The impact of the broader economic backdrop on the diagnostic market is important to consider since diagnostics companies are more sensitive to changes in the macroeconomic cycle than other parts of the health care system. 3.2 demonstrates, the industry remains dwarfed by the size of the prescription pharmaceuticals market. 3.1 is expected to grow at a compound annual growth rate of 5% (2010–2016) 8 with global sales forecast to pass the US$ 50 billion mark in 2014, 9 although as Fig. The total IVD market, which includes various classes of assays, represented in Fig. 6 Estimates show that there are currently 37 novel antibiotics in development. Growth in the overall antibiotics market is also hampered by a slowdown in product launches: the Food and Drug Administration (FDA) approved 16 new antibiotics between 19, 5 between 20, and two since 2008. ![]() This compares to aggregate industry global antibiotic sales estimated at US$ 14 billion, 5 with the market shrinking in dollar terms as key blockbuster drugs (such as Augmentin, Cipro, Zithromax) have faced patent expiry. 3 An industry report by Cowen & Company 4 suggests the aggregate market value of diagnostics for infectious disease is worth in excess of US$ 3 billion annually in the United States. US$ 4 billion) accounting for over 80% of global sales. The bulk of the IVD market is concentrated in developed countries, with the United States (US$ 19 billion), Europe (US$ 14 billion) and Japan (approx. As will be described in further detail later in this report, POC testing which occurs at or near the site of patient care, is sought after in the field of infectious bacterial diagnostics to allow the care team to receive the results more quickly and allow for immediate and informed management decisions to be made.Ī number of analyst estimates 1, 2 approximate the overall global diagnostics market to be worth US$ 40–45 billion with POC diagnostics contributing US$ 12–13 billion. a They may be reagents, techniques, instruments, or a combination of these used in vitro for the examination of specimens such as blood, urine or tissue with the goal of obtaining a diagnosis from assays in a controlled environment outside a living organism.ĭiagnostic tests are usually conducted in laboratories, private or public, equipped with appropriate and sometimes expensive instrumentation and staffed with trained and qualified personnel to perform the tests. ![]() Generally speaking in vitro diagnostics (IVD) tests are considered medical devices.
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