The cost of cell-based therapies depends on various factors, such as duration of manufacturing, vector-based cell transfection and extent of gene modification. Price of such products has been observed to vary between USD 2,000 (for cartilage implants) to USD 50,000-60,000 (for cell and gene therapies).
-- CEO, a small-sized cell therapies manufacturer
Cell Therapy Manufacturing Market Overview
The cell therapy manufacturing market is estimated to be worth $4.5 billion in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 12% during the forecast period. 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 (such as cell therapy manufacturing), 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 manufacturing 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.
Recent Developments in Cell Therapy Manufacturing Market:
Several recent developments have taken place in the field of cell therapy manufacturing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
- In August 2023, NKGen Biotech announced the dosing of SNK02, an lllogeneic NK cell therapy, to the first patient in Phase I clinical trial for the treatment of solid tumors.
- In June 2023, Quell Therapeutics entered into a license agreement with AstraZeneca to develop, manufacture and commercialize engineered Treg cell therapies for autoimmune disorders.
- In June 2023, SCTbio collaborated with Cyto-carein in order to improve the quality of cryopreservation for cell therapy development in Europe.
Scope of the Report
The “Cell Therapy Manufacturing Market 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 (5th Edition), 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.
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?