US Biologics Safety Testing Market

ID: MRFR/LS/13115-HCR
100 Pages
Satyendra Maurya
Last Updated: April 06, 2026
United States Biologics Safety Testing Market Research Report: Size, Share, Trend Analysis - Growth Outlook & Industry Forecast 2025 To 2035
US Biologics Safety Testing Market
Market Size
Forecast Period2025 - 2035
CAGR (2025 - 2035)14.02%
2024 Market Size$ 850 Million
2025 Market Size$ 969.17 Million
2035 Market Size$ 3,600 Million
Key Players
Charles River Laboratories
Eurofins Scientific
Sartorius AG
Merck KGaA
Lonza Group
WuXi AppTec
Trends
  • Regulatory Compliance and Innovation
  • Increased Focus on Personalized Medicine
  • Integration of Automation in Testing Processes
Opportunities
  • Rising Demand for Biologics
  • Stringent Regulatory Frameworks
  • Growing Awareness of Patient Safety
Summary Table of Contents Segmentation Download PDF
  1. 1 SECTION I: EXECUTIVE SUMMARY AND KEY HIGHLIGHTS
    1. 1.1 EXECUTIVE SUMMARY
      1. 1.1.1 Market Overview
      2. 1.1.2 Key Findings
      3. 1.1.3 Market Segmentation
      4. 1.1.4 Competitive Landscape
      5. 1.1.5 Challenges and Opportunities
      6. 1.1.6 Future Outlook
  2. 2 SECTION II: SCOPING, METHODOLOGY AND MARKET STRUCTURE
    1. 2.1 MARKET INTRODUCTION
      1. 2.1.1 Definition
      2. 2.1.2 Scope of the study
        1. 2.1.2.1 Research Objective
        2. 2.1.2.2 Assumption
        3. 2.1.2.3 Limitations
    2. 2.2 RESEARCH METHODOLOGY
      1. 2.2.1 Overview
      2. 2.2.2 Data Mining
      3. 2.2.3 Secondary Research
      4. 2.2.4 Primary Research
        1. 2.2.4.1 Primary Interviews and Information Gathering Process
        2. 2.2.4.2 Breakdown of Primary Respondents
      5. 2.2.5 Forecasting Model
      6. 2.2.6 Market Size Estimation
        1. 2.2.6.1 Bottom-Up Approach
        2. 2.2.6.2 Top-Down Approach
      7. 2.2.7 Data Triangulation
      8. 2.2.8 Validation
  3. 3 SECTION III: QUALITATIVE ANALYSIS
    1. 3.1 MARKET DYNAMICS
      1. 3.1.1 Overview
      2. 3.1.2 Drivers
      3. 3.1.3 Restraints
      4. 3.1.4 Opportunities
    2. 3.2 MARKET FACTOR ANALYSIS
      1. 3.2.1 Value chain Analysis
      2. 3.2.2 Porter's Five Forces Analysis
        1. 3.2.2.1 Bargaining Power of Suppliers
        2. 3.2.2.2 Bargaining Power of Buyers
        3. 3.2.2.3 Threat of New Entrants
        4. 3.2.2.4 Threat of Substitutes
        5. 3.2.2.5 Intensity of Rivalry
      3. 3.2.3 COVID-19 Impact Analysis
        1. 3.2.3.1 Market Impact Analysis
        2. 3.2.3.2 Regional Impact
        3. 3.2.3.3 Opportunity and Threat Analysis
  4. 4 SECTION IV: QUANTITATIVE ANALYSIS
    1. 4.1 Industrial Automation & Equipment, BY Testing Type (USD Million)
      1. 4.1.1 Sterility Testing
      2. 4.1.2 Endotoxin Testing
      3. 4.1.3 Bioburden Testing
      4. 4.1.4 Validation Testing
    2. 4.2 Industrial Automation & Equipment, BY Product Type (USD Million)
      1. 4.2.1 Reagents
      2. 4.2.2 Kits
      3. 4.2.3 Services
    3. 4.3 Industrial Automation & Equipment, BY Application (USD Million)
      1. 4.3.1 Vaccine Development
      2. 4.3.2 Therapeutics
      3. 4.3.3 Blood and Blood Products
      4. 4.3.4 Cellular and Gene Therapy
    4. 4.4 Industrial Automation & Equipment, BY End-Use (USD Million)
      1. 4.4.1 Pharmaceutical Companies
      2. 4.4.2 Biotechnology Companies
      3. 4.4.3 Research Institutions
  5. 5 SECTION V: COMPETITIVE ANALYSIS
    1. 5.1 Competitive Landscape
      1. 5.1.1 Overview
      2. 5.1.2 Competitive Analysis
      3. 5.1.3 Market share Analysis
      4. 5.1.4 Major Growth Strategy in the Industrial Automation & Equipment
      5. 5.1.5 Competitive Benchmarking
      6. 5.1.6 Leading Players in Terms of Number of Developments in the Industrial Automation & Equipment
      7. 5.1.7 Key developments and growth strategies
        1. 5.1.7.1 New Product Launch/Service Deployment
        2. 5.1.7.2 Merger & Acquisitions
        3. 5.1.7.3 Joint Ventures
      8. 5.1.8 Major Players Financial Matrix
        1. 5.1.8.1 Sales and Operating Income
        2. 5.1.8.2 Major Players R&D Expenditure. 2023
    2. 5.2 Company Profiles
      1. 5.2.1 Charles River Laboratories (US)
        1. 5.2.1.1 Financial Overview
        2. 5.2.1.2 Products Offered
        3. 5.2.1.3 Key Developments
        4. 5.2.1.4 SWOT Analysis
        5. 5.2.1.5 Key Strategies
      2. 5.2.2 Eurofins Scientific (FR)
        1. 5.2.2.1 Financial Overview
        2. 5.2.2.2 Products Offered
        3. 5.2.2.3 Key Developments
        4. 5.2.2.4 SWOT Analysis
        5. 5.2.2.5 Key Strategies
      3. 5.2.3 Sartorius AG (DE)
        1. 5.2.3.1 Financial Overview
        2. 5.2.3.2 Products Offered
        3. 5.2.3.3 Key Developments
        4. 5.2.3.4 SWOT Analysis
        5. 5.2.3.5 Key Strategies
      4. 5.2.4 Merck KGaA (DE)
        1. 5.2.4.1 Financial Overview
        2. 5.2.4.2 Products Offered
        3. 5.2.4.3 Key Developments
        4. 5.2.4.4 SWOT Analysis
        5. 5.2.4.5 Key Strategies
      5. 5.2.5 Lonza Group (CH)
        1. 5.2.5.1 Financial Overview
        2. 5.2.5.2 Products Offered
        3. 5.2.5.3 Key Developments
        4. 5.2.5.4 SWOT Analysis
        5. 5.2.5.5 Key Strategies
      6. 5.2.6 WuXi AppTec (CN)
        1. 5.2.6.1 Financial Overview
        2. 5.2.6.2 Products Offered
        3. 5.2.6.3 Key Developments
        4. 5.2.6.4 SWOT Analysis
        5. 5.2.6.5 Key Strategies
      7. 5.2.7 Thermo Fisher Scientific (US)
        1. 5.2.7.1 Financial Overview
        2. 5.2.7.2 Products Offered
        3. 5.2.7.3 Key Developments
        4. 5.2.7.4 SWOT Analysis
        5. 5.2.7.5 Key Strategies
      8. 5.2.8 SGS SA (CH)
        1. 5.2.8.1 Financial Overview
        2. 5.2.8.2 Products Offered
        3. 5.2.8.3 Key Developments
        4. 5.2.8.4 SWOT Analysis
        5. 5.2.8.5 Key Strategies
    3. 5.3 Appendix
      1. 5.3.1 References
      2. 5.3.2 Related Reports
  6. 6 LIST OF FIGURES
    1. 6.1 MARKET SYNOPSIS
    2. 6.2 US MARKET ANALYSIS BY TESTING TYPE
    3. 6.3 US MARKET ANALYSIS BY PRODUCT TYPE
    4. 6.4 US MARKET ANALYSIS BY APPLICATION
    5. 6.5 US MARKET ANALYSIS BY END-USE
    6. 6.6 KEY BUYING CRITERIA OF INDUSTRIAL AUTOMATION & EQUIPMENT
    7. 6.7 RESEARCH PROCESS OF MRFR
    8. 6.8 DRO ANALYSIS OF INDUSTRIAL AUTOMATION & EQUIPMENT
    9. 6.9 DRIVERS IMPACT ANALYSIS: INDUSTRIAL AUTOMATION & EQUIPMENT
    10. 6.10 RESTRAINTS IMPACT ANALYSIS: INDUSTRIAL AUTOMATION & EQUIPMENT
    11. 6.11 SUPPLY / VALUE CHAIN: INDUSTRIAL AUTOMATION & EQUIPMENT
    12. 6.12 INDUSTRIAL AUTOMATION & EQUIPMENT, BY TESTING TYPE, 2024 (% SHARE)
    13. 6.13 INDUSTRIAL AUTOMATION & EQUIPMENT, BY TESTING TYPE, 2024 TO 2035 (USD Million)
    14. 6.14 INDUSTRIAL AUTOMATION & EQUIPMENT, BY PRODUCT TYPE, 2024 (% SHARE)
    15. 6.15 INDUSTRIAL AUTOMATION & EQUIPMENT, BY PRODUCT TYPE, 2024 TO 2035 (USD Million)
    16. 6.16 INDUSTRIAL AUTOMATION & EQUIPMENT, BY APPLICATION, 2024 (% SHARE)
    17. 6.17 INDUSTRIAL AUTOMATION & EQUIPMENT, BY APPLICATION, 2024 TO 2035 (USD Million)
    18. 6.18 INDUSTRIAL AUTOMATION & EQUIPMENT, BY END-USE, 2024 (% SHARE)
    19. 6.19 INDUSTRIAL AUTOMATION & EQUIPMENT, BY END-USE, 2024 TO 2035 (USD Million)
    20. 6.20 BENCHMARKING OF MAJOR COMPETITORS
  7. 7 LIST OF TABLES
    1. 7.1 LIST OF ASSUMPTIONS
  8. 7.1.1
    1. 7.2 US MARKET SIZE ESTIMATES; FORECAST
      1. 7.2.1 BY TESTING TYPE, 2025-2035 (USD Million)
      2. 7.2.2 BY PRODUCT TYPE, 2025-2035 (USD Million)
      3. 7.2.3 BY APPLICATION, 2025-2035 (USD Million)
      4. 7.2.4 BY END-USE, 2025-2035 (USD Million)
    2. 7.3 PRODUCT LAUNCH/PRODUCT DEVELOPMENT/APPROVAL
  9. 7.3.1
    1. 7.4 ACQUISITION/PARTNERSHIP
  10. 7.4.1

US Biologics Safety Testing Market Segmentation

US Biologics Safety Testing Market By Testing Type (USD Million, 2025-2035)

  • Sterility Testing
  • Endotoxin Testing
  • Bioburden Testing
  • Validation Testing

US Biologics Safety Testing Market By Product Type (USD Million, 2025-2035)

  • Reagents
  • Kits
  • Services

US Biologics Safety Testing Market By Application (USD Million, 2025-2035)

  • Vaccine Development
  • Therapeutics
  • Blood and Blood Products
  • Cellular and Gene Therapy

US Biologics Safety Testing Market By End-Use (USD Million, 2025-2035)

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Research Institutions

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