Sterility ensures that the product meets to its superior quality. It is widely used in cell banks and drug testing. All the drugs, substance or any parenteral intended for human use need to be sterile as well as all the preparation intended to human use need to be sterile before they administered to the patients. Sterility testing should be performed in an aseptic condition, which meets the requirement of USP. All the standard procedures and requirement are been mentioned in USP and the organization must meet the requirement for the tests. The testing must be free from any pathogens or contamination to ensure the positive results of the tests. Increasing prevalence of various diseases and introduction of new diseases leads the sterility testing market. It is observed that manufacturers are constantly introducing various new drugs to the market and increasing strong government support flourish the sterility market. Furthermore, to introduce a new drug is a long processes since the drug needs to pass a number of tests before it introduced in the market. Sterility tests are divided into three major category like membrane filtration sterility testing, direct incubation sterility testing, direct transfer, and others. Membrane filtration is the most common test for the sterility testing. Beside this, increasing pharmaceutical and biotechnology companies significantly increasing the market. According to the survey carried out by OECD, 11,367 biotechnological companies were present in the US in 2015 and the number is increasing every year. Moreover, increasing number of companies, increase the sterility test market. On the other hand, high cost of the test, long delayed approvals and improper environmental condition may hamper the sterility market over the projected period.
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The Americas sterility testing market is egmented into North America and South America. North America holds the major share owing to increasing development of new drugs, huge R&D activities, and increasing number of pharmaceutical & biotechnological companies. Increasing prevalence of new diseases has significantly increased the sterility testing market. Increasing government initiatives against such diseases are also providing a push to the market growth. South America owns the least share of the sterility market. The Americas sterility testing market is segmented on the basis of products, types of test, application, and end users. On basis of type of product, the market is segmented into instrument, reagent & services, kits, and others. On the basis of type of tests, the market is segmented into membrane filtration sterility testing, direct incubation sterility testing, direct transfer, and others. On the basis of application, the market is segmented into pharmaceutical & biological manufacturing, medical devices manufacturing, and others. On the basis of end user, the market is segmented into pharmaceuticals, hospital & laboratories, and other.
Some of the major players in the market are Charles River Laboratories International, Inc. (US), Avance Biosciences (US), Boston Scientific Corporation (US), Paragon Bioservices, Inc (US), Thermo Fisher Scientific, Inc. (U.S.), Avista Pharma Solutions (US), DYNALABS LLC. (US), and Merck KGaA (Germany)
Various leading companies such as Thermo Fisher Scientific, Inc. and Charles River Laboratories International, Inc. are in the competition of discovering the new methods for sterility testing. The high saturation of the companies in the market has increased the competition from the last few years.
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Sterility testing is one of the important aspect in the healthcare sector. It ensures the purity and safety of a product or a substance. Sterilization of the product and devices ensures the safety of the products. The major driving factor for the growth of the market are increasing manufactures of the medical devices & products, increasing prevalence of many infectious diseases, and increasing in the R&D activities. According to the Centers for Disease Control and Prevention, in 2012, about half of all adults i.e. 117 million American had one or more chronic health problem. Increasing number of diseases has intensified the research activities, which has significantly driven the market. Furthermore, technological advances, growth of pharmaceutical industries, increasing support provided by the government and increasing R&D investment have fuelled the market growth in this region. However, time consuming approval process and strict regulatory guidelines are the key factors responsible for slow the market growth, which is expected to do so over the given period.
Table Of Contents
1 Report Prologue
2 Market Introduction
2.2 Scope Of Study
2.3 Research Objective
2.4 Assumptions & Limitations
3 Research Methodology
3.1 Research Process
3.2 Primary Research
3.3 Secondary Research
4. Market Dynamics
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