Global Sterility Testing Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2017 to 2025

  • ID: 4431634
  • Report
  • Region: Global
  • Acute Market Reports
1 of 4

FEATURED COMPANIES

  • Azbil Telstar S.L.
  • BioMerieux SA
  • Bioquell UK Ltd.
  • Boston Analytical
  • Merck KGaA
  • Other Notable Players
  • MORE
Sterility Testing Market - Growth, Future Prospects, Competitive Analysis, 2017 - 2025, the global Sterility Testing market was valued at US$ 548.2 Mn in 2016, and is expected to reach US$ 1,176.9 Mn by 2025 expanding at a CAGR of 8.38% from 2017 to 2025.

Market Insights

Recently there has been a changing trend in the drug discovery and development landscape primarily in the production of biological, live vaccines, large molecules and protein based injectable drugs which requires aseptic filling operations. There has been incidences where they have been exposed to human contamination during the stopper processing activity conducted during aseptic filling operations. This has led to the novel rubber formulation and launch of new techniques such as ready to sterilize and ready to use elastomeric component.

In 2016, reagents and kits segment dominated the market due to key market drivers such as stringent regulation of cGMP and cGLP making it mandatory to emphasize on sterility testing protocols and increasing reports of drug related adverse events in relation to product contamination. Instruments segment will be the fastest growing market throughout the forecast period 2017-2025, majorly due to technological improvement in the membrane filtration device and design offering inherent features such as highly effective at low pressure drop and energy consumption. Additionally the improvements in the filter performance has been carried out providing longer filter life, greater dust load capacity and easier maintenance without compromising filter efficiency. In 2016, membrane filtration dominated the testing market chiefly due to factors such as technological advancement in the membrane filtration design and operations increasing filtration efficiency, the filtration processes can function at low temperatures and low energy consumption. The limitation of membrane filtration is that it is not effective in eliminating the microbial contamination from medical devices and the techniques are prone to membrane fouling effects which results into decrease in permeate flux requiring expensive cleaning and regeneration schemes may be required. Direct inoculation segment will be the fastest growing application throughout the forecast period 2017-2025, due to the factors such as its application in performing sterility testing of products that are not filterable or deformable and smaller volumes of test articles can be used.

In 2016, North America held the largest revenue share mainly due to factors such as presence of key pharmaceutical and biotechnology industries involved in active research and development activities, existence of a proactive healthcare system emphasizing on quality of drug formulation and stringent guidelines sanctioned by the USFDA regarding environmental monitoring and product qualities in pharmaceutical and food industries. Asia Pacific will be the fastest growing market throughout the forecast period 2017-2025, majorly due to factors such as competitive market due to presence of existing and budding biopharmaceutical manufacturers involved in producing sterility testing reagents and equipment in these regions and supportive regulatory environment for sterility testing products.

Key Market Movements:
  • Stringent cGMP and cGLP norms sanctioned by the regulatory agencies
  • Technological advancement in the equipment and reagents utilized for sterility testing
  • Supportive regulatory environment for sterility testing products
  • Rising incidences of serious adverse events related to food and drug contamination will result into the growth of sterility testing market
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Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • Azbil Telstar S.L.
  • BioMerieux SA
  • Bioquell UK Ltd.
  • Boston Analytical
  • Merck KGaA
  • Other Notable Players
  • MORE
Chapter 1. Preface
1.1. Report Scope and Description
1.2. Research Methodology
1.2.1. Phase I-Secondary Research
1.2.2. Phase II-Primary Research
1.2.3. Phase III-Expert Panel Review
1.2.4. Assumptions
1.2.5. Approach Adopted

Chapter 2. Executive Summary
2.1. Global Sterility Testing Market Portraiture
2.2. Global Sterility Testing Market, by Product, 2016
2.3. Global Sterility Testing Market, by Test, 2016
2.4. Global Sterility Testing Market, by Geography, 2016

Chapter 3. Sterility Testing Market: Market Dynamics and Future Outlook
3.1. Market Overview
3.2. Drivers
3.3. Challenges
3.4. Opportunities
3.5. Porter’s Five Forces Analysis
3.6. Attractive Investment Proposition, by Geography
3.7. Competitive Landscape
3.7.1. Competitive Landscape, by Key Players, 2016

Chapter 4. Global Sterility Testing Market, by Product & Services, 2015 - 2025 (US$ Mn)
4.1. Overview
4.2. Attractive Investment Proposition: Global Sterility Testing Market, by Product & Services
4.3. Reagents and Kits
4.4. Instruments
4.5. Services

Chapter 5. Global Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
5.1. Overview
5.2. Attractive Investment Proposition: Global Sterility Testing Market, by Test
5.3. Membrane Filtration
5.4. Direct Inoculation
5.5. Other Sterility Testing

Chapter 6. Global Sterility Testing Market, by Geography, 2015 - 2025 (US$ Mn)
6.1. Overview
6.2. North America Sterility Testing Market Analysis, 2015 - 2025
6.2.1. North America Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
6.2.2. North America Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
6.2.3. North America Sterility Testing Market, by Country, 2015 - 2025 (US$ Mn)
6.2.3.1. U.S.
6.2.3.2. Canada
6.3. Europe Sterility Testing Market Analysis, 2015 - 2025
6.3.1. Europe Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
6.3.2. Europe Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
6.3.3. Europe Sterility Testing Market, by Country, 2015 - 2025 (US$ Mn)
6.3.3.1. U.K.
6.3.3.2. Germany
6.3.3.3. France
6.3.3.4. Rest of Europe
6.4. Asia Pacific Sterility Testing Market Analysis, 2015 - 2025
6.4.1. Asia Pacific Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
6.4.2. Asia Pacific Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
6.4.3. Asia Pacific Sterility Testing Market, by Country, 2015 - 2025 (US$ Mn)
6.4.3.1. Japan
6.4.3.2. China
6.4.3.3. India
6.4.3.4. Rest of APAC
6.5. Latin America Sterility Testing Market Analysis, 2015 - 2025
6.5.1. Latin America Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
6.5.2. Latin America Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
6.5.3. Latin America Sterility Testing Market, by Country, 2015 - 2025 (US$ Mn)
6.5.3.1. Brazil
6.5.3.2. Mexico
6.5.3.3. Rest of Latin America
6.6. Middle East & Africa (MEA) Sterility Testing Market Analysis, 2015 - 2025
6.6.1. MEA Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
6.6.2. MEA Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
6.6.3. MEA Sterility Testing Market, by Region, 2015 - 2025 (US$ Mn)
6.6.3.1. GCC
6.6.3.2. Rest of MEA

Chapter 7. Company Profiles
7.1. Azbil Telstar S.L.
7.1.1. Business Description
7.1.2. Financial Information (Subject to data availability)
7.1.3. Product Portfolio
7.1.4. Key Developments
7.2. Boston Analytical
7.3. Bioquell UK Ltd.
7.4. BioMerieux SA
7.5. Charles River Laboratories
7.6. Merck KGaA
7.7. Sartorius AG
7.8. SGS SA.
7.9. Thermo Fisher Scientific, Inc.
7.10. Wuxi Biologics
7.11. Other Notable Players

List of Figures
Fig. 1 Sterility Testing: Market Segmentation
Fig. 2 Global Sterility Testing Market Share, by Product, 2016 (Value %)
Fig. 3 Global Sterility Testing Market Share, by Test, 2016 (Value %)
Fig. 4 Global Sterility Testing Market Share, by Geography, 2016 (Value %)
Fig. 5 Attractive Investment Proposition, by Geography
Fig. 6 Market Competition Landscape, by Key Players, 2016
Fig. 7 Global Reagents and Kits Market, 2015 - 2025 (US$ Mn)
Fig. 8 Global Instruments Market, 2015 - 2025 (US$ Mn)
Fig. 9 Global Services Market, 2015 - 2025 (US$ Mn)
Fig. 10 Global Membrane Filtration Market, 2015 - 2025 (US$ Mn)
Fig. 11 Global Direct Inoculation Market, 2015 - 2025 (US$ Mn)
Fig. 12 Global Others Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 13 U.S. Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 14 Canada Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 15 U.K. Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 16 Germany Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 17 France Sterility Testing Market, 2015-2025 (US$ Mn)
Fig. 18 Rest of Europe Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 19 Japan Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 20 China Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 21 India Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 22 Rest of Asia Pacific Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 23 Brazil Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 24 Mexico Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 25 Rest of Latin America Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 26 GCC Sterility Testing Market, 2015 - 2025 (US$ Mn)
Fig. 27 Rest of Middle East and Africa Sterility Testing Market, 2015 - 2025 (US$ Mn)

List of Tables
Table 1 Global Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
Table 2 Global Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
Table 3 Global Sterility Testing Market, by Geography, 2015 - 2025 (US$ Mn)
Table 4 North America Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
Table 5 North America Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
Table 6 North America Sterility Testing Market, by Country, 2015 - 2025 (US$ Mn)
Table 7 Europe Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
Table 8 Europe Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
Table 9 Europe Sterility Testing Market, by Country, 2015 - 2025 (US$ Mn)
Table 10 Asia Pacific Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
Table 11 Asia Pacific Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
Table 12 Asia Pacific Sterility Testing Market, by Country, 2015 - 2025 (US$ Mn)
Table 13 Latin America Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
Table 14 Latin America Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
Table 15 Latin America Sterility Testing Market, by Country, 2015 - 2025 (US$ Mn)
Table 16 Middle East and Africa Sterility Testing Market, by Product, 2015 - 2025 (US$ Mn)
Table 17 Middle East and Africa Sterility Testing Market, by Test, 2015 - 2025 (US$ Mn)
Table 18 Middle East and Africa Sterility Testing Market, by Region, 2015 - 2025 (US$ Mn)
Table 19 Azbil Telstar S.L.: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 20 Boston Analytical: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 21 Bioquell UK Ltd.: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 22 BioMerieux SA: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 23 Charles River Laboratories: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 24 Merck KGaA: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 25 Sartorius AG: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 26 SGS SA: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 27 Thermo Fisher Scientific, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Table 28 Wuxi Biologics: Company Snapshot (Business Description; Financial Information; Product Portfolio; News Coverage)
Note: Product cover images may vary from those shown
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  • Azbil Telstar S.L.
  • Boston Analytical
  • Bioquell UK Ltd.
  • BioMerieux SA
  • Charles River Laboratories
  • Merck KGaA
  • Sartorius AG
  • SGS SA.
  • Thermo Fisher Scientific, Inc.
  • Wuxi Biologics
  • Other Notable Players
Note: Product cover images may vary from those shown
5 of 4
Note: Product cover images may vary from those shown
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