NEW YORK, March 27, 2017 /PRNewswire/ -- The "Cell Therapy Manufacturing Market, 2017-2027" report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell therapy developers with in-house manufacturing facilities. These therapies are anticipated to emerge as viable alternatives to conventional treatment options.
The scope of this report primarily includes manufacturing of advanced therapy medicinal products (ATMPs) that involve the use of immune cells such as T-cells, Tregs, dendritic cells, tumor cells and NK cells, and stem cells such as adult stem cells, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).
Several players, including cell therapy developers, research institutes, contract manufacturing organizations, and government and non-profit organizations, are playing a critical role in the development and manufacturing of these cell therapies. In fact, a number of these players have made heavy investments to expand their existing capabilities and establish new facilities for cell therapy products in order to meet the increasing demand.
Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums to accelerate the transition of these therapies from laboratories to clinics. It is important to highlight that companies that offer logistics and operational services have developed systems / tools for safer and quicker delivery of therapies from manufacturing sites to patients; this has been identified as one of the key challenges in the overall development process.
During the course of our study, we identified over 110 organizations that are actively involved in the manufacturing of cell therapies.
In addition to other elements, the study provides information on:
The current status of the market with respect to key players along with information on the location of their manufacturing facilities, scale of production, type of cells manufactured, purpose of production (fulfilling in-house requirements / as a contract service provider) and the type of organization (industry / non-industry).
Most active regions in terms of cell therapy manufacturing with schematic representations of world maps that clearly highlight the global cell therapy manufacturing hubs.
Roadmaps published by different agencies across the globe to provide strategies to advance cell therapy manufacturing.
Elaborate profiles of key players that offer contract manufacturing services (industry and non-industry) or manufacture cell therapies in-house; each profile covers an overview of the company, information on its manufacturing facilities, and recent collaborations.
Partnerships that have taken place in the recent past covering manufacturing and services agreements, agreements specific to technology / instruments / process developments, and mergers and acquisitions.
A discussion on the key enablers of the market and challenges associated with the cell therapy manufacturing process.
Potential future growth of the cell therapy manufacturing market segmented by the type of cell therapy, source of cells (autologous and allogeneic) and purpose of manufacturing (in-house and contract services). For the purposes of our analysis, we took into consideration several parameters that are likely to impact the growth of this market over the next decade; these include the likely increase in number of clinical studies, patient population, anticipated adoption of commercial cell-therapies and expected variation in manufacturing costs.
We have provided an estimate of the size of the market in the short to mid-term and long term for the period 2017 to 2027. The base year for the report is 2016. To account for the uncertainties associated with the development of novel therapeutics 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 research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth.
Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Tim Oldham (CEO, Cell Therapies), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) and Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi), Dr. Gerard J Bos (CEO, CiMaas).
Overall, we identified over 60 industry players and 50 academic institutes / non-profit organizations that are actively contributing in the field of cell-therapy manufacturing. We came across 68 players that are involved in manufacturing of immunotherapies and 66 players that possess capabilities for manufacturing adult stem cell therapies. Further, 28 organizations have facilities for both immunotherapies and adult stem cell therapies. Within the stem cell therapy market, we identified 15 and 17 organizations that are involved in the manufacturing of ESCs and iPSCs, respectively.
As majority of cell therapy products are in early phase of development, several manufacturers have facilities that meet the clinical scale production requirements. However, some players (31, as per our research) have developed / are developing commercial scale capacity for cell therapy production. Examples include (in alphabetical order) apceth Biopharma, Brammer Bio, Cell and Gene Therapy Catapult, CELLforCURE, Cognate BioServices, EUFETS, Guy's and St Thomas' Facility, Lonza, MaSTherCell, PharmaCell and WuXi AppTec.
Although the current market landscape is dominated by contract manufacturers, some well-established cell therapy developers have set up in-house manufacturing capabilities to support their requirements of cGMP grade cells. Examples include (in alphabetical order) Adaptimmune, Argos Therapeutics, Cell Medica, Cellular Biomedicine Group, Juno Therapeutics, Kite Pharma and SOTIO. In addition, we identified over 10 organizations that manufacture cell-based therapies for their own clinical research as well as offer contract services to other organizations Examples include (in alphabetical order) Amsterdam BioTherapeutics Unit (AmBTU), apceth Biopharma, Children's GMP / GMP facility (St. Jude Children's Research Hospital), Cook Myosite, John Goldmann Centre for Cellular Therapy (Imperial College London), MolMed, and PCT (a Caladrius Company).
North America has the maximum number of cell therapy manufacturing facilities (~ 43%), followed by the EU where ~40% of the global cell therapy manufacturing facilities are located. Specifically, in the EU, maximum number of manufacturing facilities are located in the UK (~44%). Other emerging pockets for cell therapy manufacturing include Australia, China, Japan, Singapore, South Korea and Israel; facilities in these regions primarily cater to the Asia-Pacific markets.
Over 140 collaborations have been inked between cell therapy developers, cell therapy manufacturers and other stakeholders of the industry. The motive behind the partnerships varies; they have been signed for obtaining manufacturing services, gaining access to services related to data management, reagent supply and logistics, upgrading technologies for manufacturing processes, and acquisition of manufacturing facilities.
The near-term demand for manufacturing of cell-based therapies will primarily be driven by clinical candidates. In the longer term, the currently approved therapies and late-stage therapies (that are likely to get commercialized in future) will act as key drivers of the market. Our outlook is highly promising; we expect the market for cell therapy manufacturing to grow at an annualized growth rate of ~42% over the course of next ten years and be worth over USD 4 billion in 2027.
The 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 may 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 over the coming ten years, 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 2 is an executive summary of the insights captured in our report. The summary offers a high level view on the current state of the cell therapy manufacturing market and its likely evolution over the coming decade.
Chapter 3 provides a general introduction to the cell-based therapies and ATMPs, their classification and definitions. It includes a detailed discussion on manufacturing of cell-based therapies, associated challenges, and application of the currently available for cell therapies. The chapter also provides a detailed description on the regulatory landscape for cell therapies.
Chapter 4 identifies the contract service providers / in-house manufacturers that are actively involved in the manufacturing of ATMPs. It provides details on the ATMP manufacturing capabilities of these organizations, specifically focusing on the type of organization, geographic location of their facilities, scale of operation, type of cells manufactured and the purpose of manufacturing (in-house requirement / third party manufacturing). It contains world maps highlighting the geographical locations of cell therapy manufacturing facilities. Further, it discusses the development trends within the overall cell therapy manufacturing landscape.
Chapter 5 provides details on the roadmaps published by different organizations in various geographies, specifically in the US. These roadmaps describe the strategies that are helpful in accelerating the translation from laboratory to clinics.
Chapter 6 contains detailed profiles of in-house manufacturers. Each profile provides a brief overview of the company, its financial performance, details on manufacturing capabilities and facilities, and the relevant collaborations that have been inked over the last few years.
Chapter 7 contains detailed profiles of key industrial contract manufacturers that have clinical and / or commercial scale manufacturing capacities. Each profile provides a brief overview of the company, details on manufacturing capabilities and facilities, and the relevant collaborations that have been inked over the last few years.
Chapter 8 contains detailed profiles of key academic players that offer contract manufacturing services for cell therapies. Each profile provides a brief overview of the organization, and details on manufacturing capabilities and facilities.
Chapter 9 discusses the role of non-profit organizations in advancing cellular therapies. It provides a list of prominent organizations and profiles of key organizations in different regions. Additionally, the chapter provides information of international / national societies that help in disseminating knowledge about the advancement of these therapies in the community.
Chapter 10 features a comprehensive analysis of the collaborations and partnerships that have been forged between the players in this market. It includes a brief description on the various types of partnership models that are employed by stakeholders in this domain. We have categorized the deals / agreements, which have been captured during our research, into different models and have provided analysis on trend of partnerships over time.
Chapter 11 presents a ten year forecast to highlight the likely growth of the cell therapy manufacturing market. We have segregated the financial opportunity by type of cell therapy (T-cell immunotherapy, cell-based cancer vaccines, stem cell therapies and other ATMPs) and the source of cells (autologous and allogeneic). All our predictions are backed by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios.
Chapter 12 provides a SWOT analysis capturing the key elements and factors that are likely to influence the market's future.
Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.
Chapter 14 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development 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 15 is a collection of interview transcripts of the discussions held with key stakeholders in the industry.
Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures in the report.
Chapter 17 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.
The use of live cells for therapeutic purposes can be traced back to 1968, when patients were first successfully treated with allogeneic human hematopoietic stem cell transplants. This practice has now become an integral part of clinical procedures in the space of bone marrow regeneration and organ transplantation. Cell-based therapies are an emerging segment of the overall biopharmaceutical industry.
Post the approval of first cell-based therapy, Carticel®, in 1997 in the US, the field has rapidly advanced and a number of such therapies are currently under development. Given the personalized nature of these treatment options, they are highly specific and hold the potential to address unmet medical needs associated with the treatment of several disorders. The promising therapeutic potential has led many pharmaceutical companies and investors to put in a significant amount of capital towards the development and commercialization of these therapies.
Popular examples of approved cell-based therapies include (in order of their year of approval) Carticel®, CreaVax-RCC®, JACE, ReliNethra, PROVENGE® and Prochymal®. In addition, over 500 cell-based therapy candidates are currently in different stages of clinical development; these are being evaluated in over 1,000 active clinical studies in various regions across the globe. The growing number of cell therapy candidates, coupled with their rapid progression through the various phases of clinical development, continues to create an increasing demand for facilities that offer manufacturing services for these therapies.
The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industry players as well as academic institutes are significantly contributing to the production of GMP grade cell types. In addition, the market has witnessed the entry of several players that offer novel technology solutions, aimed at improving and upgrading existing cell-based therapies and their manufacturing processes. We have observed that such players have signed multiple partnerships / collaborations with an aim to optimize, scale-up and expand the capabilities for production of cell-based therapies.
Looking at the evolutionary trends, we believe that the cell therapy manufacturing market will continue to be steadily driven in the mid to long term by expansion of existing manufacturing facilities and establishment of new dedicated facilities. Technological advancements to mitigate challenges posed by conventional methods of production will act as a key enabler to this growth.
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