Overview:
Sterility testing is an integral part of the pharmaceutical manufacturing. It is an essential part of every sterilization verification process in many industries. Sterility testing is an extremely difficult process that must be planned and executed with precision, which in turn help eliminate false positive results. Technician errors or laboratory contamination are the primary causes of false positive results. The sterility test should be performed in a clean room with no or minimal chance of error, which in turn help ensure compliance with U.S. Pharmacopeia requirements in terms of viable microbial air and surface counts. Moreover, the unique requirements for employing sterility testing as an official test and to determine the suitability are regulated under the good manufacturing practices guidelines.
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Drivers:
Increasing demand for sterilized products and increasing applications of sterilized products in various industries is expected to boost the growth of the global sterility testing market over the forecast period. Moreover, advancements in sterility testing technologies are expected to propel growth of the global sterility testing market. Market players are focusing on making the testing process more time efficient. For instance, Milliflex Rapid System, launched in 2010, to make the sterility testing more time efficient without hindering the test result quality.
Conventionally used microbiological testing methods to detect, sterilize, and identify are often time consuming and labor intensive. Such procedures’ lack of practical considerations often limits the extent to which microbiological tests are routinely applied in both the microbiological quality assurance and formulation development phase. Novel methods such as MF Sterility Testing Equipment from Merck Millipore which aseptically filter liquid samples for sterility test equipment used in sterility testing and can find wide application in pharmaceutical field. This in turn is also expected to augment the growth of the global sterility testing market. Rapid testing methods, such as nucleic acid probes, electrical resistance, fluorescent labeling, and ATP bioluminescence are commonly used in the pharmaceutical testing.
𝗖𝗵𝗿𝗶𝘀𝘁𝗺𝗮𝘀 𝗦𝗮𝗹𝗲 𝗜𝘀 𝗟𝗶𝘃𝗲!
𝗕𝘂𝘆 𝗡𝗼𝘄 𝗧𝗼 𝗔𝘃𝗮𝗶𝗹 𝗗𝗶𝘀𝗰𝗼𝘂𝗻𝘁 𝗙𝗿𝗼𝗺 𝟮𝟱-𝟯𝟬% 𝘁𝗶𝗹𝗹 𝟯𝟭-𝗗𝗲𝗰-𝟮𝟬𝟮𝟭
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Furthermore, market players are focusing on developing novel products, as well as are engaged in research and development process, which in turn is expected to drive growth of the market. For instance, bioMérieux SA announced the launch of the BacT/ALERT 3D Dual-T system, a possible candidate for automated growth-based sterility testing.
Market Taxonomy:
By Product Type:
- Kits and Reagents
- Instruments
- Service
By Test Type:
- Membrane Filtration
- Direct Inoculation
- Container closure integrity testing
- Antimicrobial effectiveness testing
- Rapid micro test
By Application:
- Pharmaceutical and Biological Manufacturing
- Medical Devices Manufacturing
- Bioburden Test
Others Applications
Competitive Landscape:
Key players operating in the global sterility testing market are Merck Millipore, WuXi AppTec, bioMérieux SA, Sartorius AG, SGS S.A., Thermo Fisher Scientific Inc., and Charles River Laboratories International, Inc., among others.
Key Developments:
In May 2019, Thermo Fisher Scientific Inc. planned to invest US$ 50 million in its global bio-production capabilities to provide additional capacity for manufacturing single-use bioprocess container (BPC) systems. Moreover, in March 2019, Thermo Fisher planned to invest US$ 150 million to provide additional capacity for sterile liquid and lyophilized product development and commercial manufacturing.
In February 2018, Merck announced the launch of Viresolve Barrier capsule filters to reduce the risk of bioreactor contamination.
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Table of Content
Chapter 1 Industry Overview
1.1 Definition
1.2 Assumptions
1.3 Research Scope
1.4 Market Analysis by Regions
1.5 Global Sterility Testing Market Size Analysis from 2021 to 2027
11.6 COVID-19 Outbreak: Sterility Testing Industry Impact
Chapter 2 Global Sterility Testing Competition by Types, Applications, and Top Regions and Countries
2.1 Global Sterility Testing (Volume and Value) by Type
2.3 Global Sterility Testing (Volume and Value) by Regions
Chapter 3 Production Market Analysis
3.1 Global Production Market Analysis
3.2 Regional Production Market Analysis
Chapter 4 Global Sterility Testing Sales, Consumption, Export, Import by Regions (2016-2021)
Chapter 5 North America Sterility Testing Market Analysis
Chapter 6 East Asia Sterility Testing Market Analysis
Chapter 7 Europe Sterility Testing Market Analysis
Chapter 8 South Asia Sterility Testing Market Analysis
Chapter 9 Southeast Asia Sterility Testing Market Analysis
Chapter 10 Middle East Sterility Testing Market Analysis
Chapter 11 Africa Sterility Testing Market Analysis
Chapter 12 Oceania Sterility Testing Market Analysis
Chapter 13 South America Sterility Testing Market Analysis
Chapter 14 Company Profiles and Key Figures in Sterility Testing Business
Chapter 15 Global Sterility Testing Market Forecast (2021-2027)
Chapter 16 Conclusions
Research Methodology
Continued….
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