In-vitro diagnostics is used as a diagnostic tool by clinicians for faster diagnosis and to ensure timely treatment for patients. According to the U.S. FDA, in-vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequela. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.
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Increasing product approval by market players is a major factor driving global in-vitro diagnostics market growth. For instance, in 2017, Bio-Rad Laboratories announced the U.S. Food and Drug Administration (FDA) clearance of BioPlex 2200 Syphilis Total and RPR Assay, which is a novel one-step universal testing method based on automated Treponemal/ non-Treponemal dual assay to aid in the syphilis infection.
Furthermore, inorganic strategies adopted by key players for enhancing their distribution network and offering best products in the market is expected to drive the market growth. For instance, in January 2018, Atomo Diagnostics and Access Bio partnered to expand their coverage in regions across Africa, South East Asia, and South America. The collaboration aims to access HIV infected population in these regions to market HIV rapid testing products.
Increasing global prevalence of cancer and autoimmune diseases is expected to propel the market growth
Rising prevalence of cancer and autoimmune diseases is expected to drive the global in-vitro diagnostics market. According to the American Diabetes Association 2016, an estimated 29.1 million Americans, contributing a total 9.3% of the population, had severe Type II diabetes, while around 1.25 million American children and adults having type 1 diabetes. Similarly, according to the Multiple Sclerosis Foundation, 2017, multiple sclerosis autoimmune condition affects 2.5 million people with the global incidence of around 7 cases per 100,000 people per year.
Rising strategic acquisition and collaboration by market players for expanding their offering in the market is expected to bolster the market growth. For instance, in January 2017, Qiagen N.V. acquired Omicsoft Corporation to expand its bioinformatics portfolio. The acquisition will add Qiagen with additional features to manage, analyze, and share both primary data and analyzed results. Similarly, in July 2018, Arkray, Inc. partnered with Beckman Coulter, a company that manufactures biomedical testing devices, for launching the product, iQ Urinanalysis Workcell. It is a combination of products from both the companies and the commercialization of this product was done through Beckman Coulter.
Increasing product approvals and product launches in the North America are expected to bolster the market growth
North America holds dominant position in the global in-vitro diagnostics market, owing to increasing product approvals by regulatory authorities. For instance, in 2016, Abbott Laboratories’ ZIKA molecular diagnostics test received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Furthermore, in 2017, bioMérieux, an in-vitro diagnostics manufacturer, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VITEK MS, its MALDI-TOF1 mass spectrometry system for rapid pathogen identification, and for expanded identification of mycobacteria, Nocardia, and molds.
Increasing product launches in the region is the major factor expected to propel the market growth. For instance, in May 2018, Abbott Laboratories launched its Afinion 2 analyzer in the U.S., the newest generation of the Afinion test system. The Afinion 2 analyzer is a compact rapid, multi-assay platform that streamlines and simplifies the delivery of actionable, accurate measurements of hemoglobin A1c (HbA1c), and albumin to creatinine ratio (ACR) results at the point of care.
Moreover, support from regulatory authorities as well as other government organizations is further expected to support growth of the North America in-vitro diagnostics market over the forecast period. For instance in 2017, United Nations Children’s Fund (UNICEF) announced request for proposal for sustained supply of Zika virus point-of-care diagnostics during 2017 through 2019.
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Major players operating in the global in-vitro diagnostics market include Siemens Healthineers, Sysmex Corporation, Bio-Rad Laboratories, bioMérieux S.A., Becton Dickinson, and Company, Danaher Corporation, Abbott Laboratories, F. Hoffmann-la Roche Ltd, QIAGEN N.V., Arkray, Inc., Nittobo Medical Co., Ltd., Medical & Biological Laboratories Co., Ltd., Miraca Holdings Inc., and Mizuho Medy Co., Ltd.
This post was originally published on Trading Herald