생물 안전 시험 서비스 시장 규모, 점유율 및 동향 분석 보고서 : 서비스별, 용도별, 최종 용도별, 지역별 및 부문별 예측(2026-2033년)

Biological Safety Testing Services Market Summary

The global biological safety testing services market size was valued at USD 4.2 billion in 2025 and is projected to grow from USD 4.7 billion in 2026 to USD 11.0 billion by 2033, at a CAGR of 12.8% from 2026 to 2033. North America dominated the market, accounting for the largest share of 33.3% in 2025. The growth of the biological safety testing services industry is driven by the increasing adoption of biologics and biosimilars, rising focus on cell and gene therapies, and stringent regulatory requirements for product safety.

Moreover, the growing pipeline of biopharmaceutical drugs, coupled with the expansion of contract testing services, has further fueled the market. Technological advancements such as automation, next-generation sequencing (NGS), and polymerase chain reaction (PCR)-based testing are improving efficiency and accuracy, making safety testing more reliable. Furthermore, the biopharmaceutical industry has witnessed significant growth in the past few years. According to the data published by Creative Biogene, approximately 3,700 cell and gene therapy products are in the pipeline currently, with more than 100 approved therapies globally. The growing pipeline of cell and gene therapy products, along with an increasing number of regulatory approvals, is significantly driving the market growth. These advanced therapies require stringent safety assessments to ensure the absence of microbial and viral contaminants. Thus, the growing number of cell and gene therapy product pipelines would boost the demand for these services in the coming year.

In addition, several pharmaceutical and biotechnology companies are increasingly outsourcing their biological safety testing needs to specialized service providers due to the high costs and expertise required for in-house testing. Contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) play a pivotal role in providing cost-effective, regulatory-compliant testing solutions. This trend is particularly strong in emerging biopharmaceutical companies seeking to streamline operations while focusing on drug development.

Global Biological Safety Testing Services Market Report Segmentation

This report forecasts revenue growth at the global, regional & country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global biological safety testing services market report based on service, application, end use, and region:

• Service Outlook (Revenue, USD Million/Billion, 2021 - 2033)
• Bioburden Testing Services
• Endotoxin Testing Services
• Sterility Testing Services
• Viral Clearance and Validation Services
• Cell Line Authentication and Characterization Tests
• Residual Host Contamination Testing Services
• Adventitious Agent Detection Testing Services
• Others
• Application Outlook (Revenue, USD Million/Billion, 2021 - 2033)
• Vaccine & Therapeutics
  • Monoclonal Antibodies
  • Vaccines
  • Recombinant Protein
• Cell and Gene Therapy
• Blood & Blood Products
• Tissue & Tissue-based Products
• Others
• End Use Outlook (Revenue, USD Million/Billion, 2021 - 2033)
• Biopharmaceutical Companies
• Pharmaceutical Companies
• Academic and Research Institutions
• Others
• Regional Outlook (Revenue, USD Million/Billion, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Sweden
  • Norway
  • Denmark
• Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait
  • Oman
  • Qatar

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Service
  • 1.2.2. Application
  • 1.2.3. End Use
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Information Or Data Analysis
  • 1.5.1. Data Analysis Models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity Flow Analysis
  • 1.7.2. Top-Down Analysis
  • 1.7.3. Bottom-Up Approach
  • 1.7.4. Multivariate Analysis
• 1.8. List of Secondary Sources
• 1.9. List of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Biological Safety Testing Services Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Technology Landscape
• 3.4. Pricing Model Analysis
• 3.5. Tariff Impact Analysis
• 3.6. Value Chain Analysis
  • 3.6.1. Supply Trends
  • 3.6.2. Demand Trends
• 3.7. Market Analysis Tools
  • 3.7.1. Porter's Five Forces Analysis
  • 3.7.2. PESTEL by SWOT Analysis

Chapter 4. Biological Safety Testing Services Market: Service Estimates & Trend Analysis

• 4.1. Service Market Share, 2025 & 2033
• 4.2. Service Type Segment Dashboard
• 4.3. Biological Safety Testing Services Market: Service Movement Analysis
• 4.4. Global Biological Safety Testing Services Market Size & Trend Analysis, by Service, 2021 to 2033 (USD Million/Billion)
• 4.5. Bioburden Testing Services
  • 4.5.1. Bioburden Testing Services Market Estimates & Forecasts, 2021 to 2033 (USD Million/Billion)
• 4.6. Endotoxin Testing Services
  • 4.6.1. Endotoxin Testing Services Market Estimates & Forecasts, 2021 to 2033 (USD Million/Billion)
• 4.7. Sterility Testing Services
  • 4.7.1. Sterility Testing Services Market Estimates & Forecasts, 2021 to 2033 (USD Million/Billion)
• 4.8. Viral Clearance and Validation Services
  • 4.8.1. Viral Clearance and Validation Services Market Estimates & Forecasts, 2021 to 2033 (USD Million/Billion)
• 4.9. Cell Line Authentication and Characterization Tests
  • 4.9.1. Cell Line Authentication and Characterization Tests Market Estimates & Forecasts, 2021 to 2033 (USD Million/Billion)
• 4.10. Residual Host Contamination Testing Services
  • 4.10.1. Residual Host Contamination Testing Services Market Estimates & Forecasts, 2021 to 2033 (USD Million/Billion)
• 4.11. Adventitious Agent Detection Testing Services
  • 4.11.1. Adventitious Agent Detection Testing Services Market Estimates & Forecasts, 2021 to 2033 (USD Million/Billion)
• 4.12. Others
  • 4.12.1. Others Market Estimates & Forecasts, 2021 to 2033 (USD Million/Billion)

Chapter 5. Biological Safety Testing Services Market: Application Estimates & Trend Analysis

• 5.1. Application Market Share, 2025 & 2033
• 5.2. Application Segment Dashboard
• 5.3. Global Biological Safety Testing Services Market: Application Movement Analysis
• 5.4. Global Biological Safety Testing Services Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million/Billion)
• 5.5. Vaccine & Therapeutics
  • 5.5.1. Vaccine & Therapeutics Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 5.5.2. Monoclonal Antibodies
    • 5.5.2.1. Monoclonal Antibodies Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 5.5.3. Vaccines
    • 5.5.3.1. Vaccines Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 5.5.4. Recombinant Protein
    • 5.5.4.1. Recombinant Protein Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 5.6. Cell and Gene Therapy
  • 5.6.1. Cell and Gene Therapy Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 5.7. Blood & Blood Products
  • 5.7.1. Blood & Blood Products Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 5.8. Tissue & Tissue-based Products
  • 5.8.1. Tissue & Tissue-based Products Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 5.9. Others
  • 5.9.1. Others Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)

Chapter 6. Biological Safety Testing Services Market: End Use Estimates & Trend Analysis

• 6.1. End Use Market Share, 2025 & 2033
• 6.2. End Use Segment Dashboard
• 6.3. Biological Safety Testing Services Market: End Use Movement Analysis
• 6.4. Global Biological Safety Testing Services Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million/Billion)
• 6.5. Biopharmaceutical Companies
  • 6.5.1. Biopharmaceutical Companies Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 6.6. Pharmaceutical Companies
  • 6.6.1. Pharmaceutical Companies Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 6.7. Academic and Research Institutions
  • 6.7.1. Academic and Research Institutions Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 6.8. Others
  • 6.8.1. Others Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)

Chapter 7. Biological Safety Testing Services Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Dashboard
• 7.2. Biological Safety Testing Services Market: Regional Movement Analysis
• 7.3. Market Size & Forecasts Trend Analysis, 2021 to 2033
• 7.4. North America
  • 7.4.1. North America Biological Safety Testing Services Market Estimates & Forecasts, By Country, 2021 - 2033 (USD Million/Billion)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Regulatory Framework
    • 7.4.2.3. U.S. Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Regulatory Framework
    • 7.4.3.3. Canada Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Regulatory Framework
    • 7.4.4.3. Mexico Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 7.5. Europe
  • 7.5.1. Europe Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Regulatory Framework
    • 7.5.2.3. UK Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Regulatory Framework
    • 7.5.3.3. Germany Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Regulatory Framework
    • 7.5.4.3. France Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Regulatory Framework
    • 7.5.5.3. Italy Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Regulatory Framework
    • 7.5.6.3. Spain Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Regulatory Framework
    • 7.5.7.3. Denmark Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Regulatory Framework
    • 7.5.8.3. Sweden Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Regulatory Framework
    • 7.5.9.3. Norway Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Regulatory Framework
    • 7.6.2.3. Japan Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Regulatory Framework
    • 7.6.3.3. China Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Regulatory Framework
    • 7.6.4.3. India Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Regulatory Framework
    • 7.6.5.3. Australia Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.6.6. South Korea
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Regulatory Framework
    • 7.6.6.3. South Korea Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Regulatory Framework
    • 7.6.7.3. Thailand Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 7.7. Latin America
  • 7.7.1. Latin America Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Regulatory Framework
    • 7.7.2.3. Brazil Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Regulatory Framework
    • 7.7.3.3. Argentina Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
• 7.8. Middle East and Africa
  • 7.8.1. Middle East and Africa Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Regulatory Framework
    • 7.8.2.3. South Africa Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Regulatory Framework
    • 7.8.3.3. Saudi Arabia Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Regulatory Framework
    • 7.8.4.3. UAE Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Regulatory Framework
    • 7.8.5.3. Kuwait Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.8.6. Oman
    • 7.8.6.1. Key Country Dynamics
    • 7.8.6.2. Regulatory Framework
    • 7.8.6.3. Oman Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)
  • 7.8.7. Qatar
    • 7.8.7.1. Key Country Dynamics
    • 7.8.7.2. Regulatory Framework
    • 7.8.7.3. Qatar Biological Safety Testing Services Market Estimates & Forecasts, 2021 - 2033 (USD Million/Billion)

Chapter 8. Competitive Landscape

• 8.1. Participant Overview
• 8.2. Company Market Position Analysis
• 8.3. Company Categorization
• 8.4. Strategy Mapping
• 8.5. Company Profiles/Listing
  • 8.5.1. Charles River Laboratories
    • 8.5.1.1. Company overview
    • 8.5.1.2. Financial performance
    • 8.5.1.3. Service benchmarking
    • 8.5.1.4. Strategic initiatives
  • 8.5.2. Lonza Group AG
    • 8.5.2.1. Company overview
    • 8.5.2.2. Financial performance
    • 8.5.2.3. Service benchmarking
    • 8.5.2.4. Strategic initiatives
  • 8.5.3. Merck KGaA
    • 8.5.3.1. Company overview
    • 8.5.3.2. Financial performance
    • 8.5.3.3. Service benchmarking
    • 8.5.3.4. Strategic initiatives
  • 8.5.4. SGS SA
    • 8.5.4.1. Company overview
    • 8.5.4.2. Financial performance
    • 8.5.4.3. Service benchmarking
    • 8.5.4.4. Strategic initiatives
  • 8.5.5. Eurofins Scientific
    • 8.5.5.1. Company overview
    • 8.5.5.2. Financial performance
    • 8.5.5.3. Service benchmarking
    • 8.5.5.4. Strategic initiatives
  • 8.5.6. WuXi AppTec
    • 8.5.6.1. Company overview
    • 8.5.6.2. Financial performance
    • 8.5.6.3. Service benchmarking
    • 8.5.6.4. Strategic initiatives
  • 8.5.7. Thermo Fisher Scientific Inc.
    • 8.5.7.1. Company overview
    • 8.5.7.2. Financial performance
    • 8.5.7.3. Service benchmarking
    • 8.5.7.4. Strategic initiatives
  • 8.5.8. Sartorius AG
    • 8.5.8.1. Company overview
    • 8.5.8.2. Financial performance
    • 8.5.8.3. Service benchmarking
    • 8.5.8.4. Strategic initiatives
  • 8.5.9. Toxikon Corporation
    • 8.5.9.1. Company overview
    • 8.5.9.2. Financial performance
    • 8.5.9.3. Service benchmarking
    • 8.5.9.4. Strategic initiatives
  • 8.5.10. bioMerieux SA
    • 8.5.10.1. Company overview
    • 8.5.10.2. Financial performance
    • 8.5.10.3. Service benchmarking
    • 8.5.10.4. Strategic initiatives