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市場調查報告書
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1917827

細胞庫外包市場－2026-2031年預測

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個工作天內

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簡介目錄

預計到 2025 年，外包細胞庫市場規模將達到 105.56 億美元，到 2031 年將達到 244.37 億美元，複合年成長率為 15.02%。

細胞庫外包市場由專業服務供應商負責處理關鍵的上游生物製程操作，例如細胞庫的建立、表徵、測試和在嚴格控制的條件下儲存。這種外包模式提供全面的服務，包括建立研究細胞庫 (RCB)、主細胞庫 (MCB) 和工作細胞庫 (WCB)，以及完整的分析表徵、穩定性測試和長期冷凍保存。其主要目標是確保為生物製藥生產、細胞療法和前沿研究提供穩定、有據可查且無污染的起始材料——無論是哺乳動物、昆蟲還是微生物來源。透過將此基礎流程外包給專家，客戶可以確保其核心生物資產的可追溯性、活性和合規性。

市場擴張的根本驅動力是生物技術領域，特別是先進治療藥物（ATMP）領域的爆炸性成長和資金限制。細胞和基因療法（CGT）的蓬勃發展是關鍵催化劑，而這些療法本質上依賴起始細胞材料的可靠性和可重複性，包括患者來源或基因工程改造的細胞株。對於主導此創新領域的中小型生技公司而言，建構符合GMP規範的內部細胞庫基礎設施需要大量的資本支出，這會分散它們對核心研發的精力。外包提供了一個關鍵手段，可以降低研發風險、加快研發進度，並在無需大量前期投資的情況下獲得專業技術。

同時，監管機構對細胞株歷史和特徵的審查日益嚴格，這成為推動監管合規的重要因素。包括FDA和EMA在內的監管機構要求，用於臨床和商業生產的細胞庫必須提供嚴格的文件記錄、全面的外來性病原體檢測，並證明其克隆性和穩定性。專業的合約研發生產機構（CDMO）和細胞庫服務供應商已建立起檢驗的平台和品質體系，專門用於滿足這些複雜的要求，為申辦方提供了一條高效的合規途徑。隨著治療方法進入後期臨床試驗和商業化階段，這一點變得尤為重要。

從地理角度來看，亞太地區正崛起為一個重要的、高成長的市場，這主要得益於各國政府的戰略舉措。該地區各國政府正積極透過大量資金投入、稅收優惠以及建設專業生物園區等方式，扶持國內生物技術和生物製藥產業。這種旨在提升區域先進治療方法能力的協同努力，催生了對包括細胞庫在內的配套服務的集中需求。服務供應商正在亞太地區建立或擴展業務，以掌握這一成長機遇，並接近性不斷成長的基本客群。

儘管市場促進因素明確，但該市場面臨一個重大且固有的限制：知識產權 (IP) 和專有細胞株的高度敏感性。對於生技公司而言，細胞株通常是整個治療平台賴以建立的智慧財產權資產。將細胞庫營運外包意味著將這些關鍵的生物材料及其相關資料轉移給第三方，這引發了人們對資料安全、保密性和潛在智慧財產權洩露的合理擔憂。透過強而有力的法律協議、透明的流程和可驗證的安全通訊協定來建立信任是服務供應商的首要任務。這種擔憂可能會延緩外包模式的採用，或促使贊助商尋求將最敏感的步驟保留在公司內部的混合模式。

競爭格局既有提供一體化細胞庫服務的大型全球合約研發生產機構（CDMO），也有專注於先進細胞和基因治療材料的小規模專業供應商。競爭主要集中在技術差異化領域，例如單細胞克隆技術、用於表徵的次世代定序、處理各種複雜細胞類型（例如誘導多能幹細胞、CAR-T細胞）的能力，以及強大的品質和法規支援。成功不僅在於技術卓越，更在於成為值得信賴的策略夥伴，能夠幫助客戶應對複雜的監管核准流程，同時保護客戶最寶貴的生物資產。

總之，細胞庫外包市場是現代生物製藥和先進療法生態系統中專業化但至關重要的基礎技術。其成長與資本效率高的生物技術創新以及監管機構日益嚴格的品質要求密切相關。對於業內人士而言，策略重點應放在不斷提升支持下一代細胞療法的技術能力，同時透過穩健的營運和合約保障措施解決智慧財產權保護這一至關重要的挑戰。能否提供無縫銜接、符合審核要求的服務，確保客戶細胞庫的實體完整性和法律保護，將決定市場領導地位。在這個市場取得成功意味著被視為客戶研發營運中安全可靠的延伸，而不僅僅是供應商。

本報告的主要優勢：

  • 深入分析：取得以客戶群、政府政策和社會經濟因素、消費者偏好、垂直產業和其他細分市場為重點的深入市場洞察，涵蓋主要地區和新興地區。
  • 競爭格局：了解主要企業採取的策略舉措，並了解透過正確的策略打入市場的潛力。
  • 市場促進因素與未來趨勢：探索動態因素和關鍵市場趨勢，以及它們將如何塑造未來的市場發展。
  • 可執行的建議：利用洞察力為策略決策提供訊息，從而在動態環境中開拓新的業務管道和收入來源。
  • 受眾範圍廣：對新興企業、研究機構、顧問公司、中小企業和大型企業都有益處且經濟高效。

它是用來做什麼的？

產業與市場洞察、商業機會評估、產品需求預測、打入市場策略、地理擴張、資本投資決策、法律規範及其影響、新產品開發、競爭影響

分析範圍

  • 歷史資料（2021-2025 年）和預測資料（2026-2031 年）
  • 成長機會、挑戰、供應鏈前景、法規結構、客戶行為和趨勢分析
  • 競爭對手定位、策略和市場佔有率分析
  • 按業務板塊和地區（國家）分類的收入成長和預測分析
  • 公司概況（策略、產品、財務資訊、關鍵趨勢等）

目錄

第1章執行摘要

第2章市場概述

  • 市場概覽
  • 市場定義
  • 分析範圍
  • 市場區隔

第3章 商業情境

  • 市場促進因素
  • 市場限制
  • 市場機遇
  • 波特五力分析
  • 產業價值鏈分析
  • 政策和法規
  • 策略建議

第4章 技術展望

第5章 依銀行類型分類的細胞庫外包市場

  • 介紹
  • 主細胞庫
  • 工作細胞庫

6. 依細胞類型分類的細胞庫外包市場

  • 介紹
  • 幹細胞
  • 非幹細胞

7. 依最終用戶分類的細胞庫外包市場

  • 介紹
  • 製藥和生物技術公司
  • 學術和研究機構
  • 其他

8. 按地區分類的細胞庫外包市場

  • 介紹
  • 北美洲
    • 按銀行類型
    • 按細胞類型
    • 最終用戶
    • 按國家/地區
      • 美國
      • 加拿大
      • 墨西哥
  • 南美洲
    • 按銀行類型
    • 按細胞類型
    • 最終用戶
    • 按國家/地區
      • 巴西
      • 阿根廷
      • 其他
  • 歐洲
    • 按銀行類型
    • 按細胞類型
    • 最終用戶
    • 按國家/地區
      • 德國
      • 法國
      • 英國
      • 西班牙
      • 其他
  • 中東和非洲
    • 按銀行類型
    • 按細胞類型
    • 最終用戶
    • 按國家/地區
      • 沙烏地阿拉伯
      • 阿拉伯聯合大公國
      • 其他
  • 亞太地區
    • 按銀行類型
    • 按細胞類型
    • 最終用戶
    • 按國家/地區
      • 中國
      • 印度
      • 日本
      • 韓國
      • 印尼
      • 泰國
      • 其他

第9章：競爭格局與分析

  • 主要企業和策略分析
  • 市佔率分析
  • 企業合併、協議、商業合作
  • 競爭對手儀錶板

第10章：公司簡介

  • 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11章附錄

  • 貨幣
  • 先決條件
  • 基準年和預測年時間表
  • 相關人員的主要收益
  • 分析方法
  • 簡稱
簡介目錄
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