生物学的製剤の安全試験の世界市場予測(~2022年):エンドトキシン試験、無菌試験、細胞株認証、バイオバーデン試験

◆英語タイトル:Biologics Safety Testing Market by Product (Instruments, Services, Kits & Reagents), Test (Endotoxin, Sterility Test, Cell Line Authentication, Bioburden), Application (Vaccine Development, Blood Products, Stem Cell Research) - Global Forecast to 2022
◆商品コード:MAM-BT3334
◆発行会社(調査会社):MarketsandMarkets
◆発行日:2017年7月18日
◆ページ数:142
◆レポート言語:英語
◆レポート形式:PDF
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当調査レポートでは、生物学的製剤の安全試験の世界市場について調査・分析し、エグゼクティブサマリー、市場インサイト、市場概観/市場動向、市場シェア分析、製品別分析、試験別分析、用途別分析、地域別分析、生物学的製剤の安全試験の世界市場規模及び予測、市場動向、競争状況、関連企業分析などの情報をお届けいたします。
【レポートの概要】

Biologics safety testing is a mandatory process in pharmaceutical and biotechnological companies. It is used as a quality control measure for the drug development process. The biologics safety testing market is expected to reach USD 4.90 Billion by 2022 from USD 2.75 Billion in 2017, at a CAGR of 12.2% from 2017 to 2022. Growth in pharmaceutical and biotechnology industry driven by government support in both industries, the positive trend of R&D investment in the life sciences industry and an increase in the number of new drug launches are the major factors driving the growth of this market.
On the basis of products and services, the global market is segmented into kits & reagents, services, and instruments. The kits & reagents segment accounted for the largest share of the products segment. This growth can be attributed to the regular and repeated purchase of kits & reagents as compared to instruments.

On the basis of applications, the global market is segmented into vaccine and therapeutics development; blood and blood-related products testing; cellular and gene therapy; tissue and tissue-related products testing, and stem cell research.The vaccine and therapeutics development segment holds the largest share in the market. The growth of this segment is primarily attributed to the increase in initiatives for immunization, increase company investment in vaccines development and the rising prevalence of diseases.

By region, the global biologics safety testing market is segmented into North America, Europe, Asia, and the Rest of the World (RoW). While North America holds the largest share of the market in 2016 followed by Europe, Asia is expected to grow at the highest CAGR during the forecast period. The presence of emerging economies like China and India; large population; growth in pharmaceutical and biotechnology industry; and growth in the outsourcing industry in this region are key factors driving the high growth of this regional segment.

The top four players in this market are Lonza Group LTD. (Switzerland), Charles River Laboratories (U.S.), Merck KGaA (Germany) and SGS SA (Switzerland) are. These companies have a broad product & service portfolio with comprehensive features and have a strong geographical presence.

【レポートの目次】

1 Introduction (Page No. – 13)
1.1 Objectives of the Study
1.2 Market Definition
1.2.1 Markets Covered
1.2.2 Years Considered for the Study
1.3 Currency
1.4 Limitations
1.5 Stakeholders

2 Research Methodology (Page No. – 16)
2.1 Research Approach
2.2 Research Data
2.2.1 Secondary Sources
2.2.1.1 Key Data From Secondary Sources
2.2.2 Primary Sources
2.2.2.1 Key Data From Primary Sources
2.2.2.2 Breakdown of Primary Interviews
2.3 Market Size Estimation
2.4 Market Breakdown and Data Triangulation
2.5 Research Assumptions

3 Executive Summary (Page No. – 23)

4 Biologics Safety Testing Market: Premium Insights (Page No. – 27)
4.1 Biologics Safety Testing: Market Overview
4.2 Geographic Analysis: By Product & Service (2017)
4.3 Geographic Snapshot of the Global Market
4.4 Global Market, By Application 2017 vs 2022

5 Market Overview (Page No. – 31)
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Growth in Pharmaceutical and Biotechnology Industries Driven By Government Support
5.2.1.2 Positive Trend of R&D Investments in Life Science
5.2.1.3 Increase in Number of Drug Launches
5.2.1.4 High Incidence and Large Economic Burden of Chronic Diseases
5.2.2 Opportunities
5.2.2.1 Emerging Markets
5.2.2.2 Increasing Pharmaceutical Outsourcing
5.2.3 Challenge
5.2.3.1 Dearth of Skilled Professionals

6 Biologics Safety Testing Market, By Product and Service (Page No. – 36)
6.1 Introduction
6.2 Kits & Reagents
6.3 Services
6.4 Instruments

7 Biologics Safety Testing Market, By Test Type (Page No. – 40)
7.1 Introduction
7.2 Endotoxin Tests
7.3 Sterility Tests
7.4 Cell Line Authentication and Characterization Tests
7.5 Bioburden Tests
7.6 Residual Host Contaminant Detection Tests
7.7 Adventitious Agent Detection Tests
7.8 Other Tests

8 Biologics Safety Testing Market, By Application (Page No. – 47)
8.1 Introduction
8.2 Vaccine & Therapeutics Development
8.3 Blood and Blood-Related Products Testing
8.4 Cellular and Gene Therapy
8.5 Tissue and Tissue-Related Products Testing
8.6 Stem Cell Research

9 Biologics Safety Testing Market, By Region (Page No. – 53)
9.1 Introduction
9.2 North America
9.2.1 U.S.
9.2.2 Canada
9.3 Europe
9.3.1 Germany
9.3.2 U.K.
9.3.3 France
9.3.4 Italy
9.3.5 Spain
9.3.6 Rest of Europe (RoE)
9.4 Asia
9.4.1 China
9.4.2 Japan
9.4.3 India
9.4.4 Rest of Asia
9.5 Rest of the World
9.5.1 South America, Central America, and the Caribbean
9.5.2 Pacific and Oceania
9.5.3 Africa

10 Competitive Landscape (Page No. – 91)
10.1 Overview
10.1.1 Visionary Leaders
10.1.2 Innovators
10.1.3 Dynamic Differentiators
10.1.4 Emerging Companies
10.2 Competitive Benchmarking
10.2.1 Strength of Product Portfolio
10.2.2 Business Strategy Excellence
10.3 Market Share Analysis

*Top 25 Companies Analyzed for This Studies are – Sartorius AG (Germany), SGS SA (Switzerland), Thermo Fisher Scientific, Inc. (U.S.), Lonza Group Ltd (Switzerland), Charles River Laboratories, Inc. (U.S.), Merck KGaA (Germany), Eurofins Scientific Se (Luxembourg), Source Bioscience (U.K.), F. Hoffmann-La Roche Ltd. (Switzerland), Cytovance Biologics (U.S.), Toxikon Corporation (U.S.), Avance Biosciences Inc. (U.S.), Pace Analytical Services LLC. (U.S.), Wuxi Apptec (China), Biomérieux Sa (France), Sterigenics International LLC (U.S.), Clean Cells (France), Bsl Bioservice Scientific Laboratories Munich GmbH (Germany), North American Science Associates Inc. (U.S.), Promocell GmbH (Germany), Genscript (China), Gibraltar Laboratories (U.S.), Invivogen (U.S.), Neopharm Labs Inc. (Canada), Virusure GmbH (Austria)

11 Company Profiles (Page No. – 97)
(Overview, Products Offered, Product Offering Scorecard, Business Strategy Scorecard, Recent Developments)*
11.1 Charles River Laboratories International, Inc.
11.2 Merck KGaA
11.3 Lonza Group Ltd.
11.4 SGS S.A.
11.5 Thermo Fisher Scientific Inc.
11.6 Wuxi Apptec
11.7 Sartorius AG
11.8 Cytovance Biologics, Inc.
11.9 Pace Analytical Services Inc.
11.10 Toxikon Corporation
11.11 Eurofins Scientific Se
11.12 Avance Biosciences Inc.
11.13 Source Bioscience

*Details on Marketsandmarkets View, Overview, Products Offered, Product Offering Scorecard, Business Strategy Scorecard, and Recent Developments Might Not Be Captured in Case of Unlisted Companies.

12 Appendix (Page No. – 131)
12.1 Insights of Industry Experts
12.2 Discussion Guide
12.3 Knowledge Store: Marketsandmarkets’ Subscription Portal
12.4 Introducing RT: Real-Time Market Intelligence
12.5 Available Customizations
12.6 Related Reports
12.7 Author Details

List of Tables (66 Tables)

Table 1 Biologics Safety Testing Market Summary
Table 2 Market, By Product and Service, 2015–2022 (USD Million)
Table 3 Biologics Safety Testing Kits and Reagents Market, By Region, 2015–2022 (USD Million)
Table 4 Biologics Safety Testing Services Market, By Region, 2015–2022 (USD Million)
Table 5 Biologics Safety Testing Instruments Market, By Region, 2015–2022 (USD Million)
Table 6 Market Size, By Test Type, 2015–2022 (USD Million)
Table 7 Endotoxin Tests Market, By Region, 2015–2022 (USD Million)
Table 8 Sterility Tests Market, By Region, 2015–2022 (USD Million)
Table 9 Cell Line Authentication and Characterization Tests Market, By Region, 2015–2022 (USD Million)
Table 10 Bioburden Tests Market, By Region, 2015–2022 (USD Million)
Table 11 Residual Host Contaminant Detection Tests Market, By Region, 2015–2022 (USD Million)
Table 12 Adventitious Agent Detection Tests Market, By Region, 2015–2022 (USD Million)
Table 13 Other Biologics Safety Tests Market, By Region, 2015–2022 (USD Million)
Table 14 Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 15 Market for Vaccine and Therapeutics Development, By Region, 2015–2022 (USD Million)
Table 16 Market for Blood and Blood-Related Products Testing, By Region, 2015–2022 (USD Million)
Table 17 Market for Cellular and Gene Therapy Products, By Region, 2015–2022 (USD Million)
Table 18 Market for Tissue and Tissue-Related Products Testing, By Region, 2015–2022 (USD Million)
Table 19 Market for Stem Cell Research, By Region, 2015–2022 (USD Million)
Table 20 Market, By Region, 2015–2022 (USD Million)
Table 21 North America: Biologics Safety Testing Market, By Country, 2015–2022 (USD Million)
Table 22 North America: Market, By Application, 2015–2022 (USD Million)
Table 23 North America: Market, By Product & Service, 2015–2022 (USD Million)
Table 24 North America: Market, By Test Type, 2015–2022 (USD Million)
Table 25 U.S.: Market, By Application, 2015–2022 (USD Million)
Table 26 U.S.: Market, By Product & Service, 2015–2022 (USD Million)
Table 27 Canada: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 28 Canada: Market, By Product & Service, 2015–2022 (USD Million)
Table 29 Europe: Market, By Country, 2015–2022 (USD Million)
Table 30 Europe: Market, By Application, 2015–2022 (USD Million)
Table 31 Europe: Market, By Product & Service, 2015–2022 (USD Million)
Table 32 Europe: Market, By Test Type, 2015–2022 (USD Million)
Table 33 Germany: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 34 Germany: Market, By Product & Service, 2015–2022 (USD Million)
Table 35 U.K.: Market, By Application, 2015–2022 (USD Million)
Table 36 U.K.: Market, By Product & Service, 2015–2022 (USD Million)
Table 37 France: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 38 France: Market, By Product & Service, 2015–2022 (USD Million)
Table 39 Italy: Market, By Application, 2015–2022 (USD Million)
Table 40 Italy: Market, By Product & Service, 2015–2022 (USD Million)
Table 41 Spain: Market, By Application, 2015–2022 (USD Million)
Table 42 Spain: Market, By Product & Service, 2015–2022 (USD Million)
Table 43 RoE: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 44 RoE: Market, By Product & Service, 2015–2022 (USD Million)
Table 45 Asia: Market, By Country, 2015–2022 (USD Million)
Table 46 Asia: Market, By Application, 2015–2022 (USD Million)
Table 47 Asia: Market, By Product & Service, 2015–2022 (USD Million)
Table 48 Asia: Market, By Test Type, 2015–2022 (USD Million)
Table 49 China: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 50 China: Market, By Product & Service, 2015–2022 (USD Million)
Table 51 Japan: Market, By Application, 2015–2022 (USD Million)
Table 52 Japan: Market, By Product & Service, 2015–2022 (USD Million)
Table 53 India: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 54 India: Market, By Product & Service, 2015–2022 (USD Million)
Table 55 Rest of Asia: Market, By Application, 2015–2022 (USD Million)
Table 56 Rest of Asia: Market, By Product & Service, 2015–2022 (USD Million)
Table 57 RoW: Biologics Safety Testing Market, By Region, 2015–2022 (USD Million)
Table 58 RoW: Market, By Application, 2015–2022 (USD Million)
Table 59 RoW: Market, By Product & Service, 2015–2022 (USD Million)
Table 60 RoW: Market, By Test Type, 2015–2022 (USD Million)
Table 61 South America, Central America, & the Caribbean: Market, By Application, 2015–2022 (USD Million)
Table 62 South America, Central America, & the Caribbean: Market, By Product & Service, 2015–2022 (USD Million)
Table 63 Pacific and Oceania: Biologics Safety Testing Market, By Application, 2015–2022 (USD Million)
Table 64 Pacific and Oceania: Market, By Product & Service, 2015–2022 (USD Million)
Table 65 Africa: Market, By Application, 2015–2022 (USD Million)
Table 66 Africa: Market, By Product & Service, 2015–2022 (USD Million)

List of Figures (35 Figures)

Figure 1 Research Design
Figure 2 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 3 Market Size Estimation Methodology: Bottom-Up Approach
Figure 4 Market Size Estimation Methodology: Top-Down Approach
Figure 5 Data Triangulation Methodology
Figure 6 Biologics Safety Testing Market Size, By Product & Service, 2017 vs 2022 (USD Million)
Figure 7 Global Market Size, By Application, 2017 vs 2022 (USD Million)
Figure 8 Global Market Size, By Test Type, 2017 vs 2022 (USD Million)
Figure 9 Global Market Size, By Region, 2017 vs 2022 (USD Million)
Figure 10 Global Market to Register A High, Double-Digit Growth Rate in the Forecast Period
Figure 11 Kits & Reagents Segment to Dominate the Biologics Safety Testing Market in 2017
Figure 12 Asia to Register the Highest CAGR During the Forecast Period
Figure 13 Vaccine and Therapeutics Development Will Continue to Dominate the Global Market 2022
Figure 14 Global Market: Drivers, Restraints, Opportunities, & Challenges
Figure 15 Kits & Reagents Segment to Dominate the Market During the Forecast Period
Figure 16 Endotoxin Tests Segment to Dominate the Global Market During the Forecast Period
Figure 17 Vaccine & Therapeutics Development to Dominate the Biologics Safety Testing Market During the Forecast Period
Figure 18 North America to Dominate the Global Market in 2017
Figure 19 Asia to Register the Highest CAGR During the Forecast Period (2017–2022)
Figure 20 U.S. to Witness the Highest Growth Rate in the North American Global Market During the Forecast Period (2017–2022)
Figure 21 North America: Market Snapshot
Figure 22 Germany to Witness the Highest Growth Rate in the European Market During the Forecast Period (2017–2022)
Figure 23 Asia: Market, By Country (2017)
Figure 24 Asia: Market Snapshot
Figure 25 Rest of the World: Market, By Region (2017)
Figure 26 Market (Global) Competitive Leadership Mapping, 2017
Figure 27 Market: Market Share (2016)
Figure 28 Charles River Laboratories International, Inc.: Company Snapshot (2016)
Figure 29 Merck KGaA: Company Snapshot (2016)
Figure 30 Lonza Group Ltd.: Company Snapshot (2016)
Figure 31 SGS S.A.: Company Snapshot (2016)
Figure 32 Thermo Fisher Scientific Inc.: Company Snapshot (2016)
Figure 33 Sartorius AG: Company Snapshot (2016)
Figure 34 Eurofins Scientific Se: Company Snapshot (2016)
Figure 35 Source Bioscience: Company Snapshot (2015)

【レポートのキーワード】

生物学的製剤、安全試験、エンドトキシン試験、無菌試験、細胞株認証、バイオバーデン試験、生物学的製剤検査、試験装置、試験サービス、試験キット、試薬

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