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Biologics Safety Testing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

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    Report

  • 170 Pages
  • May 2024
  • Region: Global
  • Fairfield Market Research
  • ID: 5972690
Description Jump to:
The global market for biologics safety testing is set to experience significant growth during forecast period 2024-2031, according to a new report. The increasing demand for safe biologics in drug development is driving this growth, as untested and unsafe biologics pose severe risks to global health by potentially causing new abnormalities in patients and complicating health conditions further.

Critical Role of Safety Testing in Biologics

Biologics, complex molecules produced from genes of living organisms using advanced DNA technologies, are vital in developing new medicines and improving existing drugs. Ensuring the safety of these biologics is paramount, prompting stringent regulations by government authorities worldwide. These regulations oversee the complex processes of drug development, product testing, and efficacy evaluation to prevent the inclusion of unknown entities in the drug manufacturing system.

Regional Insights: North America and APEJ Lead Market Growth

North America is anticipated to be the most lucrative market for biologics safety testing, bolstered by the presence of the FDA and robust healthcare marketplaces in the US and Canada. Additionally, the Asia-Pacific excluding Japan (APEJ) region is expected to reflect robust growth due to favorable industrial regulations, low labor wages, and ample resource availability.

Market Segmentation Highlights

By Test-Type:

  • Endotoxin Tests: Expected to register the highest growth, accounting for nearly one-third of global market revenues and showing significant market leadership.
  • Sterility and Residual Host Contamination Tests: Both anticipated to show parallel growth with similar steady growth rates.
  • Cell Line Authentication and Characterization Tests: Demand for these tests is expected to gain traction.
  • Bioburden Tests: Projected to create substantial incremental opportunities in the market.
  • Adventitious Agent Detection Tests: Expected to exhibit a relatively low growth rate, indicating limited demand in the near future.

By Product-Type & Applications:

  • Kits & Reagents: Nearly half of the global market revenues are expected to come from sales of kits and reagents.
  • Testing Services: Testing services are anticipated to record higher traction compared to products, with an expected strong growth rate over the forecast period 2024-2031
  • Applications: Vaccine and therapeutics development will remain the largest application for biologics safety testing. The application of biologics safety testing in cellular and gene therapy is anticipated to witness a gradual increase, contributing significantly to market revenues.

Key Players in the Market

Leading companies in the biologics safety testing market, such as Wuxi Apptec, Toxikon Corporation, Lonza Group Ltd., Pace Analytical Services Inc., BioMerieux SA, Genscript Biotech Corp., Thermo Fisher Scientific Inc., SGS S.A., Eurofins Scientific Se, Sigma-Aldrich Corporation (part of Merck KGaA), and Charles River Laboratories International, Inc., are expected to maintain active roles throughout the forecast period. These companies combine industry-leading expertise and operational excellence to ensure the success of critical drug development programs and manufacturing processes.

Biologics Safety Testing Market Segmentation

By Product Type

  • Kits & Reagents
  • Instruments
  • Services

By Test Type

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

By Application

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

By Region

  • North America
  • Latin America
  • Europe
  • Japan
  • APEJ
  • MEA
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Table of Contents

1. Executive Summary
1.1. Global Biologics Safety Testing Market Snapshot
1.2. Future Projections
1.3. Key Market Trends
1.4. Regional Snapshot, by Value, 2023
1.5. Analyst Recommendations
2. Market Overview
2.1. Market Definitions and Segmentations
2.2. Market Dynamics
2.2.1. Drivers
2.2.2. Restraints
2.2.3. Market Opportunities
2.3. Value Chain Analysis
2.4. Porter’s Five Forces Analysis
2.5. COVID-19 Impact Analysis
2.5.1. Supply
2.5.2. Demand
2.6. PESTLE Analysis
3. Global Biologics Safety Testing Market Outlook, 2018 - 2031
3.1. Global Biologics Safety Testing Market Outlook, by Product Type, Value (US$ Bn), 2018 - 2031
3.1.1. Key Highlights
3.1.1.1. Kits & Reagents
3.1.1.2. Instruments
3.1.1.3. Services
3.2. Global Biologics Safety Testing Market Outlook, by Test Type, Value (US$ Bn), 2018 - 2031
3.2.1. Key Highlights
3.2.1.1. Endotoxin Tests
3.2.1.2. Sterility Tests
3.2.1.3. Cell Line Authentication and Characterization Tests
3.2.1.4. Adventitious Agent Detection Tests
3.2.1.5. Bioburden Tests
3.2.1.6. Other Tests
3.3. Global Biologics Safety Testing Market Outlook, by Application, Value (US$ Bn), 2018 - 2031
3.3.1. Key Highlights
3.3.1.1. Vaccine and Therapeutics Development
3.3.1.2. Blood and Blood-related Products Testing
3.3.1.3. Cellular and Gene Therapy
3.3.1.4. Tissue-related Products Testing
3.3.1.5. Stem Cell Research
3.4. Global Biologics Safety Testing Market Outlook, by Region, Value (US$ Bn), 2018 - 2031
3.4.1. Key Highlights
3.4.1.1. North America
3.4.1.2. Europe
3.4.1.3. Asia Pacific
3.4.1.4. Latin America
3.4.1.5. Middle East & Africa
4. North America Biologics Safety Testing Market Outlook, 2018 - 2031
4.1. North America Biologics Safety Testing Market Outlook, by Product Type, Value (US$ Bn), 2018 - 2031
4.1.1. Key Highlights
4.1.1.1. Kits & Reagents
4.1.1.2. Instruments
4.1.1.3. Services
4.2. North America Biologics Safety Testing Market Outlook, by Test Type, Value (US$ Bn), 2018 - 2031
4.2.1. Key Highlights
4.2.1.1. Endotoxin Tests
4.2.1.2. Sterility Tests
4.2.1.3. Cell Line Authentication and Characterization Tests
4.2.1.4. Adventitious Agent Detection Tests
4.2.1.5. Bioburden Tests
4.2.1.6. Other Tests
4.3. North America Biologics Safety Testing Market Outlook, by Application, Value (US$ Bn), 2018 - 2031
4.3.1. Key Highlights
4.3.1.1. Vaccine and Therapeutics Development
4.3.1.2. Blood and Blood-related Products Testing
4.3.1.3. Cellular and Gene Therapy
4.3.1.4. Tissue-related Products Testing
4.3.1.5. Stem Cell Research
4.3.2. BPS Analysis/Market Attractiveness Analysis
4.4. North America Biologics Safety Testing Market Outlook, by Country, Value (US$ Bn), 2018 - 2031
4.4.1. Key Highlights
4.4.1.1. U.S. Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
4.4.1.2. U.S. Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
4.4.1.3. U.S. Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
4.4.1.4. Canada Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
4.4.1.5. Canada Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
4.4.1.6. Canada Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
4.4.2. BPS Analysis/Market Attractiveness Analysis
5. Europe Biologics Safety Testing Market Outlook, 2018 - 2031
5.1. Europe Biologics Safety Testing Market Outlook, by Product Type, Value (US$ Bn), 2018 - 2031
5.1.1. Key Highlights
5.1.1.1. Kits & Reagents
5.1.1.2. Instruments
5.1.1.3. Services
5.2. Europe Biologics Safety Testing Market Outlook, by Test Type, Value (US$ Bn), 2018 - 2031
5.2.1. Key Highlights
5.2.1.1. Endotoxin Tests
5.2.1.2. Sterility Tests
5.2.1.3. Cell Line Authentication and Characterization Tests
5.2.1.4. Adventitious Agent Detection Tests
5.2.1.5. Bioburden Tests
5.2.1.6. Other Tests
5.3. Europe Biologics Safety Testing Market Outlook, by Application, Value (US$ Bn), 2018 - 2031
5.3.1. Key Highlights
5.3.1.1. Vaccine and Therapeutics Development
5.3.1.2. Blood and Blood-related Products Testing
5.3.1.3. Cellular and Gene Therapy
5.3.1.4. Tissue-related Products Testing
5.3.1.5. Stem Cell Research
5.3.2. BPS Analysis/Market Attractiveness Analysis
5.4. Europe Biologics Safety Testing Market Outlook, by Country, Value (US$ Bn), 2018 - 2031
5.4.1. Key Highlights
5.4.1.1. Germany Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
5.4.1.2. Germany Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
5.4.1.3. Germany Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
5.4.1.4. U.K. Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
5.4.1.5. U.K. Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
5.4.1.6. U.K. Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
5.4.1.7. France Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
5.4.1.8. France Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
5.4.1.9. France Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
5.4.1.10. Italy Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
5.4.1.11. Italy Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
5.4.1.12. Italy Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
5.4.1.13. Turkey Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
5.4.1.14. Turkey Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
5.4.1.15. Turkey Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
5.4.1.16. Russia Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
5.4.1.17. Russia Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
5.4.1.18. Russia Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
5.4.1.19. Rest of Europe Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
5.4.1.20. Rest of Europe Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
5.4.1.21. Rest of Europe Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
5.4.2. BPS Analysis/Market Attractiveness Analysis
6. Asia Pacific Biologics Safety Testing Market Outlook, 2018 - 2031
6.1. Asia Pacific Biologics Safety Testing Market Outlook, by Product Type, Value (US$ Bn), 2018 - 2031
6.1.1. Key Highlights
6.1.1.1. Kits & Reagents
6.1.1.2. Instruments
6.1.1.3. Services
6.2. Asia Pacific Biologics Safety Testing Market Outlook, by Test Type, Value (US$ Bn), 2018 - 2031
6.2.1. Key Highlights
6.2.1.1. Endotoxin Tests
6.2.1.2. Sterility Tests
6.2.1.3. Cell Line Authentication and Characterization Tests
6.2.1.4. Adventitious Agent Detection Tests
6.2.1.5. Bioburden Tests
6.2.1.6. Other Tests
6.3. Asia Pacific Biologics Safety Testing Market Outlook, by Application, Value (US$ Bn), 2018 - 2031
6.3.1. Key Highlights
6.3.1.1. Vaccine and Therapeutics Development
6.3.1.2. Blood and Blood-related Products Testing
6.3.1.3. Cellular and Gene Therapy
6.3.1.4. Tissue-related Products Testing
6.3.1.5. Stem Cell Research
6.3.2. BPS Analysis/Market Attractiveness Analysis
6.4. Asia Pacific Biologics Safety Testing Market Outlook, by Country, Value (US$ Bn), 2018 - 2031
6.4.1. Key Highlights
6.4.1.1. China Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
6.4.1.2. China Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
6.4.1.3. China Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
6.4.1.4. Japan Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
6.4.1.5. Japan Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
6.4.1.6. Japan Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
6.4.1.7. South Korea Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
6.4.1.8. South Korea Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
6.4.1.9. South Korea Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
6.4.1.10. India Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
6.4.1.11. India Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
6.4.1.12. India Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
6.4.1.13. Southeast Asia Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
6.4.1.14. Southeast Asia Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
6.4.1.15. Southeast Asia Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
6.4.1.16. Rest of Asia Pacific Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
6.4.1.17. Rest of Asia Pacific Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
6.4.1.18. Rest of Asia Pacific Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
6.4.2. BPS Analysis/Market Attractiveness Analysis
7. Latin America Biologics Safety Testing Market Outlook, 2018 - 2031
7.1. Latin America Biologics Safety Testing Market Outlook, by Product Type, Value (US$ Bn), 2018 - 2031
7.1.1. Key Highlights
7.1.1.1. Kits & Reagents
7.1.1.2. Instruments
7.1.1.3. Services
7.2. Latin America Biologics Safety Testing Market Outlook, by Test Type, Value (US$ Bn), 2018 - 2031
7.2.1.1. Endotoxin Tests
7.2.1.2. Sterility Tests
7.2.1.3. Cell Line Authentication and Characterization Tests
7.2.1.4. Adventitious Agent Detection Tests
7.2.1.5. Bioburden Tests
7.2.1.6. Other Tests
7.3. Latin America Biologics Safety Testing Market Outlook, by Application, Value (US$ Bn), 2018 - 2031
7.3.1. Key Highlights
7.3.1.1. Vaccine and Therapeutics Development
7.3.1.2. Blood and Blood-related Products Testing
7.3.1.3. Cellular and Gene Therapy
7.3.1.4. Tissue-related Products Testing
7.3.1.5. Stem Cell Research
7.3.2. BPS Analysis/Market Attractiveness Analysis
7.4. Latin America Biologics Safety Testing Market Outlook, by Country, Value (US$ Bn), 2018 - 2031
7.4.1. Key Highlights
7.4.1.1. Brazil Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
7.4.1.2. Brazil Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
7.4.1.3. Brazil Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
7.4.1.4. Mexico Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
7.4.1.5. Mexico Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
7.4.1.6. Mexico Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
7.4.1.7. Argentina Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
7.4.1.8. Argentina Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
7.4.1.9. Argentina Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
7.4.1.10. Rest of Latin America Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
7.4.1.11. Rest of Latin America Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
7.4.1.12. Rest of Latin America Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
7.4.2. BPS Analysis/Market Attractiveness Analysis
8. Middle East & Africa Biologics Safety Testing Market Outlook, 2018 - 2031
8.1. Middle East & Africa Biologics Safety Testing Market Outlook, by Product Type, Value (US$ Bn), 2018 - 2031
8.1.1. Key Highlights
8.1.1.1. Kits & Reagents
8.1.1.2. Instruments
8.1.1.3. Services
8.2. Middle East & Africa Biologics Safety Testing Market Outlook, by Test Type, Value (US$ Bn), 2018 - 2031
8.2.1. Key Highlights
8.2.1.1. Endotoxin Tests
8.2.1.2. Sterility Tests
8.2.1.3. Cell Line Authentication and Characterization Tests
8.2.1.4. Adventitious Agent Detection Tests
8.2.1.5. Bioburden Tests
8.2.1.6. Other Tests
8.3. Middle East & Africa Biologics Safety Testing Market Outlook, by Application, Value (US$ Bn), 2018 - 2031
8.3.1. Key Highlights
8.3.1.1. Vaccine and Therapeutics Development
8.3.1.2. Blood and Blood-related Products Testing
8.3.1.3. Cellular and Gene Therapy
8.3.1.4. Tissue-related Products Testing
8.3.1.5. Stem Cell Research
8.3.2. BPS Analysis/Market Attractiveness Analysis
8.4. Middle East & Africa Biologics Safety Testing Market Outlook, by Country, Value (US$ Bn), 2018 - 2031
8.4.1. Key Highlights
8.4.1.1. GCC Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
8.4.1.2. GCC Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
8.4.1.3. GCC Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
8.4.1.4. South Africa Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
8.4.1.5. South Africa Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
8.4.1.6. South Africa Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
8.4.1.7. Egypt Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
8.4.1.8. Egypt Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
8.4.1.9. Egypt Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
8.4.1.10. Nigeria Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
8.4.1.11. Nigeria Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
8.4.1.12. Nigeria Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
8.4.1.13. Rest of Middle East & Africa Biologics Safety Testing Market by Product Type, Value (US$ Bn), 2018 - 2031
8.4.1.14. Rest of Middle East & Africa Biologics Safety Testing Market by Test Type, Value (US$ Bn), 2018 - 2031
8.4.1.15. Rest of Middle East & Africa Biologics Safety Testing Market by Application, Value (US$ Bn), 2018 - 2031
8.4.2. BPS Analysis/Market Attractiveness Analysis
9. Competitive Landscape
9.1. Product vs Indication Heatmap
9.2. Company Market Share Analysis, 2022
9.3. Competitive Dashboard
9.4. Company Profiles
9.4.1. Charles River Laboratories International, Inc.
9.4.1.1. Company Overview
9.4.1.2. Product Portfolio
9.4.1.3. Financial Overview
9.4.1.4. Business Strategies and Development
9.4.2. Eurofins Scientific Se
9.4.2.1. Company Overview
9.4.2.2. Product Portfolio
9.4.2.3. Financial Overview
9.4.2.4. Business Strategies and Development
9.4.3. SGS S.A.
9.4.3.1. Company Overview
9.4.3.2. Product Portfolio
9.4.3.3. Financial Overview
9.4.3.4. Business Strategies and Development
9.4.4. Thermo Fisher Scientific Inc.
9.4.4.1. Company Overview
9.4.4.2. Product Portfolio
9.4.4.3. Financial Overview
9.4.4.4. Business Strategies and Development
9.4.5. Genscript
9.4.5.1. Company Overview
9.4.5.2. Product Portfolio
9.4.5.3. Financial Overview
9.4.5.4. Business Strategies and Development
9.4.6. Biomérieux Sa
9.4.6.1. Company Overview
9.4.6.2. Product Portfolio
9.4.6.3. Financial Overview
9.4.6.4. Business Strategies and Development
9.4.7. Pace Analytical Services Inc.
9.4.7.1. Company Overview
9.4.7.2. Product Portfolio
9.4.7.3. Financial Overview
9.4.7.4. Business Strategies and Development
9.4.8. Lonza Group Ltd.
9.4.8.1. Company Overview
9.4.8.2. Product Portfolio
9.4.8.3. Financial Overview
9.4.8.4. Business Strategies and Development
9.4.9. Others
9.4.9.1. Company Overview
9.4.9.2. Product Portfolio
9.4.9.3. Financial Overview
9.4.9.4. Business Strategies and Development
10. Appendix
10.1. Research Methodology
10.2. Report Assumptions
10.3. Acronyms and Abbreviations

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Charles River Laboratories International, Inc.
  • Eurofins Scientific Se
  • SGS S.A.
  • Thermo Fisher Scientific Inc.
  • Genscript
  • Biomérieux Sa
  • Pace Analytical Services Inc.
  • Lonza Group Ltd.
  • Toxikon Corporation
  • Wuxi Apptec

Methodology

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