Sterility testing is a critical and vital sterilization test that must be performed by trained and qualified laboratory personnel, to assess whether a sterilized pharmaceutical product is free from contaminating microorganisms. Sterility testing is essential for detecting presence of viable forms of microorganisms in or on pharmacopoeal preparations. It is mandatory to perform such tests in a clean and aseptic area to avoid accidental contamination. Sterility testing is carried out at all levels of pharmaceutical and biopharmaceutical manufacturing process to minimize risk of product contamination.
The global sterility testing market is estimated to be US$ XX million in 2017 and is expected to reach US$ XX million registering a healthy CAGR of XX%, in the next 10 years. Membrane filtration method continues to maintain its dominance in terms of preference and contribution in terms of revenue generation, as it can not only circumvent, but also overcome the activity of antibiotics for which there exist practically little inactivating agents. Also, kits and reagents are the most used products currently. Due to rising government support for pharmaceutical and biological manufacturing, it is expected to account for largest revenue share.
Factors driving growth of the global sterility testing market include growth in pharmaceutical and biotechnology industries, rising R&D activities in life science research, and surge in launch of new drugs in markets globally. Increasing government support for pharmaceutical and biotechnology industries and rise in demand for sterilized products and their exclusivity in healthcare industry are accelerating market growth.
However, lengthy approval procedures, stringent regulatory policies, and high-degree of market consolidation are factors restraining market growth. High level of competition between key players in the market is projected to create challenges for new entrants operating in emerging markets.
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The market in Asia Pacific is expected to witness rapid growth and contribute major revenue share to the global sterility testing market. Countries in Asia Pacific represent major revenue generation potential, owing to rising initiatives by governments and private organizations for sterility testing research, rising outsourcing in pharmaceutical sector to emerging economies such as India and China, and escalating outlay on research in life sciences. The market in North America is also expected to contribute significantly over the forecast period.
Key players operating in the market include Merck KGaA, Charles River Laboratories International, Inc., bioMérieux SA, SGS S.A., Sartorius AG, WuXi AppTec, and Thermo Fisher Scientific, Inc.
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