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Automated and Closed Cell Therapy Processing Systems Market By Cell Processing Steps, Scale of Operations, End Users and Geographical Regions : Industry Trends and Global Forecasts, 2020 - 2030

ReportLinker
·12-min read

INTRODUCTION Advanced therapy medicinal products (ATMPs), such as cell therapies and gene therapies, have revolutionized the healthcare sector. Over the past two decades, more than 30 ATMPs have been approved.

New York, April 22, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Automated and Closed Cell Therapy Processing Systems Market By Cell Processing Steps, Scale of Operations, End Users and Geographical Regions : Industry Trends and Global Forecasts, 2020 - 2030" - https://www.reportlinker.com/p06064687/?utm_source=GNW
Moreover, according to a recent report (published by The Alliance for Regenerative Medicine), over 1,050 clinical trials are currently being conducted by over 1,000 companies, worldwide, focused on the evaluation of cell and gene therapies. However, despite the numerous advances in this field, there are certain challenges that need to be addressed in order to achieve commercial success. For instance, the current cell therapy manufacturing process is labor-intensive, time consuming and costly. Further, the production of most of these specialized therapeutic products requires manual labor and are typically carried out discretely (open processing), thereby, rendering the processes difficult to scale-up, with high risk of contamination. Another concern faced by cell and gene therapy manufacturers is batch-to-batch variability, given that even a minor change in the production protocol can affect the quality of the resulting product. Consequently, cell therapies are exorbitantly priced, ranging from USD 300,000 to USD 500,000 per dose.

Experts believe that some of the existing challenges related to cell therapy manufacturing can be addressed through the adoption of automated and closed cell processing systems. These solutions have been demonstrated to be capable of enabling stakeholders to manage various aspects of the cell therapy manufacturing process efficiently, while complying to global regulatory standards. Other benefits of such systems include reduced risk of contamination, optimum utilization of facility and resources, limited in-process variation and consistent product quality. Further, the use of such automated systems enable significant reductions (in the range of 40% to 90%) in labor costs. In recent years, the cost saving potential of these systems, coupled to their ability to streamline and simplify the complex cell therapy processing (from initial cell collection till final formulation), has effectively captured the interest of several stakeholders engaged in this domain. Given the growing demand for cost-effective, personalized medicine, coupled to the benefits of automated and closed systems, we believe that this niche market is poised to witness significant growth in the foreseen future.

SCOPE OF THE REPORT
The “Automated and Closed Cell Therapy Processing Systems Market: Focus on Apheresis, Expansion, Harvest, Fill / Finish, Cryopreservation, Thawing, 2020-2030” report features an extensive study of the current market landscape and future opportunities associated with the automated and closed cell therapy processing systems. The study also features a detailed analysis of key drivers and trends related to this evolving domain. Amongst other elements, the report includes:
A detailed assessment of the current market landscape, featuring an elaborate list of over 60 automated and closed systems, along with information on the cell therapy processing step for which they are designed (apheresis, separation, expansion, harvest, fill / finish, cryopreservation and thawing), their key features (traceability, user-friendliness, configurability and scalability, process monitoring, touch-screen user interface, data management, integration with other systems and alert system), product specifications (length, width, depth, height and weight), type of cells supported (stem cells and immune cells), type of cell culture (adherent and suspension), scale of operation (pre-clinical, clinical and commercial), application (research and therapeutic), end users (hospitals / medical centers / clinics, research institutes / academic institutes, laboratories, commercial organizations), key support services offered (product support, technical support, training, installation, qualification / validation, maintenance, regulatory support and others) and regulatory certification / accreditations obtained (GMP / cGMP, GAMP, GCP, GTP / cGTP, IEC standards, ISO standards, 21 CFR Part 11 and other).
An insightful product competitiveness analysis, taking into consideration various relevant parameters, such as supplier power (based on the experience / expertise of the developer in this industry) and portfolio-related parameters, such as number of systems offered, cells supported, type of culture supported, scale of operation, applications, end users, support services offered, regulatory certifications / accreditations obtained and key product specifications.
Elaborate profiles of industry players that are currently offering automated and closed cell therapy processing systems, featuring an overview of the company, its financial information (if available), and a detailed description of the system(s) they offer. Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth, in the foreseen future.
An analysis of the various partnerships pertaining to automated and closed cell therapy processing systems, which have been established since 2016, based on several parameters, such as year of partnership, type of partnership model adopted, type of therapy, type of cell processing step, key automated and closed cell processing systems, partner’s focus area, most active players (in terms of number of partnerships signed), and geographical location of collaborators.
A review of recent initiatives undertaken by big pharma players in automated and closed cell processing systems domain.

One of the key objectives of the report was to estimate the existing market size and the future growth potential of the automated and closed cell therapy processing systems. Based on various parameters, such as number of cell therapies under development, expected pricing, likely adoption rates, and potential cost saving opportunities from different automated and closed cell processing systems, we have developed informed estimates of the evolution of the market, over the period 2020-2030. In addition, we have provided the likely distribution of the current and forecasted opportunity across [A] different cell therapy processing steps (apheresis, separation, expansion, harvest, fill / finish, cryopreservation and thawing), [B] scale of operations (pre-clinical / clinical and commercial organizations), [C] end users (hospitals / medical centers / clinics, research institutes / academic institutes, laboratories, commercial organizations), and [D] key geographical regions (North America, Europe, Asia-Pacific, Middle East and Latin America). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry’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:
Peter Molloy (Executive Vice President, Orgenesis) and Shimon Hassin (Chief Technology Officer, Orgenesis)
Jean Sebastien Parisse (Commercial Director, Aseptic Technologies)

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 METHODOLOGY
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 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 over the coming decade, 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
Which are the popular automated and closed systems commonly used for cell therapy processing?
Who are the leading industry and non-industry players in this domain?
What type of partnership models are commonly adopted by stakeholders in this industry?
Which players are likely to be potential partners of automated and closed system providers?
What is the current and likely future cost saving opportunities associated with use of automated and closed systems for cell therapy processing?
What are the key trends within the automated and closed cell therapy processing systems market?
How is the current and future market opportunity likely to be distributed across 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 automated and closed cell therapy processing systems market and its likely evolution in the short-mid-term and long term.

Chapter 3 is an introductory chapter that presents a general overview of the cell and advanced therapies domain, along with details on the various types of products. It features a detailed discussion on the key challenges associated with currently adopted cell therapy manufacturing approaches. The chapter also highlights the role of automation in cell therapy manufacturing, providing details on the key advantages and challenges associated with such systems. Further, it features a discussion on the key growth drivers and roadblocks related to the use of such systems, as well as certain trends that the domain is expected to witness in the coming years.

Chapter 4 provides an overview of the automated and closed cell therapy processing systems landscape. It includes information on more than 60 automated and closed systems that are currently being used for processing the cell therapies. It features detailed information on the cell therapy processing step for which they are designed (apheresis, separation, expansion, harvest, fill / finish, cryopreservation and thawing), their key features (traceability, user-friendliness, configurability and scalability, process monitoring, touch-screen user interface, data management, integration with other systems and alert systems), product specifications (length, width, depth, height and weight), type of cells supported (stem cells and immune cells), type of cell culture (adherent and suspension), scale of operation (pre-clinical, clinical and commercial), application (research and therapeutic), end users (hospitals / medical centers / clinics, research institutes / academic institutes, laboratories, commercial organizations), key support services offered (product support, technical support, training, installation, qualification / validation, maintenance, regulatory support and others), regulatory certification / accreditations obtained (GMP / cGMP, GAMP, GCP, GTP / cGTP, IEC standards, ISO standards, 21 CFR Part 11 and other).

Chapter 5 presents a detailed competitiveness analysis of automated and closed cell therapy processing systems based on the supplier power and key product specifications. The analysis was designed to enable stakeholder companies to compare their existing capabilities within and beyond their respective peer groups and identify opportunities to achieve a competitive edge in the industry.

Chapter 6 presents detailed profiles of industry players that are currently offering automated and closed cell therapy processing systems, featuring an overview of the company, its financial information (if available), and a detailed description of the system(s) they offer. Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth, in the foreseen future.

Chapter 7 features an elaborate analysis of the various partnerships and collaborations that have been inked amongst players in this domain, during the period 2016-2020. It provides a brief description on the various types of partnership models adopted (including asset purchase agreement, distribution agreement, joint venture, merger / acquisition, product commercialization agreement, product development agreement, product development and commercialization agreement, product evaluation agreement, product integration agreement, product utilization agreement, research agreement and others) by stakeholders in this domain. Further, it includes analyses based on the year of partnership, type of partnership model adopted, type of therapy, type of cell processing step, key automated and closed cell processing systems, partner’s focus area, most active players (in terms of number of partnerships signed), and geographical location of collaborators.

Chapter 8 highlights the recent initiatives undertaken by big pharma players in the automated and closed cell therapy processing systems domain.

Chapter 9 features a list of more than 300 cell therapy developers and manufacturers that are anticipated to partner with automated and closed cell therapy processing system providers and have been shortlisted on the basis of parameters, such as developer strength (which takes into account a company’s size and its experience in this field), company’s pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development), type of culture used (adherent or suspension) and type of technology (automated systems or closed systems).

Chapter 10 presents a case study, highlighting the differences in cost associated with manufacturing of cell therapies using manual, partially automated and bespoke automated and closed systems, across various process operations.

Chapter 11 presents a detailed market forecast analysis, highlighting the likely growth of the automated and closed cell therapy processing systems market till the year 2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] different cell therapy processing steps (apheresis, separation, expansion, harvest, fill / finish, cryopreservation and thawing), [B] scale of operations (pre-clinical / clinical and commercial), [C] end users (hospitals / medical centers / clinics, research institutes / academic institutes, laboratories, commercial organizations), and [D] key geographical regions (North America, Europe, Asia-Pacific, Middle East and Latin America).

Chapter 12 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 Molloy (Executive Vice President, Orgenesis) and Shimon Hassin (Chief Technology Officer, Orgenesis), and Jean Sebastien Parisse (Commercial Director, Aseptic Technologies).

Chapter 13 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 14 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 15 is an appendix that provides the list of companies and organizations mentioned in the report.
Read the full report: https://www.reportlinker.com/p06064687/?utm_source=GNW

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