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  • To Be Published : Apr 2024
  • Code : CMI174
  • Formats :
      Excel and PDF
  • Industry : Biotechnology

Sterility testing in pharmaceutical manufacturing is a vital process during the sterilization and validation process along with release testing. It is an essential part of every sterilization validation process in several industries that makes it a vital procedure in manufacturing industry. It is an extremely difficult process that should be planned and executed with precision, which can be helpful in eliminating false positive results. Laboratory contamination or technician errors are the main causes of false positive results. Planned testing should be carried out in a clean room, where there is no or minimum chances of error are seen. This would also ensure compliance with U.S. Pharmacopeia (USP) requirements in terms of viable microbial air and surface counts. The unique requirements to employ sterility testing procedures as an official test and to determine the suitability are regulated under the good manufacturing practices guidelines.

An understanding of sterility testing benefits in validation process, designing is an important quality assurance issue is the need of providing an appropriate and authentic sterility test data. Furthermore, sterility testing is a tedious and artful process, which requires to be carried out by trained professionals. Also, investigation during the failure of sterility test, is a process that needs close look in environmental data along with other factors such as sample collection and sample procurement procedures. The rise in demand for sterilized products and their exclusivity in various industries is expected to fuel growth of the sterility testing market in the near future. The growth media utilized during the sterility testing must be properly prepared and tested to make the microbial growth adequately efficient. Increasing advancements in terms of sterility testing technologies is expected to support the sterility testing market growth over the forecast period (2016-2024). Various organizations are laying efforts in making the testing process more time efficient. For instance, Milliflex Rapid System, launched in 2010, for making the sterility testing procedure more time efficient without hindering the test result quality. The following decade is expected to provide major growth traction to players involved in the sterility testing market.

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 Devices Manufacturing
  • Bioburden Test
  • Others Applications

 Novel Technology in the pharmaceutical testing market is expected to favor the growth in sterility testing market:

Conventionally used microbiological testing methods for detection, enumeration, sterilization and identification tend to use culture methods majorly and were so often time consuming and labor-intensive. The drawback of such procedures in practical considerations often limits the extent to which microbiological tests applied regularly in both formulation development stage and for microbiological quality assurance. Furthermore, there are various well latest and upcoming methods such as MF sterility test apparatus from Merk Millipore, which is aseptically filter liquid samples for sterility testing apparatus used in sterility testing and may find wide application in the pharmaceutical sector. This is expected to be one of the important factors supporting growth of the sterility testing market. 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 single method for all requirements is challenging, as products vary in their specifications, which is need to be adapted by the specific demands of the pharmaceutical and medical device situation. However, it is satisfactory to have the developments in ATP bioluminescence offering with increased sensitivity under adenylate kinase amplification potential specificity, phage lysis and internal calibration against the effects of excipients, laser scanning cytometry can be benefited through more specificity in proposed development using fluorescently labeled antibodies.

Major players in the sterility testing market are engaged in research and development process. For instance, bioMérieux SA – a biopharmaceutical company engaged in world class products for in-vitro testing – launched The BacT/ALERT 3D Dual-T apparatus for rapid and easy product control with non-destructive, dual-temperature microbial detection system.

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

The global sterility testing market is highly competitive and fragmented. Major players in the market are developing novel products through major spending on research and development to get a competitive edge over their counterparts. For instance, due to the strong product pipeline under 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.

Key Developments

Key players in the market are focused on launching novel products to expand their product portfolio. For instance, in February 2018, Merck launched Viresolve Barrier capsule filters to reduce the risk of bioreactor contamination.

Increasing investment and funding related to sterility testing is 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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