Cell Cryopreservation Market Trends

Growth Drivers

• Rising adoption of cell-based therapies: The growing momentum behind cell-based therapies is significantly bolstering the demand for cryopreservation, as each autologous or allogeneic product needs dependable freezing, long-term storage, and validated cold-chain logistics. According to the Alliance for Regenerative Medicine, there are now 2,981 developers globally and 1,968 active clinical trials, backed by nearly US $3.0 billion of investment in Q3 2024. Regulatory headwinds are easing too: the FDA has removed REMS requirements for several approved autologous CAR-T therapies, reducing procedural burdens and opening the door to wider commercialization.  At the same time, agency guidance increasingly emphasizes the need for stability studies both pre-freeze and post-thaw, driving sponsors to invest more in cryostorage and controlled-rate freezing systems. This convergence of clinical scale-up, favorable regulation, and technical rigor is making cryopreservation infrastructure a foundational pillar in the cell-therapy value chain.
• Global biobanking initiatives: Growing biobanking infrastructure is significantly accelerating the cell cryopreservation market by creating vast, well-characterized repositories of cells that require reliable freezing and long-term storage. For instance, BBMRI-ERIC connects around 400 biobanks across 32 countries, collectively cataloguing samples from over 5.1 million donors.  The Italian node alone holds more than 2.1 million disease-oriented samples, including 200,000 rare-disease samples.  As national and international biobanking initiatives expand, so does the need for infrastructure-controlled-rate freezers, cryovials, validation services, and certified protocols, pushing up demand in the cryopreservation market.
• Increased R&D investments in oncology: Growing oncology R&D investment is strengthening the cell cryopreservation market by fueling the development of cell-based cancer therapies and biospecimen repositories. The U.S. National Cancer Institute (NCI) allocated over US$6.54 billion in FY 2024 across research, treatment, and diagnosis programs. At the same time, the NIH is advancing novel T-cell therapies for solid tumors (e.g., enhanced CAR-T cells in preclinical models) that require large-scale cryopreservation infrastructure for storage, stability studies, and transportation. As the number of cellular immunotherapy agents has jumped, there were 2,756 active cell-therapy agents in the immuno-oncology pipeline as of April 2022, a 36% increase over the prior year, so does the demand for controlled-rate freezers, validated cryobanking platforms, and quality-tested consumables. In parallel, the NCI’s Biobanking & Biospecimen Science program supports standardized specimen collection, processing, and long-term storage, increasing the volume of biospecimens that must be cryopreserved.

Challenges

• Substantial cost in installation and maintenance: High capital expenditure is a major barrier in the cell cryopreservation market because advanced cryogenic freezers, controlled-rate cooling systems, backup power units, and monitoring platforms require significant upfront investment, often exceeding feasible budgets for small labs and emerging biotech firms. Ongoing maintenance adds further financial strain, as facilities must comply with strict regulatory standards, perform periodic validation, and replace high-grade liquid nitrogen or refrigeration components. The need for continuous temperature monitoring and emergency systems also raises operational costs. These financial burdens slow adoption, limit scaling, and can push organizations toward outsourcing rather than in-house cryopreservation capacity.
• Risk of contamination: The possibility of contamination during freezing, storage, or thawing creates considerable operational and safety challenges, limiting broader cell cryopreservation market expansion. Even minor breaches in sterility, such as compromised cryovials, cross-contamination during liquid-nitrogen immersion, or microbial infiltration, can render stored cell batches unusable. Regulations from agencies like the FDA and CDC require stringent aseptic protocols, validated handling procedures, and pathogen-free storage environments, which add complexity and costs for compliance. Any contamination event can lead to significant financial loss and delays in clinical or research programs, discouraging widespread adoption of cryopreservation systems.