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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.
Scope of the Report:
This report studies the Biological Safety Testing market status and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Biological Safety Testing market by product type and applications/end industries.
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.
The global Biological Safety Testing market is valued at xx million USD in 2017 and is expected to reach xx million USD by the end of 2023, growing at a CAGR of xx% between 2017 and 2023.
The Asia-Pacific will occupy for more market share in following years, especially in China, also fast growing India and Southeast Asia regions.
North America, especially The United States, will still play an important role which cannot be ignored. Any changes from United States might affect the development trend of Biological Safety Testing.
Europe also play important roles in global market, with market size of xx million USD in 2017 and will be xx million USD in 2023, with a CAGR of xx%.
Market Segment by Companies, this report covers
Thermo Fisher Scientific
Charles River Laboratories International
Merck
Lonza Group
Avance Biosciences
SGS
Toxikon
NuAire
Market Segment by Regions, regional analysis covers
North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia and Italy)
Asia-Pacific (China, Japan, Korea, India and Southeast Asia)
South America (Brazil, Argentina, Colombia)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
Market Segment by Type, covers
Instruments
Services
Kits & Reagents
Market Segment by Applications, can be divided into
Vaccine Development
Blood Products
Stem Cell Research
The base year for the study has been considered 2019, historic year 2014 and 2018, the forecast period considered is from 2020 to 2027. The regions analyzed for the market include North America, Europe, South America, Asia Pacific, and Middle East and Africa. These regions are further analyzed at the country-level. The study also includes attractiveness analysis of type, application and regions which are benchmarked based on their market size, growth rate and attractiveness in terms of present and future opportunity for understanding the future growth of the market.
Market is segmented on the basis:
The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insight of the market. The report emphasizes on all the key trends that play a vital role in the enlargement of the market from 2019 to 2026.
The report provides company profile of the key players operating in the market and a comparative analysis based on their business overviews industry offering, segment market share, regional presence, business strategies, innovations, mergers & acquisitions, recent developments, joint venture, collaborations, partnerships, SWOT analysis, and key financial information.
Table of Contents
1 Biological Safety Testing Market Overview
1.1 Product Overview and Scope of Biological Safety Testing
1.2 Classification of Biological Safety Testing by Types
1.2.1 Global Biological Safety Testing Revenue Comparison by Types (2017-2023)
1.2.2 Global Biological Safety Testing Revenue Market Share by Types in 2017
1.2.3 Instruments
1.2.4 Services
1.2.5 Kits & Reagents
1.3 Global Biological Safety Testing Market by Application
1.3.1 Global Biological Safety Testing Market Size and Market Share Comparison by Applications (2013-2023)
1.3.2 Vaccine Development
1.3.3 Blood Products
1.3.4 Stem Cell Research
1.4 Global Biological Safety Testing Market by Regions
1.4.1 Global Biological Safety Testing Market Size (Million USD) Comparison by Regions (2013-2023)
1.4.1 North America (USA, Canada and Mexico) Biological Safety Testing Status and Prospect (2013-2023)
1.4.2 Europe (Germany, France, UK, Russia and Italy) Biological Safety Testing Status and Prospect (2013-2023)
1.4.3 Asia-Pacific (China, Japan, Korea, India and Southeast Asia) Biological Safety Testing Status and Prospect (2013-2023)
1.4.4 South America (Brazil, Argentina, Colombia) Biological Safety Testing Status and Prospect (2013-2023)
1.4.5 Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa) Biological Safety Testing Status and Prospect (2013-2023)
1.5 Global Market Size of Biological Safety Testing (2013-2023)
2 Manufacturers Profiles
2.1 Thermo Fisher Scientific
2.1.1 Business Overview
2.1.2 Biological Safety Testing Type and Applications
2.1.2.1 Product A
2.1.2.2 Product B
2.1.3 Thermo Fisher Scientific Biological Safety Testing Revenue, Gross Margin and Market Share (2016-2017)
2.2 Charles River Laboratories International
2.2.1 Business Overview
2.2.2 Biological Safety Testing Type and Applications
2.2.2.1 Product A
2.2.2.2 Product B
2.2.3 Charles River Laboratories International Biological Safety Testing Revenue, Gross Margin and Market Share (2016-2017)
2.3 Merck
2.3.1 Business Overview
2.3.2 Biological Safety Testing Type and Applications
2.3.2.1 Product A
2.3.2.2 Product B
2.3.3 Merck Biological Safety Testing Revenue, Gross Margin and Market Share (2016-2017)
2.4 Lonza Group
2.4.1 Business Overview
2.4.2 Biological Safety Testing Type and Applications
2.4.2.1 Product A
2.4.2.2 Product B
2.4.3 Lonza Group Biological Safety Testing Revenue, Gross Margin and Market Share (2016-2017)
2.5 Avance Biosciences
2.5.1 Business Overview
2.5.2 Biological Safety Testing Type and Applications
2.5.2.1 Product A
2.5.2.2 Product B
2.5.3 Avance Biosciences Biological Safety Testing Revenue, Gross Margin and Market Share (2016-2017)
2.6 SGS
2.6.1 Business Overview
2.6.2 Biological Safety Testing Type and Applications
2.6.2.1 Product A
2.6.2.2 Product B
2.6.3 SGS Biological Safety Testing Revenue, Gross Margin and Market Share (2016-2017)
2.7 Toxikon
2.7.1 Business Overview
2.7.2 Biological Safety Testing Type and Applications
2.7.2.1 Product A
2.7.2.2 Product B
2.7.3 Toxikon Biological Safety Testing Revenue, Gross Margin and Market Share (2016-2017)
2.8 NuAire
2.8.1 Business Overview
2.8.2 Biological Safety Testing Type and Applications
2.8.2.1 Product A
2.8.2.2 Product B
2.8.3 NuAire Biological Safety Testing Revenue, Gross Margin and Market Share (2016-2017)
3 Global Biological Safety Testing Market Competition, by Players
3.1 Global Biological Safety Testing Revenue and Share by Players (2013-2018)
3.2 Market Concentration Rate
3.2.1 Top 5 Biological Safety Testing Players Market Share
3.2.2 Top 10 Biological Safety Testing Players Market Share
3.3 Market Competition Trend
4 Global Biological Safety Testing Market Size by Regions
4.1 Global Biological Safety Testing Revenue and Market Share by Regions
4.2 North America Biological Safety Testing Revenue and Growth Rate (2013-2018)
4.3 Europe Biological Safety Testing Revenue and Growth Rate (2013-2018)
4.4 Asia-Pacific Biological Safety Testing Revenue and Growth Rate (2013-2018)
4.5 South America Biological Safety Testing Revenue and Growth Rate (2013-2018)
4.6 Middle East and Africa Biological Safety Testing Revenue and Growth Rate (2013-2018)
5 North America Biological Safety Testing Revenue by Countries
5.1 North America Biological Safety Testing Revenue by Countries (2013-2018)
5.2 USA Biological Safety Testing Revenue and Growth Rate (2013-2018)
5.3 Canada Biological Safety Testing Revenue and Growth Rate (2013-2018)
5.4 Mexico Biological Safety Testing Revenue and Growth Rate (2013-2018)
6 Europe Biological Safety Testing Revenue by Countries
6.1 Europe Biological Safety Testing Revenue by Countries (2013-2018)
6.2 Germany Biological Safety Testing Revenue and Growth Rate (2013-2018)
6.3 UK Biological Safety Testing Revenue and Growth Rate (2013-2018)
6.4 France Biological Safety Testing Revenue and Growth Rate (2013-2018)
6.5 Russia Biological Safety Testing Revenue and Growth Rate (2013-2018)
6.6 Italy Biological Safety Testing Revenue and Growth Rate (2013-2018)
7 Asia-Pacific Biological Safety Testing Revenue by Countries
7.1 Asia-Pacific Biological Safety Testing Revenue by Countries (2013-2018)
7.2 China Biological Safety Testing Revenue and Growth Rate (2013-2018)
7.3 Japan Biological Safety Testing Revenue and Growth Rate (2013-2018)
7.4 Korea Biological Safety Testing Revenue and Growth Rate (2013-2018)
7.5 India Biological Safety Testing Revenue and Growth Rate (2013-2018)
7.6 Southeast Asia Biological Safety Testing Revenue and Growth Rate (2013-2018)
8 South America Biological Safety Testing Revenue by Countries
8.1 South America Biological Safety Testing Revenue by Countries (2013-2018)
8.2 Brazil Biological Safety Testing Revenue and Growth Rate (2013-2018)
8.3 Argentina Biological Safety Testing Revenue and Growth Rate (2013-2018)
8.4 Colombia Biological Safety Testing Revenue and Growth Rate (2013-2018)
9 Middle East and Africa Revenue Biological Safety Testing by Countries
9.1 Middle East and Africa Biological Safety Testing Revenue by Countries (2013-2018)
9.2 Saudi Arabia Biological Safety Testing Revenue and Growth Rate (2013-2018)
9.3 UAE Biological Safety Testing Revenue and Growth Rate (2013-2018)
9.4 Egypt Biological Safety Testing Revenue and Growth Rate (2013-2018)
9.5 Nigeria Biological Safety Testing Revenue and Growth Rate (2013-2018)
9.6 South Africa Biological Safety Testing Revenue and Growth Rate (2013-2018)
10 Global Biological Safety Testing Market Segment by Type
10.1 Global Biological Safety Testing Revenue and Market Share by Type (2013-2018)
10.2 Global Biological Safety Testing Market Forecast by Type (2018-2023)
10.3 Instruments Revenue Growth Rate (2013-2023)
10.4 Services Revenue Growth Rate (2013-2023)
10.5 Kits & Reagents Revenue Growth Rate (2013-2023)
11 Global Biological Safety Testing Market Segment by Application
11.1 Global Biological Safety Testing Revenue Market Share by Application (2013-2018)
11.2 Biological Safety Testing Market Forecast by Application (2018-2023)
11.3 Vaccine Development Revenue Growth (2013-2018)
11.4 Blood Products Revenue Growth (2013-2018)
11.5 Stem Cell Research Revenue Growth (2013-2018)
12 Global Biological Safety Testing Market Size Forecast (2018-2023)
12.1 Global Biological Safety Testing Market Size Forecast (2018-2023)
12.2 Global Biological Safety Testing Market Forecast by Regions (2018-2023)
12.3 North America Biological Safety Testing Revenue Market Forecast (2018-2023)
12.4 Europe Biological Safety Testing Revenue Market Forecast (2018-2023)
12.5 Asia-Pacific Biological Safety Testing Revenue Market Forecast (2018-2023)
12.6 South America Biological Safety Testing Revenue Market Forecast (2018-2023)
12.7 Middle East and Africa Biological Safety Testing Revenue Market Forecast (2018-2023)
13 Research Findings and Conclusion
14 Appendix
14.1 Methodology
14.2 Data Source
List of Tables and Figures
Figure Biological Safety Testing Picture
Table Product Specifications of Biological Safety Testing
Table Global Biological Safety Testing and Revenue (Million USD) Market S
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