According to the latest report published by Credence Research, Inc. “Pharmaceutical Rapid Microbiology Testing Market – (Technology Type – Immunology based Methods, Nucleic acid based amplification tests, Mass Spectrometry based Methods, Flow Cytometry based Methods, Growth-based detection technologies, and Biochemical Tests; Application – Raw Material testing, In-Process testing, Microbial limit testing, Bioburden assessment, Process water testing, environment monitoring and sterility testing): Market Growth, Future Prospects and Competitive Analysis, 2016-2022,” the market was valued at USD 3.4 Bn in 2015, and is expected to reach USD 6.2 Bn by 2022, expanding at a CAGR of 7.3% from 2016 to 2022.
Browse the full report Pharmaceutical Rapid Microbiology Testing Market: Growth, Future Prospects and Competitive Analysis, 2016-2022 at http://www.credenceresearch.com/report/pharmaceutical-rapid-microbiology-testing-market
Antimicrobial activity and disinfection
Another major focus of pharmaceutical microbiology is to determine how a product will react in cases of contamination. For example, You have a bottle of cough medicine. Imagine you take the lid off, pour yourself a dose and forget to replace the lid. You come back to take your next dose and discover that you will indeed leave the lid off for a few hours. What happens if a microorganism “fell in” whilst the lid was off? There are tests that look at that. The product is “challenged” with a known amount of specific microorganisms, such as E. coli and C. albicans and the anti-microbial activity monitored
Pharmaceutical microbiology is additionally involved with the validation of disinfectants, either according to U.S. AOAC or European CEN standards, to evaluate the efficacy of disinfectants in suspension, on surfaces, and through field trials. Field trials help to establish the frequency of the application of detergents and disinfectants.
Methods and specifications
Testing of pharmaceutical products is carried out according to a Pharmacopeia of which there are a few types. For example: In America, the United States Pharmacopeia is used; in Japan, there is the Japanese Pharmacopeia; in the United Kingdom there is the British Pharmacopoeia and in Europe the European Pharmacopeia. These contain a test method which is to be followed when testing, along with defined specifications for the number of microorganisms allowed in a given amount of product.
The specifications change depending on the product type and method in which it is introduced into the body. The pharmacopeia also covers areas like sterility testing, endotoxin testing, the use of biological indicators, microbial limits testing and enumeration, and the testing of pharmaceutical grade water(Wiki)
Rapid microbiological tests are gaining momentum in the global market as a reliable and cost-effective method to track and monitor all types of microorganisms in the pharmaceutical application as well as in other industrial settings. In addition, rapid microbiology tests offer faster and more accurate methods to assist in the rapid detection of microbes and early diagnosis, thus saving cost and inventory. North America held the largest regional market, accounting for the market share of over 36% in 2015, and is anticipated to dominate the global rapid microbiology tests market during the forecast period 2016 to 2022. Large numbers of market-focused players providing a wider range of product portfolio are the key to the growth of the North America region. The Asia Pacific is expected to grow at the highest growth rate during the focus period, due to increase in the number of laboratories in these regions and up gradation of existing ones for automation of various instrumentation systems. Moreover, the market is wide open for advancing rapid diagnostic technologies to improve the turnaround time of the tests as compared to the conventional microbiology testing methods.
Among the technology types, nucleic acid amplification technique held the largest share in the rapid microbiology tests in the pharmaceutical industry market due to its low cost and high efficacy. Moreover, the wide applications of nucleic acid amplification testing would further fuel the market growth in the coming years. Growth based detection technologies are anticipated to grow at the highest growth rate during the forecast period due to its faster turnaround time and accuracy in the detection of the microbes.
The sterility testing application held the largest share in the global rapid microbiology tests in the pharmaceutical market due to its wide application in the final drug product and other applications. Process water testing is anticipated to witness the highest growth in the global rapid microbiology tests in the pharmaceutical industry market during the forecast period of 2016 to 2022.
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