Rapid sterility testing ensures testing in rapid and accurate manner. Rapid sterility testing is used in different industries such as pharmaceuticals, biotechnology, and medical devices. It is highly used in the pharmaceutical industry. Rapid microbial tests are preferred in the medical devices industry for quality control of devices used for translational medicine. Rapid sterility tests have absolute sensitivity and specificity for bacterial detection and can identify viable microbes within the scope of microbiological development. Several technologically advanced rapid sterility testing includes growth-based technologies, viability-based technologies, molecular methods, and others. Growth-based technologies include ATP bioluminescence, colorimetric growth detection, and autofluorescence detection. ATP bioluminescence is a well-established rapid method for measuring contamination levels in raw materials and pharmaceutical products.
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Increase in number of medical devices, technological advancement in rapid sterility test, easy test procedures, quick test results, and surge in demand for high quality products are the key factors driving the global rapid sterility testing market. For instance, technologically advanced product, “growth direct” is the growth based system. It helps sterile pharmaceutical manufacturers to accomplish consistently reliable results in about half the time, bring products to market faster than ever before, and reduce errors and investigations. Other factors such as strategic partnerships for product development, rise in demand for technologically advanced products, increase in research & development are likely to drive the global rapid sterility testing market. However, high product cost acts as a major restraint of the market.
The global rapid sterility testing market can be segmented based on test method, application, end-user, and region. In terms of test method, the market can be classified into solid phase cytometry, flow cytometry, bioluminescence, nucleic acid amplification and immunological methods. Based on application, the global rapid sterility testing market can be categorized into biopharmaceutical manufacturing, medical devices manufacturing, and others.
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In terms of region, the global rapid sterility testing market can be segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America dominates the global rapid sterility testing market. Technological advancements, rapid adoption for newer technologies, and presence of a large number of providers of pharmaceuticals as well as medical devices are likely to propel the rapid sterility testing market in North America during the forecast period. According to SelectUSA, The United States accounting for around a third of the global pharmaceutical market. Europe is the second largest market for rapid sterility testing. Factors such as presence of key players, rise in research & development activities, and increase in number of medical device companies are anticipated to accelerate the rapid sterility testing market in Europe. According to the International Federation of Pharmaceutical Manufacturers & Associations, R&D expenditure of the pharmaceutical industry in Europe increased from EUR 17,849 Mn in 2000 to EUR 31,500 Mn in 2015. The rapid sterility testing market in Asia Pacific is expected to expand at a rapid pace during the forecast period. Growth of the market in the region is attributed to increase in number of pharmaceutical and biopharmaceutical companies and rise in demand for drug products. According to the Economic Development Board Singapore, Asia has a rapidly growing economy and the number and size of publicly-listed firms in the pharmaceutical sector in the region has increased dramatically. Latin America and Middle East & Africa present significant opportunities due to investment by key players in these regions.
Major players operating in the global rapid sterility testing market include bioMérieux SA, Merck KGaA, Thermo Fisher Scientific, Inc., Sartorius AG, Becton, Dickinson and Company, Rapid Micro Biosystems, Inc., Aes Chemunex, and Sigma-Aldrich.