StemCell Therapy

NEW YORK, Nov. 7, 2019 /PRNewswire/ --

INTRODUCTIONAdvances 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 such 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.

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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. 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.

SCOPE OF THE REPORTThe "Stem Cell Therapies Contract Manufacturing Market, 2019 2030" report features an extensive study on contract service providers engaged in the development and manufacturing of stem cell therapies. The study features in-depth analyses, highlighting the capabilities of various stem cell therapy CMOs. Amongst other elements, the 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 this field, comparing the presence of stem cell therapy developers and the availability / capability of contract manufacturers across different geographies. An analysis to identify the key performance indicators for service providers active in the domain, based on the information gathered via secondary research and primary research.

One of the key objectives of the report was to estimate the future size of the market. 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 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 forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The 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 report are in USD, unless otherwise specified.

RESEARCH METHODOLOGYThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews 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. Where 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 2030, the report also provides our independent view on various technological and non-commercial trends emerging 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.

CHAPTER OUTLINESChapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the likely evolution of the stem cell therapy contract manufacturing market in the mid to long term.

Chapter 3 provides a brief introduction to the basic concepts related to stem cell therapies and the intricacies of their development and administration. In addition, it includes information on the various types of stem cell therapies (based on the source, potency and lineage of stem cells), modes of delivery and the disease indications targeted by such interventions. It also includes a discussion on the different manufacturing models (centralized and decentralized) that are used for the production of stem cell therapies, along with a list of advantages and disadvantages. Further, it provides details on the scalability of stem cell therapies. The chapter also includes a brief overview on the role of automation and supply chain management, with respect to stem cell therapies.

Chapter 4 provides a comprehensive overview of the global stem cell therapy contract manufacturing landscape. It includes information related to over 80 CMOs that are currently active in this domain. In addition, it features an in-depth analysis of the market, based on a number of parameters, such as the 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). In addition, the chapter presents a list of the in-house players involved in manufacturing of stem cell therapies.

Chapter 5 provides a detailed description on the regulatory landscape related to stem cells and cell therapies across various geographies, such as the North America (primarily the US), Europe and other regions. Further, it presents an analysis of the manufacturing facilities on the basis of certifications awarded (for contract manufacturing stem cell-based therapies) to individual sites by various regulatory bodies across the globe.

Chapter 6 provides detailed profiles of some of the key players that are active in the stem cell contract manufacturing market in North America. Each profile presents a brief overview of the company, financial information (if available), its contract service offerings highlighting the capabilities of stem cell therapy facilities, recent developments and an informed future outlook.

Chapter 7 provides detailed profiles of some of the key players that are active in the stem cell contract manufacturing market in emerging regions such as Europe and Asia-Pacific. Each profile presents a brief overview of the company, financial information (if available), its contract service offerings highlighting the capabilities of stem cell therapy facilities, recent developments and an informed future outlook.

Chapter 8 features an elaborate analysis and discussion on the collaborations and partnerships that have been inked amongst players, since 2015. It includes brief descriptions of the various partnership models (including acquisition, distribution agreement, licensing agreement, manufacturing, product development / commercialization, product development and manufacturing, process development and manufacturing, process development, R&D agreements, service alliance and others) that have been adopted by stakeholders in this domain. It also includes analysis based on 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. Further, the chapter features a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 9 presents a detailed analysis to understand the relationship between the demand and supply in this field, comparing the presence of stem cell therapy developers and the availability / capability of contract manufacturers across different geographies. The chapter presents a list of stem cell therapies along with other details, such as stage of development, source of stem cell therapy and location of the developer.

Chapter 10 features an analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of stem cell therapy products. The analysis takes into consideration the individual development and manufacturing capacities of various stakeholders (small-sized, mid-sized, and large CMOs) in the market, using data from both secondary and primary research. The results of this analysis were used to establish an informed opinion on the stem cell therapy production capabilities of organizations across different types of organization (industry and non-industry), scale of operation (clinical and commercial), geographies (North America, EU, Asia Pacific and the rest of the world) and size of the organization (small-sized, mid-sized and large-sized organizations).

Chapter 11 features an illustrative view on the demand for stem cell therapies (both clinical and commercially available) in the market, offering an informed opinion on the required scale of supply (in terms of stem cell therapy manufacturing services). For the purpose of estimating the current clinical demand, we considered the active clinical studies of different types of stem cell therapies that have been registered since 2010. The data was analyzed on the basis of various parameters, such as number of annual clinical doses, trial location, leading industry / non-industry sponsors, and the enrolled patient population across different geographies. Further, in order to estimate the commercial demand, we considered the commercialized stem cell products, based on various parameters, such as target patient population, dosing frequency and dose strength.

Chapter 12 presents an insightful market forecast analysis, highlighting the likely growth of the stem cell contract manufacturing market till the year 2030. In order to provide details on the future opportunity, 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).

Chapter 13 features an analysis on the key performance indicators of service providers based on the information available for top-ten (based on the annual revenues generated in 2017)

Chapter 14 is a summary of the entire report. It provides the key takeaways and presents our independent opinion on the stem cell therapies contract manufacturing market, based on the research and analysis described in the previous chapters. It also provides a recap of some of the upcoming future trends, which, we believe, are likely to influence the growth of stem cell therapy contract manufacturing market.

Chapter 15 features the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the stem cell therapy contract manufacturing domain. We have inputs from 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) and Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi).

Chapter 16 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 17 is an appendix that provides the list of companies and organizations mentioned in the report.

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