Table of Content

1. Introduction


2. Research Methodology


3. Executive Summary


4. Market Dynamics

4.1 Growth Drivers
4.2 Challenges


5. China In-Vitro Diagnostics Market


6. Market Share -China in Vitro Diagnostics

6.1 By Segment


7. Segments - China in Vitro Diagnostics Market

7.1 Clinical Chemistry Market
7.2 Immunoassay Market
7.3 Molecular Diagnostic Market
7.4 Microbiology Market
7.5 Hematology Market
7.6 Self-Monitoring of Blood Glucose (SMBG) Market
7.7 Point of Care Testing (POCT) Market
7.8 Coagulation Market


8. Development Environment of Chinese IVD Industry

8.1 Healthcare Reforms
8.2 Improving Quality at Grass-Root Level
8.3 Embracing Technology


9. China: Health Insurance and Reimbursement Policies

9.1 Health Insurance System

9.1.1 Basic Medical Insurance
9.1.2 Insurance for Other Groups
9.1.3 Rural Medical Insurance
9.1.4 Private Health Insurance

9.2 Reimbursement Rules

9.2.1 Device Reimbursement
9.2.2 Reimbursement for In-Vitro Diagnostics (IVDs)


10. Registration of In Vitro Diagnostic Reagents in China

10.1 Registration and Filing
10.2 Filing Obligation for Clinical Trials
10.3 Clinical Trial Institutions
10.4 Elimination of IVD Loophole for Research
10.5 Change of Manufacturing Address
10.6 Change of Main Supplier of an Antigen or Antibody
10.7 Update on China In-Vitro Diagnostics Registration

10.7.1 IVD Product Registration in China
10.7.2 China IVD Type Testing Process
10.7.3 Clinical Trials for IVD Products in China


11. Medical Devices and Reagents Class Registration in China

11.1 Process of Medical Device Registration in China
11.2 Classification of In-vitro Diagnostic Reagents in China

11.2.1 Class III: Highest Risk
11.2.2 Class II: Medium Risk
11.2.3 Class I: Lower Risk

11.3 China In-Vitro Diagnostics Reagents

11.3.1 Blood Screening Reagents ? Drug Administration
11.3.2 Varieties of Blood Screening Reagents
11.3.3 Blood Screening Reagent Test
11.3.4 Nucleic Acid Detection Kits for Blood Screening
11.3.5 Radioactive Reagents ? Drug Administration
11.3.6 Diagnostic Reagents - Medical Devices Management


12. Porters Five Forces

12.1 Overview
12.2 Bargaining Power of Buyers
12.3 Bargaining Power of Suppliers
12.4 Degree of Competition
12.5 Threat of New Entrants
12.6 Threat of Substitutes


13. Company Analysis

13.1 Roche Diagnostics

13.1.1 Overviews
13.1.2 Recent Developments
13.1.3 Revenues

13.2 Sysmex Corporation

13.2.1 Overviews
13.2.2 Recent Developments
13.2.3 Revenues

13.3 Bio-Rad Laboratories Inc.

13.3.1 Overviews
13.3.2 Recent Developments
13.3.3 Revenues

13.4 Shanghai Kehua Bio-Engineering Co. Ltd.

13.4.1 Overviews
13.4.2 Recent Developments
13.4.3 Revenues

13.5 Abbott Laboratories

13.5.1 Overviews
13.5.2 Recent Developments
13.5.3 Revenues

13.6 Danaher Corporation

13.6.1 Overviews
13.6.2 Recent Developments
13.6.3 Revenues

13.7 BioMerieux SA

13.7.1 Overviews
13.7.2 Recent Developments
13.7.3 Revenues


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

14.1 Zhejiang Di’an Diagnostics Technology Co., Ltd.

14.1.1 Products and Services Offered by Di’an

14.2 ADICON Clinical Laboratories (Privately held)

14.2.1 Products and Services Offered by ADICON

14.3 Guangzhou Kingmed Diagnostics Center Co. Ltd.

14.3.1 Products and Services Offered by Kingmed

14.4 Kindstar Global (Privately held)

14.4.1 Products and Services Offered by Kindstar

14.5 BGI-Shenzhen

14.5.1 BGI’s Innovative Approach

14.6 OriGene Technologies

14.6.1 Products and Services Offered by OriGene



List of Figures

Figure-01: China In-Vitro Diagnostics Market (Million US$), 2016 – 2021
Figure-02: Forecast for – China In-Vitro Diagnostics Market (Million US$), 2022 – 2027
Figure-03: Segments – Clinical Chemistry Market (Million US$), 2016 – 2021
Figure-04: Segments – Forecast for Clinical Chemistry Market (Million US$), 2022 – 2027
Figure-05: Segments – Immunoassay Market (Million US$), 2016 – 2021
Figure-06: Segments – Forecast for Immunoassay Market (Million US$), 2022 – 2027
Figure-07: Segments – Molecular Diagnostic Market (Million US$), 2016 – 2021
Figure-08: Segments – Forecast for Molecular Diagnostic Market (Million US$), 2022 – 2027
Figure-09: Segments – Microbiology Market (Million US$), 2016 – 2021
Figure-10: Segments – Forecast for Microbiology Market (Million US$), 2022 – 2027
Figure-11: Segments – Hematology Market (Million US$), 2016 – 2021
Figure-12: Segments – Forecast for Hematology Market (Million US$), 2022 – 2027
Figure-13: Segments – Self-Monitoring of Blood Glucose (SMBG) Market (Million US$), 2016 – 2021
Figure-14: Segments – Forecast for Self-Monitoring of Blood Glucose (SMBG) Market (Million US$), 2022 – 2027
Figure-15: Segments – Point of Care Testing (POCT) Market (Million US$), 2016 – 2021
Figure-16: Segments – Forecast for Point of Care Testing (POCT) Market (Million US$), 2022 – 2027
Figure-17: Segments – Coagulation Market (Million US$), 2016 – 2021
Figure-18: Segments – Forecast for Coagulation Market (Million US$), 2022 – 2027
Figure-19: Roche Diagnostics – Global Revenue (Million US$), 2016 – 2021
Figure-20: Roche Diagnostics – Forecast for Global Revenue (Million US$), 2022 – 2027
Figure-21: Sysmex Corporation – Global Revenue (Million US$), 2016 – 2021
Figure-22: Sysmex Corporation – Forecast for Global Revenue (Million US$), 2022 – 2027
Figure-23: Bio-Rad Laboratories Inc. – Global Revenue (Million US$), 2016 – 2021
Figure-24: Bio-Rad Laboratories Inc. – Forecast for Global Revenue (Million US$), 2022 – 2027
Figure-25: Shanghai Kehua Bio-Engineering Co. Ltd. – Global Revenue (Million US$), 2016 – 2021
Figure-26: Shanghai Kehua Bio-Engineering Co. Ltd. – Forecast for Global Revenue (Million US$), 2022 – 2027
Figure-27: Abbott Laboratories – Global Revenue (Million US$), 2016 – 2021
Figure-28: Abbott Laboratories – Forecast for Global Revenue (Million US$), 2022 – 2027
Figure-29: Danaher Corporation – Global Revenue (Million US$), 2016 – 2021
Figure-30: Danaher Corporation – Forecast for Global Revenue (Million US$), 2022 – 2027
Figure-31: BioMerieux SA – Global Revenue (Million US$), 2016 – 2021
Figure-32: BioMerieux SA – Forecast for Global Revenue (Million US$), 2022 – 2027

List of Tables

Table-01: China – In-Vitro Diagnostics Market Share by Segment (Percent), 2016 – 2021
Table-02: China – Forecast for In-Vitro Diagnostics Market Share by Segment (Percent), 2022 – 2027