Table of Content

1. Executive Summary


2. China IVD Market and Market Share Analysis (2009 - 2025)

2.1 China IVD Market and Forecast
2.2 China IVD Market Share and Forecast
2.3 China IVD Company Share and Forecast


3. China IVD - Segments Wise Market and Forecast (2009 - 2025)

3.1 China Clinical Chemistry Market and Forecast
3.2 China Immunoassay Market and Forecast
3.3 China Hematology Market and Forecast
3.4 China Coagulation Market and Forecast
3.5 China Microbiology Market and Forecast
3.6 China Molecular Testing Market and Forecast
3.7 China Self Monitoring of Blood Glucose (SMBG) Market and Forecast
3.8 China Point of Care Testing (POCT) Market and Forecast


4. Development Environment of Chinese IVD Industry

4.1 State Healthcare Reforms
4.2 State Citizen-Benefiting Policies
4.3 Requirements of Hospital Upgrading


5. Profile of In-vitro Diagnostic Reagents Registration Control

5.1 Classification of In-vitro Diagnostic Reagents in China

5.1.1 Class III: Highest Risk
5.1.2 Class II: Medium Risk
5.1.3 Class I: Lower Risk

5.2 Regulatory History in China IVD Market

5.3 Regulatory Status in China IVD Market

5.3.1 Blood Screening Reagents - Drug Administration
5.3.2 Varieties of Blood Screening Reagents
5.3.3 Blood Screening Reagent Test
5.3.4 Nucleic Acid Detection Kits for Blood Screening
5.3.5 Radioactive reagents - Drug Administration
5.3.6 Diagnostic Reagents - Medical Devices Management

5.4 Regulatory Trend in China IVD Market

5.4.1 Blood Screening Reagents Belonging
5.4.2 Quality Improvement
5.4.3 Pre-Evaluation of Registration Standards


6. Registration for In Vitro Diagnostic Reagents in China

6.1 Registration and Filing
6.2 Filing Obligation for Clinical Trials
6.3 Clinical Trial Institutions
6.4 Elimination of IVD Loophole for Research
6.5 Change of Manufacturing Address
6.6 Change of Main Supplier of An Antigen or Antibody
6.7 China In Vitro Diagnostics Registration Update

6.7.1 IVD Product Registration in China
6.7.2 China IVD Type Testing Process
6.7.3 Clinical Trials for IVD Products in China


7. Reimbursement of IVD Products in China


8. China IVD Market – Key Players Sales Analysis (2010 - 2025)

8.1 Roche Diagnostic - China IVD Sales and Forecast
8.2 Abbott Laboratories - China IVD Sales and Forecast
8.3 Sysmex Corporation - China IVD Sales and Forecast
8.4 Mindray Medical International Limited - China IVD Sales and Forecast
8.5 Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
8.6 Others - China IVD Sales and Forecast


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

9.1 Dian Diagnostics Group Co. Ltd. (Formerly Zhejiang Di’an Diagnostics Technology Co., Ltd.)

9.1.1 Company Overview
9.1.2 Products and Services Offered by Di’an

9.2 ADICON Clinical Laboratories (Privately held)

9.2.1 Company Overview
9.2.2 Products and Services Offered by ADICON

9.3 Guangzhou Kingmed Diagnostics Center Co. Ltd.

9.3.1 Company Overview
9.3.2 Products and Services Offered by Kingmed

9.4 Kindstar Global (Privately held)

9.4.1 Company Overview
9.4.2 Products and Services Offered by Kindstar

9.5 BGI-Shenzhen

9.5.1 Company Overview
9.5.2 BGI’s Innovative Approach

9.6 OriGene Technologies

9.6.1 Company Overview
9.6.2 Products and Services Offered by OriGene


10. China IVD Industry Drivers

10.1 Government Efforts to Regulate Laboratory testing
10.2 Increasing Number of Private Hospitals & Independent Testing Laboratories
10.3 Chinese Government Policies Encourage Investment in IVD


11. China IVD Industry Challenge

11.1 Lack of Expertise in Advanced Technology in the Local Companies
11.2 Price Pressures Limits the Participation of Multinational IVD Companies in the China IVD Market
11.3 Reimbursement Rates of Different Products Varies in Different Provinces



List of Figures


Figure 2-1: China - IVD Market (Million US$), 2009 - 2018
Figure 2-2: China - Forecast for IVD Market (Million US$), 2019 - 2025
Figure 2-3: China IVD Market - Company Share (Percent), 2009 - 2018
Figure 2-4: China IVD Market - Forecast for Company Share (Percent), 2019 - 2025

Figure 3-1: China - Clinical Chemistry Market (Million US$), 2009 - 2018
Figure 3-2: China - Forecast for Clinical Chemistry Market (Million US$), 2019 - 2025
Figure 3-3: China - Immunoassay Market (Million US$), 2009 - 2018
Figure 3-4: China - Forecast for Immunoassay Market (Million US$), 2019 - 2025
Figure 3-5: China - Hematology Market (Million US$), 2009 - 2018
Figure 3-6: China - Forecast for Hematology Market (Million US$), 2019 - 2025
Figure 3-7: China - Coagulation Market (Million US$), 2009 - 2018
Figure 3-8: China - Forecast for Coagulation Market (Million US$), 2019 - 2025
Figure 3-9: China - Microbiology Market (Million US$), 2009 - 2018
Figure 3-10: China - Forecast for Microbiology Market (Million US$), 2019 - 2025
Figure 3-11: China - Molecular Testing Market (Million US$), 2009 - 2018
Figure 3-12: China - Forecast for Molecular Testing Market (Million US$), 2019 - 2025
Figure 3-13: China - SMBG Market (Million US$), 2009 - 2018
Figure 3-14: China - Forecast for SMBG Market (Million US$), 2019 - 2025
Figure 3-15: China - POCT Market (Million US$), 2009 - 2018
Figure 3-16: China - Forecast for POCT Market (Million US$), 2019 - 2025

Figure 8-1: Roche Diagnostic - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-2: Roche Diagnostic - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-3: Abbott Laboratories - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-5: Sysmex Corporation - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-7: Mindray Medical - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-9: Shanghai Kehua - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-11: Others - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-12: Others - Forecast for China IVD Revenue (Million US$), 2019 - 2025

Figure 9-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012
Figure 10-1: China - Healthcare Spending and Forecast (Billion US$), 2011 - 2020

 

List of Tables



Table 2-1: China - IVD Market Share (Percent), 2009 - 2018
Table 2-2: China - Forecast for IVD Market Share (Percent), 2019 - 2025

Table 10-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China