Cell Banking Outsourcing Market Analysis

Global Cell Banking Outsourcing Market Overview

The cell banking outsourcing market is expected to cross USD 12.08 Billion by 2032 at a CAGR of 15.9% during the forecast period of 2023 to 2032. An increasing number of cell banks globally is projected to propel the growth of the cell banking outsourcing market size during the forecast period. Increasing number of applications of cell-based products for research as well as the rapies is another factor  expected to grow the market size. Moreover, asurge in the number of start-ups focused on cell-based therapies and vaccine production is likely to fuel market growth.

COVID-19 Analysis

The rising prevalenceof COVID-19 is projected to influence market growth over the forecast period.  As the coronavirus outbreak continues, the majority of the pharmaceutical companies experienced a significant loss, thereby hampering the cell banking outsourcing market.

Many companies halted their manufacturing and supply operations in the initial phase of the pandemic. However, the current situation of COVID-19 is expected to reach normalcy since the medical professionals and health authorities in the countries are taking the necessary steps to fight against the virus.The European Society for Blood and Marrow Transplantation has recommended waiting at least 21 days before donation for infected donors. In Italy, the National Transplant Centre has recommended testing through real-time RT-PCR assays for tissue and stem cell donors. Several studies worldwide are looking into whether Mesenchymal Stem Cells (MSCs) can aid the treatment of some of the effects COVID-19 can have on the respiratory system.

An article published online dated March 12, 2021, in Blood Research reviewedthe impact of COVID-19 on cord blood banking globally. It analysed the number of unrelated Stem Cell Transplantations (SCTs) using bone marrow or peripheral blood were similar in South Korea in 2019 and 2020.Thus the SCTs donations were not significantly affected by the COVID-19 pandemic in Korea. However, numbers of volunteer adult stem cell donors decreased dramatically for several months after March 2020, compared to 2018 and 2019, and then recovered since July 2020.Similarly, many drugs have been examined in clinical trials, and 10.2% of registered COVID-19 studies used stem cellsand cord blood to try to prevent the progression of COVID-19. An increasing reliance on cell-based therapies for probable COVID-19 treatment is projected to increase the demand for cell banking services such as storage and processing.

In May 2022, Anja Health raised $4.5 million in seed funding to make cord blood stem cell banking accessible for all, regardless of race, socio-economic status or income. The new funding will bring in the strengthening of the company's leadership team, promote strategic growth as well as foster its community.

In April 2022, Pluristyx and Accelerated Biosciences agreed to generate clinical-grade hESC banks under GMP guidelines (GMP) – a biotech firm focused on advanced therapeutic tools and services and the pioneer in regenerative medicine engaged in proprietary human trophoblast stem cells (hTSCs) respectively.

GMP-grade hESC banks were made between Pluristyx, a biotech firm focusing on advanced therapeutics tools and services and Accelerated Biosciences, the leading regenerative medicine pioneer using its own proprietary human trophoblast stem cells (hTSCs).

ATUM initiated Good Manufacturing Practices (cGMP) compliant Master Cell Banking production services from a California-based bioengineering company in April 2022. Such a move enables ATUM to provide end-to-end cell line development that includes DNA designing through the Release of a Master Cell Bank (MCB) and Working Cell Bank (WCB) supporting Investigational New Drug applications.

Cell Banking Outsourcing Market Trends

• 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 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.

Cell Banking Outsourcing Market Segment Insights

Cell Banking Outsourcing Bank Type Insights

• Master Cell Banking

Master Cell Bank(MCB) is expected to be the fastest-growing segment during the period of 2021–2027 dueto its need to create Working Cell Bank (WCB). In the process of cell development, cells are extracted from normal, embryonic, and malignant tissues. These cells are propagated in vitro.A master cell bank is produced from the original therapeutic-producing cell line.

• Working Cell Banking

WCBis derived from MCB.In order to prevent loss of cell lines from contamination,it is necessary to stored WCB in separate storage areas.The WCB is prepared from cells obtained from culturing the MCB under aseptic conditions.

• Viral Cell Banking

The creation of a Master Virus Bank ensures reproducible testing and production of recombinant viruses to develop vaccines and recombinant proteins.Viral banking services are completely segregated from non-viral activities to ensure no cross-contamination of products.

Cell Banking Outsourcing Cell Type Insights

• Stem Cell Banking

The process of gathering, treating, and creating repositoriesof stem cells for future is termed as stem cell banking. The growing application scope of stem cells in therapies and regenerative medicine is anticipated to increase the growth of this segment. Stem cells have the potential to regenerate. This ability to develop into many different types of blood and tissue cell increases its applications in research and therapies.

• Non-Stem Cell Banking

Non-stem cellsinclude somatic cells preserved for applications such as tissue engineering and Induced Pluripotent Stem Cells (iPSCs) development. Advanced Therapy Medicinal Products (ATMPs) such as TiGenix’s (Belgium) ChondroCelectis used to repair damaged cartilage in the knee.

Cell Banking Outsourcing Application Insights

• Cell Bank Storage

Cell banks store the biological products at negative temperatures using liquid nitrogen for cryopreservation. Most of the cell banks store MCB and WCB at -70oC to -150oC. Primary site storage facilitiesfor Master Cell Banks are divided and maintained at two different locations.The cell banks store cord blood and stem cells of newborn individuals for future use.

• Cell Bank Preparation

Cells are generally prepared for banking by expanding cultures in a progressively greater number or larger vessel size until a pool of cells can be obtained, which is sufficient to generate enough containers for the bank.This preparation of cell banks is important for pre-clinical research as well as therapy.

• Bank Characterization & Testing

The process for characterizing cell lines can be extensive, requiring an array of testing options for specific scenarios. From adventitious agent testing to identity and genetic stability testing, it is important to know availableoptions, time to perform tests, and the impact of testing on the overall project schedule and outcome.Chinese Hamster Ovary (CHO) cells are by far the most used production cell lines in the pharmaceutical industry.

Cell Banking Outsourcing Region Insights

• North America:

The North Americancell bank outsourcing market held the largest share in 2020 due to the presence of major manufacturers,favorable government regulations, and high healthcare expenditure in the region. The availability of an increasing number of stem cell banks (both public and private) is anticipated to support the market growth globally.

• Europe:

The European cell banking outsourcing market is driven byincreasing government initiatives and the large availability of research grants. The growing geriatric population, predisposition to chronic diseases, and large support for storage of cord blood and stem cells are projected to expand the size of the cell banking outsourcing market in the region.

• Asia-Pacific:

The cell banking outsourcing market is projected to record at the highest CAGR during the forecast period. This regional market growth is attributed to the rising population, increasing number of patients suffering from chronic diseases such as oncological diseases,and the increasing number of contractual research and development organizations. The clinical trials in the region continue to grow rapidly. Novotech (Australia), a contract research organization, observed biotech clinical activity up by 26% in 2019.Furthermore, in September 2020, Anglo-Swedish pharma firm AstraZeneca teamed with Contract Development and Manufacturing Organization (CDMO) Samsung Biologics (South Korea) in a long-term deal. Samsung Biologics has also announced a plethora of contracts with smaller biopharma firms, including Belgian firm UCB, Cytodyn (US), PharmAbcine (South Korea), Panolos Bioscience (South Korea), Immunomedics (US), ImmuneOncia Therapeutics Inc. (South Korea), and STCube (South Korea).

• Rest of the World:

The rest of the world is segmented into Middle East, Africa, and Latin America. The cell banking outsourcing market in the region is driven bytechnological development, developing healthcare infrastructure, and growing acceptance of advanced therapies.

Competitive Landscape

The cell banking outsourcing market is characterized by the presence of many global, regional, and local vendors catering to the demand created by research scientists and pharmaceutical and biotechnology companies operating in the industry.The growing demand from customers is propelling the cell banking outsourcing market growth.The market is highly competitive, with players competing and partnering to gain a substantial market share. For instance, in February 2021, Catalent (US), a global provider of manufacturing solution for drugs, biologics, cell and gene therapiessigned an agreement with Trizell GmbH (Germany), to support the manufacturing of Trizell’s Phase 1 cell therapy for the treatment of micro- and macroangiopathies.The prominent players are involved in strategic agreements and joint ventures to sustain their market positions.

Recent Developments

• In February 2021, Paragon Biosciences (US) launched CiRC Biosciences, a cell therapy company developing treatments for diseases with high, unmet needs with an initial focus on the eye diseases


• In April 2020, Hope Biosciences (US), a clinical-stage biotech company focused on developing cell-based therapeutics, received FDA approval for a Phase II clinical trial evaluating the efficacy and safety of its mesenchymal stem cells to provide immune support against COVID-19

Key Players

• CordLife (Singapore)


• Cleancells (France)


• Charles River Laboratories (US)


• BSL Bioservice (Germany)


• BioReliance (US)


• Sartorius (Germany)


• Covance (US)


• LifeCell International Pvt. Ltd. (India)


• Goodwin Biotechnology Inc.(US)


• GlobalStem Inc.(US)


• , Cryo-Cell International Inc. (US)


• Lonza (Switzerland)


• PX’TherapeuticsSA (France)


• Wuxi Apptec (China)


• SGS Life Sciences (Switzerland)

Cell Banking Outsourcing Market Segmentation

Cell Banking Outsourcing Bank Type Outlook

• Master Cell Banking


• Working Cell Banking


• Viral Cell Banking

Cell Banking Outsourcing Cell Type Outlook

• 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

Cell Banking Outsourcing Application Outlook

• Cell Bank Storage
  
  
  
  • Master Cell Bank Storage
  
  
  • Working Cell Bank Storage
  
  
  • Cell Storage Stability Testing
  
  
  
  


• Cell Bank Preparation
  
  
  
  • Master Cell Bank Preparation
  
  
  • Working Cell Bank Preparation
  
  
  
  


• Bank Characterization & Testing
  
  
  
  • Viral Cell Bank Safety Testing
  
  
  • Microbial Cell Bank Safety Testing
  
  
  • Gene Expression Testing
  
  
  • Karyology Testing
  
  
  • Gene Sequencing Testing
  
  
  
  

Cell Banking Outsourcing Region Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia Pacific
  
  
  
  


• Rest of the World




• Middle East


• Africa


• Latin America