Sterility Testing Market - Synopsis

The Global Sterility Testing Market is predicted to touch USD 1,245.2 million by 2023 from USD 575 million in 2016, expanding at an astounding CAGR of 11.7% during the assessment period (2017-2023).

The rise in demands for sterile drugs can open up avenues for suppliers and manufacturers of sterility testing market. Developing countries, such as China and India, owing to advancements in biotechnology and pharmaceuticals, are emerging as prospective markets and have turned out to be the favorite destination of investment of various market players who are now expanding their operations in these regions.

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The sterility testing market is segmented on the basis of product type, test type, and end-user. By product type, the global market for sterility testing is segmented into instruments, consumables, and services.

The service segment is sub-segmented into sterility assurance tests, sterilization validations, cleaning and disinfection, stability testing, and others. Mostly, sterility assurance tests are performed to determine the sterility-assurance level (SAL) of perishable pharmaceutical products, such as injectable to ensure the sterility of the drugs. Owing to these features, the sterility assurance tests segment held the largest market in 2016 with a market valuation of USD 67.1 million. Current predictions estimate its valuation at USD 151.6 million by the end of the forecast period.

Global Market for Sterility Testing – Segmental Analysis

Segmentation based on test type includes membrane filtration sterility testing, direct transfer sterility testing, product flush sterility testing, and others. The membrane filtration sterility test is a regulatory method for filterable pharmaceutical samples containing preservatives, bacteriostatic compounds, inhibiting the microbial growth of potential contaminants.

This method helps in retaining microorganisms via 0.45-micron pore size filter, and suitable solutions are used to rinse all the inhibiting compounds. The technique is followed by the selection of an appropriate media to support the growth of anaerobic and aerobic microorganisms on the membrane filters.

The final results come after an incubation period of 14 days. Furthermore, its advantages, such as applicability to large volume samples and ability to remove inhibitory substances from the sample, boost the growth of this segment. Currently, the membrane filtration sterility testing segment generates the largest market share and is expected to reach USD 348.6 million by 2023 with a stellar CAGR of 12.1% during the forecast period.

End-users comprise pharmaceutical companies, hospital & clinics, academic & research laboratories, and others. Treatment of chronic diseases, such as cancer, cardiovascular diseases, and others have spurred the demands for sterile injectables, which in turn ensured pharmaceutical companies’ domination of the global market.  A staggering growth has been predicted for this segment where it can reach USD 428.0 million, at a CAGR of 12.1% by the end of the foreccast period.

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Top Industry Players:

Bioquell

Belimed Deutschland

Baxter BioPharma Solutions

Charles River Laboratories

Boston Scientific Corporation

BioMérieux

SGS SA

And others.

Regional Market Summary:

The global sterility testing market, by regions, is segmented into the Americas, Europe, Asia Pacific (APAC) and the Middle East and Africa (MEA).

The Americas accounted for the most significant market share of about 42.1% in the global sterility testing market due to the presence of top-tier manufacturers, surging technological advancement in the pharmaceutical and biotechnology industries, and others.

Europe accounted for the second largest market share. The market in the region is experiencing a rapid increase in healthcare expenditures, and this can act as a market booster for sterility testing market.

The APAC market is expected to register the fastest CAGR of 12.4% during the forecast period. The region has a lot of developing economies with markets offering various opportunities making it a potential global influencer.

The MEA has a few deterrents, such as the presence of low-income countries and stringent government regulations, which impeded the growth in the past. The MEA market accounted for the least market share in 2016.

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