临床试验生物库和归檔解决方案市场机会、成长动力、产业趋势分析与预测 2025 - 2034

2024 年全球临床试验生物库和归檔解决方案市场价值为 46 亿美元，预计 2025 年至 2034 年期间将以 8.3% 的强劲复合年增长率增长。 这一增长受到多种关键因素的推动，包括临床试验数量的激增、严格的监管合规要求、对长期数据存储 这一增长受到多种关键因素的推动，包括临床试验数量的激增、严格的监管合规要求、对长期资料存储的需求不断增长以及对生物银行的投资基础增长。随着生物製药领域在药物研发和个人化医疗方面的突破性发展而不断发展，生物库在保护关键生物样本方面的作用已变得不可或缺。这一趋势凸显了对能够满足全球临床试验大量需求的创新解决方案日益增长的需求。

慢性病发病率的不断上升以及对尖端疗法的需求推动製药和生物製药公司加快研发力度。这些公司不仅引领了临床试验的热潮，而且还大力投资最先进的生物银行和存檔系统。这种系统对于维持新疗法严格测试所需的生物样本的品质、安全性和完整性至关重要。此外，生物库解决方案的技术进步（例如自动储存系统和先进的追踪功能）进一步提升了市场的吸引力。

市场按产品类型细分为临床前产品和临床产品，其中临床产品部分在 2024 年占据 73.7% 的市场份额。临床试验日益复杂以及保存这些生物样本的需要凸显了强大的储存和管理解决方案的重要性。

生物库和归檔解决方案的最终用户包括製药公司、生物技术公司、合约研究组织 (CRO) 以及学术和研究机构。 2024 年，製药公司占据最大的市场份额，为 46.7%，反映了其作为临床试验主要发起者的关键作用。这些公司依靠先进的生物库服务来管理大规模临床研究期间收集的大量生物样本。确保样品品质并符合监管标准对于成功的试验结果至关重要。

2024 年，美国市场产值达 17 亿美元，美国将持续引领全球临床研究工作。美国进行的临床试验数量不断增长，对复杂的生物库和归檔解决方案的需求也空前庞大。该国强大的研究基础设施，加上对创新生物银行技术的大量投资，巩固了其作为市场成长关键驱动力的地位。

目录

第 1 章：方法论与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业衝击力
  • 成长动力
    • 临床试验的增加
    • 遵守严格法规的需求日益增长
    • 对长期资料储存和保存的需求不断增加
    • 增加对生物银行基础设施的投资
  • 产业陷阱与挑战
    • 与资料安全相关的担忧
    • 先进储存设施的资本密集性质
• 成长潜力分析
• 差距分析
• 监管格局
• 技术格局
• 未来市场趋势
• 波特的分析
• PESTEL 分析

第四章：竞争格局

• 介绍
• 公司市占率分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 战略展望

第 5 章：市场估计与预测：按产品类型，2021 年至 2034 年

• 主要趋势
• 临床前产品
• 临床产品
  • 人体组织
  • 器官
  • 干细胞
  • 其他临床产品

第六章：市场估计与预测：按服务，2021 年至 2034 年

• 主要趋势
• 生物样本库服务
  • 仓储
  • 样品处理
  • 运输
  • 其他服务
• 归檔解决方案服务
  • 资料库索引和管理
  • 扫描和销毁

第七章：市场估计与预测：依阶段，2021 – 2034 年

• 主要趋势
• 临床前
• 第一阶段
• 第二阶段
• 第三阶段
• 第四阶段

第 8 章：市场估计与预测：依最终用途，2021 年至 2034 年

• 主要趋势
• 製药公司
• 生技公司
• 合约研究组织
• 学术及研究机构

第 9 章：市场估计与预测：按地区，2021 年至 2034 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十章：公司简介

• American Type Culture Collection
• Azenta US Inc.
• BioStorage Technologies
• Celerion
• Celerion
• Charles River Laboratories
• CryoPort
• Hamilton Company
• IQVIA
• Labcorp
• NMDP BioTherapies
• STC Biologics
• Thermo Fisher Scientific
• Veristat
• VWR International (Avantor)

The Global Clinical Trial Biorepository And Archiving Solutions Market was valued at USD 4.6 billion in 2024 and is projected to grow at a robust CAGR of 8.3% from 2025 to 2034. This growth is fueled by several critical factors, including the surging number of clinical trials, stringent regulatory compliance requirements, rising demand for long-term data storage, and increased investments in advanced biobanking infrastructure. As the biopharmaceutical sector continues to evolve with groundbreaking developments in drug discovery and personalized medicine, the role of biorepositories in safeguarding critical biological samples has become indispensable. This trend underscores the expanding need for innovative solutions that can cater to the high-volume demands of global clinical trials.

The increasing prevalence of chronic diseases and the demand for cutting-edge therapies drive pharmaceutical and biopharmaceutical companies to accelerate their research and development efforts. These companies are not only spearheading the surge in clinical trials but also investing heavily in state-of-the-art biobanking and archiving systems. Such systems are crucial for maintaining the quality, safety, and integrity of biological samples required for rigorous testing of novel treatments. Moreover, technological advancements in biorepository solutions, such as automated storage systems and advanced tracking capabilities, further boost the market's appeal.

The market is segmented by product type into preclinical and clinical products, with the clinical products segment dominating at 73.7% of the market share in 2024. This segment encompasses human tissues, organs, stem cells, and other biological materials that are vital for testing the efficacy and safety of new drugs. The growing complexity of clinical trials and the need to preserve these biological samples underscore the importance of robust storage and management solutions.

End users of biorepository and archiving solutions include pharmaceutical companies, biotechnology firms, contract research organizations (CROs), and academic and research institutions. In 2024, pharmaceutical companies held the largest market share at 46.7%, reflecting their pivotal role as primary sponsors of clinical trials. These companies rely on advanced biorepository services to manage the vast volumes of biological samples collected during large-scale clinical studies. Ensuring sample quality and compliance with regulatory standards is critical to achieving successful trial outcomes.

The U.S. market generated USD 1.7 billion in 2024, with the country continuing to lead global clinical research efforts. The growing volume of clinical trials conducted in the U.S. has created an unparalleled demand for sophisticated biorepository and archiving solutions. The nation's strong research infrastructure, coupled with significant investments in innovative biobanking technologies, solidifies its position as a key driver of market growth.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rise in clinical trials
    • 3.2.1.2 Growing demand for adhering to stringent regulations
    • 3.2.1.3 Increasing demand for long term data storage and preservation
    • 3.2.1.4 Increasing investments in biobanking infrastructure
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Concerns related to data security and safety
    • 3.2.2.2 Capital intensive nature of advanced storage facilities
• 3.3 Growth potential analysis
• 3.4 Gap analysis
• 3.5 Regulatory landscape
• 3.6 Technological landscape
• 3.7 Future market trends
• 3.8 Porter's analysis
• 3.9 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Competitive analysis of major market players
• 4.4 Competitive positioning matrix
• 4.5 Strategy outlook

Chapter 5 Market Estimates and Forecast, By Product Type, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Preclinical products
• 5.3 Clinical products
  • 5.3.1 Human tissue
  • 5.3.2 Organs
  • 5.3.3 Stem cells
  • 5.3.4 Other clinical products

Chapter 6 Market Estimates and Forecast, By Services, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Biorepository services
  • 6.2.1 Warehousing and storage
  • 6.2.2 Sample processing
  • 6.2.3 Transportation
  • 6.2.4 Other services
• 6.3 Archiving solution services
  • 6.3.1 Database indexing and management
  • 6.3.2 Scanning and destruction

Chapter 7 Market Estimates and Forecast, By Phase, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Preclinical
• 7.3 Phase I
• 7.4 Phase II
• 7.5 Phase III
• 7.6 Phase IV

Chapter 8 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Pharmaceutical companies
• 8.3 Biotechnology companies
• 8.4 Contract research organizations
• 8.5 Academic and research institutions

Chapter 9 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 American Type Culture Collection
• 10.2 Azenta US Inc.
• 10.3 BioStorage Technologies
• 10.4 Celerion
• 10.5 Celerion
• 10.6 Charles River Laboratories
• 10.7 CryoPort
• 10.8 Hamilton Company
• 10.9 IQVIA
• 10.10 Labcorp
• 10.11 NMDP BioTherapies
• 10.12 STC Biologics
• 10.13 Thermo Fisher Scientific
• 10.14 Veristat
• 10.15 VWR International (Avantor)