세포은행 아웃소싱 시장 예측(-2032년) : 유형별, 세포 유형별, 단계별, 최종사용자별, 지역별 세계 분석

According to Stratistics MRC, the Global Cell Banking Outsourcing Market is accounted for $17.51 billion in 2025 and is expected to reach $56.93 billion by 2032 growing at a CAGR of 18.34% during the forecast period. Cell banking outsourcing is assigning specialized third-party service providers to create, store, and maintain cell banks, including master cell banks (MCBs) and working cell banks (WCBs). By utilizing the infrastructure and experience of CDMOs, this strategy assists biopharmaceutical companies in ensuring regulatory compliance, cutting costs, and expediting their development timelines. Outsourced cell banking services often include checking cell lines, storing them according to good manufacturing practices (GMP), and testing their stability, offering reliable and flexible solutions for both clinical and commercial production needs.

According to the FDA Office of Cellular, Tissue and Gene Therapies (CBER), approximately 40 % of clinical holds issued by CDER between 2017-2021 were for cell and gene therapy trials, emphasizing the regulatory complexity and need for standardized, outsourced cell banking capabilities.

Market Dynamics:

Driver:

Growing interest in cell therapies and biologics

Biologics, such as vaccines, monoclonal antibodies, and sophisticated cell and gene therapies, are quickly taking the place of pharmaceuticals as the mainstay of contemporary medicine. The importance of large-scale master and working cell banks that are traceable, dependable, and compliant with international regulatory standards is growing as clinical research activity and approvals increase. Additionally, pharmaceutical companies can speed up their development timelines and maintain the integrity and quality of these biologic products by outsourcing because it gives them access to ready infrastructure and proven expertise.

Restraint:

Concerns about protecting intellectual property (ip) and data security

There are serious issues with data confidentiality and intellectual property ownership when vital biological resources, such as cell lines, are outsourced to outside vendors. High-value therapeutic products are often based on patient-derived or proprietary cell lines, which biopharmaceutical companies frequently work with. Companies, particularly early-stage biotech firms, may be discouraged from outsourcing due to concerns about data breaches, unauthorized access, or intellectual property misuse. Furthermore, the management of sensitive data is made more difficult by regulations like GDPR and HIPAA, especially when outsourcing crosses international borders.

Opportunity:

Technological developments in storage and cryopreservation

The quality and security of cell banking are being improved by advancements in automated inventory systems, digital tracking, cryogenic storage, and cell freezing media. In addition to lowering the chance of cell deterioration, these technological developments give outsourcing companies a competitive edge through scalability, efficiency, and traceability. Moreover, businesses that provide tech-integrated, round-the-clock monitored repositories will be in a better position to support the upcoming biologics and cell therapy technologies.

Threat:

Uncertainty in regulations and changing guidelines

The regulatory environment surrounding gene and cell therapies, and consequently, cell banking, is always changing. Biologic material handling GMP regulations, documentation standards, and quality expectations are regularly updated by organizations like the FDA, EMA, PMDA, and NMPA. Providers of cell banking outsourcing must constantly adjust to new regulations pertaining to documentation, traceability, and sterility. Any noncompliance may result in license revocations, client losses, or batch failures. Furthermore, global outsourcing is made more difficult by the fact that different countries have different regulatory requirements.

Covid-19 Impact:

The COVID-19 pandemic affected the cell banking outsourcing market in a variety of ways, but ultimately in a revolutionary way. At first, supply chain interruptions and lockdowns hindered the transportation and storage of biological materials and postponed ongoing biopharmaceutical projects. However, the need for GMP-compliant cell banking services-particularly for the production of viral vectors and monoclonal antibodies-increased due to the global emphasis on vaccine development and therapeutic research. In order to reduce operational risks, the pandemic also highlighted the significance of scalable and trustworthy outsourcing models, leading numerous biopharma companies to re-evaluate their supply chains and outsource non-core functions like cell banking.

The master cell bank (MCB) segment is expected to be the largest during the forecast period

The master cell bank (MCB) segment is expected to account for the largest market share during the forecast period because MCBs are the original source of a cell line used in the production of biologics and cell therapies, they are essential for quality, consistency, and regulatory compliance. Because MCBs are developed under stringent GMP guidelines and thoroughly examined for identity, purity, and stability, outsourcing their creation guarantees access to top-notch resources and knowledge. Moreover, the market dominance of MCBs is fueled by pharmaceutical companies' growing reliance on outsourcing partners to set up and run MCBs in response to the growing demand for monoclonal antibodies, vaccines, and gene therapies.

The contract research organizations (CROs) segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the contract research organizations (CROs) segment is predicted to witness the highest growth rate. CROs provide highly specialized, flexible, and affordable services that are being embraced by big pharmaceutical companies and up-and-coming biotech companies looking to optimize R&D procedures. CROs are evolving into strategic partners in cell line characterization, GMP cell banking, and quality assurance due to the growing demand for quicker biologics development, regulatory compliance, and risk mitigation. Additionally, their scalability, technological know-how, and global reach put them in a strong position to support intricate projects like gene and cell therapies, which has fueled their explosive growth in the outsourcing market.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, driven by the presence of top CDMOs, a robust regulatory environment, and an advanced biopharmaceutical industry. Due to the United States' leadership in the development of cell therapies and biologics, there is a significant need for GMP-compliant cell banking services. The area also gains from large R&D expenditures, a strong healthcare system, and regular collaborations between pharmaceutical companies and specialized outsourcing providers. Furthermore, the early adoption of cutting-edge technologies, along with an emphasis on quality control and regulatory compliance, further solidifies North America's leading position in the global outsourcing market for cell banking.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by the biotechnology and pharmaceutical industries' explosive growth in nations like China, India, South Korea, and Singapore. These nations' governments are actively promoting biomanufacturing through funding, infrastructure development, and supportive policies. The area is desirable for outsourcing cell banking services due to the availability of qualified personnel at reduced operating expenses. Additionally, Asia-Pacific is becoming a high-growth outsourcing destination as a result of the growing involvement of regional players in the development of biologics, biosimilars, and cell therapies, which is increasing demand for scalable and compliant cell storage solutions.

Key players in the market

Some of the key players in Cell Banking Outsourcing Market include Charles River Laboratories, Inc., Merck KGaA, Texcell, LifeCell International Pvt. Ltd., Cryo-Cell International, Inc., SGS Societe Generale de Surveillance SA, Lonza Group, GBI (Goodwin Biotechnology Inc.), Cordlife Group Limited, WuXi AppTec, Reliance Life Sciences, Bio Outsource (Sartorious), Clean Biologics Inc and BSL Bioservice Inc.

Key Developments:

In April 2025, Merck KGaA and SpringWorks Therapeutics Inc have entered into a definitive agreement for Merck KGaA, Darmstadt, Germany, to acquire SpringWorks. The agreed acquisition of SpringWorks is a major step in our active portfolio strategy to position our company as a globally diversified, innovation and technology powerhouse. For our Healthcare sector, it sharpens the focus on rare tumors, accelerates growth, and strengthens our presence in the U.S.

In October 2024, Lonza has announced a long-term extension of its collaboration with a key global biopharmaceutical partner for the manufacture of antibody-drug conjugates (ADCs) at commercial scale. The name of the partner was not disclosed. The extended agreement, Lonza said, will expand the dedicated bioconjugation footprint for the customer through the construction of a new bioconjugation suite at the company's Ibex Biopark in Visp, Switzerland.

In February 2024, Charles River Laboratories International, Inc. announced a strategic agreement with Wheeler Bio, Inc., an antibody contract development and manufacturing organization (CDMO) focused on preclinical and early clinical supply of recombinant proteins, providing clients access to Wheeler's Portable CMC(R) platform. This new alliance provides early-stage biotechnology companies a unique solution to rapidly transition from pre-clinical activities to first-in-human clinical trials.

Types Covered:

• Master Cell Banks (MCB)
• Working Cell Banks (WCB)
• Viral Cell Banking (VCB)

Cell Types Covered:

• Stem Cell
• Non-stem Cell

Phases Covered:

• Bank Storage
• Bank Characterization & Testing
• Bank Preparation

End Users Covered:

• Biopharmaceutical Companies
• Contract Research Organizations (CROs)

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 End User Analysis
• 3.7 Emerging Markets
• 3.8 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Cell Banking Outsourcing Market, By Type

• 5.1 Introduction
• 5.2 Master Cell Banks (MCB)
• 5.3 Working Cell Banks (WCB)
• 5.4 Viral Cell Banking (VCB)

6 Global Cell Banking Outsourcing Market, By Cell Type

• 6.1 Introduction
• 6.2 Stem Cell
  • 6.2.1 Cord Cell
  • 6.2.2 Embryonic Stem Cell
  • 6.2.3 Adult Stem Cell
  • 6.2.4 Dental Stem Cell
  • 6.2.5 Induced Pluripotent Stem Cells (iPSCs)
• 6.3 Non-stem Cell
  • 6.3.1 Microbial Cells
  • 6.3.2 Mammalian Cells

7 Global Cell Banking Outsourcing Market, By Phase

• 7.1 Introduction
• 7.2 Bank Storage
  • 7.2.1 Master Cell Bank Storage
  • 7.2.2 Working Cell Bank Storage
  • 7.2.3 Cell Storage Stability Testing
• 7.3 Bank Characterization & Testing
  • 7.3.1 Safety Testing
    • 7.3.1.1 Viral Cell Banks
    • 7.3.1.2 Microbial Cell Banks
  • 7.3.2 Gene Expression Testing
  • 7.3.3 Karyology Testing
  • 7.3.4 Gene Sequencing Testing
• 7.4 Bank Preparation
  • 7.4.1 Master Cell Bank Preparation
  • 7.4.2 Working Cell Bank Preparation

8 Global Cell Banking Outsourcing Market, By End User

• 8.1 Introduction
• 8.2 Biopharmaceutical Companies
• 8.3 Contract Research Organizations (CROs)

9 Global Cell Banking Outsourcing Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Charles River Laboratories, Inc.
• 11.2 Merck KGaA
• 11.3 Texcell
• 11.4 LifeCell International Pvt. Ltd.
• 11.5 Cryo-Cell International, Inc.
• 11.6 SGS Societe Generale de Surveillance SA
• 11.7 Lonza Group
• 11.8 GBI (Goodwin Biotechnology Inc.)
• 11.9 Cordlife Group Limited
• 11.10 WuXi AppTec
• 11.11 Reliance Life Sciences
• 11.12 Bio Outsource (Sartorious)
• 11.13 Clean Biologics Inc
• 11.14 BSL Bioservice Inc