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The global biological safety testing market size was valued at USD 4.53 billion in 2023, driven by the increasing number of cases of infectious diseases across the globe. The market size is anticipated to grow at a CAGR of 13.2% during the forecast period of 2024-2032 to achieve a value of USD 13.82 billion by 2032.
Biological safety testing refers to a set of procedures and assessments conducted to ensure the safety of biopharmaceuticals, medical devices, and other products derived from biological sources. This testing aims to evaluate potential risks associated with these products, including contamination and adverse biological effects, ensuring compliance with regulatory standards. Techniques such as sterility testing, endotoxin testing, and cell-based assays are employed to assess the purity, potency, and safety of biological materials.
By rigorously examining these factors, biological safety testing guarantees the integrity and quality of biologically derived products, safeguarding public health and adhering to regulatory guidelines in the pharmaceutical and healthcare industries.
The increasing number of biopharmaceutical firms and laboratories in the market is one of the major factors bolstering the market growth. With more biopharmaceutical firms and laboratories, the market is also expected to experience an increase in the production of new biologics, which will further contribute to the rising biological safety testing market demand.
The recent strategic moves by Charles River Laboratories International, Inc. (CRL) and Merck are poised to significantly contribute to the growth of the global market for biological safety testing during the forecast period. Charles River's acquisition of SAMDI Tech, a provider of label-free high-throughput screening solutions for drug discovery research, expands its capabilities in biochemical analysis and binding interaction identification. This move aligns with the increasing demand for advanced technologies in drug development, driving the adoption of high-quality screening solutions.
The market growth is fostered by the rising interest of key players in investing in research and development activities. For example, Merck's substantial investment of 35 million euros in biosafety testing at its Glasgow and Stirling sites in Scotland underscores the industry's commitment to ensuring the safety and efficacy of pharmaceutical products. The expansion not only enhances Merck's capacity for biosafety testing but also creates job opportunities, reflecting a positive economic impact, and bolstering the global biological safety testing market growth.
These strategic initiatives collectively contribute to the strengthening of capabilities in drug development and manufacturing, emphasizing the importance of rigorous biosafety testing. As the pharmaceutical industry continues to advance, the global market is expected to experience growth, driven by increased demand for safety assurance in drug development processes and adherence to regulatory standards.
Market Breakup by Product Type
Market Breakup by Test
Market Breakup by Application
Market Breakup by Region
The market is driven by the increased research and development activities in the pharmaceuticals and biotechnology field. The increasing awareness of the benefits and importance of quality control in the healthcare sector is a major factor responsible for the market growth. The escalating demand for improved testing methods such as nucleic acid amplification and sequencing techniques and the increasing prevalence of infectious diseases are also driving the global biological safety market growth. The increasing awareness of sterility tests among pharmaceutical and biotechnological firms due to the stringent regulatory guidelines is collectively bolstering the market growth in the forecast period. The increasing production of pharmaceutical products due to the increasing prevalence of infectious medical conditions is a major factor responsible for market growth.
Geographically, North America is leading the market and is expected to drive the market in the forecast period. The regional market can be attributed to the increasing presence of biotechnology and pharmaceutical companies due to rising innovative technologies and the presence of favourable government initiatives.
The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
Please note that this only represents a partial list of companies, and the complete list has been provided in the report.
REPORT FEATURES | DETAILS |
Base Year | 2023 |
Historical Period | 2017-2023 |
Forecast Period | 2024-2032 |
Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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Breakup by Product Type |
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Breakup by Test |
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Breakup by Application |
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Breakup by Region |
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Market Dynamics |
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Competitive Landscape |
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Companies Covered |
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Biological Safety Testing Market Overview
3.1 Global Biological Safety Testing Market Historical Value (2017-2023)
3.2 Global Biological Safety Testing Market Forecast Value (2024-2032)
4 Global Biological Safety Testing Market Landscape
4.1 Global Biological Safety Testing Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Biological Safety Testing Product Landscape
4.2.1 Analysis by Type
4.2.2 Analysis by Technology
4.2.3 Analysis by Application
5 Global Biological Safety Testing Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Biological Safety Testing Market Segmentation
6.1 Global Biological Safety Testing Market by Product Type
6.1.1 Market Overview
6.1.2 Reagents and Kits
6.1.3 Instruments
6.1.4 Other Products
6.2 Global Biological Safety Testing Market by Test
6.2.1 Market Overview
6.2.2 Sterility Tests
6.2.3 Bioburden Tests
6.2.4 Endotoxin Tests
6.2.5 Other Tests
6.3 Global Biological Safety Testing Market by Application
6.3.1 Market Overview
6.3.2 Vaccines and Therapeutics
6.3.3 Cellular and Gene Therapy
6.3.4 Blood and Blood-Based Therapy
6.3.5 Other Applications
6.4 Global Biological Safety Testing Market by Region
6.4.1 Market Overview
6.4.2 North America
6.4.3 Europe
6.4.4 Asia Pacific
6.4.5 Latin America
6.4.6 Middle East and Africa
7 North America Biological Safety Testing Market
7.1 Market Share by Country
7.2 United States of America
7.3 Canada
8 Europe Biological Safety Testing Market
8.1 Market Share by Country
8.2 United Kingdom
8.3 Germany
8.4 France
8.5 Italy
8.6 Others
9 Asia Pacific Biological Safety Testing Market
9.1 Market Share by Country
9.2 China
9.3 Japan
9.4 India
9.5 ASEAN
9.6 Australia
9.7 Others
10 Latin America Biological Safety Testing Market
10.1 Market Share by Country
10.2 Brazil
10.3 Argentina
10.4 Mexico
10.5 Others
11 Middle East and Africa Biological Safety Testing Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.4 Nigeria
11.5 South Africa
11.6 Others
12 Patent Analysis
12.1 Analysis by Type of Patent
12.2 Analysis by Publication year
12.3 Analysis by Issuing Authority
12.4 Analysis by Patent Age
12.5 Analysis by CPC Analysis
12.6 Analysis by Patent Valuation
12.7 Analysis by Key Players
13 Grants Analysis
13.1 Analysis by year
13.2 Analysis by Amount Awarded
13.3 Analysis by Issuing Authority
13.4 Analysis by Grant Application
13.5 Analysis by Funding Institute
13.6 Analysis by NIH Departments
13.7 Analysis by Recipient Organization
14 Funding Analysis
14.1 Analysis by Funding Instances
14.2 Analysis by Type of Funding
14.3 Analysis by Funding Amount
14.4 Analysis by Leading Players
14.5 Analysis by Leading Investors
14.6 Analysis by Geography
15 Partnership and Collaborations Analysis
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 INDIA CDSCO
16.1.4 JAPAN PMDA
16.1.5 Others
17 Supplier Landscape
17.1 Avance Biosciences
17.1.1 Financial Analysis
17.1.2 Product Portfolio
17.1.3 Demographic Reach and Achievements
17.1.4 Mergers and Acquisition
17.1.5 Certifications
17.2 Cytovance Biologics
17.2.1 Financial Analysis
17.2.2 Product Portfolio
17.2.3 Demographic Reach and Achievements
17.2.4 Mergers and Acquisition
17.2.5 Certifications
17.3 Eurofins Scientific
17.3.1 Financial Analysis
17.3.2 Product Portfolio
17.3.3 Demographic Reach and Achievements
17.3.4 Mergers and Acquisition
17.3.5 Certifications
17.4 Lonza
17.4.1 Financial Analysis
17.4.2 Product Portfolio
17.4.3 Demographic Reach and Achievements
17.4.4 Mergers and Acquisition
17.4.5 Certifications
17.5 Merck KGaA
17.5.1 Financial Analysis
17.5.2 Product Portfolio
17.5.3 Demographic Reach and Achievements
17.5.4 Mergers and Acquisition
17.5.5 Certifications
17.6 Promega Corporation
17.6.1 Financial Analysis
17.6.2 Product Portfolio
17.6.3 Demographic Reach and Achievements
17.6.4 Mergers and Acquisition
17.6.5 Certifications
17.7 Thermo Fisher Scientific
17.7.1 Financial Analysis
17.7.2 Product Portfolio
17.7.3 Demographic Reach and Achievements
17.7.4 Mergers and Acquisition
17.7.5 Certifications
17.8 Toxikon
17.8.1 Financial Analysis
17.8.2 Product Portfolio
17.8.3 Demographic Reach and Achievements
17.8.4 Mergers and Acquisition
17.8.5 Certifications
17.9 WuXi AppTec
17.9.1 Financial Analysis
17.9.2 Product Portfolio
17.9.3 Demographic Reach and Achievements
17.9.4 Mergers and Acquisition
17.9.5 Certifications
17.10 Biomerieux SA
17.10.1 Financial Analysis
17.10.2 Product Portfolio
17.10.3 Demographic Reach and Achievements
17.10.4 Mergers and Acquisition
17.10.5 Certifications
17.11 Nelson Laboratories, LLC
17.11.1 Financial Analysis
17.11.2 Product Portfolio
17.11.3 Demographic Reach and Achievements
17.11.4 Mergers and Acquisition
17.11.5 Certifications
17.12 Almac Group
17.12.1 Financial Analysis
17.12.2 Product Portfolio
17.12.3 Demographic Reach and Achievements
17.12.4 Mergers and Acquisition
17.12.5 Certifications
17.13 GenScript
17.13.1 Financial Analysis
17.13.2 Product Portfolio
17.13.3 Demographic Reach and Achievements
17.13.4 Mergers and Acquisition
17.13.5 Certifications
17.14 InvivoGen
17.14.1 Financial Analysis
17.14.2 Product Portfolio
17.14.3 Demographic Reach and Achievements
17.14.4 Mergers and Acquisition
17.14.5 Certifications
17.15 Maravai LifeSciences
17.15.1 Financial Analysis
17.15.2 Product Portfolio
17.15.3 Demographic Reach and Achievements
17.15.4 Mergers and Acquisition
17.15.5 Certifications
18 Global Biological Safety Testing Market - Distribution Model (Additional Insight)
18.1 Overview
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
21.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
The market attained a value of about USD 4.53 billion in 2023, driven by increased investments in the market.
The market is anticipated to grow at a CAGR of 13.2% during the forecast period of 2024-2032 and is likely to reach a market value of USD 13.82 billion by 2032.
The increasing number of biopharmaceutical firms and laboratories, along with the increasing awareness about the importance of biological safety and product sterility, are among the major factors driving the market growth.
Increasing acquisitions and investments by key players are among the key trends influencing the market growth.
The major regions of the market include North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America is currently leading the global market.
Different product types include instruments, reagents and kits, among other products.
Different tests in the market can be categorised into sterility tests, bioburden tests, and endotoxin tests, among others.
They find wide applications in vaccines and therapeutics, cellular and gene therapy, blood and blood-based therapy, among other applications.
Key players involved in the market are Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, WuXi AppTec, Biomerieux SA, Nelson Laboratories, LLC, Almac Group, GenScript, InvivoGen, and Maravai LifeSciences.
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