Major players in the pharmaceutical sterility testing market are Pacific Biolabs, STRERIS Corporation, Boston Analytical, Gibraltar Laboratories, Sartorius AG, SolviasAG, SGS AG, Toxikon, Inc., Pace Analytical Services LLC and Charles River Laboratories International Inc.
The global pharmaceutical sterility testing market is expected to grow from $1.01 billion in 2020 to $1.12 billion in 2021 at a compound annual growth rate (CAGR) of 10.9%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $1.69 billion in 2025 at a CAGR of 10.8%.
The pharmaceutical sterility testing market consists of sales of pharmaceutical sterility testing products and related services which are used to confirm that pharmaceutical products are free from the presence of viable microorganisms.Pharmaceutical sterility tests are procedures for checking the presence of microorganism in biological parenteral which are intended for human use.
Pharmaceutical sterility testing is an important process in pharmaceuticals, medical equipment, and drugs manufacturing to assess the effectiveness of a sterilization process and is carried out at all levels of manufacturing to reduce the risk of product contamination.
The pharmaceutical sterility testing market covered in this report is segmented by sample into sterile drugs, medical devices, biologics and therapeutics. It is also segmented by product type into instruments, kits and reagents, services; by type into in- house, outsourcing; by test type into sterility testing, bioburden testing, bacterial endotoxin testing and by end- user into compounding pharmacies, medical devices companies, pharmaceutical companies.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
Companies in the pharmaceutical testing market are rising new pharmaceutical sterility testing products and services to enhance its product portfolio and increase its presence in the market.The companies are launching technologically superior outcomes and well-equipped services to utilize the growth potential of the rising pharmaceutical sterility market.
For instance, In 2019, RSSL started a sterility testing service for pharmaceutical and medical device companies, which gives fast, active, and flexible test services.RSSL’s new sterility testing service includes two methods, membrane filtration for aqueous, ethanol, solution, and oil-based products and direct injection tests for non-soluble to determine the presence of infecting microorganisms in sterilized or aseptic drug products.
Similarly, in October 2019, Alcami Corporation, a leading provider of a fully-integrated system for the pharmaceutical and biologics industries, launched a new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to give significantly faster-testing returns to customers.
In August 2018, Sotera Health, a USA based pharmaceutical company, acquired Gibraltar Laboratories for an undisclosed amount.The acquisition is expected to expand the business of analytical testing capabilities of Sotera Health’s Nelson Labs.
Gibraltar Laboratories is an external provider of microbiological and analytical chemical tests that includes sterilization services for pharmaceutical and medical device manufacturers.
An Increase in the number of drug launches and rising investment in research and development (R&D) contributed to the growth of the pharmaceutical sterility testing market.Sterility is an important step in the manufacture of drugs to avoid product contamination and make the drugs free from any viable microorganism.
According to a report published by Fierce Biotech shows that the top ten pharmaceutical companies invested over $82 billion in R&D in 2019. Additionally, according to Pharma and Annual Review 2019 report, 1,273 new drugs were launched in the global market in 2019, a 6.2% increase from the previous year. Increased emphasis on quality and sterility coupled with increasing R&D activities in the pharmaceutical sector and rising production and launch of drug and medical devices is driving the market.
The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
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