Table of Content

1. Executive Summary


2. China IVD Market and Market Share Analysis (2010 - 2028)

2.1 China IVD Market and Forecast
2.2 China IVD Market Share and Forecast - By Segment
2.3 China IVD Market Share and Forecast - By Company


3. China IVD - Segments Wise Market and Forecast (2010 - 2028)

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
4.4 Healthy China 2030


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 (2015 - 2028)

8.1 Roche Diagnostics

8.1.1 Business Overview
8.1.2 Roche Diagnostics - China IVD Sales and Forecast
8.1.3 Recent Developments

8.2 Abbott Laboratories

8.2.1 Business Overview
8.2.2 Abbott Laboratories - China IVD Sales and Forecast
8.2.3 Recent Developments

8.3 Sysmex Corporation

8.3.1 Business Overview
8.3.2 Sysmex Corporation - China IVD Sales and Forecast
8.3.3 Recent Developments

8.4 Mindray Medical International Limited

8.4.1 Business Overview
8.4.2 Mindray Medical International Limited - China IVD Sales and Forecast
8.4.3 Recent Developments

8.5 Shanghai Kehua Bio-Engineering Co. Ltd.

8.5.1 Business Overview
8.5.2 Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
8.5.3 Recent Developments

8.6 bioM?rieux SA

8.6.1 Business Overview
8.6.2 bioM?rieux SA - China IVD Sales & Forecast
8.6.3 Recent Developments

8.7 Bio-Rad Laboratories, Inc

8.7.1 Business Overview
8.7.2 Bio-Rad Laboratories, Inc. - China IVD Sales & Forecast
8.7.3 Recent Developments

8.8 Danaher Corporation

8.8.1 Business Overview
8.8.2 Danaher Corporation - China IVD Sales & Forecast
8.8.3 Recent Developments

8.9 Thermo Fisher Scientific Inc.

8.9.1 Business Overview
8.9.2 Thermo Fisher Scientific Inc. - China IVD Sales & Forecast
8.9.3 Recent Developments

8.10 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. In-Vitro Diagnostics (IVD) Market - Major Deals

10.1 2023
10.2 2022
10.3 2021
10.4 2020
10.5 2019


11. In-Vitro Diagnostics (IVD) Market - Recent Developments


12. China IVD Market - Driving Factors

12.1 Government Efforts to Regulate Laboratory testing
12.2 Healthy China 2030 Initiatives to Fuel China IVD Market
12.3 Increasing Number of Private Hospitals & Independent Testing Laboratories
12.4 Chinese Government Policies Encourage Investment in IVD
12.5 Technology Advancement Spurring the IVD Market
12.6 High Prevalence of Chronic and Infectious Diseases


13. China IVD Market - Challenges

13.1 Lack of Expertise in Advanced Technology in the Local Companies
13.2 Price Pressures Limits Participation of Multinational IVD Companies in China IVD Market
13.3 Reimbursement Rates of Different Products Varies in Different Provinces
13.4 Operational Barriers Faced in Conducting Diagnostic Tests



List of Figures

List of Figures:

Figure 2-1: China - IVD Market (Million US$), 2010 - 2022
Figure 2-2: China - Forecast for IVD Market (Million US$), 2023 - 2028

Figure 3-1: China - Clinical Chemistry Market (Million US$), 2010 - 2022
Figure 3-2: China - Forecast for Clinical Chemistry Market (Million US$), 2023 - 2028
Figure 3-3: China - Immunoassay Market (Million US$), 2010 - 2022
Figure 3-4: China - Forecast for Immunoassay Market (Million US$), 2023 - 2028
Figure 3-5: China - Hematology Market (Million US$), 2010 - 2022
Figure 3-6: China - Forecast for Hematology Market (Million US$), 2023 - 2028
Figure 3-7: China - Coagulation Market (Million US$), 2010 - 2022
Figure 3-8: China - Forecast for Coagulation Market (Million US$), 2023 - 2028
Figure 3-9: China - Microbiology Market (Million US$), 2010 - 2022
Figure 3-10: China - Forecast for Microbiology Market (Million US$), 2023 - 2028
Figure 3-11: China - Molecular Testing Market (Million US$), 2010 - 2022
Figure 3-12: China - Forecast for Molecular Testing Market (Million US$), 2023 - 2028
Figure 3-13: China - SMBG Market (Million US$), 2010 - 2022
Figure 3-14: China - Forecast for SMBG Market (Million US$), 2023 - 2028
Figure 3-15: China - POCT Market (Million US$), 2010 - 2022
Figure 3-16: China - Forecast for POCT Market (Million US$), 2023 - 2028

Figure 8-1: Roche Diagnostics - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-2: Roche Diagnostics - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-3: Abbott Laboratories - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-5: Sysmex Corporation - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-7: Mindray Medical - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-9: Shanghai Kehua - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-11: bioM?rieux SA - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-12: bioM?rieux SA - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-13: Bio-Rad Laboratories, Inc. - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-14: Bio-Rad Laboratories, Inc. - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-15: Danaher Corporation - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-16: Danaher Corporation - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-17: Thermo Fisher Scientific Inc. - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-18: Thermo Fisher Scientific Inc. - Forecast for China IVD Revenue (Million US$), 2023 - 2028
Figure 8-19: Others - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-20: Others - Forecast for China IVD Revenue (Million US$), 2023 - 2028

Figure 9-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012

List of Tables

List of Tables:

Table 2-1: China - IVD Market Share (Percent), 2010 - 2022
Table 2-2: China - Forecast for IVD Market Share (Percent), 2023 - 2028
Table 2-3: China IVD Market - Company Share (Percent), 2015 - 2022
Table 2-4: China IVD Market - Forecast for Company Share (Percent), 2023 - 2028

Table 12-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China