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TABLE OF CONTENTS

1 INTRODUCTION 16
1.1 OBJECTIVES OF THE STUDY 16
1.2 MARKET DEFINITION 16
1.3 MARKET SCOPE 17
1.3.1 MARKETS COVERED 17
1.3.2 YEARS CONSIDERED FOR THE STUDY 18
1.4 CURRENCY 18
1.5 STAKEHOLDERS 18

2 RESEARCH METHODOLOGY 19
2.1 MARKET SIZE ESTIMATION 21
2.2 MARKET BREAKDOWN AND DATA TRIANGULATION 23
2.3 MARKET SHARE ESTIMATION 24
2.3.1 KEY DATA FROM SECONDARY SOURCES 24
2.3.2 KEY DATA FROM PRIMARY SOURCES 24
2.3.3 ASSUMPTIONS FOR THE STUDY 25

3 EXECUTIVE SUMMARY 26

4 PREMIUM INSIGHTS 31
4.1 LUCRATIVE OPPORTUNITIES IN THE GLOBAL BIOLOGICS SAFETY TESTING MARKET 31
4.2 LIFE CYCLE ANALYSIS, BY REGION 33

5 MARKET OVERVIEW 34
5.1 INTRODUCTION 35
5.2 MARKET SEGMENTATION 35
5.2.1 BY APPLICATION 35
5.2.2 BY PRODUCT 35
5.2.3 BY TEST 36
5.3 MARKET DYNAMICS 36
5.3.1 DRIVERS 37
5.3.1.1 Rapid growth in pharmaceutical and biotechnology industries 37
5.3.1.2 Increasing number of new drug launches 37
5.3.1.3 Strong trend of R&D investments in life sciences 38
5.3.1.4 Increasing government support for pharmaceutical and biotechnology industries 38
5.3.1.5 High incidence and large economic burden of chronic diseases 39
5.3.2 RESTRAINTS 40
5.3.2.1 High degree of consolidation acts as an entry barrier for new entrants 40
5.3.3 OPPORTUNITIES 41
5.3.3.1 Increasing pharmaceutical outsourcing 41
5.3.3.2 Developing countries 41
5.3.4 CHALLENGES 42
5.3.4.1 Stringent regulatory frameworks and time-consuming approval processes 42

6 INDUSTRY INSIGHTS 43
6.1 INTRODUCTION 43
6.2 PORTER’S FIVE FORCES ANALYSIS 43
6.2.1 THREAT OF NEW ENTRANTS 44
6.2.2 THREAT OF SUBSTITUTES 44
6.2.3 BARGAINING POWER OF BUYERS 44
6.2.4 BARGAINING POWER OF SUPPLIERS 44
6.2.5 INTENSITY OF RIVALRY 45
6.3 STRATEGIC BENCHMARKING 45
6.3.1 EXPANSIONS AND ACQUISITIONS 46
6.4 SUPPLY CHAIN ANALYSIS 46
6.4.1 KEY INFLUENCERS 47

7 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION 48
7.1 INTRODUCTION 49
7.2 VACCINES AND THERAPEUTICS 50
7.3 BLOOD AND BLOOD PRODUCTS 52
7.4 CELLULAR AND GENE THERAPY PRODUCTS 53
7.5 TISSUE AND TISSUE PRODUCTS 55
7.6 STEM CELL PRODUCTS 56

8 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT 58
8.1 INTRODUCTION 59
8.2 KITS & REAGENTS 60
8.3 SERVICES 64
8.4 INSTRUMENTS 67

9 BIOLOGICS SAFETY TESTING MARKET, BY TEST 71
9.1 INTRODUCTION 72
9.2 ENDOTOXIN TESTS 74
9.3 STERILITY TESTS 77
9.4 CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS 80
9.5 BIOBURDEN TESTS 83
9.6 RESIDUAL HOST CONTAMINANT DETECTION TESTS 86
9.7 ADVENTITIOUS AGENT DETECTION TESTS 89
9.8 OTHER TESTS 92

10 BIOLOGICS SAFETY TESTING MARKET, BY REGION 95
10.1 INTRODUCTION 96
10.2 NORTH AMERICA 98
10.2.1 U.S. 104
10.2.2 CANADA 106
10.3 EUROPE 109
10.4 ASIA 113
10.4.1 CHINA 118
10.4.2 JAPAN 120
10.4.3 INDIA 123
10.4.4 REST OF ASIA (ROA) 125
10.5 REST OF THE WORLD (ROW) 128

11 COMPETITIVE LANDSCAPE 132
11.1 OVERVIEW 132
11.2 MARKET SHARE ANALYSIS 133
11.3 COMPETITIVE SITUATION AND TRENDS 135
11.3.1 EXPANSIONS 136
11.3.2 ACQUISITIONS 138
11.3.3 AGREEMENTS, COLLABORATIONS, AND PARTNERSHIPS 139
11.3.4 NEW PRODUCT AND SERVICE LAUNCHES 140
11.3.5 OTHER DEVELOPMENTS 141

12 COMPANY PROFILES 142
(Overview, Financials, Products & Services, Strategy, & Developments)*
12.1 INTRODUCTION 142
12.2 CHARLES RIVER LABORATORIES INTERNATIONAL, INC. 143
12.3 LONZA GROUP 146
12.4 SIGMA-ALDRICH CORPORATION 149
12.5 SGS S.A. 152
12.6 WUXI PHARMATECH (CAYMAN) INC. 155
12.7 AVANCE BIOSCIENCES INC. 158
12.8 BSL BIOSERVICE 159
12.9 CYTOVANCE BIOLOGICS, INC. 160
12.10 MERCK & CO., INC. 162
12.11 TOXIKON CORPORATION 164
*Details on Financials, Product & Services, Strategy, & Developments might not be captured in case of unlisted companies.

13 APPENDIX 165
13.1 INSIGHTS OF INDUSTRY EXPERTS 165
13.2 DISCUSSION GUIDE 166
13.3 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 168
13.4 AVAILABLE CUSTOMIZATIONS 169
13.5 RELATED REPORTS 170