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生物安全检测市场规模、份额及成长分析（按产品类型、检测类型、应用和地区划分）－2026-2033年产业预测

市场调查报告书

商品编码

1901883

生物安全检测市场规模、份额及成长分析（按产品类型、检测类型、应用和地区划分）－2026-2033年产业预测

Biological Safety Testing Market Size, Share, and Growth Analysis, By Product (Reagents & Kits, Services), By Test Type (Endotoxin Tests, Sterility Tests), By Application, By Region - Industry Forecast 2026-2033

出版日期: 2025年12月16日 | 出版商:

SkyQuest | 英文 157 Pages | 商品交期: 3-5个工作天内

价格

简介目录

全球生物安全检测市场规模预计在 2024 年达到 58.1 亿美元，从 2025 年的 64.9 亿美元增长到 2033 年的 157.3 亿美元，在预测期（2026-2033 年）内复合年增长率为 11.7%。

由于製药和生物技术行业研发活动的活性化以及医疗保健领域对品管意识的提高，全球生物安全检测市场预计将显着增长。该市场涵盖生物製品（包括疫苗和细胞疗法）上市前安全性和有效性的评估。严格的监管标准要求进行严谨的安全测试，以降低不利事件的风险。此外，对核酸扩增和定序等创新检测方法的需求不断增长，提高了检测潜在污染物的敏感度和特异性，从而提升了患者安全。体外检测技术（例如基于细胞的检测和免疫检测）的日益普及也推动了市场扩张，这些技术能够提供更快的检测结果，减少动物试验，并提高成本效益。

全球生物安全检测市场驱动因素

由于体外检测方法（包括细胞检测和免疫检测）日益受到青睐，全球生物安全检测市场正经历显着成长。这些创新技术相比传统的动物实验具有许多优势，例如更快的检测速度、更少的动物实验依赖以及更高的成本效益。随着越来越多的机构认识到这些现代方法的优势，体外检测方法的普及速度正在加快，其应用率也随之提高。这种转变不仅符合伦理考量，也促进了整体市场扩张，并凸显了生物安全检测领域的变革趋势。

限制全球生物安全检测市场的因素

全球生物安全检测市场的成长可能受到合格检测技术人员短缺的限制。这些调查方法的复杂性要求专业人员具备生物样本管理、准确解读结果以及遵守监管要求等方面的专业知识。缺乏此类训练有素的人员可能会阻碍市场扩张，因为企业可能难以吸引具备必要专业知识的人才来维持高标准并在行业内进行创新。因此，熟练专业人员的短缺可能会对市场发展速度和服务提升产生重大影响。

全球生物安全检测市场趋势

全球生物安全检测市场呈现显着成长趋势，这主要得益于医疗保健产业对病人安全的日益重视。随着对高品质生物製药需求的不断增长，包括医疗服务提供者、监管机构和生产商在内的相关人员相关方正优先考虑严格的安全通讯协定，以降低受污染或不合格产品带来的风险。对潜在不利事件的日益关注，强化了全面生物安全检测的必要性，促使各机构投资于先进的调查方法和技术，从而推动市场成长。因此，市场正朝着加强品管措施、确保各种医疗环境中的病人安全和健康的方向发展。

北美洲
- 美国
- 加拿大
欧洲
- 德国
- 西班牙
- 法国
- 英国
- 义大利
- 其他欧洲地区
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 亚太其他地区
拉丁美洲
- 巴西
- 其他拉丁美洲地区
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

前五大公司对比
主要企业的市场定位（2025 年）
主要市场参与者所采取的策略
近期市场趋势
公司市占率分析（2025 年）
主要企业公司简介
- 公司详情
- 产品系列分析
- 依业务板块进行公司股票分析
- 2023-2025年营收年比比较

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）

结论与建议

简介目录

Product Code: SQMIG35J2092

Global Biological Safety Testing Market size was valued at USD 5.81 Billion in 2024 and is poised to grow from USD 6.49 Billion in 2025 to USD 15.73 Billion by 2033, growing at a CAGR of 11.7% during the forecast period (2026-2033).

The global biological safety testing market is poised for substantial growth, driven by escalating research and development efforts within the pharmaceutical and biotechnology industries, along with a heightened awareness of quality control in healthcare. This market encompasses the assessment of biological products, including vaccines and cell-based therapies, to ensure their safety and efficacy prior to commercialization. Stringent regulatory standards necessitate rigorous safety testing to mitigate risks of adverse events. Additionally, the rising demand for innovative testing methods, such as nucleic acid amplification and sequencing, enhances detection sensitivity and specificity of potential contaminants, thereby fostering patient safety. The increasing preference for in vitro testing techniques like cell-based assays and immunoassays is also fueling market expansion, offering faster results, reduced animal testing, and greater cost effectiveness.

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 Segments 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 experiencing a significant boost from the rising preference for in vitro testing methods, including cell-based assays and immunoassays. These innovative techniques present numerous benefits compared to conventional animal testing, such as delivering faster results, minimizing the reliance on animal subjects, and enhancing cost-effectiveness. As more organizations recognize the advantages of these modern approaches, the transition towards in vitro methods is accelerating, leading to increased adoption rates. This shift not only contributes to ethical considerations in testing but also supports the overall expansion of the market, highlighting a transformative trend within the biological safety testing landscape.

Restraints in the Global Biological Safety Testing Market

The growth of the Global Biological Safety Testing market may be hindered by a shortage of qualified professionals skilled in testing techniques. The advanced nature of these methodologies necessitates individuals who possess specialized knowledge in managing biological samples, accurately interpreting results, and adhering to regulatory requirements. The scarcity of such trained personnel can create obstacles for the market's expansion, as organizations may struggle to find the expertise needed to maintain high standards and innovate within the sector. Consequently, this lack of skilled professionals could significantly impact the pace at which the market develops and enhances its service offerings.

Market Trends of the Global Biological Safety Testing Market

The Global Biological Safety Testing market is witnessing a significant trend driven by an increased emphasis on patient safety within the healthcare sector. As the demand for high-quality biological products grows, stakeholders-including healthcare providers, regulatory bodies, and manufacturers-are prioritizing stringent safety protocols to mitigate risks associated with contaminated or substandard products. This heightened awareness of potential adverse events reinforces the necessity for thorough biological safety testing, thereby propelling market growth as organizations invest in advanced testing methodologies and technologies. Consequently, the market is evolving to enhance quality control measures, ensuring the safety and well-being of patients across various healthcare settings.

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, 2025
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 (2026-2033)

Market Overview
Reagents & Kits
Services
Instruments

Global Biological Safety Testing Market Size by Test Type & CAGR (2026-2033)

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 (2026-2033)

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 (2026-2033)

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, 2025
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2025
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2023-2025)

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