Cell Banking Outsourcing Market Insights on Cryopreservation Regulatory Support and Biosafety Testing Services

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Cell Banking Outsourcing Market Size, Share & Trends Analysis Report, By Service Type (Cell Line Expansion & Banking, Cell Line Characterization & Testing, Cryopreservation & Storage, Regulatory Support (CMC Documentation, Release Testing), Biosafety Testing (Sterility, Mycoplasma, Adventitious Agents), and Others), By Cell Type (Mammalian Cells (CHO Cells, BHK Cells, Vero Cells, HEK 293 Cells, Others), Stem Cells (Induced Pluripotent Stem Cells (iPSCs), Mesenchymal Stem Cells (MSCs), Embryonic Stem Cells (ESCs)), Microbial Cells (Yeast Cells, E. coli, Others), Hybridoma Cells, and Others (e.g., Insect Cells, Primary Cells)), By Bank Type, By Application, By Phase, By End-use, By Region-Market Outlook And Industry Analysis 2034"

The Global Cell Banking Outsourcing Market is valued at US$ 14.2 Bn in 2024 and it is expected to reach US$ 65.5 Bn by the year 2034, with a CAGR of 16.8% during the forecast period of 2025-2034.

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Cell banking outsourcing involves leveraging external service providers to store and maintain cell lines, ensuring a reliable supply of authenticated, contaminant-free cells for research and manufacturing purposes. The production of biopharmaceuticals depends on the secure and systematic preservation of cell lines, including master cell banks (MCBs) and working cell banks (WCBs). The market for cell banking outsourcing is being driven by rising demand for monoclonal antibodies, the development of efficient biopharmaceuticals, advancements in cryopreservation and cell bank preparation technologies, and the expanding application of stem cell therapies.

Furthermore, the increasing adoption of stem cell therapies, coupled with the growing requirement for monoclonal antibodies and biopharmaceutical production, is contributing to market growth. According to CellTrials.org, new trial enrollments for advanced cell therapies increased by nearly 30% globally in the first quarter of 2020, underscoring the rising demand for cell banking services. In addition, supportive government initiatives and the introduction of innovative cell line storage and characterization technologies are expected to further propel the expansion of the cell banking outsourcing market.

List of Prominent Players in the Cell Banking Outsourcing Market:

·      Lonza Group

·      AGC Biologics

·      BioReliance (Merck KGaA)

·      Aldevron

·      QTP Labs

·      Sino Biological

·      BioOutsource (Sartorius)

·      Thermo Fisher Scientific (Patheon)

·      Vibalogics

·      Charles River Laboratories

·      Eurofins Scientifi

·      Fujifilm Diosynth Biotechnologies

·      Cell and Gene Therapy Catapult

·      Rentschler Biopharma

·      Samsung Biologics

·      Novartis Contract Manufacturing

·      Paragon Bioservices (Catalent)

·      Porton Advanced

·      Syngene International

·      WuXi Advanced Therapies (WuXi AppTec)

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Market Dynamics:

Drivers:

The cell banking outsourcing market is experiencing significant growth, primarily driven by the rising prevalence of chronic diseases, which has intensified the demand for advanced biopharmaceuticals. Chronic conditions such as cancer, diabetes, and autoimmune disorders have increased the need for novel therapies, particularly biologics. To optimize operational efficiency, reduce time-to-market, and concentrate on core competencies, biopharmaceutical companies are increasingly outsourcing cell banking activities to specialized service providers.

This trend is expected to continue, further propelling market expansion. Additionally, technological advancements in cell line development—including innovations in genetic engineering, cell culture, and cryopreservation—are enhancing the reliability and efficiency of cell banking processes, serving as another key growth driver.

Challenges:

The market faces several challenges, with stringent regulatory requirements being a primary constraint. Regulatory agencies such as the FDA and EMA have established rigorous standards for the characterization, documentation, and storage of cell lines, necessitating substantial investments in specialized infrastructure, expertise, and quality control systems. Compliance with these regulations can be costly and complex, potentially limiting market growth. Moreover, the risk of contamination and cross-contamination in cell banks underscores the critical need for stringent quality assurance measures to ensure the safety and integrity of stored cell lines.

Regional Trends:

In 2024, North America held the largest share of the cell banking outsourcing market, supported by a well-established biopharmaceutical sector, advanced healthcare infrastructure, and a favorable regulatory environment. The presence of leading biopharmaceutical companies and contract research organizations (CROs) actively engaged in cell banking outsourcing further reinforces the region’s market dominance. Demand for biologics and the increasing prevalence of chronic diseases are additional factors driving growth in North America.

Over the forecast period, the Asia Pacific region is expected to exhibit the highest growth rate in the cell banking outsourcing market. Rapid expansion of the biopharmaceutical and biotechnology sectors in the region is increasing the demand for cell banking services to support research and development activities. Additionally, the region’s large and genetically diverse population presents opportunities for personalized therapies and stem cell research, further boosting the need for efficient cell banking and storage solutions.

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Recent Developments:

·      April 2025: Open Access BPO, an outsourcing business headquartered in the United States (US), was acquired by TDCX. As businesses look to use outsourcing to deal with the rapidly evolving business climate and competitive labor market, the acquisition enhances TDCX's capacity to satisfy the growing demand for strategic outsourced services with new facilities in Davao, Manila, and Taipei.

·      October 2024: TERUMO, a global leader in medical technology, and NAMSA, a top medtech Contract Research Organization (CRO) providing end-to-end market access services, announced a strategic outsourcing partnership to expedite the commercialization and regulatory approval of Terumo's product portfolio.

·      May 2023: In order to evaluate the ability of panCELLa's genetically modified iPSC-derived feeder cells to activate and favorably impact the growth rate, total yield, and potency of generated NK cells, the company has signed a research agreement with BioCentriq, Inc.

Segmentation of Cell Banking Outsourcing Market-

Cell Banking Outsourcing Market- By Service Type

·      Cell Line Expansion & Banking

·      Cell Line Characterization & Testing

·      Cryopreservation & Storage

·      Regulatory Support

o  CMC Documentation

o  Release Testing

·      Biosafety Testing

o  Sterility

o  Mycoplasma

o  Adventitious Agents

·      Others

Cell Banking Outsourcing Market- By Cell Type

·      Mammalian Cells

o  CHO Cells

o  BHK Cells

o  Vero Cells

o  HEK 293 Cells

o  Others

·      Stem Cells

o  Induced Pluripotent Stem Cells (iPSCs)

o  Mesenchymal Stem Cells (MSCs)

o  Embryonic Stem Cells (ESCs)

·      Microbial Cells

o  Yeast Cells

o  E. coli

o  Others

·      Hybridoma Cells

·      Others (e.g., Insect Cells, Primary Cells)

Cell Banking Outsourcing Market- By Bank Type

·      Research Cell Bank (RCB)

·      Master Cell Bank (MCB)

·      End-of-Production Cell Bank (EOPCB)

·      Working Cell Bank (WCB)

·      Others (e.g., Parental Cell Bank, Stability Cell Bank)

Cell Banking Outsourcing Market- By Application

·      Vaccine Production

·      Cell & Gene Therapy

·      Tissue Engineering

·      Biologics Manufacturing

·      Regenerative Medicine

·      Research and Development

·      Others

Cell Banking Outsourcing Market- By Phase

·      Preclinical

·      Clinical

o  Phase I

o  Phase II

o  Phase III

·      Commercial

Cell Banking Outsourcing Market- By End-use

·      Biopharmaceutical Companies

·      Contract Development and Manufacturing Organizations (CDMOs)

·      Cell Therapy Companies

·      Academic & Research Institutions

·      Others

Cell Banking Outsourcing Market- By Region

North America-

·      The US

·      Canada

Europe-

·      Germany

·      The UK

·      France

·      Italy

·      Spain

·      Rest of Europe

Asia-Pacific-

·      China

·      Japan

·      India

·      South Korea

·      South East Asia

·      Rest of Asia Pacific

Latin America-

·      Brazil

·      Argentina

·      Mexico

·      Rest of Latin America

 Middle East & Africa-

·      GCC Countries

·      South Africa

·      Rest of Middle East and Africa

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