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China In-Vitro Diagnostics (IVD) Market (By Segment and Company), Size, Share, Regulations, Reimbursement, Major Deals, Trends & Recent Developments - Forecast to 2028

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Date: 14-Jun-2023
No. of pages: 247

China In-Vitro Diagnostics (IVD) market is predicted to exceed US$ 25 Billion by 2028. China is a large and fast-growing in vitro diagnostics (IVD) market - in fact, the largest in vitro diagnostics market in the Asia-Pacific region, and only second to the United States in terms of value. Due to the upsurge of the geriatric population and the high burden of chronic and infectious diseases, like diabetes, cancer, and COVID-19, the China IVD market is slated to show significant growth, as these chronic disorders can be diagnosed and monitored using in-vitro diagnostics (IVD) products. Moreover, The State Council issued a guideline to implement the country's Healthy China initiative to diminish the incidence of disability among elderly people aged between 65 and 74 years by offering medical and health services. Such initiatives by the government are expected to boost market growth during the forecast period. However, a lack of proper reimbursement and stringent regulatory framework restricts the market’s growth.

China In Vitro Diagnostics (IVD) Market – Recent Developments


  • In April 2023, Oxford Nanopore Technologies plc, and bioMérieux SA teamed up to improve health outcomes globally by exploring selected opportunities to bring nanopore sequencing to the infectious disease diagnostics market.

  • In December 2022, bioMérieux announced the CE-marking of VIDAS KUBE, the next generation automated immunoassay system for the VIDAS range.

  • In July 2022, DiaCarta Inc., a molecular diagnostics company announced that the company has received CE-IVD Mark for its newly developed QuantiVirus SARS-CoV-2 & Flu A/B test.

  • In February 2022, Sysmex Corporation formed a capital and business tie-up with KAINOS Laboratories, Inc. with a view toward strengthening capabilities to develop and produce diagnostic reagents in the immunochemistry field.


By Segment China IVD Market and Forecast – Key Takeaway


  • Immunoassays accounted for lion’s share of the total China IVD market, and is likely to maintain its dominant position over the forecast period as well.

  • Clinical Chemistry holds the 2nd position in the China IVD market, but its share is likely to continually decline over the forecast period.

  • Molecular Testing is the fastest growing segment of the China IVD market, driven by increasing demand for polymerase chain reaction (PCR) products in China.

  • China SMBG market is dominated by foreign IVD companies such as Roche.

  • SMBG and Hematology segments are competing closely with each other to grab maximum share of the pie.


China IVD Market Company Analysis


  • In the China IVD market, Roche Diagnostics is the leader with majority share, followed by Danaher Corporation, Shanghai Kehua Bio-Engineering Co. Ltd. and Mindray Medical International Limited.

  • Sysmex Corporation, Abbott Laboratories, and Thermo Fisher Scientific Inc. are the other top players in the China IVD market.

  • Sysmex is focusing on Tier 2 and 3 hospitals in China, as they will play a crucial role in providing more advanced treatment, training future generations, and raising the level of regional medical care.

  • In the diagnostics business, Abbott will focus on driving sales growth from its Alinity suite of diagnostics instruments and its portfolio of rapid diagnostic testing system.

  • In April 2023, bioMérieux submitted a 510(k) premarket notification to the U.S. FDA for the VITEK REVEAL, formerly known as SPECIFIC REVEAL Rapid AST System.


This report titled “China In-Vitro Diagnostics (IVD) Market (By Segment and Company), Size, Share, Regulations, Reimbursement, Major Deals, Trends & Recent Developments - Forecast to 2028” provides a comprehensive analysis of the China In-Vitro Diagnostics (IVD) Market.

This 247 Page report with 39 Figures and 5 Tables has been analyzed from 12 View Points:


  • 1) China IVD Market and Forecast (2010 - 2028)

  • 2) China IVD Market Share and Forecast (2010 - 2028)

  • 3) China IVD Market & Forecast - By Segment (2010 - 2028)

  • 4) Development Environment and Regulatory Status in China IVD market

  • 5) China IVD Market - Key Players Sales Analysis (2015 - 2028)

  • 6) Registration for In Vitro Diagnostic Reagents in China

  • 7) Regulatory History/Status/Trends in China IVD Market

  • 8) Reimbursement of IVD Products in China

  • 9) Profiles of Select Private Clinical Labs and Diagnostic Services Companies

  • 10) IVD Market - Major Deals

  • 11) IVD Market - Recent Developments

  • 12) China IVD Industry Drivers & Challenges


China IVD Market - By Application Segment


  • 1. Clinical Chemistry

  • 2. Immunoassays

  • 3. Hematology

  • 4. Coagulation

  • 5. Microbiology

  • 6. Molecular Testing

  • 7. Self-Monitoring of Blood Glucose (SMBG)

  • 8. Point of Care Testing (POCT)


China IVD Market - Key Players Sales Analysis


  • 1. Roche Diagnostics

  • 2. Abbott Laboratories

  • 3. Sysmex Corporation

  • 4. Mindray Medical International Limited

  • 5. Shanghai Kehua Bio-Engineering Co. Ltd.

  • 6. bioMérieux SA

  • 7. Bio-Rad Laboratories, Inc

  • 8. Danaher Corporation

  • 9. Thermo Fisher Scientific Inc.

  • 10. Others


Profiles of Private Clinical Labs and Diagnostic Services Companies in China


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

  • ADICON Clinical Laboratories

  • Guangzhou Kingmed Diagnostics Center Co. Ltd.

  • Kindstar Global

  • BGI-Shenzhen

  • OriGene Technologies


Research Methodologies

Primary Research Methodologies: Questionnaires, Surveys, Interviews with Individuals, Small Groups, Telephonic Interview, etc.

Secondary Research Methodologies: Printable and Non-printable sources, Newspaper, Magazine and Journal Content, Government and NGO Statistics, white Papers, Information on the Web, Information from Agencies Such as Industry Bodies, Companies Annual Report, Government Agencies, Libraries and Local Councils and a large number of Paid Databases.

China In-Vitro Diagnostics (IVD) Market (By Segment and Company), Size, Share, Regulations, Reimbursement, Major Deals, Trends & Recent Developments - Forecast to 2028

Table of Contents

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 bioMérieux SA
8.6.1 Business Overview
8.6.2 bioMérieux 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:

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: bioMérieux SA - China IVD Revenue (Million US$), 2015 - 2022
Figure 8-12: bioMérieux SA - Forecast for China IVD Revenue (Million US$), 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:

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

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