생물 안전성 시험 시장 규모, 점유율, 성장 분석 : 제품 유형별, 시험 유형별, 용도별, 지역별 - 업계 예측(2026-2033년)

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.

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, 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

Conclusion & Recommendations