Sterility Testing Market Research Report and Forecast up to 2025 Sterility Testing Market - Global Industry Analysi
Sterility Testing Market - Global Industry
Analysis, Size, Share, Growth, Trends, and
Forecast 2017 - 2025
Sterility testing is used for routine quality control, sterilization validation, as well as
to detect contamination in a batch. It is an exceptionally tough process designed to
eliminate false positive results caused by laboratory contamination from the testing
environment or technician error. Sterility testing of cell lines, media, in-process
material, and final products must be demonstrated during the manufacture of
pharmaceuticals and medical devices. Products necessary for sterilization include
injections, implants, syringes, and surgical instruments. Sterility testing is of three
types: direct inoculation (immersion), membrane filtration, and direct transfer. In
the former, the test articles are inoculated directly into tubes or bottles containing
an appropriate medium and incubated for a period of 14 days. In the second
method, the test article first passes through a size exclusion membrane capable of
retaining microorganisms. Different tests exhibit different advantages.
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Factors such as the prevalence of chronic diseases, rapid population growth,
increasing research and development activities, and government initiatives are
predicted to drive the sterility testing market globally. Growing demand for high
quality products, technological advancements, and the burgeoning pharmaceutical
& biotechnological industries are bound to play a role too. Singapore invested US$
2.8 Mn in research and development in biomedical sciences from 2011 to 2015. On
the other hand, strict government regulation may hinder the development of the
sterility testing market.
The market has been segmented by product type into the following categories:
instruments and kits & reagents. The latter are expected to register a higher growth
rate due to their ease of use and affordability. In terms of test type, the membrane
filtration segment is projected to witness significant growth owing to new product
launches and growth in the pharmaceutical & biotechnology industries. Based on
end-user, the market is divided into the following groups: pharmaceuticals, medical
devices, cosmeceuticals, and biotechnology.
Geographically, the sterility testing market is distributed over North America, Latin
America, Europe, Asia Pacific, and Middle East & Africa. North America dominated
the market due technological advancements, the burgeoning pharmaceutical &
biotechnology industries, and increasing geriatric population in the region.