Cell Therapy Manufacturing Market | Industry Analysis- 2021-2030

1. THE CELL THERAPY MANUFACTURING MARKET, INDUSTRY TRENDS AND GLOBAL FORECASTS, 2019-2030 For various reasons, the demand for cell therapies is expected to increase in the coming years. Therefore, both therapy developers and contracted service providers may need to strengthen their skills and expand available capacity. In this regard, automation is expected to be a key enabler in the cell therapy manufacturing and contract services industry. Growing at an annualized rate of more than 16.5%, the cell therapy manufacturing market is projected to reach close to USD 11 billion by 2030, according to Roots Analysis. Cell therapy manufacturers are also gradually choosing to automate various operations in the supply chain; The main goal is to achieve favorable bench-to-clinic timelines and to reduce production-related losses. Currently, the installed global capacity for cell therapy manufacturing is estimated to be spread across 1.2+ million square feet of dedicated cleanroom area distributed across various scales of operation. It has been estimated that more than 70,000 patients have been enrolled in cell therapy clinical trials. The demand for cell therapies is expected to increase significantly over the next decade. Revenues from manufacturing T-cell therapies are expected to capture a larger market share. The advantage is achieved through autologous and allogeneic therapies in different regions of the world. Clinical-scale manufacturing operations are likely to determine future market size, considering both internal and contractual service requirements.

2. KEY MARKET INSIGHTS Over 160 organizations claim to be involved in the manufacture of cell therapies The market landscape is dominated by industry players, accounting for more than 60% of the total number of stakeholders. Among them are more than 55 large or medium-sized companies (with more than 50 employees). Over 100 players focused on stem cell and T cell therapies Most of these players focus on manufacturing T cell therapies, including CART, TCR, or TIL. It should be noted that more than 35 organizations claim to have the capacity to manufacture both types of therapies. More than 70 companies currently have commercial capacities Since most cell therapy products are in clinical trials, demand at this scale is high. However, it is worth noting that several players (~50%) have already developed commercial cell therapy capabilities. Currently, Europe is considered the current center for manufacturing cell therapies. Various players have set up more than 220 production facilities around the world; 35% of these are in Europe, followed by those in North America. Other emerging regions are Australia, China, Japan, Singapore, South Korea, and Israel.

3. 50+ facility expansions reported between 2015-2019 More than 85% of the expansions are related to the installation of new equipment in different regions. Most expansion activity has been recorded in the United States and certain countries in the Asia-Pacific region. 20+ companies offer automated solutions to cell therapy developers Players that claim to offer consultancy services related to automation include (in alphabetical order) Berkeley Lights, Cesca Therapeutics, Ferro Logix, Flu Design Sonics, GE Healthcare and Terumo BCT. In addition, we have identified players namely (in alphabetical order) Fraunhofer Institute for Manufacturing Engineering and Automation IPA, Invetech, KMC Systems, Mayo Clinic Center for Regenerative Medicine, and RoosterBio that offer automation-related consulting solutions. Associative activity grew at an annual rate of 16% between 2014 and 2018 More than 200 agreements have been signed in the last 5 years. Most of these focused on supplying cell-based therapy products for clinical trials. Other popular types of collaboration models include manufacturing process development agreements (16%), service level agreements (12%), and acquisitions (10%). By 2030, developed regions will capture more than 60% of the market share The Asia-Pacific region is expected to take the largest share (~36%) of the market by 2030. It is also important to note that financial resources, technical know-how, and an established infrastructure are likely to drive the cell therapy manufacturing market in Europe which is estimated at a CAGR of approximately 26%.

4. More than 100 industry players and more than 60 non-industry players currently claim to manufacture different types of cell therapies, either for internal or contract needs. The market is fragmented, with established players and new entrants claiming to operate at different scales and manufacturing a wide range of cell therapies. Other key Highlights of the report - •An analysis of the various expansion initiatives undertaken by service providers, to augment their respective cell therapy manufacturing capabilities, over the period 2015-2019. •An analysis of the recent partnerships focused on the manufacturing of cell-based therapies, which have been established in the period 2014-2019. •Informed estimates of the annual commercial and clinical demand for cell therapies, in terms of number of cells produced and area dedicated to manufacturing. •An estimate of the overall, installed capacity for manufacturing cell-based therapies based on information reported by industry stakeholders in the public domain A competitiveness analysis of biological targets, featuring insightful pictorial summaries and representations. •A detailed analysis of the various factors that are likely to influence the pricing of cell-based therapies, featuring different models / approaches that may be adopted by manufacturers while deciding the prices of their proprietary offerings. •A qualitative analysis, highlighting the various factors that need to be taken into consideration by cell therapy developers while deciding whether to manufacture their respective products in- house or engage the services of a CMO. •An elaborate discussion on the role of automation technologies in improving current manufacturing methods. •A discussion on cell therapy manufacturing regulations across various geographies, including North America, Europe, and Asia Pacific. •Elaborate profiles of key players (industry and non-industry) that offer contract manufacturing services.