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レポート概要
| ※当調査レポートでは、生物学的安全性試験の世界市場について調査・分析し、生物学的安全性試験の世界市場規模、市場動向、主要企業別マーケットシェア、主要地域別市場規模、企業プロフィールなどの情報をまとめました。また、セグメント分析では、種類別（器具、サービス、キット・試薬）、用途別（ワクチン開発、血液製剤、幹細胞研究）、地域別（北米、ヨーロッパ、中国、日本国内、東南アジア、インド、中南米）に区分して市場規模を算出しました。 ・レポートの概要 ・世界の生物学的安全性試験市場動向 ・主要企業別マーケットシェア ・生物学的安全性試験の種類別市場規模2014-2019 （器具、サービス、キット・試薬） ・生物学的安全性試験の用途別市場規模2014-2019 （ワクチン開発、血液製剤、幹細胞研究） ・生物学的安全性試験の北米市場：主要企業・種類別/用途別市場規模 ・生物学的安全性試験のヨーロッパ市場：主要企業・種類別/用途別市場規模 ・生物学的安全性試験の中国市場：主要企業・種類別/用途別市場規模 ・生物学的安全性試験の日本国内市場：主要企業・種類別/用途別市場規模 ・生物学的安全性試験の東南アジア市場：主要企業・種類別/用途別市場規模 ・生物学的安全性試験のインド市場：主要企業・種類別/用途別市場規模 ・生物学的安全性試験の中南米市場：主要企業・種類別/用途別市場規模 ・主要企業のプロフィール （Thermo Fisher Scientific、Charles River Laboratories International、Merck、Lonza Group、Avance Biosciences、SGS、Toxikon、NuAire） ・生物学的安全性試験の市場規模予測2019-2025 （種類別、用途別、地域別市場予測） ・アナリストの観点・結論 ... |
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
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
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