Pharmaceutical Sterility Testing Market Size Worth US$ 3.68 Bn by 2030, With Growing CAGR of 12.1% | SNS Insider

"As per the SNS Insider Research, The pharmaceutical sterility testing market is primarily driven by the increasing demand for sterile pharmaceutical products, coupled with the rising incidence of hospital-acquired infections."

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Pune, Feb. 20, 2023 (GLOBE NEWSWIRE) -- The Pharmaceutical Sterility Testing Market Size was estimated to be worth USD 1.45 billion in 2022 and is projected to increase to USD 3.68 billion by 2030, growing at a CAGR of 12.1% from 2022 to 2030.

Sales made to ensure that medicinal items are devoid of living germs make up the pharmaceutical sterility testing business. Pharmaceutical sterility tests look for microorganisms in biological parenteral intended for human use. A crucial phase in the manufacturing of drugs, medical devices, and therapies is pharmaceutical sterility testing. At every stage of production, the effectiveness of a sterilising procedure is assessed in order to reduce the likelihood of product contamination. Sterility assurance is an essential stage in the process that manufacturers of medical equipment go through in order to produce goods that are both safe and effective. The sterility of medical equipment is assessed using soybean-casein digest medium.

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Market Report Scope:

Report AttributesDetails
Market Size in 2022US$ 1.45 Bn
Market Size by 2030US$ 3.60 Bn
CAGRCAGR of 12.1% From 2023 to 2030
Base Year2022
Forecast Period2023-2030
Historical Data2020-2021
Key Market Segmentation• By Sample (Sterile Drugs, Medical Devices, Biologics)
• By Product Type (Instruments, Kits & Reagents, Services, Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing)
• By Type (In-house, Outsourcing)
• By End User (Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies)


In 2021, Pharmaceuticals held the largest market share of 37.7%. The market is divided into three categories based on the sample: medicines, medical devices, and biopharmaceuticals. Products like parenteral, aerosols, ointments, eye drops, and others are included in the pharmaceutical category. These dose types are the most popular ones. One of the key factors fostering the market's expansion is an increase in demand for the aforementioned dosage forms on a global scale. The necessity for sterility testing of pharmaceuticals is further supported by the growing frequency of recalls of these dosage forms due to a lack of sterility. Sterility testing was utilised by pharmaceutical companies to assess the quality of raw materials, process control, and final product validation. Good manufacturing practises (GMP) regulations and "pharmacopoeia" methodologies are frequently used by pharmaceutical companies when testing drugs. The market is expanding as a result of an increase in pharmaceutical companies and the introduction of new drugs on a global scale.

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KEY PLAYERS:
SGS SA, Pace Analytical Services, LLC, Sotera Health, Merck KGaA, Solvias AG, Thermo Fisher Scientific, Inc., Sartorius AG, Toxikon, Inc., BioMérieux, Inc., Charles River Laboratories International, Inc., Boston Analytical, Rapid Micro Biosystems, Pace Analytical Services, LLC, and Toxikon, Inc.

Asia Pacific is anticipated to increase at the fastest rate throughout the projection period. This is a result of emerging countries increasingly harmonising their regulatory norms with ICH standards. Additionally, several of the region's growing economies are adopting a variety of steps to expand their domestic pharmaceutical industry and are enticing global corporations to establish facilities there (collaborations that support outsourcing activities). Such efforts are probably going to help with regional development.

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