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Sterility Testing Market to Witness Many Strategic Alliances During 2019 to 2026: Industry Analysis by Size, Share, Growth, Trends, Demand, Business Opportunities and Challenges

Sterility testing is an important procedure in the sterilization and validation process across every manufacturing sector. This process helps eliminate contamination or technician error. Such testing should be carried out in a clean room, where there is no or minimum chances of error. This would also ensure compliance with U.S. Pharmacopeia (USP) requirements in terms of viable microbial air and surface counts. Regulation are supervised under various manufacturing practices guidelines.

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Sterility testing assures the validation process, designing is an important quality assurance issue, which provides appropriate and authentic sterility test data. Furthermore, sterility testing is a tedious and artful process, which has to be carried out by trained professionals. The growth for the demand for sterilized products and their exclusivity across industries is projected to fuel the growth of the sterility testing market in the near future. The growth media utilized during sterility testing must be properly prepared and tested to make the microbial growth adequately efficient. Growing advancements in terms of sterility testing technologies are projected to support the sterility testing market growth over the forecast period (2016-2024). For instance, Milliflex Rapid System, launched in 2010, for making the sterility testing procedure more time-efficient without hindering the test result quality. The market of sterility testing is expected to gain benefits in the near future.

Sterility Testing Market Taxonomy:

By Product Type

  • Kits and Reagents
  • Instruments
  • Service

By Test Type

  • Membrane Filtration
  • Direct Inoculation
  • Container closure integrity testing
  • Antimicrobial effectiveness testing
  • Rapid micro-test
    • ATP bioluminescence
    • Fluorescent labeling
    • Electrical resistance

By Application

  • Pharmaceutical and Biological Manufacturing
  • Medical devises Manufacturing
  • Bioburden Test
  • Others Applications

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The advent of novel technology across in terms of testing market is expected to favor the growth in sterility testing market:

Traditionally testing was done by using microbiological testing methods for detection, enumeration, sterilization, and identification. However, various latest and upcoming methods are available in the market such as the MF sterility test apparatus from Merk Millipore, which is aseptically filtered liquid samples for sterility testing apparatus used in sterility testing. Thus, this is expected to propel the market growth. Rapid testing methods such as ATP bioluminescence, fluorescent labeling, nucleic acid probes, and electrical resistance are commonly used in pharmaceutical testing. Obtaining perfect results by incorporating a single method for all requirements is challenging, as products vary in their specifications, which it needs to be adopted by the specific demands of the pharmaceutical and medical device situation. However, it is satisfactory to have the advancement in ATP bioluminescence that offers increased sensitivity under adenylate kinase amplification potential specificity, phage lysis and internal calibration against the effects of excipients, laser scanning cytometry which can be benefited through more specificity in proposed development by using fluorescently labeled antibodies.

Presence of major players in parenteral product manufacturing is projected to favor the growth of the sterility testing market

The global sterility testing market is highly competitive and fragmented. Major players in the market focusing on developing novel products through investment in research and development in order to expand their market presence. For instance, due to the strong product pipeline under the market segment, Merck Millipore and bioMérieux are considered to be the toughest competitor in the market. Key players operating in the sterility testing market include Merck Millipore, Thermo Fisher Scientific, Inc., bioMérieux SA, SGS S.A., Sartorius AG, WuXi AppTec, and Charles River Laboratories International, Inc.

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Key Developments

The growing focus of key players in launching novel products to expand their product portfolio is expected to support market growth. For instance, in February 2018, Merck launched Viresolve Barrier capsule filters to reduce the risk of bioreactor contamination.

Moreover, rising investment and funding related to sterility testing are also expected to propel the market growth. For instance, in May 2019, Thermo Fisher Scientific Inc. announced to invest over US$ 50 million in its global bioproduction capabilities to offer additional capacity for manufacturing single-use bioprocess container (BPC) systems that are used for critical, sterile liquid-handling applications in the biopharmaceutical industry.

Moreover, in March 2019, Thermo Fisher Scientific Inc. announced to invest US$ 150 million in its Pharma Services business to offer additional capacity for sterile liquid and lyophilized product development and commercial manufacturing.

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Last Updated: 01-Dec-2020