The latest market report published by Credence Research, Inc. “Global 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.
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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.
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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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