Cell therapy manufacturing market is estimated to be valued at USD 4.91 Bn in 2024, and is expected to exhibit a CAGR of 14.9% over the forecast period (2024-2031). Global cell therapy manufacturing market growth is driven by increasing investments in cell-based research from both private and public sectors. Cell therapy manufacturing aims to develop therapies by growing cells in controlled environments and reintroducing them into patients to replace or regenerate damaged tissues and cells.
Market Dynamics:
Rising prevalence of chronic diseases such as cancer and cardiovascular diseases boosts development of cell-based therapies worldwide. According to WHO, cancer burden is expected to grow by over 50% in the next 20 years. This will significantly boost demand for cell therapies in the near future. Significant funding from both private and public sources boosts cell-based research activities. For instance, NIH funded over US$ 1.5 billion in 2020 towards stem cell research. This funding promotes development of advanced cell therapy manufacturing technologies and infrastructure required to produce cell therapies at scale. While high costs associated with cell therapies and lack of standardized regulations pose challenges for the market growth, the overall outlook for the market remains positive due to growing focus on personalized medicine globally.
Growing awareness and use of regenerative medicine therapies
Along with rising clinical research, there is also a growing awareness among patients and physicians of regenerative medicine therapies including various types of cell therapies. Diseases such as cancer, cardiovascular conditions and neurological disorders currently have limited treatment options. Cell therapies potentially provide an alternative approach for these diseases. The appeal of cell therapies to potentially cure or provide lasting benefits with just a single dose administration is generating interest among patients and medical professionals. As regenerative therapies become more mainstream and integrated into standards of care, manufacturing requirements will increase substantially to meet clinical and commercial demands.
Major growth in cell therapy clinical trials registered in recent years
The number of cell therapy clinical trials registered globally has increased significantly over the past decade. Between 2010-2020, clinical trials utilizing various types of cell therapies have grown at a CAGR of over 15%. This significant rise in clinical research and development activities focused on cell therapies boosts demand for cell therapy manufacturing. More clinical trials mean need for more production of investigational cell therapy products to treat patients enrolled in these trials. Leading pharmaceutical and biotech companies are also increasingly investing in developing their own proprietary cell therapy pipelines, and this boosts the need for cell therapy manufacturing services and capacity.
High costs associated with cell therapy manufacturing
One of the major restraints impacting the cell therapy manufacturing market is extremely high costs associated with building and maintaining current good manufacturing practice (cGMP) compliant facilities for cell therapy production. Building a single cleanroom facility for cell therapy manufacturing can easily exceed US$ 100 million in capital investments. Operating expenses including specialized personnel, equipment and consumables required to produce cell therapies under strict regulatory standards significantly increases the manufacturing costs.
Regulatory uncertainties surrounding advanced therapy product approvals
Regulatory frameworks and guidelines for advanced therapy products like cell-based therapies are still evolving. There is uncertainty regarding data requirements, product characterization standards and other aspects of the approval pathway. Frequent changes to regulations or lack of clarity poses risks for manufacturers. It impacts manufacturing processes, quality systems implementation as well as clinical and commercial product development timelines. Navigating an uncertain global regulatory environment increases compliance complexities and costs. This regulatory uncertainty acts as a restraint for both new market entrants as well as established players in planning long-term strategies and capacity investments.
Outsourcing to third-party CMOs
Given the prohibitive costs of internal manufacturing, an increasing number of biopharma companies and research institutions are outsourcing their cell therapy production requirements to third-party contract manufacturing organizations (CMOs). This outsourcing trend provides enormous opportunities for specialized CMOs with expertise and facilities for cell therapy manufacturing. According to industry forecasts, over 60% of future cell therapy manufacturing will be outsourced to CMOs. Outsourcing allows sponsors to avoid hefty capital costs while accessing specialized expertise of CMOs. It also provides flexibility to adjust production needs based on clinical demand. This outsourcing model is expected to drive significant market demand for CMO cell therapy services globally.
Developing markets across Asia Pacific Present
While North America and Europe currently dominate the cell therapy manufacturing landscape, emerging Asian markets like China, India, South Korea and Singapore present major opportunities. Countries across Asia offer attractive manufacturing location alternatives as compared to high-cost regions. For instance, infrastructure and operating costs for cell therapy facilities can be 30-50% lower in some Asian countries. Several Asian governments actively promote the life sciences industry through funding initiatives and policy support.
*Link: https://www.coherentmarketinsights.com/market-insight/cell-therapy-manufacturing-market-1728
Key Development
- On February 20, 2024, BioNTech SE, a next-generation immunotherapy company, announced a collaboration with Autolus Therapeutics plc, a biotechnology company, to advance both companies’ autologous CAR-T programs towards market, pending market authorization
- On January 8, 2024, Pluri Biotech Ltd., an Israel based cell technology company, launched its contract development and manufacturing division- PluriCDMO. PluriCDMO will offer manufacturing support from the preclinical and development stages to late stage clinical and commercial production, including fill and finish and logistics
- In October 2023, Bayer AG, a pharmaceutical company, announced the opening of its first Cell Therapy Launch Facility in Berkeley, California, U.S. to create the capacity to bring cell therapies to patients on a global scale
- In May 2020, Takara Bio Inc., a biotechnology company, announced the completion of a new facility, the Center for Gene and Cell Therapy Processing II (CGCPII) in Shiga, Japan
Key Players: WuXi AppTec, Inc., Lineage Cell Therapeutics, Inc., Healios Ltd. , Lonza , Merck KGaA, Takara Bio Inc., Sumitomo Dainippon Pharma Co., LTD. , Fujifilm Holdings Corporation , Thermo Fisher Scientific, Inc., Astellas Pharma Inc., OXGENE, Cytiva, Exothera, Charles River Laboratories, Cell Therapies Pty Ltd, Bio-Techne, Catalent, Inc
