According to the current analysis of Reports and Data, the global Pharmaceutical 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%. Pharmaceutical 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. Pharmaceutical Sterility Testing studies help analyze the effectiveness of each step of the manufacturing process to remove or detect microbial contamination. Pharmaceutical 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.

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Further key findings from the report suggest

  • Several industry players are focusing on expanding the product portfolio in the field. For instance, Merck one of the leading provider of Pharmaceutical Sterility Testing device, launched its new Pharmaceutical Sterility Testing device- Steritest NEO. Charles River Laboratories International, Inc. in 2019 announced the launch of two new products in its microbial solutions portfolio. Thus helping the Pharmaceutical Sterility Testing of the products with its new technology. WuXi AppTec in November 2020, announced its new medical device laboratory testing center opened in Suzhou, China to form a globally integrated medical device testing platform to serve medical device customers and offer Pharmaceutical Sterility Testing services
  • Various key players are focused in developing the advanced technologies in testing sterility for wide application area. For instance, recently Alcami Corp. has launched its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver faster testing results
  • During 2019-2028, Pharmaceutical Sterility Testing market is expected to register a CAGR of 13.3% in Asia Pacific; followed by North America and Europe, with 12.4% and 12.1% CAGR, respectively. Increasing drug release in developed as well as developing nation and favorable government policies for Pharmaceutical Sterility Testing are key factors driving the market demand
  • The membrane filtration system test method of Pharmaceutical Sterility Testing segment dominates the field with highest market share in the year 2020. It is estimated to grow at a CAGR of 12.4% during the forecast period to reach USD 616.7 million by 2028
  • Based on application segment, raw materials Pharmaceutical Sterility Testing is expected to account for the CAGR 12.8% of the global market, as drastically growing incidences of raw material contamination across the world
  • Asia Pacific is expected to account for the CAGR 13.3% of the global Pharmaceutical Sterility Testing market. Developing nations such China, and India are likely to witness high growth due to presence of target population, rising industrial globalization and increased healthcare expenditure and growing R&D investment
  • Based on end use biopharmaceutical & pharmaceutical companies dominate the total market share of Pharmaceutical Sterility Testing. Due to the growth registered in pharmaceutical & biotechnology companies
  • Time-consuming and stringent regulatory standards are the key factors likely to hamper growth of the Pharmaceutical Sterility Testing market

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Key Players covered in this report are

  • 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 

Test Methods Outlook (Revenue, USD Million; 2018-2028)

  • Membrane Filtration System Sterility Test
    • Instrument
    • Reagent/Kits
    • Consumables
    • Key Market Players
  • Direct Transfer Pharmaceutical Sterility Testing
    • Instrument
    • Reagent/Kits
    • Consumables
    • Key Market Players
  • Product Flush Pharmaceutical Sterility Testing
    • Instrument
    • Reagent/Kits
    • Consumables
    • Key Market Players
  • Others
    • Instrument
    • Reagent/Kits
    • Consumables

Applications Outlook (Revenue, USD Million; 2018-2028)

  • Raw Materials
  • Personnel
  • Equipment
  • Manufacturing Environment
  • Pharmaceutical Preparations
    • Injectable
    • Biologics
    • Medical Devices
    • 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

Based on Region market is segmented into:

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East & Africa

Major Points covered in this report are as below:

  • An analysis of Pharmaceutical Sterility Testing industry development trends and marketing channels, as well as an assessment of the feasibility of new investment projects, is presented in the study.
  • In addition to providing key statistics on the industry, the report provides valuable guidance and direction for companies and individuals interested in this market through tables and figures.
  • In addition to developing policies and plans, this report analyzes manufacturing processes and cost structures. It also provides information about import/export demand, costs, prices, revenues, and gross margins.
  • This report provides information on the market status of Pharmaceutical Sterility Testing manufacturers and provides valuable insight into the market for companies and individuals.

We can also provide the customized data for separate regions like North America, United States, Canada, Mexico, Asia-Pacific, China, India, Japan, South Korea, Australia, Indonesia, Singapore, Rest of Asia-Pacific, Europe, Germany, France, UK, Italy, Spain, Russia, Rest of Europe, Central & South America, Brazil, Argentina, Rest of South America, Middle East & Africa, Saudi Arabia, Turkey, Rest of Middle East & Africa

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This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the market’s future growth.

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