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Biological Safety Testing-Global Market Insights and Sales Trends 2024
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 size is expected to reach US$ 5057.2 million by 2029, growing at a CAGR of 10.0% from 2023 to 2029. The market is mainly driven by the significant applications of Biological Safety Testing in various end use industries. The expanding demands from the Vaccine Development, Blood Products and Stem Cell Research,, are propelling Biological Safety Testing market. Instruments, one of the segments analysed in this report, is projected to record % CAGR and reach US$ million by the end of the analysis period. Growth in the Services segment is estimated at % CAGR for the next seven-year period.
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.
Report Objectives
This report provides market insight on the different segments, by players, by Type, by Application. Market size and forecast (2018-2029) has been provided in the report. The primary objectives of this report are to provide 1) global market size and forecasts, growth rates, market dynamics, industry structure and developments, market situation, trends; 2) global market share and ranking by company; 3) comprehensive presentation of the global market for Biological Safety Testing, with both quantitative and qualitative analysis through detailed segmentation; 4) detailed value chain analysis and review of growth factors essential for the existing market players and new entrants; 5) emerging opportunities in the market and the future impact of major drivers and restraints of the market.
Key Features of The Study:
This report provides in-depth analysis of the global Biological Safety Testing market, and provides market size (US$ million) and CAGR for the forecast period (2023-2029), considering 2022 as the base year.
This report profiles key players in the global Biological Safety Testing market based on the following parameters - company details (found date, headquarters, manufacturing bases), products portfolio, Biological Safety Testing sales data, market share and ranking.
This report elucidates potential market opportunities across different segments and explains attractive investment proposition matrices for this market.
This report illustrates key insights about market drivers, restraints, opportunities, market trends, regional outlook.
Key companies of Biological Safety Testing covered in this report include Thermo Fisher Scientific, Charles River Laboratories International, Merck, Lonza Group, Avance Biosciences, SGS, Toxikon and NuAire, etc.
The global Biological Safety Testing market report caters to various stakeholders in this industry including investors, suppliers, product players, distributors, new entrants, and financial analysts.
Market Segmentation
Company Profiles:
Thermo Fisher Scientific
Charles River Laboratories International
Merck
Lonza Group
Avance Biosciences
SGS
Toxikon
NuAire
Global Biological Safety Testing market, by region:
North America (U.S., Canada, Mexico)
Europe (Germany, France, UK, Italy, etc.)
Asia Pacific (China, Japan, South Korea, Southeast Asia, India, etc.)
South America (Brazil, etc.)
Middle East and Africa (Turkey, GCC Countries, Africa, etc.)
Global Biological Safety Testing market, Segment by Type:
Instruments
Services
Kits & Reagents
Global Biological Safety Testing market, by Application
Vaccine Development
Blood Products
Stem Cell Research
Core Chapters
Chapter One: Introduces the report scope of the report, executive summary of global and regional market size and CAGR for the history and forecast period (2018-2023, 2024-2029). 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 Two: 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 Three: 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 Four: Detailed analysis of Biological Safety Testing companies’ competitive landscape, revenue, market share and ranking, latest development plan, merger, and acquisition information, etc.
Chapter Five: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product introduction, revenue, recent development, etc.
Chapter Six, Seven, Eight, Nine and Ten: North America, Europe, Asia Pacific, Latin America, Middle East & Africa, revenue by country.
Chapter Eleven: 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 Twelve: Research Finding/Conclusion
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 size is expected to reach US$ 5057.2 million by 2029, growing at a CAGR of 10.0% from 2023 to 2029. The market is mainly driven by the significant applications of Biological Safety Testing in various end use industries. The expanding demands from the Vaccine Development, Blood Products and Stem Cell Research,, are propelling Biological Safety Testing market. Instruments, one of the segments analysed in this report, is projected to record % CAGR and reach US$ million by the end of the analysis period. Growth in the Services segment is estimated at % CAGR for the next seven-year period.
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.
Report Objectives
This report provides market insight on the different segments, by players, by Type, by Application. Market size and forecast (2018-2029) has been provided in the report. The primary objectives of this report are to provide 1) global market size and forecasts, growth rates, market dynamics, industry structure and developments, market situation, trends; 2) global market share and ranking by company; 3) comprehensive presentation of the global market for Biological Safety Testing, with both quantitative and qualitative analysis through detailed segmentation; 4) detailed value chain analysis and review of growth factors essential for the existing market players and new entrants; 5) emerging opportunities in the market and the future impact of major drivers and restraints of the market.
Key Features of The Study:
This report provides in-depth analysis of the global Biological Safety Testing market, and provides market size (US$ million) and CAGR for the forecast period (2023-2029), considering 2022 as the base year.
This report profiles key players in the global Biological Safety Testing market based on the following parameters - company details (found date, headquarters, manufacturing bases), products portfolio, Biological Safety Testing sales data, market share and ranking.
This report elucidates potential market opportunities across different segments and explains attractive investment proposition matrices for this market.
This report illustrates key insights about market drivers, restraints, opportunities, market trends, regional outlook.
Key companies of Biological Safety Testing covered in this report include Thermo Fisher Scientific, Charles River Laboratories International, Merck, Lonza Group, Avance Biosciences, SGS, Toxikon and NuAire, etc.
The global Biological Safety Testing market report caters to various stakeholders in this industry including investors, suppliers, product players, distributors, new entrants, and financial analysts.
Market Segmentation
Company Profiles:
Thermo Fisher Scientific
Charles River Laboratories International
Merck
Lonza Group
Avance Biosciences
SGS
Toxikon
NuAire
Global Biological Safety Testing market, by region:
North America (U.S., Canada, Mexico)
Europe (Germany, France, UK, Italy, etc.)
Asia Pacific (China, Japan, South Korea, Southeast Asia, India, etc.)
South America (Brazil, etc.)
Middle East and Africa (Turkey, GCC Countries, Africa, etc.)
Global Biological Safety Testing market, Segment by Type:
Instruments
Services
Kits & Reagents
Global Biological Safety Testing market, by Application
Vaccine Development
Blood Products
Stem Cell Research
Core Chapters
Chapter One: Introduces the report scope of the report, executive summary of global and regional market size and CAGR for the history and forecast period (2018-2023, 2024-2029). 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 Two: 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 Three: 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 Four: Detailed analysis of Biological Safety Testing companies’ competitive landscape, revenue, market share and ranking, latest development plan, merger, and acquisition information, etc.
Chapter Five: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product introduction, revenue, recent development, etc.
Chapter Six, Seven, Eight, Nine and Ten: North America, Europe, Asia Pacific, Latin America, Middle East & Africa, revenue by country.
Chapter Eleven: 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 Twelve: Research Finding/Conclusion
Index1 Market Overview of Biological Safety Testing
1.1 Biological Safety Testing Market Overview
1.1.1 Biological Safety Testing Product Scope
1.1.2 Biological Safety Testing Market Status and Outlook
1.2 Global Biological Safety Testing Market Size Overview by Region 2018 VS 2022 VS 2029
1.3 Global Biological Safety Testing Market Size by Region (2018-2029)
1.4 Global Biological Safety Testing Historic Market Size by Region (2018-2023)
1.5 Global Biological Safety Testing Market Size Forecast by Region (2024-2029)
1.6 Key Regions, Biological Safety Testing Market Size (2018-2029)
1.6.1 North America Biological Safety Testing Market Size (2018-2029)
1.6.2 Europe Biological Safety Testing Market Size (2018-2029)
1.6.3 Asia-Pacific Biological Safety Testing Market Size (2018-2029)
1.6.4 Latin America Biological Safety Testing Market Size (2018-2029)
1.6.5 Middle East & Africa Biological Safety Testing Market Size (2018-2029)
2 Biological Safety Testing Market by Type
2.1 Introduction
2.1.1 Instruments
2.1.2 Services
2.1.3 Kits & Reagents
2.2 Global Biological Safety Testing Market Size by Type: 2018 VS 2022 VS 2029
2.2.1 Global Biological Safety Testing Historic Market Size by Type (2018-2023)
2.2.2 Global Biological Safety Testing Forecasted Market Size by Type (2024-2029)
2.3 Key Regions Market Size by Type
2.3.1 North America Biological Safety Testing Revenue Breakdown by Type (2018-2029)
2.3.2 Europe Biological Safety Testing Revenue Breakdown by Type (2018-2029)
2.3.3 Asia-Pacific Biological Safety Testing Revenue Breakdown by Type (2018-2029)
2.3.4 Latin America Biological Safety Testing Revenue Breakdown by Type (2018-2029)
2.3.5 Middle East and Africa Biological Safety Testing Revenue Breakdown by Type (2018-2029)
3 Biological Safety Testing Market Overview by Application
3.1 Introduction
3.1.1 Vaccine Development
3.1.2 Blood Products
3.1.3 Stem Cell Research
3.2 Global Biological Safety Testing Market Size by Application: 2018 VS 2022 VS 2029
3.2.1 Global Biological Safety Testing Historic Market Size by Application (2018-2023)
3.2.2 Global Biological Safety Testing Forecasted Market Size by Application (2024-2029)
3.3 Key Regions Market Size by Application
3.3.1 North America Biological Safety Testing Revenue Breakdown by Application (2018-2029)
3.3.2 Europe Biological Safety Testing Revenue Breakdown by Application (2018-2029)
3.3.3 Asia-Pacific Biological Safety Testing Revenue Breakdown by Application (2018-2029)
3.3.4 Latin America Biological Safety Testing Revenue Breakdown by Application (2018-2029)
3.3.5 Middle East and Africa Biological Safety Testing Revenue Breakdown by Application (2018-2029)
4 Biological Safety Testing Competition Analysis by Players
4.1 Global Biological Safety Testing Market Size by Players (2018-2023)
4.2 Global Top Players by Company Type (Tier 1, Tier 2 and Tier 3) & (based on the Revenue in Biological Safety Testing as of 2022)
4.3 Date of Key Players Enter into Biological Safety Testing Market
4.4 Global Top Players Biological Safety Testing Headquarters and Area Served
4.5 Key Players Biological Safety Testing Product Solution and Service
4.6 Competitive Status
4.6.1 Biological Safety Testing Market Concentration Rate
4.6.2 Mergers & Acquisitions, Expansion Plans
5 Company (Top Players) Profiles
5.1 Thermo Fisher Scientific
5.1.1 Thermo Fisher Scientific Profile
5.1.2 Thermo Fisher Scientific Main Business
5.1.3 Thermo Fisher Scientific Biological Safety Testing Products, Services and Solutions
5.1.4 Thermo Fisher Scientific Biological Safety Testing Revenue (US$ Million) & (2018-2023)
5.1.5 Thermo Fisher Scientific Recent Developments
5.2 Charles River Laboratories International
5.2.1 Charles River Laboratories International Profile
5.2.2 Charles River Laboratories International Main Business
5.2.3 Charles River Laboratories International Biological Safety Testing Products, Services and Solutions
5.2.4 Charles River Laboratories International Biological Safety Testing Revenue (US$ Million) & (2018-2023)
5.2.5 Charles River Laboratories International Recent Developments
5.3 Merck
5.3.1 Merck Profile
5.3.2 Merck Main Business
5.3.3 Merck Biological Safety Testing Products, Services and Solutions
5.3.4 Merck Biological Safety Testing Revenue (US$ Million) & (2018-2023)
5.3.5 Lonza Group Recent Developments
5.4 Lonza Group
5.4.1 Lonza Group Profile
5.4.2 Lonza Group Main Business
5.4.3 Lonza Group Biological Safety Testing Products, Services and Solutions
5.4.4 Lonza Group Biological Safety Testing Revenue (US$ Million) & (2018-2023)
5.4.5 Lonza Group Recent Developments
5.5 Avance Biosciences
5.5.1 Avance Biosciences Profile
5.5.2 Avance Biosciences Main Business
5.5.3 Avance Biosciences Biological Safety Testing Products, Services and Solutions
5.5.4 Avance Biosciences Biological Safety Testing Revenue (US$ Million) & (2018-2023)
5.5.5 Avance Biosciences Recent Developments
5.6 SGS
5.6.1 SGS Profile
5.6.2 SGS Main Business
5.6.3 SGS Biological Safety Testing Products, Services and Solutions
5.6.4 SGS Biological Safety Testing Revenue (US$ Million) & (2018-2023)
5.6.5 SGS Recent Developments
5.7 Toxikon
5.7.1 Toxikon Profile
5.7.2 Toxikon Main Business
5.7.3 Toxikon Biological Safety Testing Products, Services and Solutions
5.7.4 Toxikon Biological Safety Testing Revenue (US$ Million) & (2018-2023)
5.7.5 Toxikon Recent Developments
5.8 NuAire
5.8.1 NuAire Profile
5.8.2 NuAire Main Business
5.8.3 NuAire Biological Safety Testing Products, Services and Solutions
5.8.4 NuAire Biological Safety Testing Revenue (US$ Million) & (2018-2023)
5.8.5 NuAire Recent Developments
6 North America
6.1 North America Biological Safety Testing Market Size by Country (2018-2029)
6.2 U.S.
6.3 Canada
7 Europe
7.1 Europe Biological Safety Testing Market Size by Country (2018-2029)
7.2 Germany
7.3 France
7.4 U.K.
7.5 Italy
7.6 Russia
7.7 Nordic Countries
7.8 Rest of Europe
8 Asia-Pacific
8.1 Asia-Pacific Biological Safety Testing Market Size by Region (2018-2029)
8.2 China
8.3 Japan
8.4 South Korea
8.5 Southeast Asia
8.6 India
8.7 Australia
8.8 Rest of Asia-Pacific
9 Latin America
9.1 Latin America Biological Safety Testing Market Size by Country (2018-2029)
9.2 Mexico
9.3 Brazil
9.4 Rest of Latin America
10 Middle East & Africa
10.1 Middle East & Africa Biological Safety Testing Market Size by Country (2018-2029)
10.2 Turkey
10.3 Saudi Arabia
10.4 UAE
10.5 Rest of Middle East & Africa
11 Biological Safety Testing Market Dynamics
11.1 Biological Safety Testing Industry Trends
11.2 Biological Safety Testing Market Drivers
11.3 Biological Safety Testing Market Challenges
11.4 Biological Safety Testing Market Restraints
12 Research Finding /Conclusion
13 Methodology and Data Source
13.1 Methodology/Research Approach
13.1.1 Research Programs/Design
13.1.2 Market Size Estimation
13.1.3 Market Breakdown and Data Triangulation
13.2 Data Source
13.2.1 Secondary Sources
13.2.2 Primary Sources
13.3 Disclaimer
13.4 Author List
Published By : QY Research
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