune Cells, Stem Cells and Others ), Source of Cell (Autologous and Allogeneic), Scale of Operation (Preclinical, Clinical and Commercial), Purpose of Manufacturing (In-house and Contract) and Key Geographical Regions (North America, Europe, Asia Pacific and Rest of the World) - Industry Trends and Global Forecasts, 2022-2035” report features an extensive study of the current market landscape and future opportunities associated with the cell therapy manufacturing market, along with information on both contract manufacturers, as well as developers having in-house manufacturing capabilities, offering an in-depth analyses of the various business entities engaged in this domain, across key geographic locations. Amongst other elements, the report includes:

A general overview of cell therapies, along with information on the key challenges and factors influencing the cell therapy manufacturing market. It provides details on the automation tools and technologies being utilized for improving manufacturing processes and the future prospects in this domain.

A detailed review of the overall market landscape of players engaged in the manufacturing of cell-based therapies, along with information on type of cells manufactured (including immune cells (T cells, dendritic cells, NK cells), stem cells (adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), source of cell (autologous and allogeneic), scale of operation (preclinical, clinical and commercial), purpose of production (fulfilling in-house requirements and contract services), manufacturing capabilities / services offered (R&D, cell culture development, quality testing, packaging, cell banking, supply chain management services, and regulatory services), location of headquarters and their respective manufacturing facilities.

A discussion on cell therapy manufacturing related regulations across various geographies, including North America (focusing on the US), Europe and Asia (focusing on Japan and China), featuring an analysis of the diverse certifications / accreditations awarded to the manufacturing facilities by important regulatory bodies across the globe.

An overview of the various roadmaps published by different agencies across the globe in order to provide strategies to advance cell therapy manufacturing processes.

An elaborate discussion on the role of technology automation in order to improve the current manufacturing methods, along with a comparative (qualitive) analysis of the cost differences between manual and automated processes.

Elaborate profiles of key industry players that offer contract manufacturing services for cell therapies at the clinical and / or commercial scales of operation. Each profile features a brief overview of the company, along with details related to its cell therapy manufacturing service portfolio, its manufacturing capabilities and facilities, recent partnerships and an informed future outlook.

Elaborate profiles of non-industry players that offer contract manufacturing services for cell therapies, featuring an overview of the organization, along with details related to its cell therapy manufacturing service portfolio and manufacturing facilities.

A discussion on the role of non-profit organizations, featuring a list of organizations that are actively involved in the development and production of cell-based therapies, across different geographical locations, along with information on various international / national societies that help in disseminating knowledge about the advancement of these therapies to the general community.

An analysis of completed, ongoing and planned clinical trials, based on several relevant parameters, such as trial registration year, enrolled patient population, trial status, trial phase, type of sponsor / collaborator, patient segment, target therapeutic area, study design, most active industry and non-industry players (in terms of number of clinical trials conducted) and regional distribution of trials.

A detailed analysis of the recent partnerships and collaborations inked by players focused on the manufacturing of cell-based therapies, during the period 2016-2022, based on several relevant parameters, such as the year of agreement, type of partnership model adopted, type of cells manufactured and scale of operation.

An analysis of the various expansion initiatives undertaken by service providers engaged in this domain in order to augment their respective cell therapy manufacturing capabilities, during the period 2016-2022, based on several relevant parameters, such as year of expansion, type of cell manufactured, scale of operation, purpose of expansion (facility expansion and new facility), location of expanded manufacturing facility, and most active players (in terms of number of expansion initiatives undertaken).

An in-depth analysis of the various cell therapy manufacturing focused initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of cell manufactured.

An estimate of the overall, installed capacity for the manufacturing of cell-based therapies, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity on the basis of scale of operation (clinical and commercial), company size (small, mid-sized and large firms) and key geographical regions (North America, Europe and Asia Pacific).

Informed estimates of the annual commercial and clinical demand for cell therapies (in terms of number of patients), based on type of cell therapy and key geographical regions.

A detailed analysis of various factors that are likely to influence the price of cell-based therapies, featuring different models / approaches adopted by manufacturers in order to determine the price 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 in-depth analysis of cell therapy manufacturers using three versatile representations, namely, a three dimensional grid analysis, presenting the distribution of companies on the basis of type of cell manufactured, scale of operation and purpose of production, a logo landscape, based on the type of cell manufactured, geographical location of manufacturer (North America, Europe and Asia Pacific), and type and size of organization (non-industry players, and small, mid-sized and large companies), and a schematic world map representation, highlighting the geographical location of cell therapy manufacturing facilities of both industry and non-industry stakeholders.

A collection of key insights derived from the study, including a grid analysis, two logo landscapes and two schematic world map representations highlighting various offerings and details of the cell therapy manufacturing service providers across different continents.

A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry’s evolution, under an elaborate SWOT framework, along with a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall market dynamics.

Insights generated in a market-wide survey, featuring inputs solicited from experts who are directly / indirectly involved in the development and / or manufacturing of cell-based therapies.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the cell therapy manufacturing market. Based on relevant parameters, such as number of ongoing / planned clinical studies, cell therapy manufacturing costs, target patient population, and anticipated adoption of such therapies, we have provided informed estimates on the evolution of the market in the short to mid-term and mid to long-term, for the period 2022-2035. The report also features the likely distribution of the current and forecasted opportunity across important parameters, such as [A] type of cell therapy (T cell therapies, dendritic cell therapies, NK cell therapies, stem cell therapies and others), [B] source of cell (autologous and allogeneic), [C] scale of operation (clinical and commercial), [D] purpose of manufacturing (in-house and contract), and [E] key geographical regions (North America, Europe, Asia Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:

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 (Ex-Business Development Manager, Roslin CT)

David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota)

Victor Lietao Li (Ex- Co-Founder and Chief Executive Officer, Lion TCR)

Arnaud Deladeriere (Ex-Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy)

Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)

Mathilde Girard (Ex-Department Leader, Cell Therapy Innovation and Development, Yposkesi)

Tim Oldham (Ex-Chief Executive Officer, Cell Therapies)

Gerard MJ Bos (Chief Executive Officer, CiMaas)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

MARKET SEGMENTATIONS

Cell Therapy Manufacturing Market (5th Edition): Market Segmentations

Market Segments Details

Forecast Period 2022 – 2035

Type of Cell Therapy

T Cell Therapies

Dendritic Cell Therapies

NK Cell Therapies

Stem Cell Therapies

Other Therapies

Source of Cells Autologous

Allogeneic

Scale of Operation Clinical

Commercial

Purpose of Manufacturing
In-house Manufacturing

Contract Manufacturing

Key Geographical Regions
North America

Europe

Asia-Pacific

Rest of the World

Source: Roots Analysis

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various emerging trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED

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 manufacturing capacity for cell therapies?

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 manufacturing of cell therapies in the recent past?

What are the different types of automated technology platforms that are available to be adopted for the development and manufacturing of cell therapies?

Who are the key players (industry / non-industry) engaged in the manufacturing of cell-based therapies 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?

How is the current and future market opportunity likely to be distributed across various key market segments?

CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the cell-based therapy manufacturing market and its likely evolution in the short to mid-term, and long term.

Chapter 3 provides a general introduction to cell-based therapies and ATMPs. It further features a detailed discussion on the manufacturing process of cell-based therapies, and associated challenges, along with information on the applications of currently approved products. Additionally, it highlights information on the different manufacturing models (centralized and decentralized) that are being used for manufacturing of cell-based therapies, as well as their associated advantages and disadvantages. Furthermore, it features details related to the scalability of cell-based therapies. The chapter also includes a brief overview of the role of automation and the need for effective supply chain management for cell-based therapies.

Chapter 4 features a detailed list of all the industry, as well as non-industry players that are actively involved in the manufacturing of cell-based therapies. It provides information on the type of cell manufactured (including immune cells (T cells, dendritic cells, NK cells), stem cells (adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), source of cell (autologous and allogeneic), scale of operation (preclinical, clinical and commercial), purpose of production (fulfilling in-house requirements and contract services), manufacturing capabilities / services offered (R&D, cell culture development, quality testing, packaging, cell banking, supply chain management services, and regulatory services), location of headquarters and their respective manufacturing facilities.

Chapter 5 features a detailed discussion on the regulatory landscape related to cell therapies across various geographies, such as the US, Europe, Japan and China. Further, it presents an analysis of the manufacturing facilities on basis of the certifications awarded (for manufacturing cell-based therapies) to individual sites by various regulatory bodies across the globe.

Chapter 6 describes the strategies that are likely to be adopted to accelerate the translation of cell-based therapies from laboratory to clinics. It provides details on roadmaps published by different organizations located across various geographies, specifically in the US.

Chapter 7 discusses the role of technology automation in order to optimize the current manufacturing practices with the use of closed and single use systems. Further, it features a roadmap that provides information on the steps to develop automation devices, supported by two case studies. It also presents a qualitive analysis on the cost incurred while manufacturing cell-based therapies using manual versus automated manufacturing approaches. In addition, it features a list of organizations that offer automated technologies for manufacturing operations or provide services to therapy developers to automate their production processes.

Chapter 8 features elaborate profiles of key industry players that offer contract manufacturing services for cell therapies at the clinical and / or commercial scales of operation. Each profile features a brief overview of the company, along with details related to its cell therapy manufacturing capabilities and facilities, recent partnerships and an informed future outlook.

Chapter 9 features elaborate profiles of non-industry players that offer contract manufacturing services for cell therapies. Each profile provides a brief overview of the organization, along with details related to its cell therapy manufacturing service portfolio and manufacturing facilities.

Chapter 10 discusses the role of non-profit organizations in this domain. It provides a list of organizations that are actively involved in the development and production of cell-based therapies, across different geographical locations. Further, it includes profiles of organizations that provide financial and / or technological support to cell therapy manufacturers and developers. Additionally, the chapter provides information on various international / national societies that help in disseminating knowledge about the advancement of these therapies to the general community.

Chapter 11 presents a detailed analysis of completed, ongoing and planned clinical trials, based on several relevant parameters, such as trial registration year, enrolled patient population, trial status, trial phase, type of sponsor / collaborator, patient segment, target therapeutic area, study design, most active industry and non-industry players (in terms of number of clinical trials conducted) and regional distribution of trials.

Chapter 12 features an analysis of the various partnerships and collaborations inked amongst players engaged in this domain, between 2016-2022 (till July). It includes a brief description on the various types of partnership models that are employed by stakeholders in this market, and an analysis on the trend of partnerships. It also includes analyses based on year of agreement, type of partnership, scale of operation, type of cells manufactured and most active players. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals. Further, the chapter features an analysis of the various acquisitions that have taken place in this domain, highlighting geographical activity. The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain.

Chapter 13 presents detailed analysis on the expansions that have taken place in the cell therapy manufacturing industry, since 2016. It includes information on expansions carried out for increasing existing capabilities, as well as those intended for setting-up of new facilities by manufacturers engaged in this domain. The expansion instances were analyzed based on various parameters, including year of expansion, type of cell manufactured, scale of operation, purpose of expansion (facility expansion and new facility), location of expanded manufacturing facility, and most active players (in terms of number of expansion initiatives undertaken).

Chapter 14 provides an in-depth analysis of the various cell therapy manufacturing focused initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of cell manufactured.

Chapter 15 features a comprehensive analysis of the overall installed capacity of cell-based therapy manufacturers. The analysis is based on meticulous data collection of reported capacities, via both secondary and primary research, of various small, mid-sized and large companies, and non-industry players distributed across their respective facilities. The results of this analysis were used to establish an informed opinion on the cell-based therapy production capabilities of organizations across different types of organization (industry and non-industry), scale of operation (clinical and commercial), geographies (North America, Europe and Asia Pacific) and company size (small, mid-sized and large organizations).

Chapter 16 features a detailed analysis of the annual demand for cell therapies (in terms of number of patients), considering various relevant parameters, such as target patient population, dosing frequency and dose strength of the approved cell therapies, as well as those therapies that are currently being evaluated in clinical trials. The demand analysis has been segmented across different types of cell therapies (including CAR-T cells, TCR cells, TIL cells, NK cells, dendritic cells and stem cells), scale of operation (clinical and commercial) and regions (North America, Europe and Asia Pacific).

Chapter 17 highlights our views on various factors, including manufacturing costs, that may be taken into consideration while pricing cell-based therapies. It features discussions on different pricing models / approaches adopted by manufacturers in order to determine the price of its proprietary products.

Chapter 18 presents a qualitative analysis that highlights 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.

Chapter 19 presents a company size-wise, detailed analysis of the total cost of ownership for cell therapy manufacturing organizations, during the period 2022-2042.

Chapter 20 presents an elaborate market forecast analysis, highlighting the future potential of the market till the year 2035. The chapter presents a detailed market segmentation on the basis of type of cell therapy (T cell therapies, dendritic cell therapies, NK cell therapies, stem cell therapies and others), source of cell (autologous and allogeneic), scale of operation (clinical and commercial), purpose of manufacturing (in-house and contract), and key geographical regions (North America, Europe, Asia Pacific and Rest of the World).

Chapter 21 presents a collection of key insights derived from the study. It includes a grid analysis, highlighting the distribution of cell-based therapy manufacturers on the basis of type of cell manufactured, scale of operation and purpose of production (fulfilling in-house requirement / contract service provider). In addition, it consists of two logo landscapes, representing the distribution of cell-based therapy manufacturers based on the type of cell manufactured (immune cells and stem cells), geographical regions (North America, Europe and Asia Pacific) and the type / size of organization (non-industry, small, mid-sized and large companies). The chapter also comprises of two schematic world map representations to highlight the locations of various cell-based therapy manufacturing facilities across different continents.

Chapter 22 provides a discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall cell therapy manufacturing industry.

Chapter 23 is a summary the overall report. The chapter provides the key takeaways from the report, and presents facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the cell therapy manufacturing market.

Chapter 24 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development and / or manufacturing of different types of cell therapies. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 25 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with 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, Roslin CT), 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) and Gerard MJ Bos (Chief Executive Officer, CiMaas).

Chapter 26 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 27 is an appendix, which contains a list of companies and organizations mentioned in this report.