Cell Banking Outsourcing Market Report Scope & Overview:

The Cell Banking Outsourcing Market Size was valued at USD 12.5 Billion in 2023 and is expected to reach USD 49.9 Billion by 2032, growing at a CAGR of 16.6% over the forecast period 2024-2032.

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The cell banking outsourcing market report provides key statistical insights and trends shaping the industry, including development trends, competitive landscape analysis, and key region's development status. It also evaluates the incidence and prevalence of cell-based therapies and the cell bank volume trends. The analysis of outsourcing trends is based on pharma, biotech, and research institute population with particular interest in regional regulatory compliance (GMP, FDA, EMA). It also details biopharma R&D spend regarding cell banking services as well as the uptake of AI, robotics and new methods of cryopreservation. The analysis provides an evidence-based perspective on market expansion, investment patterns, and technology development. the cell bank outsourcing market is growing as biopharmaceuticals demand increases, advanced cell therapy development, & strict regulations.

Market Dynamics

Drivers

• Growing demand for biologics and personalized medicine is increasing the need for specialized cell banking services.

Growing demand for biologics and personalized medicine is the key factor contributing to the edge of outsourcing cell banking market. They are made using live organisms (biologics), which means they need specialized cell lines for production, leading to the need for comprehensive cell banking systems. Personalized medicine tailor treatment to an individual’s genetic profile; this often uses cell-based therapies that are dependent on well-characterized, maintained banks of cells. Recent developments in the industry highlight this shift. AstraZeneca invested USD 2B, intending to increase production capabilities of biologics and cell therapies at its U.S. facilities In November 2024. The area of personalized medicine is also rapidly growing. The rising genomic technology level and an improved understanding of the disease mechanism, results in much more precise and beneficial therapies. Consequently, the need for reliable cell banking services has intensified, as they provide the essential infrastructure for developing and producing these innovative treatments.

Restraints:

• High costs associated with cell banking services may limit adoption, especially among smaller research entities.

The industry is significantly restrained from the high costs associated with outsourcing cell banking. Cell banks must be set up and maintained, which incur huge investments in infrastructure, specialized equipment, and compliance with demanding regulatory standards. Such costs can be prohibitive, especially for small research institutions and emerging biotech firms. As an example, the global cell banking outsourcing market has a revenue value of USD 14.38 billion in 2024, exemplifying the high financial scale of the industry. Moreover, the complexity of cryopreservation, cell characterization, and quality assurance requires well-trained professionals, which further increases operational costs. As a result, overcoming the financial burden in outsourcing cell banking services may be hampering biopharmaceutical R&D progress.

Opportunities:

• Emerging markets with increasing healthcare investments present new avenues for cell banking outsourcing providers.

The potential for cell banking outsourcing is huge in the healthcare sector with emerging markets primarily creating new opportunities for this space with the amount of investments coming into the healthcare sectors in emerging economies. The Swedish private equity firm EQT has poured more than USD 6 billion into India over the past 18 months, focusing on sectors including healthcare. While out-of-country referrals are increasing, this influx of cash is focused on building healthcare infrastructure and services, creating a potential demand for specialized services such as cell banking outsourcing. In the same vein, Bain Capital recently announced its USD 157 million investment in Indonesia’s Mayapada Healthcare Group to increase the number of operating hospitals and the number of beds. This growth is expected to stimulate the demand for high-end cell banking services that assist in medical therapies and research programs.

In the face of geopolitical animosities, big pharma also has been on the acquisition trail in China to expand its footprint. A landmark acquisition of Gracell Biotechnologies by AstraZeneca for USD 1.2 billion stands out among the October deals, emphasizing the region's dedication to drug development. Such investments are expected to fuel the demand for cell banking outsourcing services for biopharmaceutical research and development. In terms of geography, emerging countries are witnessing huge investments accounting for the expansion of the cell banking outsourcing market. High-dependency services like cell banking are becoming vital because as healthcare establishments grow and advance, they need supportive services for complex health issues.

Challenges:

• Intense competition among outsourcing providers can lead to price wars and reduced profit margins.

The cell banking outsourcing market is currently facing significant challenges due to intense competition among service providers. As more players enter the market, competition between different providers intensifies, resulting in price wars that can inevitably dig into profit margins and potential businesses financial stability. The market is annualized by a high concentration of players, and companies are doing everything they can to maintain their market share providing competitive prices and extensive service packages. For example, numerous big firms such as Bio Outsource (Sartorius), BSL Bioservice, Cryo-Cell International, Inc., Charles River Laboratories, are expanding their services portfolio and enhancing their global visibility to cater to the increasing adoption of cell banking services.

Companies are forced in this competitive atmosphere to constantly innovate and enhance the quality of service to remain competitive. Well, the impetus to lower the prices might restrict the funding available for such creative endeavours and may affect the quality of services to comply with rigorous regulations. Moreover, newer market entrants or smaller players may struggle to compete against well-established firms, creating barriers to entry and innovation that hinder the diversity of the industry. As a result, although competition serves as a motivator for improving services, the current level of competition threatens the viability and growth of cell banking outsourcing suppliers.

Segment analysis

By Type

In 2023, Master Cell Banking segment dominated the market and accounted 63% revenue share. This prominence can be explained by the importance of master cell banks for the generation of reliable and high-quality cell lines for the production of biopharmaceuticals. The U.S. FDA's "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)" guidance emphasizes that well-characterized master cell banks form the basis of gene therapy manufacturing and are crucial to the generation of safe and effective products. According to the National Institute of Standards and Technology (NIST), standardization efforts in cell line authentication have increased by 30% since 2020, driving the demand for master cell banking services. According to the CDC, the use of cell-based vaccines dependent on master cell banks increased by 25% over the past three years and propelled the overall market share of the segment.

The preference for master cell banking is also supported by its cost-effectiveness and reduced risk of genetic drift. The National Cancer Institute (NCI) estimates that using well-established master cell banks can reduce cell line development costs by up to 40% compared to repeated de novo cell line generation. In addition, year-on-year growth in FDA approvals of Biologics License Application (BLA) applications for master cell bank-derived products is now 18% reflecting regulatory acceptance and trust in this strategy.

By Cell Type

In 2023, the stem cells segment commanded the largest market share at 53%. This large market share is majorly attributed to the growing research and therapeutic applications of them in various medical fields. Federal funding for stem cell research grew to USD 2.1 billion in fiscal year 2024, a 12% increase from the previous year, according to the National Institutes of Health (NIH). Since 2020, stem cell-based therapies have seen an annual increase of 22% in the number of FDA-approved clinical trials using stem cells, with a strong pipeline for the development of stem cell-based therapies, as per the California Institute for Regenerative Medicine (CIRM).

According to the U.S. Department of Health and Human Services (HHS), the number of stem cell transplants for hematological disorders has increased 35% in the past five years, which shows the growing clinical adoption of stem cell therapies. Moreover, according to NCBI, published scientific literature on induced pluripotent stem cells (iPSCs) lengthened by 40% from 2021, reflecting the scientific community's attention towards this promising cell. In January 2025, there were 45 stem cell-based products with Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, reinforcing the dominance of the stem cell segment in cell banking outsourcing.

By Phase

In 2023, bank storage held the largest share of 42%. This sizable market share is due to the vital need for long-term, stable cell line storage in the biopharmaceutical market. According to the National Institute of Standards and Technology (NIST), the demand for cryogenic storage facilities for biological materials has increased by 28% since 2020. According to the Office of Biological and Environmental Research in the U.S. Department of Energy, investments in biorepository infrastructure have increased 15% year on year over the last three years, indicating the growing demand for top-notch storage options.

The FDA's guidance on "Container Closure Systems for Packaging Human Drugs and Biologics" emphasizes the importance of maintaining cell viability during storage, which has led to a 20% increase in the adoption of automated cryopreservation systems since 2022. According to the Centers for Disease Control and Prevention (CDC), the shelf life of cell lines can be exponentially extended to about 25 years through proper cell bank storage, emphasizing the long-term return on investment of high-quality storage facilities. Additionally, NIH (United States National Institute of Health) has reported a 33% increase in investment in projects that can potentially improve cell preservation technologies in the last two years, further fueling innovation in the bank storage stage of outsourcing cell banking.

Regional analysis

North America held the largest share of the Cell Banking Outsourcing Market in 2023, with a share of 45%, Its dominance can be attributed to the region's well-established biopharmaceutical industry and strong research infrastructure for cell and gene therapy. The U.S. Food and Drug Administration (FDA) latest reported that biologics license applications (BLAs) for cell-based therapies increased by 30% year on year from 2020, which suggests a rising demand for cell banking services across North America. In fiscal year 2024, the National Institutes of Health (NIH) awarded USD 3.2 billion for regenerative medicine research, a 15% increase from the prior year, which further propels market growth in North America.

The Asia-Pacific region is projected to grow at the fastest CAGR from 2024 to 2032. Asia-Pacific's rapid growth is driven by increasing investments in biotechnology and a growing focus on precision medicine. Since 2021, government spending on cell therapy research in China has increased at an annual rate of 25%, according to the China National Center for Biotechnology Development. In Japan, the Ministry of Health, Labour and Welfare reports that the number of approved regenerative medicine products has doubled in the past three years, stimulating demand for cell banking services.

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Recent developments

• In Jan 2024, VivaCyte, an automated, single-cell potency characterization platform was launched by Cellply Srl to support cellular immunotherapy development.

• In April 2023, BioOutsource Ltd. launched a monoclonal antibodies biosimilars characterization service to assist the growing biosimilar market.

• In May 2023, panCELLa partnered with BioCentriq, Inc. to evaluate genetically engineered iPSC-derived feeder cells to enhance NK cell expansion and potency.

Key Players

Key Service Providers/Manufacturers

• Charles River Laboratories, Inc. (Master Cell Bank Production, Working Cell Bank Storage)

• Lonza Group (GS Gene Expression System, XS Microbial Fermentation Platform)

• WuXi AppTec (cGMP Cell Banking Services, Viral Clearance Studies)

• Merck KGaA (Cellvento CHO Media, VirusExpress Lentiviral Production Platform)

• Cryo-Cell International Inc. (Cord Blood Banking, Cord Tissue Banking)

• Clean Biologics (Cell Line Characterization, GMP Cell Banking)

• SGS Life Sciences (Cell Bank Characterization, Biosafety Testing)

• LifeCell International Pvt. Ltd. (BabyCord Stem Cell Banking, Community Cord Blood Banking)

• Texcell (Viral Safety Testing, Cell Bank Characterization)

• Cryo Stemcell (Stem Cell Banking, Genetic Testing Services)

Key Users:

• Pfizer Inc.

• Novartis AG

• Johnson & Johnson

• Roche Holding AG

• Sanofi S.A.

• GlaxoSmithKline plc

• AstraZeneca plc

• Eli Lilly and Company

• AbbVie Inc.

• Bristol-Myers Squibb Company

Cell Banking Outsourcing Market Report Scope