Table of Content

1. Introduction


2. Executive Summary


3. Market Dynamics

3.1 Growth Drivers
3.2 Challenges


4. China IVD Market


5. Market Share

5.1 By Segments


6. Segments – China IVD Market

6.1 Clinical Chemistry Market
6.2 Immunoassay Market
6.3 Molecular Diagnostic Market
6.4 Microbiology Market
6.5 Hematology Market
6.6 Self Monitoring of Blood Glucose (SMBG) Market
6.7 Point of Care Testing (POCT) Market
6.8 Coagulation Market


7. Development Environment of Chinese IVD Industry

7.1 Healthcare Reforms
7.2 Improving Quality at Grass-Root Level
7.3 Embracing Technology


8. China: Health Insurance and Reimbursement Policies

8.1 Health Insurance System

8.1.1 Basic Medical Insurance
8.1.2 Insurance for Other Groups
8.1.3 Rural Medical Insurance
8.1.4 Private Health Insurance

8.2 Reimbursement Rules

8.2.1 Device Reimbursement
8.2.2 Reimbursement for In-Vitro Diagnostics (IVDs)


9. Registration of In Vitro Diagnostic Reagents in China

9.1 Registration and Filing
9.2 Filing Obligation for Clinical Trials
9.3 Clinical Trial Institutions
9.4 Elimination of IVD Loophole for Research
9.5 Change of Manufacturing Address
9.6 Change of Main Supplier of an Antigen or Antibody
9.7 Update on China In-Vitro Diagnostics Registration

9.7.1 IVD Product Registration in China
9.7.2 China IVD Type Testing Process
9.7.3 Clinical Trials for IVD Products in China


10. Medical Devices and Reagents Class Registration in China

10.1 Process of Medical Device Registration in China
10.2 Classification of In-vitro Diagnostic Reagents in China

10.2.1 Class III: Highest Risk
10.2.2 Class II: Medium Risk
10.2.3 Class I: Lower Risk

10.3 China In-Vitro Diagnostics Reagents

10.3.1 Blood Screening Reagents ? Drug Administration
10.3.2 Varieties of Blood Screening Reagents
10.3.3 Blood Screening Reagent Test
10.3.4 Nucleic Acid Detection Kits for Blood Screening
10.3.5 Radioactive Reagents ? Drug Administration
10.3.6 Diagnostic Reagents - Medical Devices Management


11. Company Sales Analysis

11.1 Roche Diagnostics

11.1.1 Overview
11.1.2 Initiatives & Recent Developments
11.1.3 Sales Revenue

11.2 Sysmex Corporation

11.2.1 Overview
11.2.2 Initiatives & Recent Developments
11.2.3 Sales Revenue

11.3 Mindray Medical International Limited

11.3.1 Overview
11.3.2 Initiatives & Recent Developments
11.3.3 Sales Revenue

11.4 Shanghai Kehua Bio-Engineering Co. Ltd.

11.4.1 Overview
11.4.2 Initiatives & Recent Developments
11.4.3 Sales Revenue

11.5 Abbott Laboratories

11.5.1 Overview
11.5.2 Initiatives & Recent Developments
11.5.3 Sales Revenue


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

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

12.1.1 Products and Services Offered by Di’an

12.2 ADICON Clinical Laboratories (Privately held)

12.2.1 Products and Services Offered by ADICON

12.3 Guangzhou Kingmed Diagnostics Center Co. Ltd.

12.3.1 Products and Services Offered by Kingmed

12.4 Kindstar Global (Privately held)

12.4.1 Products and Services Offered by Kindstar

12.5 BGI-Shenzhen

12.5.1 BGI’s Innovative Approach

12.6 OriGene Technologies

12.6.1 Products and Services Offered by OriGene



List of Figures



Figure 3-1: China – Healthcare Spending (Billion US$), 2011 & 2020
Figure 4-1: China – IVD Market (Billion US$), 2014 – 2020
Figure 4-2: China – Forecast for IVD Market (Billion US$), 2021 – 2026
Figure 5-1: China – IVD Market Share by Segments (Percent), 2014 – 2020
Figure 5-2: China – Forecast for IVD Market Share by Segments (Percent), 2021 – 2026
Figure 6-1: China IVD – Clinical Chemistry Market (Million US$), 2014 – 2020
Figure 6-2: China IVD – Forecast for Clinical Chemistry Market (Million US$), 2021 – 2026
Figure 6-3: China IVD – Immunoassay Market (Million US$), 2014 – 2020
Figure 6-4: China IVD – Forecast for Immunoassay Market (Million US$), 2021 – 2026
Figure 6-5: China IVD – Molecular Testing Market (Million US$), 2014 – 2020
Figure 6-6: China IVD – Forecast for Molecular Testing Market (Million US$), 2021 – 2026
Figure 6-7: China IVD – Microbiology Market (Million US$), 2014 – 2020
Figure 6-8: China IVD – Forecast for Microbiology Market (Million US$), 2021 – 2026
Figure 6-9: China – Hematology Market (Million US$), 2014 – 2020
Figure 6-10: China – Forecast for Hematology Market (Million US$), 2021 – 2026
Figure 6-11: China IVD – SMBG Market (Million US$), 2014 – 2020
Figure 6-12: China IVD – Forecast for SMBG Market (Million US$), 2021 – 2026
Figure 6-13: China IVD – POCT Market (Million US$), 2014 – 2020
Figure 6-14: China IVD – Forecast for POCT Market (Million US$), 2021 – 2026
Figure 6-15: China IVD – Coagulation Market (Million US$), 2014 – 2020
Figure 6-16: China IVD – Forecast for Coagulation Market (Million US$), 2021 – 2026
Figure 10-1: Process of Medical Device Registration in China
Figure 10-2: In-vitro Diagnostic System Applied for Market Approval in China
Figure 11-1: Roche Diagnostics – China IVD Revenue (Million US$), 2014 - 2020
Figure 11-2: Roche Diagnostics – Forecast for China IVD Revenue (Million US$), 2021 - 2026
Figure 11-3: Sysmex Corporation – China IVD Revenue (Million US$), 2014 - 2020
Figure 11-4: Sysmex Corporation – Forecast for China IVD Revenue (Million US$), 2021 - 2027
Figure 11-5: Qiagen – China IVD Revenue (Million US$), 2014 - 2020
Figure 11-6: Qiagen – Forecast for China IVD Revenue (Million US$), 2021 - 2027
Figure 11-7: Shanghai Kehua – China IVD Revenue (Million US$), 2016 - 2020
Figure 11-8: Shanghai Kehua – Forecast for China IVD Revenue (Million US$), 2021 - 2027
Figure 11-9: Abbott Laboratories – China IVD Revenue (Million US$), 2014 - 2020
Figure 11-10: Abbott Laboratories – Forecast for China IVD Revenue (Million US$), 2021 - 2027
Figure 12-1: Kindstar – Collaboration with hospitals in China (Number), 2006-2013

 

List of Tables


List of Table:

Table 3-1: Number of hospital beds for every 1,000 people
Table 10-1: Registration Type, 2016