临床试验生物样本库及存檔解决方案市场－全球产业规模、份额、趋势、机会、预测：按服务、产品、地区和竞争对手划分，2021-2031年

全球临床试验生物样本库和存檔解决方案市场预计将从 2025 年的 41.9 亿美元成长到 2031 年的 62.6 亿美元，复合年增长率为 6.92%。

该领域涵盖生物检体和临床研究数据的安全收集、处理、储存和长期管理所需的基础设施和服务。推动该领域发展的主要因素包括：对个人化医疗日益增长的需求（这需要高品质的生物样本进行基因组分析），以及对资料完整性和可追溯性的严格监管要求。此外，药物研发领域的大量资金投入也为此扩张提供了支持。根据欧洲製药工业协会联合会 (EFPIA) 的报告，到 2024 年，欧洲以研发为基础的生物製药产业在研发方面的投资金额约为 550 亿欧元。

儘管成长势头强劲，但由于跨境生物材料运输和储存的法规环境复杂且分散，市场仍面临许多障碍。遵守各种关于检体处理和资料隐私的国际合规标准，会带来巨大的物流挑战和营运成本。这些监管障碍可能会阻碍全球存檔网路的顺利发展，并使多区域临床试验的管理更加复杂。

市场驱动因素

全球临床试验生物样本库和存檔解决方案市场成长的主要驱动力是生物製药研发投资的激增。随着製药公司投入巨资研发新治疗方法，需要合规且安全储存的临床试验和生物检体数量也随之成长。这一趋势在行业巨额支出中显而易见。美国製药製造商协会 (PhRMA) 于 2024 年 8 月发布的《2024 年会员调查》显示，2023 年会员公司在研发方面的投资金额创下历史新高，达到 1,035 亿美元。因此，候选药物研发管线不断扩展，对第三方生物样本库服务的需求也日益增长，这些服务用于管理检体储存的物流。罗氏公司于 2024 年 2 月发布的《2023 年年度报告》进一步证实了这一现实，该报告显示，罗氏的研发支出为 132 亿瑞士法郎。

慢性疾病（尤其是肿瘤疾病）发生率的激增是另一个重要的市场驱动因素，因为这需要进行复杂的纵向研究，而这些研究依赖高度可靠的生物样本保存。随着产业向精准肿瘤学转型，长期保存血液和组织样本以进行回顾性分析和生物标记发现的需求日益增长，这使得对专业保存技术的依赖性日益凸显。全球疾病负担的不断加重进一步凸显了这项需求的迫切性。国际癌症研究机构（IARC）在2024年2月的新闻稿中估计，到2050年，新增癌症病例将比2022年增加77%，超过3500万例。疾病发生率的激增迫使赞助公司采用先进的保存系统，以确保样本的长期存活，从而满足监管标准和科学目标。

市场挑战

跨境生物检体储存和运输的监管框架分散且复杂，对市场造成了重大障碍。储存服务和生物样本库依赖中心实验室和采集点之间高效的检体转运，以维持样本的完整性和数据的一致性。然而，各国关于生物主权和资料隐私的国际法律各不相同，需要严格的法律监管和复杂的物流协调。这种复杂性推高了营运成本，增加了运输延误的风险。这威胁到时效性生物材料的保存，并可能阻碍集中式全球檔案库的建立。

这些监管壁垒对更广泛的研究生态系统产生影响，导致研究停滞，尤其是在合规要求严格的地区。根据欧洲製药工业协会联合会（EFPIA）2024年的数据，欧洲在全球临床试验中所占的份额从2013年的22%急剧下降至2023年的12%。这一下降凸显了法规环境的碎片化如何扼杀临床研究活动，从而降低了关键区域市场对整合式存檔和生物样本库解决方案的需求和有效性。

市场趋势

重塑市场格局的一大趋势是，企业策略性地转向外包生物样本库和归檔服务模式。这一趋势的驱动力在于，製药公司越来越倾向于营运柔软性，而非维护资本密集的内部设施。临床试验申办方日益依赖第三方供应商来维护合规的储存记录，并管理全球各地不同温控区域所带来的物流风险。这种转变使企业能够将固定储存成本转化为变动成本，同时也能利用稳定性测试通讯协定的专业知识。这种对外部支援的需求反映在财务表现中。 Cryoport在2024年3月公布的数据显示，其2023财年的生物储存/生物服务业务收益年增45%，显示第三方解决方案正被迅速采用。

同时，自动化储存和搜寻系统（ASRS）的实施已成为提高搜寻速度和检体完整性的关键营运重点。生物样本库正越来越多地利用先进的机器人基础设施，以减少人为接触样本，并降低长期储存过程中交叉污染和温度偏差的风险。这些自动化平台对于管理现代治疗研究至关重要的大量温控材料至关重要。 Azenta 于 2024 年 8 月发布的 2024 年第三季财报也反映了这一市场向技术转型的趋势，该财报显示，样本管理解决方案的收入同比增长 7%，这主要得益于对低温存储平台和大规模自动化存储平台的需求增长。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：全球临床试验生物样本库与存檔解决方案市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 特定服务（生物样本库服务、存檔解决方案服务）
  • 依产品分类（临床前产品、临床产品）
  • 按地区
  • 按公司（2025 年）
• 市场地图

第六章：北美临床试验生物样本库与存檔解决方案市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国别分析
  • 我们
  • 加拿大
  • 墨西哥

第七章：欧洲临床试验生物样本库与存檔解决方案市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国别分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太地区临床试验生物样本库和存檔解决方案的市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国别分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：中东和非洲临床试验生物样本库和存檔解决方案的市场展望

• 市场规模及预测
• 市占率及预测
• 中东与非洲：国别分析
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 南非

第十章：南美洲临床试验生物样本库与存檔解决方案市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国别分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章 市场动态

• 促进因素
• 任务

第十二章 市场趋势与发展

• 併购
• 产品发布
• 近期趋势

第十三章 全球临床试验生物样本库与存檔解决方案市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的议价能力
• 顾客权力
• 替代品的威胁

第十五章 竞争格局

• Azenta US, Inc.
• Thermo Fisher Scientific Inc.
• Precision for Medicine, Inc.
• Medpace Holdings, Inc.
• Laboratory Corporation of America Holdings
• Q2 Solutions LLC
• Labconnect Inc.
• Charles River Laboratories International, Inc.
• Cell&Co SAS
• The Jackson Laboratory

第十六章 策略建议

第十七章：关于研究公司及免责声明

The Global Clinical Trial Biorepository & Archiving Solutions Market is projected to expand from a valuation of USD 4.19 Billion in 2025 to USD 6.26 Billion by 2031, registering a CAGR of 6.92%. This sector comprises the essential infrastructure and services required for the secure collection, processing, preservation, and long-term management of biological specimens and clinical research data. Growth is primarily propelled by the intensifying demand for personalized medicine, which necessitates high-quality biospecimens for genomic profiling, alongside strict regulatory requirements for data integrity and traceability. Furthermore, significant financial investments in drug development underpin this expansion; as reported by the European Federation of Pharmaceutical Industries and Associations, the research-based biopharmaceutical sector in Europe invested approximately €55,000 million in R&D in 2024.

Despite these positive growth trajectories, the market encounters substantial obstacles due to the complicated and fragmented regulatory environment regarding the cross-border transport and storage of biological materials. Adhering to varied international compliance standards for specimen handling and data privacy creates significant logistical challenges and operational costs. These regulatory barriers can hinder the seamless development of global archiving networks, complicating the management of multi-regional clinical trials.

Market Driver

A primary catalyst for the growth of the Global Clinical Trial Biorepository & Archiving Solutions Market is the surging investment in biopharmaceutical research and development. As pharmaceutical organizations dedicate vast resources to discovering new therapies, there is a proportional increase in the volume of clinical trials and biological samples that require compliant, secure storage. This trend is highlighted by substantial industry spending; the Pharmaceutical Research and Manufacturers of America's '2024 PhRMA Annual Membership Survey', released in August 2024, revealed that member companies invested a record $103.5 billion in R&D during 2023. Consequently, the pipeline of drug candidates is expanding, driving the need for third-party biorepository services to handle the logistics of specimen retention, a reality further illustrated by Roche's 'Annual Report 2023' from February 2024, which reported R&D expenditures of CHF 13.2 billion.

The escalating prevalence of chronic diseases, especially oncology, serves as another crucial market driver by necessitating complex longitudinal studies that depend on high-integrity biospecimen archiving. The industry's pivot toward precision oncology demands the long-term preservation of blood and tissue samples to facilitate retrospective analysis and biomarker discovery, establishing a reliance on specialized storage capabilities. The urgency of this requirement is underscored by the rising global disease burden; the International Agency for Research on Cancer estimated in a February 2024 press release that new cancer cases will increase by 77% from 2022 levels to over 35 million by 2050. This surge in disease incidence compels sponsors to implement advanced archiving systems that ensure sample viability over extended durations to satisfy both regulatory standards and scientific goals.

Market Challenge

The market faces significant impediments due to the fragmented and complex regulatory framework governing the cross-border storage and transportation of biological samples. Archiving services and biorepositories rely on the efficient transfer of specimens between central laboratories and collection sites to maintain sample integrity and data consistency. However, adherence to disparate international laws regarding biosovereignty and data privacy requires extensive legal oversight and sophisticated logistical coordination. These complexities drive up operational costs and heighten the risk of shipping delays, which can threaten the viability of time-critical biological materials and discourage the creation of centralized global archives.

The impact of these regulatory barriers extends to the broader research ecosystem, leading to stagnation in regions with particularly burdensome compliance requirements. Data from the European Federation of Pharmaceutical Industries and Associations in 2024 revealed that Europe's share of global clinical trials dropped significantly to 12% in 2023, down from 22% in 2013. This decline highlights how a disjointed regulatory environment can suppress clinical research activity, consequently reducing the demand for and efficacy of integrated archiving and biorepository solutions in key regional markets.

Market Trends

A prominent trend reshaping the market is the strategic transition toward outsourced archiving and biorepository service models, as pharmaceutical firms increasingly prioritize operational flexibility over maintaining capital-intensive internal facilities. Sponsors of clinical trials are turning to third-party providers to manage the logistical risks involved in maintaining compliant chain-of-custody documentation and diverse temperature zones across global locations. This shift allows companies to convert fixed storage costs into variable expenses while utilizing specialized expertise for stability protocols. The demand for such external support is reflected in financial results; Cryoport, Inc. reported in March 2024 that its BioStorage/BioServices revenue rose by 45% year-over-year in 2023, signaling the rapid adoption of third-party solutions.

Simultaneously, the integration of Automated Storage and Retrieval Systems (ASRS) has emerged as a vital operational priority to enhance retrieval speed and specimen integrity. Biobanks are increasingly utilizing advanced robotic infrastructure to limit human contact with samples, thereby mitigating risks of cross-contamination and temperature excursions during long-term storage. These automated platforms are indispensable for managing the expanding volume of temperature-sensitive materials essential for modern therapeutic research. The market's shift toward these technologies is evidenced by Azenta, Inc.'s 'Third Quarter Results for Fiscal 2024', released in August 2024, which showed a 7% year-over-year growth in Sample Management Solutions revenue, attributed specifically to the demand for cryogenic and large-automated storage platforms.

Key Market Players

• Azenta U.S., Inc.
• Thermo Fisher Scientific Inc.
• Precision for Medicine, Inc.
• Medpace Holdings, Inc.
• Laboratory Corporation of America Holdings
• Q2 Solutions LLC
• Labconnect Inc.
• Charles River Laboratories International, Inc.
• Cell&Co SAS
• The Jackson Laboratory

Report Scope

In this report, the Global Clinical Trial Biorepository & Archiving Solutions Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Clinical Trial Biorepository & Archiving Solutions Market, By Service

• Biorepository Services
• Archiving Solution Services

Clinical Trial Biorepository & Archiving Solutions Market, By Product

• Preclinical Products
• Clinical Products

Clinical Trial Biorepository & Archiving Solutions Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Clinical Trial Biorepository & Archiving Solutions Market.

Available Customizations:

Global Clinical Trial Biorepository & Archiving Solutions Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Clinical Trial Biorepository & Archiving Solutions Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Service (Biorepository Services, Archiving Solution Services)
  • 5.2.2. By Product (Preclinical Products, Clinical Products)
  • 5.2.3. By Region
  • 5.2.4. By Company (2025)
• 5.3. Market Map

6. North America Clinical Trial Biorepository & Archiving Solutions Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Service
  • 6.2.2. By Product
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Service
      • 6.3.1.2.2. By Product
  • 6.3.2. Canada Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Service
      • 6.3.2.2.2. By Product
  • 6.3.3. Mexico Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Service
      • 6.3.3.2.2. By Product

7. Europe Clinical Trial Biorepository & Archiving Solutions Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Service
  • 7.2.2. By Product
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Service
      • 7.3.1.2.2. By Product
  • 7.3.2. France Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Service
      • 7.3.2.2.2. By Product
  • 7.3.3. United Kingdom Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Service
      • 7.3.3.2.2. By Product
  • 7.3.4. Italy Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Service
      • 7.3.4.2.2. By Product
  • 7.3.5. Spain Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Service
      • 7.3.5.2.2. By Product

8. Asia Pacific Clinical Trial Biorepository & Archiving Solutions Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Service
  • 8.2.2. By Product
  • 8.2.3. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Service
      • 8.3.1.2.2. By Product
  • 8.3.2. India Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Service
      • 8.3.2.2.2. By Product
  • 8.3.3. Japan Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Service
      • 8.3.3.2.2. By Product
  • 8.3.4. South Korea Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Service
      • 8.3.4.2.2. By Product
  • 8.3.5. Australia Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Service
      • 8.3.5.2.2. By Product

9. Middle East & Africa Clinical Trial Biorepository & Archiving Solutions Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Service
  • 9.2.2. By Product
  • 9.2.3. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Service
      • 9.3.1.2.2. By Product
  • 9.3.2. UAE Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Service
      • 9.3.2.2.2. By Product
  • 9.3.3. South Africa Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Service
      • 9.3.3.2.2. By Product

10. South America Clinical Trial Biorepository & Archiving Solutions Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Service
  • 10.2.2. By Product
  • 10.2.3. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Service
      • 10.3.1.2.2. By Product
  • 10.3.2. Colombia Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Service
      • 10.3.2.2.2. By Product
  • 10.3.3. Argentina Clinical Trial Biorepository & Archiving Solutions Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Service
      • 10.3.3.2.2. By Product

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Clinical Trial Biorepository & Archiving Solutions Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Azenta U.S., Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Thermo Fisher Scientific Inc.
• 15.3. Precision for Medicine, Inc.
• 15.4. Medpace Holdings, Inc.
• 15.5. Laboratory Corporation of America Holdings
• 15.6. Q2 Solutions LLC
• 15.7. Labconnect Inc.
• 15.8. Charles River Laboratories International, Inc.
• 15.9. Cell&Co SAS
• 15.10. The Jackson Laboratory

16. Strategic Recommendations

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