Sterility testing finds application for use on raw materials, cell banks, and final drug offerings. However, it is also used for testing various articles, preparations, and substances which are needed to be made sterile as per the laws penned down by the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP). All biological parenteral preparations formulated for human use undergo sterility testing for the purpose of revealing the absence or presence of extraneous viable microorganisms with contamination capability. Sterility tests can be executed in a cleanroom environment or an isolator using membrane filtration or direct inoculation methods.
The validation of a sterility test is performed with the help of bacteriostasis and fungistasis testing. The testing also helps to check for the presence of any antimicrobial property within a test article that would impede the discovery of microbial organisms during a sterility examination.
Global Sterility Testing Market: Key Trends
Some of the top factors deemed responsible for driving the growth of the world sterility testing market could be the rising research and development activities in life science, surge in the launch of new drugs, and tangible magnification of the biotechnology and pharmaceutical sectors.
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On account of the impressive growth witnessed in the biotech and pharma sectors, by application, the biological and pharmaceutical manufacturing market had acquired a mammoth share in 2016. In the same year, the membrane filtration market by test had secured a king-sized share on the back of the swift growth earned by the biotechnology and pharmaceutical end-use sectors. Due to the advancing inclination toward kit-based testing and repeat purchase requirement, the market for kits and reagents is anticipated to win a significant share by the end of the forecast period 2017 – 2025.
Global Sterility Testing Market: Market Potential
Provider of cleanroom, analytical chemistry, and microbiology services, Avista Pharma Solutions, Inc. has recently announced its investment to extend service offerings and complement current capabilities for benefiting medical device and pharmaceutical clients. Avista Pharma CEO, Patrick Walsh was proud to make the announcement of the company’s US$4.0 mn expansion with a 4,200 sq. ft. of additional space at the 2017 Interphex global conference held in New York City. The enhanced facility will offer an International Standards Organization (ISO) 6 cleanroom for medical device sterility testing and isolator technology-enabled modular cleanroom area along with a new microbiology laboratory.
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Global Sterility Testing Market: Regional Outlook
The international sterility testing market is expected to reward Asia Pacific as a region with a higher growth rate, owing to the ballooning trend of pharmaceutical outsourcing to countries such as China and India. The success of Asia Pacific could also be attributed to the multiplying outlay on life science research. Nonetheless, North America could be a dominating geographical segment in the market followed by Rest of the World and Europe. The enlarging count of drug approvals in North America is predicted to set the tone of the regional market for sterility testing.
Global Sterility Testing Market: Competitive Landscape
New entrants in the worldwide sterility testing market are prognosticated to face challenges because of the high degree of consolidation witnessed. Besides this, long-delayed approval procedures and stiff regulatory frameworks could be the other deterrents in the market. However, developing geographies such as Asia Pacific and the elevating level of pharmaceutical outsourcing are prophesied to help players tackle the challenges in the market. Thermo Fisher Scientific, Inc., WuXi AppTec, Sartorius AG, SGS SA, bioMérieux SA, Charles River Laboratories International, Inc., and Merck KgaA are some of the exceptional companies operating in the market.
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