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.
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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.
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.
On the flip side, high costs of microbial enumeration instruments and lack of standardization of test reports and certificates are the key factors projected to impede the growth of the market. Also, complicated and time-consuming regulatory policies act as growth barricaders for the bioburden testing market. Nevertheless, increasing RD support and funding from governments for test discoveries would support market growth throughout the predicted period
Bioburden Testing Global Market – Segments
The is segmented into five dynamics;
By Test Type : Aerobic Count, Anaerobic Count, Fungi Count, Spore Count, and others.
By Product Type : Consumables (Reagents & Kits, others), Instruments (Polymerase Chain Reaction Machine, Microscopes, others), and others.
By Application : Raw Materials Testing, Medical Devices Testing, In-Process Material Testing, Sterilization Validation Testing, Equipment Cleaning Validation, and others.
By End-User : Pharmaceutical & Biotechnology Companies, Microbial Testing Laboratories, and others.
By Region : America, Europe, Asia Pacific, and Rest of the World.
Global Bioburden Testing Market – Geographical Analysis
North America dominates the global bioburden testing market. The largest market share attributes to the well-spread awareness for healthcare and the importance of quality control of pharmaceutical and medical products with their microbial limit testing. Besides, the presence of notable key players and well-developed healthcare infrastructure in the region drive the market growth. Moreover, favorable reimbursement scenario in this region fuels the growth of the market.
Also, advances in biotechnology act as a significant tailwind for the market growth. Rising awareness towards the advantages of bioburden testing, alongside augmented governmental spending for R&D to develop novel test kits foster the growth of the market. The North American bioburden testing market is estimated to retain its leading position in the global market throughout the assessment period.
Europe stands second in the global bioburden testing market. The market is predominantly driven by the substantial R&D funds for research invested by the public as well as private sectors. European governments substantially spend on innovations, developing new tests, and improving the existing test kits. The European bioburden testing market is expected to grow pervasively in the years to come, continuing with the same trends.
The Asia pacific bioburden testing market is surging rapidly despite several adversaries. The presence of highly qualified lab professionals and growing numbers of biotechnology companies in India and China predominantly drive the market. Also, factors such as ongoing programs to increase awareness and developments in healthcare propel the growth of the market. Moreover, the growing rate of literacy and per capita income in the region push market growth. The APAC bioburden testing market is poised to register a modest CAGR over the forecast period.
Bioburden Testing Market – Competitive Analysis
Although still in its embryonic stage, the bioburden testing market already appears moderately competitive. To gain a larger competitive share, these players incorporate strategies such as mergers & acquisitions, collaboration, expansion, and product launch. Players invest substantially in R&D and trials to develop tests that can give a reading on the microbial limit on pharmaceutical products and medical products for quality control.
Companies also focus on regions with high unmet needs and require further innovation despite the progress that has been made. This market demonstrates pretty good growth prospects that are expected to attract new entrants, further intensifying the market competition.
Major Players:
Players leading the global bioburden testing market include Charles River, SGS SA, Wuxi AppTec, Merck KGaA, Becton, Dickinson, and Company, Nelson Laboratories, LLC, North American Science Associates Inc, Pacific Biolabs, ATS Laboratories, Inc., and Dynatec Labs, among others.
Industry/ Innovations/ Related News
January 03, 2019 ---- Healthcare Laundry Accreditation Council (HLAC), developers of the HLAC laundry process monitoring toolkit, announced the availability of new process monitoring toolkit – Toolkitâ. The new toolkit validates the effectiveness of a laundry’s processes by measuring the number of microorganisms found in a laundry on hard surfaces, in the air, on linen, in the water, and on the hands of employees. Toolkitâ provides Total Aerobic Microbial Counts (TAMC), Total Yeast & Mold Counts (TYMC), and anaerobic spore-forming bacteria such as Clostridium difficile (C. diff).
HLAC, a non-profit organization, inspects and accredits laundries processing textiles for hospitals, nursing homes, and other healthcare facilities. HLAC has developed the Laundry Process Monitoring Toolkit to respond to the challenge for operators to know the progress of their processes and whether their standards are on target as initially intended.
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