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 2023 – 2031
Biological Safety Testing Market Outlook 2031
The Biological Safety Testing Market was USD 3.60 Billion in 2022 and is likely to reach USD 11.08 Billion by 2031, expanding at a CAGR of 13.3% during 2023 – 2031. 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.
Biological Safety Testing 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 Biological Safety Testing Market 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.
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Attributes |
Details |
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Report Title |
Biological Safety Testing Market –Global Industry Analysis, Growth, Share, Size, Trends, and Forecast |
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Base Year |
2022 |
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Historic Data |
2016–2021 |
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Forecast Period |
2023–2031 |
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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) |
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Regions |
Asia Pacific, North America, Latin America, Europe, and Middle East & Africa |
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Report Coverage |
Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast |
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Key Players Covered in the Report |
Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation and Thermo Fisher Scientific |
Biological Safety Testing 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.
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.
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.
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