Globally upcomingBioburden Testing Market trends is expected to grow significantly over the forecast period. It is estimated that the global bioburden testing market is expected to register a CAGR of Approx. 9.15% during the forecast period of 2018–2023 with an estimated market value of USD 455 million. Bioburden testing refers to an estimation of microbial load on a medical instrument, raw material, packaged goods among others. Bioburden testing is carried out to ascertain if the types and numbers of micro-organisms present are satisfactory or unsatisfactory when compared to predefined acceptance criteria.
Several factors such as increasing food safety concerns, rising medical spending, growing product recalls due to microbial contamination are expected to drive the growth of the market. The major players are involved in strategic collaborations and new product launches to strengthen their position in the market. For instance, in October 2018, SGS SA acquired IBR Inc., a non-clinical contract research organization (CRO). IBR Inc. focuses on integral services in biopharmaceutical analytics for the development of biologics, biosimilars and vaccines, and provides several filter testing and particle counting services.
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However, high costs of microbial enumeration instruments and complex and time-consuming regulatory standards in some economies may hinder the market growth during the assessment period. Also, test reports and certificates tend to be different from one country to another which hampers international trade. Therefore, in December 2017, International Organization for Standardization (ISO) published a new edition of ISO/IEC 17025 standard. This standard is an international reference for laboratories carrying out calibration and testing activities around the world. ISO/IEC 17025 helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries.
Regional Analysis:
The market in the Americas is expected to dominate the global bioburden testing market during the forecast period owing to the presence of well-established healthcare system, increasing healthcare expenditure, and favorable reimbursement scenario. The European market is expected to be the second-largest due to availability of funds for research from public and private sources. Moreover, the market in Asia-Pacific is predicted to be the fastest-growing during the assessment period owing to growing disposable income, and continuously developing economies. The market in the Middle East & Africa is likely to account for the smallest share of the global bioburden testing market. The market growth in this region can be attributed to the growing government initiatives.
Segmentation:
The global bioburden testing market has been segmented into test type, product type, application and end-user.
The market, on the basis of type, has been segmented into aerobic count, anaerobic count, fungi count and spore count.
The market, on the basis of product type, has been segmented into consumables and instruments.
The market, by consumables, has been sub-segmented into reagents and kits, and others.
The market, by instruments, has been further segmented into polymerase chain reaction machine (PCR), microscopes, and others.
The market, by application, has been segmented into raw materials testing, medical devices testing, in-process material testing, sterilization validation testing, and equipment cleaning validation.
The market, by end-user, has been segmented into pharmaceutical and biotechnology companies, microbial testing laboratories, and others.
Key Players:
Some of the key players in the global bioburden testing market are WuXi AppTec, Charles River, SGS SA, Merck KGaA, NORTH AMERICAN SCIENCE ASSOCIATES INC., Becton, Dickinson, and Company, Nelson Laboratories, LLC, Pacific Biolabs, ATS Laboratories, Inc., and Dynatec Labs.
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