Sterility Testing Market

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

Report Code: BT 5095 Mar, 2017, by marketsandmarkets.com

[124 Pages Report] 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. Pharmaceutical, biotechnological, and medical device companies carry out sterility testing to investigate the quality of raw materials as well as process control and validation of end products. Sterility testing is used for bulk and final drug products, cell banks, and raw materials. The base year considered for the study is 2015, and the forecast has been provided for the period between 2016 and 2021.

Market Dynamics

Drivers

  • Growth of pharmaceutical & biotechnology companies
  • Increasing number of drug launches
  • Government support for pharmaceutical and biotechnology industries
  • Increasing R&D investment in life sciences

Restraints

  • High degree of consolidation, major barrier for new market entrants
  • Stringent regulatory frameworks and time-consuming approval processes

Opportunities

  • Emerging markets
  • Increasingly pharmaceutical outsourcing

Challenges

  • Shortage of skilled professionals

Growth of pharmaceutical and biotechnology companies drives the global sterility testing market

In pharmaceutical and biopharmaceutical industries, sterility testing is carried out at all levels of manufacturing to minimize the risk of product contamination. Subsequently, the growth of this end-use industry in the coming years will considerably boost the overall use of sterility testing. With stringent regulatory controls in place, process monitoring and quality control are carried out for the entire production chain of pharmaceutical and biopharmaceutical products. In this process, sterility testing is carried out for raw materials, bulk lot release testing, and final product release testing. According to the International Trade Administration, U.S. Department of Commerce, the global pharmaceuticals market is projected to grow from USD 1 trillion in 2015 to USD 1.3 trillion by 2020 at a CAGR of 4.9%. Strong growth in pharmaceutical and biopharmaceutical industries will drive the sterility testing market.

The following are the major objectives of the study.

  • To define, describe, and forecast the sterility testing market on the basis of product, test, application, and region
  • To provide detailed information regarding the major factors influencing growth of the market (drivers, restraints, opportunities, and industry-specific challenges)
  • To strategically analyze micromarkets1 with respect to individual growth trends, future prospects, and contributions to the overall market
  • To analyze the opportunities in the market for stakeholders and provide details of a competitive landscape for market leaders
  • To forecast revenue of the market segments with respect to four main regional segments, namely, Asia, Europe, North America, and the Rest of the World
  • To profile key players and comprehensively analyze their market shares and core competencies2 in terms of market development and growth strategies
  • To track and analyze competitive developments such as partnerships, agreements, and collaborations; mergers and acquisitions; product launches; expansions; and research and development activities in the sterility testing market

During this research study, major players operating in the sterility testing market in various regions have been identified, and their offerings, regional presence, and distribution channels have been analyzed through in-depth discussions. Top-down and bottom-up approaches have been used to determine the overall market size. Sizes of the other individual markets have been estimated using the percentage splits obtained through secondary sources such as Hoovers, Bloomberg BusinessWeek, and Factiva, along with primary respondents. The entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews with industry experts such as CEOs, VPs, directors, and marketing executives for key insights (both qualitative and quantitative) pertaining to the market. The figure below shows the breakdown of the primaries on the basis of the company type, designation, and region considered during the research study.

Sterility Testing Market

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

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

Major Market Developments

  • In September 2016, Merck KGaA (Germany) launched Steritest Symbio Pump systems accessories. The accessories enable faster, safer sterility testing in any setting.
  • In August 2014, Merck KGaA (Germany) launched Steritest Symbio Pumps. The product helps researchers in easier, safer, and more reliable sterility testing of pharmaceutical products in laminar flow hoods, isolators and clean rooms.
  • In June 2014, Nelson Laboratories (U.S.) announced the expansion of its service offerings by adding the Technical Consulting Services group for MedTech companies. These services include product development, facility and process validation, product performance testing, and regulatory support.
  •  In November 2014, Merck KGaA completed the acquisition of Sigma-Aldrich Corporation (U.S.). The deal was valued at USD 17 billion. This acquisition helped Merck expand its business in various geographies and enhance its product portfolio.
  • In August 2015, Danaher acquired Pall Corporation (U.S.). This acquisition helped the company to add Pall Corporation’s sterility filtration products to its existing product portfolio.

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

Scope of the Report:

This report categorizes the sterility testing 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)

Critical questions which the report answers

  • What are new application areas which the sterility testing companies are exploring?
  • Which are the key players in the market and how intense is the competition?

Available Customizations

  • 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

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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%. 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.

Sterility testing is a microbiological analysis to determine the presence of organisms in a given sample. It is carried out in a wide range of fields, including pharmaceuticals and biologicals, medical devices, water purification, food and beverages, and laboratory glass products. This process is mandatory at every stage in the drug development and production process. Sterility testing studies help analyze the effectiveness of each step of the manufacturing process to remove or detect bacterial toxins.

On the basis of product, the sterility testing 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.

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. Growth in the outsourcing industry in Asia is another major factor supporting overall market growth in the region. The rapidly increasing demand for the outsourcing of microbial testing in countries such as China, India, Japan, and Singapore is expected to drive market growth during the forecast period. To capitalize on the opportunities in the Asian market, a number of companies have worked to increase their market share and customer base in the region.

Sterility Testing Market

Sterility testing applications in pharmaceutical and biological manufacturing and medical device manufacturing drive the growth of sterility testing market

Pharmaceutical and biological manufacturing

With stringent regulatory controls in place, process monitoring and quality control are carried out for the entire production chain of pharmaceutical and biopharmaceutical products. In this process, sterility testing is carried out for raw materials, bulk lot release testing, and final product release testing.

Medical Device manufacturing

In the medical device industry, the product sterility test is necessary for ensuring that medical devices are free from viable microorganisms. Some of the important medical devices tested for sterility tests include catheters, needles, orthopedic implants, contact lenses, anesthetic and respiratory equipment, and dental implants.

Critical questions the report answers:

  • Where will all these developments take the industry in the mid to long term?
  • What are the upcoming industry applications for sterility testing?

There is a high degree of rivalry amongst market players, owing to which the market is highly competitive. Furthermore, the top players in this market are large and well -established, and enjoy a high degree of brand loyalty. New entrants in this market have to compete with existing players and differentiate themselves with innovative product offerings. The high degree of consolidation and the need for extensive R&D act as major entry barriers for new entrants. This is expected to restrict investments and thus the growth potential of this market. Furthermore, the requirement of high-capital investments and the high cost of R&D and manufacturing will also deter new players from entering this market.

The major players in the sterility testing market include Merck KGaA (Germany), Charles River Laboratories International, Inc. (U.S.), bioM้rieux SA (France), SGS S.A. (Switzerland), Sartorius AG (Germany), WuXi AppTec (China), and Thermo Fisher Scientific, Inc. (U.S.). These players are increasingly undertaking mergers and acquisitions, and product launches to develop and introduce new technologies and products in the market.

To speak to our analyst for a discussion on the above findings, click Speak to Analyst

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 Biom้rieux 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 Biom้rieux 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)


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BT 5095
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