The field of cell cryopreservation is introducing transformative approaches to healthcare. It is critical for advancing cellular therapies, regenerative medicine, and biological research. And it is used in organ transplantation and drug discovery, making a broad impact across therapeutic and pharmaceutical sectors.

Cell cryopreservation is the process of preserving cells and tissues at extremely low temperatures, typically chilled with liquid nitrogen at –196 °C. That enables the long-term storage and transportation of biological samples while maintaining their viability and functionality. Global Market Insights (GMI) predicts that the global cell-cryopreservation market size will exceed US$57.5 billion by 2032 (1).

Technological developments have improved cell viability after thawing, improving the efficiency and effectiveness of cell cryopreservation. For example, novel cryoprotectant solutions and automated freezing systems contribute to the viability and integrity of cells upon retrieval. Pluristyx recently launched its PluriFreeze cryopreservation medium solution in a research use only (RUO) formulation. The solution facilitates cell metabolism and smooths the freezing and thawing process for highly active cells, improving their viability and functionality.

With the global rise in diseases such as cancer, diabetes, and neurodegenerative disorders, the demand for innovative treatments has escalated. Cell therapies supported by robust cryopreservation techniques offer new avenues for treatment. According to the World Health Organization (WHO), over 3.7 million new cases of cancer are reported in Europe every year. Cell cryopreservation offers a viable method for storing cancer cells and tissue samples (2). Preserving the genetic and phenotypic profiles of cancerous cells can help scientists to study cancer progression, mechanisms, and treatments.

Cryopreservation facilitates long-term studies by enabling the creation of extensive biobanks. Such biobanks aid the development of personalized medicine by testing therapies on stored cells and accelerating the pace of discovery in drug development and immunotherapy.

Ethical and Regulatory Support: Ethical guidelines and regulatory frameworks conducive to cell research and therapy development have helped ensure that life-saving treatments can reach patients safely. The US Food and Drug Administration (FDA) offers documents such as its “Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products” to establish standards for preclinical evaluations of cell therapies (3).

The European Medicines Agency (EMA) governs cell-based products under the framework of advanced therapy medicinal products (ATMPs), offering protocols for the development and authorization of new therapies. Those frameworks significantly affect the cell-cryopreservation industry with requirements for the handling, storage, and transport of biological materials.

Stem cells are known for their pluripotency and capacity for self-renewal. They are used in therapies for blood and immune disorders — such as leukemia and lymphoma — through hematopoietic stem-cell transplantation.

Stem-cell cryopreservation empowers regenerative medicine and offers hope to patients with incurable diseases. A GMI report identifies stem-cell therapies as a rapidly growing sector, underscoring the intersection of scientific advancement and clinical application in stem-cell–based therapies. During 2023, the stem-cell–cryopreservation sector was valued at about $4 billion (1). It is anticipated to grow significantly over the next decade.

Future Perspectives: Merging expertise from diverse sectors can help to harness the intricacies of stem-cell therapies and transition from laboratory research to clinical applications. Ongoing investment in research infrastructure, adherence to ethical standards, and enhanced regulatory structures are pivotal for advancing and implementing such therapies.

The GMI report indicates a strong outlook for the cell-cryopreservation market, reflective of an advancing sector poised to revolutionize medical treatment paradigms. Cell cryopreservation is not merely a technical accomplishment; it represents a gateway to promising new treatments and brings hope to millions of patients.

However, the journey is not without obstacles. The market faces regulatory complexities, the need for specialized storage and handling protocols, and ethical concerns surrounding stem-cell research. Addressing such challenges requires a concerted effort from industry players, regulatory bodies, and the global research community to foster an environment that supports innovation and ensures adherence to ethical standards and patient safety.

References

1 Cell Cryopreservation Market Size. Global Market Insights: Selbyville, DE, 2024; https://www.gminsights.com/industry-analysis/cell-cryopreservation-market.

2 Cancer. World Health Organization: Geneva, Switzerland, 2024; https://www.who.int/europe/health-topics/cancer.

3 CBER. Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products. US Food and Drug Administration: Rockville, MD, 2019; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/preclinical-assessment-investigational-cellular-and-gene-therapy-products.

Ashwin Avhad is senior executive officer at Global Market Insights; [email protected].