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市场调查报告书
商品编码
1917827

细胞库外包市场－2026-2031年预测

Cell Banking Outsourcing Market - Forecast from 2026 to 2031
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 148 Pages | 商品交期: 最快1-2个工作天内

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简介目录

预计到 2025 年，外包细胞库市场规模将达到 105.56 亿美元，到 2031 年将达到 244.37 亿美元，复合年增长率为 15.02%。

细胞库外包市场由专业服务供应商负责处理关键的上游生物製程操作，例如细胞库的建立、表征、测试和在严格控制的条件下储存。这种外包模式提供全面的服务，包括建立研究细胞库 (RCB)、主细胞库 (MCB) 和工作细胞库 (WCB)，以及完整的分析表征、稳定性测试和长期冷冻保存。其主要目标是确保为生物製药生产、细胞疗法和前沿研究提供稳定、有据可查且无污染的起始材料——无论是哺乳动物、昆虫还是微生物来源。透过将此基础流程外包给专家，客户可以确保其核心生物资产的可追溯性、活性和合规性。

市场扩张的根本驱动力是生物技术领域，特别是先进治疗药物（ATMP）领域的爆炸性成长和资金限制。细胞和基因疗法（CGT）的蓬勃发展是关键催化剂，而这些疗法本质上依赖起始细胞材料的可靠性和可重复性，包括患者来源或基因工程改造的细胞株。对于主导此创新领域的中小型生技公司而言，建构符合GMP规范的内部细胞库基础设施需要大量的资本支出，这会分散它们对核心研发的精力。外包提供了一个关键手段，可以降低研发风险、加快研发进度，并在无需大量前期投资的情况下获得专业技术。

同时，监管机构对细胞株历史和特征的审查日益严格，这成为推动监管合规的重要因素。包括FDA和EMA在内的监管机构要求，用于临床和商业生产的细胞库必须提供严格的文件记录、全面的外来性病原体检测，并证明其克隆性和稳定性。专业的合约研发生产机构（CDMO）和细胞库服务供应商已建立起检验的平台和品质体系，专门用于满足这些复杂的要求，为申办方提供了一条高效的合规途径。随着治疗方法进入后期临床试验和商业化阶段，这一点变得尤为重要。

从地理角度来看，亚太地区正崛起为一个重要的、高成长的市场，这主要得益于各国政府的战略倡议。该地区各国政府正积极透过大量资金投入、税收优惠以及建设专业生物园区等方式，扶持国内生物技术和生物製药产业。这种旨在提升区域先进治疗方法能力的协同努力，催生了对包括细胞库在内的配套服务的集中需求。服务供应商正在亚太地区建立或扩展业务，以掌握这一成长机会，并接近性不断成长的基本客群。

儘管市场驱动因素明确，但该市场面临一个重大且固有的限制：知识产权 (IP) 和专有细胞株的高度敏感性。对于生技公司而言，细胞株通常是整个治疗平台赖以建立的智慧财产权资产。将细胞库营运外包意味着将这些关键的生物材料及其相关资料转移给第三方，这引发了人们对资料安全、保密性和潜在智慧财产权洩露的合理担忧。透过强而有力的法律协议、透明的流程和可验证的安全通讯协定来建立信任是服务供应商的首要任务。这种担忧可能会延缓外包模式的采用，或促使赞助商寻求将最敏感的步骤保留在公司内部的混合模式。

竞争格局既有提供一体化细胞库服务的大型全球合约研发生产机构（CDMO），也有专注于先进细胞和基因治疗材料的小规模专业供应商。竞争主要集中在技术差异化领域，例如单细胞克隆技术、用于表征的次世代定序、处理各种复杂细胞类型（例如诱导多能干细胞、CAR-T细胞）的能力，以及强大的品质和法规支援。成功不仅在于技术卓越，更在于成为值得信赖的策略伙伴，能够帮助客户应对复杂的监管核准流程，同时保护客户最宝贵的生物资产。

总之，细胞库外包市场是现代生物製药和先进疗法生态系统中专业化但至关重要的基础技术。其成长与资本效率高的生物技术创新以及监管机构日益严格的品质要求密切相关。对于业内人士而言，策略重点应放在不断提升支持下一代细胞疗法的技术能力，同时透过稳健的营运和合约保障措施解决智慧财产权保护这一至关重要的挑战。能否提供无缝衔接、符合审核要求的服务，确保客户细胞库的实体完整性和法律保护，将决定市场领导地位。在这个市场取得成功意味着被视为客户研发营运中安全可靠的延伸，而不仅仅是供应商。

本报告的主要优势：

  • 深入分析：取得以客户群、政府政策和社会经济因素、消费者偏好、垂直产业和其他细分市场为重点的深入市场洞察，涵盖主要地区和新兴地区。
  • 竞争格局：了解主要企业采取的策略倡议，并了解透过正确的策略打入市场的潜力。
  • 市场驱动因素与未来趋势：探索动态因素和关键市场趋势，以及它们将如何塑造未来的市场发展。
  • 可执行的建议：利用洞察力为策略决策提供讯息，从而在动态环境中开拓新的业务管道和收入来源。
  • 受众范围广：对新兴企业、研究机构、顾问公司、中小企业和大型企业都有益处且经济高效。

它是用来做什么的？

产业与市场洞察、商业机会评估、产品需求预测、打入市场策略、地理扩张、资本投资决策、法律规范及其影响、新产品开发、竞争影响

分析范围

  • 历史资料（2021-2025 年）和预测资料（2026-2031 年）
  • 成长机会、挑战、供应链前景、法规结构、客户行为和趋势分析
  • 竞争对手定位、策略和市场占有率分析
  • 按业务板块和地区（国家）分類的收入成长和预测分析
  • 公司概况（策略、产品、财务资讯、关键趋势等）

目录

第一章执行摘要

第二章市场概述

  • 市场概览
  • 市场定义
  • 分析范围
  • 市场区隔

第三章 商业情境

  • 市场驱动因素
  • 市场限制
  • 市场机会
  • 波特五力分析
  • 产业价值链分析
  • 政策和法规
  • 策略建议

第四章 技术展望

第五章 依银行类型分類的细胞库外包市场

  • 介绍
  • 主细胞库
  • 工作细胞库

6. 依细胞类型分類的细胞库外包市场

  • 介绍
  • 干细胞
  • 非干细胞

7. 依最终用户分類的细胞库外包市场

  • 介绍
  • 製药和生物技术公司
  • 学术和研究机构
  • 其他的

8. 按地区分類的细胞库外包市场

  • 介绍
  • 北美洲
    • 按银行类型
    • 按细胞类型
    • 最终用户
    • 按国家/地区
      • 美国
      • 加拿大
      • 墨西哥
  • 南美洲
    • 按银行类型
    • 按细胞类型
    • 最终用户
    • 按国家/地区
      • 巴西
      • 阿根廷
      • 其他的
  • 欧洲
    • 按银行类型
    • 按细胞类型
    • 最终用户
    • 按国家/地区
      • 德国
      • 法国
      • 英国
      • 西班牙
      • 其他的
  • 中东和非洲
    • 按银行类型
    • 按细胞类型
    • 最终用户
    • 按国家/地区
      • 沙乌地阿拉伯
      • 阿拉伯聯合大公国
      • 其他的
  • 亚太地区
    • 按银行类型
    • 按细胞类型
    • 最终用户
    • 按国家/地区
      • 中国
      • 印度
      • 日本
      • 韩国
      • 印尼
      • 泰国
      • 其他的

第九章：竞争格局与分析

  • 主要企业和策略分析
  • 市占率分析
  • 企业合併、协议、商业合作
  • 竞争对手仪錶板

第十章：公司简介

  • Sartorius AG
  • Cryosite Limited
  • Charles River Laboratories Inc.
  • Cryo-Cell International, Inc
  • GBI Biomanufacturing
  • Lonza Group
  • SGS SA
  • WuXi AppTec
  • Eurofins Scientific
  • SK Pharmteco Inc
  • Biofortuna Limited

第十一章附录

  • 货币
  • 先决条件
  • 基准年和预测年时间表
  • 相关人员的主要收益
  • 分析方法
  • 简称
简介目录
Product Code: KSI061615812

Cell Banking Outsourcing Market is expected to grow at a 15.02% CAGR, increasing to USD 24.437 billion in 2031 from USD 10.556 billion in 2025.

The cell banking outsourcing market comprises specialized service providers that handle the critical upstream bioprocess activities of developing, characterizing, testing, and storing cell banks under stringent, controlled conditions. This outsourcing model delivers comprehensive services encompassing the establishment of research cell banks (RCBs), master cell banks (MCBs), and working cell banks (WCBs), alongside full analytical characterization, stability testing, and long-term cryogenic storage. The primary goal is to ensure the provision of a consistent, well-documented, and contaminant-free starting material-whether mammalian, insect, or microbial cells-for use in biopharmaceutical production, cell-based therapies, and advanced research. By entrusting this foundational step to experts, clients secure the traceability, viability, and regulatory compliance of their core biological assets.

Market expansion is fundamentally driven by the explosive growth and capital constraints of the biotechnology sector, particularly in advanced therapeutic medicinal products (ATMPs). The primary catalyst is the burgeoning pipeline of cell and gene therapies (CGTs), which are inherently dependent on the reliable and reproducible performance of starting cell materials, including patient-derived or engineered cell lines. For small and mid-sized biotechs, which dominate this innovative space, building internal GMP-compliant cell banking infrastructure represents a prohibitive capital expenditure and a distraction from core R&D. Outsourcing provides a critical path to de-risk development, accelerate timelines, and access specialized technical expertise without massive upfront investment.

A parallel and powerful driver is the intensifying global regulatory scrutiny over cell line history and characterization. Regulatory agencies, including the FDA and EMA, mandate rigorous documentation, comprehensive testing for adventitious agents, and proof of clonality and stability for cell banks used in clinical and commercial production. Specialized Contract Development and Manufacturing Organizations (CDMOs) and dedicated cell banking service providers have established validated platforms and quality systems designed explicitly to meet these complex requirements, offering sponsors a streamlined route to regulatory compliance. This is especially critical as therapies advance toward late-stage clinical trials and commercialization.

Geographically, the Asia-Pacific region is emerging as a significant and high-growth market, propelled by strategic government initiatives. National policies across the region are actively fostering domestic biotech and biopharmaceutical industries through substantial funding, tax incentives, and the development of specialized bioparks. This concerted effort to build regional capacity in advanced therapies is creating a concentrated demand for supporting services, including cell banking. Service providers are establishing or expanding capabilities in APAC to capture this growth and offer geographic proximity to a burgeoning client base.

Despite clear drivers, the market faces a significant and intrinsic constraint: the profound sensitivity surrounding intellectual property (IP) and proprietary cell lines. For biotech companies, a cell line often represents the foundational IP asset of their entire therapeutic platform. The decision to outsource its banking involves transferring this critical biological material and associated data to a third party, raising legitimate concerns over data security, confidentiality, and potential IP leakage. Building trust through robust legal agreements, transparent processes, and demonstrable security protocols is paramount for service providers. This concern can slow adoption or lead sponsors to seek hybrid models where the most sensitive steps are kept in-house.

The competitive landscape features a mix of large, global CDMOs with integrated cell banking services and smaller, niche providers specializing exclusively in advanced cell and gene therapy starting materials. Competition centers on technical differentiation in areas like single-cell cloning technologies, next-generation sequencing for characterization, the ability to handle diverse and complex cell types (e.g., iPSCs, CAR-T cells), and the robustness of quality and regulatory support. Success hinges not only on technical excellence but on becoming a trusted strategic partner, capable of safeguarding a client's most valuable biological assets while navigating the complex path to regulatory approval.

In conclusion, the cell banking outsourcing market is a specialized but essential enabler of the modern biopharmaceutical and advanced therapy ecosystem. Its growth is structurally linked to the rise of capital-efficient biotech innovation and the stringent quality demands of regulators. For industry experts, strategic focus must center on addressing the paramount concern of IP security through ironclad operational and contractual safeguards, while continuously advancing technical capabilities to support next-generation cell therapies. The ability to offer seamless, audit-ready services that ensure both the physical integrity and the legal protection of a client's cell banks will be the defining factor for market leadership. Success in this market means being perceived not merely as a vendor, but as a secure and reliable extension of a client's own research and development operations.

Key Benefits of this Report:

  • Insightful Analysis: Gain detailed market insights covering major as well as emerging geographical regions, focusing on customer segments, government policies and socio-economic factors, consumer preferences, industry verticals, and other sub-segments.
  • Competitive Landscape: Understand the strategic maneuvers employed by key players globally to understand possible market penetration with the correct strategy.
  • Market Drivers & Future Trends: Explore the dynamic factors and pivotal market trends and how they will shape future market developments.
  • Actionable Recommendations: Utilize the insights to exercise strategic decisions to uncover new business streams and revenues in a dynamic environment.
  • Caters to a Wide Audience: Beneficial and cost-effective for startups, research institutions, consultants, SMEs, and large enterprises.

What do businesses use our reports for?

Industry and Market Insights, Opportunity Assessment, Product Demand Forecasting, Market Entry Strategy, Geographical Expansion, Capital Investment Decisions, Regulatory Framework & Implications, New Product Development, Competitive Intelligence

Report Coverage:

  • Historical data from 2021 to 2025 & forecast data from 2026 to 2031
  • Growth Opportunities, Challenges, Supply Chain Outlook, Regulatory Framework, and Trend Analysis
  • Competitive Positioning, Strategies, and Market Share Analysis
  • Revenue Growth and Forecast Assessment of segments and regions including countries
  • Company Profiling (Strategies, Products, Financial Information, and Key Developments among others.)

Cell Banking Outsourcing Market Segmentation

  • By Bank Type
  • Master Cell Bank
  • Working Cell Bank
  • By Cell Type
  • Stem Cell
  • Non-Stem Cell
  • By End-User
  • Pharmaceutical & Biotech Companies
  • Academic & Research Institutes
  • Others
  • By Geography
  • North America
  • USA
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • Germany
  • France
  • United Kingdom
  • Spain
  • Others
  • Middle East and Africa
  • Saudi Arabia
  • UAE
  • Others
  • Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Indonesia
  • Thailand
  • Others

TABLE OF CONTENTS

1. EXECUTIVE SUMMARY

2. MARKET SNAPSHOT

  • 2.1. Market Overview
  • 2.2. Market Definition
  • 2.3. Scope of the Study
  • 2.4. Market Segmentation

3. BUSINESS LANDSCAPE

  • 3.1. Market Drivers
  • 3.2. Market Restraints
  • 3.3. Market Opportunities
  • 3.4. Porter's Five Forces Analysis
  • 3.5. Industry Value Chain Analysis
  • 3.6. Policies and Regulations
  • 3.7. Strategic Recommendations

4. TECHNOLOGICAL OUTLOOK

5. CELL BANKING OUTSOURCING MARKET BY BANK TYPE

  • 5.1. Introduction
  • 5.2. Master Cell Bank
  • 5.3. Working Cell Bank

6. CELL BANKING OUTSOURCING MARKET BY CELL TYPE

  • 6.1. Introduction
  • 6.2. Stem Cell
  • 6.3. Non-Stem Cell

7. CELL BANKING OUTSOURCING MARKET BY END-USER

  • 7.1. Introduction
  • 7.2. Pharmaceutical & Biotech Companies
  • 7.3. Academic & Research Institutes
  • 7.4. Others

8. CELL BANKING OUTSOURCING MARKET BY GEOGRAPHY

  • 8.1. Introduction
  • 8.2. North America
    • 8.2.1. By Bank Type
    • 8.2.2. By Cell Type
    • 8.2.3. By End-User
    • 8.2.4. By Country
      • 8.2.4.1. USA
      • 8.2.4.2. Canada
      • 8.2.4.3. Mexico
  • 8.3. South America
    • 8.3.1. By Bank Type
    • 8.3.2. By Cell Type
    • 8.3.3. By End-User
    • 8.3.4. By Country
      • 8.3.4.1. Brazil
      • 8.3.4.2. Argentina
      • 8.3.4.3. Others
  • 8.4. Europe
    • 8.4.1. By Bank Type
    • 8.4.2. By Cell Type
    • 8.4.3. By End-User
    • 8.4.4. By Country
      • 8.4.4.1. Germany
      • 8.4.4.2. France
      • 8.4.4.3. United Kingdom
      • 8.4.4.4. Spain
      • 8.4.4.5. Others
  • 8.5. Middle East and Africa
    • 8.5.1. By Bank Type
    • 8.5.2. By Cell Type
    • 8.5.3. By End-User
    • 8.5.4. By Country
      • 8.5.4.1. Saudi Arabia
      • 8.5.4.2. UAE
      • 8.5.4.3. Others
  • 8.6. Asia Pacific
    • 8.6.1. By Bank Type
    • 8.6.2. By Cell Type
    • 8.6.3. By End-User
    • 8.6.4. By Country
      • 8.6.4.1. China
      • 8.6.4.2. India
      • 8.6.4.3. Japan
      • 8.6.4.4. South Korea
      • 8.6.4.5. Indonesia
      • 8.6.4.6. Thailand
      • 8.6.4.7. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 9.1. Major Players and Strategy Analysis
  • 9.2. Market Share Analysis
  • 9.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 9.4. Competitive Dashboard

10. COMPANY PROFILES

  • 10.1. Sartorius AG
  • 10.2. Cryosite Limited
  • 10.3. Charles River Laboratories Inc.
  • 10.4. Cryo-Cell International, Inc
  • 10.5. GBI Biomanufacturing
  • 10.6. Lonza Group
  • 10.7. SGS SA
  • 10.8. WuXi AppTec
  • 10.9. Eurofins Scientific
  • 10.10. SK Pharmteco Inc
  • 10.11. Biofortuna Limited

11. APPENDIX

  • 11.1. Currency
  • 11.2. Assumptions
  • 11.3. Base and Forecast Years Timeline
  • 11.4. Key Benefits for the Stakeholders
  • 11.5. Research Methodology
  • 11.6. Abbreviations