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The biologics safety testing market is growing at a favorable rate. The major drivers for the market include growth of the pharmaceutical and biological industries and an increasing number of new drug launches. Over the years, the number of drug approvals in North American countries has increased. Between 2001 and 2010, the FDA approved 225 drug applications and Health Canada approved 99. In addition, according to WIPO, Europe accounted for 3,822 of the pharmaceutical and 1,998 of the biotechnology patents granted in 2012. Furthermore, according to OECD estimates, in 2011, the total number of biotechnology companies in the U.S. was 7,970. This will spur the growth of biologics safety testing market.

The global pharmaceutical industry is expected to grow at a CAGR between 5% and 8%. According to the IMS Institute of Healthcare Informatics, the global biologics market has increased from $46 billion in 2002 to $169 billion in 2012. Biologics accounted for 11% of the total sales of drugs in 2002, which increased to 18% in 2012. It is estimated that this figure will rise to 20% by 2017, with a total market value of $221 billion. According to Ernst & Young’s Global Biotechnology Report 2013, companies in biotech centers in the U.S., Europe, Canada, and Australia achieved revenues of about $90 billion in 2012. This was an 8% increase over their revenues in 2011. According to OECD estimates, in 2011, the total number of biotechnology companies in the U.S. was 7,970, followed by Spain (3,025 biotechnology companies), and France (1,481 biotechnology companies). Owing to the rise in the number of biotechnology companies, biopharmaceutical production has increased globally. Biologics safety testing is carried out at all levels of pharmaceutical and biopharmaceutical manufacturing process to minimize the risk of product contamination. Growth in pharmaceutical and biotechnology industries will drive the growth of the biologics safety testing market.

This report segments the global biologic safety testing market based on product, type of test, application, and geography. The product segments included in the report are instruments, kits & reagents, and services. Based on test, this market is categorized into adventitious agents detection test, bioburden tests, cell line authentication and characterization tests, endotoxin tests, residual host contaminant detection tests, sterility testing, and other tests (efficacy tests, toxicity tests, stability tests). The application segments included in the report are blood & blood products, cellular & gene therapy products, stem cell products, tissues & tissue products, and vaccines and therapeutics.

The geographic segments included in this report are Asia, Europe, North America and the Rest of the World (RoW). Asia is further divided into China, India, Japan, and the Rest of Asia. North America includes Canada and the U.S.

A combination of bottom-up and top-down approaches were used to calculate market sizes and growth rates of the global biologics safety testing market and its subsegments. Secondary information was used to identify overall revenue, geographic reach, and product portfolios of market players. Estimates of their biologics safety testing market segment revenues were validated through primary interviews. Primary interviews with key opinion leaders were also used to determine the percentage shares of each subsegment and the relative differences in growth rates.

The report provides qualitative insights on key market shares, growth rates, and market drivers for all important subsegments. It maps market sizes and the growth rates of each subsegment and identifies segments poised to see rapid growth. The report also includes company profiles of market leaders. These company profiles include the financial performances, product portfolios, and developments of each company. The report also provides a competitive landscape of the biologic safety testing market. The competitive landscape covers growth strategies adopted by industry players over the last three years, and includes analyses of industry developments like mergers and acquisitions, agreements and partnerships, and new product launches.



Reasons to Buy the Report:

The report will enable both established firms and new entrants to gauge the pulse of the market and help them make important strategic growth decisions.



The report provides insights on the following:
- Product Development/Innovation: Product portfolios of top players in the biologic safety testing market. Detailed insights on upcoming technologies, research and development activities, and new product launches in the biologic safety testing market
- Competitive Assessment: In-depth assessment of market shares, strategies, geographic and business segments, and product portfolios of leading players in the biologic safety testing market
- Market Development: Comprehensive information about lucrative emerging markets. The report analyzes the market for various biologics safety testing products across geographies
- Market Diversification: Exhaustive information about new products and services, recent developments, and investments in the biologics safety testing market

Table Of Contents

Biological Safety Testing Market by Application, Product, and Test - Global Forecast to 2019
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 25
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 34
5 MARKET OVERVIEW 35
5.1 INTRODUCTION 36
5.2 MARKET SEGMENTATION 36
5.2.1 BY APPLICATION 36
5.2.2 BY PRODUCT 36
5.2.3 BY TEST 37
5.3 MARKET DYNAMICS 37
5.3.1 DRIVERS 38
5.3.1.1 Rapid growth in pharmaceutical and biotechnology industries 38
5.3.1.2 Increasing number of new drug launches 38
5.3.1.3 Strong trend of RandD investments in life sciences 39
5.3.1.4 Increasing government support for pharmaceutical and biotechnology industries 39
5.3.1.5 High incidence and large economic burden of chronic diseases 40

5.3.2 RESTRAINTS 41
5.3.2.1 High degree of consolidation acts as an entry barrier for new entrants 41
5.3.3 OPPORTUNITIES 42
5.3.3.1 Increasing pharmaceutical outsourcing 42
5.3.3.2 Developing countries 42
5.3.4 CHALLENGES 43
5.3.4.1 Stringent regulatory frameworks and time-consuming approval processes 43
6 INDUSTRY INSIGHTS 44
6.1 INTRODUCTION 44
6.2 PORTER'S FIVE FORCES ANALYSIS 44
6.2.1 THREAT OF NEW ENTRANTS 45
6.2.2 THREAT OF SUBSTITUTES 45
6.2.3 BARGAINING POWER OF BUYERS 45
6.2.4 BARGAINING POWER OF SUPPLIERS 45
6.2.5 INTENSITY OF RIVALRY 46
6.3 STRATEGIC BENCHMARKING 46
6.3.1 EXPANSIONS AND ACQUISITIONS 47
6.4 SUPPLY CHAIN ANALYSIS 47
6.4.1 KEY INFLUENCERS 48
7 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION 49
7.1 INTRODUCTION 50
7.2 VACCINES AND THERAPEUTICS 52
7.3 BLOOD AND BLOOD PRODUCTS 53
7.4 CELLULAR AND GENE THERAPY PRODUCTS 55
7.5 TISSUE AND TISSUE PRODUCTS 57
7.6 STEM CELL PRODUCTS 58
8 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT 60
8.1 INTRODUCTION 61
8.2 KITS and REAGENTS 62
8.3 SERVICES 66
8.4 INSTRUMENTS 69
9 BIOLOGICS SAFETY TESTING MARKET, BY TEST 73
9.1 INTRODUCTION 74
9.2 ENDOTOXIN TESTS 76
9.3 STERILITY TESTS 79

9.4 CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS 83
9.5 BIOBURDEN TESTS 87
9.6 RESIDUAL HOST CONTAMINANT DETECTION TESTS 91
9.7 ADVENTITIOUS AGENT DETECTION TESTS 95
9.8 OTHER TESTS 99
10 BIOLOGICS SAFETY TESTING MARKET, BY REGION 103
10.1 INTRODUCTION 104
10.2 NORTH AMERICA 107
10.2.1 U.S. 113
10.2.2 CANADA 115
10.3 EUROPE 118
10.4 ASIA 122
10.4.1 CHINA 127
10.4.2 JAPAN 129
10.4.3 INDIA 132
10.4.4 REST OF ASIA (ROA) 134
10.5 REST OF THE WORLD (ROW) 137
11 COMPETITIVE LANDSCAPE 141
11.1 OVERVIEW 141
11.2 MARKET SHARE ANALYSIS 142
11.3 COMPETITIVE SITUATION AND TRENDS 144
11.3.1 EXPANSIONS 145
11.3.2 ACQUISITIONS 147
11.3.3 AGREEMENTS, COLLABORATIONS, AND PARTNERSHIPS 148
11.3.4 NEW PRODUCT AND SERVICE LAUNCHES 149
11.3.5 OTHER DEVELOPMENTS 150
12 COMPANY PROFILES 151
(Overview, Products and Services, Financials, Strategy and Development)*
12.1 INTRODUCTION 151
12.2 CHARLES RIVER LABORATORIES INTERNATIONAL, INC. 152
12.3 LONZA GROUP 156
12.4 SIGMA-ALDRICH CORPORATION 159
12.5 SGS S.A. 162
12.6 WUXI PHARMATECH (CAYMAN) INC. 165
12.7 AVANCE BIOSCIENCES INC. 168
12.8 BSL BIOSERVICE 169

12.9 CYTOVANCE BIOLOGICS, INC. 170
12.10 MERCK KGAA 172
12.11 TOXIKON CORPORATION 175
*Details on Overview, Products and Services, Financials, Strategy and Development might not be Captured in case of Unlisted Companies.
13 APPENDIX 176
13.1 INSIGHTS OF INDUSTRY EXPERTS 176
13.2 DISCUSSION GUIDE 177
13.3 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 179
13.4 AVAILABLE CUSTOMIZATIONS 180
13.5 RELATED REPORTS 181


LIST OF TABLES

TABLE 1 BIOLOGICS SAFETY TESTING MARKET SUMMARY 26
TABLE 2 RAPID GROWTH IN THE PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRIES IS PROPELLING THE GROWTH OF THE BIOLOGICS SAFETY TESTING MARKET 40
TABLE 3 HIGH DEGREE OF CONSOLIDATION ACTS AS AN ENTRY BARRIER FOR NEW ENTRANTS 41
TABLE 4 INCREASING PHARMACEUTICAL OUTSOURCING PAVES NEW GROWTH AVENUES FOR PLAYERS IN THE BIOLOGICS SAFETY TESTING MARKET 42
TABLE 5 STRINGENT REGULATORY FRAMEWORKS ARE MAJOR CHALLENGES FOR MARKET PLAYERS 43
TABLE 6 MARKET DEVELOPMENTS BETWEEN 2011 AND 2014 46
TABLE 7 BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 51
TABLE 8 BIOLOGICS SAFETY TESTING MARKET SIZE FOR VACCINES AND THERAPEUTICS,
BY REGION, 2012-2019 (USD MILLION) 53
TABLE 9 BIOLOGICS SAFETY TESTING MARKET SIZE FOR BLOOD AND BLOOD PRODUCTS, BY REGION, 2012-2019 (USD MILLION) 54
TABLE 10 BIOLOGICS SAFETY TESTING MARKET SIZE FOR CELLULAR AND GENE THERAPY PRODUCTS, BY REGION, 2012-2019 (USD MILLION) 56
TABLE 11 BIOLOGICS SAFETY TESTING MARKET SIZE FOR TISSUE AND TISSUE PRODUCTS, BY REGION, 2012-2019 (USD MILLION) 58
TABLE 12 BIOLOGICS SAFETY TESTING MARKET SIZE FOR STEM CELL PRODUCTS,
BY REGION, 2012-2019 (USD MILLION) 59
TABLE 13 BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 62
TABLE 14 BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET SIZE, BY REGION, 2012-2019 (USD MILLION) 63
TABLE 15 NORTH AMERICA: BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET SIZE, BY COUNTRY, 2012-2019 (USD MILLION) 64
TABLE 16 ASIA: BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET SIZE,
BY COUNTRY, 2012-2019 (USD MILLION) 65
TABLE 17 BIOLOGICS SAFETY TESTING SERVICES MARKET SIZE, BY REGION,
2012-2019 (USD MILLION) 67
TABLE 18 NORTH AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET SIZE,
BY COUNTRY, 2012-2019 (USD MILLION) 68
TABLE 19 ASIA: BIOLOGICS SAFETY TESTING SERVICES MARKET SIZE, BY COUNTRY,
2012-2019 (USD MILLION) 69
TABLE 20 BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET SIZE, BY REGION,
2012-2019 (USD MILLION) 70
TABLE 21 NORTH AMERICA: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET SIZE,
BY COUNTRY, 2012-2019 (USD MILLION) 71
TABLE 22 ASIA: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET SIZE,
BY COUNTRY/REGION, 2012-2019 (USD MILLION) 72
TABLE 23 BIOLOGICS SAFETY TESTING MARKET, BY TEST, 2012-2019 (USD MILLION) 75
TABLE 24 BIOLOGICS SAFETY TESTING MARKET FOR ENDOTOXIN TESTS, BY REGION,
2012-2019 (USD MILLION) 76
TABLE 25 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ENDOTOXIN TESTS, BY COUNTRY, 2012-2019 (USD MILLION) 77
TABLE 26 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR ENDOTOXIN TESTS,
BY COUNTRY/REGION, 2012-2019 (USD MILLION) 78
TABLE 27 BIOLOGICS SAFETY TESTING MARKET FOR STERILITY TESTS, BY REGION,
2012-2019 (USD MILLION) 80
TABLE 28 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR STERILITY TESTS,
BY COUNTRY, 2012-2019 (USD MILLION) 81
TABLE 29 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR STERILITY TESTS,
BY COUNTRY/REGION, 2012-2019 (USD MILLION) 82
TABLE 30 BIOLOGICS SAFETY TESTING MARKET FOR CELL LINE AUTHENTICATION
AND CHARACTERIZATION TESTS, BY REGION, 2012-2019 (USD MILLION) 84
TABLE 31 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR
CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS, BY COUNTRY,
2012-2019 (USD MILLION) 85
TABLE 32 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS, BY COUNTRY/REGION, 2012-2019 (USD MILLION) 86
TABLE 33 BIOLOGICS SAFETY TESTING MARKET FOR BIOBURDEN TESTS, BY REGION,
2012-2019 (USD MILLION) 88
TABLE 34 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR BIOBURDEN TESTS, BY COUNTRY, 2012-2019 (USD MILLION) 89
TABLE 35 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR BIOBURDEN TESTS,
BY COUNTRY/REGION, 2012-2019 (USD MILLION) 90
TABLE 36 BIOLOGICS SAFETY TESTING MARKET FOR RESIDUAL HOST CONTAMINANT DETECTION TESTS, BY REGION, 2012-2019 (USD MILLION) 92
TABLE 37 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR RESIDUAL HOST CONTAMINANT DETECTION TESTS, BY COUNTRY, 2012-2019 (USD MILLION) 93
TABLE 38 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR RESIDUAL HOST CONTAMINANT DETECTION TESTS, BY COUNTRY/REGION, 2012-2019 (USD MILLION) 94
TABLE 39 BIOLOGICS SAFETY TESTING MARKET FOR ADVENTITIOUS AGENT DETECTION TESTS, BY REGION, 2012-2019 (USD MILLION) 96
TABLE 40 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ADVENTITIOUS AGENT DETECTION TESTS, BY COUNTRY, 2012-2019 (USD MILLION) 97
TABLE 41 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR ADVENTITIOUS AGENT DETECTION TESTS, COUNTRY/REGION, 2012-2019 (USD MILLION) 98
TABLE 42 BIOLOGICS SAFETY TESTING MARKET FOR OTHER TESTS, BY REGION,
2012-2019 (USD MILLION) 100
TABLE 43 NORTH AMERICA: BIOLOGICS SAFETY TESTS MARKET FOR OTHER TESTS,
BY COUNTRY, 2012-2019 (USD MILLION) 101
TABLE 44 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR OTHER TESTS,
BY COUNTRY/REGION, 2012-2019 (USD MILLION) 102
TABLE 45 BIOLOGICS SAFETY TESTING MARKET SIZE, BY REGION,
2012-2019 (USD MILLION) 105
TABLE 46 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY,
2012-2019 (USD MILLION) 109
TABLE 47 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 110
TABLE 48 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2012-2019 (USD MILLION) 111
TABLE 49 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2012-2019 (USD MILLION) 112
TABLE 50 U.S.: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 114
TABLE 51 U.S.: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 115
TABLE 52 CANADA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 116
TABLE 53 CANADA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 117
TABLE 54 EUROPE: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 119
TABLE 55 EUROPE: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 120
TABLE 56 EUROPE: BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2012-2019 (USD MILLION) 121
TABLE 57 ASIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY/REGION,
2012-2019 (USD MILLION) 123
TABLE 58 ASIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 124
TABLE 59 ASIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 125
TABLE 60 ASIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2012-2019 (USD MILLION) 126
TABLE 61 CHINA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 128
TABLE 62 CHINA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 129
TABLE 63 JAPAN: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 130
TABLE 64 JAPAN: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 131
TABLE 65 INDIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 133
TABLE 66 INDIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 134
TABLE 67 ROA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 135
TABLE 68 ROA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 136
TABLE 69 ROW: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012-2019 (USD MILLION) 138
TABLE 70 ROW: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012-2019 (USD MILLION) 139
TABLE 71 ROW: BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2012-2019 (USD MILLION) 140
TABLE 72 EXPANSIONS, 2012-2015 146
TABLE 73 ACQUISITIONS, 2012-2015 147
TABLE 74 AGREEMENTS, COLLABORATIONS, AND PARTNERSHIPS, 2012-2015 148
TABLE 75 NEW PRODUCT AND SERVICE LAUNCHES, 2012-2015 149
TABLE 76 OTHER DEVELOPMENTS, 2012-2015 150


LIST OF FIGURES

FIGURE 1 GLOBAL BIOLOGICS SAFETY TESTING MARKET 17
FIGURE 2 RESEARCH DESIGN 19
FIGURE 3 MARKET SIZE ESTIMATION METHODOLOGY: BOTTOM-UP APPROACH 21
FIGURE 4 MARKET SIZE ESTIMATION METHODOLOGY: TOP-DOWN APPROACH 22
FIGURE 5 BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION,
AND REGION 22
FIGURE 6 DATA TRIANGULATION METHODOLOGY 23
FIGURE 7 BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2014 VS. 2019 (USD MILLION) 27
FIGURE 8 BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2014 VS. 2019 (USD MILLION) 28
FIGURE 9 BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2014 VS. 2019 (USD MILLION) 28
FIGURE 10 BIOLOGICS SAFETY TESTING MARKET SIZE, BY REGION,
2014 VS. 2019 (USD MILLION) 29
FIGURE 11 NORTH AMERICA COMMANDED LARGEST SHARE IN 2014 30
FIGURE 12 INCREASE IN PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRIES WILL DRIVE MARKET GROWTH 31
FIGURE 13 KITS AND REAGENTS SEGMENT ACCOUNTED FOR THE LARGEST MARKET SHARE IN 2014 32
FIGURE 14 ASIAN MARKET TO EXPERIENCE FASTEST GROWTH IN THE FORECAST PERIOD (2014 TO 2019) 33
FIGURE 15 ASIA POISED FOR LUCRATIVE GROWTH DURING THE FORECAST PERIOD 34
FIGURE 16 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION: BY APPLICATION 36
FIGURE 17 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION: BY PRODUCT 36
FIGURE 18 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION: BY TEST 37
FIGURE 19 GROWTH IN PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRIES WILL DRIVE THE BIOLOGICS SAFETY TESTING MARKET 37
FIGURE 20 INCREASING NUMBER OF NEW DRUG LAUNCHES TO DRIVE THE BIOLOGICS SAFETY TESTING MARKET IN THE FORECAST PERIOD 39
FIGURE 21 HIGH CAPITAL INVESTMENTS TO RESTRICT THE ENTRY OF NEW PLAYERS 44
FIGURE 22 DIRECT DISTRIBUTION STRATEGY PREFERRED BY PROMINENT COMPANIES 48
FIGURE 23 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION 50
FIGURE 24 BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2014 (USD MILLION) 51
FIGURE 25 VACCINE AND THERAPEUTICS WILL BE THE FASTEST-GROWING APPLICATION SEGMENT IN THE FORECAST PERIOD 52
FIGURE 26 NORTH AMERICA DOMINATED THE BLOOD AND BLOOD PRODUCTS APPLICATION SEGMENT IN 2014 54
FIGURE 27 ASIA TO WITNESS HIGHEST GROWTH IN THE CELLULAR AND GENE THERAPY PRODUCTS APPLICATION SEGMENT IN THE FORECAST PERIOD 55
FIGURE 28 NORTH AMERICA TO COMMAND LARGEST SHARE OF THE TISSUE AND TISSUE PRODUCTS APPLICATION SEGMENT IN THE FORECAST PERIOD 57
FIGURE 29 ASIA TO WITNESS HIGHEST GROWTH IN THE STEM CELL PRODUCTS APPLICATION SEGMENT TILL 2019 59
FIGURE 30 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION, BY PRODUCT 61
FIGURE 31 BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2014 (USD MILLION) 61
FIGURE 32 NORTH AMERICA DOMINATED THE BIOLOGICS SAFETY TESTING KITS
AND REAGENTS MARKET IN 2014 63
FIGURE 33 U.S. DOMINATED THE BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET IN NORTH AMERICA IN 2014 64
FIGURE 34 CHINA TO DOMINATED THE BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET IN ASIA IN 2014 65
FIGURE 35 ASIA TO WITNESS THE HIGHEST GROWTH IN THE BIOLOGICS SAFETY TESTING SERVICES MARKET IN THE FORECAST PERIOD 66
FIGURE 36 U.S. TO DOMINATED THE BIOLOGICS SAFETY TESTING SERVICES MARKET IN NORTH AMERICA IN 2014 67
FIGURE 37 CHINA TO DOMINATE THE BIOLOGICS SAFETY TESTING SERVICES MARKET IN ASIA 68
FIGURE 38 NORTH AMERICA TO DOMINATE THE BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET IN THE FORECAST PERIOD 70
FIGURE 39 U.S. TO DOMINATED THE BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET IN NORTH AMERICA IN 2014 71
FIGURE 40 CHINA TO DOMINATE THE BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET IN ASIA IN THE FORECAST PERIOD 72
FIGURE 41 BIOLOGICS SAFETY TESTING MARKET, BY TEST 74
FIGURE 42 BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST, 2014-2019 (USD MILLION) 74
FIGURE 43 NORTH AMERICA TO ACCOUNT FOR THE LARGEST SHARE OF THE ENDOTOXIN TESTS SEGMENT DURING THE FORECAST PERIOD 76
FIGURE 44 THE U.S. TO ACCOUNT FOR THE LARGEST SHARE IN THE ENDOTOXIN TESTS SEGMENT IN NORTH AMERICA IN 2019 77
FIGURE 45 CHINA TO ACCOUNT FOR THE LARGEST SHARE IN THE ENDOTOXIN TESTS MARKET IN ASIA DURING THE FORECAST PERIOD 78
FIGURE 46 NORTH AMERICA TO ACCOUNT FOR THE LARGEST SHARE IN THE STERILITY TESTS SEGMENT IN 2019 79
FIGURE 47 THE U.S. TO ACCOUNT FOR THE LARGEST SHARE OF THE STERILITY TESTS SEGMENT IN NORTH AMERICA IN 2019 80
FIGURE 48 CHINA ACCOUNTED FOR THE LARGEST SHARE IN THE STERILITY TESTS SEGMENT IN ASIA IN 2014 81
FIGURE 49 NORTH AMERICA WILL ACCOUNT FOR THE LARGEST SHARE IN THE CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS SEGMENT IN 2019 83
FIGURE 50 THE U.S. TO ACCOUNTED FOR THE LARGEST SHARE OF THE CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS SEGMENT IN NORTH AMERICA IN 2014 84
FIGURE 51 CHINA ACCOUNTED FOR THE LARGEST SHARE IN THE CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS SEGMENT IN ASIA IN 2014 85
FIGURE 52 NORTH AMERICA ACCOUNTED FOR THE LARGEST SHARE IN THE BIOBURDEN TESTS SEGMENT IN 2014 87
FIGURE 53 THE U.S. ACCOUNTED FOR THE LARGEST SHARE IN THE BIOBURDEN TESTS SEGMENT IN NORTH AMERICA IN 2014 88
FIGURE 54 CHINA ACCOUNTED FOR THE LARGEST SHARE IN THE BIOBURDEN TESTS SEGMENT IN ASIA IN2014 89
FIGURE 55 NORTH AMERICA ACCOUNTED FOR THE LARGEST SHARE OF THE RESIDUAL HOST CONTAMINANT DETECTION TESTS SEGMENT IN 2014 91
FIGURE 56 THE U.S. TO ACCOUNT FOR THE LARGEST SHARE IN THE RESIDUAL HOST CONTAMINANT DETECTION TESTS SEGMENT IN NORTH AMERICA DURING THE FORECAST PERIOD 92
FIGURE 57 CHINA TO ACCOUNT FOR THE LARGEST SHARE IN THE RESIDUAL HOST CONTAMINANT DETECTION TESTS SEGMENT IN ASIA DURING THE FORECAST PERIOD 93
FIGURE 58 NORTH AMERICA TO ACCOUNT FOR THE LARGEST SHARE IN THE ADVENTITIOUS AGENT DETECTION TESTS SEGMENT DURING THE FORECAST PERIOD 95
FIGURE 59 THE U.S. TO ACCOUNT FOR THE LARGEST SHARE IN THE ADVENTITIOUS AGENT DETECTION TESTS SEGMENT IN NORTH AMERICA DURING THE FORECAST PERIOD 96
FIGURE 60 CHINA TO ACCOUNT FOR THE LARGEST SHARE IN THE ADVENTITIOUS AGENT DETECTION TESTS SEGMENT IN ASIA DURING THE FORECAST PERIOD 97
FIGURE 61 NORTH AMERICA TO ACCOUNT FOR THE LARGEST SHARE IN THE OTHER TESTS SEGMENT DURING THE FORECAST PERIOD 99
FIGURE 62 THE U.S. TO ACCOUNT FOR THE LARGEST SHARE IN THE OTHER TESTS SEGMENT IN NORTH AMERICA DURING THE FORECAST PERIOD 100
FIGURE 63 CHINA TO ACCOUNT FOR THE LARGEST SHARE IN THE OTHER TESTS SEGMENT IN ASIA DURING THE FORECAST PERIOD 101
FIGURE 64 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION, BY REGION 104
FIGURE 65 BIOLOGICS SAFETY TESTING MARKET SIZE,
BY REGION (MARKET SIZE AND GROWTH RATE), 2014-2019 105
FIGURE 66 ASIAN MARKET FOR BIOLOGICS SAFETY TESTING EXPECTED TO GROW AT THE HIGHEST RATE FROM 2014 TO 2019 106
FIGURE 67 U.S. COMMANDS THE LARGEST SHARE OF THE NORTH AMERICAN BIOLOGICS SAFETY TESTING MARKET IN THE FORECASTED PERIOD 108
FIGURE 68 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET,
BY REGION (MARKET SIZE AND GROWTH RATE), 2014-2019 109
FIGURE 69 KITS AND REAGENTS HELD THE LARGEST SHARE OF THE BIOLOGICS SAFETY TESTING MARKET IN NORTH AMERICA IN 2014 110
FIGURE 70 VACCINES AND THERAPEUTICS FORMED THE LARGEST APPLICATION SEGMENT IN NORTH AMERICA IN 2014 111
FIGURE 71 ENDOTOXIN TESTS FORMED THE LARGEST TEST SEGMENT IN
NORTH AMERICA IN 2014 112
FIGURE 72 KITS AND REAGENTS FORMED THE LARGEST PRODUCT SEGMENT IN
THE U.S. IN 2014 113
FIGURE 73 VACCINES AND THERAPEUTICS APPLICATION SEGMENT HELD THE LARGEST SHARE IN THE U.S. MARKET DURING THE FORECAST PERIOD 114
FIGURE 74 KITS AND REAGENTS HELD THE LARGEST SHARE AMONG ALL PRODUCT SEGMENTS IN CANADA IN 2014 116
FIGURE 75 VACCINES AND THERAPEUTICS FORMED THE LARGEST APPLICATION SEGMENT IN CANADA IN 2014 117
FIGURE 76 KITS AND REAGENTS HELD THE LARGEST SHARE OF THE BIOLOGICS SAFETY TESTING PRODUCTS MARKET IN EUROPE IN 2014 118
FIGURE 77 VACCINES AND THERAPEUTICS FORMED THE LARGEST APPLICATION SEGMENT IN EUROPE IN 2014 119
FIGURE 78 ENDOTOXIN TESTS ACCOUNTED FOR THE LARGEST SHARE OF BIOLOGICS SAFETY TESTING MARKET IN 2014 120
FIGURE 79 CHINA COMMANDS THE LARGEST SHARE OF THE ASIAN BIOLOGICS SAFETY TESTING MARKET DURING THE FORECAST PERIOD 122
FIGURE 80 ASIA: BIOLOGICS SAFETY TESTING MARKET,
BY REGION (MARKET SIZE AND GROWTH RATE) 123
FIGURE 81 KITS AND REAGENTS PRODUCT SEGMENT DOMINATED ASIAN BIOLOGICS SAFETY TESTING MARKET IN 2014 124
FIGURE 82 VACCINES AND THERAPEUTICS APPLICATION SEGMENT ACCOUNTED FOR LARGEST SHARE OF ASIAN BIOLOGICS SAFETY TESTING MARKET IN 2014 125
FIGURE 83 ENDOTOXIN TESTS ACCOUNTED FOR THE LARGEST SHARE OF THE BIOLOGICS SAFETY TESTING MARKET IN ASIA IN 2014 126
FIGURE 84 KITS AND REAGENTS WERE THE LARGEST PRODUCT SEGMENT IN CHINA IN 2014 127
FIGURE 85 VACCINES AND THERAPEUTICS HELD THE LARGEST SHARE OF THE CHINESE MARKET IN 2014 128
FIGURE 86 KITS AND REAGENTS FORMED THE LARGEST PRODUCT SEGMENT
IN JAPAN IN 2014 130
FIGURE 87 VACCINES AND THERAPEUTICS APPLICATION SEGMENT HELD
THE LARGEST SHARE OF THE JAPANESE MARKET IN 2014 131
FIGURE 88 KITS AND REAGENTS FORMED THE LARGEST AND FASTEST-GROWING PRODUCT SEGMENT IN INDIA IN 2014 132
FIGURE 89 VACCINES AND THERAPEUTICS FORMED THE LARGEST AND
THE FASTEST-GROWING APPLICATION SEGMENT IN INDIA IN 2014 133
FIGURE 90 KITS AND REAGENTS COMMANDED THE LARGEST SHARE OF THE ROA BIOLOGICS SAFETY TESTING MARKET IN 2014 135
FIGURE 91 VACCINES AND THERAPEUTICS APPLICATION SEGMENT DOMINATES ROA MARKET IN 2014 136
FIGURE 92 KITS AND REAGENTS COMMANDED THE LARGEST SHARE OF THE ROW BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT 137
FIGURE 93 VACCINES AND THERAPEUTICS WERE THE LARGEST APPLICATION SEGMENT
IN 2014 138
FIGURE 94 ENDOTOXIN TESTS SEGMENT DOMINATES ROW MARKET IN 2014 139
FIGURE 95 EXPANSIONS AND ACQUISITIONS ARE THE KEY STRATEGIES ADOPTED BY PLAYERS 141
FIGURE 96 BIOLOGICS SAFETY TESTING MARKET SHARE ANALYSIS, BY KEY PLAYER, 2014 142
FIGURE 97 BATTLE FOR MARKET SHARE: EXPANSIONS AND ACQUISITIONS WERE THE KEY STRATEGIES 144
FIGURE 98 MARKET EVOLUTION FRAMEWORK: EXPANSION AND ACQUISITION HAVE AIDED MARKET GROWTH 145
FIGURE 99 SNAPSHOT FOR THE FINANCIAL PERFORMANCES OF THE LEADING MARKET PLAYERS 151
FIGURE 100 CHARLES RIVER LABORATORIES INTERNATIONAL, INC.: COMPANY SNAPSHOT 152
FIGURE 101 LONZA GROUP: COMPANY SNAPSHOT 156
FIGURE 102 SIGMA-ALDRICH CORPORATION: COMPANY SNAPSHOT 159
FIGURE 103 SGS SA: COMPANY SNAPSHOT 162
FIGURE 104 WUXI PHARMATECH (CAYMAN) INC.: COMPANY SNAPSHOT 165
FIGURE 105 MERCK KGAA: COMPANY SNAPSHOT 172

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