Worldwide Sterility Testing Market 2019 Research Report implements an exhaustive study on Market Research Future. This Report Cover Key Market Driver, market size, growth rate, opportunities, market Dynamics and Overall Analysis.
Global Sterility Testing Market – Overview
The market is forecasted to demonstrate a gradual growth by 2023, Global Sterility Testing Market is expected to grow at a CAGR of 12.3 % during forecasted period 2017-2023.
Sterility testing is done by two methods: membrane filtration for aqueous, oily, alcoholic and other miscible solutions and direct inoculation for concentrated product.
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Pharmaceutical companies have to follow sterility testing that is compliant with both U.S. Pharmacopeia and European Pharmacopoeia regulations. A bacteriostasis and fungistasis test is also carried out to check whether the test product inhibits the growth of microorganisms or not. The technician performing the sterility test must be appropriately gowned in sterile garments that prevent microbial contamination into the clean room.
The market is growing with incremental growth during the forecast period. The key factor driving the growth of the market is increasing number of pharmaceutical & biotechnological companies, medical devices companies, life science research institutes and other companies producing materials that claim to be free from viable microorganisms. Also, increasing expenditure on life science research, broadening of biotechnology sector, introduction of innovative entities or molecules, technological advancements in sterility test, increasing demand for diagnostics, and various others factors attribute to increase in global sterility testing market.
Whereas the high priced techniques used for sterility testing may hamper the growth of the market.
- Avance Biosciences (U.S.)
- Boston Scientific Corporation (U.S.)
- Paragon Bioservices
- Merck KGaA (Germany)
- Thermo Fisher Scientific
- Charles River Laboratories International
- Avista Pharma Solutions (U.S.)
- and Dynalabs LLC. (U.S.)
- bioMérieux SA (France) and more.
The sterility testing market, on the basis of region, is segmented into the Americas, Europe, Asia Pacific (APAC), and the Middle East and Africa (MEA). The Americas are expected to dominate the global market owing to the large patient population and demand for sterile drugs. Growth witnessed in domestic biotechnology and pharmaceutical sectors coupled with increased healthcare spending allotted to states are factors anticipated to fuel market growth over the forecast period.
Europe is predicted to be the second largest market, followed by APAC. Presence of well-established healthcare infrastructure, huge patient pool, and investments in life sciences can elicit huge market demand during the forecast period. Developed nations such as France, the U.K., and Italy are expected to contribute to overall market revenue.
The APAC sterility testing market is projected to showcase a robust CAGR over the forecast period owing to strong economies of Indian and China. It can enjoy good market demand owing to the presence of various contract manufacturing organizations.
The MEA market commands a smaller market share compared to others owing to stringent government policies and less emphasis on healthcare expenditure. The Middle East region is highly lucrative owing to the presence of nations such as Kuwait, Dubai, Qatar, and others.
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MRFR’s report offers a detailed segmental analysis of the market based on product type, test type, end-user, and region. By product type, the market has been segmented into consumables, instruments, and services. Services are further segmented into stability testing, sterility assurance tests, cleaning and disinfection, and sterility validations. The sterility assurance test segment is anticipated to be worth USD 151.6 million by 2023.
By test type, the market is segmented into product flush sterility testing, direct transfer sterility testing, membrane filtration sterility testing, and others. The membrane filtration sterility testing segment can touch a valuation of USD 348.6 million by 2023. Membrane filtration is a method used in filtering microorganisms or bacteria capable of infecting solutions. Benefits such as testing in large volumes and inhibiting bacterial growth are expected to spur segment growth till 2023.
Major end-users include academic and research laboratories, hospitals and clinics, pharmaceutical companies, and others. The pharmaceutical companies segment is projected to register a 12.1% CAGR over the forecast period. Rising demand for sterile injectables is expected to fuel segment demand.
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