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

The Biological Safety Testing Market is segmented by Product (Reagents and Kits, Instruments and Other Products), by Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy and 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 report offers the value (in USD million) for the above segments.

Market Snapshot

Biological Safety Testing Market_Image 1
Study Period: 2018 - 2026
Base Year: 2020
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 12.4 %

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Market Overview

The biological safety testing market is expected to witness a CAGR of 12.4% during the forecast period, 2021-2026. 

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 on 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 treatment 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 2019, biologics accounted for six 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 19 billion sales, as per the Top 15 Best-selling Drugs of 2019 report. Humira was also the fastest-growing biological drug.

Further, 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, these products needs 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.

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. The Biological Safety Testing market is segmented by Product (Reagents and Kits, Instruments and Other Products), by Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy and 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 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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Key Market Trends

Bioburden Testing Segment is Expected to Hold Significant Share in the Test Segment of the Market Over the Forecast Period

Bioburden Testing Segment is expected to hold a significant share in the test segment of the market over the forecast period. Organizations like the World Health Organization have also released instructions for health managers and health workers on required infrastructures and standard procedures for effective sterilization, and decontamination of medical devices. These factors are expected to increase the demand for proper sterilization, which is expected to boost the demand of Bioburden testing as it acts as an efficient tool in the validation of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes to ensure safety. 

Bioburden testing is an integral part of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes, monitoring of raw materials, components, or packaging, and overall environmental monitoring programs. The high adoption rate, to determine bioburden limits in wide-ranging biologics and medical devices. Further, the development of new products in the market is expected to accelerate the market studied. For instance, in December 2019, the company has launched the BD Kiestra IdentifA system in Europe and Canada, that is used for microbial identification. It has incorporated automated sample processing steps that ensures accuracy and minimal error. 

Furthermore, there are high bioburden and microbial contamination rates during pharmaceutical and biologics manufacturing, which is expected to drive government and private organizations to improve underlying biological safety practices. Hence, all these practices performed might drive the overall market. 

PhRMA Member Company R&D Expenditure (in USD billlion), the United States, 2018 and 2019

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

North America Dominates the Market and is expected to do the same in the forecast period. The United States is expected to contribute majorly to the market growth of this region. Due to the outbreak of COVID-19, the rising R&D activities related to the COVID-19 have impacted positively on the market growth. 

The growth of the biological safety testing market in this region 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. Also, the emerging need for validation of drugs and devices process of manufacturing is expected to boost the demand for the market studied. According to the United States Food & Drug Administration (FDA) report, in 2019, the United States had about 4,676 manufacturing sites for drugs.  

Additionally, the advanced healthcare infrastructure and rising R&D spending are expected to increase the revenue size further. According to the data of Pharmaceutical Research and Manufacturers of America (PhRMA), in the United States, about USD 83 billion were spent by the pharmaceuticalndustry on the R&D. Thus, this is expected to boost the market growth over the forecast period.

Biological Safety Testing Market - Growth Rate by Region

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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.

Recent Developments

In April 2021, Lonza expanded its product ''PyroTec PRO Automated Robotic Solution'' for endotoxin testing. It is compatible with the company's product PYROGENT-5000 Turbidimetric LAL (Limulus Amebocyte Lysate) Assay, Kinetic-QCL Chromogenic LAL Assay, and the PyroGene rFC Assay.

In December 2020, Redberry introduced a new product ''Red One Automated Bioburden Detection'' that enables instantaneous bioburden detection of microorganisms and has been designed for water and pharmaceutical testing.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 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 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

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Product

      1. 5.1.1 Reagents and Kits

      2. 5.1.2 Instruments

      3. 5.1.3 Other Products

    2. 5.2 By 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 By Test

      1. 5.3.1 Sterility Tests

      2. 5.3.2 Bioburden Tests

      3. 5.3.3 Endotoxin Tests

      4. 5.3.4 Other Tests

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        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 United Kingdom

        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

      10. 6.1.10 Biomerieux SA

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

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

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Frequently Asked Questions

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

The Global Biological Safety Testing Market is growing at a CAGR of 12.4% over the next 5 years.

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 Global Biological Safety Testing Market.

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