세계의 생물학적 안전성 검사 서비스 시장 : 시장 규모, 점유율 및 동향 분석(서비스별, 용도별, 최종 용도별, 지역별), 부문별 예측(2025-2030년)

Biological Safety Testing Services Market Growth & Trends:

The global biological safety testing services market size is expected to reach USD 6.33 billion by 2030, growing at a CAGR of 11.78% during the forecast period, according to a new report by Grand View Research, Inc. The market can be attributed to benefits offered to biological safety testing services, such as cost savings, an increased focus on sterility assurance, and the rising development of new pharmaceuticals, therapies, & medical devices. In addition, stringent regulatory requirements, a growing emphasis on patient safety, advancements in biotechnology, and the increasing prevalence of chronic and infectious diseases are some of the factors contributing to the market growth.

The biological safety testing services industry is experiencing rapid growth due to the increasing demand for biologics, cell & gene therapies, and vaccines. Some of the others key trends in the market include the expansion of biological safety testing services by contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), as well as rising investments in biopharmaceutical research and development (R&D).

Moreover, stringent regulatory requirements from the FDA, EMA, and ICH have made biosafety testing essential for ensuring product safety, efficacy, and compliance. This has led to an increasing need for viral clearance, sterility, endotoxin, mycoplasma, and bioburden testing requirements which aims to improve efficiency and ethical compliance. This has led most of the market players to increasingly outsourcing biosafety testing who are seeking cost-effective and specialized expertise with their emerging pipelines for biologic drugs. Furthermore, technological innovations such as automation, next-generation sequencing (NGS), real-time PCR, and AI-driven analytics are enhancing the accuracy, speed, and regulatory compliance of tests. Therefore, biological safety testing services are expected to evolve during the forecast period to meet the complex regulatory and quality control needs of the industry.

The strategic partnerships and accelerating product launches are also driving the market growth. For instance, in Aprill 2024, Merck introduced the Aptegra CHO Genetic Stability Assay, the first all-in-one, validated genetic stability assay. Utilizing whole genome sequencing and bioinformatics, this innovation enhances biosafety testing efficiency, enabling faster transitions to commercial production

Biological Safety Testing Services Market Report Highlights:

• The bioburden testing services segment dominated the market in 2024. Growth in the segment can be attributed to the increasing focus on sterility assurance of medical devices and pharmaceutical drugs and growing concern for product safety. These services are actively preferred to determine a test unit's microbial quality or cleanliness, thereby determining the sterilization process needed for effective decontamination.
• Based on application, the vaccine & therapeutics segment held the largest market share in 2024, attributed to the stringent regulatory scenarios, growing demand for vaccines and biologic therapeutics, rapid adoption of automation, next-generation sequencing (NGS), and AI-driven analytics ensuring compliance and product safety drives the segment growth.
• Based on end use, the biopharmaceutical companies segment dominated the market in 2024. This is attributable to increasing R&D investment, growing focus on product safety and testing, rising cost-efficiency service offerings, and increased biological production.
• North America market accounted for the largest share of 33.15% in 2024 due to rising number of medical device companies & pharmaceutical companies in countries like the U.S. and Canada, the North America is anticipated to witness rapid growth over the estimated time. The presence of established market players within the region offering cost-efficient services in the U.S. is another factor anticipated to propel market growth.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
  • 1.2.1. Service Segment
  • 1.2.2. Application Segment
  • 1.2.3. End Use Segment
• 1.3. Information Analysis
  • 1.3.1. Market Formulation & Data Visualization
• 1.4. Data Validation & Publishing
• 1.5. Information Procurement
  • 1.5.1. Primary Research
• 1.6. Information or Data Analysis
• 1.7. Market Formulation & Validation
• 1.8. Market Model
• 1.9. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. 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 Trends and Outlook
• 3.3. Market Dynamics
  • 3.3.1. Market Driver Analysis
  • 3.3.2. Market Restraint Analysis
• 3.4. Industry Analysis Tools
  • 3.4.1. Porter's Five Forces Analysis
  • 3.4.2. PESTEL Analysis
  • 3.4.3. COVID-19 Impact Analysis

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

• 4.1. Segment Dashboard
• 4.2. Biological Safety Testing Services Market; Service Movement Analysis
• 4.3. Biological Safety Testing Services Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
• 4.4. Bioburden Testing Services
  • 4.4.1. Bioburden testing services market estimates and forecasts 2018 to 2030 (USD Million)
• 4.5. Endotoxin Testing Services
  • 4.5.1. Endotoxin testing services market estimates and forecasts 2018 to 2030 (USD Million)
• 4.6. Sterility Testing Services
  • 4.6.1. Sterility testing services market estimates and forecasts 2018 to 2030 (USD Million)
• 4.7. Viral Clearance and Validation Services
  • 4.7.1. Viral clearance and validation services market estimates and forecasts 2018 to 2030 (USD Million)
• 4.8. Cell Line Authentication and Characterization Tests
  • 4.8.1. Cell line authentication and characterization tests market estimates and forecasts 2018 to 2030 (USD Million)
• 4.9. Residual Host Contamination Testing Services
  • 4.9.1. Residual host contamination testing services market estimates and forecasts 2018 to 2030 (USD Million)
• 4.10. Adventitious Agent Detection Testing Services
  • 4.10.1. Adventitious agent detection testing services market estimates and forecasts 2018 to 2030 (USD Million)
• 4.11. Others
  • 4.11.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

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

• 5.1. Segment Dashboard
• 5.2. Biological Safety Testing Services Market; Application Movement Analysis
• 5.3. Biological Safety Testing Services Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 5.4. Vaccine & Therapeutics
  • 5.4.1. Vaccine & therapeutics market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.2. Monoclonal Antibodies
    • 5.4.2.1. Monoclonal antibodies market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.3. Vaccines
    • 5.4.3.1. Vaccines market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.4. Recombinant Protein
    • 5.4.4.1. Recombinant protein market estimates and forecasts 2018 to 2030 (USD Million)

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

• 6.1. Segment Dashboard
• 6.2. Biological Safety Testing Services Market; End Use Movement Analysis
• 6.3. Biological Safety Testing Services Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 6.4. Biopharmaceutical Companies
  • 6.4.1. Biopharmaceutical companies market estimates and forecasts 2018 to 2030 (USD Million)
• 6.5. Pharmaceutical Companies
  • 6.5.1. Pharmaceutical companies market estimates and forecasts 2018 to 2030 (USD Million)
• 6.6. Academic and Research Institutions
  • 6.6.1. Academic and research institutions market estimates and forecasts 2018 to 2030 (USD Million)
• 6.7. Others
  • 6.7.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

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

• 7.1. Regional Dashboard
• 7.2. Market Size & Forecasts and Trend Analysis, 2018 to 2030
• 7.3. North America
  • 7.3.1. North America biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.3.2. U.S.
    • 7.3.2.1. Key Country Dynamics
    • 7.3.2.2. Competitive Scenario
    • 7.3.2.3. Regulatory Framework
    • 7.3.2.4. U.S. biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.3.3. Canada
    • 7.3.3.1. Key Country Dynamics
    • 7.3.3.2. Competitive Scenario
    • 7.3.3.3. Regulatory Framework
    • 7.3.3.4. Canada biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.3.4. Mexico
    • 7.3.4.1. Key Country Dynamics
    • 7.3.4.2. Competitive Scenario
    • 7.3.4.3. Regulatory Framework
    • 7.3.4.4. Mexico biological safety testing services market, 2018 - 2030 (USD Million)
• 7.4. Europe
  • 7.4.1. Europe biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4.2. Germany
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Germany biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4.3. UK
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. UK biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4.4. France
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. France biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4.5. Italy
    • 7.4.5.1. Key Country Dynamics
    • 7.4.5.2. Competitive Scenario
    • 7.4.5.3. Regulatory Framework
    • 7.4.5.4. Italy biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4.6. Spain
    • 7.4.6.1. Key Country Dynamics
    • 7.4.6.2. Competitive Scenario
    • 7.4.6.3. Regulatory Framework
    • 7.4.6.4. Spain biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4.7. Denmark
    • 7.4.7.1. Key Country Dynamics
    • 7.4.7.2. Competitive Scenario
    • 7.4.7.3. Regulatory Framework
    • 7.4.7.4. Denmark biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4.8. Sweden
    • 7.4.8.1. Key Country Dynamics
    • 7.4.8.2. Competitive Scenario
    • 7.4.8.3. Regulatory Framework
    • 7.4.8.4. Sweden biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4.9. Norway
    • 7.4.9.1. Key Country Dynamics
    • 7.4.9.2. Competitive Scenario
    • 7.4.9.3. Regulatory Framework
    • 7.4.9.4. Norway biological safety testing services market, 2018 - 2030 (USD Million)
• 7.5. Asia Pacific
  • 7.5.1. Asia Pacific biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.5.2. Japan
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Japan biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.5.3. China
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. China biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.5.4. India
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. India biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.5.5. South Korea
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. South Korea biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.5.6. Australia
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Australia biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.5.7. Thailand
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Thailand biological safety testing services market, 2018 - 2030 (USD Million)
• 7.6. Latin America
  • 7.6.1. Latin America biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.6.2. Brazil
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Brazil biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.6.3. Argentina
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Argentina biological safety testing services market, 2018 - 2030 (USD Million)
• 7.7. MEA
  • 7.7.1. MEA biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.7.2. South Africa
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. South Africa biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.7.3. Saudi Arabia
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Saudi Arabia biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.7.4. UAE
    • 7.7.4.1. Key Country Dynamics
    • 7.7.4.2. Competitive Scenario
    • 7.7.4.3. Regulatory Framework
    • 7.7.4.4. UAE biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.7.5. Kuwait
    • 7.7.5.1. Key Country Dynamics
    • 7.7.5.2. Competitive Scenario
    • 7.7.5.3. Regulatory Framework
    • 7.7.5.4. Kuwait biological safety testing services market, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Company Market Position Analysis, 2024
• 8.3. Company Profiles
  • 8.3.1. Charles River Laboratories
    • 8.3.1.1. Company overview
    • 8.3.1.2. Financial performance
    • 8.3.1.3. Service benchmarking
    • 8.3.1.4. Strategic initiatives
  • 8.3.2. Lonza Group Ltd.
    • 8.3.2.1. Company overview
    • 8.3.2.2. Financial performance
    • 8.3.2.3. Service benchmarking
    • 8.3.2.4. Strategic initiatives
  • 8.3.3. Merck KGaA
    • 8.3.3.1. Company overview
    • 8.3.3.2. Financial performance
    • 8.3.3.3. Service benchmarking
    • 8.3.3.4. Strategic initiatives
  • 8.3.4. SGS SA
    • 8.3.4.1. Company overview
    • 8.3.4.2. Financial performance
    • 8.3.4.3. Service benchmarking
    • 8.3.4.4. Strategic initiatives
  • 8.3.5. Eurofins Scientific
    • 8.3.5.1. Company overview
    • 8.3.5.2. Financial performance
    • 8.3.5.3. Service benchmarking
    • 8.3.5.4. Strategic initiatives
  • 8.3.6. WuXi AppTec
    • 8.3.6.1. Company overview
    • 8.3.6.2. Financial performance
    • 8.3.6.3. Service benchmarking
    • 8.3.6.4. Strategic initiatives
  • 8.3.7. Thermo Fisher Scientific Inc.
    • 8.3.7.1. Company overview
    • 8.3.7.2. Financial performance
    • 8.3.7.3. Service benchmarking
    • 8.3.7.4. Strategic initiatives
  • 8.3.8. Sartorius AG
    • 8.3.8.1. Company overview
    • 8.3.8.2. Financial performance
    • 8.3.8.3. Service benchmarking
    • 8.3.8.4. Strategic initiatives
  • 8.3.9. Toxikon Corporation
    • 8.3.9.1. Company overview
    • 8.3.9.2. Financial performance
    • 8.3.9.3. Service benchmarking
    • 8.3.9.4. Strategic initiatives
  • 8.3.10. bioMerieux SA
    • 8.3.10.1. Company overview
    • 8.3.10.2. Financial performance
    • 8.3.10.3. Service benchmarking
    • 8.3.10.4. Strategic initiatives