Biological Safety Testing Market Size, Share, and Trends 2024 to 2034

The global biological safety testing market size is calculated at USD 5.51 billion in 2025 and is forecasted to reach around USD 17.00 billion by 2034, accelerating at a CAGR of 13.36% from 2025 to 2034. The North America market size surpassed USD 2.04 billion in 2024 and is expanding at a CAGR of 13.35% during the forecast period. The market sizing and forecasts are revenue-based (USD Million/Billion), with 2024 as the base year.

  • Last Updated : February 2025
  • Report Code : 4608
  • Category : Healthcare

Chapter 1. Introduction

1.1. Research Objective

1.2. Scope of the Study

1.3. Definition

Chapter 2. Research Methodology (Premium Insights)

2.1. Research Approach

2.2. Data Sources

2.3. Assumptions & Limitations

Chapter 3. Executive Summary

3.1. Market Snapshot

Chapter 4. Market Variables and Scope 

4.1. Introduction

4.2. Market Classification and Scope

4.3. Industry Value Chain Analysis

4.3.1. Raw Material Procurement Analysis 

4.3.2. Sales and Distribution Channel Analysis

4.3.3. Downstream Buyer Analysis

Chapter 5. COVID 19 Impact on Biological Safety Testing Market 

5.1. COVID-19 Landscape: Biological Safety Testing Industry Impact

5.2. COVID 19 - Impact Assessment for the Industry

5.3. COVID 19 Impact: Global Major Government Policy

5.4. Market Trends and Opportunities in the COVID-19 Landscape

6.1. Market Dynamics

6.1.1. Market Drivers

6.1.2. Market Restraints

6.1.3. Market Opportunities

6.2. Porter’s Five Forces Analysis

6.2.1. Bargaining power of suppliers

6.2.2. Bargaining power of buyers

6.2.3. Threat of substitute

6.2.4. Threat of new entrants

6.2.5. Degree of competition

Chapter 7. Competitive Landscape

7.1.1. Company Market Share/Positioning Analysis

7.1.2. Key Strategies Adopted by Players

7.1.3. Vendor Landscape

7.1.3.1. List of Suppliers

7.1.3.2. List of Buyers

Chapter 8. Global Biological Safety Testing Market, By Product

8.1. Biological Safety Testing Market, by Product

8.1.1 Reagents & Kits

8.1.1.1. Market Revenue and Forecast

8.1.2. Instruments

8.1.2.1. Market Revenue and Forecast

8.1.3. Other Products

8.1.3.1. Market Revenue and Forecast

Chapter 9. Global Biological Safety Testing Market, By Application

9.1. Biological Safety Testing Market, by Application

9.1.1. Vaccines & Therapeutics

9.1.1.1. Market Revenue and Forecast

9.1.2. Cellular & Gene Therapy

9.1.2.1. Market Revenue and Forecast

9.1.3. Blood & Blood-Based Therapy

9.1.3.1. Market Revenue and Forecast

9.1.4. Other Applications

9.1.4.1. Market Revenue and Forecast

Chapter 10. Global Biological Safety Testing Market, By Test 

10.1. Biological Safety Testing Market, by Test

10.1.1. Sterility Tests

10.1.1.1. Market Revenue and Forecast

10.1.2. Bioburden Tests

10.1.2.1. Market Revenue and Forecast

10.1.3. Endotoxin Tests

10.1.3.1. Market Revenue and Forecast

10.1.4. Other Tests

10.1.4.1. Market Revenue and Forecast

Chapter 11. Global Biological Safety Testing Market, Regional Estimates and Trend Forecast

11.1. North America

11.1.1. Market Revenue and Forecast, by Product

11.1.2. Market Revenue and Forecast, by Application

11.1.3. Market Revenue and Forecast, by Test

11.1.4. U.S.

11.1.4.1. Market Revenue and Forecast, by Product

11.1.4.2. Market Revenue and Forecast, by Application

11.1.4.3. Market Revenue and Forecast, by Test

11.1.5. Rest of North America

11.1.5.1. Market Revenue and Forecast, by Product

11.1.5.2. Market Revenue and Forecast, by Application

11.1.5.3. Market Revenue and Forecast, by Test

11.2. Europe

11.2.1. Market Revenue and Forecast, by Product

11.2.2. Market Revenue and Forecast, by Application

11.2.3. Market Revenue and Forecast, by Test

11.2.4. UK

11.2.4.1. Market Revenue and Forecast, by Product

11.2.4.2. Market Revenue and Forecast, by Application

11.2.4.3. Market Revenue and Forecast, by Test

11.2.5. Germany

11.2.5.1. Market Revenue and Forecast, by Product

11.2.5.2. Market Revenue and Forecast, by Application

11.2.5.3. Market Revenue and Forecast, by Test

11.2.6. France

11.2.6.1. Market Revenue and Forecast, by Product

11.2.6.2. Market Revenue and Forecast, by Application

11.2.6.3. Market Revenue and Forecast, by Test

11.2.7. Rest of Europe

11.2.7.1. Market Revenue and Forecast, by Product

11.2.7.2. Market Revenue and Forecast, by Application

11.2.7.3. Market Revenue and Forecast, by Test

11.3. APAC

11.3.1. Market Revenue and Forecast, by Product

11.3.2. Market Revenue and Forecast, by Application

11.3.3. Market Revenue and Forecast, by Test

11.3.4. India

11.3.4.1. Market Revenue and Forecast, by Product

11.3.4.2. Market Revenue and Forecast, by Application

11.3.4.3. Market Revenue and Forecast, by Test

11.3.5. China

11.3.5.1. Market Revenue and Forecast, by Product

11.3.5.2. Market Revenue and Forecast, by Application

11.3.5.3. Market Revenue and Forecast, by Test

11.3.6. Japan

11.3.6.1. Market Revenue and Forecast, by Product

11.3.6.2. Market Revenue and Forecast, by Application

11.3.6.3. Market Revenue and Forecast, by Test

11.3.7. Rest of APAC

11.3.7.1. Market Revenue and Forecast, by Product

11.3.7.2. Market Revenue and Forecast, by Application

11.3.7.3. Market Revenue and Forecast, by Test

11.4. MEA

11.4.1. Market Revenue and Forecast, by Product

11.4.2. Market Revenue and Forecast, by Application

11.4.3. Market Revenue and Forecast, by Test

11.4.4. GCC

11.4.4.1. Market Revenue and Forecast, by Product

11.4.4.2. Market Revenue and Forecast, by Application

11.4.4.3. Market Revenue and Forecast, by Test

11.4.5. North Africa

11.4.5.1. Market Revenue and Forecast, by Product

11.4.5.2. Market Revenue and Forecast, by Application

11.4.5.3. Market Revenue and Forecast, by Test

11.4.6. South Africa

11.4.6.1. Market Revenue and Forecast, by Product

11.4.6.2. Market Revenue and Forecast, by Application

11.4.6.3. Market Revenue and Forecast, by Test

11.4.7. Rest of MEA

11.4.7.1. Market Revenue and Forecast, by Product

11.4.7.2. Market Revenue and Forecast, by Application

11.4.7.3. Market Revenue and Forecast, by Test

11.5. Latin America

11.5.1. Market Revenue and Forecast, by Product

11.5.2. Market Revenue and Forecast, by Application

11.5.3. Market Revenue and Forecast, by Test

11.5.4. Brazil

11.5.4.1. Market Revenue and Forecast, by Product

11.5.4.2. Market Revenue and Forecast, by Application

11.5.4.3. Market Revenue and Forecast, by Test

11.5.5. Rest of LATAM

11.5.5.1. Market Revenue and Forecast, by Product

11.5.5.2. Market Revenue and Forecast, by Application

11.5.5.3. Market Revenue and Forecast, by Test

Chapter 12. Company Profiles

12.1. Cytovance Biologics

12.1.1. Company Overview

12.1.2. Product Offerings

12.1.3. Financial Performance

12.1.4. Recent Initiatives

12.2. Biomerieux SA

12.2.1. Company Overview

12.2.2. Product Offerings

12.2.3. Financial Performance

12.2.4. Recent Initiatives

12.3. Promega Corporation

12.3.1. Company Overview

12.3.2. Product Offerings

12.3.3. Financial Performance

12.3.4. Recent Initiatives

12.4. Thermo Fisher Scientific

12.4.1. Company Overview

12.4.2. Product Offerings

12.4.3. Financial Performance

12.4.4. Recent Initiatives

12.5. WuXi AppTec

12.5.1. Company Overview

12.5.2. Product Offerings

12.5.3. Financial Performance

12.5.4. Recent Initiatives

12.6. Nelson Laboratories, LLC

12.6.1. Company Overview

12.6.2. Product Offerings

12.6.3. Financial Performance

12.6.4. Recent Initiatives

12.7. Almac Group

12.7.1. Company Overview

12.7.2. Product Offerings

12.7.3. Financial Performance

12.7.4. Recent Initiatives

12.8. GenScript

12.8.1. Company Overview

12.8.2. Product Offerings

12.8.3. Financial Performance

12.8.4. Recent Initiatives

12.9. InvivoGen

12.9.1. Company Overview

12.9.2. Product Offerings

12.9.3. Financial Performance

12.9.4. Recent Initiatives

12.10. Toxikon

12.10.1. Company Overview

12.10.2. Product Offerings

12.10.3. Financial Performance

12.10.4. Recent Initiatives

Chapter 13. Research Methodology

13.1. Primary Research

13.2. Secondary Research

13.3. Assumptions

Chapter 14. Appendix

14.1. About Us

14.2. Glossary of Terms

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Frequently Asked Questions

The global biological safety testing market size is expected to increase USD 17.00 billion by 2034 from USD 4.85 billion in 2024.

The biological safety testing market is anticipated to grow at a CAGR of over 13.36% between 2025 and 2034.

The major players operating in the biological safety testing market are Cytovance Biologics, Biomerieux SA, Promega Corporation, Thermo Fisher Scientific, WuXi AppTec, Nelson Laboratories, LLC, Almac Group, GenScript, InvivoGen, Toxikon, Maravai LifeSciences, Merck KGaA, Thermo Fisher Scientific Inc., Charles River Laboratories International, Inc., Lonza Group AG, SGS SA, WuXi AppTec, Eurofins Scientific SE, Cytiva, Sartorius AG, Charles River Laboratories, F. Hoffmann-La Roche, and Others.

The driving factors of the biological safety testing market are the rapid growth of the pharmaceutical and biotechnology sector and increasing development of mAbs and biosimilars.

North America region will lead the global biological safety testing market during the forecast period 2025 to 2034.

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