생물학적 안전성 시험 제품 및 서비스 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 용도별, 시험별, 지역별, 부문별 예측(2026-2033년)

Biological Safety Testing Products & Services Market Summary

The global biological safety testing products & services market size was estimated at USD 5.38 billion in 2025 and is projected to reach USD 12.09 billion by 2033, growing at a CAGR of 10.69% from 2026 to 2033. The growing prevalence of target diseases and rising production of next-generation biologics by various biotechnology and pharmaceutical organizations are anticipated to boost the biological safety testing products & services industry.

The growing demand for biologics has led to an extraordinary increase in the number of biopharmaceutical companies. The rising competition to produce highly effective therapeutic drugs on a large scale has enabled manufacturers to focus on enhancing aspects of industrial processes, including cost-effectiveness and productivity. For instance, in July 2023, Biocon Biologics, an Indian-based organization, announced the launch of the rheumatoid arthritis drug Humira, a biosimilar version of AbbVie in the U.S. at a lower price that would be easily available across the region. Several organizations are thus executing better manufacturing practices involving thorough biological testing at various levels of the production cycle with easy accessibility, thereby fueling the growth of the market.

The expansion of the biopharmaceutical and biotechnology sectors is a key driver for the biological safety testing products and services industry. The global growth of biologics, biosimilars, cell and gene therapies, and regenerative medicines is accelerating demand for precise, validated biosafety testing. As regulatory expectations rise and therapeutic pipelines deepen, companies are investing heavily in testing infrastructure, innovation, and partnerships to meet the biosafety needs of evolving biologic modalities. This growth is being reinforced by a wave of capital projects, mergers, and platform developments globally.

Government-led initiatives aimed at strengthening biosafety and public health infrastructure are expected to significantly boost demand for biological safety testing products and services in the coming years. Many countries are increasing investments in laboratory capacity, disease surveillance, and regulatory frameworks to ensure the safe development of pharmaceuticals, vaccines, and biologics. Programs supporting quality assurance, standardized testing protocols, and rapid pathogen detection are further driving adoption of advanced biosafety technologies. In addition, funding for pandemic preparedness and antimicrobial resistance monitoring is expanding, creating new opportunities for industry growth. As governments prioritize safety and resilience in healthcare systems, the biosafety testing market is projected to experience steady, sustained expansion.

Moreover, the presence of regulatory authorities to enforce significant safety standards is anticipated to boost the adoption of testing tools. For instance, in June 2023, FDA introduced a new guideline that would encourage biosimilar developers to adopt a more cost-effective approach to testing. The FDA guideline, called "BioRationality," aims to promote a more scientifically rational and efficient approach to the development and approval of biosimilars. The new guideline suggests alternative testing methodologies to streamline the development process and reduce costs. Stringent guidelines and recommendations issued by these authorities increase the incorporation of these tools by quality assurance technicians, thus fueling market growth.

Biological safety testing services play a crucial role in verifying the absence of bacterial contaminants and ensuring the safety of vaccines and biopharmaceuticals. These services encompass a range of assessments, including bioburden testing, toxicology testing, and analytical testing. Parameters such as accuracy, linearity, range, and specificity are evaluated to assess the quality of products offered by companies in this field.

Global Biological Safety Testing Products & Services Market Report Segmentation

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

• Product 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 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
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Biological Safety Testing Products & Services Market: Methodology and Scope

• 1.1. Market Segmentation and Scope
  • 1.1.1. Segment Definitions
    • 1.1.1.1. Product Segment
    • 1.1.1.2. Application Segment
    • 1.1.1.3. Test segment
• 1.2. Regional Scope
• 1.3. Estimates and Forecast Timeline
• 1.4. Objectives
  • 1.4.1. Objective - 1
  • 1.4.2. Objective - 2
  • 1.4.3. Objective - 3
• 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 Secondary Sources
• 1.11. List of Abbreviations

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

• 2.1. Market Snapshot
• 2.2. Product and Application Snapshot
• 2.3. Test Snapshot
• 2.4. Competitive Landscape Snapshot

Chapter 3. 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. Increasing 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. Porter's Five Forces Analysis
• 3.7. PESTLE Analysis
• 3.8. Pipeline Analysis

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

• 4.1. Biological Safety Testing Products & Services Market: Product Movement Analysis
• 4.2. Reagents & Kits
  • 4.2.1. Reagents & Kits Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.3. Services
  • 4.3.1. Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.4. Instruments
  • 4.4.1. Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)

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

• 5.1. Biological Safety Testing Products & Services Market: Application Movement Analysis
• 5.2. Vaccines & Therapeutics
  • 5.2.1. Vaccines & Therapeutics Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.2.2. Vaccines
    • 5.2.2.1. Vaccines Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.2.3. Monoclonal Antibodies
    • 5.2.3.1. Monoclonal Antibodies Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.2.4. Recombinant Protein
    • 5.2.4.1. Recombinant Protein Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.3. Blood & Blood-based Products
  • 5.3.1. Blood & Blood-based Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.4. Gene Therapy
  • 5.4.1. Gene Therapy Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Tissue & Tissue-based Products
  • 5.5.1. Tissue & Tissue-based Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Stem Cells
  • 5.6.1. Stem Cells Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

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

• 6.1. Biological Safety Testing Products & Services Market: Test Movement Analysis
• 6.2. Endotoxin Tests
  • 6.2.1. Endotoxin Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.3. Sterility Tests
  • 6.3.1. Sterility Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.4. Cell Line Authentication & Characterization Tests
  • 6.4.1. Cell Line Authentication & Characterization Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Bioburden Tests
  • 6.5.1. Bioburden Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Adventitious Agent Detection Tests
  • 6.6.1. Adventitious Agent Detection Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Residual Host Contamination Detection Tests
  • 6.7.1. Residual Host Contamination Detection Tests Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Others
  • 6.8.1. Others Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Biological Safety Testing Products & Services Market: Regional Business Analysis

• 7.1. Regional Market Snapshot
• 7.2. North America
  • 7.2.1. North America Biological Safety Testing Products & Services Market Estimates And Forecast, 2021 - 2033 (USD Million)
  • 7.2.2. U.S.
    • 7.2.2.1. U.S. Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.2.2.2. Key Country Dynamics
    • 7.2.2.3. Regulatory Framework
    • 7.2.2.4. Reimbursement Scenario
    • 7.2.2.5. Competitive Scenario
  • 7.2.3. Canada
    • 7.2.3.1. Canada Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.2.3.2. Key Country Dynamics
    • 7.2.3.3. Regulatory Framework
    • 7.2.3.4. Reimbursement Scenario
    • 7.2.3.5. Competitive Scenario
  • 7.2.4. Mexico
    • 7.2.4.1. Mexico Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.2.4.2. Key Country Dynamics
    • 7.2.4.3. Regulatory Framework
    • 7.2.4.4. Reimbursement Scenario
    • 7.2.4.5. Competitive Scenario
• 7.3. Europe
  • 7.3.1. Europe Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
  • 7.3.2. UK
    • 7.3.2.1. UK Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.2.2. Key Country Dynamics
    • 7.3.2.3. Regulatory Framework
    • 7.3.2.4. Reimbursement Scenario
    • 7.3.2.5. Competitive Scenario
  • 7.3.3. Germany
    • 7.3.3.1. Germany Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.3.2. Key Country Dynamics
    • 7.3.3.3. Regulatory Framework
    • 7.3.3.4. Reimbursement Scenario
    • 7.3.3.5. Competitive Scenario
  • 7.3.4. Spain
    • 7.3.4.1. Spain Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.4.2. Key Country Dynamics
    • 7.3.4.3. Regulatory Framework
    • 7.3.4.4. Reimbursement Scenario
    • 7.3.4.5. Competitive Scenario
  • 7.3.5. France
    • 7.3.5.1. France Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.5.2. Key Country Dynamics
    • 7.3.5.3. Regulatory Framework
    • 7.3.5.4. Reimbursement Scenario
    • 7.3.5.5. Competitive Scenario
  • 7.3.6. Italy
    • 7.3.6.1. Italy Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.6.2. Key Country Dynamics
    • 7.3.6.3. Regulatory Framework
    • 7.3.6.4. Reimbursement Scenario
    • 7.3.6.5. Competitive Scenario
  • 7.3.7. Denmark
    • 7.3.7.1. Denmark Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.7.2. Key Country Dynamics
    • 7.3.7.3. Regulatory Framework
    • 7.3.7.4. Reimbursement Scenario
    • 7.3.7.5. Competitive Scenario
  • 7.3.8. Sweden
    • 7.3.8.1. Sweden Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.8.2. Key Country Dynamics
    • 7.3.8.3. Regulatory Framework
    • 7.3.8.4. Reimbursement Scenario
    • 7.3.8.5. Competitive Scenario
  • 7.3.9. Norway
    • 7.3.9.1. Norway Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.3.9.2. Key Country Dynamics
    • 7.3.9.3. Regulatory Framework
    • 7.3.9.4. Reimbursement Scenario
    • 7.3.9.5. Competitive Scenario
• 7.4. Asia Pacific
  • 7.4.1. Asia-Pacific Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
  • 7.4.2. Japan
    • 7.4.2.1. Japan Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.2.2. Key Country Dynamics
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Reimbursement Scenario
    • 7.4.2.5. Competitive Scenario
  • 7.4.3. China
    • 7.4.3.1. China Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.3.2. Key Country Dynamics
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Reimbursement Scenario
    • 7.4.3.5. Competitive Scenario
  • 7.4.4. India
    • 7.4.4.1. India Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.4.2. Key Country Dynamics
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Reimbursement Scenario
    • 7.4.4.5. Competitive Scenario
  • 7.4.5. South Korea
    • 7.4.5.1. South Korea Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.5.2. Key Country Dynamics
    • 7.4.5.3. Regulatory Framework
    • 7.4.5.4. Reimbursement Scenario
    • 7.4.5.5. Competitive Scenario
  • 7.4.6. Thailand
    • 7.4.6.1. Thailand Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.6.2. Key Country Dynamics
    • 7.4.6.3. Regulatory Framework
    • 7.4.6.4. Reimbursement Scenario
    • 7.4.6.5. Competitive Scenario
  • 7.4.7. Australia
    • 7.4.7.1. Australia Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.4.7.2. Key Country Dynamics
    • 7.4.7.3. Regulatory Framework
    • 7.4.7.4. Reimbursement Scenario
    • 7.4.7.5. Competitive Scenario
• 7.5. Latin America
  • 7.5.1. Latin America Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
  • 7.5.2. Brazil
    • 7.5.2.1. Brazil Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.5.2.2. Key Country Dynamics
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Reimbursement Scenario
    • 7.5.2.5. Competitive Scenario
  • 7.5.3. Argentina
    • 7.5.3.1. Argentina Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.5.3.2. Key Country Dynamics
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Reimbursement Scenario
    • 7.5.3.5. Competitive Scenario
• 7.6. MEA
  • 7.6.1. MEA Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
  • 7.6.2. South Africa
    • 7.6.2.1. South Africa Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.6.2.2. Key Country Dynamics
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Reimbursement Scenario
    • 7.6.2.5. Competitive Scenario
  • 7.6.3. Saudi Arabia
    • 7.6.3.1. Saudi Arabia Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.6.3.2. Key Country Dynamics
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Reimbursement Scenario
    • 7.6.3.5. Competitive Scenario
  • 7.6.4. UAE
    • 7.6.4.1. UAE Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.6.4.2. Key Country Dynamics
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Reimbursement Scenario
    • 7.6.4.5. Competitive Scenario
  • 7.6.5. Kuwait
    • 7.6.5.1. Kuwait Biological Safety Testing Products & Services Market, 2021 - 2033 (USD Million)
    • 7.6.5.2. Key Country Dynamics
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Reimbursement Scenario
    • 7.6.5.5. Competitive Scenario

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Strategy Mapping
  • 8.2.1. NEW PRODUCT LAUNCH
  • 8.2.2. PARTNERSHIPS
  • 8.2.3. ACQUISITION
  • 8.2.4. COLLABORATION
  • 8.2.5. FUNDING
• 8.3. Key Company Market Share Analysis, 2024
• 8.4. Company Heat Map Analysis
• 8.5. Company Profiles
  • 8.5.1. CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
    • 8.5.1.1. Company Overview
    • 8.5.1.2. Financial Performance
    • 8.5.1.3. Product Benchmarking
    • 8.5.1.4. Strategic Initiatives
  • 8.5.2. BSL BIOSERVICE
    • 8.5.2.1. Company Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. LONZA
    • 8.5.3.1. Company Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. MERCK KGAA (MILLIPORESIGMA)
    • 8.5.4.1. Company Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. SAMSUNG BIOLOGICS
    • 8.5.5.1. Company Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. SARTORIUS AG
    • 8.5.6.1. Company Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. EUROFINS SCIENTIFIC
    • 8.5.7.1. Company Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. SGS SOCIETE GENERALE DE SURVEILLANCE SA
    • 8.5.8.1. Company Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives
  • 8.5.9. THERMO FISHER SCIENTIFIC INC.
    • 8.5.9.1. Company Overview
    • 8.5.9.2. Financial Performance
    • 8.5.9.3. Product Benchmarking
    • 8.5.9.4. Strategic Initiatives
  • 8.5.10. BIOMERIEUX
    • 8.5.10.1. Company Overview
    • 8.5.10.2. Financial Performance
    • 8.5.10.3. Product Benchmarking
    • 8.5.10.4. Strategic Initiatives