The Market Reports
Call: +1-631-407-1315 / +91-750-729-1479
Email: sales@themarketreports.com
Global Biological Safety Testing Market Research Report 2025
Synopsis
Biological safety testing is carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. It is a major step towards the launch of innovative biopharmaceutical products. Biological safety testing is essential to ensure product safety, and ensure the quality of biopharmaceutical products. It is conducted to ensure that the drug-producing microbes or cells are free from microbial or viral pathogens, for process validation of virus inactivation, clearance capability during biopharmaceutical production, and to test these biological materials during biopharmaceutical production for verifying the identity and characteristics. In addition, it is also used to ensure the purity, sterility, and genetic stability of the production cell bank. Bioburden testing, sterility testing, adventitious agent’s detection test, cell line authentication and characterization tests, endotoxin tests, and residual host contaminant detection tests are the major biological safety tests. Biological safety testing is used in vaccine, cellular, and gene therapy products, blood and blood products, tissue and tissue products, and stem cell products. It is performed by contract testing laboratories on the behalf of drug developers. These laboratories are confronted with a number of ethical issues and tasked with maintaining confidentiality in handling the results.
The global Biological Safety Testing market was valued at US$ 2582.3 million in 2023 and is anticipated to reach US$ 5057.2 million by 2030, witnessing a CAGR of 10.0% during the forecast period 2024-2030.
Rising need for biologics has resulted in unprecedented growth in number of biopharmaceutical companies. This increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve on aspects such as productivity, cost efficiency, and deviations. Companies are thus implementing good manufacturing practices involving thorough biological testing at various levels of production cycles, thereby contributing toward market growth. Rising number of government initiatives to promote biological safety testing products is anticipated to drive overall market growth over the coming years. High microbial contamination rates and bioburden during pharmaceutical and biologics manufacturing are expected to drive government and private organizations to improve underlying biological safety practices. Moreover, presence of regulatory authorities to enforce significant safety standards is anticipated to provide boost adoption of testing tools. Stringent guidelines and recommendations laid down by these authorities increases incorporation of these tools by quality assurance technicians, thus providing a significant boost to the overall industry.
This report aims to provide a comprehensive presentation of the global market for Biological Safety Testing, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Biological Safety Testing.
Report Scope
The Biological Safety Testing market size, estimations, and forecasts are provided in terms of revenue ($ millions), considering 2023 as the base year, with history and forecast data for the period from 2019 to 2030. This report segments the global Biological Safety Testing market comprehensively. Regional market sizes, concerning products by Type, by Application, and by players, are also provided.
For a more in-depth understanding of the market, the report provides profiles of the competitive landscape, key competitors, and their respective market ranks. The report also discusses technological trends and new product developments.
The report will help the Biological Safety Testing companies, new entrants, and industry chain related companies in this market with information on the revenues, sales volume, and average price for the overall market and the sub-segments across the different segments, by company, by Type, by Application, and by regions.
Market Segmentation
By Company
Thermo Fisher Scientific
Charles River Laboratories International
Merck
Lonza Group
Avance Biosciences
SGS
Toxikon
NuAire
Segment by Type
Instruments
Services
Kits & Reagents
Segment by Application
Vaccine Development
Blood Products
Stem Cell Research
By Region
North America
United States
Canada
Europe
Germany
France
UK
Italy
Russia
Nordic Countries
Rest of Europe
Asia-Pacific
China
Japan
South Korea
Southeast Asia
India
Australia
Rest of Asia
Latin America
Mexico
Brazil
Rest of Latin America
Middle East & Africa
Turkey
Saudi Arabia
UAE
Rest of MEA
Chapter Outline
Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by Type, by Application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter 2: Introduces executive summary of global market size, regional market size, this section also introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by companies in the industry, and the analysis of relevant policies in the industry.
Chapter 3: Detailed analysis of Biological Safety Testing companies’ competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 5: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 6, 7, 8, 9, 10: North America, Europe, Asia Pacific, Latin America, Middle East and Africa segment by country. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and capacity of each country in the world.
Chapter 11: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product sales, revenue, price, gross margin, product introduction, recent development, etc.
Chapter 12: The main points and conclusions of the report.
Biological safety testing is carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. It is a major step towards the launch of innovative biopharmaceutical products. Biological safety testing is essential to ensure product safety, and ensure the quality of biopharmaceutical products. It is conducted to ensure that the drug-producing microbes or cells are free from microbial or viral pathogens, for process validation of virus inactivation, clearance capability during biopharmaceutical production, and to test these biological materials during biopharmaceutical production for verifying the identity and characteristics. In addition, it is also used to ensure the purity, sterility, and genetic stability of the production cell bank. Bioburden testing, sterility testing, adventitious agent’s detection test, cell line authentication and characterization tests, endotoxin tests, and residual host contaminant detection tests are the major biological safety tests. Biological safety testing is used in vaccine, cellular, and gene therapy products, blood and blood products, tissue and tissue products, and stem cell products. It is performed by contract testing laboratories on the behalf of drug developers. These laboratories are confronted with a number of ethical issues and tasked with maintaining confidentiality in handling the results.
The global Biological Safety Testing market was valued at US$ 2582.3 million in 2023 and is anticipated to reach US$ 5057.2 million by 2030, witnessing a CAGR of 10.0% during the forecast period 2024-2030.
Rising need for biologics has resulted in unprecedented growth in number of biopharmaceutical companies. This increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve on aspects such as productivity, cost efficiency, and deviations. Companies are thus implementing good manufacturing practices involving thorough biological testing at various levels of production cycles, thereby contributing toward market growth. Rising number of government initiatives to promote biological safety testing products is anticipated to drive overall market growth over the coming years. High microbial contamination rates and bioburden during pharmaceutical and biologics manufacturing are expected to drive government and private organizations to improve underlying biological safety practices. Moreover, presence of regulatory authorities to enforce significant safety standards is anticipated to provide boost adoption of testing tools. Stringent guidelines and recommendations laid down by these authorities increases incorporation of these tools by quality assurance technicians, thus providing a significant boost to the overall industry.
This report aims to provide a comprehensive presentation of the global market for Biological Safety Testing, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Biological Safety Testing.
Report Scope
The Biological Safety Testing market size, estimations, and forecasts are provided in terms of revenue ($ millions), considering 2023 as the base year, with history and forecast data for the period from 2019 to 2030. This report segments the global Biological Safety Testing market comprehensively. Regional market sizes, concerning products by Type, by Application, and by players, are also provided.
For a more in-depth understanding of the market, the report provides profiles of the competitive landscape, key competitors, and their respective market ranks. The report also discusses technological trends and new product developments.
The report will help the Biological Safety Testing companies, new entrants, and industry chain related companies in this market with information on the revenues, sales volume, and average price for the overall market and the sub-segments across the different segments, by company, by Type, by Application, and by regions.
Market Segmentation
By Company
Thermo Fisher Scientific
Charles River Laboratories International
Merck
Lonza Group
Avance Biosciences
SGS
Toxikon
NuAire
Segment by Type
Instruments
Services
Kits & Reagents
Segment by Application
Vaccine Development
Blood Products
Stem Cell Research
By Region
North America
United States
Canada
Europe
Germany
France
UK
Italy
Russia
Nordic Countries
Rest of Europe
Asia-Pacific
China
Japan
South Korea
Southeast Asia
India
Australia
Rest of Asia
Latin America
Mexico
Brazil
Rest of Latin America
Middle East & Africa
Turkey
Saudi Arabia
UAE
Rest of MEA
Chapter Outline
Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by Type, by Application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter 2: Introduces executive summary of global market size, regional market size, this section also introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by companies in the industry, and the analysis of relevant policies in the industry.
Chapter 3: Detailed analysis of Biological Safety Testing companies’ competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 4: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 5: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 6, 7, 8, 9, 10: North America, Europe, Asia Pacific, Latin America, Middle East and Africa segment by country. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and capacity of each country in the world.
Chapter 11: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product sales, revenue, price, gross margin, product introduction, recent development, etc.
Chapter 12: The main points and conclusions of the report.
Index1 Report Overview
1.1 Study Scope
1.2 Market Analysis by Type
1.2.1 Global Biological Safety Testing Market Size Growth Rate by Type: 2019 VS 2023 VS 2030
1.2.2 Instruments
1.2.3 Services
1.2.4 Kits & Reagents
1.3 Market by Application
1.3.1 Global Biological Safety Testing Market Growth by Application: 2019 VS 2023 VS 2030
1.3.2 Vaccine Development
1.3.3 Blood Products
1.3.4 Stem Cell Research
1.4 Study Objectives
1.5 Years Considered
1.6 Years Considered
2 Global Growth Trends
2.1 Global Biological Safety Testing Market Perspective (2019-2030)
2.2 Biological Safety Testing Growth Trends by Region
2.2.1 Global Biological Safety Testing Market Size by Region: 2019 VS 2023 VS 2030
2.2.2 Biological Safety Testing Historic Market Size by Region (2019-2024)
2.2.3 Biological Safety Testing Forecasted Market Size by Region (2025-2030)
2.3 Biological Safety Testing Market Dynamics
2.3.1 Biological Safety Testing Industry Trends
2.3.2 Biological Safety Testing Market Drivers
2.3.3 Biological Safety Testing Market Challenges
2.3.4 Biological Safety Testing Market Restraints
3 Competition Landscape by Key Players
3.1 Global Top Biological Safety Testing Players by Revenue
3.1.1 Global Top Biological Safety Testing Players by Revenue (2019-2024)
3.1.2 Global Biological Safety Testing Revenue Market Share by Players (2019-2024)
3.2 Global Biological Safety Testing Market Share by Company Type (Tier 1, Tier 2, and Tier 3)
3.3 Players Covered: Ranking by Biological Safety Testing Revenue
3.4 Global Biological Safety Testing Market Concentration Ratio
3.4.1 Global Biological Safety Testing Market Concentration Ratio (CR5 and HHI)
3.4.2 Global Top 10 and Top 5 Companies by Biological Safety Testing Revenue in 2023
3.5 Biological Safety Testing Key Players Head office and Area Served
3.6 Key Players Biological Safety Testing Product Solution and Service
3.7 Date of Enter into Biological Safety Testing Market
3.8 Mergers & Acquisitions, Expansion Plans
4 Biological Safety Testing Breakdown Data by Type
4.1 Global Biological Safety Testing Historic Market Size by Type (2019-2024)
4.2 Global Biological Safety Testing Forecasted Market Size by Type (2025-2030)
5 Biological Safety Testing Breakdown Data by Application
5.1 Global Biological Safety Testing Historic Market Size by Application (2019-2024)
5.2 Global Biological Safety Testing Forecasted Market Size by Application (2025-2030)
6 North America
6.1 North America Biological Safety Testing Market Size (2019-2030)
6.2 North America Biological Safety Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
6.3 North America Biological Safety Testing Market Size by Country (2019-2024)
6.4 North America Biological Safety Testing Market Size by Country (2025-2030)
6.5 United States
6.6 Canada
7 Europe
7.1 Europe Biological Safety Testing Market Size (2019-2030)
7.2 Europe Biological Safety Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
7.3 Europe Biological Safety Testing Market Size by Country (2019-2024)
7.4 Europe Biological Safety Testing Market Size by Country (2025-2030)
7.5 Germany
7.6 France
7.7 U.K.
7.8 Italy
7.9 Russia
7.10 Nordic Countries
8 Asia-Pacific
8.1 Asia-Pacific Biological Safety Testing Market Size (2019-2030)
8.2 Asia-Pacific Biological Safety Testing Market Growth Rate by Region: 2019 VS 2023 VS 2030
8.3 Asia-Pacific Biological Safety Testing Market Size by Region (2019-2024)
8.4 Asia-Pacific Biological Safety Testing Market Size by Region (2025-2030)
8.5 China
8.6 Japan
8.7 South Korea
8.8 Southeast Asia
8.9 India
8.10 Australia
9 Latin America
9.1 Latin America Biological Safety Testing Market Size (2019-2030)
9.2 Latin America Biological Safety Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
9.3 Latin America Biological Safety Testing Market Size by Country (2019-2024)
9.4 Latin America Biological Safety Testing Market Size by Country (2025-2030)
9.5 Mexico
9.6 Brazil
10 Middle East & Africa
10.1 Middle East & Africa Biological Safety Testing Market Size (2019-2030)
10.2 Middle East & Africa Biological Safety Testing Market Growth Rate by Country: 2019 VS 2023 VS 2030
10.3 Middle East & Africa Biological Safety Testing Market Size by Country (2019-2024)
10.4 Middle East & Africa Biological Safety Testing Market Size by Country (2025-2030)
10.5 Turkey
10.6 Saudi Arabia
10.7 UAE
11 Key Players Profiles
11.1 Thermo Fisher Scientific
11.1.1 Thermo Fisher Scientific Company Detail
11.1.2 Thermo Fisher Scientific Business Overview
11.1.3 Thermo Fisher Scientific Biological Safety Testing Introduction
11.1.4 Thermo Fisher Scientific Revenue in Biological Safety Testing Business (2019-2024)
11.1.5 Thermo Fisher Scientific Recent Development
11.2 Charles River Laboratories International
11.2.1 Charles River Laboratories International Company Detail
11.2.2 Charles River Laboratories International Business Overview
11.2.3 Charles River Laboratories International Biological Safety Testing Introduction
11.2.4 Charles River Laboratories International Revenue in Biological Safety Testing Business (2019-2024)
11.2.5 Charles River Laboratories International Recent Development
11.3 Merck
11.3.1 Merck Company Detail
11.3.2 Merck Business Overview
11.3.3 Merck Biological Safety Testing Introduction
11.3.4 Merck Revenue in Biological Safety Testing Business (2019-2024)
11.3.5 Merck Recent Development
11.4 Lonza Group
11.4.1 Lonza Group Company Detail
11.4.2 Lonza Group Business Overview
11.4.3 Lonza Group Biological Safety Testing Introduction
11.4.4 Lonza Group Revenue in Biological Safety Testing Business (2019-2024)
11.4.5 Lonza Group Recent Development
11.5 Avance Biosciences
11.5.1 Avance Biosciences Company Detail
11.5.2 Avance Biosciences Business Overview
11.5.3 Avance Biosciences Biological Safety Testing Introduction
11.5.4 Avance Biosciences Revenue in Biological Safety Testing Business (2019-2024)
11.5.5 Avance Biosciences Recent Development
11.6 SGS
11.6.1 SGS Company Detail
11.6.2 SGS Business Overview
11.6.3 SGS Biological Safety Testing Introduction
11.6.4 SGS Revenue in Biological Safety Testing Business (2019-2024)
11.6.5 SGS Recent Development
11.7 Toxikon
11.7.1 Toxikon Company Detail
11.7.2 Toxikon Business Overview
11.7.3 Toxikon Biological Safety Testing Introduction
11.7.4 Toxikon Revenue in Biological Safety Testing Business (2019-2024)
11.7.5 Toxikon Recent Development
11.8 NuAire
11.8.1 NuAire Company Detail
11.8.2 NuAire Business Overview
11.8.3 NuAire Biological Safety Testing Introduction
11.8.4 NuAire Revenue in Biological Safety Testing Business (2019-2024)
11.8.5 NuAire Recent Development
12 Analyst's Viewpoints/Conclusions
13 Appendix
13.1 Research Methodology
13.1.1 Methodology/Research Approach
13.1.2 Data Source
13.2 Disclaimer
13.3 Author Details
Published By : QY Research
Why ‘The Market Reports’
In Business:
Pre Sales Support:
Post Sales Support:
Turn Around Time:
Clients Served:
Clients Assisted:
Client Types:
Payment:
- Accept global payments [Credit Card / PayPal / Wire Transfer]
- Accept local payments in South Korea, Germany, China and India [Can pay in local currency]
Latest Life Science Market Reports
Payments Accepted From
Connect with us at
Complete Secure Website
