Bioburden Testing Market Clinical Review, Drug Descriptions, Analysis and Synthesis 2027

Global bioburden testing market is witnessing a rapid increase in revenues. The market growth attributes to the rising awareness of the importance of microbial limit testing of pharmaceutical and medical products. Besides, increasing food safety concerns and growing product recalls due to microbial contamination increase the demand for quality control of pharmaceutical products and medical devices.

All medical instruments, raw material, and packaged goods are subject to the microbial contamination risks. Hence, governments actively participate in promoting the use of microbial limits test (MLT) to determine the presence of aerobic bacteria, molds, yeast, and other specific bacteria, such as E. coli, salmonella, and several other harmful microbes.

Bioburden testing or MLT is based on the pharmacopeia regulatory, which sets standards for medicines and food ingredients. For instance, the United States Pharmacopeia (USP) is an official global standard-setting authority. USP provides strict measures to ascertain that the materials are subjected to optimum pharmaceutical quality assurance to prevent bacterial and fungal contamination.

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According to Market Research Future (MRFR), the global bioburden testing market is poised to create a valuation of USD 455 MN, registering over 9.15% CAGR throughout the forecast period (2018–2023). Growing awareness for bioburden testing and developments of a large number of testing kits, act as key tailwinds pushing the market growth. However, there is a vast scope for the development of more MLT tests.

Competitive Analysis

The prominent players operating in the bioburden testing market comprises Nelson Laboratories LLC, ATS Laboratories Inc., SGS SA, NORTH AMERICAN SCIENCE ASSOCIATES INC., WuXi AppTec, Merck KGaA, Dynatec Labs, Becton, Dickinson and Company, Pacific Biolabs, and Charles River.

Segmentation Analysis

The global bioburden testing market has been segmented based on product type, test type, end-user, and application.

  • By mode of Type, the global bioburden testing market has been segmented into anaerobic count, aerobic count, spore count, and fungi count. Among these, the aerobic count segment is estimated to witness a significant growth owing to the requirement of performing aerobic count test to ensure the safety of biotechnology and pharmaceutical products.
  • By mode of Product Type, the global bioburden testing market has been segmented into instruments and consumables. Among these, the consumables segment is likely to gain prominence in the coming years owing to the requirement of repeat purchase of reagents and kits, unlike instruments which are regarded as a one-time investment.
  • By mode of Application, the global bioburden testing market has been segmented into medical devices testing, raw materials testing, sterilization validation testing, in-process material testing, and equipment cleaning validation. Among these, the raw materials testing segment is likely to gain prominence in the coming years owing to the increased quality standards in order to ensure the safety of finished goods.
  • By mode of End-user, the global bioburden testing market has been segmented into microbial testing laboratories, pharmaceutical and biotechnology companies, and others.

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.

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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.

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