The latest market report published by Credence Research, Inc. “Global Sterility Testing Market By Product & Services (Reagents And Kits, Instruments), By Test (Membrane Filtration, Direct Inoculation) - Growth, Future Prospects, Competitive Analysis, 2017 - 2025,” the global market for sterility testing was valued at US$ 548.2 million in 2016 and is expected to reach US$ 1.176.9 million by 2025 with a CAGR increase 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 that require aseptic filling operations. There have been incidences of human contamination during stopper processing activities during aseptic filling operations. This led to a novel rubber formulation and the introduction of new techniques such as sterilization-ready and ready-to-use elastomeric components.

Browse the full report at https://www.credenceresearch.com/report/sterility-testing-market

In 2016, the segment of reagents and kits dominated the market due to key market drivers such as strict regulation of cGMP and cGLP making it mandatory to emphasize sterility testing protocols and to increasing reports of drug-related adverse events related to product contamination. The instrument segment will be the fastest-growing market in the 2017-2025 forecast period, largely due to the technological improvement of the membrane filtration device and the design offering inherent features such as high efficiency at low pressure and energy consumption. In addition, improvements in filter performance have been made to provide longer filter life, increased dust load ability and easier maintenance without compromising filter effectiveness. In 2016, membrane filtration dominated the testing market mainly due to factors such as technological advances in membrane filtration design and operations that increase filtration efficiency, the filtration processes can operate at low temperatures and low energy consumption. The limitation of membrane filtration is that it is not effective in eliminating microbial contamination from medical devices and that techniques are prone to membrane fouling effects which may result in a decrease in permeate flux requiring expensive cleaning and regeneration schemes. Direct inoculation will be the fastest-growing application during the forecast period 2017-2025, due to factors such as its application in the performance of sterility testing of non-filterable or deformable products and the use of smaller volumes of test articles.

In 2016, North America held the largest revenue share, mainly due to factors such as the presence of key pharmaceutical and biotechnology industries involved in active research and development activities, the existence of a proactive healthcare system focusing on drug quality formulation, and the USFDA's strict guidelines on environmental monitoring and product quality in the field of pharming. Asia Pacific will be the fastest growing market in the 2017-2025 forecast period, mainly due to factors such as competitive market presence of existing and emerging biopharmaceutical manufacturers involved in the production of sterility testing reagents and equipment in these regions and a supportive regulatory environment for sterility testing products.

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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.

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
Report Scope by Segments

By Product and Services

Reagents and Kits
Instruments
Services
By Test Type

Membrane Filtration
Direct Inoculation
Other Sterility Testing
 By Geography Segment

North America
Europe
Asia Pacific (APAC)
Middle East & Africa (MEA)
Latin America
Medium Blog: https://medium.com/@kumarganesh028/sterility-testing-market-8-38-50a778eec33e