Bioburden testing is a process of measuring viable microorganisms on medical devices, raw material, or package. The process helps in determining parameters for its sterilization process to ensure safety and effectiveness of medical devices. It further aids in routine monitoring of raw material, components, and assembly processes in manufacturing process. The bioburden testing is used for assessment of cleaning processes and packaging of products is conducted to ensure safety.
Growth in the medical devices, pharmaceutical and rising product recalls due to microbial contamination are factors that drive the growth of the world bioburden testing market. In addition, biotechnology industries and increasing food & beverage safety concerns supplements growth. However, high cost of microbial enumeration instruments obstructs the growth of the market. Increasing preference for contract manufacturing and emerging economies are creating opportunities in the market.
The world bioburden testing market is segmented into product, test, application, end user, and geography. The product segment is further classified into instruments and consumables. The instruments covered in the report are PCR and microscopes. While, consumables included in the report are kits and reagents. The tests are further classified into aerobic, anaerobic, fungi, and spore. The application segment is further classified into raw material and in-process applications. The end users included in the report are pharmaceutical, biotechnology, and CMO. Geographically, the market is segmented into North America, Asia, Europe, and Latin America, Middle East and Africa (LAMEA).
The prominent companies operating in the market are Charles River Laboratories International Inc., Sigma-Aldrich Corporation, SGS S.A., Wuxi Pharmatech (CAYMAN) Inc., Merck & Co. Inc., Becton, Dickinson, and Company, North American Science Associates Inc., Nelson Laboratories Inc., Pacific Biolabs, and ATS Labs Inc. They have formulated strategies such as partnerships, collaborations, mergers & acquisitions, joint ventures, expansions, and others to sustain in the market.
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