Bioburden testing estimates the number of microbial load on instruments and devices in medical, pharmaceutical, and food industry. In addition, unsafe or unhygienic food is likely to contain parasites or chemical substances, harmful bacteria, and viruses that has potential to cause over 200 diseases ranging from diarrhea to cancer. According to WHO, around 600 million people across the globe fall sick after consuming any contaminated food.
Food contamination particularly affects infants, young children, and elderly. To combat this situation, numerous governments are focusing on enforcing better guidelines for bioburden testing such as European Medical Agency for bioburden testing for pharmaceutical industry.
Raw Material Testing to Dominate the Global Bioburden Market
Pharmaceutical products cannot be manufactured without performing raw material analysis, identity purity and quality of the raw materials to ensure the product is suitable for its intended use. Rising demand for bioburden testing in analysis of cosmetic and pharmaceutical industry is expected to drive the market growth. For instance, Merck KGaA, Darmstadt, Milliflex offers bioburden testing kit for analysis of raw materials in pharmaceutical and cosmetics. Furthermore, testing of raw material is highly regulated in the pharmaceutical and food industries. Stringent government regulations for testing raw materials, excipients, and finished products based on various compendia including UPS/NF, JP, EP, FCC, and BP provide standardized test methods for the most common and widely used materials. Furthermore, raw material analysis is an integral part of Good Manufacturing Practice (GMP) and the requirements in the GMP regulations.
Europe is Witnessing Rapid Demand for Microbiology Screening in the Pharmaceutical and Food Industries
Europe is the second largest market for bioburden testing. This can be attributed to the increasing prevalence of food poisoning in the region. According to the European Union (EU), around 100,000 human salmonellosis cases are reported each year. With rapid expansion of hospitals, pharmaceutical, and biotechnology industries, ensuring safety from the bioburden presence has become paramount. For instance, as per European Federation of Pharmaceutical Industries and Association, the pharmaceutical industry was valued at over USD 224268 million at ex-factory prices of European Pharmaceutical industry. Furthermore, rapidly expanding food industry is also offering a growth opportunity for the bioburden testing market. For instance, Europe food and beverage industries were valued at USD 1 trillion and 230 billion in 2018, respectively.
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Growth Opportunity for Bioburden Testing Market in Asia Pacific
Asia Pacific is witnessing the fastest growth in the global bioburden testing market on account of rapidly expanding pharmaceutical sector in the region. For instance, according to the, India Brand Equity Foundation, pharmaceutical sector was valued at USD 33 billion in 2017. Furthermore, the pharmaceutical industry is expected to expand at a CAGR of 22.4% 2015–2020 to reach USD 55 billion by 2020. Moreover, India is the leading provider of generic drugs globally. For instance, the country caters to around 50% of the global demand for vaccines, and ships 25% of all the medicine to U.K and fulfil 40% demand for generic medicines in the U.S. Apart from this, India is also witnessing flourishing growth in the hospital sector. In 2017, India hospital industry was valued at USD 61.800 billion and is projected to grow at a CAGR of around 17% in the years to come.
Some of the key players in the global bioburden testing market are Charles River (U.S.), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), BD Company (U.S.), , Nelson Laboratories, LLC (U.S.), Thermo Fisher Scientific (U.S.), biomérieux SA (France), and Pacific BioLabs (U.S.)
The global bioburden testing market is witnessing huge competition, owing to presence of large number of international and small players across the globe. Increasing research & devolvement activities in bioburden testing is adding fuel to the market growth. Apart from this, some leading players are focusing on merger and acquisition for their geographical expansion
In 2018, Charles River acquired MPI Research for development of innovative technology for bioburden testing method.
In 2016, SGS SA acquired Quality Compliance Laboratories to provide bioburden testing service to nutraceutical, pharmaceutical and cosmeceutical industries.
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