Global Bioburden Testing Market 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.

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.

The market, by region, into the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The bioburden testing market in the Americas has further been segmented into North America and South America, with the North American market divided into the US and Canada.

The European bioburden testing market has been segmented into Western Europe and Eastern Europe. Western Europe has been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe.

The bioburden testing market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The Bioburden Testing market in the Middle East & Africa has been segmented into the Middle East and Africa.

Key players:

Charles River, SGS SA, WuXi AppTec, Merck KGaA, NORTH AMERICAN SCIENCE ASSOCIATES INC., Becton, Dickinson, and Company, Nelson Laboratories, LLC, Pacific Biolabs, ATS Laboratories, Inc., and Dynatec Labs are some of the major players in the global bioburden testing market.

Geographically, the Americas is anticipated to dominate the global bioburden testing market owing to a well-developed healthcare infrastructure, and growing healthcare expenditure. Moreover, favourable reimbursement scenario in this region fuels the growth of the market.

Europe is expected to hold the second largest position in the global bioburden testing market. The market growth in this region is attributed to the availability of funds for research.

Asia-Pacific is anticipated to be the fastest growing region in the market due to the presence of a huge patient population, continuously developing economies, and increasing government funding for healthcare sector. Also, there is a strong presence of major players in this region which boosts the market growth.

On the other hand, the Middle East and Africa has the least share of the market. Majority of the market share of this region is expected to be held by the Middle East region due to the growing government initiatives for the healthcare sector.