바이오의약품 안전성 시험 시장 : 세계 산업 분석, 규모, 점유율, 성장, 동향, 예측(2024-2031년)

Persistence Market Research has recently released a comprehensive report on the worldwide market for biologics safety testing. The report offers a thorough assessment of crucial market dynamics, including drivers, trends, opportunities, and challenges, providing detailed insights into the market structure. This research publication presents exclusive data and statistics outlining the anticipated growth trajectory of the global biologics safety testing market from 2024 to 2031.

Key Insights:

• Biologics Safety Testing Market Size (2024E): USD 4111.9 Million
• Projected Market Value (2031F): USD 8608.6 Million
• Global Market Growth Rate (CAGR 2024 to 2031): 11.1%

Biologics Safety Testing Market - Report Scope:

Biologics safety testing plays a critical role in ensuring the safety and efficacy of biologic drugs, including monoclonal antibodies, vaccines, gene therapies, and cell-based therapies. The testing process involves detecting contaminants, verifying potency, and ensuring that biologics meet regulatory requirements. These tests are conducted at various stages of biologic development, from early-phase research to post-marketing surveillance. The biologics safety testing market caters to pharmaceutical and biotechnology companies, contract research organizations (CROs), and testing laboratories, providing services such as endotoxin testing, sterility testing, and viral safety testing.

Market growth is driven by the increasing demand for biologics, the expansion of personalized medicine, and growing regulatory scrutiny surrounding drug safety. Advances in analytical technologies, coupled with the rising emphasis on patient safety and regulatory compliance, continue to bolster the biologics safety testing market.

Market Growth Drivers:

The biologics safety testing market is propelled by several key factors, including the growing number of biologic drugs in development, especially for chronic diseases, cancer, and autoimmune disorders. With biologics becoming a preferred treatment for many diseases, there is an increasing need for comprehensive safety testing protocols to ensure their effectiveness and safety. Regulatory agencies like the FDA and EMA are imposing stricter guidelines on biologic testing, which drives the demand for high-quality testing services.

Moreover, the rise of personalized medicine, which includes gene and cell-based therapies, has created a need for specialized testing solutions to ensure these treatments' safety and efficacy. Innovations in testing methodologies, such as next-generation sequencing (NGS) and cell-based assays, further support market growth by providing more accurate and efficient testing.

Market Restraints:

Despite promising growth prospects, the biologics safety testing market faces challenges related to the high costs of testing, especially for emerging biologics like gene therapies. The complexity of these treatments requires advanced and expensive testing methods, which could limit access in regions with budget constraints. Additionally, the lengthy and complex regulatory approval process for biologics may delay the introduction of new testing methods and technologies.

Another challenge is the shortage of skilled professionals in the field of biologics safety testing, which can hinder the industry's ability to scale up operations to meet the growing demand for testing services.

Market Opportunities:

The biologics safety testing market presents significant growth opportunities driven by technological advancements, strategic partnerships, and an expanding drug pipeline. The integration of automated testing systems, such as robotics and artificial intelligence (AI), can improve efficiency, accuracy, and cost-effectiveness in safety testing procedures. Additionally, the rising focus on biosimilars presents a new market segment, requiring testing to ensure the quality and safety of these alternatives to branded biologics.

The increasing adoption of contract research organizations (CROs) for biologics testing presents an opportunity for industry players to enter new markets and regions, particularly in developing economies where the demand for biologics is rising. By investing in research and development and forming strategic alliances with biotechnology companies, testing laboratories can tap into emerging opportunities and stay competitive in the evolving biologics landscape.

Key Questions Answered in the Report:

• What are the primary factors driving the growth of the biologics safety testing market globally?
• Which testing methods are most widely adopted for biologics safety testing, and how are they evolving?
• How are advancements in testing technologies reshaping the competitive landscape of the biologics safety testing market?
• Who are the key players contributing to the biologics safety testing market, and what strategies are they employing to maintain market relevance?
• What are the emerging trends and future prospects in the global biologics safety testing market?

Competitive Intelligence and Business Strategy:

Leading players in the global biologics safety testing market, such as Charles River Laboratories, Lonza Group, and WuXi AppTec, focus on innovation, product differentiation, and strategic partnerships to gain a competitive edge. These companies invest heavily in R&D to develop advanced testing solutions that are faster, more accurate, and cost-effective. Collaborations with pharmaceutical companies, CROs, and regulatory bodies enhance market access and promote the adoption of state-of-the-art testing services.

Furthermore, market players emphasize regulatory compliance, patient safety, and technological advancements as critical strategies to enhance their market position. These efforts are expected to fuel market growth and lead to improvements in biologics safety testing standards.

Key Companies Profiled:

• Charles River Laboratories
• Lonza Group
• WuXi AppTec
• Merck KGaA
• Q2 Solutions
• BioReliance (Merck)
• Eurofins Scientific
• Labcorp Drug Development
• Intertek Group
• Ecolab

Market Segmentation:

Region

• North America
• Latin America
• Europe
• Japan
• APEJ
• MEA

Product Type

• Kits & Reagents
• Instruments
• Services

Test Type

• Endotoxin Tests
• Sterility Tests
• Cell Line Authentication and Characterization Tests
• Adventitious Agent Detection Tests
• Bioburden Tests
• Other Tests

Application

• Vaccine and Therapeutics Development
• Blood and Blood-related Products Testing
• Cellular and Gene Therapy
• Tissue-related Products Testing
• Stem Cell Research

Table of Contents

1. Executive Summary

2. Global Biologics Safety Testing Market Overview

• 2.1. Introduction
  • 2.1.1. Global Biologics Safety Testing Market Taxonomy
  • 2.1.2. Global Biologics Safety Testing Market Definition
• 2.2. Global Biologics Safety Testing Market Size (US$ Mn) and Forecast, 2024-2031
  • 2.2.1. Global Biologics Safety Testing Market Y-o-Y Growth
• 2.3. Global Biologics Safety Testing Market Dynamics
• 2.4. Supply Chain
• 2.5. Cost Structure
• 2.6. Pricing Analysis
• 2.7. Raw Material Sourcing Strategy and Analysis
• 2.8. Supplier List
• 2.9. Key Participants Market Presence (Intensity Map) By Region

3. Global Biologics Safety Testing Market Analysis and Forecast By Product Type

• 3.1. Global Biologics Safety Testing Market Size and Forecast By Product Type, 2024-2031
  • 3.1.1. Kits & Reagents Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 3.1.1.1. Revenue (US$ Mn) Comparison, By Region
    • 3.1.1.2. Market Share Comparison, By Region
    • 3.1.1.3. Y-o-Y growth Comparison, By Region
  • 3.1.2. Instruments Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 3.1.2.1. Revenue (US$ Mn) Comparison, By Region
    • 3.1.2.2. Market Share Comparison, By Region
    • 3.1.2.3. Y-o-Y growth Comparison, By Region
  • 3.1.3. Services Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 3.1.3.1. Revenue (US$ Mn) Comparison, By Region
    • 3.1.3.2. Market Share Comparison, By Region
    • 3.1.3.3. Y-o-Y growth Comparison, By Region

4. Global Biologics Safety Testing Market Analysis and Forecast By Test Type

• 4.1. Global Biologics Safety Testing Market Size and Forecast By Test Type, 2024-2031
  • 4.1.1. Endotoxin Tests Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 4.1.1.1. Revenue (US$ Mn) Comparison, By Region
    • 4.1.1.2. Market Share Comparison, By Region
    • 4.1.1.3. Y-o-Y growth Comparison, By Region
  • 4.1.2. Sterility Tests Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 4.1.2.1. Revenue (US$ Mn) Comparison, By Region
    • 4.1.2.2. Market Share Comparison, By Region
    • 4.1.2.3. Y-o-Y growth Comparison, By Region
  • 4.1.3. Cell Line Authentication and Characterization Tests Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 4.1.3.1. Revenue (US$ Mn) Comparison, By Region
    • 4.1.3.2. Market Share Comparison, By Region
    • 4.1.3.3. Y-o-Y growth Comparison, By Region
  • 4.1.4. Residual Host Contamination Detection Tests Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 4.1.4.1. Revenue (US$ Mn) Comparison, By Region
    • 4.1.4.2. Market Share Comparison, By Region
    • 4.1.4.3. Y-o-Y growth Comparison, By Region
  • 4.1.5. Adventitious Agent Detection Tests Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 4.1.5.1. Revenue (US$ Mn) Comparison, By Region
    • 4.1.5.2. Market Share Comparison, By Region
    • 4.1.5.3. Y-o-Y growth Comparison, By Region
  • 4.1.6. Bioburden Tests Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 4.1.6.1. Revenue (US$ Mn) Comparison, By Region
    • 4.1.6.2. Market Share Comparison, By Region
    • 4.1.6.3. Y-o-Y growth Comparison, By Region
  • 4.1.7. Other Tests Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 4.1.7.1. Revenue (US$ Mn) Comparison, By Region
    • 4.1.7.2. Market Share Comparison, By Region
    • 4.1.7.3. Y-o-Y growth Comparison, By Region

5. Global Biologics Safety Testing Market Analysis and Forecast By Application

• 5.1. Global Biologics Safety Testing Market Size and Forecast By Application, 2024-2031
  • 5.1.1. Vaccine and Therapeutics Development Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 5.1.1.1. Revenue (US$ Mn) Comparison, By Region
    • 5.1.1.2. Market Share Comparison, By Region
    • 5.1.1.3. Y-o-Y growth Comparison, By Region
  • 5.1.2. Blood and Blood-related Products Testing Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 5.1.2.1. Revenue (US$ Mn) Comparison, By Region
    • 5.1.2.2. Market Share Comparison, By Region
    • 5.1.2.3. Y-o-Y growth Comparison, By Region
  • 5.1.3. Cellular and Gene Therapy Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 5.1.3.1. Revenue (US$ Mn) Comparison, By Region
    • 5.1.3.2. Market Share Comparison, By Region
    • 5.1.3.3. Y-o-Y growth Comparison, By Region
  • 5.1.4. Tissue and Tissue-related Products Testing Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 5.1.4.1. Revenue (US$ Mn) Comparison, By Region
    • 5.1.4.2. Market Share Comparison, By Region
    • 5.1.4.3. Y-o-Y growth Comparison, By Region
  • 5.1.5. Stem Cell Research Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 5.1.5.1. Revenue (US$ Mn) Comparison, By Region
    • 5.1.5.2. Market Share Comparison, By Region
    • 5.1.5.3. Y-o-Y growth Comparison, By Region

6. Global Biologics Safety Testing Market Analysis and Forecast By Region

• 6.1. Global Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 6.1.1. North America Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 6.1.1.1. Revenue (US$ Mn) Comparison, By Product Type
    • 6.1.1.2. Revenue (US$ Mn) Comparison, By Test Type
    • 6.1.1.3. Revenue (US$ Mn) Comparison, By Application
  • 6.1.2. Latin America Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 6.1.2.1. Revenue (US$ Mn) Comparison, By Product Type
    • 6.1.2.2. Revenue (US$ Mn) Comparison, By Test Type
    • 6.1.2.3. Revenue (US$ Mn) Comparison, By Application
  • 6.1.3. Europe Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 6.1.3.1. Revenue (US$ Mn) Comparison, By Product Type
    • 6.1.3.2. Revenue (US$ Mn) Comparison, By Test Type
    • 6.1.3.3. Revenue (US$ Mn) Comparison, By Application
  • 6.1.4. Japan Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 6.1.4.1. Revenue (US$ Mn) Comparison, By Product Type
    • 6.1.4.2. Revenue (US$ Mn) Comparison, By Test Type
    • 6.1.4.3. Revenue (US$ Mn) Comparison, By Application
  • 6.1.5. APEJ Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 6.1.5.1. Revenue (US$ Mn) Comparison, By Product Type
    • 6.1.5.2. Revenue (US$ Mn) Comparison, By Test Type
    • 6.1.5.3. Revenue (US$ Mn) Comparison, By Application
  • 6.1.6. MEA Biologics Safety Testing Market Size and Forecast, 2024-2031
    • 6.1.6.1. Revenue (US$ Mn) Comparison, By Product Type
    • 6.1.6.2. Revenue (US$ Mn) Comparison, By Test Type
    • 6.1.6.3. Revenue (US$ Mn) Comparison, By Application

7. North America Biologics Safety Testing Market Analysis and Forecast, By Country, 2024-2031

• 7.1. US Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 7.1.1. Revenue (US$ Mn) Comparison, By Product Type
  • 7.1.2. Revenue (US$ Mn) Comparison, By Test Type
  • 7.1.3. Revenue (US$ Mn) Comparison, By Application
• 7.2. Canada Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 7.2.1. Revenue (US$ Mn) Comparison, By Product Type
  • 7.2.2. Revenue (US$ Mn) Comparison, By Test Type
  • 7.2.3. Revenue (US$ Mn) Comparison, By Application

8. Latin America Biologics Safety Testing Market Analysis and Forecast, By Country, 2024-2031

• 8.1. Brazil Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 8.1.1. Revenue (US$ Mn) Comparison, By Product Type
  • 8.1.2. Revenue (US$ Mn) Comparison, By Test Type
  • 8.1.3. Revenue (US$ Mn) Comparison, By Application
• 8.2. Mexico Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 8.2.1. Revenue (US$ Mn) Comparison, By Product Type
  • 8.2.2. Revenue (US$ Mn) Comparison, By Test Type
  • 8.2.3. Revenue (US$ Mn) Comparison, By Application
• 8.3. Argentina Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 8.3.1. Revenue (US$ Mn) Comparison, By Product Type
  • 8.3.2. Revenue (US$ Mn) Comparison, By Test Type
  • 8.3.3. Revenue (US$ Mn) Comparison, By Application

9. Europe Biologics Safety Testing Market Analysis and Forecast, By Country, 2024-2031

• 9.1. Germany Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 9.1.1. Revenue (US$ Mn) Comparison, By Product Type
  • 9.1.2. Revenue (US$ Mn) Comparison, By Test Type
  • 9.1.3. Revenue (US$ Mn) Comparison, By Application
• 9.2. UK Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 9.2.1. Revenue (US$ Mn) Comparison, By Product Type
  • 9.2.2. Revenue (US$ Mn) Comparison, By Test Type
  • 9.2.3. Revenue (US$ Mn) Comparison, By Application
• 9.3. France Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 9.3.1. Revenue (US$ Mn) Comparison, By Product Type
  • 9.3.2. Revenue (US$ Mn) Comparison, By Test Type
  • 9.3.3. Revenue (US$ Mn) Comparison, By Application
• 9.4. Spain Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 9.4.1. Revenue (US$ Mn) Comparison, By Product Type
  • 9.4.2. Revenue (US$ Mn) Comparison, By Test Type
  • 9.4.3. Revenue (US$ Mn) Comparison, By Application
• 9.5. Italy Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 9.5.1. Revenue (US$ Mn) Comparison, By Product Type
  • 9.5.2. Revenue (US$ Mn) Comparison, By Test Type
  • 9.5.3. Revenue (US$ Mn) Comparison, By Application
• 9.6. Nordic Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 9.6.1. Revenue (US$ Mn) Comparison, By Product Type
  • 9.6.2. Revenue (US$ Mn) Comparison, By Test Type
  • 9.6.3. Revenue (US$ Mn) Comparison, By Application

10. Japan Biologics Safety Testing Market Analysis and Forecast, By Country, 2024-2031

• 10.1. Japan Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 10.1.1. Revenue (US$ Mn) Comparison, By Product Type
  • 10.1.2. Revenue (US$ Mn) Comparison, By Test Type
  • 10.1.3. Revenue (US$ Mn) Comparison, By Application

11. APEJ Biologics Safety Testing Market Analysis and Forecast, By Country, 2024-2031

• 11.1. China Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 11.1.1. Revenue (US$ Mn) Comparison, By Product Type
  • 11.1.2. Revenue (US$ Mn) Comparison, By Test Type
  • 11.1.3. Revenue (US$ Mn) Comparison, By Application
• 11.2. India Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 11.2.1. Revenue (US$ Mn) Comparison, By Product Type
  • 11.2.2. Revenue (US$ Mn) Comparison, By Test Type
  • 11.2.3. Revenue (US$ Mn) Comparison, By Application
• 11.3. Malaysia Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 11.3.1. Revenue (US$ Mn) Comparison, By Product Type
  • 11.3.2. Revenue (US$ Mn) Comparison, By Test Type
  • 11.3.3. Revenue (US$ Mn) Comparison, By Application
• 11.4. Thailand Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 11.4.1. Revenue (US$ Mn) Comparison, By Product Type
  • 11.4.2. Revenue (US$ Mn) Comparison, By Test Type
  • 11.4.3. Revenue (US$ Mn) Comparison, By Application
• 11.5. Singapore Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 11.5.1. Revenue (US$ Mn) Comparison, By Product Type
  • 11.5.2. Revenue (US$ Mn) Comparison, By Test Type
  • 11.5.3. Revenue (US$ Mn) Comparison, By Application
• 11.6. Australia Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 11.6.1. Revenue (US$ Mn) Comparison, By Product Type
  • 11.6.2. Revenue (US$ Mn) Comparison, By Test Type
  • 11.6.3. Revenue (US$ Mn) Comparison, By Application

12. MEA Biologics Safety Testing Market Analysis and Forecast, By Country, 2024-2031

• 12.1. GCC Countries Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 12.1.1. Revenue (US$ Mn) Comparison, By Product Type
  • 12.1.2. Revenue (US$ Mn) Comparison, By Test Type
  • 12.1.3. Revenue (US$ Mn) Comparison, By Application
• 12.2. South Africa Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 12.2.1. Revenue (US$ Mn) Comparison, By Product Type
  • 12.2.2. Revenue (US$ Mn) Comparison, By Test Type
  • 12.2.3. Revenue (US$ Mn) Comparison, By Application
• 12.3. Nigeria Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 12.3.1. Revenue (US$ Mn) Comparison, By Product Type
  • 12.3.2. Revenue (US$ Mn) Comparison, By Test Type
  • 12.3.3. Revenue (US$ Mn) Comparison, By Application
• 12.4. Israel Biologics Safety Testing Market Size and Forecast, 2024-2031
  • 12.4.1. Revenue (US$ Mn) Comparison, By Product Type
  • 12.4.2. Revenue (US$ Mn) Comparison, By Test Type
  • 12.4.3. Revenue (US$ Mn) Comparison, By Application

13. Global Biologics Safety Testing Market Company Share, Competition Landscape and Company Profiles

• 13.1. Company Share Analysis
• 13.2. Competition Landscape
• 13.3. Company Profiles
  • 13.3.1. Charles River Laboratories International, Inc.
  • 13.3.2. Eurofins Scientific Se
  • 13.3.3. SGS S.A.
  • 13.3.4. Thermo Fisher Scientific Inc.
  • 13.3.5. Genscript
  • 13.3.6. Biomerieux Sa
  • 13.3.7. Pace Analytical Services Inc.
  • 13.3.8. Lonza Group Ltd.
  • 13.3.9. Toxikon Corporation
  • 13.3.10. Wuxi Apptec

14. Research Methodology

15. Secondary and Primary Sources

16. Assumptions and Acronyms

17. Disclaimer