Biological Safety Testing Market by Application, Product, & Test - Global Forecast to 2019

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

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