Biological Safety Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

The biological safety testing market is segmented by product, application, test (sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and other tests), and geography.

Market Snapshot

Biological Safety Testing Market_Image 1
Study Period:

2018 - 2026

Base Year:


Fastest Growing Market:

Asia Pacific

Largest Market:

North America


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Market Overview

The biological safety testing market is expected witness a CAGR of 12.4% during the forecast period. Factors that are driving the market growth include growth in the pharmaceutical and biotechnology industries, along with increasing investments, and rising production of new biologics due to high disease burden.

  • The biotechnology-derived products or biologicals have effectively made their ways into various aspects of healthcare, including diagnoses, prevention, and treatments of diseases.
  • However, there remain certain potential safety concerns, which generally arise from the manufacturing processes and complex biological and structural characteristics of these products.
  • Therefore, such products require detailed and systematic biological safety testing, which eventually enables the adequate assessment of safety, before any kind of clinical investigation.
  • Hence, the market is expected to observe significant growth, globally, over the forecast period.

Scope of the Report

Biological safety testing refers to the testing procedures that are carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. This includes various types of sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and residual host contamination detection tests, among others.

Reagents and Kits
Other Products
Vaccines and Therapeutics
Cellular and Gene Therapy
Blood and Blood-based Therapy
Other Applications
Sterility Tests
Cell Line Authentication and Characterisation Tests
Bioburden Tests
Endotoxin Tests
Adventitious Agent Detection Tests
Other Tests
North America
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle East & Africa
South Africa
Rest of Middle East & Africa
South America
Rest of South America

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Key Market Trends

Vaccines and Therapeutics Segment is Expected to Hold Significant Share in the Application Segment of the Market

Vaccination is considered the most effective way of preventing infection and severe outcomes caused by a number of deadly viruses. Every licensed and recommended vaccine has to go through years of safety testing, including the testing and evaluation of the vaccine, before it is licensed by the Food and Drug Administration (FDA) and recommended for use by the Centers for Disease Control and Prevention (CDC). Safety testing also includes monitoring the vaccine’s safety after it is recommended for infants, children, or adults. The vaccine continues to be tested, even after it receives approval. The company that manufactures the vaccine continues to test several batches, in order to make sure that the vaccine is potent, pure, and sterile.

Biological Safety Testing Market_Image 2

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North America Dominates the Market and is Expected to do the Same in the Forecast Period

The growth of the biological safety testing market in North America can be directly attributed to the growing biotechnology and pharmaceutical industries in the region. The high growth of these industries is further attributable to factors, such as innovative technologies and the presence of favorable government initiatives. Additionally, the advanced healthcare infrastructure and rising R&D spending is expected to increase the revenue size further.

Biological Safety Testing Market_Image 3

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Competitive Landscape

The biological safety testing market is highly competitive and consists of a few major players. Companies, like Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, and WuXi AppTec, among others, hold a substantial share in the market.

Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Growth in the Pharmaceutical and Biotechnology Industries, along with Increasing Investments

      2. 4.2.2 Rising Production of New Biologics due to High Disease Burden

    3. 4.3 Market Restraints

      1. 4.3.1 Time Consuming Approval Process

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 Product

      1. 5.1.1 Reagents and Kits

      2. 5.1.2 Instruments

      3. 5.1.3 Other Products

    2. 5.2 Application

      1. 5.2.1 Vaccines and Therapeutics

      2. 5.2.2 Cellular and Gene Therapy

      3. 5.2.3 Blood and Blood-based Therapy

      4. 5.2.4 Other Applications

    3. 5.3 Test

      1. 5.3.1 Sterility Tests

      2. 5.3.2 Cell Line Authentication and Characterisation Tests

      3. 5.3.3 Bioburden Tests

      4. 5.3.4 Endotoxin Tests

      5. 5.3.5 Adventitious Agent Detection Tests

      6. 5.3.6 Other Tests

    4. 5.4 Geography

      1. 5.4.1 North America

        1. US

        2. Canada

        3. Mexico

      2. 5.4.2 Europe

        1. Germany

        2. UK

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.4.4 Middle East & Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East & Africa

      5. 5.4.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Avance Biosciences

      2. 6.1.2 Cytovance Biologics

      3. 6.1.3 Eurofins Scientific

      4. 6.1.4 Lonza

      5. 6.1.5 Merck KGaA

      6. 6.1.6 Promega Corporation

      7. 6.1.7 Thermo Fisher Scientific

      8. 6.1.8 Toxikon

      9. 6.1.9 WuXi AppTec

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Biological Safety Testing Market market is studied from 2018 - 2026.

The Biological Safety Testing Market is valued at 12.4% in 2018.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2020.

  • Eurofins Scientific
  • Lonza
  • Merck KGaA
  • Promega Corporation
  • Thermo Fisher Scientific

Are the major companies operating in Biological Safety Testing Market.

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