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Global Biological Safety Testing Market Size (2024 - 2029)

The biological safety testing market is poised for significant growth, driven by the increasing demand for ensuring the safety and efficacy of vaccines and biologics, particularly in the wake of COVID-19. The expansion of the pharmaceutical and biotechnology sectors, coupled with rising investments and the development of new biologics, is contributing to the market's upward trajectory. Despite the complexities and time-consuming nature of biological safety testing, which may pose challenges, the need for thorough safety assessments before clinical investigations underscores the market's potential for growth.

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Market Size of Global Biological Safety Testing Industry

Biological Safety Testing Market_Image 1
Study Period 2019 - 2029
Base Year For Estimation 2023
CAGR 12.40 %
Fastest Growing Market Asia Pacific
Largest Market North America
Market Concentration Medium

Major Players

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*Disclaimer: Major Players sorted in no particular order

Biological Safety Testing Market Analysis

The biological safety testing market is expected to witness a CAGR of 12.4% during the forecast period.

With the emergence of COVID-19, many pharmaceutical and biotechnology companies began developing novel treatments and vaccines against COVID-19. These rising R&D activities impacted positively the biological safety testing market studied. For instance, in March 2020, Regeneron and Sanofi initiated the development of their biologic Kevzara for the treatment of patients with COVID-19. Kevzara (Sarilumab), jointly developed by Regeneron and Sanofi, also inhibits the IL-6 pathway. Biological safety testing plays a major role in ensuring the purity of vaccines and other biological products. Thus, with the development of new treatments for COVID-19, the demand for biological safety testing has also increased.

Some of the major factors that are driving the market growth are rapidly growing pharmaceutical and biotechnology industries, along with increasing investments, and rising production of new biologics due to the high disease burden. For instance, in 2021, biologics accounted for second of the top-eight drugs in terms of revenue. Humira (adalimumab), which was developed by AbbVie for the treatment of rheumatoid arthritis, psoriasis, Crohn's, and other autoimmune diseases, led to USD 20.7 billion sales, as per the Top 15 Best-selling Drugs of 2021 report. Humira was also the fastest-growing biological drug.

Further, biotechnology-derived products or biologicals have effectively made their way 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, these products need detailed and systematic biological safety testing, that eventually enables the adequate assessment of safety, before any kind of clinical investigation. Hence, the market is expected to thrive over the forecast period.

However, the biological safety process is quite time-consuming and complex which is expected to hinder the market growth.

Biological Safety Testing Industry Segmentation

Biological safety testing refers to the testing procedures that are carried out to ensure the 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. The Biological Safety Testing market is segmented by Product (Reagents and Kits, Instruments, Other Products), by Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, Other Applications), by Test (Sterility Tests, Bioburden Tests, Endotoxin Tests, Other Tests), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Product
Reagents and Kits
Instruments
Other Products
By Application
Vaccines and Therapeutics
Cellular and Gene Therapy
Blood and Blood-based Therapy
Other Applications
By Test
Sterility Tests
Bioburden Tests
Endotoxin Tests
Other Tests
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
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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Global Biological Safety Testing Market Size Summary

The biological safety testing market is poised for significant growth, driven by the increasing demand for ensuring the purity and safety of vaccines and biological products. The surge in research and development activities, particularly in response to the COVID-19 pandemic, has been a major catalyst for this market expansion. Pharmaceutical and biotechnology companies have been actively developing novel treatments and vaccines, which has heightened the need for rigorous biological safety testing. This market is further bolstered by the rapid growth of the pharmaceutical and biotechnology sectors, alongside substantial investments and the production of new biologics to address the high disease burden. Despite the complexities and time-consuming nature of biological safety processes, the market is expected to thrive, supported by the critical role of testing in assessing the safety of biotechnology-derived products.

North America is the dominant region in the biological safety testing market, with the United States playing a pivotal role in its growth. The region's robust biotechnology and pharmaceutical industries, coupled with innovative technologies and favorable government initiatives, have significantly contributed to market expansion. The need for validation of drug and device manufacturing processes is also driving demand. The advanced healthcare infrastructure and increased R&D spending in the United States further enhance the market's revenue potential. The market is highly competitive, with major players like Avance Biosciences, Cytovance Biologics, and Thermo Fisher Scientific holding substantial shares. Recent product innovations, such as automated solutions for endotoxin testing and bioburden detection, are expected to propel market growth over the forecast period.

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Global Biological Safety Testing Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Growth in the Pharmaceutical and Biotechnology Industries, along with Increasing Investments

      2. 1.2.2 Rising Production of New Biologics due to High Disease Burden

    3. 1.3 Market Restraints

      1. 1.3.1 Time Consuming Approval Process

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size - Value in USD million)

    1. 2.1 By Product

      1. 2.1.1 Reagents and Kits

      2. 2.1.2 Instruments

      3. 2.1.3 Other Products

    2. 2.2 By Application

      1. 2.2.1 Vaccines and Therapeutics

      2. 2.2.2 Cellular and Gene Therapy

      3. 2.2.3 Blood and Blood-based Therapy

      4. 2.2.4 Other Applications

    3. 2.3 By Test

      1. 2.3.1 Sterility Tests

      2. 2.3.2 Bioburden Tests

      3. 2.3.3 Endotoxin Tests

      4. 2.3.4 Other Tests

    4. 2.4 Geography

      1. 2.4.1 North America

        1. 2.4.1.1 United States

        2. 2.4.1.2 Canada

        3. 2.4.1.3 Mexico

      2. 2.4.2 Europe

        1. 2.4.2.1 Germany

        2. 2.4.2.2 United Kingdom

        3. 2.4.2.3 France

        4. 2.4.2.4 Italy

        5. 2.4.2.5 Spain

        6. 2.4.2.6 Rest of Europe

      3. 2.4.3 Asia-Pacific

        1. 2.4.3.1 China

        2. 2.4.3.2 Japan

        3. 2.4.3.3 India

        4. 2.4.3.4 Australia

        5. 2.4.3.5 South Korea

        6. 2.4.3.6 Rest of Asia-Pacific

      4. 2.4.4 Middle East and Africa

        1. 2.4.4.1 GCC

        2. 2.4.4.2 South Africa

        3. 2.4.4.3 Rest of Middle East and Africa

      5. 2.4.5 South America

        1. 2.4.5.1 Brazil

        2. 2.4.5.2 Argentina

        3. 2.4.5.3 Rest of South America

Global Biological Safety Testing Market Size FAQs

The Global Biological Safety Testing Market is projected to register a CAGR of 12.40% during the forecast period (2024-2029)

Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation and Thermo Fisher Scientific are the major companies operating in the Global Biological Safety Testing Market.

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