Driver Increasing strategic decisions by key players
The rising demand for cell and gene-based therapies globally for various indications is encouraging key players to strategize and expand their geographic reach
The recent mergers and acquisitions by leading players are shaping the global cell banking outsourcing market. For instance, in March 2021,WuXiAppTec (China), announced the acquisition of OXGENE, a UK-based contract research and development organization focused on
gene therapy technologies. This acquisition enables WuXiAppTec to expand its manufacturing capabilities
Similarly, Cryo-Cell International, Inc. (US) completed the acquisition of substantially all of the assets of Cord Blood Bank, Inc. (US). The company intends to use acquired assets and extend its leadership position into the public cord blood banking arena
Rising applications and clinical trials related to stem cells
There are over 5,000 registered clinical trials involving stem cell research on ClinicalTrials.gov, with new clinical trials related to COVID-19 expected to increase during the forecast period. The listed clinical trials can be categorized under various intervention types. These categories include bone & muscle, brain & nerves, digestive system disease, eye disease, heart & blood vessels, infertility, kidney disease, lung diseases, skin disease, trauma, and urological diseases
Similarly, the number of Hematopoietic Cell Transplantation (HCT) in Europe and collaborating countries continues to rise with 48,512 HCT in 43,581 patients, comprising of 19,798 (41%) allogeneic and 28,714 (59%) autologous transfers, reported by 700 centers in 51 countries during 2019
Market Restraints
High capital investment and ethical issues related to the donation of cells
Issues surrounding the procedures used to obtain informed consent from potential cord blood donors and concerns about disclosure of donors with respect to significant clinical information discovered during the donor screening process is acting as a restraint to cell banking outsourcing market growth
Market Opportunities
Development of cell banks in developing countries
Cell banks helps in characterizations of cell lines.They reduce the cost of cell culture processes by storing and retrieving cell lines whenever required. Similarly, the increasing focus on regenerative and personalized medicine is likely to create an opportunity for the cell banking outsourcing market to grow.Several key players focus on catering products and services to the American and European markets due to well-established healthcare infrastructure, huge patient population, and high healthcare expenditure.No public cord blood banks are present in Africa, and the prohibitive cost of bringing in cord blood units from overseas is not simply feasible for most patients.
The launch of subsidiaries in the developing regions can be profitable with first to market advantage.
Value Chain Analysis
The cell banking outsourcing market is projected to exhibit significant growth over the forecast period, which can be attributed to factors such as a rise in the per capita disposable income, rapid technological advancements in the cell banking outsourcing services, and the availability of better medical facilities, along with increasing patient pool in need of cell-based therapies. The value chain analysis for the cell banking outsourcing industry comprises four major components, which start with the research & product development, followed by the manufacturing of the products, distribution, and ends with post marketing surveillance.
The trend towards cell banking outsourcing is increasingly recognized as a strategic approach for biopharmaceutical companies seeking to enhance operational efficiency and focus on core competencies, while ensuring compliance with stringent regulatory standards.
U.S. Food and Drug Administration (FDA)
