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Sterility Testing Market 2020 Growing Trend and Demand in Healthcare Sector 2023

Feb 3rd 2020 at 3:54 AM

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 2019-2023.

Global Sterility Testing Market   - Competitive Analysis

Some of the major key player in the market are Avance Biosciences (U.S.), Boston Scientific Corporation (U.S.), Paragon Bioservices, Inc (U.S.), Merck KGaA (Germany), Thermo Fisher Scientific, Inc. (U.S.), Charles River Laboratories International, Inc. (U.S.), Avista Pharma Solutions (U.S.), and Dynalabs LLC. (U.S.), WuXi AppTec Group (China), bioMérieux SA (France), SGS S.A. (Switzerland), Eurofins and others.

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 to the 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.

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.

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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. In November 2017, Merck launched Stericup Quick Release, a new filter bottle system, which is used for sterile filtration of cell culture media, buffers and reagents. Merck also released new sterites symbio pump accessories in September 2016, it enables safety and ease during sample handling, filtration, waste management, and incubation.  These sterility tests can be performed in compact environments like laminar flow hoods, isolators. It also introduced the IsoBag specifically designed for environmental monitoring in isolators and critical cleanrooms. These new releases extends Merck’s comprehensive portfolio of products specifically designed for sterility testing. In November 2015, Merck completed acquisition of Sigma-Aldrich. This acquisition will enhance Merck’s customer service, customer interface and geographic reach.

Thermo Fisher Scientific Inc. an American multinational biotech company completed its acquisition of Alfa Aesar in September, 2015. Alfa Aesar a manufacturer of research chemicals, has operations in the United Kingdom, United States, Germany, China, South Korea and India. With this integration, Thermo Fisher can broaden its product range in chemicals, solvents, and reagents.

WuXi AppTec Group, a Chinese pharmaceutical, Biopharmaceutical Company which provides several analytical services like Microbiological testing, analytical testing for formulation development and cleaning validation to its customers globally. In April 2018, WuXi AppTec (WuXi STA), announced that it has signed an agreement with the government of Shanghai Jinshan District to build a new research and development centre in Shanghai.  Thus this new facility will enable the company to strengthen its manufacturing process.

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