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

Overview

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. 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.

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?