Cell banking is a process of replicating and storing cells for the purpose of future use. Storage of these cell samples can be utilized for research purposes and for surgical reconstruction of damaged body structures. Cells are frozen in cryovials at -196 degrees Celsius along with cryoprotection agents such as 10% solution of DMSO. Cell banking is most commonly used in stem cell research and therapy. The different types of cell banking include master cell banks and working cell banks. Master cell banks are expanded to form working cell banks. Master cell banks consist of pure cells, from which cells are replicated, whereas working cell banks consist of thawed cells that are replicated in cell culture. Cell banking provides detailed characterization and avoids contamination of cell lines, as well as saves costs incurred by maintaining cells in cell culture.
Growing number of stem cell therapies to drive growth of the cell banking outsourcing market
Growing number of stem cell therapies over the recent past, is expected to drive growth of the cell banking outsourcing market. As per survey by World Network for Blood and Marrow Transplantation (WBMN), during 2006–2014, around one million hematopoietic stem cell transplantation were undertaken. These included removing stem cells from bone marrow or peripheral blood and proliferating and storing them in cell banks for later use in patients. Stem cell therapy is applicable for treatment of over 100 diseases currently, as per a report by World Marrow Donor Association, in 2016. Furthermore, increasing research and development in therapy areas such as immunotherapy (Checkpoint Inhibitors, CAR-T, and ACTRC), are being initiated for the treatment of diseases such as cancer. Immunotherapy involves genetically modifying T cells of patients, in vitro proliferation of these cells, storing of these cells in cell banks, further injecting them back into the patient’s body, to produce immune response and kill cancerous cells. Furthermore, increasing demand for biologic products such as vaccines, which involve the use of viral cell banking and viral cell banking safety testing are expected to propel growth of the cell banking outsourcing market.
However, high cost associated with storing these cells in cell banks is a major challenge faced by this market. On an average, storage of cells account for up to US$ 2,500 annually, which in turn, is expected to hamper expansion of the cell banking outsourcing market. Furthermore, some legal challenges associate with banking a variety of cells, especially considering stem cells banking, are expected to restrain market growth. For instance, in October 2017, the Indian government banned cell banking of biological products, except umbilical blood, due to lack of evidence of it being a therapeutic agent. Storing of one’s own cord blood is still illegal in Italy and France. There is also a problem of reimbursement for cell banking. For instance, in the U.S., insurance companies provide reimbursement for cord blood banking only when medically necessary. This limits the choice of new parents to store such cells for future use, in turn hindering growth of the cell banking outsourcing market.
Cell banking Outsourcing Market Taxonomy
On the basis of type of bank:
- Master Cell Banking
- Working Cell Banking
- Viral Cell Banking
On the basis of type of cell:
- Stem Cell Banking
- Cord Stem Cell Banking
- Embryonic Stem Cell Banking
- Adult Stem Cell Banking
- Dental Stem Cell Banking
- IPS Stem Cell Banking
- Non-stem Cell Banking
On the basis of phases of banking:
- Cell Bank Storage
- Master Cell Bank Storage
- Working Cell Bank Storage
- Cell Storage Stability Testing
- Bank Characterization and Testing
- Safety Testing
- Viral Cell Bank Safety Testing
- Microbial Cell Bank Safety Testing
- Gene Expression Testing
- Karyology Testing
- Gene Sequencing Testing
- Cell Bank Preparation
- Master Cell Bank Preparation
- Working Cell Bank Preparation
U.S. is expected to drive market for cell banking outsourcing
The U.S. is expected to drive growth of the cell banking outsourcing market during the forecast period. The U.S. recorded over 1 million stem cell donors in 2016, according to a report by World Marrow Donor Association (WMDA). Increasing number of ongoing research and development projects in the domain of gene therapy, cell therapy, and biological products in the country are also boosting market growth. Cells are used to express different proteins such as antigen, anti-bodies, and to utilize viruses to produce live attenuated and inactivated vaccines, thus cell banking is increasingly being used as an essential part of the development of biologics. Regions such as Asia Pacific are expected to witness significant growth due to increasing awareness among new parents about benefits of storing umbilical cord blood of their new born children.
Major players operating in the cell banking outsourcing market include Charles River Laboratories, Cryo-Cell International Inc., BioOutsource (Part of Sartorious Stedim Biotech Group)Ltd., BioReliance Corporation, BSL Bioservice Scientific Laboratories Munich GmbH, Cleancells, CordLife Group Ltd, Covance, Inc., Cryobanks International India, GlobalStem Inc., LifeCell International Pvt. Ltd., Goodwin Biotechnology Inc., Lonza. Additionally, PX’Therapeutics SA, Reliance Life Sciences, SGS Life Sciences, Texcell SA, Toxikon Corporation, Transcell Biologics Pvt. Ltd., and Wuxi Apptec.
- In January 2018, PX’Therapeutics announced its collaboration with biotech firm, Advaxis, for process development of immunotherapies of Advaxis
- In June 2017, Alligator Bioscience announced partnership with Sartorius Stedim Biotech Group (BioOutsource), as Cell Line Development Partner in its immuno-oncology antibody drug candidate development
- In 2013, Cryo-Cell International Inc. affiliates -Saneron CCEL Therapeutics, Inc. and the University of South Florida, received patent for processing of umbilical cord blood for treatment of neurodegenerative diseases and spinal cord and brain injuries
- In September 2017, GE Healthcare announced the introduction of Thaw CB1000, for thawing large volumes of cell therapies cryopreserved in cryo-bags majorly intended for use in research laboratory