세포 은행 아웃소싱 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the cell banking outsourcing market size is expected to grow from USD 16.78 billion in 2025 to USD 19.58 billion in 2026 and is forecast to reach USD 42.31 billion by 2031 at 16.71% CAGR over 2026-2031.

This report is Segmented by Bank Type (Master Cell Banking, Working Cell Banking, Viral Cell Banking, and More), Cell Type (Stem Cell Banking, Embryonic Stem Cells and More), Outsourced Service (Cell Line Development, and More), End User (Biopharma & Biotech Companies, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Cell Banking Outsourcing Market Trends and Insights

Surge in Cell & Gene Therapy Pipelines

Global investigational activity fuels the cell banking outsourcing market, with the U.S. FDA monitoring more than 2,500 active INDs and preparing for 10-20 novel approvals each year from 2025 onward. Every cell- or gene-based therapeutic requires multiple tiered banks-master, working and viral-driving multi-cycle demand. Allogeneic CAR-T and natural killer platforms magnify the requirement because single donor cells treat numerous patients, necessitating larger, more rigorously characterized banks. Late-stage portfolios are expanding: WuXi Biologics disclosed 51 Phase III programs in 2023, nearly double 2022 levels, and most rely on external banking capacity. Distributed manufacturing nodes outlined in recent FDA draft guidance also require parallel micro-banks at several qualified sites. Manufacturing costs exceeding USD 2.1 million per dose for first-generation CAR-T products highlight the economic incentive to outsource banking and amortize fixed costs.

Rising Adoption of Stem-Cell Banking

Asia-Pacific leads growth as clinical use of cord blood climbs from 30,000 procedures in 2023 to nearly 40,000 in 2024, accompanied by 99% survival in thalassemia treatments. Automated cryopreservation systems deliver consistent cooling rates, improving post-thaw viability and lowering storage failures. Induced pluripotent stem cells circumvent embryonic-cell ethics while retaining pluripotency, making them a preferred option for disease modeling and autologous therapies. Hybrid public-private banks in China and South Korea broaden access while generating revenue streams that sustain large-scale repositories. Next-generation sequencing panels offered by Charles River Laboratories detect latent viral contamination faster than legacy assays, enhancing regulatory confidence.

High Cost of GMP-Compliant Services

Building and validating a modern cell-banking suite can exceed USD 200 million, as illustrated by Fujifilm's 2024 North Carolina expansion that added eight 20,000-liter bioreactors and extensive storage vaults. Service pricing often represents 15-25% of total therapy development budgets, challenging seed-stage ventures. Charles River Laboratories reported revenue headwinds in early 2025 after a client withdrew a commercial contract, highlighting the sensitivity of project flow to cost escalation. Surge demand compresses available slots, giving incumbent providers pricing leverage. Long-term contracts partially offset fixed outlays, yet up-front capital remains a deterrent for new entrants.

Other drivers and restraints analyzed in the detailed report include:

1. Regulatory Push for GMP Compliance
2. AI-Driven Cell-Line Authentication Gains
3. Ethical & Legal Issues Around Embryonic Cells

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Master cell banks accounted for 37.64% of the cell banking outsourcing market in 2025 as they establish the genetic blueprint for all downstream operations. Viral cell banks, though smaller today, register an 17.52% CAGR through 2031, propelled by CAR-T, oncolytic virus and gene-editing modalities that rely on high-titer vectors. The cell banking outsourcing market size for viral banks is projected to surpass USD 9.2 billion by 2031, reflecting heightened biosafety and sequencing requirements. Outsourced partners deploy BSL-2+/BSL-3 suites, barrier isolators and closed-system bioreactors that minimize cross-contamination risk while scaling yield. Stringent replication-competent virus assays align with evolving FDA guidance, favoring vendors already equipped with quantitative PCR and digital droplet platforms.

Rapid commercialization of virotherapy programs intensifies demand for expedited master and working viral banks. Providers that bundle analytical development, plasmid supply and cryogenic warehousing achieve higher utilization rates and recurring revenue. Smaller sponsors opt for subscription-style agreements that lock-in capacity through licensure, shielding projects from future slot scarcity. These dynamics reinforce the cell banking outsourcing market's shift toward full-service CDMOs with dedicated viral-bank centers.

Stem-cell repositories controlled 60.12% of overall revenue in 2025, with cord blood, tissue-derived and embryonic lines serving regenerative and immuno-oncology pipelines. Induced pluripotent stem cells log the fastest trajectory at 18.76% CAGR, benefitting from patent expirations that lower licensing fees and from protocols that skip oncogenic integration. The cell banking outsourcing market share for iPSC inventories is expected to cross 16.15% by 2031, up from 7.3% in 2025.

Capital-heavy players such as Fujifilm allocate more than USD 200 million to expand iPSC GMP suites in Wisconsin, adding closed automated thaw-wash-fill systems that prevent operator contact. AI-powered imaging now scores colonies for pluripotency markers in real time, boosting batch acceptance rates. Public-private hybrid banks in China guarantee long-term storage funding through state subsidies while opening fee-for-service tiers to industry users. These structures stabilize cash flow and anchor regional manufacturing clusters.

Geography Analysis

North America accounted for 45.25% of the cell banking outsourcing market in 2025, underpinned by FDA leadership in cell-therapy approvals, abundant venture funding and a dense cluster of GMP-qualified vaults. The United States drives regional momentum, hosting expansions by Charles River Laboratories, Thermo Fisher Scientific and Fujifilm that collectively add more than 4 million cryogenic vials of incremental capacity. Canada's supportive incentives attract early-stage developers, while Mexico's forthcoming NOM-260-SSA1 standard invites cross-border collaborations and creates new requests for bilingual documentation.

Europe commands approximately 29.15% market share, sustained by German, British and French pharmaceutical hubs. The European Medicines Agency's post-marketing surveillance requirements necessitate long-term sample retention, creating annuity revenue for banks with EU tissue establishment licenses. Switzerland and the Netherlands strengthen their positions as import gateways by streamlining customs clearance for frozen biologics, reducing transit time and viability loss.

Asia-Pacific records the fastest CAGR at 17.38% through 2031. China leads absolute growth on the back of aggressive cord blood expansion and central-government grants supporting iPSC lines for rare-disease projects. Japan's expedited Sakigake designation accelerates local approvals, growing demand for release testing and GMP storage under the Pharmaceuticals and Medical Devices Agency framework. India updates its national guidelines in 2025, emphasizing stricter donor screening and documentation, which favors international providers familiar with OECD-aligned practices. South Korea and Australia continue to leverage strong academic networks and rising clinical-trial counts, cementing the region's strategic importance.

1. Charles River
2. Merck
3. Lonza Group
4. WuXi App Tec
5. Cryo-Cell International
6. Cordlife Group Ltd.
7. LifeCell International
8. SGS Life Sciences
9. Clean Biologics
10. Texcell
11. Reliance Life Sciences
12. ATCC
13. Thermo Fisher Scientific
14. Eurofins
15. FUJIFILM
16. Cryoport Systems
17. Roslin CT
18. ViaCord (AMAG Pharmaceuticals)
19. Vcanbio
20. CCBC (China Cord Blood Corp.)

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Surge In Cell & Gene Therapy Pipelines
  • 4.2.2 Rising Adoption Of Stem Cell Banking
  • 4.2.3 Increasing Chronic Disease Burden
  • 4.2.4 Regulatory Push For GMP Compliance
  • 4.2.5 AI-Driven Cell Line Authentication Gains
  • 4.2.6 Decentralized Clinical-Trial Micro-Banks
• 4.3 Market Restraints
  • 4.3.1 High Cost Of GMP-Compliant Services
  • 4.3.2 Ethical & Legal Issues Around Embryonic Cells
  • 4.3.3 Cryogenic Logistics Capacity Crunch
  • 4.3.4 Energy-Efficiency Mandates For ULT Storage
• 4.4 Porter's Five Forces
  • 4.4.1 Bargaining Power of Suppliers
  • 4.4.2 Bargaining Power of Buyers
  • 4.4.3 Threat of New Entrants
  • 4.4.4 Threat of Substitutes
  • 4.4.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Bank Type
  • 5.1.1 Master Cell Bank (MCB)
  • 5.1.2 Working Cell Bank (WCB)
  • 5.1.3 Viral Cell Bank (VCB)
  • 5.1.4 Research & Development Cell Bank
  • 5.1.5 End-of-Production Cell Bank
• 5.2 By Cell Type
  • 5.2.1 Stem Cell Banking
  • 5.2.2 Cord Blood & Tissue Stem Cells
  • 5.2.3 Embryonic Stem Cells
  • 5.2.4 Adult Stem Cells
  • 5.2.5 Dental Pulp Stem Cells
  • 5.2.6 Induced Pluripotent Stem Cells
  • 5.2.7 Non-stem Cell Banking
  • 5.2.8 Microbial Cell Banking
  • 5.2.9 Mammalian Cell Banking
  • 5.2.10 Hybridoma Cell Banking
• 5.3 By Outsourced Service
  • 5.3.1 Cell Line Development
  • 5.3.2 Characterization & Testing
  • 5.3.3 GMP Manufacturing & Expansion
  • 5.3.4 Cryopreservation & Storage
  • 5.3.5 Logistics & Cold Chain Management
• 5.4 By End User
  • 5.4.1 Biopharma & Biotech Companies
  • 5.4.2 Academic & Research Institutes
  • 5.4.3 Contract Research Organizations
  • 5.4.4 Hospitals & Transplant Centers
• 5.5 Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Charles River Laboratories Inc.
  • 6.3.2 Merck KGaA
  • 6.3.3 Lonza Group
  • 6.3.4 Wuxi AppTec
  • 6.3.5 Cryo-Cell International Inc.
  • 6.3.6 Cordlife Group Ltd.
  • 6.3.7 LifeCell International Pvt. Ltd
  • 6.3.8 SGS Life Sciences
  • 6.3.9 Clean Biologics
  • 6.3.10 Texcell SA
  • 6.3.11 Reliance Life Sciences
  • 6.3.12 ATCC
  • 6.3.13 Thermo Fisher Scientific
  • 6.3.14 Eurofins Scientific
  • 6.3.15 Fujifilm Diosynth Biotechnologies
  • 6.3.16 Cryoport Systems
  • 6.3.17 Roslin CT
  • 6.3.18 ViaCord (AMAG Pharmaceuticals)
  • 6.3.19 Vcanbio
  • 6.3.20 CCBC (China Cord Blood Corp.)

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment