The global Sterility Testing market was valued at USD 594.9 Million in 2020 and is expected to reach USD 1,453.5 Million by the year 2028, at a CAGR of 12.4%. Sterility testing is an assessment of the product/surface to determine the presence of the microorganism in a given sample. This process plays a crucial role throughout the drug development and production process. Sterility testing studies help analyze the effectiveness of each step of the manufacturing process to remove or detect microbial contamination. Sterility testing is carried out at all manufacturing levels in the pharmaceutical and biopharmaceutical industries to minimize the risk of product contamination.
It is carried out in a wide range of fields, including pharmaceuticals and biologicals, medical devices, water purification, biopharmaceutical, and laboratory glass products. In this type of testing, the product or raw materials to be monitored are incubated in the medium (FTM/SCDM) and then examined. Assessment of large equipment/containers or hollow devices is carried out by using the product flush method, or the sample is extracted from the required surface and is then filtered through the membrane. Rapid sterility method is the new advanced methodology used, which provide a quick result (3-4 times faster than the traditional tests). A substantial increase in pharmaceutical outsourcing during previous years due to the high costs associated with the setup of the testing infrastructure. It is anticipated to be an excellent opportunity for the players in the market to procure the untapped market potentials.
Companies are highly focused on research and development to bring more reliable products with less turnaround time making the market highly competitive and posing a threat to the companies operating on the conventional approach. Moreover, Biotechnology is one of the most sophisticated industries in the healthcare sector. According to the International Trade Administration, U.S. Department of Commerce, the worldwide pharmaceutical market is expected to rise from USD 1 trillion in 2015 to USD 1.3 trillion by 2020. The sterility monitoring market will be strengthened by strong growth in the pharmaceutical and biopharmaceutical industries.
Top Companies Profiled in the Report Include:
Charles River, Merck KGaA, Biomérieux SA, SGS S.A., Danaher Corporation, Nelson Laboratories, Pacific Biolabs, Thermo Fisher Scientific Inc., Sartorius AG, Toxikon Corporation, Wuxi Apptec, Eurofins Scientific
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Market Overview:
The pharma and healthcare industry has undergone a revolutionary change owing to the COVID-19 pandemic with individuals increasing their focus on health and wellness. Companies operating in the industry have invested heavily in clinical trials and research studies to develop medications to cater to the growing unmet clinical demand on a global level. Implementation of cutting-edge technology in healthcare sector and increasing investment in research and development have contributed significantly to revenue growth of the market in the recent past. In addition, availability of favorable health insurance and reimbursement policies have also positively impacted the healthcare sector with more and more individuals opting to get treatment at hospital and clinical facilities. Rapid development of novel drugs and pharmaceuticals, increasing incidence of lifestyle and chronic diseases, establishment of state-of-the-art healthcare facilities, and rising availability of over-the-counter medications have significantly contributed to the revenue growth of the market.
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The report has gather vital information about recent mergers and acquisitions, joint ventures, collaborations, partnerships, brand promotions, R&D activities, and government and corporate deals, among others through extensive primary and secondary research. The report also offers detailed analysis of each competitor along with their financial standing, global market position, product portfolio, manufacturing and production capacity, and business expansion plans.
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Additionally, the report consists a detailed analysis of the segmentation of the Sterility Testing market based on product types and end-use/application offered in the Sterility Testing market.
Test Methods Outlook (Revenue, USD Million; 2018-2028)
· Membrane Filtration System Sterility Test
o Instrument
o Reagent/Kits
o Consumables
o Key Market Players
· Direct Transfer Sterility Testing
o Instrument
o Reagent/Kits
o Consumables
o Key Market Players
· Product Flush Sterility Testing
·
o Instrument
o Reagent/Kits
o Consumables
o Key Market Players
· Others
o Instrument
o Reagent/Kits
o Consumables
Applications Outlook (Revenue, USD Million; 2018-2028)
· Raw Materials
· Personnel
· Equipment
· Manufacturing Environment
· Pharmaceutical Preparations
o Injectable
o Biologics
o Medical Devices
o Transfusion Assembly
· Vectors
· Packaging/Bulk Finished Products
· Others
End Use Outlook (Revenue, USD Million; 2018-2028)
· Biopharmaceutical & Pharmaceutical Companies
· Contract Research Organization (CRO)
· Contract Manufacturing Organization (CMO)
· Cell Banks
· Academic Research Institutes
The report offers a comprehensive overview of the regional bifurcation of the market with respect to market share, market size, revenue growth, import/export, production and consumption patterns, macro and micro economic growth factors, regulatory framework, investment and funding opportunities, and presence of key players in each region including North America, Asia Pacific, Latin America, Europe, and Middle East & Africa. The report offers a country-wise analysis to further discuss the revenue growth and lucrative growth opportunities for the Sterility Testing market in these key regions.
Country-wise regional analysis covers:
· North America
o U.S.
o Canada
o Mexico
· Europe
o Germany
o France
o U.K.
o BENELUX
o Italy
o Spain
o Switzerland
o Russia
o Rest of Europe
· Asia Pacific
o China
o India
o Japan
o South Korea
o Rest of APAC
· Latin America
o Brazil
o Rest of LATAM
· Middle East & Africa
o Saudi Arabia
o U.A.E.
o South Africa
o Turkey
o Rest of MEA
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