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.

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.

The sterility testing of the pharmaceutical and biological preparation 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 the false positive results which are generally due to laboratory contamination from the testing environment or human error. In 2016, 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 on 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 2017-2025 majorly due to the technological advancement in the membrane filtration device and design with inherent features such as highly effective at low pressure drop and energy consumption. Additionally the improvements in the filter performance has been carried out providing longer filter life, greater dust load capacity and easier maintenance without compromising filter efficiency. The major players in 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., Wuxi Biologics.

The sterility testing is witnessing tremendous growth significantly due to increasing sterility testing conducted by the pharmaceutical and biotechnology industries, and stringent regulatory guidelines has made it necessary to eliminate microbial contamination related to 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 healthcare industry. In 2016, membrane filtration segment dominated the market mainly due to factors such as technological advancement in the membrane filtration design and operations increasing filtration efficiency, the filtration processes can function at low temperatures and low energy consumption. The limitation of membrane filtration is that it is not effective in eliminating the microbial contamination from medical devices and the techniques are prone to membrane fouling effects which results into decrease in permeate flux requiring expensive cleaning and regeneration schemes. Direct inoculation segment is anticipated to project faster growth throughout the forecast period 2017-2025, chiefly due to factors such as its application in performing sterility testing of products that are not filterable or deformable and application of smaller volumes of test articles is possible.

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.

Historical & Forecast Period

This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Sterility Testing market are as follows:

• Research and development budgets of manufacturers and government spending
• Revenues of key companies in the market segment
• Number of end users and consumption volume, price and value.
• Geographical revenues generate by countries considered in the report
• Micro and macro environment factors that are currently influencing the Sterility Testing market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Key questions answered in this report

• What are the key micro and macro environmental factors that are impacting the growth of Sterility Testing market?
• What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
• Estimated forecast and market projections up to 2032.
• Which segment accounts for the fastest CAGR during the forecast period?
• Which market segment holds a larger market share and why?
• Are low and middle-income economies investing in the Sterility Testing market?
• Which is the largest regional market for Sterility Testing market?
• What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
• Which are the key trends driving Sterility Testing market growth?
• Who are the key competitors and what are their key strategies to enhance their market presence in the Sterility Testing market worldwide?