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

生物安全测试市场规模预计在2023年达到52.5亿美元，并从2024年的58.6亿美元增长到2032年的142.1亿美元，预测期内（2025-2032年）的复合年增长率为11.7%。

生物安全测试是确保生物来源的生物製药和医疗设备安全的重要过程。这种综合方法旨在透过分析污染和不利的生物效应来评估和减轻潜在风险。遵守严格的监管标准对于确保这些材料的纯度、效力和整体安全性至关重要。无菌测试、内毒素评估和细胞化验分析等关键技术在评估是否符合严格的安全基准方面发挥关键作用。随着对安全有效医疗产品的需求不断增加，生物安全测试市场也将不断扩大，这得益于监管要求的不断提高以及对公共健康和病人安全的日益关注。

目录

介绍

• 调查目的
• 研究范围
• 定义

调查方法

• 资讯采购
• 次要和主要资料方法
• 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

生物安全测试市场规模（依产品/服务及复合年增长率） (2025-2032)

• 市场概况
• 耗材
  • 霉浆菌检测服务
  • 灭菌测试服务
  • 内毒素检测服务
  • 病毒安全测试服务
  • 微生物附着量测试服务
• 装置
• 服务
• 试剂和套件
• 其他生物安全检测服务

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
• 灭菌测试
• 霉浆菌检测
• 微生物附着量测试
• 残留宿主细胞蛋白质和 DNA 检测测试
• 病毒安全测试
• 外来性病原体检测
• 其他考试类型

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
• 单株抗体开发与生产
• 疫苗研发和生产
• 细胞和基因治疗产品的开发和製造
• 血液及血液製品的开发与生产
• 其他用途

生物安全测试市场规模（按最终用户和复合年增长率） (2025-2032)

• 市场概况
• 製药和生物技术公司
• CRO＆CDMO
• 学术研究所

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
  • 公司详细信息
  • 产品系列分析
  • 公司分部份额分析
  • 收益与前一年同期比较对比（2022-2024 年）

主要企业简介

• Charles River Laboratories（United States）
• Lonza Group（Switzerland）
• bioMerieux SA（France）
• SGS Societe Generale de Surveillance SA（Switzerland）
• Eurofins Scientific（Luxembourg）
• Samsung Biologics（South Korea）
• FUJIFILM Wako Pure Chemical Corporation（Japan）
• Thermo Fisher Scientific Inc.（United States）
• Sartorius AG（Germany）
• Merck KGaA（Germany）
• WuXi AppTec（China）
• Intertek Group plc（United Kingdom）
• West Pharmaceutical Services, Inc.（United States）
• Ajinomoto Bio-Pharma Services（United States）
• Gateway Analytical（United States）
• Reading Scientific Services Ltd.（RSSL）（United Kingdom）
• Tentamus Group（Germany）
• IQVIA（United States）

结论和建议

Biologics Safety Testing Market size was valued at USD 5.25 billion in 2023 and is poised to grow from USD 5.86 billion in 2024 to USD 14.21 billion by 2032, growing at a CAGR of 11.7% during the forecast period (2025-2032).

Biological safety testing is an essential process focused on ensuring the safety of biopharmaceuticals and medical devices derived from biological sources. This comprehensive approach aims to assess and mitigate potential risks by analyzing contamination and adverse biological effects. Adhering to stringent regulatory standards is crucial for confirming the purity, potency, and overall safety of these materials. Key techniques, including sterility testing, endotoxin assessment, and cell-based assays, play vital roles in evaluating compliance with rigorous safety benchmarks. As the demand for safe and effective medical products grows, the biological safety testing market is poised for expansion, driven by increasing regulatory requirements and a heightened focus on public health and patient safety.

Top-down and bottom-up approaches were used to estimate and validate the size of the Biologics 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.

Biologics Safety Testing Market Segments Analysis

Global Biologics Safety Testing Market is segmented by Product and Services, Test Type, Application, End User and region. Based on Product and Services, the market is segmented into Consumables, Instruments, Services, Reagents and kits and Other Biologics Safety Testing Services. Based on Test Type, the market is segmented into Endotoxin tests, Sterility tests, Mycoplasma tests, Bioburden tests, Residual host-cell proteins and DNA detection tests, Virus safety tests, Adventitious agent detection tests and Other test types. Based on Application, the market is segmented into Monoclonal Antibodies Development And Manufacturing, Vaccines Development And Manufacturing, Cellular & Gene Therapy Products Development And Manufacturing, Blood & Blood Products Development And Manufacturing and Other Applications. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Cros & Cdmos and Academic & Research Institutes. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Biologics Safety Testing Market

Recent expansions in the pharmaceutical and biotechnology sectors, driven by significant investments in research and development, mark a critical phase in the evolution of healthcare. These industries are at the leading edge of developing pharmaceuticals, biologics, and vaccines, effectively tackling complex healthcare challenges, particularly in the fight against intricate diseases. This wave of innovation inherently heightens the demand for rigorous safety assessments, where biologics safety testing becomes essential in ensuring patient safety. As the landscape of healthcare continues to evolve, the importance of robust safety testing mechanisms will become increasingly vital in maintaining public health standards and fostering trust in new therapeutic solutions.

Restraints in the Biologics Safety Testing Market

The Biologics Safety Testing market faces several challenges that may hinder its growth. Key restraints include stringent regulatory requirements that can complicate the testing processes, alongside the high costs associated with developing and maintaining testing protocols. Furthermore, the constantly evolving landscape of biologics, coupled with the rapid advancement of biotechnology, necessitates ongoing updates in testing methodologies, which can be resource-intensive. Additionally, the limited availability of skilled professionals in the field may impede market expansion. These factors create significant hurdles for stakeholders aiming to navigate the complexities of biologics safety testing, ultimately affecting their ability to innovate and maintain compliance.

Market Trends of the Biologics Safety Testing Market

The Biologics Safety Testing market is experiencing significant growth, driven by intensified regulatory scrutiny on biopharmaceutical products, which emphasizes patient safety and product quality. As global regulatory bodies enforce stringent safety evaluations, biological safety testing has become essential for drug approvals, compelling pharmaceutical and biotech companies to prioritize compliance. This shift not only underscores the importance of comprehensive safety assessments but also stimulates heightened demand for specialized testing services. Consequently, the market is solidifying its position as a critical component in pharmaceutical development, ensuring that companies can navigate the complexities of regulatory requirements and achieve timely market entry.

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

Global Biologics Safety Testing Market Size by Product and Services & CAGR (2025-2032)

• Market Overview
• Consumables
  • Mycoplasma Testing Services
  • Sterility Testing Services
  • Endotoxin Testing Services
  • Virus Safety Testing Services
  • Bioburden Testing Services
• Instruments
• Services
• Reagents and kits
• Other Biologics Safety Testing Services

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

• Market Overview
• Endotoxin tests
• Sterility tests
• Mycoplasma tests
• Bioburden tests
• Residual host-cell proteins and DNA detection tests
• Virus safety tests
• Adventitious agent detection tests
• Other test types

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

• Market Overview
• Monoclonal Antibodies Development And Manufacturing
• Vaccines Development And Manufacturing
• Cellular & Gene Therapy Products Development And Manufacturing
• Blood & Blood Products Development And Manufacturing
• Other Applications

Global Biologics Safety Testing Market Size by End User & CAGR (2025-2032)

• Market Overview
• Pharmaceutical & Biotechnology Companies
• Cros & Cdmos
• Academic & Research Institutes

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

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

• Charles River Laboratories (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lonza Group (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• bioMerieux SA (France)
  • 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
• Eurofins Scientific (Luxembourg)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Biologics (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• FUJIFILM Wako Pure Chemical Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck KGaA (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek Group plc (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• West Pharmaceutical Services, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Ajinomoto Bio-Pharma Services (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Gateway Analytical (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Reading Scientific Services Ltd. (RSSL) (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tentamus Group (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IQVIA (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations