New York, US, May 09, 2022 (GLOBE NEWSWIRE) -- Pharmaceutical Sterility Testing Market Overview
According to a Comprehensive Research Report by Market Research Future (MRFR),"Pharmaceutical Sterility Testing Market Information by Sample, Product Type, Type, Test Type, End User and Region - Forecast till 2027”, the market is estimated to exceed USD 1,285.8 Million by 2027, growing at a CAGR of 6.6%.
Market Scope:
The invention or verification of product-specific procedures and reliable sterility testing are key phases in drug discovery and development. Sterility testing is essential to confirm no viable contaminating microorganisms in a product. Pharmaceutical sterility testing is a critical component of good manufacturing practice microbiology and is required for tissue samples, pharmaceutical preparations, and medical equipment, all of which must be sterile owing to their intended use. Furthermore, it is used in cell banks, raw materials, and pharmaceutical finished items. This testing is done in an isolator or cleanroom setting using direct inoculation or membrane filtration methods.
Market Competitive Landscape:
The distinguished contenders in the pharmaceutical sterility testing market are
- BioMérieux, Inc. (France)
- Charles River Laboratories International, Inc. (US)
- Pacific Biolabs Inc. (US)
- STRERIS Corporation (US)
- WuXi AppTec (China)
- Thermo Fisher Scientific, Inc. (US)
- Merck KGaA (Germany)
- Rapid Micro Biosystems (US)
- Sartorius AG (Germany)
- Solvias AG (Switzerland)
- SGS SA (Switzerland)
- Boston Analytical (US)
- Pace Analytical Services, LLC (US)
- Toxikon, Inc. (US)
- Sotera Health (US)
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Market USP Covered:
Market Drivers:
Over the years, new approved drugs and drug introductions have increased. These new product introductions are increasing acceptance of pharmaceutical sterility testing, and the worldwide market is predicted to increase throughout the forecast period. Furthermore, pharmaceutical sterility testing is carried out at all production levels in the pharmaceutical and biopharmaceutical industries to decrease the chance of product contamination. Technological developments in pharmaceutical sterility testing procedures reduced procedural time and human contact, enhancing test efficiency and accuracy and propelling the market.
Market Restraints:
Sterility testing is the first step in determining the quality of pharmaceutical medications. Nevertheless, in many countries, tight regulatory laws, regulations, and time-consuming processes may hinder the growth of the pharmaceutical sterility testing market.
COVID 19 Analysis
The global pharmaceutical sterility testing industry emerged from the COVID-19 shutdown due to pharmaceutical and biotech businesses racing to develop a COVID-19 vaccine. Rapid testing is required to ensure that vaccination is acceptable, effective, and approved by regulatory organizations. Every vaccine and injection provided to patients must undergo final product sterility testing to be deemed safe. This will propel the pharmaceutical sterility testing industry, which is predicted to expand rapidly during the pandemic period. Concerns about sterility and out-of-spec test reports are two prominent causes of drug recalls. The troubles have now struck two pharmaceutical companies at the same time. It's not the first time the FDA has expressed worry about one of the companies' production practices. Teligent Pharma, an injectable and topical specialist, and Edge Pharma, an outsourcing facility, issued separate recalls in December 2021 for superpotent test results and sterility issues, respectively. Using medicine that is supposed to be sterile but isn't can result in site-specific infections and major systemic infections that can be fatal.
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Market Segmentation
By Sample
The sterile drugs segment is estimated to capture a majority stake in the forecast period.
By Product Type
Pharmaceutical sterility testing companies are introducing novel sterility testing services to supplement their product line and enhance their market position. Corporates have created well-equipped services to capitalize on the pharmaceutical sterility testing market. Medical device firms, by kind, lack the requisite infrastructure to conduct high-quality sterility testing. They would rather outsource these services. Furthermore, to save money, many firms outsource sterility testing, leading to the segment's growth.
By Test Type
Bioburden testing will achieve a maximum stake in the forecast period.
By End User
Pharmaceutical businesses launched an increasing number of drugs globally, and the growing number of pharmaceutical businesses drives the market's growth.
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Regional Insights
Due to the presence of a large number of foreign and domestic competitors in the region and innovative technologies, the North American market represented the biggest market share. Furthermore, increased R&D expenditure and upgraded healthcare infrastructure are projected to influence the expansion of the pharmaceutical sterility testing market throughout the forecast period. The European pharmaceutical sterility testing market is being propelled by increased government initiatives and abundant research funds. Because of the region's expanding biopharmaceutical product design and technological improvements, the European market is brimming with sophisticated, well-equipped outsourced organizations for pharmaceutical sterility testing. Because of the rising harmonization of regulatory standards, the pharmaceutical sterility testing industry is estimated to be the key regional market. Furthermore, numerous developing economies in the region are taking initiatives to strengthen the pharma market and encourage global firms to establish operations in the region, fueling the expansion of the Asia-Pacific pharmaceutical sterility testing market.
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Recently, Piramal Pharma Solutions, a CDMO, plans to increase the operations of its Antibody-Drug Conjugate facility in Grangemouth, Scotland, and invest in new Active Pharmaceutical Ingredient facilities at its England plant. The additions and enhancements represent a total investment of £55 million in medication research and manufacturing abilities in the UK and new job opportunities for operational and technical workers. The new structure was built to support future development, with future stages including a new sterile fill/finish suite devoted to ADCs and two extra large-scale manufacturing facilities capable of handling larger batch sizes. A new client experience facility will also assist clients who visit the property while it is under development or manufacture.
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