China In-Vitro Diagnostics Market to exceed US$ 12 Billion by 2024
07 Aug, 2018

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The report China In-Vitro Diagnostics Market, by Diagnostics [Clinical Chemistry, Immunoassay, Hematology, Coagulation, Microbiology, Molecular Testing, Self Monitoring of Blood Glucose (SMBG), Point of Care Testing (POCT)], Companies (Roche Diagnostics, Sysmex Corporation, Mindray Medical International Limited, Shanghai Kehua Bio-Engineering Co. Ltd., Abbott Laboratories & Others)” provides a complete analysis of China In–Vitro Diagnostics (IVD) Market. The market for China In-Vitro Diagnostics (IVD) is likely to exceed US$ 12 Billion by the end of year 2024.

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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 – 2024)

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 – 2024)

1.    Roche Diagnostics 
2.    Sysmex Corporation
3.    Mindray Medical International Limited
4.    Shanghai Kehua Bio-Engineering Co. Ltd.
5.    Abbott Laboratories
6.    Others

Key Topics Covered :

1.    Executive Summary

2.    China IVD Market (2007 – 2024)

3.    Market Share – China In Vitro Diagnostics (IVD) (2011 – 2024)

3.1    Segments – China IVD
3.2    Companies – China IVD

4.    Segments – China IVD Market (2007 – 2024)

4.1    Clinical Chemistry Market
4.2    Immunoassay Market
4.3    Hematology Market
4.4    Coagulation Market
4.5    Microbiology Market
4.6    Molecular Diagnostic Market
4.7    Self Monitoring of Blood Glucose (SMBG) Market
4.8    Point of Care Testing (POCT) Market

5.    Development Environment of Chinese IVD Industry

5.1    Healthcare Reforms
5.2    Improving Quality at Grass-Root Level
5.3    Embracing Technology

6.    China: Health Insurance and Reimbursement Policies

6.1    Health Insurance System
6.2    Reimbursement Rules

7.    Registration of In Vitro Diagnostic Reagents in China

7.1    Registration and Filing
7.2    Filing Obligation for Clinical Trials
7.3    Clinical Trial Institutions
7.4    Elimination of IVD Loophole for Research
7.5    Change of Manufacturing Address
7.6    Change of Main Supplier of an Antigen or Antibody
7.7    Update on China In-Vitro Diagnostics Registration

8.    Medical Devices and Reagents Class Registration in China

8.1    Process of Medical Device Registration in China
8.2    Classification of In-vitro Diagnostic Reagents in China
8.3    China In-Vitro Diagnostics Reagents

9.    China IVD Industry Drivers

9.1    Increasing Demand from Middle Class for High Quality Healthcare Products
9.2    Rising Incidences of Lifestyle Diseases in China
9.3    Growth in Private Hospitals & Independent Diagnostic Centers

10.    China IVD Industry Challenges

10.1    Chinese Local Firms Lack of Expertise in Advanced Technology
10.2    Cost Factor Restricts the Contribution of Global IVD Companies in the Chinese IVD Market
10.3    Reimbursement Rates varies from Province to Province in China

11.    Company Sales Analysis (2011 – 2024)

11.1    Roche Diagnostics - China IVD Sales & Forecast
11.2    Sysmex Corporation - China IVD Sales & Forecast
11.3    Mindray Medical International Limited - China IVD Sales & Forecast
11.4    Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
11.5    Abbott Laboratories - China IVD Sales & Forecast
11.6    Others - China IVD Sales & Forecast

12.    Profiles of Select Private Clinical Labs and Diagnostic Services Companies

12.1    Zhejiang Di’an Diagnostics Technology Co., Ltd.
12.2    ADICON Clinical Laboratories (Privately held)
12.3    Guangzhou Kingmed Diagnostics Center Co. Ltd.
12.4    Kindstar Global (Privately held)
12.5    BGI-Shenzhen
12.6    OriGene Technologies

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