生物学的安全性試験の世界市場:バイオバーデン試験、エンドトキシン試験、残留汚染物質検出試験、外来性物質検出試験、無菌試験

◆英語タイトル: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
◆商品コード:MAM-BT-3334
◆発行会社(調査会社):MarketsandMarkets
◆発行日:2015年4月21日
◆ページ数:171
◆レポート言語:英語
◆レポート形式:PDF
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◆調査対象地域:グローバル
◆産業分野:バイオ技術
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【レポートの概要】

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

【レポートの目次】

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

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 39
TABLE 3 HIGH DEGREE OF CONSOLIDATION ACTS AS AN ENTRY BARRIER FOR NEW ENTRANTS 40
TABLE 4 INCREASING PHARMACEUTICAL OUTSOURCING PAVES NEW GROWTH AVENUES FOR PLAYERS IN THE BIOLOGICS SAFETY TESTING MARKET 41
TABLE 5 STRINGENT REGULATORY FRAMEWORKS ARE MAJOR CHALLENGES FOR MARKET PLAYERS 42
TABLE 6 MARKET DEVELOPMENTS BETWEEN 2011 AND 2014 45
TABLE 7 BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 50
TABLE 8 BIOLOGICS SAFETY TESTING MARKET SIZE FOR VACCINES AND THERAPEUTICS,
BY REGION, 2012–2019 ($MILLION) 51
TABLE 9 BIOLOGICS SAFETY TESTING MARKET SIZE FOR BLOOD AND BLOOD PRODUCTS, BY REGION, 2012–2019 ($MILLION) 53
TABLE 10 BIOLOGICS SAFETY TESTING MARKET SIZE FOR CELLULAR AND GENE THERAPY PRODUCTS, BY REGION, 2012–2019 ($MILLION) 54
TABLE 11 BIOLOGICS SAFETY TESTING MARKET SIZE FOR TISSUE AND TISSUE PRODUCTS, BY REGION, 2012–2019 ($MILLION) 55
TABLE 12 BIOLOGICS SAFETY TESTING MARKET SIZE FOR STEM CELL PRODUCTS,
BY REGION, 2012–2019 ($MILLION) 57
TABLE 13 BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2012–2019 ($MILLION) 60
TABLE 14 BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET SIZE, BY REGION, 2012–2019 ($MILLION) 61
TABLE 15 NORTH AMERICA: BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET SIZE, BY COUNTRY, 2012–2019 ($MILLION) 62
TABLE 16 ASIA: BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET SIZE,
BY COUNTRY, 2012–2019 ($MILLION) 63
TABLE 17 BIOLOGICS SAFETY TESTING SERVICES MARKET SIZE, BY REGION,
2012–2019 ($MILLION) 65
TABLE 18 NORTH AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET SIZE,
BY COUNTRY, 2012–2019 ($MILLION) 66
TABLE 19 ASIA: BIOLOGICS SAFETY TESTING SERVICES MARKET SIZE, BY COUNTRY,
2012–2019 ($MILLION) 67
TABLE 20 BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET SIZE, BY REGION,
2012–2019 ($MILLION) 68
TABLE 21 NORTH AMERICA: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET SIZE,
BY COUNTRY, 2012–2019 ($MILLION) 69
TABLE 22 ASIA: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET SIZE,
BY COUNTRY/REGION, 2012–2019 ($MILLION) 70
TABLE 23 BIOLOGICS SAFETY TESTING MARKET, BY TEST, 2012–2019 ($MILLION) 73
TABLE 24 BIOLOGICS SAFETY TESTING MARKET FOR ENDOTOXIN TESTS, BY REGION,
2012–2019 ($MILLION) 74
TABLE 25 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ENDOTOXIN TESTS, BY COUNTRY, 2012–2019 ($MILLION) 75
TABLE 26 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR ENDOTOXIN TESTS,
BY COUNTRY/REGION, 2012–2019 ($MILLION) 76
TABLE 27 BIOLOGICS SAFETY TESTING MARKET FOR STERILITY TESTS, BY REGION,
2012–2019 ($MILLION) 77
TABLE 28 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR STERILITY TESTS,
BY COUNTRY, 2012–2019 ($MILLION) 78
TABLE 29 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR STERILITY TESTS,
BY COUNTRY/REGION, 2012–2019 ($MILLION) 79
TABLE 30 BIOLOGICS SAFETY TESTING MARKET FOR CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS, BY REGION, 2012–2019 ($MILLION) 80
TABLE 31 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS, BY COUNTRY,
2012–2019 ($MILLION) 81
TABLE 32 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS, BY COUNTRY/REGION, 2012–2019 ($MILLION) 82
TABLE 33 BIOLOGICS SAFETY TESTING MARKET FOR BIOBURDEN TESTS, BY REGION,
2012–2019 ($MILLION) 83
TABLE 34 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR BIOBURDEN TESTS, BY COUNTRY, 2012–2019 ($MILLION) 84
TABLE 35 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR BIOBURDEN TESTS,
BY COUNTRY/REGION, 2012–2019 ($MILLION) 85
TABLE 36 BIOLOGICS SAFETY TESTING MARKET FOR RESIDUAL HOST CONTAMINANT DETECTION TESTS, BY REGION, 2012–2019 ($MILLION) 86
TABLE 37 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR RESIDUAL HOST CONTAMINANT DETECTION TESTS, BY COUNTRY, 2012–2019 ($MILLION) 87
TABLE 38 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR RESIDUAL HOST CONTAMINANT DETECTION TESTS, BY COUNTRY/REGION, 2012–2019 ($MILLION) 88
TABLE 39 BIOLOGICS SAFETY TESTING MARKET FOR ADVENTITIOUS AGENT DETECTION TESTS, BY REGION, 2012–2019 ($MILLION) 89
TABLE 40 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ADVENTITIOUS AGENT DETECTION TESTS, BY COUNTRY, 2012–2019 ($MILLION) 90
TABLE 41 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR ADVENTITIOUS AGENT DETECTION TESTS, COUNTRY/REGION, 2012–2019 ($MILLION) 91
TABLE 42 BIOLOGICS SAFETY TESTING MARKET FOR OTHER TESTS, BY REGION,
2012–2019 ($MILLION) 92
TABLE 43 NORTH AMERICA: BIOLOGICS SAFETY TESTS MARKET FOR OTHER TESTS,
BY COUNTRY, 2012–2019 ($MILLION) 93
TABLE 44 ASIA: BIOLOGICS SAFETY TESTING MARKET FOR OTHER TESTS,
BY COUNTRY/REGION, 2012–2019 ($MILLION) 94
TABLE 45 BIOLOGICS SAFETY TESTING MARKET SIZE, BY REGION, 2012–2019 ($MILLION) 97
TABLE 46 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY,
2012–2019 ($MILLION) 100
TABLE 47 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 101
TABLE 48 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2012–2019 ($MILLION) 102
TABLE 49 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2012–2019 ($MILLION) 103
TABLE 50 U.S.: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 105
TABLE 51 U.S.: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 106
TABLE 52 CANADA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 107
TABLE 53 CANADA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 108
TABLE 54 EUROPE: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 110
TABLE 55 EUROPE: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 111
TABLE 56 EUROPE: BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2012–2019 ($MILLION) 112
TABLE 57 ASIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY COUNTRY/REGION,
2012–2019 ($MILLION) 114
TABLE 58 ASIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 115
TABLE 59 ASIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 116
TABLE 60 ASIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2012–2019 ($MILLION) 117
TABLE 61 CHINA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 119
TABLE 62 CHINA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 120
TABLE 63 JAPAN: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 121
TABLE 64 JAPAN: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 122
TABLE 65 INDIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 124
TABLE 66 INDIA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 125
TABLE 67 ROA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 126
TABLE 68 ROA: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 127
TABLE 69 ROW: BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT,
2012–2019 ($MILLION) 129
TABLE 70 ROW: BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2012–2019 ($MILLION) 130
TABLE 71 ROW: BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST,
2012–2019 ($MILLION) 131
TABLE 72 BIOLOGICS SAFETY TESTING MARKET SHARE ANALYSIS, BY KEY PLAYER, 2014 133
TABLE 73 EXPANSIONS, 2012–2015 137
TABLE 74 ACQUISITIONS, 2012–2015 138
TABLE 75 AGREEMENTS, COLLABORATIONS, AND PARTNERSHIPS, 2012–2015 139
TABLE 76 NEW PRODUCT AND SERVICE LAUNCHES, 2012–2015 140
TABLE 77 OTHER DEVELOPMENTS, 2012–2015 141


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 ($MILLION) 27
FIGURE 8 BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION,
2014 VS. 2019 ($MILLION) 28
FIGURE 9 BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST, 2014 VS. 2019 ($MILLION) 28
FIGURE 10 BIOLOGICS SAFETY TESTING MARKET SIZE, BY REGION,
2014 VS. 2019 ($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) 32
FIGURE 15 ASIA POISED FOR LUCRATIVE GROWTH DURING THE FORECAST PERIOD 33
FIGURE 16 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION: BY APPLICATION 35
FIGURE 17 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION: BY PRODUCT 35
FIGURE 18 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION: BY TEST 36
FIGURE 19 GROWTH IN PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRIES WILL DRIVE THE BIOLOGICS SAFETY TESTING MARKET 36
FIGURE 20 INCREASING NUMBER OF NEW DRUG LAUNCHES TO DRIVE THE BIOLOGICS SAFETY TESTING MARKET IN THE FORECAST PERIOD 38
FIGURE 21 HIGH CAPITAL INVESTMENTS TO RESTRICT THE ENTRY OF NEW PLAYERS 43
FIGURE 22 DIRECT DISTRIBUTION STRATEGY PREFERRED BY PROMINENT COMPANIES 47
FIGURE 23 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION 49
FIGURE 24 BIOLOGICS SAFETY TESTING MARKET SIZE, BY APPLICATION, 2014 ($MILLION) 49
FIGURE 25 VACCINE AND THERAPEUTICS WILL BE THE FASTEST-GROWING APPLICATION SEGMENT IN THE FORECAST PERIOD 51
FIGURE 26 NORTH AMERICA DOMINATED THE BLOOD AND BLOOD PRODUCTS APPLICATION SEGMENT IN 2014 52
FIGURE 27 ASIA TO WITNESS HIGHEST GROWTH IN THE CELLULAR AND GENE THERAPY PRODUCTS APPLICATION SEGMENT IN THE FORECAST PERIOD 54
FIGURE 28 NORTH AMERICA TO COMMAND LARGEST SHARE OF THE TISSUE AND TISSUE PRODUCTS APPLICATION SEGMENT IN THE FORECAST PERIOD 55
FIGURE 29 ASIA TO WITNESS HIGHEST GROWTH IN THE STEM CELL PRODUCTS APPLICATION SEGMENT TILL 2019 56
FIGURE 30 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION, BY PRODUCT 59
FIGURE 31 BIOLOGICS SAFETY TESTING MARKET SIZE, BY PRODUCT, 2014 ($MILLION) 59
FIGURE 32 NORTH AMERICA DOMINATED THE BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET IN 2014 61
FIGURE 33 U.S. DOMINATED THE BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET IN NORTH AMERICA IN 2014 62
FIGURE 34 CHINA TO DOMINATED THE BIOLOGICS SAFETY TESTING KITS AND REAGENTS MARKET IN ASIA IN 2014 63
FIGURE 35 ASIA TO WITNESS THE HIGHEST GROWTH IN THE BIOLOGICS SAFETY TESTING SERVICES MARKET IN THE FORECAST PERIOD 64
FIGURE 36 U.S. TO DOMINATED THE BIOLOGICS SAFETY TESTING SERVICES MARKET IN NORTH AMERICA IN 2014 65
FIGURE 37 CHINA TO DOMINATE THE BIOLOGICS SAFETY TESTING SERVICES MARKET IN ASIA 66
FIGURE 38 NORTH AMERICA TO DOMINATE THE BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET IN THE FORECAST PERIOD 68
FIGURE 39 U.S. TO DOMINATED THE BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET IN NORTH AMERICA IN 2014 69
FIGURE 40 CHINA TO DOMINATE THE BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET IN ASIA IN THE FORECAST PERIOD 70
FIGURE 41 BIOLOGICS SAFETY TESTING MARKET, BY TEST 72
FIGURE 42 BIOLOGICS SAFETY TESTING MARKET SIZE, BY TEST, 2014–2019 ($MILLION) 72
FIGURE 43 NORTH AMERICA TO ACCOUNT FOR THE LARGEST SHARE OF THE ENDOTOXIN TESTS SEGMENT DURING THE FORECAST PERIOD 74
FIGURE 44 THE U.S. TO ACCOUNT FOR THE LARGEST SHARE IN THE ENDOTOXIN TESTS SEGMENT IN NORTH AMERICA IN 2019 75
FIGURE 45 CHINA TO ACCOUNT FOR THE LARGEST SHARE IN THE ENDOTOXIN TESTS MARKET IN ASIA DURING THE FORECAST PERIOD 76
FIGURE 46 NORTH AMERICA TO ACCOUNT FOR THE LARGEST SHARE IN THE STERILITY TESTS SEGMENT IN 2019 77
FIGURE 47 THE U.S. TO ACCOUNT FOR THE LARGEST SHARE OF THE STERILITY TESTS SEGMENT IN NORTH AMERICA IN 2019 78
FIGURE 48 CHINA ACCOUNTED FOR THE LARGEST SHARE IN THE STERILITY TESTS SEGMENT IN ASIA IN 2014 79
FIGURE 49 NORTH AMERICA WILL ACCOUNT FOR THE LARGEST SHARE IN THE CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS SEGMENT IN 2019 80
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 81
FIGURE 51 CHINA ACCOUNTED FOR THE LARGEST SHARE IN THE CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS SEGMENT IN ASIA IN 2014 82
FIGURE 52 NORTH AMERICA ACCOUNTED FOR THE LARGEST SHARE IN THE BIOBURDEN TESTS SEGMENT IN 2014 83
FIGURE 53 THE U.S. ACCOUNTED FOR THE LARGEST SHARE IN THE BIOBURDEN TESTS SEGMENT IN NORTH AMERICA IN 2014 84
FIGURE 54 CHINA ACCOUNTED FOR THE LARGEST SHARE IN THE BIOBURDEN TESTS SEGMENT IN ASIA IN2014 85
FIGURE 55 NORTH AMERICA ACCOUNTED FOR THE LARGEST SHARE OF THE RESIDUAL HOST CONTAMINANT DETECTION TESTS SEGMENT IN 2014 86
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 87
FIGURE 57 CHINA TO ACCOUNT FOR THE LARGEST SHARE IN THE RESIDUAL HOST CONTAMINANT DETECTION TESTS SEGMENT IN ASIA DURING THE FORECAST PERIOD 88
FIGURE 58 NORTH AMERICA TO ACCOUNT FOR THE LARGEST SHARE IN THE ADVENTITIOUS AGENT DETECTION TESTS SEGMENT DURING THE FORECAST PERIOD 89
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 90
FIGURE 60 CHINA TO ACCOUNT FOR THE LARGEST SHARE IN THE ADVENTITIOUS AGENT DETECTION TESTS SEGMENT IN ASIA DURING THE FORECAST PERIOD 91
FIGURE 61 NORTH AMERICA TO ACCOUNT FOR THE LARGEST SHARE IN THE OTHER TESTS SEGMENT DURING THE FORECAST PERIOD 92
FIGURE 62 THE U.S. TO ACCOUNT FOR THE LARGEST SHARE IN THE OTHER TESTS SEGMENT IN NORTH AMERICA DURING THE FORECAST PERIOD 93
FIGURE 63 CHINA TO ACCOUNT FOR THE LARGEST SHARE IN THE OTHER TESTS SEGMENT IN ASIA DURING THE FORECAST PERIOD 94
FIGURE 64 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION, BY REGION 96
FIGURE 65 BIOLOGICS SAFETY TESTING MARKET SIZE, BY REGION (MARKET SIZE AND GROWTH RATE), 2014-2019 96
FIGURE 66 ASIAN MARKET FOR BIOLOGICS SAFETY TESTING EXPECTED TO GROW AT THE HIGHEST RATE FROM 2014 TO 2019 97
FIGURE 67 U.S. COMMANDS THE LARGEST SHARE OF THE NORTH AMERICAN BIOLOGICS SAFETY TESTING MARKET IN THE FORECASTED PERIOD 99
FIGURE 68 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY REGION (MARKET SIZE AND GROWTH RATE), 2014-2019 100
FIGURE 69 KITS AND REAGENTS HELD THE LARGEST SHARE OF THE BIOLOGICS SAFETY TESTING MARKET IN NORTH AMERICA IN 2014 101
FIGURE 70 VACCINES AND THERAPEUTICS FORMED THE LARGEST APPLICATION SEGMENT IN NORTH AMERICA IN 2014 102
FIGURE 71 ENDOTOXIN TESTS FORMED THE LARGEST TEST SEGMENT IN NORTH AMERICA IN 2014 103
FIGURE 72 KITS AND REAGENTS FORMED THE LARGEST PRODUCT SEGMENT IN THE U.S. IN 2014 104
FIGURE 73 VACCINES AND THERAPEUTICS APPLICATION SEGMENT HELD THE LARGEST SHARE IN THE U.S. MARKET DURING THE FORECAST PERIOD 105
FIGURE 74 KITS AND REAGENTS HELD THE LARGEST SHARE AMONG ALL PRODUCT SEGMENTS IN CANADA IN 2014 107
FIGURE 75 VACCINES AND THERAPEUTICS FORMED THE LARGEST APPLICATION SEGMENT IN CANADA IN 2014 108
FIGURE 76 KITS AND REAGENTS HELD THE LARGEST SHARE OF THE BIOLOGICS SAFETY TESTING PRODUCTS MARKET IN EUROPE IN 2014 109
FIGURE 77 VACCINES AND THERAPEUTICS FORMED THE LARGEST APPLICATION SEGMENT IN EUROPE IN 2014 110
FIGURE 78 ENDOTOXIN TESTS ACCOUNTED FOR THE LARGEST SHARE OF BIOLOGICS SAFETY TESTING MARKET IN 2014 111
FIGURE 79 CHINA COMMANDS THE LARGEST SHARE OF THE ASIAN BIOLOGICS SAFETY TESTING MARKET DURING THE FORECAST PERIOD 113
FIGURE 80 ASIA: BIOLOGICS SAFETY TESTING MARKET, BY REGION (MARKET SIZE AND GROWTH RATE) 114
FIGURE 81 KITS AND REAGENTS PRODUCT SEGMENT DOMINATED ASIAN BIOLOGICS SAFETY TESTING MARKET IN 2014 115
FIGURE 82 VACCINES AND THERAPEUTICS APPLICATION SEGMENT ACCOUNTED FOR LARGEST SHARE OF ASIAN BIOLOGICS SAFETY TESTING MARKET IN 2014 116
FIGURE 83 ENDOTOXIN TESTS ACCOUNTED FOR THE LARGEST SHARE OF THE BIOLOGICS SAFETY TESTING MARKET IN ASIA IN 2014 117
FIGURE 84 KITS AND REAGENTS WERE THE LARGEST PRODUCT SEGMENT IN CHINA IN 2014 118
FIGURE 85 VACCINES AND THERAPEUTICS HELD THE LARGEST SHARE OF THE CHINESE MARKET IN 2014 119
FIGURE 86 KITS AND REAGENTS FORMED THE LARGEST PRODUCT SEGMENT IN JAPAN IN 2014 121
FIGURE 87 VACCINES AND THERAPEUTICS APPLICATION SEGMENT HELD THE LARGEST SHARE OF THE JAPANESE MARKET IN 2014 122
FIGURE 88 KITS AND REAGENTS FORMED THE LARGEST AND FASTEST-GROWING PRODUCT SEGMENT IN INDIA IN 2014 123
FIGURE 89 VACCINES AND THERAPEUTICS FORMED THE LARGEST AND THE FASTEST-GROWING APPLICATION SEGMENT IN INDIA IN 2014 124
FIGURE 90 KITS AND REAGENTS COMMANDED THE LARGEST SHARE OF THE ROA BIOLOGICS SAFETY TESTING MARKET IN 2014 126
FIGURE 91 VACCINES AND THERAPEUTICS APPLICATION SEGMENT DOMINATES ROA MARKET IN 2014 127
FIGURE 92 KITS AND REAGENTS COMMANDED THE LARGEST SHARE OF THE ROW BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT 128
FIGURE 93 VACCINES AND THERAPEUTICS WERE THE LARGEST APPLICATION SEGMENT IN 2014 129
FIGURE 94 ENDOTOXIN TESTS SEGMENT DOMINATES ROW MARKET IN 2014 130
FIGURE 95 EXPANSIONS AND ACQUISITIONS ARE THE KEY STRATEGIES ADOPTED BY PLAYERS 132
FIGURE 96 BATTLE FOR MARKET SHARE: EXPANSIONS AND ACQUISITIONS WERE THE KEY STRATEGIES 135
FIGURE 97 MARKET EVOLUTION FRAMEWORK: EXPANSION AND ACQUISITION HAVE AIDED MARKET GROWTH 136
FIGURE 98 SNAPSHOT FOR THE FINANCIAL PERFORMANCES OF THE LEADING MARKET PLAYERS 142
FIGURE 99 CHARLES RIVER LABORATORIES INTERNATIONAL, INC.: COMPANY SNAPSHOT 143
FIGURE 100 LONZA GROUP: COMPANY SNAPSHOT 146
FIGURE 101 SIGMA-ALDRICH CORPORATION: COMPANY SNAPSHOT 149
FIGURE 102 SGS SA: COMPANY SNAPSHOT 152
FIGURE 103 WUXI PHARMATECH (CAYMAN) INC.: COMPANY SNAPSHOT 155
FIGURE 104 MERCK & CO., INC.: COMPANY SNAPSHOT 162


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