The Cell Expansion Market is estimated to be valued at USD 19.69 billion in 2024 and with CAGR of 11.8% over the forecast period 2024-2031.The increasing prevalence of chronic diseases and the growing incidence of genetic disorders have increased the demand for cell expansion techniques for developing effective treatment procedures. Furthermore, the rising number of clinical trials for cell-based therapies is also augmenting the market growth.
Market Dynamics:
The growth of the global cell expansion market is driven by two key factors: Increasing R&D funding for cell-based research: Significant funding from both public and private sectors has increased the R&D related to cell therapies. Government organizations are investing heavily to support the development of new cell-based treatment options. This increasing investment is encouraging more drug manufacturing companies to enter the market, thereby propelling market growth. Growing applications of cell expansion in disease modelling: Cell expansion techniques are widely used in disease modelling applications to study disease pathogenesis as well as for drug discovery and preclinical testing. The growing utilization of cell cultures for disease modelling research is expected to generate substantial demand for cell expansion products and services over the forecast period.
Significant Advancements in Cell Therapy Research and Development is Driving Market Growth
Advancements in cell therapy research and development have been a major driver of growth in the cell expansion market. As more clinical trials are conducted evaluating new cell therapy approaches for various diseases, there is increased demand for tools and technologies required to produce large quantities of cells. Many new cell therapies in clinical trials are showing promising results for conditions like cancer, cardiovascular disease and neurodegenerative disorders. This success is generating more investment in cell therapy R&D from biopharmaceutical companies and government research agencies. As the pipeline of new cell therapies in development continues to grow, it is creating sustained demand for cell expansion solutions to enable scaled manufacturing of these therapies.
Growing Awareness and Prevalence of Chronic and Life-Threatening Conditions is Increasing Interest in Cell Therapy
Another key driver has been the growing awareness and prevalence of chronic and life-threatening medical conditions for which cell therapy may provide treatment options. Diseases like cancer, heart disease, diabetes and neurodegenerative disorders impact millions of people worldwide and present huge unmet needs. As more people are affected by these conditions or know someone who is, interest in novel cell-based treatments is increasing. This raises hopes for cell therapy and drives demand for the associated tools and infrastructure needed for research and commercialization, such as cell expansion systems. The cell expansion market allows the promise of cell therapy to become reality by enabling production of therapeutic cells at commercial scale.
High Manufacturing and Process Development Costs Pose Challenges
One major restraint for the cell expansion market is the high costs associated with manufacturing and process development. Producing therapeutic cells for clinical use and commercial products involves complex multi-step production processes and advanced technologies for cell expansion, differentiation, purification and quality control. The infrastructure, equipment, materials and labor required result in very high costs that must be recouped. For early stage companies and academic research groups, these costs present a significant barrier. Economic challenges can slow clinical progress and market adoption if costs remain prohibitively high.
Stringent Regulatory Approvals Raise Risk and Timelines
Another key restraint is the stringent regulatory environment for cell therapies. Due to safety and efficacy concerns, cell therapy products undergo extensive preclinical testing and clinical trial requirements overseen by regulatory agencies like the FDA. Gaining approval is a long, complex and expensive process that can take over a decade. This high regulatory risk and lengthy timelines discourage some companies and investors. Slow approval timelines also mean longer waits for patients and contribute to the high overall costs of developing and manufacturing cell therapies. Regulatory demands, while important for safety, present financial and operational challenges that have restricted market growth.
Growth of Outsourcing Increases Market Opportunity
A major opportunity for the cell expansion market is the growing trend of outsourcing. As cell therapy development becomes more specialized, many companies are outsourcing manufacturing and process development to contract development and manufacturing organizations (CDMOs). This avoids the need for in-house infrastructure and expertise and reduces upfront capital costs. CDMOs with end-to-end cell therapy services, including cell expansion capacity, allow sponsors to focus on core development activities. Outsourcing to CDMOs with process optimization experience speeds development timelines. This growing outsourced model is creating strong market demand for CDMOs with good manufacturing practice (GMP) compliant cell expansion capabilities.
Personalized Medicine Drives Need for Point-of-Care Solutions
Another key opportunity is the emergence of personalized medicine approaches using patient-specific cell therapies. While initial cell therapies use allogeneic "off-the-shelf" products, personalized therapies derived directly from a patient could provide improved outcomes. This sparks the need for point-of-care cell expansion technologies that allow clinicians to produce cells from a small sample for immediate therapeutic use with minimal manipulation. Current central laboratory models are not practical for personalized approaches. Portable, automatable point-of-care cell expansion solutions enable new care models and represent an important market potential as personalized cell therapies advance.
Link - https://www.coherentmarketinsights.com/market-insight/cell-expansion-market-1293
Key Development
- In December 2023, FUJIFILM Corporation, a multinational conglomerate, announced significant USD 200 million investment in two of its subsidiaries, aimed at substantially bolstering global cell therapy contract development and manufacturing (CDMO) capabilities. This strategic investment aims to strengthen Fujifilm's capacity to serve the rapidly expanding cell therapy sector, projected to experience an annual growth rate exceeding 30%, compared to USD 3.3 billion in FY2022.
- In February 2023, Terumo Blood and Cell Technologies, a leading medical technology company, unveiled data from its Quantum Flex Cell Expansion System for the first time at a significant conference. The presentation highlighted how its hollow-fiber perfusion technique accelerates the development of T-cell treatments across various bioreactors. Scientists from Terumo BCT shared the outcomes of several T-cell expansion runs at the CAR-TCR Summit Europe in London, demonstrating a notable 60% to 70% decrease in media utilization and achieving 8.7 to 9.6 population doublings within an 8-day timeframe.
- In September 2021, Bio-Techne Corporation, a company specializing in the development, manufacturing, and distribution of life science reagents, introduced a new medium designed for the amplification and maintenance of induced pluripotent stem cells (iPSCs). The ExCellerate iPSC Expansion Medium marks the newest addition to Bio-Techne's comprehensive Regenerative Medicine product line. This medium is tailored for both research and translational applications and seamlessly integrates with Bio-Techne's stem cell process solutions, covering cell isolation, reprogramming, genome engineering, cell proliferation, differentiation, and characterization.
- In March 2021, AGC Biologics, a leading global biopharmaceutical contract development and manufacturing organization (CDMO), has unveiled plans to enhance its Cell and Gene Therapy Center of Excellence in Milan. This expansion initiative involves augmenting capacity and incorporating viral vector suspension capabilities. AGC Biologics intends to add two additional floors to the existing suite and upgrade equipment on the current floor. The new facilities are scheduled to become fully operational in 2022.
Key Players: Becton, Dickinson and Company, Sartorius AG, Merck KGaA, Corning, Inc., Eppendorf SE, Lonza Group AG, PromoCell, Danaher, Thermo Fisher Scientific, HiMedia Laboratories, STEMCELL Technologies Inc., REPROCELL Inc., Bio-Techne, Valiant Co., Ltd., Miltenyi Biotec, and Biologos, Cyagen US Inc.
