生物安全检测市场规模、份额和成长分析（按产品、检测类型、应用和地区）- 产业预测 2025-2032

2023 年全球生物安全测试市场规模价值 52 亿美元，预计将从 2024 年的 58.1 亿美元成长到 2032 年的 140.8 亿美元，预测期内（2025-2032 年）的复合年增长率为 11.7%。

由于製药和生物技术领域研发的快速成长、感染疾病的增加以及医疗保健品管意识的增强，全球生物安全测试市场预计将大幅成长。该市场专注于评估疫苗、血液製品和细胞治疗等生物製药的安全性和有效性，并遵守严格的监管标准，要求彻底的测试以降低不良事件的风险。核酸扩增和序列测定等先进检测技术的出现将提高污染物检测的灵敏度并提高患者的安全性。此外，基于细胞化验分析和免疫测量等体外检测方法的使用越来越多，透过提供更快、更具成本效益的结果并减少对动物测试的依赖，正在加速市场扩大。

目录

介绍

• 调查目的
• 研究范围
• 定义

调查方法

• 资讯采购
• 次要和资料资料
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分市场机会分析

市场动态及展望

• 市场概况
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特的分析

主要市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 市场吸引力指数（2024 年）
• PESTEL 分析
• 总体经济指标
• 价值链分析
• 定价分析
• 监管格局
• 案例研究
• 技术进步

生物安全测试市场规模（按产品和复合年增长率） (2025-2032)

• 市场概况
• 试剂和套件
• 服务
• 装置

生物安全测试市场规模（按测试类型和复合年增长率） (2025-2032)

• 市场概况
• 内毒素检测
• 无菌测试
• 细胞株认证和特性测试
• 微生物附着量测试
• 外来性病原体检测
• 残留宿主污染检测测试
• 其他的

生物安全测试市场规模（按应用划分）及复合年增长率（2025-2032）

• 市场概况
• 疫苗和治疗
  • 疫苗
  • 单株抗体
  • 重组蛋白
• 血液和血液相关产品
• 基因治疗
• 组织和基于组织的产品
• 干细胞
• 其他的

生物安全测试市场规模（按地区）及复合年增长率（2025-2032）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲国家
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前 5 家公司对比
• 主要企业市场定位（2024年）
• 主要市场参与者所采用的策略
• 近期市场趋势
• 公司市场占有率分析（2024 年）
• 主要企业简介
  • 公司简介
  • 产品系列分析
  • 按细分市场分析市场份额
  • 收益与前一年同期比较（2022-2024 年）

主要企业简介

• bioMerieux SA（France）
• Charles River Laboratories International, Inc.（United States）
• Eurofins Scientific SE（Luxembourg）
• Lonza Group Ltd.（Switzerland）
• Merck KGaA（Germany）
• Samsung Biologics（South Korea）
• Sartorius AG（Germany）
• SGS Societe Generale de Surveillance SA（Switzerland）
• Thermo Fisher Scientific Inc.（United States）
• Avance Biosciences（United States）
• Promega Corporation（United States）
• Toxikon Corporation（United States）
• WuXi AppTec（China）
• Pace Analytical Services LLC（United States）
• Nelson Laboratories, LLC（United States）
• BioReliance Corporation（United States）
• Microbac Laboratories, Inc.（United States）
• Intertek Group plc（United Kingdom）
• Covance Inc.（United States）

结论和建议

Global Biological Safety Testing Market size was valued at USD 5.2 billion in 2023 and is poised to grow from USD 5.81 billion in 2024 to USD 14.08 billion by 2032, growing at a CAGR of 11.7% during the forecast period (2025-2032).

The global biological safety testing market is poised for substantial growth, fueled by a surge in research and development across pharmaceutical and biotechnology sectors, an increase in infectious diseases, and heightened awareness of healthcare quality control. This market focuses on the safety and efficacy evaluation of biological products like vaccines, blood products, and cell-based therapies, adhering to stringent regulatory standards that mandate thorough testing to mitigate adverse risks. The advent of advanced testing technologies, including nucleic acid amplification and sequencing, enhances sensitivity in contaminant detection, thus improving patient safety. Furthermore, the rising utilization of in vitro testing methods, such as cell-based assays and immunoassays, is expediting market expansion by providing quicker, cost-effective results and reducing animal testing reliance.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biological Safety Testing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Biological Safety Testing Market Segmental Analysis

Global Biological Safety Testing Market is segmented by Product, Test Type, Application and region. Based on Product, the market is segmented into Reagents & Kits, Services and Instruments. Based on Test Type, the market is segmented into Endotoxin Tests, Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests and Others. Based on Application, the market is segmented into Vaccines & Therapeutics, Blood & Blood-based Products, Gene Therapy, Tissue & Tissue-based Products, Stem Cell and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Biological Safety Testing Market

The Global Biological Safety Testing market is being significantly influenced by the rising adoption of in vitro testing methods, including cell-based assays and immunoassays. These innovative approaches are favored due to their numerous benefits over conventional animal testing, such as faster results, decreased reliance on animal subjects, and enhanced cost-effectiveness. The urgency to combat the growing prevalence of infectious diseases, highlighted by the COVID-19 pandemic, has intensified the focus on biological safety testing. This has increased the demand for advanced testing techniques that can reliably detect and mitigate the risks posed by pathogens and contaminants, further propelling market expansion.

Restraints in the Global Biological Safety Testing Market

One of the significant challenges facing the Global Biological Safety Testing market is the shortage of skilled professionals with expertise in this specialized field. The intricate methodologies involved in biological safety testing demand a high level of training and experience, particularly in areas such as sample handling, result interpretation, and adherence to regulatory compliance. This scarcity of qualified personnel can significantly hinder market growth, as organizations may struggle to find individuals capable of executing these complex tests efficiently. Consequently, the lack of available talent may restrict market expansion and innovation within the biological safety testing sector.

Market Trends of the Global Biological Safety Testing Market

The Global Biological Safety Testing market is experiencing a notable upward trend, driven by an increasing emphasis on patient safety within the healthcare sector. The demand for rigorous testing protocols is propelled by heightened awareness of the repercussions associated with contaminated or low-quality biological products. As healthcare providers, regulatory authorities, and manufacturers prioritize stringent quality control measures to safeguard patient wellbeing, the market is witnessing growth in comprehensive testing services. This trend reflects a broader commitment to enhance safety standards, positioning biological safety testing as an essential component in the lifecycle of biological products, thus driving innovation and investment across the industry.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Regulatory Landscape
• Case Studies
• Technological Advancement

Global Biological Safety Testing Market Size by Product & CAGR (2025-2032)

• Market Overview
• Reagents & Kits
• Services
• Instruments

Global Biological Safety Testing Market Size by Test Type & CAGR (2025-2032)

• Market Overview
• Endotoxin Tests
• Sterility Tests
• Cell Line Authentication & Characterization Tests
• Bioburden Tests
• Adventitious Agent Detection Tests
• Residual Host Contamination Detection Tests
• Others

Global Biological Safety Testing Market Size by Application & CAGR (2025-2032)

• Market Overview
• Vaccines & Therapeutics
  • Vaccines
  • Monoclonal Antibodies
  • Recombinant Protein
• Blood & Blood-based Products
• Gene Therapy
• Tissue & Tissue-based Products
• Stem Cell
• Others

Global Biological Safety Testing Market Size & CAGR (2025-2032)

• North America (Product, Test Type, Application)
  • US
  • Canada
• Europe (Product, Test Type, Application)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product, Test Type, Application)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product, Test Type, Application)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product, Test Type, Application)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• bioMerieux S.A. (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories International, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific SE (Luxembourg)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lonza Group Ltd. (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck KGaA (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Biologics (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SGS Societe Generale de Surveillance SA (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Avance Biosciences (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Promega Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Toxikon Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical Services LLC (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nelson Laboratories, LLC (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BioReliance Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Microbac Laboratories, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek Group plc (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Covance Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations