Stem Cell Manufacturing Market

Stem Cell Manufacturing Market Overview

The stem cell manufacturing market for CMO is estimated to be worth $293 million in 2019 and is expected to grow at CAGR of 18% during the forecast period. Advances in the fields of cell biology and regenerative medicine have led to the development of a variety of stem cell-based therapies for many cardiovascular, oncological, metabolic and musculoskeletal disorders. Driven by the revenues generated from stem cell therapies, the regenerative medicine market is anticipated to generate revenues worth USD 100 billion by 2030. With a promising pipeline of over 200 stem cell therapy candidates, it has become essential for developers to scale up the production of stem cells therapeutic interventions. Given that stem cell therapy manufacturing requires highly regulated, state-of-the-art technologies, it is difficult for stakeholders to establish in-house expertise for large-scale manufacturing of stem cell therapies. As a result, stem cell therapy developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs). Specifically, small and mid-sized players in this sector tend to outsource a substantial proportion of clinical and commercial-scale manufacturing processes to contract service providers. In addition, even big pharma players, with established in-house capabilities, are gradually entering into long-term business relationships with CMOs in order to optimize resource utilization and manage costs.

According to a recent Nice Insight CDMO survey, about 55% of 700 respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development requirements. Considering the prevalent trends, we believe that the stem cell therapy manufacturing market is poised to grow at a steady pace, driven by a robust pipeline of therapy candidates and technological advances aimed at mitigating challenges posed by conventional methods of production of stem cells. Amidst tough competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor and is likely to grant a competitive advantage to certain CMOs over other players in the industry. Infact, the demand for these contract manufacturing services is likely to be fueled by the increase in number of stem cell therapies being developed for treatment of COVID-19. For instance, stem cell therapy developers such as Athersys and Lattice Biologics have already taken initiatives to find solutions to the fight the novel Coronavirus outbreak.

Key Companies in Stem Cell Manufacturing Market

Examples of key stem cell manufacturers engaged in stem cell manufacturing market (which have also been profiled in this market report; the complete list of stem cell companies is available in the full report) include FUJIFILM Cellular Dynamics, GenCure, Progenitor Cell Therapy (PCT), Waisman Biomanufacturing, WuXi Advanced Therapies, BioNTech Innovative Manufacturing Services, Cell and Gene Therapy Catapult, Lonza, Roslin Cells, MEDINET and Nikon CeLL innovation. This market report includes an easily searchable excel database of all the stem cell companies, worldwide.

Recent Developments in Stem Cell Manufacturing Market:

Several recent developments have taken place in the field of stem cell manufacturing market. 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 September 2023, FDA approved Motixafortide plus filgrastim used for the stem cell mobilization in multiple myeloma. 
• In August 2023, a research article published in the New England Journal of Medicine revealed that stem cell gene therapy might have the potential for the treatment of Sickle Cell Disease (SCD). The data is backed by the Novartis’ Phase I/II clinical trial for the use of cryopreserved stem cells to reduce vaso-constriction. 
• In May 2023, Sernova entered into research collaboration with AstraZeneca with an aim to evaluate novel potential therapeutic cell applications.

Scope of the Report

The “Stem Cell Manufacturing Market, 2019 – 2030” market report features an extensive study on current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the stem cell manufacturing market. The market research report features in-depth analyses, highlighting the capabilities of various stem cell therapy CMOs.

Amongst other elements, the market research report includes:

• A detailed review of the contract manufacturing landscape for stem cell therapies, featuring a comprehensive list of active CMOs and analysis based on a number of parameters, such as year of establishment, company size, geographical location, number of stem cell therapy manufacturing facilities, source of stem cells (allogenic and autologous), types of services offered (culture development, stem cell identification / validation, stem cell banking, cryopreservation, logistics, fill / finish and regulatory filings), scale of operation (preclinical, clinical and commercial), types of stem cells (adult, embryonic and induced pluripotent) and therapeutic area (oncology and non-oncology). 
• An elaborate discussion of the various guidelines laid down by regulatory bodies related to stem cells and other cell-based therapies across various geographies, such as the North America (primarily the US), Europe and other regions.
• Elaborate profiles of the key players based in North America, Europe and Asia-Pacific that have a diverse range of capabilities for the development, manufacturing and packaging of stem cell therapies. Each profile includes an overview of the company, its financial performance (if available), information on service portfolio, stem cell therapy manufacturing facilities, and details on partnerships, recent developments and an informed future outlook. 
• An analysis of the recent collaborations (signed since 2015) focused on the contract manufacturing of stem cell therapies, based on various parameters, such as year of agreement, type of agreement, scale of operation, source of stem cells used, types of stem cells and location of companies entering the partnership.
• An informed estimate of the annual demand for stem cell therapies in terms of area (in square feet) dedicated to stem-cell related operations, based on various parameters, such as target patient population, price of the therapy, dosing frequency and dose strength.
• A detailed capacity analysis, taking into consideration the manufacturing capacities of various stakeholders (small-sized, mid-sized and large CMOs) in the market, based on data gathered via secondary and primary research. It also provides the distribution of global stem cell therapy manufacturing capacity by company size (small-sized, mid-sized and large), and geography (North America, Europe and Asia-Pacific) and scale of operation (preclinical / clinical and commercial).
• A detailed analysis to understand the relationship between the demand and supply in stem cell manufacturing market, comparing the presence of stem cell therapy developers and the availability / capability of stem cell manufacturers across different geographies.
• An analysis to identify the key performance indicators for service providers active in stem cell manufacturing market, based on the information gathered via secondary research and primary research.

The key objective of stem cell manufacturing market report is to provide a detailed market analysis in order to estimate the existing market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for stem cell manufacturing market during the forecast period. Based on parameters, such as increase in number of clinical studies, target patient population, anticipated adoption of stem cell therapies and expected variation in manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the mid to long term, for the forecast period 2019-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] source of stem cells (autologous and allogenic), [B] types of stem cells (adult, embryonic and induced pluripotent), [C] size of contract service provider company (small-sized, mid-sized and large), [D] scale of operation (preclinical, clinical and commercial) and [E] key geographical regions (North America, Europe and Asia and rest of the world). To account for the uncertainties associated with the manufacturing of stem cell therapies and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the market report were influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcripts of interviews held with the following industry stakeholders:

• Arik Hasson, Executive VP Research and Development, Kadimastem
• Brian Dattilo Manager of Business Development, Waisman Biomanufacturing
• David Mckenna, Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota
• Fiona Bellot, Business Development Manager, Roslin Cell Therapies  
• Gilles Devillers, General Manager, Bio Elpida
• Mathilde Girard, Department Leader, Cell Therapy Innovation and Development, YposKesi

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

Frequently Asked Questions

Question 1: What is stem cell manufacturing?

Answer: Stem cell manufacturing refers to manufacturing services provided by specific organizations to pharmaceutical product manufacturers for the development production of novel stem cell therapies.

Question 2: How big is the stem cell manufacturing market?

Answer: The stem cell manufacturing market size for CMO is estimated to be worth $293 million in 2019.

Question 3: What is the projected market growth of the stem cell manufacturing market?

Answer: The stem cell manufacturing market for CMO is expected to grow at compounded annual growth rate (CAGR) of 18% during the forecast period 2019 – 2030.

Question 4: Who are the leading CMO in the stem cell manufacturing market?

Answer: Examples of key CMO engaged in stem cell manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include FUJIFILM Cellular Dynamics, GenCure, Progenitor Cell Therapy (PCT), Waisman Biomanufacturing, WuXi Advanced Therapies, BioNTech Innovative Manufacturing Services, Cell and Gene Therapy Catapult, Lonza, Roslin Cells, MEDINET and Nikon CeLL innovation.

Question 5: How many CMO are currently engaged in the stem cell manufacturing market?

Answer: Presently, over 80 CMO are engaged in the stem cell manufacturing market, having the capabilities to manufacture novel stem cell therapies.

Question 6: How many partnership deals have been inked between the companies engaged in the stem cell manufacturing market?

Answer: Over 100 partnership deals have been inked between the companies engaged in the stem cell manufacturing market, indicating the consolidation efforts of stakeholders in the industry.

Question 7: Which region emerged as the hub for companies engaged in the stem cell manufacturing market?

Answer: Europe emerged as the hub for companies engaged in the stem cell manufacturing market, with 35% of the CMO established in the region.