Cell Banking Outsourcing Market

Market Overview

The global cell banking outsourcing market size was valued at USD 12.2 billion in 2023 and is projected to reach a value of USD 48.7 billion by 2032, registering a CAGR of 16.6% during the forecast period (2024-2032). One of the primary drivers of the cell banking outsourcing market share is the increasing innovation of cryopreservation and cell bank preparation methods.

Cell banking outsourcing is contracting specialized services for storing, characterizing, and administering cell lines or cell-based products with third-party suppliers. Biopharmaceutical businesses, research institutes, and contract research organizations (CROs) frequently use outsourcing to gain knowledge, infrastructure, and regulatory compliance for cell banking activities.

An increasing number of cell banks worldwide is expected to drive the growth of the outsourcing market during the forecast period. Furthermore, more research and development in therapy areas like immunotherapy (Checkpoint Inhibitors, CAR-T, and ACTRC) are being conducted to treat diseases like cancer. Immunotherapy entails genetically altering patients' T cells, growing them in vitro, keeping them in cell banks, and injecting them back into the patient's body to stimulate an immune response and kill malignant cells. Furthermore, rising demand for biological products like vaccines, which need viral cell banking and viral cell banking safety testing, is projected to drive growth in the cell banking outsourcing market. However, the excessive expense of preserving these cells in cell banks presents a significant hurdle to this business.

Highlights

• Master Cell Banking influenced the market growth by type.
• Stem Cell led the market by cell type.
• Bank Storage dominates the market by phase.

Market Dynamics

Global Cell Banking Outsourcing Market Drivers

Increasing Demand for Biopharmaceuticals

The increasing demand for biopharmaceutical products, such as monoclonal antibodies, recombinant proteins, and cell-based therapeutics, necessitates the development of efficient and scalable cell banking technologies. Outsourcing cell banking services enables biopharmaceutical businesses to optimize manufacturing processes, shorten product development timeframes, and fulfill the growing demand for new biologics.

According to McKinsey & Co., the biopharma industry now boasts the broadest and most diverse clinical pipeline in history, resulting from decades of groundbreaking research. The number of unique medications in development increased from 3,200 in 2012 to 6,100 by 2022. The ability to deliver on this expansive pipeline has been made possible by government investment—including an estimated USD18 billion made available for Operation Warp Speed and USD 48 billion invested annually by the National Institutes of Health alone—and private markets, with an estimated USD 146 billion in life sciences venture capital funding in the last three years.

Additionally, to fulfill the growing demand for biopharmaceuticals, businesses must build robust cell banking systems that assure a long-term and scalable supply of high-quality cell lines for bioproduction. Outsourcing cell banking services to specialist providers provides biopharmaceutical businesses with the expertise, infrastructure, and regulatory compliance capabilities required for efficient and compliant cell banking operations. Further, The rising frequency of chronic diseases, aging populations, and advances in biotechnology are driving global demand for biopharmaceutical products. According to the World Health Organization (WHO), noncommunicable diseases (NCDs) kill 41 million people each year, accounting for 74% of all global fatalities. Cardiovascular disease is the leading cause of NCD fatalities, followed by cancer, chronic respiratory illness, and diabetes. Chronic diseases and mental health issues account for almost 90% of the USD 4.1 trillion in yearly healthcare spending.

Thus, as biopharmaceutical companies work to bring innovative therapies to market and address unmet medical needs, demand for cell banking outsourcing services is expected to rise, driven by the need for expertise, capacity, and regulatory compliance in cell-based drug development and manufacturing. Outsourcing cell banking enables businesses to concentrate on their core capabilities while accelerating the research and commercialization of life-saving biopharmaceutical products.

Global Cell Banking Outsourcing Market Restraints

Regulatory Compliance Challenges

Biopharmaceutical is strictly regulated to ensure the safety, efficacy, and quality of cell-based products. Cell banking activities, such as cell line characterization, preservation, and distribution, are subject to stringent regulatory regulations imposed by health authorities such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory bodies worldwide. Compliance with GMP standards, GLP guidelines, and applicable regulatory filings is critical for regulatory approval for biopharmaceutical products.

In addition, the FDA's Center for Biologics Evaluation and Research (CBER) regulates cell-based therapies and biologics in the United States. Companies developing cell-based products must follow FDA regulations, including 21 CFR Parts 210 and 211 for GMP compliance, as well as cell banking-specific guidance documents and regulations, such as FDA Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.

Furthermore, according to RAPS, regulatory compliance is a significant concern for biopharmaceutical companies. Regulatory affairs specialists ensure that healthcare products follow regulations and are approved for sale and manufacturing. These problems underline the significance of solid regulatory strategies and experience when negotiating the regulatory landscape for cell banking outsourcing activities.

Global Cell Banking Outsourcing Market Opportunity

Rising Demand for Advanced Therapies

The field of regenerative medicine and cell-based therapeutics is quickly advancing, focusing on discovering new treatments for various diseases such as cancer, neurological disorders, and cardiovascular disease. Cell-based therapies use stem cells, immune cells, and other cell types to rebuild damaged tissues, regulate immunological responses, and restore physiological function. Cell treatment was extended in 2023, mainly for autoimmune illnesses. Exagamglogene autotemcel, the first CRISPR-edited cell treatment, has obtained landmark approval. Developers are also shifting their focus from T cells to NK cells, with more than 60% of NK therapies being allogeneic compared to 21% for T cell therapies.

Furthermore, a report published in Nature Reviews Drug Discovery shows the expanding pipeline of cell-based medicines in clinical trials across various therapeutic domains. The survey covers more than 1,000 cell therapy items in clinical trials, with indications including cancer, cardiovascular illness, neurological disorders, and autoimmune ailments. As the pipeline of innovative medicines grows, so will the demand for cell banking outsourcing services to support cell line generation, characterization, and storage, creating considerable potential for outsourced providers to profit from the expanding market.

Moreover, the growing need for innovative therapeutics, such as cell-based therapies and regenerative medicine products, creates an attractive opportunity for the worldwide cell banking outsourcing market. Outsourcing providers can position themselves as strategic partners to biopharmaceutical companies and academic institutions by providing specialized expertise, infrastructure, and regulatory compliance capabilities to support the development and commercialization of advanced therapies, thereby driving innovation and growth in the rapidly changing biopharmaceutical landscape.

Regional Analysis

The global cell banking outsourcing market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global cell banking outsourcing market shareholder and is estimated to grow at a CAGR of 16.0% over the forecast period. North America dominated the market, accounting for 45% of the total market in 2023, owing to the presence of substantial R&D facilities and rising occurrences of metabolic illnesses such as Parkinson's, Alzheimer's, and several other forms of cancers that can be treated with gene therapies. The rapid expansion of financial services, a symptom of rapid change, adds to the organizational diversity of the North American healthcare system.

Furthermore, the growing number of stem cell-based research studies for treating numerous chronic diseases, including type 1 diabetes (T1DM), Parkinson's disease, amyotrophic lateral sclerosis, Alzheimer's disease, heart disease, and others, is the primary driver of the segment's growth. For example, an article published in Stem Cell Research and Therapy in July 2022 found that mesenchymal stem cells (MSCs) are the most promising. It can differentiate into dopaminergic neurons and produce neurotrophic factors, curing neurodegenerative diseases. 

Thus, such research projects are expected to boost the use of stem cell-based therapies and medications to treat various ailments. Demand for cell banking services is expected to increase, driving market growth. 

Asia-Pacific is anticipated to exhibit a CAGR of 16.8% over the forecast period. This exponential CAGR is attributed to the presence of pharmaceutical companies, who are prioritizing the enormous and largely untapped populations in Asia.  The low cost of clinical trials and substantial investments in the biotechnology sector are projected to drive the growth of this regional market. The International Conference on Stem Cell Research and Therapy was conducted in China in May 2022 to provide a venue for academicians, researchers, and industry experts to present their research and debate breakthroughs and advancements in stem cells. Such attempts by private and public sector groups to discuss and encourage stem cell research are expected to aid market growth in this area.

Europe holds a significant market share. Increased government initiatives and many research awards are driving the European cell banking outsourcing market. The region's cell banking outsourcing market is expected to develop because of the expanding senior population, a tendency to chronic diseases, and widespread support for cord blood and stem cell storage.

Segmental Analysis

The global cell banking outsourcing market is segmented based on type, cell type, and phase.

The market is further segmented by type into Master Cell Banking, Working Cell Banking, and Viral Cell Banking.

Master cell banking accounted for the most significant part (65%) in 2023 since its preparation is required to manufacture and use functional cell banks. Master Cell Banking (MCB) entails establishing a well-characterized and extensively tested repository of cells generated from a single source, usually a single cell line or clone. MCBs are the principal source of cells for large-scale biopharmaceutical manufacturing, providing the consistency, reproducibility, and traceability of cell-based products throughout their lifecycle. MCBs, including genetic stability testing, phenotypic analysis, and functionality assays, are thoroughly characterized to determine their eligibility for bioproduction.

Furthermore, MCBs are critical for guaranteeing batch-to-batch consistency and quality control in biomanufacturing processes, reducing product variability and contamination risk. They are kept for extended periods, encouraging the use of high-quality cryopreservation procedures and equipment, enhancing this segment's income base. Master cell banks have applications in different research and development areas, including stem cell treatment and gene therapy. The rising prevalence of autoimmune illnesses and cancer, which can be treated using therapies in conjunction with regenerative medicine, is likely to drive the growth of this segment over the forecast period.

Working Cell Banking (WCB) is the multiplication and distribution of cells from the MCB to support ongoing bioproduction operations. WCBs are the operational cell bank for routine production runs, ensuring a consistent supply of cells to manufacture therapeutic proteins, vaccines, and other biologics. Periodic testing and monitoring of WCBs confirms cell viability, growth characteristics, and genetic stability, confirming their eligibility for bioprocessing. WCBs are critical for sustaining productivity, consistency, and scalability in biopharmaceutical manufacturing operations, allowing for efficient and cost-effective manufacturing of cell-based products on a commercial scale.

Based on cell type, the market is fragmented into Stem Cell, Non-Stem Cell.

The stem cell sector led the market, accounting for 50%. Stem cells are derived from cord blood, embryonic, adult, dental, and IPS cells, whereas non-stem cells are somatic cells kept for use in tissue engineering and IPS cell development. The segment's growth is driven by a surge in R&D activity related to stem cell applications. For example, in February 2021, American CryoStem teamed with BioTherapeutic Labs Corp to conduct stem cell research and development. 

Cord cell banking had a high market share in revenue in 2023, which can be ascribed to the growing number of cord blood banks and banking services worldwide. Cord blood has several advantages, including its use as a source of hematopoietic stem cells, donor convenience, reduced risk of graft versus host illness, minimal risk of viral contamination, and immediate availability.

Non-stem cell banking refers to storing and preserving non-stem cells such as primary cells, immortalized cell lines, and differentiated cells produced from various tissues. Non-stem cells are used as models in illness research, drug discovery, and bioproduction applications, giving researchers and biopharmaceutical businesses valuable tools for understanding cellular physiology, disease processes, and therapeutic targets.

Additionally, non-stem cell banks collect and store various cell types, including epithelial cells, fibroblasts, hepatocytes, and neuronal cells, to satisfy their clients' research and development needs. Non-stem cell banking has a wide range of uses, including drug screening, toxicity testing, and cell-based assays, which help to enhance scientific research and therapeutic innovation.

The market can be bifurcated into phases: bank storage, bank characterization and testing, and bank preparation.

Bank storage accounted for the most significant part of 45% in 2022 due to sophisticated preservation requirements required to operate either master or functioning banks properly. Furthermore, technologically advanced cryopreservation procedures are projected to drive growth in this market throughout the forecast period. Bank Storage is the initial stage of the cell banking process, in which cells are collected, processed, and cryopreserved for long-term storage. During this stage, cells are extracted from donor samples, grown, and expanded to create a sufficient cell population for banking. Once the required cell population has been established, the cells are cryopreserved using specialized freezing media and storage techniques to ensure their viability and stability.

Furthermore, Bank storage facilities use cryogenic storage systems, such as liquid nitrogen dewars or automated biorepositories, to keep cell banks at ultra-low temperatures (-80°C to -196°C) for long periods, preserving cell integrity and functionality for future use in research, therapy, or bioproduction applications.

Bank Characterization and Testing are the intermediate stages of the cell banking process, which include detailed analysis, validation, and quality control assessments of stored cell banks. Cell banks are rigorously characterized during this phase to ensure their identity, purity, potency, stability, and compliance with regulatory and quality standards. Genetic profiling, phenotypic analysis, functional tests, and microbiological testing can all be used to evaluate cell banks' biological and physicochemical features. In addition, banked cells are tested for infectious agents, mycoplasma contamination, and endotoxin levels to reduce contamination risk and ensure product safety.

Moreover, Bank characterization and testing techniques are critical for determining the quality and suitability of cell banks for research, clinical, or commercial applications, as well as offering confidence in the dependability and repeatability of cell-based products.

Recent Developments

• April 2024- Sartorius and TheWell Bioscience collaborated to make more accurate forecasts in drug discovery.
• April 2024- Charles River and Deciphex launched Patholytix Foresight, a transformative AI-powered decision support tool for toxicologic pathology.
• February 2024- Charles River collaborated with Pluristyx to expand its portfolio of human pluripotent stem cells.