The Cell Cryopreservation Market, estimated at USD 12.44 Bn in 2025, is expected to exhibit a CAGR of 23.2% and reach USD 53.64 Bn by 2032.
The market growth is fueled by rising demand for advanced biotechnology solutions that improve healthcare outcomes, along with increasing adoption in areas such as drug development, diagnostics, and personalized medicine. Innovations in genomics, cell and gene therapies, and biomanufacturing, supported by strong R&D investments, are enhancing treatment effectiveness, efficiency, and accessibility. Furthermore, favorable regulatory support, strategic collaborations, and the growing focus on precision medicine are accelerating market expansion and opening new opportunities for industry participants.
Market Dynamics:
Rising adoption of stem cell therapy: Stem cell therapy is used for treating various chronic and debilitating conditions such as cancer, cardiac ailments, and neurological disorders. Cryopreservation plays a vital role in stem cell storage and transportation for research and therapeutic applications. Increasing use of stem cell therapy boosts the need for cell cryopreservation procedures.
Advanced cell therapy pipelines: Pharmaceutical manufacturers are actively engaged in developing advanced cell therapies such as CAR T-cell therapies for cancer treatment. Extensive research activities in this field will involve large scale cryopreservation of different cell types. This can boost demand for high quality cell cryopreservation solutions.
Growing biotechnology and healthcare industry
Advancements in regenerative medicine, genetic therapies and drug development have increased the need for storing viable cells and tissues for long periods of time. Cell cryopreservation plays a crucial role in supporting research activities across various therapeutic areas such as cancer, cardiovascular diseases and others. It allows scientists to store cell samples securely and retrieve them whenever required for testing, without compromising their viability. Expansion of the biotech and pharmaceutical sectors can boost demand for effective cell cryopreservation techniques and products.
Increasing adoption of personalized medicine approaches
Personalized medicine involves developing customized treatment and diagnostic solutions tailored to an individual's specific genetic parameters. It requires detailed analysis of individual biomarkers and cellular profiles. Cell cryopreservation helps in storing patient samples securely for an extended period to enable studies related to personalized treatment approaches. Growing adoption of personalized medicine boosts demand for robust cell preservation technologies capable of maintaining cell viability over many years. Various companies are focusing on developing innovative cell cryopreservation solutions to support the personalized medicine revolution and move clinical practice towards more targeted therapeutic interventions.
High cost of establishing cryopreservation facilities
Setting up facilities for cell cryopreservation requires substantial capital investments in high-end equipment such as liquid nitrogen storage tanks, controlled-rate freezers, refrigerators, biosafety cabinets and cryogenic vials. Procuring and maintaining this equipment entails high operating costs. Furthermore, training personnel to handle sensitive biological samples safely increases the overall expenses. The significant capital requirements for equipping cryopreservation facilities can pose challenge, especially for small and mid-sized biobanks and research organizations with limited budgets. High setup and maintenance costs discourage some potential end users, thus, hampering the market growth.
Stringent regulatory guidelines concerning the handling of biological samples create compliance issues.
Various regulatory bodies have framed stringent norms and guidelines to ensure the safety, integrity and traceability of biological samples involved in scientific research and clinical applications. Non-compliance with these complex regulations can invite severe penalties. For example, compliance with ISO 9001 and ISO 14001 standards is essential for cell banking. FDA, EMA and other agencies have laid down detailed rules for reporting, documenting cryopreservation processes, and auditing sample quality post-thaw. Following these compliances in operations requires specialized expertise and human resources, increasing operational costs substantially. The regulatory challenges associated with demonstrating continuous adherence to international quality standards discourage some end users.
Expanding field of stem cell research and banking
Stem cell research has immense potential in developing novel cures for various incurable diseases. However, stem cells have unique requirements for long-term storage and preservation of viability and differentiation potential. Their application in clinical therapies and bio-banking necessitates adherence to the highest standards of cryopreservation practice. This growing field offers lucrative opportunities for established as well as emerging players to develop innovative, GMP-compliant solutions for stem cell cryopreservation. Companies are investing heavily in R&D to create optimized protocols, cryoprotectants and automated storage equipment catering to specific stem cell types.
Increasing interest in cord blood and tissue banking
Private and public cord blood and tissue banks are becoming increasingly popular with expectant parents who want the option to utilize stem cells from umbilical cord and placental tissues for their family's future healthcare needs or donate them for life-saving transplant therapies. Operators of these banks require robust solutions for long-term cryogenic sample storage and retrieval. This fast-emerging sector presents significant commercial potential for market stakeholders to offer customized tissue banking equipment as well as technical services. Growing public awareness about benefits of cord blood stem cells can drive the market growth.
Link: https://www.coherentmarketinsights.com/market-insight/cell-cryopreservation-market-1698
Key Developments:
- In June 2023, BioLife Solutions, Inc., a prominent provider of bioproduction tools and services for cell and gene therapy, introduced a new large-capacity controlled-rate freezer (CRF) as part of its expanded product line. This addition, which now includes three different form factors, addresses a significant demand from customers seeking increased production capacity for cell therapies on tabletop freezers.
- In 2022, AMSBIO, a leading provider of quality life science research reagents and services, launched 'STEM-CELLBANKER EX,' an innovative cryopreservation product designed to accelerate the development of cell therapy products. This chemically defined cryopreservation medium includes inactive ingredients approved for intravenous use, providing a premium solution for preserving stem cells. This advancement can enhance research and development in the field of cell therapy.
- In May 2022, Bristol Myers Squibb, a global biopharma company, received European Commission approval for Breyanzi, a CAR T cell therapy targeting CD19, to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more prior treatments. This authorization applies to all European Union member states.
- In July 2020, Kite, a biotechnology company, received FDA approval for Tecartus, another CAR T cell therapy, for adult patients with relapsed or refractory mantle cell lymphoma (MCL). Tecartus was approved following a priority review and FDA Breakthrough Therapy Designation, based on results from the ZUMA-2 study. Notably, 18% experienced Grade 3 or higher cytokine release syndrome (CRS) and 37% had Grade 3 or higher neurologic toxicities among those evaluated for safety.
Key Players: Thermo Fisher Scientific Inc., Merck KGaA, GE Healthcare, Lonza Group Ltd., STEMCELL Technologies Inc., BioLife Solutions, Inc., Cryolife, Inc., Organ Recovery Systems Inc., Custom Biogenic Systems, Sartorius AG, Takara Bio Inc., Chart Industries, Inc., Biocision, LLC, Cardinal Health, Inc., Helmer Scientific
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