Sterility Testing Market by Product (Instruments, Services, Kits and Reagents), Test (Membrane Filtration Sterility Testing, Direct Inoculation Sterility Testing), Application (Pharmaceutical & Biotechnology, Medical Devices) - Global Forecasts to 2021

The sterility testing market is expected to reach USD 941.0 million by 2021 from USD 528.0 million in 2016, at a CAGR of 12.3%. The major drivers for the market include growth in the pharmaceutical and biotechnology industries, increase in the number of new drug launches, and increasing R&D in life science research. Over the years, the number of drug approvals in North American has increased. In 2015, the FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs); as opposed to this, only 22 novel drugs were approved in 2006. The increasing number of drug approvals will boost the sterility testing market.
According to OECD estimates, in 2015, the total number of biotechnology companies in the U.S. was 11,367. Owing to the rise in the number of biotechnology companies, biopharmaceutical production has increased globally. Sterility 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 sterility testing market.
On the basis of product, the sterility testing market is segmented into kits and reagents, instruments, and services. The kits and reagents segment is projected to witness the highest growth in this market. The large share of the kits and reagents segment can be attributed to the requirement of the repeat purchase of these products, coupled with the increasing preference for kit-based testing.
On the basis of test, the sterility testing market is segmented into membrane filtration, direct inoculation, and other sterility tests. The membrane filtration segment is projected to witness the highest growth in this market due to new product launches and growth in the pharmaceutical and biotechnology industries.
On the basis of application, sterility testing market is segmented into pharmaceutical and biological manufacturing, medical devices manufacturing, and others applications. The pharmaceutical and biological manufacturing segment is projected to witness the highest growth in this market due to rapid growth in the pharma and biotech industries.
Geographically, the sterility testing market is dominated by North America, followed by Europe, Asia, and the Rest of the World (RoW). The Asian market will witness the highest growth during the forecast period, primarily due to the increasing expenditure on life science research in the region and growing trend of pharmaceutical outsourcing to Asian countries like India and China.
The key players in the sterility testing market include Merck KGaA (Germany), Charles River Laboratories International, Inc. (U.S.), bioMerieux SA (France), SGS S.A. (Switzerland), Sartorius AG (Germany), WuXi AppTec (China), and Thermo Fisher Scientific, Inc. (U.S.).
ResearchCoverage
In addition to comprehensive geographic and product analysis and market sizing, the report also provides a competitive landscape that covers the growth strategies adopted by industry players over the last three years. The company profiles in this report comprise the product portfolios, developments, and strategies adopted by players to maintain and increase their shares in the market. The above mentioned market research data, current market size, and forecast of future trends will help key market players and new entrants to make the necessary decisions regarding product offerings, geographic focus, change in strategic approach, and levels of output in order to remain successful in the sterility testing market.
Reasons to Buy the Report:
This report will enable both established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn will help these firms garner greater market shares. Firms purchasing the report can use any one or a combination of the below-mentioned five strategies (market penetration, product development/innovation, market development, market diversification, and competitive assessment) for strengthening their market shares.

The report provides insights on the following pointers:

‧ Market Penetration: Comprehensive information on the product portfolios of the top players in the sterility testing market. The report analyses the in sterility testing market by product, test, and application
‧ Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and new product launches in the sterility testing market
‧ Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments, and product portfolios of the leading players in the sterility testing market
‧ Market Development: Comprehensive information about emerging markets. This report analyzes the market for various sterility testing products across geographies
‧ Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the sterility testing market

TABLE OF CONTENTS

1 INTRODUCTION 14
1.1 OBJECTIVES OF THE STUDY 14
1.2 MARKET DEFINITION 14
1.3 MARKET SCOPE 15
1.3.1 MARKETS COVERED 15
1.3.2 YEARS CONSIDERED FOR THE STUDY 15
1.4 CURRENCY 16
1.5 LIMITATIONS 16
1.6 STAKEHOLDERS 16
2 RESEARCH METHODOLOGY 17
2.1 MARKET SIZE ESTIMATION 18
2.2 MARKET BREAKDOWN AND DATA TRIANGULATION 21
2.3 MARKET SHARE ESTIMATION 22
2.3.1 KEY DATA FROM SECONDARY SOURCES 22
2.3.2 KEY DATA FROM PRIMARY SOURCES 23
2.3.3 ASSUMPTIONS FOR THE STUDY 23
3 EXECUTIVE SUMMARY 24
4 PREMIUM INSIGHTS 28
4.1 SIGNIFICANT OPPORTUNITIES IN THE STERILITY TESTING MARKET 28
4.2 GEOGRAPHIC ANALYSIS: STERILITY TESTING MARKET, BY PRODUCT (2016) 29
4.3 GEOGRAPHIC SNAPSHOT OF THE STERILITY TESTING MARKET 30
5 MARKET OVERVIEW 31
5.1 INTRODUCTION 32
5.2 MARKET DYNAMICS 32
5.2.1 DRIVERS 33
5.2.1.1 Growth of pharmaceutical & biotechnology companies 33
5.2.1.2 Increasing number of drug launches 33
5.2.1.3 Government support for pharmaceutical and biotechnology industries 33
5.2.1.4 Increasing R&D investments in life sciences 34
5.2.2 RESTRAINTS 34
5.2.2.1 High degree of consolidation, a major barrier for new market entrants 34
5.2.2.2 Stringent regulatory frameworks and time-consuming approval processes 34
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5.2.3 OPPORTUNITIES 35
5.2.3.1 Emerging Markets 35
5.2.3.2 Increasing pharmaceutical outsourcing 35
5.2.4 CHALLENGE 35
5.2.4.1 Shortage of skilled professionals 35
5.3 PORTER’S FIVE FORCES ANALYSIS 36
5.4 SUPPLY CHAIN ANALYSIS 37
6 STERILITY TESTING MARKET, BY PRODUCT 38
6.1 INTRODUCTION 39
6.2 KITS & REAGENTS 40
6.3 SERVICES 40
6.4 INSTRUMENTS 41
7 STERILITY TESTING MARKET, BY TEST 42
7.1 INTRODUCTION 43
7.2 MEMBRANE FILTRATION 44
7.3 DIRECT INOCULATION 45
7.4 OTHER TESTS 46
8 STERILITY TESTING MARKET, BY APPLICATION 47
8.1 INTRODUCTION 48
8.2 PHARMACEUTICAL AND BIOLOGICAL MANUFACTURING 49
8.3 MEDICAL DEVICE MANUFACTURING 50
8.4 OTHER APPLICATIONS 51
9 STERILITY TESTING MARKET, BY REGION 52
9.1 INTRODUCTION 53
9.2 NORTH AMERICA 55
9.2.1 U.S. 58
9.2.2 CANADA 60
9.3 EUROPE 62
9.3.1 GERMANY 65
9.3.2 U.K. 66
9.3.3 FRANCE 68
9.3.4 ITALY 69
9.3.5 SPAIN 70
9.3.6 REST OF EUROPE (ROE) 71
9.4 ASIA 73
9.4.1 CHINA 76
9.4.2 JAPAN 78
9.4.3 INDIA 79
9.4.4 REST OF ASIA 80
9.5 REST OF THE WORLD 82
9.5.1 SOUTH AMERICA, CENTRAL AMERICA, AND THE CARIBBEAN 83
9.5.2 PACIFIC AND OCEANIA 85
9.5.3 AFRICA 86
10 COMPETITIVE LANDSCAPE 88
10.1 OVERVIEW 88
10.2 STRATEGIC OVERVIEW 88
10.3 MARKET SHARE ANALYSIS 89
10.4 COMPETITIVE SITUATION AND TRENDS 90
10.4.1 EXPANSIONS 91
10.4.2 MERGERS & ACQUISITIONS 92
10.4.3 AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS 93
10.4.4 PRODUCT LAUNCHES 94
11 COMPANY PROFILES 95
(Introduction, Products & Services, Strategy, & Analyst Insights, Developments, MnM View)*
11.1 INTRODUCTION 95
11.2 MERCK KGAA 96
11.3 CHARLES RIVER LABORATORIES INTERNATIONAL, INC. 99
11.4 BIOMERIEUX SA 101
11.5 SGS S.A. 103
11.6 DANAHER CORPORATION 105
11.7 NELSON LABORATORIES 107
11.8 PACIFIC BIOLABS 108
11.9 SARTORIUS AG 109
11.10 THERMO FISHER SCIENTIFIC INC. 111
11.11 TOXIKON CORPORATION 113
11.12 WUXI APPTEC 114
*Details on MarketsandMarkets view, Introduction, Product & Services, Strategy, & Analyst Insights, New Developments might not be captured in case of unlisted companies.
12 APPENDIX 116
12.1 INSIGHTS OF INDUSTRY EXPERTS 116
12.2 DISCUSSION GUIDE 117
12.3 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 119
12.4 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 121
12.5 AVAILABLE CUSTOMIZATIONS 122
12.6 RELATED REPORTS 123
12.7 AUTHOR DETAILS 124