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Meridian Bioscience is a fully integrated life science company, that engages in the development, manufacture, sale, and distribution of diagnostic test kits primarily for respiratory, gastrointestinal, viral, and parasitic infectious diseases. The immunodiagnostic technologies used in its diagnostic test kits include evarious popular methods used by reference laboratories, hospitals, and physicians' offices. The company also manufactures and distributes bulk antigens, antibodies, and reagents used by researchers and other diagnostic manufacturers.
The Company operates in three segments: U.S. Diagnostics, European Diagnostics and Life Science. The company continues to establish a position in tests that can be used near patients, deemed point of care testing (POCT). This close proximity testing allows for immediate diagnosis and treatment of patients, without having to wait hours or even days for results from central laboratories.
During the 2009/2010 flu season (Q3 2009- Q1 2010) Meridian Bioscience saw record high quarterly revenues (and total year 2009 revenues) due largely to an increase in use of its point of care tests, namely those for influenza and respiratory syncytial virus (RSV). Record high influenza infections and the use of RSV tests as a secondary test to influenza drove testing volumes. The company also leveraged the growing use of tests for Clostridium difficile (C.diff) and Helicobacter pylori (H. pylori). The increasing utilazation of these POCT tests has led the company to work on next generation molecular based point of care tests.
Infectious disease are particularlly prone to outbreaks due to strain mutations, lack of immunizations, and development of new diseases.
As an example, for influenza in just the U.S. alone, according to the CDC, every year 5 to 20 percent of the U.S. population gets the flu, causing more than 200,000 hospitalizations and about 36,000 flu related deaths. In 2009, this average was driven higher due to the emergence of the 2009 H1N1 virus (also know as "Swine Flu"). Average estimates for the impact of 2009 H1N1 between April and mid December of 2009 had 55 million people infected, of which 246,000 were hospitalized and over eleven thousand people died due to the virus. Infections were much higher outside of the U.S. and along with it also was testing.
In comparison to seasonal influenza, 2009 H1N1 affected a much different patient population, which also fueled concern and drove testing. According to the CDC, for seasonal flu about 60 percent of hospitalizations and 90 percent of deaths occur in people 65 years and older. While for 2009 H1N1, approximately 90 percent of estimated hospitalizations and 88 percent of estimated deaths occurred in people younger than 65 years old.
The diagnostic testing market will continue to be impacted by increases in the aging and treatment populations. According to the U.S. Census Bureau in 2008, over 94 million people, roughly 31 percent of the population, was over the age of 50. This population is growing at just under three percent. Unfortunately, chronic diseases affect older adults disproportionately and, as a result, the U.S. will be increasingly pressured to handle a growing sick population. Even with over 225,000 physician offices in the U.S., the American College of Physicians forecasts an estimated shortage of 44,000-46,000 physicians by 2025. According to the American Hospital Association (AHA), at least half of the emergency departments are at or over capacity, citing a lack of beds as the main reason. The increase in acutely ill patients, coupled with personnel shortages, is straining clinical laboratory resources from providing test results in a timely manner. In order to relieve the growing burden on clinical laboratories, POCT is becoming increasingly adopted to diagnose and treat patients rapidly for improved patient outcomes.
Meridian Bioscience competes with large manufacturers and distributers of laboratory products, large multinational diagnostics companies, and specialized POCT firms that tend to focus on certain market segments. Its primary competitors are: