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China In-Vitro Diagnostics Market (By Segment, Company), Size, Share, Regulations, Reimbursement, Major Deals, Trends, Key Company Profiles, Sales Analysis, and Recent Developments - Forecast to 2030

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    Report

  • 282 Pages
  • February 2024
  • Region: China
  • iGATE Research
  • ID: 5822863

China's in-vitro diagnostics market is predicted to reach US$ 28.13 Billion by 2030, from US$ 11.96 Billion in 2023. China is the largest in-vitro diagnostics market in the Asia-Pacific region, and only second to the United States in terms of value. In-vitro diagnostics refers to the diagnosis of disease or other conditions of the human body through the collection, preparation, and testing of human samples with reagents, instruments, and systems. China is facing the challenges of fighting infectious diseases including HBV, TB, HCV, and HIV, as well as various chronic diseases and cancer. In-vitro diagnostics play an important role in the detection of infectious and chronic diseases.

Due to the upsurge in 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 products. Moreover, the Chinese government is taking several initiatives to improve the healthcare sector in the country. For instance, 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 over the forecast period. However, a lack of proper reimbursement and a stringent regulatory framework restricts the market’s growth.

China In-Vitro Diagnostics Market - Recent Developments

  • In January 2024, bioMérieux announced the acquisition of LUMED, a software company that has developed a clinical decision support system to help hospitals optimize antimicrobial prescriptions and monitor healthcare-associated infections.
  • In August 2023, Sysmex Corporation announced an expansion of the Global Business Partnership Agreement (GBPA) with Roche Diagnostics International Ltd.
  • 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 July 2022, DiaCarta Inc., a molecular diagnostics company announced that the company had received CE-IVD Mark for its newly developed QuantiVirus SARS-CoV-2 & Flu A/B test.

By Segment: China In-Vitro Diagnostics Market and Forecast - Key Takeaways

  • Immunoassay and Clinical Chemistry are the leading segments of the China IVD market. Together they contributed around 60 percent to the total China IVD market in 2023.
  • Molecular Testing is the fastest-growing segment of the China IVD market, driven by increasing demand for polymerase chain reaction (PCR) products in China.
  • POCT and SMBG segments are competing closely to grab the maximum market share of the pie. POCT is transforming diagnostic practices through its convenience and efficiency.
  • China's SMBG market is dominated by foreign IVD companies such as Roche.
  • Microbiology testing is witnessing growth due to technological advancements and increasing infectious disease incidences.
  • The growth of the hematology market is attributed to factors such as the increasing incidences of blood disorders, the growing adoption of automated hematology instruments by diagnostic laboratories, the emergence of high throughput hematology analyzers, and the introduction of technologically advanced hematology instruments.

China In-Vitro Diagnostics Market - Company Analysis

  • In the China IVD market, Roche Diagnostics is the leader with a majority share, followed by Mindray Medical International Limited and Shanghai Kehua Bio-Engineering Co. Ltd.
  • Danaher Corporation, 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 systems.
  • In August 2023, Sysmex Corporation announced an expansion of the Global Business Partnership Agreement (GBPA) with Roche Diagnostics International Ltd.
  • 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.

The report provides a comprehensive analysis of the China In-Vitro Diagnostics (IVD) Market.

This 282 Page report with 43 Figures and 5 Tables has been analyzed from 12 View Points:

1) China IVD Market and Forecast (2014 - 2030)
2) China IVD Market Share and Forecast (2014 - 2030)
3) By Segment - China IVD Market & Forecast (2014 - 2030)
4) Development Environment and Regulatory Status in China IVD market
5) China IVD Market - Key Players Sales Analysis (2015 - 2030)
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 - Market Dynamics

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 Company Profiles

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. Snibe Diagnostic
11. Dirui Medical
12. Autobio Diagnostics
13. YHLO Biotech
14. Beijing Strong Biotechnologies, Inc.
15. 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

Data Source

The publisher employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. This report is built by using data and information sourced from the Proprietary Information Database, Primary and Secondary Research Methodologies, and house analysis by a dedicated team of qualified professionals with deep industry experience and expertise.

Research Methodologies

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

Table of Contents


1. Executive Summary
2. China IVD Market and Market Share Analysis (2014 - 2030)
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 (2014 - 2030)
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 the Chinese IVD Industry
4.1 State Healthcare Reforms
4.2 State Citizen-Benefiting Policies
4.3 Requirements for 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 - 2030)
8.1 Roche Diagnostics
8.1.1 Company Overview
8.1.2 Roche Diagnostics - China IVD Sales and Forecast
8.1.3 Recent Developments
8.2 Abbott Laboratories
8.2.1 Company Overview
8.2.2 Abbott Laboratories - China IVD Sales and Forecast
8.2.3 Recent Developments
8.3 Sysmex Corporation
8.3.1 Company 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 Company 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 S.A.
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 Company Overview
8.7.2 Bio-Rad Laboratories, Inc. - China IVD Sales & Forecast
8.7.3 Recent Developments
8.8 Danaher Corporation
8.8.1 Company Overview
8.8.2 Danaher Corporation - China IVD Sales & Forecast
8.8.3 Recent Developments
8.9 Thermo Fisher Scientific Inc.
8.9.1 Company Overview
8.9.2 Thermo Fisher Scientific Inc. - China IVD Sales & Forecast
8.9.3 Recent Developments
8.10 Snibe Diagnostic
8.10.1 Company Overview
8.10.2 Snibe Diagnostic - Global IVD Sales
8.10.3 Recent Developments
8.11 Dirui Medical
8.11.1 Company Overview
8.11.2 Dirui Medical - Global Sales
8.12 Autobio Diagnostics
8.12.1 Company Overview
8.12.2 Autobio Diagnostics - Global Sales
8.12.3 Recent Developments
8.13 YHLO Biotech
8.13.1 Company Overview
8.13.2 YHLO Biotech - Global Sales
8.13.3 Recent Developments
8.14 Beijing Strong Biotechnologies, Inc.
8.14.1 Company Overview
8.14.2 Beijing Strong Biotechnologies, Inc. - China IVD Sales
8.14.3 Recent Developments
8.15 Others - China IVD Sales and Forecast

9. Profiles of Select 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
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
9.4.1 Company Overview
9.4.2 Products and Services Offered by Kindstar
9.5 BGI Group
9.5.1 Company Overview
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 Deals11. In-Vitro Diagnostics (IVD) Market - Recent Developments
12. China In-Vitro Diagnostics - Market Dynamics
12.1 China IVD Market - Driving Factors
12.2 China IVD Market - Challenges

List of Figures
Figure 2-1: China - IVD Market (Million US$), 2014 - 2023
Figure 2-2: China - Forecast for IVD Market (Million US$), 2024 - 2030
Figure 3-1: China - Clinical Chemistry Market (Million US$), 2014 - 2023
Figure 3-2: China - Forecast for Clinical Chemistry Market (Million US$), 2024 - 2030
Figure 3-3: China - Immunoassay Market (Million US$), 2014 - 2023
Figure 3-4: China - Forecast for Immunoassay Market (Million US$), 2024 - 2030
Figure 3-5: China - Hematology Market (Million US$), 2014 - 2023
Figure 3-6: China - Forecast for Hematology Market (Million US$), 2024 - 2030
Figure 3-7: China - Coagulation Market (Million US$), 2014 - 2023
Figure 3-8: China - Forecast for Coagulation Market (Million US$), 2024 - 2030
Figure 3-9: China - Microbiology Market (Million US$), 2014 - 2023
Figure 3-10: China - Forecast for Microbiology Market (Million US$), 2024 - 2030
Figure 3-11: China - Molecular Testing Market (Million US$), 2014 - 2023
Figure 3-12: China - Forecast for Molecular Testing Market (Million US$), 2024 - 2030
Figure 3-13: China - SMBG Market (Million US$), 2014 - 2023
Figure 3-14: China - Forecast for SMBG Market (Million US$), 2024 - 2030
Figure 3-15: China - POCT Market (Million US$), 2014 - 2023
Figure 3-16: China - Forecast for POCT Market (Million US$), 2024 - 2030
Figure 8-1: Roche Diagnostics - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-2: Roche Diagnostics - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-3: Abbott Laboratories - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-5: Sysmex Corporation - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-7: Mindray Medical - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-9: Shanghai Kehua - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-11: bioMérieux SA - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-12: bioMérieux SA - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-13: Bio-Rad Laboratories, Inc. - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-14: Bio-Rad Laboratories, Inc. - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-15: Danaher Corporation - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-16: Danaher Corporation - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-17: Thermo Fisher Scientific Inc. - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-18: Thermo Fisher Scientific Inc. - Forecast for China IVD Revenue (Million US$), 2024 - 2030
Figure 8-19: Snibe Diagnostic - Global IVD Revenue (Million US$), 2018 - 2023e
Figure 8-20: Dirui Medical - Global Revenue (Million US$), 2019 - 2023e
Figure 8-21: Autobio Diagnostics - Global Revenue (Million US$), 2018 - 2023e
Figure 8-22: YHLO Biotech - Global Revenue (Million US$), 2019 - 2023e
Figure 8-23: Beijing Strong Biotechnologies, Inc. - China IVD Revenue (Million US$), 2018 - 2023e
Figure 8-24: Others - China IVD Revenue (Million US$), 2015 - 2023
Figure 8-25: Others - Forecast for China IVD Revenue (Million US$), 2024 - 2030

List of Tables
Table 2-1: China - IVD Market Share (Percent), 2014 - 2023
Table 2-2: China - Forecast for IVD Market Share (Percent), 2024 - 2030
Table 2-3: China IVD Market - Company Share (Percent), 2015 - 2023
Table 2-4: China IVD Market - Forecast for Company Share (Percent), 2024 - 2030
Table 12-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China

Companies Mentioned

  •  OriGene Technologies
  • Abbott Laboratories
  • ADICON Clinical Laboratories
  • Autobio Diagnostics
  • Beijing Strong Biotechnologies, Inc.
  • BGI-Shenzhen 
  • Bio-Rad Laboratories, Inc
  • bioMérieux SA
  • Danaher Corporation
  • Dian Diagnostics Group Co. Ltd. (Formerly Zhejiang Di’an Diagnostics Technology Co., Ltd.)
  • Dirui Medical
  • Guangzhou Kingmed Diagnostics Center Co. Ltd.
  • Kindstar Global 
  • Mindray Medical International Limited
  • Roche Diagnostics
  • Shanghai Kehua Bio-Engineering Co. Ltd.
  • Snibe Diagnostic
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • YHLO Biotech