The bioburden testing market is expected to register a CAGR of nearly 8% during the forecast period. 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 the manufacturing process. The bioburden testing is used for assessment of cleaning processes, and packaging of products 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 biotechnology and food and beverage industries, the safety concerns supplement the growth. The presence of bacteria on the surface can affect industries, like pharmaceuticals, which is directly related to the human begins. Various regulations have been made to check all the parameter of safety and cleaning in the industry or their products.
For instance, in the United States, the Title 21 is the code of federal regulation that covers the drugs and food for the FDA. Many other organizations are also having the code and standard parameter for monitoring.
Key Market Trends
Consumables is Expected to Hold Largest Share of Global Bioburden Testing Market, over the forecast period
Consumables accounted for the largest market share in the global bioburden testing market, due to the high requirement of kits and reagents, whereas the instruments are a one-time investment. The long shelf life of the kits and reagents and the repeated purchase of media, kits, and reagents are driving the adoption of the bioburden testing consumables.
North America Region Holds the Largest Market Share of Bioburden Testing Market
North America was the largest regional market in terms of revenue. Sustained growth in pharmaceutical and biotechnology industries, the rising food and medicine safety concerns in general public, and a strong trend of R&D investments in life sciences, by both industry and academia, are the primary factors driving the growth of the market. Increasing government support for pharmaceutical and biotechnology companies is also impacting the growth of the market in North America.
Furthermore, according to the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research, in 2017, around 4,402 products related to drugs and devices were recalled in the United States. Thus, it is expected to impact positively on the bioburden testing market growth.
The bioburden testing market consists of several major players. The companies are implementing certain strategic initiatives, such as a merger, new product launch, acquisition, and partnerships that help them in strengthening their market position. For instance, Charles River Laboratories is adopting an innovative technology platform for helping in streamline bioburden testing. Additionally, one of the players, Merck KGaA., developed the product for testing of bioburden and others, called EZ Fluo Rapid Detection, Ready-to-Use Culture Media.
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