Sterility Testing Market

Market Insights

In light of the recently passed federal drug quality and security act (DQSA), sterility testing of compounded sterile preparations has come under scrutiny. L No. 113–54, which stresses the validation of the biological indicators for the completion of sterility testing. Biological indicators such as Geobacillus stearothermophilus endospores, which are used due to the advantages provided, such as the 6-log efficiency challenge, are used in the process testing controls of the sterile preparations to reduce the risks of false positives. Furthermore, technological advancements in sterility testing equipment, such as modular aseptic workstations and isolators with ergonomics, inbuilt hydrogen peroxide vapor technology, a 20-minute decontamination cycle, and providing 30 minutes between load decontamination, drive the sterility testing market.

For the purpose of this study, the various products studied include reagents and kits, instruments, and services. Tests are classified as membrane filtration, direct inoculation, and sterility testing. Market size estimates and forecasts for these segments are provided in US$ Mn, along with the respective CAGRs for the period 2017-2025, using 2016 as the base year.The global sterility testing market is segmented geographically into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa markets.

Market size estimates and forecasts for these segments are provided in US$ Mn, along with the respective CAGRs for the period 2017-2025, using 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 a profile of key market players currently enjoying prominent positions 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., and Wuxi Biologics.

Based on product, the global sterility testing market is categorized into:

• Reagents and Kits
• Instruments
• Services

Sterility testing of the pharmaceutical and biological preparations 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 false positive results, which are generally due to laboratory contamination from the testing environment or human error. In 2016, the 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 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 of 2017–2025, primarily due to the technological advancement in the membrane filtration device and design with inherent features such as high effectiveness at the low-pressure drop and low energy consumption. Additionally, improvements in the filter performance have been carried out, providing longer filter life, greater dust load capacity, and easier maintenance without compromising filter efficiency. The major players in the 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., and Wuxi Biologics.

Based on the test, the global sterility testing market is categorized into:

• Membrane Filtration
• Direct Inoculation
• additional sterility testing

The sterility testing industry is expanding rapidly as the pharmaceutical and biotechnology industries conduct more sterility testing, and stringent regulatory guidelines have made it necessary to eliminate microbial contamination caused by the 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 the healthcare industry. In 2016, the membrane filtration segment dominated the market, owing to factors such as technological advancements in membrane filtration design and operations, which increased filtration efficiency, and the fact that filtration processes can operate at low temperatures while consuming little energy.

The limitation of membrane filtration is that it is not effective in eliminating microbial contamination from medical devices, and the techniques are prone to membrane fouling effects, which result in a decrease in permeate flux and require expensive cleaning and regeneration schemes. The direct inoculation segment is anticipated to project faster growth throughout the forecast period of 2017–2025, chiefly due to factors such as its application in performing sterility testing of products that are not filterable or deformable and the possibility of applying smaller volumes of test articles.

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 the Middle East and Africa

In the base year 2016, North America was observed to be the largest market for sterility testing. The dominance of North America is mainly attributed to the presence of key pharmaceutical and biotechnology industries involved in active research and development activities, the existence of a proactive healthcare system emphasizing the quality of drug formulation, and stringent guidelines sanctioned by the USFDA regarding environmental monitoring and product qualities in the pharmaceutical and food industries. The market growth in Europe is mainly attributed to the increasing number of pharmaceutical and biotechnology industries and the stringent guidelines imposed by the ICH.

Asia Pacific was observed as the fastest-growing regional segment throughout the forecast period of 2017–2025. Factors that are anticipated to propel the market growth are the technological development of sterility testing devices and instruments, the competitive market due to the presence of existing major players and budding industries involved in the manufacturing and sale of sterility testing products in this region, and a 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 the sterility testing market in Latin America, the Middle East, and Africa 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

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)