Global Biological Safety Testing Market Size, Status and Forecast 2019-2025


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.
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.
The Americas will be the major revenue contributor to the biosafety testing services market till 2021. The region has the presence of several NPOs and regulatory organizations that promote biological safety testing. Additionally, the focus of organizations such as the FDA, the CDC, and the American Biological Safety Association (ABSA) towards promoting biological safety in several industries such as pharmaceutical and biotechnology, will also drive the growth of the market in this region.
In 2018, the global Biological Safety Testing market size was xx million US$ and it is expected to reach xx million US$ by the end of 2025, with a CAGR of xx% during 2019-2025.

This report focuses on the global Biological Safety Testing status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Biological Safety Testing development in United States, Europe and China.

The key players covered in this study
    Thermo Fisher Scientific
    Charles River Laboratories International
    Merck
    Lonza Group
    Avance Biosciences
    SGS
    Toxikon
    NuAire

Market segment by Type, the product can be split into
    Instruments
    Services
    Kits & Reagents

Market segment by Application, split into
    Vaccine Development
    Blood Products
    Stem Cell Research

Market segment by Regions/Countries, this report covers
    United States
    Europe
    China
    Japan
    Southeast Asia
    India
    Central & South America

The study objectives of this report are:
    To analyze global Biological Safety Testing status, future forecast, growth opportunity, key market and key players.
    To present the Biological Safety Testing development in United States, Europe and China.
    To strategically profile the key players and comprehensively analyze their development plan and strategies.
    To define, describe and forecast the market by product type, market and key regions.

In this study, the years considered to estimate the market size of Biological Safety Testing are as follows:
    History Year: 2014-2018
    Base Year: 2018
    Estimated Year: 2019
    Forecast Year 2019 to 2025
For the data information by region, company, type and application, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.
Table of Contents

1 Report Overview
    1.1 Study Scope
    1.2 Key Market Segments
    1.3 Players Covered
    1.4 Market Analysis by Type
        1.4.1 Global Biological Safety Testing Market Size Growth Rate by Type (2014-2025)
        1.4.2 Instruments
        1.4.3 Services
        1.4.4 Kits & Reagents
    1.5 Market by Application
        1.5.1 Global Biological Safety Testing Market Share by Application (2014-2025)
        1.5.2 Vaccine Development
        1.5.3 Blood Products
        1.5.4 Stem Cell Research
    1.6 Study Objectives
    1.7 Years Considered

2 Global Growth Trends
    2.1 Biological Safety Testing Market Size
    2.2 Biological Safety Testing Growth Trends by Regions
        2.2.1 Biological Safety Testing Market Size by Regions (2014-2025)
        2.2.2 Biological Safety Testing Market Share by Regions (2014-2019)
    2.3 Industry Trends
        2.3.1 Market Top Trends
        2.3.2 Market Drivers
        2.3.3 Market Opportunities

3 Market Share by Key Players
    3.1 Biological Safety Testing Market Size by Manufacturers
        3.1.1 Global Biological Safety Testing Revenue by Manufacturers (2014-2019)
        3.1.2 Global Biological Safety Testing Revenue Market Share by Manufacturers (2014-2019)
        3.1.3 Global Biological Safety Testing Market Concentration Ratio (CR5 and HHI)
    3.2 Biological Safety Testing Key Players Head office and Area Served
    3.3 Key Players Biological Safety Testing Product/Solution/Service
    3.4 Date of Enter into Biological Safety Testing Market
    3.5 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Type and Application
    4.1 Global Biological Safety Testing Market Size by Type (2014-2019)
    4.2 Global Biological Safety Testing Market Size by Application (2014-2019)

5 United States
    5.1 United States Biological Safety Testing Market Size (2014-2019)
    5.2 Biological Safety Testing Key Players in United States
    5.3 United States Biological Safety Testing Market Size by Type
    5.4 United States Biological Safety Testing Market Size by Application

6 Europe
    6.1 Europe Biological Safety Testing Market Size (2014-2019)
    6.2 Biological Safety Testing Key Players in Europe
    6.3 Europe Biological Safety Testing Market Size by Type
    6.4 Europe Biological Safety Testing Market Size by Application

7 China
    7.1 China Biological Safety Testing Market Size (2014-2019)
    7.2 Biological Safety Testing Key Players in China
    7.3 China Biological Safety Testing Market Size by Type
    7.4 China Biological Safety Testing Market Size by Application

8 Japan
    8.1 Japan Biological Safety Testing Market Size (2014-2019)
    8.2 Biological Safety Testing Key Players in Japan
    8.3 Japan Biological Safety Testing Market Size by Type
    8.4 Japan Biological Safety Testing Market Size by Application

9 Southeast Asia
    9.1 Southeast Asia Biological Safety Testing Market Size (2014-2019)
    9.2 Biological Safety Testing Key Players in Southeast Asia
    9.3 Southeast Asia Biological Safety Testing Market Size by Type
    9.4 Southeast Asia Biological Safety Testing Market Size by Application

10 India
    10.1 India Biological Safety Testing Market Size (2014-2019)
    10.2 Biological Safety Testing Key Players in India
    10.3 India Biological Safety Testing Market Size by Type
    10.4 India Biological Safety Testing Market Size by Application

11 Central & South America
    11.1 Central & South America Biological Safety Testing Market Size (2014-2019)
    11.2 Biological Safety Testing Key Players in Central & South America
    11.3 Central & South America Biological Safety Testing Market Size by Type
    11.4 Central & South America Biological Safety Testing Market Size by Application

12 International Players Profiles
    12.1 Thermo Fisher Scientific
        12.1.1 Thermo Fisher Scientific Company Details
        12.1.2 Company Description and Business Overview
        12.1.3 Biological Safety Testing Introduction
        12.1.4 Thermo Fisher Scientific Revenue in Biological Safety Testing Business (2014-2019)
        12.1.5 Thermo Fisher Scientific Recent Development
    12.2 Charles River Laboratories International
        12.2.1 Charles River Laboratories International Company Details
        12.2.2 Company Description and Business Overview
        12.2.3 Biological Safety Testing Introduction
        12.2.4 Charles River Laboratories International Revenue in Biological Safety Testing Business (2014-2019)
        12.2.5 Charles River Laboratories International Recent Development
    12.3 Merck
        12.3.1 Merck Company Details
        12.3.2 Company Description and Business Overview
        12.3.3 Biological Safety Testing Introduction
        12.3.4 Merck Revenue in Biological Safety Testing Business (2014-2019)
        12.3.5 Merck Recent Development
    12.4 Lonza Group
        12.4.1 Lonza Group Company Details
        12.4.2 Company Description and Business Overview
        12.4.3 Biological Safety Testing Introduction
        12.4.4 Lonza Group Revenue in Biological Safety Testing Business (2014-2019)
        12.4.5 Lonza Group Recent Development
    12.5 Avance Biosciences
        12.5.1 Avance Biosciences Company Details
        12.5.2 Company Description and Business Overview
        12.5.3 Biological Safety Testing Introduction
        12.5.4 Avance Biosciences Revenue in Biological Safety Testing Business (2014-2019)
        12.5.5 Avance Biosciences Recent Development
    12.6 SGS
        12.6.1 SGS Company Details
        12.6.2 Company Description and Business Overview
        12.6.3 Biological Safety Testing Introduction
        12.6.4 SGS Revenue in Biological Safety Testing Business (2014-2019)
        12.6.5 SGS Recent Development
    12.7 Toxikon
        12.7.1 Toxikon Company Details
        12.7.2 Company Description and Business Overview
        12.7.3 Biological Safety Testing Introduction
        12.7.4 Toxikon Revenue in Biological Safety Testing Business (2014-2019)
        12.7.5 Toxikon Recent Development
    12.8 NuAire
        12.8.1 NuAire Company Details
        12.8.2 Company Description and Business Overview
        12.8.3 Biological Safety Testing Introduction
        12.8.4 NuAire Revenue in Biological Safety Testing Business (2014-2019)
        12.8.5 NuAire Recent Development

13 Market Forecast 2019-2025
    13.1 Market Size Forecast by Regions
    13.2 United States
    13.3 Europe
    13.4 China
    13.5 Japan
    13.6 Southeast Asia
    13.7 India
    13.8 Central & South America
    13.9 Market Size Forecast by Product (2019-2025)
    13.10 Market Size Forecast by Application (2019-2025)

14 Analyst's Viewpoints/Conclusions

15 Appendix
    15.1 Research Methodology
        15.1.1 Methodology/Research Approach
            15.1.1.1 Research Programs/Design
            15.1.1.2 Market Size Estimation
            12.1.1.3 Market Breakdown and Data Triangulation
        15.1.2 Data Source
            15.1.2.1 Secondary Sources
            15.1.2.2 Primary Sources
    15.2 Disclaimer
    15.3 Author Details

List of Tables and Figures Table Biological Safety Testing Key Market Segments Table Key Players Biological Safety Testing Covered Table Global Biological Safety Testing Market Size Growth Rate by Type 2014-2025 (Million US$) Figure Global Biological Safety Testing Market Size Market Share by Type 2014-2025 Figure Instruments Figures Table Key Players of Instruments Figure Services Figures Table Key Players of Services Figure Kits & Reagents Figures Table Key Players of Kits & Reagents Table Global Biological Safety Testing Market Size Growth by Application 2014-2025 (Million US$) Figure Vaccine Development Case Studies Figure Blood Products Case Studies Figure Stem Cell Research Case Studies Figure Biological Safety Testing Report Years Considered Table Global Biological Safety Testing Market Size 2014-2025 (Million US$) Figure Global Biological Safety Testing Market Size and Growth Rate 2014-2025 (Million US$) Table Global Biological Safety Testing Market Size by Regions 2014-2025 (Million US$) Table Global Biological Safety Testing Market Size by Regions 2014-2019 (Million US$) Table Global Biological Safety Testing Market Share by Regions 2014-2019 Figure Global Biological Safety Testing Market Share by Regions 2014-2019 Figure Global Biological Safety Testing Market Share by Regions 2019 Table Market Top Trends Table Global Biological Safety Testing Revenue by Manufacturers (2014-2019) (Million US$) Table Global Biological Safety Testing Market Share by Manufacturers (2014-2019) Figure Global Biological Safety Testing Market Share by Manufacturers in 2018 Table Global Biological Safety Testing Manufacturers Market Concentration Ratio (CR5 and HHI) Table Key Players Head office and Area Served Table Key Players Biological Safety Testing Product/Solution/Service Table Date of Enter into Biological Safety Testing Market Table Mergers & Acquisitions, Expansion Plans Table Global Biological Safety Testing Market Size by Type (2014-2019) (Million US$) Table Global Biological Safety Testing Market Size Share by Type (2014-2019) Figure Global Biological Safety Testing Market Size Market Share by Type (2014-2019) Table Global Biological Safety Testing Market Size by Application (2014-2019) (Million US$) Table Global Biological Safety Testing Market Size Share by Application (2014-2019) Figure Global Biological Safety Testing Market Size Market Share by Application (2014-2019) Figure Global Biological Safety Testing Revenue Market Share by Application in 2018 Figure United States Biological Safety Testing Market Size 2014-2019 (Million US$) Table United States Key Players Biological Safety Testing Revenue (2018-2019) (Million US$) Table United States Key Players Biological Safety Testing Market Share (2018-2019) Table United States Biological Safety Testing Market Size by Type (2014-2019) (Million US$) Table United States Biological Safety Testing Market Share by Type (2014-2019) Table United States Biological Safety Testing Market Size by Application (2014-2019) (Million US$) Table United States Biological Safety Testing Market Share by Application (2014-2019) Figure Europe Biological Safety Testing Market Size 2014-2019 (Million US$) Table Europe Key Players Biological Safety Testing Revenue (2018-2019) (Million US$) Table Europe Key Players Biological Safety Testing Market Share (2018-2019) Table Europe Biological Safety Testing Market Size by Type (2014-2019) (Million US$) Table Europe Biological Safety Testing Market Share by Type (2014-2019) Table Europe Biological Safety Testing Market Size by Application (2014-2019) (Million US$) Table Europe Biological Safety Testing Market Share by Application (2014-2019) Figure China Biological Safety Testing Market Size 2014-2019 (Million US$) Table China Key Players Biological Safety Testing Revenue (2018-2019) (Million US$) Table China Key Players Biological Safety Testing Market Share (2018-2019) Table China Biological Safety Testing Market Size by Type (2014-20189) (Million US$) Table China Biological Safety Testing Market Share by Type (2014-2019) Table China Biological Safety Testing Market Size by Application (2014-2019) (Million US$) Table China Biological Safety Testing Market Share by Application (2014-2019) Figure Japan Biological Safety Testing Market Size 2014-2019 (Million US$) Table Japan Key Players Biological Safety Testing Revenue (2018-2019) (Million US$) Table Japan Key Players Biological Safety Testing Market Share (2018-2019) Table Japan Biological Safety Testing Market Size by Type (2014-2019) (Million US$) Table Japan Biological Safety Testing Market Share by Type (2014-2019) Table Japan Biological Safety Testing Market Size by Application (2014-2019) (Million US$) Table Japan Biological Safety Testing Market Share by Application (2014-2019) Figure Southeast Asia Biological Safety Testing Market Size 2014-2019 (Million US$) Table Southeast Asia Key Players Biological Safety Testing Revenue (2018-2019) (Million US$) Table Southeast Asia Key Players Biological Safety Testing Market Share (2018-2019) Table Southeast Asia Biological Safety Testing Market Size by Type (2014-2019) (Million US$) Table Southeast Asia Biological Safety Testing Market Share by Type (2014-2019) Table Southeast Asia Biological Safety Testing Market Size by Application (2014-2019) (Million US$) Table Southeast Asia Biological Safety Testing Market Share by Application (2014-2019) Figure India Biological Safety Testing Market Size 2014-2019 (Million US$) Table India Key Players Biological Safety Testing Revenue (2018-2019) (Million US$) Table India Key Players Biological Safety Testing Market Share (2018-2019) Table India Biological Safety Testing Market Size by Type (2014-2019) (Million US$) Table India Biological Safety Testing Market Share by Type (2014-2019) Table India Biological Safety Testing Market Size by Application (2014-2019) (Million US$) Table India Biological Safety Testing Market Share by Application (2014-2019) Figure Central & South America Biological Safety Testing Market Size 2014-2019 (Million US$) Table Central & South America Key Players Biological Safety Testing Revenue (2018-2019) (Million US$) Table Central & South America Key Players Biological Safety Testing Market Share (2018-2019) Table Central & South America Biological Safety Testing Market Size by Type (2014-2019) (Million US$) Table Central & South America Biological Safety Testing Market Share by Type (2014-2019) Table Central & South America Biological Safety Testing Market Size by Application (2014-2019) (Million US$) Table Central & South America Biological Safety Testing Market Share by Application (2014-2019) Table Thermo Fisher Scientific Company Details Table Thermo Fisher Scientific Revenue in Biological Safety Testing Business (2014-2019) (Million US$) Figure Thermo Fisher Scientific Revenue Growth Rate in Biological Safety Testing Business (2014-2019) Table Thermo Fisher Scientific Recent Development Table Charles River Laboratories International Company Details Table Charles River Laboratories International Revenue in Biological Safety Testing Business (2014-2019)(Million US$) Figure Charles River Laboratories International Revenue Growth Rate in Biological Safety Testing Business (2014-2019) Table Charles River Laboratories International Recent Development Table Merck Company Details Table Merck Revenue in Biological Safety Testing Business (2014-2019)(Million US$) Figure Merck Revenue Growth Rate in Biological Safety Testing Business (2014-2019) Table Merck Recent Development Table Lonza Group Company Details Table Lonza Group Revenue in Biological Safety Testing Business (2014-2019)(Million US$) Figure Lonza Group Revenue Growth Rate in Biological Safety Testing Business (2014-2019) Table Lonza Group Recent Development Table Avance Biosciences Company Details Table Avance Biosciences Revenue in Biological Safety Testing Business (2014-2019)(Million US$) Figure Avance Biosciences Revenue Growth Rate in Biological Safety Testing Business (2014-2019) Table Avance Biosciences Recent Development Table SGS Company Details Table SGS Revenue in Biological Safety Testing Business (2014-2019)(Million US$) Figure SGS Revenue Growth Rate in Biological Safety Testing Business (2014-2019) Table SGS Recent Development Table Toxikon Company Details Table Toxikon Revenue in Biological Safety Testing Business (2014-2019)(Million US$) Figure Toxikon Revenue Growth Rate in Biological Safety Testing Business (2014-2019) Table Toxikon Recent Development Table NuAire Company Details Table NuAire Revenue in Biological Safety Testing Business (2014-2019)(Million US$) Figure NuAire Revenue Growth Rate in Biological Safety Testing Business (2014-2019) Table NuAire Recent Development Table Global Biological Safety Testing Market Size by Regions (Million US$) 2019-2025 Figure Global Biological Safety Testing Market Size Share by Regions (2019-2025) Figure Global Biological Safety Testing Market Size Share by Regions in 2025 Figure United States Biological Safety Testing Market Size Forecast (2019-2025)(Million USD) Figure Europe Biological Safety Testing Market Size Forecast (2019-2025)(Million USD) Figure China Biological Safety Testing Market Size Forecast (2019-2025)(Million USD) Figure Japan Biological Safety Testing Market Size Forecast (2019-2025)(Million USD) Figure Southeast Asia Biological Safety Testing Market Size Forecast (2019-2025)(Million USD) Figure India Biological Safety Testing Market Size Forecast (2019-2025)(Million USD) Figure Central & South America Biological Safety Testing Market Size Forecast (2019-2025)(Million USD) Table Global Biological Safety Testing Market Size by Product (2019-2025) (Million US$) Figure Global Biological Safety Testing Market Size by Product (2019-2025) Figure Global Biological Safety Testing Market Size by Product in 2025 Table Global Biological Safety Testing Market Size by Application (2019-2025) (Million US$) Figure Global Biological Safety Testing Market Size by Application (2019-2025) Figure Global Biological Safety Testing Market Size by Application in 2025 Table Research Programs/Design for This Report Figure Bottom-up and Top-down Approaches for This Report Figure Data Triangulation Table Key Data Information from Secondary Sources Table Key Data Information from Primary Sources

This research study involved the extensive usage of both primary and secondary data sources.  The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. Top-down and bottom-up approaches are used to validate the global market size market and estimate the market size for manufacturers, regions segments, product segments and applications (end users). All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or other factors are not accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from QYResearch and presented in this report.
 

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation, extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub segments listed in this report. Extensive qualitative and further quantitative analysis is also done from all the numbers arrived at in the complete market engineering process to list key information throughout the report.
 

Secondary Sources occupies Approximately 25% of Sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on; This research study involved the usage of widespread secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; BIS Statistics; ICIS; company house documents; CAS(American Chemical Society); investor presentations; and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the Light Aircraft market. It was also used to obtain important information about the top players, market classification and segmentation according to industry trends to the bottom-most level, and key developments related to market and technology perspectives.
 

In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers etc.
 

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.
 

Primary research was conducted to identify segmentation types, product price range, product applications, key players, raw materials supply and the downstream demand, industry status and outlook, and key market dynamics such as risks, influence factors, opportunities, market barriers, industry trends, and key player strategies.
 

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