Bioburden Testing Market Highlights
Bioburden testing, also known as microbial limits testing or microbial enumeration test is a procedure used for the determination of microbial content in raw materials, in-process samples, and finished product in the pharmaceutical, biological, cosmetics, nutritional products, and medical device industry. The global bioburden testing market is showing significant progress and is expected to reach a valuation of USD 455 Mn at a CAGR of 9.15% by the end of the forecast period of 2018-2023, predicts Market Research Future (MRFR) in a detailed study.
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Bioburden testing is carried out to limit the chances of any microbial contamination in a non-sterile product. Increasing food safety concerns is among a key factor supporting the growth of the market. Rise in a number of product recalls due to microbial contamination, food & beverage manufacturers are directing their focus towards prevention of contamination. The US FDA has mandated enactment of food safety measures for protecting consumer health which has further generated demand for bioburden testing.
Bioburden testing is standard in quality control of medical devices to ensure suitability of the devices which fosters the growth of the global bioburden testing market. Surging cases of sterility failures, raw material contamination, and requirement to ensure compliance with stringent FDA regulations pertaining to medical device testing has generated demand for bioburden testing.
Test methods and specifications outlined by federal agencies of numerous countries suggest performing bioburden testing to ensure the viability of the volume of microorganisms present in pharmaceutical products. This can positively affect market prospects.
However, bioburden testing procedures are time, labor and space intensive which might restrain the growth of the market. The high cost of microbial enumeration instruments is also a hindrance to the market. Lack of uniform international standards might also curb the growth of the market. However, the development of more efficient bioburden testing procedures has contributed to the growth of the market.
Bioburden Testing Market Segmentation
The global bioburden testing market has been segmented based on test type, product type, application, and end-user.
By type, the global bioburden testing market has been segmented into aerobic count, anaerobic count, fungi count, and spore count.
By product type, the global bioburden testing market has been segmented into consumables and instruments.
By consumables, the global bioburden testing market has been sub-segmented into reagents and kits, and others.
By instruments, the global bioburden testing market has been further segmented into polymerase chain reaction machine (PCR), microscopes, and others.
By application, the global bioburden testing market has been segmented into raw materials testing, in-process material testing, sterilization validation testing,medical devices testing, and equipment cleaning validation.
By end-user, the global bioburden testing market has been segmented into pharmaceutical and biotechnology companies, microbial testing laboratories, and others.
Bioburden Testing Market Regional Analysis
The Americas, Asia Pacific (APAC), Europe, and the Middle East & Africa (MEA) are the key markets for bioburden testing.
The Americas is the largest market for bioburden testing. In the US, the FDA closely monitors the activities of industries such as food & beverage, pharmaceutical, and medical device which propels the growth of the market.
In Europe, quality requirements set by pharmacopeia commission for the safe production of processed foods, beverages, and medicines is driving the market for bioburden testing.
APAC is poised to showcase a relatively faster growth rate as compared to other markets. The growth of the pharmaceutical industry which is a major key end user of bioburden testing, a growing number of medical device manufacturers in Australia and amendment of food and drug safety regulations provide an impetus to the growth of the APAC bioburden testing market.
The MEA market is spurred by the growing use of bioburden testing for food and water contamination.
Bioburden Testing Market Competitive Landscape
The key players in the global bioburden testing market include SGS SA, ATS Laboratories, Inc.,
Dynatec Labs, Becton, Dickinson, and Company, WuXi AppTec, NORTH AMERICAN SCIENCE ASSOCIATES INC., Charles River, Pacific Biolabs, Nelson Laboratories, LLC, Merck KGaA.
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