Sterility Testing Market By Product & Services (Reagents And Kits, Instruments), By Test (Membrane Filtration, Direct Inoculation) - Growth, Future Prospects And Competitive Analysis, 2017 - 2025

The sterility testing of compounded sterile preparations have come under scrutiny in the light of the newly passed federal drug quality and security act (DQSA), pub. L No. 113-54 which stresses on the validation of the biological indicators for the completion of sterility testing. Biological indicators such as Geobacillus stearothermophilus endospores which is used due to the advantages provided such as 6 log efficiency challenge, in process testing controls of the sterile preparations to reduce the risks of false positives. Additionally technological advancement in the sterility testing equipment’s such as modular aseptic workstation/ isolators with added features such as ergonomics, inbuilt hydrogen peroxide vapor technology, 20 minutes decontamination cycle and provides 30 minutes between load decontamination drives the sterility testing market.

For the purpose of this study, the various products studied includes reagents and kits, instruments and services. Tests are classified as membrane filtration, direct inoculation and other sterility testing. Market size estimates and forecast of these segments for the period 2015 to 2025 are provided in terms of US$ Mn along with the respective CAGRs for the period 2017 to 2025, considering 2016 as the base year.

The geographic segmentation of the global sterility testing market is performed for the regions North America, Europe, Asia Pacific, Latin America and Middle East and Africa markets. The regions are also further sub-segmented on the basis of major countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Rest of Asia Pacific
  • Latin America
    • Mexico
    • Brazil
    • Rest of LATAM
  • Middle East and Africa
    • GCC
    • Rest of Middle East and Africa

Market size estimates and forecast for these segments for the period 2015 to 2025 are provided in terms of US$ Mn along with the respective CAGRs for the period 2017 to 2025, considering 2016 as the base year.

This report also includes qualitative assessment factors such as market dynamics (drivers, restraints and opportunities) to have a good understanding of the current and anticipated trends in the global sterility testing market. Competition assessment tools such as Porter’s five forces analysis, market attractiveness assessment and competitive landscape analysis by key players are also presented in the study. Furthermore, this report concludes with profiling of key market players currently enjoying prominent position in the global sterility testing market. The key players profiled in this report are Azbil Telstar S.L., Boston Analytical, Bioquell UK Ltd., BioMerieux SA, Charles River Laboratories, Merck KGaA, Sartorius AG, SGS SA., Thermo Fisher Scientific, Inc., Wuxi Biologics.

Sterility Testing Market

For the purpose of this study, the global sterility testing market is categorized into the following regional and country specific markets:

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East and Africa
    • GCC
    • Rest of Middle East and Africa

Sterility Testing Market

North America was observed to be the largest market for sterility testing in the base year 2016. The dominance of North America is mainly attributed to the presence of key pharmaceutical and biotechnology industries involved in active research and development activities, existence of a proactive healthcare system emphasizing on quality of drug formulation and stringent guidelines sanctioned by the USFDA regarding environmental monitoring and product qualities in pharmaceutical and food industries. The market growth in Europe is mainly attributed to the increasing number of pharmaceutical and biotechnology industries and stringent guidelines imposed by ICH. Asia Pacific was observed as the fastest growing regional segment throughout the forecast period 2017-2025. Factors that are anticipated to propel the market growth are the technological development in the sterility testing devices and instruments, competitive market due to presence of existing major players and budding industries involved in the manufacturing and sale of sterility testing products in this region and supportive regulatory environment for sterility testing products. Moreover, factors such as developing health infrastructure and rising demand for high quality food and drugs are going to fuel the rapid growth of sterility testing market in Latin America, and Middle East and Africa region in the near future.

Choose License Type
Published Date:  Sep 2017
Category:  Biotechnology
Report ID:   58692
Report Format:   PDF
Pages:   120
Rating:    4.5 (60)
Connect With Us
+1-408-641-3282
24/7 Research Support