Sterility Testing Market Growth Is Attributed to the Rapid Growth of Pharmaceutical Industry

Sterility testing is an essential part of the sterilization and validation process in pharmaceutical industry. The test is designed to demonstrate both the presence and absence of external viable contaminating microorganisms in a biological parenteral designed for human use. Thus, there is an increasing demand for sterility testing services in the pharmaceutical and medical device companies, driving the growth of the sterility testing market. For example, in November 2019, Reading Scientific Services Ltd. (RSSL) launched a new, fast, responsive, and flexible sterility testing service for pharmaceutical and medical device companies.

The move enables the leading contract research organizations to further enhance the scope of its biopharmaceutical services and increase testing capacity. Sterility testing is used to ensure that pharmaceutical and biopharmaceutical therapeutics are actually sterile and safe for human use. Sterility testing can be performed by two different methods, such as direct immersion or membrane filtration, and can be performed in an isolator or cleanroom environment. Medical device, biotechnological, and pharmaceutical companies use sterility testing to investigate the quality of raw materials as well as process control and validation of end products.

Sterility Testing Market Size, Expected CAGR, Top Manufacturers and Consumer Analysis across the Region and Globe, Opportunities and Growth till 2023.

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Sterility Testing Markets Outlook (Revenue, USD Million; 2018-2026)
Membrane Filtration System Sterility Test
Direct Transfer Sterility Testing
Product Flush Sterility Testing
Others

Applications Outlook (Revenue, USD Million; 2016-2026)
Raw Materials
Personnel
Equipment
Manufacturing Environment
Pharmaceutical Preparations
Vectors
Packaging/Bulk Finished Products
Others

End Use Outlook (Revenue, USD Million; 2016-2026)
Biopharmaceutical & Pharmaceutical Companies
Contract Research Organization (CRO)
Contract Manufacturing Organization (CMO)
Cell Banks
Academic Research Institutes

Thus, there is an increasing demand for sterility testing in medical device, biotechnological, and pharmaceutical companies, augmenting the sterility testing market growth. For example, in October 2019, Alcami Corporation announced the launch of its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver significantly faster testing results to clients. Moreover, the company invested in the Milliflex Rapid System for the rapid sterility test, which uses adenosine triphosphate bioluminescence for detection of microorganisms after five days. Sterility testing services are used for raw materials, cell banks, and bulk and final drug products.

Moreover, the growth of the sterility testing market is mainly driven by the rapid growth of pharmaceutical and biotechnology companies and government support for pharmaceutical and biotechnology industries, worldwide. The pharmaceutical industry has experienced significant growth during the past two decades, and pharma revenues worldwide totaled 1.25 trillion U.S. dollars in 2019. Major players in the market are engaged in research and development activities for the development of safe and effective drugs and therapeutics for various types of diseases. Thus, require sterility testing services to ensure that novel drugs and therapeutics are safe and actually sterile for human use.

However, major factors such as stringent regulatory frameworks and time-consuming approval processes are restraining the growth of the sterility testing market.

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