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.
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. Geriatrics represent about 14.5% of the U.S. population. According to the U.S. department of health and human services, by 2060, this number is likely to rise to 98 million – which is twice that of 2014. Europe is the second leading market for sterility testing on account of the increasing number of research and development activities. Asia Pacific is estimated to develop at a higher rate due to the rapid population growth, high prevalence of chronic diseases, government initiatives, and rising research & development in the region. According to SIRO Clinpharm, by 2050, Asia is likely to account for 60% of the world’s population, thereby offering tremendous opportunities for recruiting patients and expanding research of new lifestyle diseases treatment drugs.
Key players operating in this market include Merck KGaA, Bioquell UK Ltd, bioMérieux SA, Sartorius AG, Thermo Fisher Scientific Inc., SGS SA, Charles River Laboratories, and WuXi Biologics.
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