Sterility Testing Market is Expected To Reach USD 1,453.5 Million By 2028 - Reports and Data

According to the current analysis of Reports and Data, 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.

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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.

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 sterility testing device, launched its new 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 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 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, 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 sterility testing are key factors driving the market demand
  • The membrane filtration system test method of 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 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 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 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 sterility testing market

The ongoing pandemic is significantly changing the dynamics of the pharma and healthcare sector. Various countries are facing challenges such as shortage of medicines, vaccines, healthcare devices in hospitals. This is expected to open lucrative growth opportunities for market players in the coming years.

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Competitive Landscape:

The global market comprises various market players operating at regional and global levels. These key players are adopting various strategies such as R&D investments, license agreements, partnerships, merger and acquisitions, collaborations, and joint ventures to gain robust footing in the market.

Top Companies Profiled in the Report:

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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Sterility Testing Market Segmentation:

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

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

Regional Outlook:

  • North America (U.S., Canada, Mexico)
  • Europe (Germany, U.K., Italy, France, BENELUX, Rest of Europe)
  • Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific)
  • Latin America (Brazil, Rest of LATAM)
  • Middle East & Africa (Saudi Arabia, U.A.E., South Africa, 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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