American Ceramic Society Bulletin, Vol. 100, No. 8 | 7 Celebrating 100 years business and market view I n vitro diagnostics (IVD) are the highest revenue segment of the medical device market. The global market for IVD products is estimated to be $74.1 billion in 2020, and it is expected to grow at a com- pound annual growth rate of 6.7% to reach $102.4 billion through 2025. IVD includes analyzers, reagents, disposable and reusable products, and accessory software products used by both clinical and research laboratories around the world. IVDs range from simple self- use tests to state-of-the-art genomic tests performed in laboratories, which can be used in the diagnosis of infectious and chronic diseases, as well as for preventive care and drug therapy monitoring. Factors influencing the global IVD market include Need for disease detection before appearance of symptoms—Rapid advances in human genome sequencing enable the identification of faulty genes, increasing the probability of diagnosing a disease before its symptoms appear and thus starting treatment much earlier. Need to identify the right patients for drug therapy—New tests, known as companion diagnostics, generate critical data on a patient’s rate of drug metabo- lism and efficacy, for example, thus enabling healthcare experts to identify the right patient for a specific drug. Need for faster real-time tests that enable personalized treatment—Faster tests provide real-time results and thus allow healthcare providers to make timely deci- sions, reduce chances of any adverse side effects of drugs, and educate and motivate patients to make lifestyle modifications for improving their health conditions. Need to minimize dependence on lab testing—Point-of-care tests pro- vide critical information at the point of healthcare delivery, thus enabling timely diagnoses and treatment commencement by the medical care personnel, which in turn results in improved patient compli- ance with physicians’ recommendations. Challenges affecting the global IVD market include Declining reimbursement for IVDs in Europe—In European countries such as Germany and the U.K., reimbursements were significantly reduced for tests such as glucose monitoring, hampering the growth of the point-of-care test segment. Similar trends in the U.S., such as Medicare cuts, were introduced, which may negatively affect the growth of certain IVDs. U.S. medical device tax reduces profits for manufacturers—In 2013, the U.S. government mandated a 2.3% excise tax on the sales revenues of medi- cal devices. This tax put a significant burden on companies, especially those that are in early stages and are yet to begin a positive cash flow. Stringent regulatory framework— Since the beginning of 2005, the U.S. Food and Drug Administration’s process of reviewing and approving medical devices became lengthy and difficult, delaying the commercial launch of new and innovative products to the market. High R&D and marketing costs— High research & development and marketing costs may result in an increase in partnerships and acquisitions to cut expenditures and enhance productivity. The number of mergers and acquisitions since the early 2000s has increased, and since 2010, the trend intensified. Because of its large population and position as a medical technology innova- tion hub, North America is the global leader in terms of IVD use, accounting for roughly 42.0% of the total market in 2020. The emerging markets of India, China, Russia, and Brazil are poised to grow at double-digit growth rates due to rising incomes, growing healthcare bud- gets, and heightened health awareness among the population. About the author Jon Evans has been involved in busi- ness development and research for the medical industry since 1984. For more information, please contact Dr. Helia Jalili, director of advanced materials, at Resource J. Evans, “In vitro diagnostics: Technologies and global markets” BCC Research Report HLC186C, May 2021. 100 A regular column featuring excerpts from BCC Research reports on industry sectors involving the ceramic and glass industry. In vitro diagnostics: Technologies and global markets By Jon Evans Table 1. Different types of coronavirus tests, 2020 Molecular test Antigen test Antibody test How it works Detects the virus’s genetic material Detects specific proteins from Looks for antibodies that are the virus made by the immune system in response to a threat How the sample is Nasopharyngeal (the part of the Nasal or nasal pharyngeal swab Finger stick or blood draw taken throat behind the nose), nasal or throat swab, saliva What it shows Diagnoses active coronavirus Diagnoses active coronavirus Shows if you’ve been infected infection infection by coronavirus in the past What it can’t do Shows if you ever had COVID-19 Antigen tests are more likely to Diagnose COVID-19 at the time or were infected with the virus miss an active COVID-19 or show that you do not have that causes COVID-19 in the past infection compared to molecular COVID-19. tests. A healthcare provider may order a molecular test if an antigen test shows a negative result, but the person has symptoms of COVID-19.
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