Biological Safety Testing Market - Growth, Trends, and Forecast (2019 - 2024)

The market is segmented by Product, Application, Test (Sterility tests, Cell line authentication and characterization tests, Bioburden tests, Endotoxin tests, Adventitious Agent Detection Tests, Others), and Geography

Market Snapshot

Biological Safety Testing Market_Image 1
Study Period:

2016-2024

Base Year:

2018

Fastest Growing Market:

Asia Pacific

Largest Market:

North America

CAGR:

12.4%

Key Players:

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Market Overview

Global Biological Safety Testing market is expected witness a CAGR of 12.4% during the forecast period. Certain factors that are driving the market growth include growth in pharmaceutical and biotechnology industries along with increasing investments, and increasing production of new biologics due to high disease burden.

The biotechnology-derived products or biologicals have effectively made their way into various aspects of healthcare including diagnosis, prevention as well as treatment of disease. However, there remain potential safety concerns which generally arise from their manufacturing processes and also from the complex biological and structural characteristics of these products. Therefore, such products require detailed and systematic biological safety testing which eventually enables for adequate assessment of safety before any kind of clinical investigation. Hence, the market is expected to observe significant growth all across the globe over the forecast period.

Scope of the Report

Biological safety testing refers to the testing procedures which are carried out to ensure non-contamination of biopharmaceuticals and vaccines and also in order to comply with regulations regarding the same. These include various types of sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, residual host contamination detection tests etc.

Product
Reagents & Kits
Instruments
Others
Application
Vaccines & Therapeutics
Cellular and Gene Therapy
Blood & Blood-based Therapy
Others
Test
Sterility tests
Cell Line Authentication and Characterisation Tests
Bioburden tests
Endotoxin tests
Adventitious Agent Detection Tests
Others
Geography
North America
US
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
Rest of Europe
Asia Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

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

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 testing and evaluation of the vaccine before it’s licensed by the Food and Drug Administration (FDA) and recommended for use by the Centers for Disease Control and Prevention (CDC). The safety testing also includes the monitoring the vaccine’s safety after it is recommended for infants, children, or adults. Once a vaccine gets approval, it continues to be tested. The company that manufactures the vaccine continues to test batches to make sure the vaccine is potent, pure, and sterile.

Biological Safety Testing Market_Image 2

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

The growth of the biological safety testing market in North America can be directly attributed to the growing biotechnology and pharmaceutical industry 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. Furthermore, advanced healthcare infrastructure and rising R&D spending should further spur revenue size.

Biological Safety Testing Market_Image 3

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Competitive Landscape

The global 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, WuXi AppTec, among others, hold the substantial market share in the Biological Safety Testingmarket.

Major Players

  1. Eurofins Scientific
  2. Lonza
  3. Merck KGaA
  4. Promega Corporation
  5. Thermo Fisher Scientific

* Complete list of players covered available in the table of contents below

Biological Safety Testing Market_Image 4

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

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

      2. 4.2.2 Increasing 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 Force 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

  5. 5. MARKET SEGMENTATION

    1. 5.1 Product

      1. 5.1.1 Reagents & Kits

      2. 5.1.2 Instruments

      3. 5.1.3 Others

    2. 5.2 Application

      1. 5.2.1 Vaccines & Therapeutics

      2. 5.2.2 Cellular and Gene Therapy

      3. 5.2.3 Blood & Blood-based Therapy

      4. 5.2.4 Others

    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 Others

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 US

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 UK

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    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
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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