Sterility Testing Market By Product & Services (Reagents And Kits, Instruments), By Test (Membrane Filtration, Direct Inoculation) - Growth, Future Prospects And Competitive Analysis, 2017 - 2025
The sterility testing of compounded sterile preparations have come under scrutiny in the light of the newly passed federal drug quality and security act (DQSA), pub. L No. 113-54 which stresses on the validation of the biological indicators for the completion of sterility testing. Biological indicators such as Geobacillus stearothermophilus endospores which is used due to the advantages provided such as 6 log efficiency challenge, in process testing controls of the sterile preparations to reduce the risks of false positives. Additionally technological advancement in the sterility testing equipment’s such as modular aseptic workstation/ isolators with added features such as ergonomics, inbuilt hydrogen peroxide vapor technology, 20 minutes decontamination cycle and provides 30 minutes between load decontamination drives the sterility testing market.
For the purpose of this study, the various products studied includes reagents and kits, instruments and services. Tests are classified as membrane filtration, direct inoculation and other sterility testing. Market size estimates and forecast of these segments for the period 2015 to 2025 are provided in terms of US$ Mn along with the respective CAGRs for the period 2017 to 2025, considering 2016 as the base year.
The geographic segmentation of the global sterility testing market is performed for the regions North America, Europe, Asia Pacific, Latin America and Middle East and Africa markets. The regions are also further sub-segmented on the basis of major countries:
- North America
- U.S.
- Canada
- Europe
- U.K.
- Germany
- France
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Rest of Asia Pacific
- Latin America
- Mexico
- Brazil
- Rest of LATAM
- Middle East and Africa
- GCC
- Rest of Middle East and Africa
Market size estimates and forecast for these segments for the period 2015 to 2025 are provided in terms of US$ Mn along with the respective CAGRs for the period 2017 to 2025, considering 2016 as the base year.
This report also includes qualitative assessment factors such as market dynamics (drivers, restraints and opportunities) to have a good understanding of the current and anticipated trends in the global sterility testing market. Competition assessment tools such as Porter’s five forces analysis, market attractiveness assessment and competitive landscape analysis by key players are also presented in the study. Furthermore, this report concludes with profiling of key market players currently enjoying prominent position in the global sterility testing market. The key players profiled in this report are 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.
Based on product, the global sterility testing market is categorized into
- Reagents and Kits
- Instruments
- Services
The sterility testing of the pharmaceutical and biological preparation is required during the sterilization validation process as well as routine release testing. Sterility testing is an extremely difficult process that must be designed in order to eliminate the false positive results which are generally due to laboratory contamination from the testing environment or human error. In 2016, kits and reagents segment held the largest market share chiefly due to factors 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 will be the fastest growing market throughout the forecast period 2017-2025 majorly due to the technological advancement in the membrane filtration device and design with 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. The major players in sterility testing market are 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.
Based on test, the global sterility testing market is categorized into
- Membrane Filtration
- Direct Inoculation
- Other Sterility Testing
The sterility testing is witnessing tremendous growth significantly due to increasing sterility testing conducted by the pharmaceutical and biotechnology industries, and stringent regulatory guidelines has made it necessary to eliminate microbial contamination related to environment or human contact. Additionally, the rise in the launch of novel drugs and increasing research and development activities in the life science industries will enhance the market penetration of healthcare industry. In 2016, membrane filtration segment dominated the market mainly 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. Direct inoculation segment is anticipated to project faster growth throughout the forecast period 2017-2025, chiefly due to factors such as its application in performing sterility testing of products that are not filterable or deformable and application of smaller volumes of test articles is possible.
For the purpose of this study, the global sterility testing market is categorized into the following regional and country specific markets:
- North America
- U.S.
- Canada
- Europe
- U.K.
- Germany
- France
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Rest of Asia Pacific
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East and Africa
- GCC
- Rest of Middle East and Africa
North America was observed to be the largest market for sterility testing in the base year 2016. The dominance of North America is mainly attributed to the 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. The market growth in Europe is mainly attributed to the increasing number of pharmaceutical and biotechnology industries and stringent guidelines imposed by ICH. Asia Pacific was observed as the fastest growing regional segment throughout the forecast period 2017-2025. Factors that are anticipated to propel the market growth are the technological development in the sterility testing devices and instruments, competitive market due to presence of existing major players and budding industries involved in the manufacturing and sale of sterility testing products in this region and supportive regulatory environment for sterility testing products. Moreover, factors such as developing health infrastructure and rising demand for high quality food and drugs are going to fuel the rapid growth of sterility testing market in Latin America, and Middle East and Africa region in the near future.
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
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)
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)
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