Biological Safety Testing Market by Application (Stem Cell, Blood, Gene Therapy), Product (Instruments, Services, Kits, Reagents), & Test (Bioburden, Endotoxin, Cell Line Authentication, Residual Contamination, Adventitious Agents) - Global Forecast to 2019

Biological Safety Testing Market by Application (Stem Cell, Blood, Gene Therapy), Product (Instruments, Services, Kits, Reagents), & Test (Bioburden, Endotoxin, Cell Line Authentication, Residual Contamination, Adventitious Agents) - Global Forecast to 2019

Table of Contents

1 Introduction
1.1 Objectives of the Study
1.2 Market Definition
1.3 Market Scope
1.3.1 Markets Covered
1.3.2 Years Considered for the Study
1.4 Currency
1.5 Stakeholders

2 Research Methodology
2.1 Market Size Estimation
2.2 Market Breakdown and Data Triangulation
2.3 Market Share Estimation
2.3.1 Key Data From Secondary Sources
2.3.2 Key Data From Primary Sources
2.3.3 Assumptions for the Study

3 Executive Summary

4 Premium Insights
4.1 Lucrative Opportunities in the Global Biologics Safety Testing Market
4.2 Life Cycle Analysis, By Region

5 Market Overview
5.1 Introduction
5.2 Market Segmentation
5.2.1 By Application
5.2.2 By Product
5.2.3 By Test
5.3 Market Dynamics
5.3.1 Drivers
5.3.1.1 Rapid Growth in Pharmaceutical and Biotechnology Industries
5.3.1.2 Increasing Number of New Drug Launches
5.3.1.3 Strong Trend of R&D Investments in Life Sciences
5.3.1.4 Increasing Government Support for Pharmaceutical and Biotechnology Industries
5.3.1.5 High Incidence and Large Economic Burden of Chronic Diseases
5.3.2 Restraints
5.3.2.1 High Degree of Consolidation Acts as an Entry Barrier for New Entrants
5.3.3 Opportunities
5.3.3.1 Increasing Pharmaceutical Outsourcing
5.3.3.2 Developing Countries
5.3.4 Challenges
5.3.4.1 Stringent Regulatory Frameworks and Time-Consuming Approval Processes

6 Industry Insights
6.1 Introduction
6.2 Porter’s Five Forces Analysis
6.2.1 Threat From New Entrants
6.2.2 Threat From Substitutes
6.2.3 Bargaining Power of Buyers
6.2.4 Bargaining Power of Suppliers
6.2.5 Intensity of Rivalry
6.3 Strategic Benchmarking
6.3.1 Expansions and Acquisitions
6.4 Supply Chain Analysis
6.4.1 Key Influencers

7 Biologics Safety Testing Market, By Application
7.1 Introduction
7.2 Vaccines and Therapeutics
7.3 Blood and Blood Products
7.4 Cellular and Gene Therapy Products
7.5 Tissue and Tissue Products
7.6 Stem Cell Products

8 Biologics Safety Testing Market, By Product
8.1 Introduction
8.2 Kits & Reagents
8.3 Services
8.4 Instruments

9 Biologics Safety Testing Market, By Tests
9.1 Introduction
9.2 Endotoxin Tests
9.3 Sterility Tests
9.4 Cell Line Authentication and Characterization Tests
9.5 Bioburden Tests
9.6 Residual Host Contaminant Detection Tests
9.7 Adventitious Agent Detection Tests
9.8 Other Tests

10 Geographic Analysis
10.1 Introduction
10.2 North America
10.2.1 U.S.
10.2.2 Canada
10.3 Europe
10.4 Asia
10.4.1 China
10.4.2 Japan
10.4.3 India
10.4.4 Rest of Asia (RoA)
10.5 Rest of the World (RoW)

11 Competitive Landscape
11.1 Overview
11.2 Market Share Analysis
11.3 Competitive Situation and Trends
11.3.1 Expansions
11.3.2 Acquisitions
11.3.3 Agreements, Collaborations, and Partnerships
11.3.4 New Product and Service Launches
11.3.5 Other Developments

12 Company Profiles
12.1 Introduction
12.2 Charles River Laboratories International, Inc.
12.2.1 Business Overview
12.2.2 Products & Services
12.2.3 Recent Developments
12.2.4 MNM View
12.2.4.1 Financial Analysis
12.2.4.2 Strategic Analysis
12.3 Lonza Group
12.3.1 Business Overview
12.3.2 Products & Services
12.3.3 Recent Developments
12.3.4 MNM View
12.3.4.1 Financial Analysis
12.3.4.2 Strategic Analysis
12.4 Sigma-Aldrich Corporation
12.4.1 Business Overview
12.4.2 Products & Services
12.4.3 Recent Developments
12.4.4 MNM View
12.4.4.1 Financial Analysis
12.4.4.2 Strategic Analysis
12.5 SGS S.A.
12.5.1 Business Overview
12.5.2 Services Portfolio
12.5.3 Recent Developments
12.5.4 MNM View
12.6 Wuxi Pharmatech (Cayman) Inc.
12.6.1 Business Overview
12.6.2 Services Portfolio
12.6.3 Recent Developments
12.6.4 MNM View
12.6.4.1 Financial Analysis
12.6.4.2 Strategic Analysis
12.7 Avance Biosciences Inc.
12.7.1 Business Overview
12.7.2 Services Portfolio
12.8 Bsl Bioservice
12.8.1 Business Overview
12.8.2 Services Portfolio
12.9 Cytovance Biologics, Inc.
12.9.1 Business Overview
12.9.2 Services Portfolio
12.10 Merck & Co., Inc.
12.10.1 Business Overview
12.10.2 Products & Services
12.10.3 Recent Developments
12.10.4 Key Strategy
12.11 Toxikon Corporation
12.11.1 Business Overview
12.11.2 Products & Services

13 Appendix
13.1 Insights of Industry Experts
13.2 Discussion Guide
13.3 Introducing RT: Real-Time Market Intelligence
13.4 Available Customizations
13.5 Related Reports

List of Tables

Table 1 Biologics Safety Testing Market Summary
Table 2 Rapid Growth in the Pharmaceutical and Biotechnology Industries is Propelling the Growth of Biologics Safety Testing Market
Table 3 High Degree of Consolidation Acts as an Entry Barrier for New Entrants
Table 4 Increasing Pharmaceutical Outsourcing Are Paving New Growth Avenues for Players in the Biologics Safety  Testing Market
Table 5 Stringent Regulatory Frameworks Are Major Challenges for Market Players
Table 6 Market Developments Between 2011 and 2014
Table 7 Biological Safety Testing Market Size, By Application, 2012–2019 ($Million)
Table 8 Biologics Safety Testing Market Size for Vaccines and Therapeutics, By Region, 2012–2019 ($Million)
Table 9 Biological Safety Testing Market Size for Blood and Blood Products, By Region, 2012–2019 ($Million)
Table 10 Biological Safety Testing Market Size for Cellular and Gene Therapy Products, By Region, 2012-2019 ($Million)
Table 11 Biologics Safety Testing Market Size for Tissue and Tissue Products, By Region, 2012–2019 ($Million)
Table 12 Market Size for Stem Cell Products, By Region, 2012-2019 ($Million)
Table 13 Biological Safety Testing Market Size, By Product, 2012–2019 ($Million)
Table 14 Biologics Safety Testing Kits and Reagents Market Size, By Region, 2012–2019 ($Million)
Table 15 North America: Biological Safety Testing Kits and Reagents Market Size, By Country, 2012–2019 ($Million)
Table 16 Asia: Biologics Safety Testing Kits and Reagents Market Size, By Country, 2012–2019 ($Million)
Table 17 Biological Safety Testing Services Market Size, By Region, 2012–2019 ($Million)
Table 18 North America: Biologics Safety Testing Services Market Size, By Country, 2012–2019 ($Million)
Table 19 Asia: Biological Safety Testing Services Market Size, By Country, 2012–2019 ($Million)
Table 20 Biologics Safety Testing Instruments Market Size, By Region, 2012–2019 ($Million)
Table 21 North America: Biological Safety Testing Instruments Market Size, By Country, 2012–2019 ($Million)
Table 22 Asia: Biological Safety Testing Instruments Market Size, By Country, 2012–2019 ($Million)
Table 23 Biologics Safety Testing Market, By Test, 2012–2019 ($Million)
Table 24 Biological Safety Testing Market for Endotoxin Tests, By Region, 2012–2019 ($Million)
Table 25 North America: Market for Endotoxin Tests, By Region, 2012–2019 ($Million)
Table 26 Asia: Biological Safety Testing Market for Endotoxin Tests, By Region, 2012–2019 ($Million)
Table 27 Biologics Safety Testing Market for Sterility Tests, By Region, 2012–2019 ($Million)
Table 28 North America: Biologics Safety Tests Market for Sterility Tests, By Region, 2012–2019 ($Million)
Table 29 Asia: Biologics Safety Tests Market for Sterility Tests, By Region, 2012–2019 ($Million)
Table 30 Biological Safety Testing Market for Cell Line Authentication and Characterization Tests, By Region, 2012–2019 ($Million)
Table 31 North America: Biological Safety Testing Market for Cell Line Authentication and Characterization Tests, By Region, 2012–2019 ($Million)
Table 32 Asia: Biologics Safety Testing Market for Cell Line Authentication and Characterization Tests, By Region, 2012–2019 ($Million)
Table 33 Biological Safety Testing Market for Bioburden Tests, By Region, 2012–2019 ($Million)
Table 34 North America Biologics Safety Testing Market for Bioburden Tests, By Region, 2012–2019 ($Million)
Table 35 Asia: Biological Safety Testing Market for Bioburden Tests, By Region, 2012–2019 ($Million)
Table 36 Market for Residual Host Contaminant Detection Tests, By Region, 2012–2019 ($Million)
Table 37 North America: Biological Safety Testing Market for Residual Host Contaminant Detection Tests, By Region, 2012–2019 ($Million)
Table 38 Asia: Biologics Safety Testing Market for Residual Host Contaminant Detection Tests, By Region, 2012–2019 ($Million)
Table 39 Biological Safety Testing Market for Adventitious Agent Detection Tests, By Region, 2012–2019 ($Million)
Table 40 North America: Biologics Safety Testing Market for Adventitious Agent Detection Tests, By Region, 2012–2019 ($Million)
Table 41 Asia: Biological Safety Testing Market for Adventitious Agent Detection Tests, By Region, 2012–2019 ($Million)
Table 42 Biologics Safety Testing Market for Other Tests, By Region, 2012–2019 ($Million)
Table 43 North America: Biologics Safety Tests Market for Other Tests, By Region, 2012–2019 ($Million)
Table 44 Asia: Biological Safety Testing Market for Other Tests, By Region, 2012–2019 ($Million)
Table 45 Biologics Safety Testing Market Size, By Region, 2012–2019 ($Million)
Table 46 North America: Biological Safety Testing Market Size, By Region, 2012–2019 ($Million)
Table 47 North America: Biologics Safety Testing Market Size, By Product, 2012–2019 ($Million)
Table 48 North America: Market Size, By Application, 2012–2019 ($Million)
Table 49 North America: Market Size, By Test, 2012–2019 ($Million)
Table 50 U.S.: Biologics Safety Testing Market Size, By Product, 2012–2019 ($Million)
Table 51 U.S.: Market Size, By Application, 2012–2019 ($Million)
Table 52 Canada: Biologics Safety Testing Market Size, By Product, 2012–2019 ($Million)
Table 53 Canada: Market Size, By Application, 2012–2019 ($Million)
Table 54 Europe: Biological Safety Testing Market Size, By Product, 2012–2019 ($Million)
Table 55 Europe: Market Size, By Application, 2012–2019 ($Million)
Table 56 Europe: Market Size, By Test, 2012–2019 ($Million)
Table 57 Asia: Biologics Safety Testing Market Size, By Region, 2012–2019 ($Million)
Table 58 Asia: Biological Safety Testing Market Size, By Product, 2012–2019 ($Million)
Table 59 Asia: Market Size, By Application, 2012–2019 ($Million)
Table 60 Asia: Market Size, By Test, 2012–2019 ($Million)
Table 61 China: Market Size, By Product, 2012–2019 ($Million)
Table 62 China: Biological Safety Testing Market Size, By Application, 2012–2019 ($Million)
Table 63 Japan: Biologics Safety Testing Market Size, By Product, 2012–2019 ($Million)
Table 64 Japan: Biological Safety Testing Market Size, By Application, 2012–2019 ($Million)
Table 65 India:  Market Size, By Product, 2012–2019 ($Million)
Table 66 India: Market Size, By Application, 2012–2019 ($Million)
Table 67 RoA: Biologics Safety Testing Market Size, By Product, 2012–2019 ($Million)
Table 68 RoA: Market Size, By Application, 2012–2019 ($Million)
Table 69 RoW: Market Size, By Product, 2012–2019 ($Million)
Table 70 RoW: Market Size, By Application, 2012–2019 ($Million)
Table 71 RoW: Biological Safety Testing Market Size, By Test, 2012–2019 ($Million)
Table 72 Market Share Analysis, By Key Player, 2014
Table 73 Expansions, 2012–2015
Table 74 Acquisitions, 2012–2015
Table 75 New Product and Service Launches, 2012–2015
Table 76 Other Developments, 2012–2015

List of Figures

Figure 1 Global Biologics Safety Testing Market
Figure 2 Research Methodology
Figure 3 Market Size Estimation Methodology: Bottom-Up Approach
Figure 4 Market Size Estimation Methodology: Top-Down Approach
Figure 5 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 6 Data Triangulation Methodology
Figure 7 Biologics Safety Testing Market Size, By Product, 2014 vs. 2019 ($Million)
Figure 8 Biological Safety Testing Market Size, By Application, 2014 vs. 2019 ($Million)
Figure 9 Market Size, By Test, 2014 vs. 2019 ($Million)
Figure 10 Biologics Testing Market Size, By Region, 2014 vs. 2019 ($Million)
Figure 11 Increase in Pharmaceutical and Biotechnology Industries Will Drive Market Growth
Figure 12 Kits and Reagents Segment Accounted for the Largest Market Share in 2014
Figure 13 Asian Market to Experience Fastest Growth in the Forecast Period (2014 to 2019)
Figure 14 Asia Poised for Lucrative Growth
Figure 15 Biologics Safety Testing Market Segmentation: By Application
Figure 16 Biological Safety Testing Market Segmentation: By Product
Figure 17 Market Segmentation: By Test
Figure 18 Growth in Pharmaceutical and Biotechnology Industries Will Drive the Biological Safety Testing Market
Figure 19 Increasing Number of New Drug Launches to Drive the Biologics Safety Testing Market
Figure 20 High Capital Investments to Restrict the Entry of New Players
Figure 21 Direct Distribution Strategy Preferred By Prominent Companies
Figure 22 Biologics Safety Testing Market, By Application
Figure 23 Biological Safety Testing Market Size, By Application, 2014 ($Million)
Figure 24 Vaccine and Therapeutics Will Be the Fastest-Growing Application Segment of the Biologics Safety Testing Market
Figure 25 North America Dominated the Blood and Blood Products Application Segment in 2104
Figure 26 Asia to Witness Highest Growth in the Cellular and Gene Therapy Products Application Segment
Figure 27 North America to Command Largest Share of the Tissue and Tissue Products Application Segment in the Forecast Period
Figure 28 Asia to Witness Highest Growth in the Stem Cell Products Application Segment
Figure 29 Market Segmentation, By Product
Figure 30 Biological Safety Testing Market Size, By Product, 2014 ($Million)
Figure 31 North America Dominated the Biologics Safety Testing Kits and Reagents Market in 2014
Figure 32 U.S. to Dominate the Biological Safety Testing Kits and Reagents Market in North America
Figure 33 China to Dominate the Biologics Safety Testing Kits and Reagents Market in Asia
Figure 34 Asia to Witness the Highest Growth in the Biological Safety Testing Services Market in the Forecast Period
Figure 35 U.S. to Dominate the Biologics Safety Testing Services Market in North America
Figure 36 China to Dominate the Biological Safety Testing Services Market in Asia
Figure 37 North America to Dominate the Biologics Safety Testing Instruments Market in the Forecast Period
Figure 38 U.S. to Dominate the Biological Safety Testing Instruments Market in North America
Figure 39 China to Dominate the Biologics Safety Testing Instruments Market in Asia
Figure 40 Biologics Safety Testing Market, By Test
Figure 41 Market Size, By Test, 2014–2019 ($Million)
Figure 42 North America to Account for the Largest Share of the Endotoxin Tests Segment
Figure 43 The U.S. to Account for the Largest Share in the Endotoxin Tests Segment in North America
Figure 44 China to Account for the Largest Share in the Endotoxin Tests Market in Asia
Figure 45 North America to Account for the Largest Share in the Sterility Tests Segment
Figure 46 The U.S. to Account for the Largest Share of the Sterility Tests Segment in North America
Figure 47 China to Account for the Largest Share in the Sterility Tests Segment in Asia
Figure 48 North America Will Account for the Largest Share in the Cell Line Authentication and Characterization Tests Segment
Figure 49 The U.S. to Account for the Largest Share of the Cell Line Authentication and Characterization Tests Segment in North America
Figure 50 China to Account for the Largest Share in the Cell Line Authentication and Characterization Tests Segment in Asia
Figure 51 North America to Account for the Largest Share in the Bioburden Tests Segment
Figure 52 The U.S. to Account for the Largest Share in the Bioburden Tests Segment in North America
Figure 53 China to Account for the Largest Share in the Bioburden Tests Segment in Asia
Figure 54 North America to Account for the Largest Share of the Residual Host Contaminant Detection Tests Segment
Figure 55 The U.S. to Account for the Largest Share in the Residual Host Contaminant Detection Tests Segment in North America
Figure 56 China to Account for the Largest Share in the Residual Host Contaminant Detection Tests Segment in Asia
Figure 57 North America to Account for the Largest Share in the Adventitious Agent Detection Tests Segment
Figure 58 The U.S. to Account for the Largest Share in the Adventitious Agent Detection Tests Segment in North America
Figure 59 China to Account for the Largest Share in the Adventitious Agent Detection Tests Segment in Asia
Figure 60 North America to Account for the Largest Share in the Other Tests Segment
Figure 61 The U.S. to Account for the Largest Share in the Other Tests Segment in North America
Figure 62 China to Account for the Largest Share in the Other Tests Segment in Asia
Figure 63 Biologics Safety Testing Market Segmentation, By Region
Figure 64 Biological Safety Testing Market Size, By Region (Market Size and Growth Rate), 2014-2019
Figure 65 Asian Market for Biologics Safety Testing Expected to Grow at the Highest Rate From 2014 to 2019
Figure 66 North America: Market Snapshot
Figure 67 North America: Market, By Region (Market Size and Growth Rate), 2014-2019
Figure 68 Kits and Reagents Held the Largest Share of the Biologics Safety Testing Market in North America in 2014
Figure 69 Vaccines and Therapeutics Formed the Largest Application Segment in North America
Figure 70 Endotoxin Tests Formed the Largest Test Segment in North America in 2014
Figure 71 Kits and Reagents Formed the Largest Product Segment in the U.S.
Figure 72 Vaccines and Therapeutics Application Segment Held the Largest Share in the U.S. Market
Figure 73 Kits and Reagents Held the Largest Share Among All Product Segments in Canada
Figure 74 Vaccines and Therapeutics Formed the Largest Application Segment in Canada
Figure 75 Kits and Reagents Held the Largest Share of the Biologics Safety Testing Products Market in Europe
Figure 76 Vaccines and Therapeutics Formed the Largest Application Segment in Europe in 2014
Figure 77 Endotoxin Tests Accounted for the Largest Share of Biologics Safety Testing Market
Figure 78 Asia: Market Snapshot
Figure 79 Asia: Biologics Safety Testing Market, By Region (Market Size and Growth Rate)
Figure 80 Kits and Reagents Product Segment Dominated Asian Biologics Safety Testing Market in 2014
Figure 81 Vaccines and Therapeutics Application Segment Accounted for Largest Share of Asian Biologics Safety Testing Market
Figure 82 Endotoxin Tests Accounted for the Largest Share of the Market in Asia
Figure 83 Kits and Reagents Were the Largest Product Segment in China in 2014
Figure 84 Vaccines and Therapeutics Held the Largest Share of the Chinese Market in 2014
Figure 85 Kits and Reagents Formed the Largest Product Segment in Japan
Figure 86 Vaccines and Therapeutics Application Segment Held the Largest Share of the Japanese Market
Figure 87 Kits and Reagents Formed the Largest and Fastest-Growing Product Segment in India
Figure 88 Vaccines and Therapeutics Form the Largest and the Fastest-Growing Application Segment in India
Figure 89 Kits and Reagents Commanded the Largest Share of the RoA Biologics Safety Testing Market in 2014
Figure 90 Vaccines and Therapeutics Application Segment Dominates RoA Market
Figure 91 Kits and Reagents Commanded the Largest Share of the RoW Biologics Safety Testing Market, By Product
Figure 92 Vaccines and Therapeutics Were the Largest Application Segment in 2014
Figure 93 Endotoxin Tests Segment Dominates RoW Market
Figure 94 Expansions and Acquisitions Are the Key Strategies Adopted By Players
Figure 95 Battle for Market Share: Expansions and Acquisitions Were the Key Strategies
Figure 96 Expansions, 2012–2015
Figure 97 Acquisitions, 2012–2015
Figure 98 Agreements, Collaborations, and Partnerships, 2012–2015
Figure 99 Agreements, Collaborations, and Partnerships, 2012–2015
Figure 100 New Product and Service Launches, 2012–2015
Figure 101 Other Developments, 2012–2015
Figure 102 Snapshot for the Financial Performances of the Leading Market Players
Figure 103 Charles River Laboratories International, Inc.: Company Snapshot
Figure 104 Lonza Group: Company Snapshot
Figure 105 Sigma-Aldrich Corporation: Company Snapshot
Figure 106 SGS SA: Company Snapshot
Figure 107 Wuxi Pharmatech (Cayman) Inc.: Company Snapshot
Figure 108 Merck & Co., Inc.: Company Snapshot

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