Report Title:
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 Published On: December 2016
Category: Life Sciences
Pages: 182
Report Overview: 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
24marketreports | International +1 646 781 7170 | www.24marketreports.com
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
24marketreports | International +1 646 781 7170 | www.24marketreports.com
• 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: 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 R&D 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
24marketreports | International +1 646 781 7170 | www.24marketreports.com
? 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 & 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
24marketreports | International +1 646 781 7170 | www.24marketreports.com
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 & 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 & 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
Get More Information about the Report:
24marketreports | International +1 646 781 7170 | www.24marketreports.com
Report URL: https://www.24marketreports.com/life-sciences/biological-safety-testing-market-by-applicationstem-cell-blood-gene-therapy-product-instruments-services-kits-reagents-26-test-bioburdenendotoxin-cell-line-authentication-residual-contamination-adventitious-agents---global-forecastto-2019 To get Report Sample: https://www.24marketreports.com/request-sample/biological-safety-testing-market-by-applicati on-stem-cell-blood-gene-therapy-product-instruments-services-kits-reagents-26-test-bioburdenendotoxin-cell-line-authentication-residual-contamination-adventitious-agents---global-forecastto-2019
24marketreports | International +1 646 781 7170 | www.24marketreports.com