The report China In-Vitro Diagnostics Market, Forecast, Companies Analysis, Registration Rules The market for China In-Vitro Diagnostics (IVD) is likely to be thrice of its present market, growing at a CAGR of 19% by 2022.
In Vitro Diagnostics (IVDs) - Devices and Reagents
In Vitro Diagnostics (IVDs) are medical devices and accessories that are used to perform tests on the specimens taken from the human body such as blood, urine and tissue in order to treat, mitigate, monitor drug therapies, cure, or prevent illness or its abnormality.
In vitro diagnostic (IVD) products are those reagents, instruments, and systems intended for use in the collection, preparation, and examination of specimens to diagnose disease or other conditions, including a decision of the state of health.
A Look on China In Vitro Diagnostic (IVD) Market
By Testing, the Immunoassay accounted for the largest share of the market in 2016 while Microbiology Market has grown approximately 4 times in 2016 compared to its market value in 2007 driven by growing prevalence of chronic lifestyle diseases, increasing aging population and demand for tests in urban and rural areas.
In Vitro Diagnostic (IVD) Enhancing Healthcare System
In vitro diagnostic (IVD) is an important segment of the healthcare industry. The market is observing rapid growth ignited by technological enhancements, better diagnostic devices and tools, advanced monitoring systems, and increased availability of over-the-counter tests. IVDs add momentous value to healing processes and medical diagnoses, strengthening the well-being of the general public.
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FDA Approval and Process
FDA classifies IVD products into Class I, II, or III according to the level of regulatory regulations, with the aim to assure safety and effectiveness. The classification of an IVD (or other medical devices) determines the suitable premarket approval and process.
• Class I
• Class II
• Class III
The Report Studies the China (PRC) IVD Market on the basis of:
Segment Analysis (2007 – 2022)
1. Clinical Chemistry Market
2. Immunoassay Market
3. Hematology Market
4. Coagulation Market
5. Microbiology Market
6. Molecular Testing Market
7. Self Monitoring of Blood Glucose (SMBG) Market
8. Point of Care Testing (POCT) Market
Key Players (2011 – 2022)
1. Roche Diagnostics
2. Sysmex Corporation
3. Mindray Medical International Limited
4. Shanghai Kehua Bio-Engineering Co. Ltd.
5. Abbott Laboratories
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