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 was valued at USD 528.0 Million in 2016 and poised to grow at a CAGR of 12.3% between 2016 and 2021, to reach USD 941.0 Million in 2021. Sterility testing is conducted for the presence or absence of viable microorganisms capable of developing and multiplying under favorable conditions. Sterility testing is used by pharmaceutical & biotechnological companies and medical devices companies to ensure the absence of contaminants in biologics and medical devices. Growth in the pharmaceutical and biotechnology industries, increase in the number of new drug launches, and increasing R&D in life science research are the key factors driving the growth of this market. The market is further driven by factors such as increasing government support for pharmaceutical and biotechnology industries. On the other hand, the high degree of market consolidation is a major factor restraining the growth of this market.

In this report, the global sterility testing market is segmented on the basis of product, test, application, and region.

On the basis of product, the market is segmented into kits and reagents, instruments, and services. The kits and reagents segment is expected to account for the largest share of the 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 market is segmented into membrane filtration, direct inoculation, and other sterility tests. In 2016, the membrane filtration segment accounted for the largest share. The large share of this segment can primarily be attributed to rapid growth in the pharmaceutical and biotechnology end-use industry.

On the basis of application, the market is segmented into pharmaceutical and biological manufacturing, medical devices manufacturing, and others applications. In 2016, the pharmaceutical and biological manufacturing segment is expected to account for the largest share primarily due to the rapid growth in the pharma and biotech industries.

On the basis of region, the global market is segmented into North America, 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.

Key players operating in the market include Merck KGaA (Germany), Charles River Laboratories International, Inc. (U.S.), bioMérieux SA (France), SGS S.A. (Switzerland), Sartorius AG (Germany), WuXi AppTec (China), and Thermo Fisher Scientific, Inc. (U.S.).

Target Audience for this Report:

• Sterility Testing Product Manufacturers
• Sterility Testing Product Distributors
• Various Research and Consulting Companies
• Various Research Associations Related to Sterility Testing

Value Addition for the Buyer:

This report aims to provide insights into the global market. It provides valuable information on products, test, and applications. Details on regional markets for these segments are also presented in this report. In addition, leading players in the market are profiled to study their product offerings and understand the strategies undertaken by them to be competitive in this market.

To know about the assumptions considered for the study, download the pdf brochure

Scope of the Report:

This report categorizes the global market into the following segments:

Sterility Testing Market, by Product

• Kits and Reagents
• Instruments
• Services

Sterility Testing Market, by Test

• Membrane Filtration
• Direct Inoculation
• Other Sterility Tests

Sterility Testing Market, by Application

• Pharmaceutical and Biological Manufacturing
• Medical Devices Manufacturing
• Others Applications

Sterility Testing Market, by Region

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia
  • China
  • Japan
  • India
  • Rest of Asia (RoA)
• Rest of the World (RoW)

Customization Options:

• Company Information: Detailed company profiles of five or more market players
• Opportunity Assessment: A detailed report underlining the various growth opportunities presented in the market

Table of Contents

1 Introduction (Page No. - 14)
    1.1 Objectives of the Study
    1.2 Market Definition
    1.3 Market Scope
           1.3.1 Markets Covered
           1.3.2 Years Considered for the Study
    1.4 Currency
    1.5 Limitations
    1.6 Stakeholders

2 Research Methodology (Page No. - 17)
    2.1 Market Size Estimation
    2.2 Market Breakdown and Data Triangulation
    2.3 Market Share Estimation
           2.3.1 Key Data From Secondary Sources
           2.3.2 Key Data From Primary Sources
           2.3.3 Assumptions for the Study

3 Executive Summary (Page No. - 24)

4 Premium Insights (Page No. - 28)
    4.1 Significant Opportunities in the Sterility Testing Market
    4.2 Geographic Analysis: Sterility Testing Market, By Product (2016)
    4.3 Geographic Snapshot of the Market

5 Market Overview (Page No. - 31)
    5.1 Introduction
    5.2 Market Dynamics
           5.2.1 Drivers
                    5.2.1.1 Growth of Pharmaceutical & Biotechnology Companies
                    5.2.1.2 Increasing Number of Drug Launches
                    5.2.1.3 Government Support for Pharmaceutical and Biotechnology Industries
                    5.2.1.4 Increasing R&D Investments in Life Sciences
           5.2.2 Restraints
                    5.2.2.1 High Degree of Consolidation, A Major Barrier for New Market Entrants
                    5.2.2.2 Stringent Regulatory Frameworks and Time-Consuming Approval Processes
           5.2.3 Opportunities
                    5.2.3.1 Emerging Markets
                    5.2.3.2 Increasing Pharmaceutical Outsourcing
           5.2.4 Challenge
                    5.2.4.1 Shortage of Skilled Professionals
    5.3 Porter’s Five Forces Analysis
    5.4 Supply Chain Analysis

6 Sterility Testing Market, By Product (Page No. - 38)
    6.1 Introduction
    6.2 Kits & Reagents
    6.3 Services
    6.4 Instruments

7 Sterility Testing Market, By Test (Page No. - 42)
    7.1 Introduction
    7.2 Membrane Filtration
    7.3 Direct Inoculation
    7.4 Other Tests

8 Sterility Testing Market, By Application (Page No. - 47)
    8.1 Introduction
    8.2 Pharmaceutical and Biological Manufacturing
    8.3 Medical Device Manufacturing
    8.4 Other Applications

9 Sterility Testing Market, By Region (Page No. - 52)
    9.1 Introduction
    9.2 North America
           9.2.1 U.S.
           9.2.2 Canada
    9.3 Europe
           9.3.1 Germany
           9.3.2 U.K.
           9.3.3 France
           9.3.4 Italy
           9.3.5 Spain
           9.3.6 Rest of Europe (RoE)
    9.4 Asia
           9.4.1 China
           9.4.2 Japan
           9.4.3 India
           9.4.4 Rest of Asia
    9.5 Rest of the World
           9.5.1 South America, Central America, and the Caribbean
           9.5.2 Pacific and Oceania
           9.5.3 Africa

10 Competitive Landscape (Page No. - 88)
     10.1 Overview
     10.2 Strategic Overview
     10.3 Market Share Analysis
     10.4 Competitive Situation and Trends
             10.4.1 Expansions
             10.4.2 Mergers & Acquisitions
             10.4.3 Agreements, Partnerships, and Collaborations
             10.4.4 Product Launches

11 Company Profiles (Page No. - 95)
(Introduction, Products & Services, Strategy, & Analyst Insights, Developments, MnM View)*
     11.1 Introduction
     11.2 Merck KGaA
     11.3 Charles River Laboratories International, Inc.
     11.4 Biomérieux SA
     11.5 SGS S.A.
     11.6 Danaher Corporation
     11.7 Nelson Laboratories
     11.8 Pacific Biolabs
     11.9 Sartorius AG
     11.10 Thermo Fisher Scientific Inc.
     11.11 Toxikon Corporation
     11.12 Wuxi Apptec

*Details on Marketsandmarkets View, Introduction, Product & Services, Strategy, & Analyst Insights, New Developments Might Not Be Captured in Case of Unlisted Companies.

12 Appendix (Page No. - 116)
     12.1 Insights of Industry Experts
     12.2 Discussion Guide
     12.3 Knowledge Store: Marketsandmarkets’ Subscription Portal
     12.4 Introducing RT: Real-Time Market Intelligence
     12.5 Available Customizations
     12.6 Related Reports
     12.7 Author Details

List of Tables (67 Tables)

Table 1 Sterility Testing Market Summary
Table 2 Market Size, By Product, 2014–2021 (USD Million)
Table 3 Sterility Testing Kits & Reagents Market Size, By Region, 2014–2021 (USD Million)
Table 4 Sterility Testing Services Market Size, By Region, 2014–2021 (USD Million)
Table 5 Sterility Testing Instruments Market Size, By Region, 2014–2021 (USD Million)
Table 6 Market Size, By Test, 2014–2021 (USD Million)
Table 7 Market Size for Membrane Filtration, By Region, 2014–2021 (USD Million)
Table 8 Market Size for Direct Inoculation, By Region, 2014–2021 (USD Million)
Table 9 Market Size for Other Tests, By Region, 2014–2021 (USD Million)
Table 10 Market Size, By Application, 2014–2021 (USD Million)
Table 11 Market Size for Pharmaceutical and Biological Manufacturing, By Region, 2014–2021 (USD Million)
Table 12 Market Size for Medical Device Manufacturing, By Region, 2014–2021 (USD Million)
Table 13 Market Size for Other Applications, By Region, 2014–2021 (USD Million)
Table 14 Market Size, By Region, 2014–2021 (USD Million)
Table 15 North America: Market Size, By Country, 2014–2021 (USD Million)
Table 16 North America: Market Size, By Product, 2014–2021 (USD Million)
Table 17 North America: Market Size, By Test, 2014–2021 (USD Million)
Table 18 North America: Market Size, By Application, 2014–2021 (USD Million)
Table 19 U.S.: Market Size, By Product, 2014–2021 (USD Million)
Table 20 U.S.: Market Size, By Test, 2014–2021 (USD Million)
Table 21 U.S.: Market Size, By Application, 2014–2021 (USD Million)
Table 22 Canada: Market Size, By Product, 2014–2021 (USD Million)
Table 23 Canada: Market Size, By Test, 2014–2021 (USD Million)
Table 24 Canada: Market Size, By Application, 2014–2021 (USD Million)
Table 25 Europe: Market Size, By Country, 2014–2021 (USD Million)
Table 26 Europe: Market Size, By Product, 2014–2021 (USD Million)
Table 27 Europe: Market Size, By Test, 2014–2021 (USD Million)
Table 28 Europe: Market Size, By Application, 2014–2021 (USD Million)
Table 29 Germany: Market Size, By Product, 2014–2021 (USD Million)
Table 30 Germany: Market Size, By Test, 2014–2021 (USD Million)
Table 31 U.K.: Market Size, By Product, 2014–2021 (USD Million)
Table 32 U.K.: Market Size, By Test, 2014–2021 (USD Million)
Table 33 France: Market Size, By Product, 2014–2021 (USD Million)
Table 34 France: Market Size, By Test, 2014–2021 (USD Million)
Table 35 Italy: Market Size, By Product, 2014–2021 (USD Million)
Table 36 Italy: Market Size, By Test, 2014–2021 (USD Million)
Table 37 Spain: Market Size, By Product, 2014–2021 (USD Million)
Table 38 Spain: Market Size, By Test, 2014–2021 (USD Million)
Table 39 RoE: Market Size, By Product, 2014–2021 (USD Million)
Table 40 RoE: Market Size, By Test, 2014–2021 (USD Million)
Table 41 Asia: Market Size, By Country, 2014–2021 (USD Million)
Table 42 Asia: Market Size, By Product, 2014–2021 (USD Million)
Table 43 Asia: Market Size, By Test, 2014–2021 (USD Million)
Table 44 Asia: Market Size, By Application, 2014–2021 (USD Million)
Table 45 China: Market Size, By Product, 2014–2021 (USD Million)
Table 46 China: Market Size, By Test, 2014–2021 (USD Million)
Table 47 Japan: Market Size, By Product, 2014–2021 (USD Million)
Table 48 Japan: Market Size, By Test, 2014–2021 (USD Million)
Table 49 India: Market Size, By Product, 2014–2021 (USD Million)
Table 50 India: Market Size, By Test, 2014–2021 (USD Million)
Table 51 Rest of Asia: Market Size, By Product, 2014–2021 (USD Million)
Table 52 Rest of Asia: Market Size, By Test, 2014–2021 (USD Million)
Table 53 RoW: Sterility Testing Market Size, By Region, 2014–2021 (USD Million)
Table 54 RoW: Market Size, By Product, 2014–2021 (USD Million)
Table 55 RoW: Sterility Testing Market Size, By Test, 2014–2021 (USD Million)
Table 56 RoW: Market Size, By Application, 2014–2021 (USD Million)
Table 57 South America, Central America, & the Caribbean: Sterility Testing Market Size, By Product, 2014–2021 (USD Million)
Table 58 South America, Central America, & the Caribbean: Market Size, By Test, 2014–2021 (USD Million)
Table 59 Pacific and Oceania: Sterility Testing Market Size, By Product, 2014–2021 (USD Million)
Table 60 Pacific and Oceania: Market Size, By Test, 2014–2021 (USD Million)
Table 61 Africa: Sterility Testing Market Size, By Product, 2014–2021 (USD Million)
Table 62 Africa: Market Size, By Test, 2014–2021 (USD Million)
Table 63 Market Developments, 2013–2016
Table 64 Expansions, 2013–2016
Table 65 Mergers & Acquisitions, 2013–2016
Table 66 Agreements, Partnerships, and Collaborations, 2013–2016
Table 67 Product Launches, 2013–2016

List of Figures (35 Figures)

Figure 1 Research Design
Figure 2 Market Size Estimation Methodology: Bottom-Up Approach
Figure 3 Market Size Estimation Methodology: Top-Down Approach
Figure 4 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 5 Data Triangulation Methodology
Figure 6 Sterility Testing Market Size, By Product and Service, 2016 vs 2021 (USD Million)
Figure 7 Market Size, By Test, 2016 vs 2021 (USD Million)
Figure 8 Sterility Testing Market Size, By Application, 2016 vs 2021 (USD Million)
Figure 9 Sterility Testing Market Size, By Region, 2016 vs 2021 (USD Million)
Figure 10 Market to Register A Double-Digit Growth Rate in the Forecast Period
Figure 11 Kits and Reagents Accounted for the Largest Share of the Sterility Testing Market in 2016
Figure 12 Asia to Register the Highest Growth Rate in the Forecast Period
Figure 13 Sterility Testing Market: Drivers, Restraints, Opportunities, & Challenges
Figure 14 Market: Porter’s Five Forces Analysis
Figure 15 Sterility Testing Market: Supply Chain Analysis
Figure 16 Kits and Reagents Segment to Dominate the Sterility Testing Products Market During the Forecast Period
Figure 17 Membrane Filtration to Dominate the Sterility Testing Market, By Test, During the Forecast Period
Figure 18 Pharmaceutical and Biological Manufacturing Segment to Dominate the Sterility Testing Applications Market
Figure 19 North America to Dominate the Sterility Testing Market in 2016
Figure 20 Asian Market to Witness the Highest Growth During the Forecast Period (2016-2021)
Figure 21 U.S. to Witness Highest Growth in the North American Sterility Testing Market During the Forecast Period (2016-2021)
Figure 22 North America: Sterility Testing Market Snapshot
Figure 23 Europe: Sterility Testing Market, By Country (Market Size and Growth Rate)
Figure 24 Asia: Sterility Testing Market Size, By Country, 2016, (Market Size and Growth Rate)
Figure 25 Asia: Sterility Testing Market Snapshot
Figure 26 Key Developments in the Sterility Testing Market, 2013–2016
Figure 27 Global Sterility Testing Market Share Analysis, By Key Player, 2015
Figure 28 Geographic Revenue Mix of Top 4 Market Players
Figure 29 Merck KGaA: Company Snapshot (2015)
Figure 30 Charles River Laboratories International, Inc.: Company Snapshot (2015)
Figure 31 Biomérieux SA: Company Snapshot (2015)
Figure 32 SGS S.A.: Company Snapshot (2015)
Figure 33 Danaher Corporation: Company Snapshot (2015)
Figure 34 Sartorius AG: Company Snapshot (2015)
Figure 35 Thermo Fisher Scientific Inc.: Company Snapshot (2015)

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 global market is segmented on the basis of product, test, and application. Sterility testing is an important and mandatory step in the manufacturing process to remove or inactivate potential bacterial contaminants. Growth in the pharmaceutical and biotechnology industries, increase in the number of new drug launches, and increasing R&D in life science research are the key factors driving the growth of this market.

On the basis of product, the market is segmented into kits and reagents, instruments, and services. The kits and reagents segment is expected to account for the largest share of the 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 market is segmented into membrane filtration, direct inoculation, and other sterility tests. In 2016, the membrane filtration segment accounted for the largest share. The large share of this segment can primarily be attributed to rapid growth in the pharmaceutical and biotechnology end-use industry.

On the basis of application, the market is segmented into pharmaceutical and biological manufacturing, medical devices manufacturing, and others applications. In 2016, the pharmaceutical and biological manufacturing segment accounted for the largest share primarily due to the rapid growth in the pharma and biotech industries.

Based on region, the global sterility testing market is segmented into North America, Europe, Asia, and the Rest of the World (RoW). The market is dominated by North America, followed by Europe, Asia, and the Rest of the World (RoW). However, 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 major players in the market include Merck KGaA (Germany), Charles River Laboratories International, Inc. (U.S.), bioMérieux SA (France), SGS S.A. (Switzerland), Sartorius AG (Germany), WuXi AppTec (China), and Thermo Fisher Scientific, Inc. (U.S.).

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