Global Sterility Testing Market – Overview:
Sterility testing is done by two methods: membrane filtration for aqueous, oily, alcoholic and other miscible solutions and direct inoculation for concentrated product. 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 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.
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.
• Avance Biosciences
• Boston Scientific Corporation
• Paragon Bioservices, Inc
• Merck KGaA
• Thermo Fisher Scientifi
• Charles River Laboratories International
• Avista Pharma Solutions
• Dynalabs LLC
• WuXi AppTec Group
• bioMérieux SA
• SGS S.A
Global Sterility Testing Market - Competitive Analysis
The global market of sterility testing is very vast and the market can be divided depending on product type, types of test, application, and end users. Due to advancement in technology and high healthcare expenditures, America accounts for the largest share of sterility testing market. Some of the major players in sterility testing market responsible for growth are: Merck Group, Eurofins, Thermo Fisher Scientific Inc, WuXi AppTec Group and others.
Eurofins an international group of laboratories in Brussels, provides GMP testing tothe pharmaceutical, food, environmental, agriscience and consumer products industries and to governments. On 1st January 2018, Eurofin’s pharmaceutical testing department was transferred to a separate legal unit and was named Eurofins BioPharma Product Testing NZ Limited (Eurofins BPT NZ). It provides several GMP testing for the pharmaceutical industry including full microbiological testing, raw materials analysis, and others. This change will allow Eurofins to provide a dedicated GMP Testing unit in New Zealand and enable customers to access the full support of Eurofins Global BioPharma Product Testing group.
Founded in 1668, Merck Group a multinational German pharmaceutical, chemical and Life Science Company headquartered in Darmstadt, and is one of the largest and oldest pharmaceutical company worldwide.
Sterility Testing – Segmental Analysis
• 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.