Summary In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. The Food and Drug Administration (FDA) has been involved in the regulation of in vitro diagnostic devices (IVDs or laboratory tests) since the introduction of the Medical Device Amendments of 1976. FDA classifies IVD products into Class I, II, or III according to the level of regulatory control that is necessary to assure safety and effectiveness. The classification of an IVD (or other medical device) determines the appropriate premarket process. The Global In-Vitro Diagnostics market is estimated to reach 61.6 Billion USD in 2017. On the basis of region, North America is the largest market segment of In-Vitro Diagnostics, followed by Europe and Asia Pacific. In the report, HeyReport says Immunochemistry dominates the largest Application share in 2017. The objective of report is to define, segment, and project the market on the basis of type, application, and region, and to describe the content about the factors influencing market dynamics, policy, economic, technology and market entry etc. Based on products type, the report describes major products type share of regional market. Products mentioned as follows: By Type Test Instruments Test Reagents Based on region, the report describes major regions market by products and application. Regions mentioned as follows: North America Europe Asia Pacific Based on Application, the report describes major Application share of regional market. Application mentioned as follows: Immunochemistry Self-monitoring Blood Glucose Point-of-Care Diagnostics Molecular Diagnostics Tissue Diagnostics Hematology Microbiology Leading vendors in the market are included based on profile, business performance etc. Vendors mentioned as follows: Roche SIEMENS Danaher Abbott Thermo Fisher BD Alere Sysmex BioM?rieux?s Johnson and Johnson Bio-rad Hologic KHB
Table of Contents 1 Market Overview 1.1 Objectives of Research 1.1.1 Definition 1.1.2 Specifications 1.2 Market Segment 1.2.1 by Type 1.2.1.1 Test Instruments 1.2.1.2 Test Reagents 1.2.2 by Application 1.2.2.1 Immunochemistry 1.2.2.2 Self-monitoring Blood Glucose 1.2.2.3 Point-of-Care Diagnostics
