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

In light of the recently passed federal drug quality and security act (DQSA), sterility testing of compounded sterile preparations has come under scrutiny. L No. 113–54, which stresses the validation of the biological indicators for the completion of sterility testing. Biological indicators such as Geobacillus stearothermophilus endospores, which are used due to the advantages provided, such as the 6-log efficiency challenge, are used in the process testing controls of the sterile preparations to reduce the risks of false positives. Furthermore, technological advancements in sterility testing equipment, such as modular aseptic workstations and isolators with ergonomics, inbuilt hydrogen peroxide vapor technology, a 20-minute decontamination cycle, and providing 30 minutes between load decontamination, drive the sterility testing market.

For the purpose of this study, the various products studied include reagents and kits, instruments, and services. Tests are classified as membrane filtration, direct inoculation, and sterility testing. Market size estimates and forecasts for these segments are provided in US$ Mn, along with the respective CAGRs for the period 2017-2025, using 2016 as the base year.The global sterility testing market is segmented geographically into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa markets.

Market size estimates and forecasts for these segments are provided in US$ Mn, along with the respective CAGRs for the period 2017-2025, using 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 a profile of key market players currently enjoying prominent positions 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., and Wuxi Biologics.

Based on product, the global sterility testing market is categorized into:

  • Reagents and Kits
  • Instruments
  • Services

Sterility testing of the pharmaceutical and biological preparations is required during the sterilization validation process, as well as routine release testing. Sterility testing is an extremely difficult process that must be designed in order to eliminate false positive results, which are generally due to laboratory contamination from the testing environment or human error. In 2016, the kits and reagents segment held the largest market share, chiefly due to factors such as stringent regulation of cGMP and cGLP, making it mandatory to emphasize sterility testing protocols, and increasing reports of drug-related adverse events in relation to product contamination.

Instruments will be the fastest-growing market throughout the forecast period of 2017–2025, primarily due to the technological advancement in the membrane filtration device and design with inherent features such as high effectiveness at the low-pressure drop and low energy consumption. Additionally, improvements in the filter performance have been carried out, providing longer filter life, greater dust load capacity, and easier maintenance without compromising filter efficiency. The major players in the sterility testing market 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., and Wuxi Biologics.

Based on the test, the global sterility testing market is categorized into:

  • Membrane Filtration
  • Direct Inoculation
  • additional sterility testing

The sterility testing industry is expanding rapidly as the pharmaceutical and biotechnology industries conduct more sterility testing, and stringent regulatory guidelines have made it necessary to eliminate microbial contamination caused by the environment or human contact. Additionally, the rise in the launch of novel drugs and increasing research and development activities in the life science industries will enhance the market penetration of the healthcare industry. In 2016, the membrane filtration segment dominated the market, owing to factors such as technological advancements in membrane filtration design and operations, which increased filtration efficiency, and the fact that filtration processes can operate at low temperatures while consuming little energy.

The limitation of membrane filtration is that it is not effective in eliminating microbial contamination from medical devices, and the techniques are prone to membrane fouling effects, which result in a decrease in permeate flux and require expensive cleaning and regeneration schemes. The direct inoculation segment is anticipated to project faster growth throughout the forecast period of 2017–2025, chiefly due to factors such as its application in performing sterility testing of products that are not filterable or deformable and the possibility of applying smaller volumes of test articles.

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 the Middle East and Africa

In the base year 2016, North America was observed to be the largest market for sterility testing. The dominance of North America is mainly attributed to the presence of key pharmaceutical and biotechnology industries involved in active research and development activities, the existence of a proactive healthcare system emphasizing the quality of drug formulation, and stringent guidelines sanctioned by the USFDA regarding environmental monitoring and product qualities in the pharmaceutical and food industries. The market growth in Europe is mainly attributed to the increasing number of pharmaceutical and biotechnology industries and the stringent guidelines imposed by the ICH.

Asia Pacific was observed as the fastest-growing regional segment throughout the forecast period of 2017–2025. Factors that are anticipated to propel the market growth are the technological development of sterility testing devices and instruments, the competitive market due to the presence of existing major players and budding industries involved in the manufacturing and sale of sterility testing products in this region, and a 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 the sterility testing market in Latin America, the Middle East, and Africa in the near future.

Frequently Asked Questions:

The market for Sterility Testing Market is expected to reach US$ 1,176.9 Mn by 2025.

The Sterility Testing Market is expected to see significant CAGR growth over the coming years, at 8.38%.

The report is forecasted from 2017-2025.

The base year of this report is 2016.

Azbil Telstar S.L., Boston Analytical, Bioquell UK Ltd., BioMerieux SA, Charles River Laboratories, Merck KGaA, Sartorius AG, SGS SA, Thermo Fisher Scientific, Inc are some of the major players in the global market.

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Godaddy
Published Date:  Sep 2017
Category:  Biotechnology
Report ID:   58692
Report Format:   PDF
Pages:   120
Rating:    4.5 (80)
Delivery Time: 24 Hours to 48 Hours   
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