Biological Safety Testing Market

Global Biological Safety Testing Market by Product (Reagents and Kits, Instruments and Others), Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy and Others), Test (Sterility Tests, Bioburden Tests, Endotoxin Tests, and Others), and Regions (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) -Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021 – 2028

  • Report ID: HC-1037
  • Author: Growth Market Reports
  • Rating: 4.9
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  • No. Of Pages: 124
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The global biological safety testing market size is estimated to register a substantial CAGR during the forecast period, 2021–2028. Growth of the market is attributed to rising occurrence of health issues and diseases and rapid growing pharmaceutical and biotechnology industries.

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

The biologicals or biotechnology-derived products have effectively influenced various aspects of healthcare such as prevention, diagnoses, and treatments of diseases. However, there are definite potential safety concerns, which generally arise from the manufacturing processes of complex biologicals and structural features of these products. Thus, these products need systematic and detailed biological safety testing which enables the adequate assessment of safety.

The Covid-19 pandemic had positive impact on the biological safety testing market, many biotechnologies and pharmaceutical companies began developing vaccines against COVID-19. For instance, in March 2020, Sanofi and Regeneron launched the development of their biologic Kevzara for the treatment of patients with COVID-19. Kevzara (Sarilumab) which also inhibits the IL-6 pathway. Biological safety testing plays a crucial 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.

Global Biological Safety Testing Market Summary

Market Trends, Drivers, Restraints, and Opportunities

  • Increasing pharmaceutical and biotechnology industries are expected to drive the biological safety testing market during the forecast period
  • Rising investments and rising production of new biologics are projected to propel the market growth.
  • Biological safety process is time consuming and complex which is anticipated to hinder the market growth.
  • R&D investment and technological advancement in biological safety testing market are expected to offer lucrative opportunities for the market players.

Scope of the Report

The report on global biological safety testing market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Attributes

Details

Report Title

Global Biological Safety Testing Market –Global Industry Analysis, Growth, Share, Size, Trends, and Forecast

Base Year

2020

Historic Data

2018–2019

Forecast Period

2021–2028

Segmentation

Product (Reagents and Kits, Instruments and Others), Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, and Others), Test (Sterility Tests, Bioburden Tests, Endotoxin Tests, and Others)

Regions

Asia Pacific, North America, Latin America, Europe, and Middle East & Africa

Report Coverage

Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast

Key Players Covered in the Report

Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation and Thermo Fisher Scientific

 

Market Segment insights

The reagents and kits segment is projected to constitute a large market share
Based on product, the biological safety testing market is segregated into reagents and kits, instruments and others. The reagents and kits segment is expected to account for a key share of the market during the forecast period owing to emerging need for validation of drugs and devices process of manufacturing.

Global Biological Safety Testing Market By Product

The vaccines and therapeutics segment is expected to register a substantial CAGR
Based on application, the biological safety testing market is divided into vaccines and therapeutics, cellular and gene therapy, blood and blood-based therapy, and others. The vaccines and therapeutics segment accounts for a key share of the market and is estimated to propel even further over the forecast period owing to several pharmaceutical and biotechnology companies developing novel treatments and vaccines against COVID-19 and rising R&D activities influencing therapeutics.

Global Biological Safety Testing Market By Application

The bioburden tests segment is estimated to grow at a rapid pace
Based on test, the biological safety testing market is segregated into sterility tests, bioburden tests, endotoxin tests, and others. The bioburden tests segment is expected to account for a key share of the market during the forecast period owing to standard procedures for effective sterilization, and decontamination of medical devices by World Health Organization (WHO). 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. Moreover, 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 and further fuel the market growth.

North America is expected to dominate the market
In terms of regions, the market is broadly classified into Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. The market in North America is anticipated to expand at a robust CAGR during the forecast period. The growing biotechnology and pharmaceutical industries and advanced healthcare infrastructure and rising R&D spending in this region is expected to drive the market growth in near future. Furthermore, high growth of these industries is further attributable to innovative technologies and the presence of favorable government initiatives.

Global Biological Safety Testing Market By Region

1. Executive Summary
2. Assumptions and Acronyms Used
3. Research Methodology
4. Biological Safety Testing Market Overview
  4.1. Introduction
     4.1.1. Market Taxonomy
     4.1.2. Market Definition
  4.2. Macro-Economic Factors
     4.2.1. Industry Outlook
  4.3. Biological Safety Testing Market Dynamics
     4.3.1. Market Drivers
     4.3.2. Market Restraints
     4.3.3. Opportunity
     4.3.4. Market Trends
  4.4. Biological Safety Testing Market - Supply Chain
  4.5. Global Biological Safety Testing Market Forecast
     4.5.1. Biological Safety Testing Market Size (US$ Mn) and Y-o-Y Growth
     4.5.2. Biological Safety Testing Market Size (000’ Units) and Y-o-Y Growth
     4.5.3. Biological Safety Testing Market Absolute $ Opportunity
5. Global Biological Safety Testing Market Analysis and Forecast by Applications
  5.1. Market Trends
  5.2. Introduction
     5.2.1. Basis Point Share (BPS) Analysis by Applications
     5.2.2. Y-o-Y Growth Projections by Applications
  5.3. Biological Safety Testing Market Size and Volume Forecast by Applications
     5.3.1. Vaccines and Therapeutics
     5.3.2. Cellular and Gene Therapy
     5.3.3. Blood and Blood-based Therapy
     5.3.4. Others
  5.4. Absolute $ Opportunity Assessment by Applications
  5.5. Market Attractiveness/Growth Potential Analysis by Applications
6. Global Biological Safety Testing Market Analysis and Forecast by Region
  6.1. Market Trends
  6.2. Introduction
     6.2.1. Basis Point Share (BPS) Analysis by Region
     6.2.2. Y-o-Y Growth Projections by Region
  6.3. Biological Safety Testing Market Size and Volume Forecast by Region
     6.3.1. North America
     6.3.2. Latin America
     6.3.3. Europe
     6.3.4. Asia Pacific
     6.3.5. Middle East and Africa (MEA)
  6.4. Absolute $ Opportunity Assessment by Region
  6.5. Market Attractiveness/Growth Potential Analysis by Region
  6.6. Global Biological Safety Testing Demand Share Forecast, 2019-2026
7. North America Biological Safety Testing Market Analysis and Forecast
  7.1. Introduction
     7.1.1. Basis Point Share (BPS) Analysis by Country
     7.1.2. Y-o-Y Growth Projections by Country
  7.2. North America Biological Safety Testing Market Size and Volume Forecast by Country
     7.2.1. U.S.
     7.2.2. Canada
  7.3. Absolute $ Opportunity Assessment by Country
  7.4. North America Biological Safety Testing Market Size and Volume Forecast by Applications
     7.4.1. Vaccines and Therapeutics
     7.4.2. Cellular and Gene Therapy
     7.4.3. Blood and Blood-based Therapy
     7.4.4. Others
  7.5. Basis Point Share (BPS) Analysis by Applications
  7.6. Y-o-Y Growth Projections by Applications
  7.7. Market Attractiveness/Growth Potential Analysis
     7.7.1. By Country
     7.7.2. By Product Type
     7.7.3. By Application
  7.8. North America Biological Safety Testing Demand Share Forecast, 2019-2026
8. Latin America Biological Safety Testing Market Analysis and Forecast
  8.1. Introduction
     8.1.1. Basis Point Share (BPS) Analysis by Country
     8.1.2. Y-o-Y Growth Projections by Country
     8.1.3. Latin America Average Pricing Analysis
  8.2. Latin America Biological Safety Testing Market Size and Volume Forecast by Country
      8.2.1. Brazil
      8.2.2. Mexico
      8.2.3. Rest of Latin America
   8.3. Absolute $ Opportunity Assessment by Country
  8.4. Latin America Biological Safety Testing Market Size and Volume Forecast by Applications
     8.4.1. Vaccines and Therapeutics
     8.4.2. Cellular and Gene Therapy
     8.4.3. Blood and Blood-based Therapy
     8.4.4. Others
  8.5. Basis Point Share (BPS) Analysis by Applications
  8.6. Y-o-Y Growth Projections by Applications
  8.7. Market Attractiveness/Growth Potential Analysis
     8.7.1. By Country
     8.7.2. By Product Type
     8.7.3. By Application
  8.8. Latin America Biological Safety Testing Demand Share Forecast, 2019-2026
9. Europe Biological Safety Testing Market Analysis and Forecast
  9.1. Introduction
     9.1.1. Basis Point Share (BPS) Analysis by Country
     9.1.2. Y-o-Y Growth Projections by Country
     9.1.3. Europe Average Pricing Analysis
  9.2. Europe Biological Safety Testing Market Size and Volume Forecast by Country
     9.2.1. Germany
     9.2.2. France
     9.2.3. Italy
     9.2.4. U.K.
     9.2.5. Spain
     9.2.6. Russia
     9.2.7. Rest of Europe
  9.3. Absolute $ Opportunity Assessment by Country
  9.4. Europe Biological Safety Testing Market Size and Volume Forecast by Applications
     9.4.1. Vaccines and Therapeutics
     9.4.2. Cellular and Gene Therapy
     9.4.3. Blood and Blood-based Therapy
     9.4.4. Others
  9.5. Basis Point Share (BPS) Analysis by Applications
  9.6. Y-o-Y Growth Projections by Applications
  9.7. Market Attractiveness/Growth Potential Analysis
     9.7.1. By Country
     9.7.2. By Product Type
     9.7.3. By Application
  9.8. Europe Biological Safety Testing Demand Share Forecast, 2019-2026
10. Asia Pacific Biological Safety Testing Market Analysis and Forecast
  10.1. Introduction
     10.1.1. Basis Point Share (BPS) Analysis by Country
     10.1.2. Y-o-Y Growth Projections by Country
     10.1.3. Asia Pacific Average Pricing Analysis
  10.2. Asia Pacific Biological Safety Testing Market Size and Volume Forecast by Country
     10.2.1. China
     10.2.2. Japan
     10.2.3. South Korea
     10.2.4. India
     10.2.5. Australia
     10.2.6. Rest of Asia Pacific (APAC)
  10.3. Absolute $ Opportunity Assessment by Country
  10.4. Asia Pacific Biological Safety Testing Market Size and Volume Forecast by Applications
     10.4.1. Vaccines and Therapeutics
     10.4.2. Cellular and Gene Therapy
     10.4.3. Blood and Blood-based Therapy
     10.4.4. Others
  10.5. Basis Point Share (BPS) Analysis by Applications
  10.6. Y-o-Y Growth Projections by Applications
  10.7. Market Attractiveness/Growth Potential Analysis
     10.7.1. By Country
     10.7.2. By Product Type
     10.7.3. By Application
  10.8. Asia Pacific Biological Safety Testing Demand Share Forecast, 2019-2026
11. Middle East & Africa Biological Safety Testing Market Analysis and Forecast
  11.1. Introduction
     11.1.1. Basis Point Share (BPS) Analysis by Country
     11.1.2. Y-o-Y Growth Projections by Country
     11.1.3. Middle East & Africa Average Pricing Analysis
  11.2. Middle East & Africa Biological Safety Testing Market Size and Volume Forecast by Country
     11.2.1. Saudi Arabia
     11.2.2. South Africa
     11.2.3. UAE
     11.2.4. Rest of Middle East & Africa (MEA)
  11.3. Absolute $ Opportunity Assessment by Country
  11.4. Middle East & Africa Biological Safety Testing Market Size and Volume Forecast by Applications
     11.4.1. Vaccines and Therapeutics
     11.4.2. Cellular and Gene Therapy
     11.4.3. Blood and Blood-based Therapy
     11.4.4. Others
  11.5. Basis Point Share (BPS) Analysis by Applications
  11.6. Y-o-Y Growth Projections by Applications
  11.7. Market Attractiveness/Growth Potential Analysis
     11.7.1. By Country
     11.7.2. By Product Type
     11.7.3. By Application
  11.8. Middle East & Africa Biological Safety Testing Demand Share Forecast, 2019-2026
12. Competition Landscape
  12.1. Global Biological Safety Testing Market: Market Share Analysis
  12.2. Biological Safety Testing Distributors and Customers
  12.3. Biological Safety Testing Market: Competitive Dashboard
  12.4. Company Profiles (Details: Overview, Financials, Developments, Strategy)
     12.4.1. Eurofins Scientific
     12.4.2. Lonza
     12.4.3. Merck KGaA
     12.4.4. Promega Corporation
     12.4.5. Thermo Fisher Scientific
Segments Covered in the Report
The global biological safety testing market has been segmented on the basis of:

Product
  • Reagents and Kits
  • Instruments
  • Others
Application
  • Vaccines and Therapeutics
  • Cellular and Gene Therapy
  • Blood and Blood-based Therapy
  • Others
Test
  • Sterility Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Others
Regions
  • Asia Pacific
  • North America
  • Latin America
  • Europe
  • Middle East & Africa
Key Companies
  • Eurofins Scientific
  • Lonza
  • Merck KGaA
  • Promega Corporation
  • Thermo Fisher Scientific

Key players competing in the global biological safety testing market include Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation and Thermo Fisher Scientific.

Some of these players are using several market strategies such as mergers, acquisitions, partnerships, collaborations, capacity expansion, and product launches to enhance their market shares.

For instance,

  • In April 2021, Lonza launched 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 launched a new product ''Red One Automated Bioburden Detection'' that authorise instantaneous bioburden detection of microorganisms and has been designed for water and pharmaceutical testing.

Global Biological Safety Testing Market By Key Players

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