미국의 생물학적 안전성 시험 제품 및 서비스 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 용도별, 테스트 유형별, 부문별 예측(2025-2033년)

Market Size & Trends:

The U.S. biological safety testing products and services market size was estimated at USD 1.44 billion in 2024 and is expected to grow at a CAGR of 9.88% from 2025 to 2033. The rapid growth of the biopharmaceutical and biotechnology industries in the U.S. is one of the foremost drivers of the biological safety testing market. With increasing R&D investment in biologics, biosimilars, gene therapies, and regenerative medicines, there is heightened demand for validated, precise biosafety testing. These therapies, being complex and sensitive, require robust safety protocols to meet regulatory and clinical expectations.

The surge in novel therapeutic candidates has led to an expansion in testing volumes and a need for new assay types, accelerating the development of cutting-edge biosafety platforms. The strategic push toward personalized medicine, combined with an aging population and increasing prevalence of chronic diseases, further amplifies this need. Merck's October 2024 launch of a USD 305 million biosafety testing and cell bank facility in Maryland illustrates how major players are responding to this demand. The site integrates testing with analytical development and manufacturing, streamlining workflows. Its proprietary Blazar CHO AOF panel, which reduces testing timelines by more than half, exemplifies the emphasis on speed and reliability in biosafety services. Such investments signify the foundational role of biological safety in securing the therapeutic pipeline and enabling rapid market entry for high-value biologics.

Regulatory oversight in the U.S. is a key force shaping the biological safety testing market. agencies like the U.S. Food and Drug Administration (FDA) and the U.S. Pharmacopeia (USP) enforce rigorous safety testing mandates for biologics throughout their development and manufacturing lifecycle. These include sterility, endotoxin, bioburden, and mycoplasma tests, among others. Regulatory expectations are especially strict for products such as monoclonal antibodies, vaccines, and gene therapies, where contamination risks can compromise safety and efficacy. As a result, pharmaceutical companies and contract research organizations (CROs) are compelled to implement high-quality, validated biosafety procedures to secure approvals and minimize risks.

Non-compliance can result in clinical holds, product recalls, or market withdrawal, increasing the strategic importance of robust safety frameworks. Thermo Fisher Scientific's February 2024 enhancement of its GMP lab in Middleton, Wisconsin-adding rapid qPCR-based mycoplasma testing-demonstrates industry alignment with these expectations. The new method delivers results in just five days, enabling manufacturers to meet FDA timelines without compromising quality. As biologic modalities become more complex and distributed, regulatory harmonization efforts will continue to drive innovations and investments in safety infrastructure, ensuring that U.S.-based firms remain compliant while accelerating therapeutic delivery.

Innovations such as qPCR, next-generation sequencing (NGS), biosensors, and automation are transforming traditional testing models. These technologies enable earlier detection of microbial or viral contaminants, significantly reducing the time and cost associated with batch release and product development. Automated and integrated platforms are also enhancing throughput, a crucial capability as testing demand increases with larger therapeutic pipelines. Companies are not only modernizing existing facilities but also building new centers equipped with digital and robotic systems to support high-volume testing with minimal human error. SGS North America's July 2024 expansion of its Center of Excellence in Lincolnshire, Illinois, exemplifies this trend. The 60,000 sq. ft. upgrade added new instrumentation to support biosimilar and novel biologic testing across all drug development stage. These integrated systems offer end-to-end analytical support, enhancing traceability and data integrity-two core requirements in regulated environments. Looking ahead, technology convergence with AI and machine learning may enable predictive biosafety analytics, ushering in a new era of proactive contamination risk management. The increasing availability of such sophisticated tools cements the U.S.'s position as a global leader in biosafety innovation.

U.S. Biological Safety Testing Products And Services Market Report Segmentation

This report forecasts revenue growth at regional & country levels and provides an analysis on the industry trends in each of the sub-segments from 2021 to 2033. For the purpose of this study, Grand View Research has segmented the U.S. biological safety testing products and services market report on the basis of product, application, and test type:

• Product and Service Outlook (Revenue, USD Million, 2021 - 2033)
• Reagents & Kits
• Instruments
• Services
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Vaccines & Therapeutics
  • Vaccines
  • Monoclonal Antibodies
  • Recombinant Protein
• Blood & Blood-based Products
• Gene Therapy
• Tissue & Tissue-based Products
• Stem Cell
• Test Type Outlook (Revenue, USD Million, 2021 - 2033)
• Endotoxin Tests
• Sterility Tests
• Cell Line Authentication & Characterization Tests
• Bioburden Tests
• Adventitious Agent Detection Tests
• Residual Host Contamination Detection Tests
• Others

Table of Contents

Chapter 1. Methodology And Scope

• 1.1. Market Segmentation And Scope
  • 1.1.1. Segment Definitions
    • 1.1.1.1. Products Segment
    • 1.1.1.2. Application Segment
    • 1.1.1.3. Test Type Segment
• 1.2. Regional Scope
• 1.3. Estimates And Forecast Timeline
• 1.4. Objectives
  • 1.4.1. Objective - 1
  • 1.4.2. Objective - 2
• 1.5. Research Methodology
• 1.6. Information Procurement
  • 1.6.1. Purchased Database
  • 1.6.2. GVR's Internal Database
  • 1.6.3. Secondary Sources
  • 1.6.4. Primary Research
• 1.7. Information Or Data Analysis
  • 1.7.1. Data Analysis Models
• 1.8. Market Formulation & Validation
• 1.9. Model Details
  • 1.9.1. Commodity Flow Analysis
• 1.10. List Of Primary Sources
• 1.11. List Of Abbreviations

Chapter 2. U.S. Biological Safety Testing Products & Services Market: Executive Summary

• 2.1. Market Snapshot
• 2.2. Products And Services Snapshots
• 2.3. Application and Test Type Snapshot
• 2.4. Competitive Landscape Snapshot

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

• 3.1. Market Segmentation And Scope
• 3.2. Market Lineage Outlook
  • 3.2.1. Parent Market Outlook
  • 3.2.2. Related/Ancillary Market Outlook
• 3.3. Market Dynamics
• 3.4. Market Drivers Analysis
  • 3.4.1. Increase number of government initiatives and recommendations
  • 3.4.2. Increasing production of new biologics due to high disease burden
  • 3.4.3. High R&D investments in clinical research and life sciences research
• 3.5. Market Restraint Analysis
  • 3.5.1. Time-consuming approval process
• 3.6. U.S. Biological Safety Testing Products & Services Market Analysis Tools
  • 3.6.1. Industry Analysis - Porter's
    • 3.6.1.1. Supplier Power
    • 3.6.1.2. Buyer Power
    • 3.6.1.3. Substitution Threat
    • 3.6.1.4. Threat Of New Entrant
    • 3.6.1.5. Competitive Rivalry
  • 3.6.2. PESTLE Analysis
    • 3.6.2.1. Political Landscape
    • 3.6.2.2. Technological Landscape
    • 3.6.2.3. Economic Landscape

Chapter 4. U.S. Biological Safety Testing Products & Services: Products Estimates & Trend Analysis

• 4.1. Product Market Share, 2024 & 2033
• 4.2. Segment Dashboard
• 4.3. U.S. Biological Safety Testing Products & Services Market By Product Outlook
• 4.4. Market Size & Forecasts And Trend Analyses, 2021 To 2033 For The Following
  • 4.4.1. Reagents & Kits
    • 4.4.1.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 4.4.2. Services
    • 4.4.2.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 4.4.3. Instruments
    • 4.4.3.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)

Chapter 5. U.S. Biological Safety Testing Products & Services: Application Estimates & Trend Analysis

• 5.1. Application Market Share, 2024 & 2033
• 5.2. Segment Dashboard
• 5.3. U.S. Biological Safety Testing Products & Services Market By Application Outlook
• 5.4. Market Size & Forecasts And Trend Analyses, 2021 To 2033 For The Following
  • 5.4.1. Vaccine & Therapeutics Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.1.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
      • 5.4.1.1.1. Vaccines Market Estimates And Forecasts 2021 To 2033 (USD Million)
        • 5.4.1.1.1.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
      • 5.4.1.1.2. Monoclonal Antibodies Market Estimates And Forecasts 2021 To 2033 (USD Million)
        • 5.4.1.1.2.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
      • 5.4.1.1.3. Recombinant Protein Market Estimates And Forecasts 2021 To 2033 (USD Million)
        • 5.4.1.1.3.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 5.4.2. Blood & Blood-based Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 5.4.3. Gene Therapy Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 5.4.4. Tissue & Tissue-based Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.4.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 5.4.5. Stem Cells Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.5.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)

Chapter 6. Biological Safety Testing Products & Services: Test Type Estimates & Trend Analysis

• 6.1. Test Type Market Share, 2024 & 2033
• 6.2. Segment Dashboard
• 6.3. Global U.S. Biological Safety Testing Products & Services Market By Test Type Outlook
• 6.4. Market Size & Forecasts And Trend Analyses, 2021 To 2033 For The Following
  • 6.4.1. Endotoxin Tests
    • 6.4.1.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 6.4.2. Sterility Tests
    • 6.4.2.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 6.4.3. Cell Line Authentication & Characterization Tests
    • 6.4.3.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 6.4.4. Bioburden Tests
    • 6.4.4.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 6.4.5. Adventitious Agent Detection Tests
    • 6.4.5.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 6.4.6. Residual Host Contamination Detection Tests
    • 6.4.6.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
  • 6.4.7. Others
    • 6.4.7.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Recent Developments & Impact Analysis, By Key Market Participants
• 7.2. Company /Competition Categorization
• 7.3. Vendor Landscape
  • 7.3.1. List Of Key Distributors And Channel Partners
  • 7.3.2. Key Customers
  • 7.3.3. Key Company Market Share Analysis, 2024
  • 7.3.4. Charles River Laboratories
    • 7.3.4.1. Overview
    • 7.3.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.4.3. Product Benchmarking
    • 7.3.4.4. Strategic Initiatives
  • 7.3.5. BSL Bioservice
    • 7.3.5.1. Overview
    • 7.3.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.5.3. Product Benchmarking
    • 7.3.5.4. Strategic Initiatives
  • 7.3.6. Merck KGaA
    • 7.3.6.1. Overview
    • 7.3.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.6.3. Product Benchmarking
    • 7.3.6.4. Strategic Initiatives
  • 7.3.7. Samsung Biologics
    • 7.3.7.1. Overview
    • 7.3.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.7.3. Product Benchmarking
    • 7.3.7.4. Strategic Initiatives
  • 7.3.8. Sartorius AG
    • 7.3.8.1. Overview
    • 7.3.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.8.3. Product Benchmarking
    • 7.3.8.4. Strategic Initiatives
  • 7.3.9. Eurofins Scientific
    • 7.3.9.1. Overview
    • 7.3.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.9.3. Product Benchmarking
    • 7.3.9.4. Strategic Initiatives
  • 7.3.10. SGS Societe Generale de Surveillance SA
    • 7.3.10.1. Overview
    • 7.3.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.10.3. Product Benchmarking
    • 7.3.10.4. Strategic Initiatives
  • 7.3.11. Thermo Fisher Scientific Inc.
    • 7.3.11.1. Overview
    • 7.3.11.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.11.3. Product Benchmarking
    • 7.3.11.4. Strategic Initiatives
  • 7.3.12. BIOMERIEUX
    • 7.3.12.1. Overview
    • 7.3.12.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.12.3. Product Benchmarking
    • 7.3.12.4. Strategic Initiatives
  • 7.3.13. Lonza
    • 7.3.13.1. Overview
    • 7.3.13.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 7.3.13.3. Product Benchmarking
    • 7.3.13.4. Strategic Initiatives