Home > > > > Report Detail

China In-Vitro Diagnostics (IVD) Market, Size, Share, Trends, Regulations, Reimbursement & Key Players Analysis - Forecast to 2026

Publisher Name :
Date: 09-Mar-2020
No. of pages: 108

China In-Vitro Diagnostics (IVD) market is likely to reach around US$ 17.6 Billion by 2026. China represents one of the largest clinical laboratory markets in the Asia-Pacific region, and the fastest growing among the top ten IVD country markets.  Historically, large multinational companies have dominated IVD market in China; today, domestic companies such as Shanghai Kehua Bio-Engineering (KHB) being one of the largest - are now gaining market share.

China is a large and fast-growing in vitro diagnostics (IVD) market - in fact, only second to the United States in terms of value. China’s quickly aging population means the country is experiencing an explosion of chronic conditions such as diabetes, heart disease and cancer. All of these conditions can be diagnosed and monitored using IVD products.  Further, the average Chinese consumer is now willing and able to pay more for healthcare than a decade years ago. Hence, China has the potential for more dramatic growth in the future.

China IVD Market Segment Wise Analysis


  • Immunoassay captures maximum share of the China IVD market.

  • Clinical Chemistry holds the 2nd position in China IVD market being followed by Molecular Testing.

  • The molecular testing market in China is expected to show double digits growth rate during the forecast period.

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

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

  • Point of Care Testing accounts for least share of the China IVD market.


China IVD Market Company Analysis


  • Roche captures maximum share of the China IVD market.

  • Sysmex Corporation and Mindary Medical are other top two players in the China IVD market.

  • Sysmex has built a robust infrastructure in China, working with more than 200 sales distributors to provide products and services throughout the country.

  • In Abbott’s worldwide diagnostics business, sales growth over the last three years reflected the acquisition of Alere in October of 2017.

  • At present, many local players are present in China IVD market and their combined market share is likely to exceed 60 percent by 2026.


“China In-Vitro Diagnostics (IVD) Market, Size, Share, Trends, Regulations, Reimbursement & Key Players Analysis - Forecast to 2026” provides a comprehensive analysis of the China In-Vitro Diagnostics (IVD Market.

This 108 Page report with 34 Figures and 3 Tables has been analyzed from 10 View Points:


  • China IVD Market and Forecast (2010 - 2026)

  • China IVD Market Share and Forecast (2010 - 2026)

  • China IVD Market & Forecast – By Segment (2010 - 2026)

  • Development Environment and Regulatory Status in China IVD market

  • China IVD Market & Forecast – Key Players Sales Analysis (2010 - 2026)

  • Registration for In Vitro Diagnostic Reagents in China

  • Regulatory History/Status/Trends in China IVD Market

  • Reimbursement of IVD Products in China

  • Profiles of Select Private Clinical Labs and Diagnostic Services Companies

  • China IVD Industry Drivers & Challenges


China IVD Market – By Application Segments


  • Clinical Chemistry Market

  • Immunoassay Market

  • Hematology Market

  • Coagulation Market

  • Microbiology Market

  • Molecular Testing Market

  • Self-Monitoring of Blood Glucose (SMBG) Market

  • Point of Care Testing (POCT) Market


China IVD Sales & Forecast – Key Players Analysis


  • Roche Diagnostics

  • Abbott Laboratories

  • Sysmex Corporation

  • Mindray Medical International Limited

  • Shanghai Kehua Bio-Engineering Co. Ltd.

  • 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, Size, Share, Trends, Regulations, Reimbursement & Key Players Analysis - Forecast to 2026

Table of Contents

1. Executive Summary

2. China IVD Market and Market Share Analysis (2010 - 2026)
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 (2010 - 2026)
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 - 2026)
8.1 Roche Diagnostics - 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 Tables:

Table 2-1: China - IVD Market Share (Percent), 2010 - 2019
Table 2-2: China - Forecast for IVD Market Share (Percent), 2020 - 2026
Table 10-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China

List of Figures:

Figure 2-1: China - IVD Market (Million US$), 2010 - 2019
Figure 2-2: China - Forecast for IVD Market (Million US$), 2020 - 2026
Figure 2-3: China IVD Market - Company Share (Percent), 2010 - 2019
Figure 2-4: China IVD Market - Forecast for Company Share (Percent), 2020 - 2026
Figure 3-1: China - Clinical Chemistry Market (Million US$), 2010 - 2019
Figure 3-2: China - Forecast for Clinical Chemistry Market (Million US$), 2020 - 2026
Figure 3-3: China - Immunoassay Market (Million US$), 2010 - 2019
Figure 3-4: China - Forecast for Immunoassay Market (Million US$), 2020 - 2026
Figure 3-5: China - Hematology Market (Million US$), 2010 - 2019
Figure 3-6: China - Forecast for Hematology Market (Million US$), 2020 - 2026
Figure 3-7: China - Coagulation Market (Million US$), 2010 - 2019
Figure 3-8: China - Forecast for Coagulation Market (Million US$), 2020 - 2026
Figure 3-9: China - Microbiology Market (Million US$), 2010 - 2019
Figure 3-10: China - Forecast for Microbiology Market (Million US$), 2020 - 2026
Figure 3-11: China - Molecular Testing Market (Million US$), 2010 - 2019
Figure 3-12: China - Forecast for Molecular Testing Market (Million US$), 2020 - 2026
Figure 3-13: China - SMBG Market (Million US$), 2010 - 2019
Figure 3-14: China - Forecast for SMBG Market (Million US$), 2020 - 2026
Figure 3-15: China - POCT Market (Million US$), 2010 - 2019
Figure 3-16: China - Forecast for POCT Market (Million US$), 2020 - 2026
Figure 8-1: Roche Diagnostics - China IVD Revenue (Million US$), 2010 - 2019
Figure 8-2: Roche Diagnostics - Forecast for China IVD Revenue (Million US$), 2020 - 2026
Figure 8-3: Abbott Laboratories - China IVD Revenue (Million US$), 2010 - 2019
Figure 8-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2020 - 2026
Figure 8-5: Sysmex Corporation - China IVD Revenue (Million US$), 2010 – 2019
Figure 8-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2020 - 2026
Figure 8-7: Mindray Medical - China IVD Revenue (Million US$), 2010 - 2019
Figure 8-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2020 - 2026
Figure 8-9: Shanghai Kehua - China IVD Revenue (Million US$), 2010 - 2019
Figure 8-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2020 - 2026
Figure 8-11: Others - China IVD Revenue (Million US$), 2010 - 2019
Figure 8-12: Others - Forecast for China IVD Revenue (Million US$), 2020 - 2026
Figure 9-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012
Figure 10-1: China - Healthcare Spending and Forecast (Billion US$), 2011 - 2020

  • Infectious Disease Diagnostics Market by Product & Service (Reagents, Kits), Test Type (Lab, PoC), Sample (Blood, Urine), Technology (Immunodiagnostics, NGS, PCR, ISH, INAAT), Disease (Hepatitis, HIV, HAI, HPV, Syphilis, TB, Flu) - Global Forecast to 2028
    Published: 10-Jan-2024        Price: US 4950 Onwards        Pages: 309
    “Rising focus on decentralized diagnostics is driving the overall growth of the infectious disease diagnostics market.” The infectious disease diagnostics market is valued at an estimated USD 21.4 billion in 2023 and is projected to reach USD 31.5 billion by 2028 at a CAGR of 8.0% during the forecast period. The rising focus on decentralized diagnostics and the growing demand for CLIA-waived PoC tests have driven the use of PoC technologies. The trend towa......
  • Global Pharmaceutical Testing Services Market Research Report 2024
    Published: 08-Jan-2024        Price: US 2900 Onwards        Pages: 102
    Pharmaceutical Testing Service is often used to identify The chemical composition and molecular structure of each individual substance contained in a medication. This knowledge provides insight into a drug's performance and safety considerations. Pharmaceutical testing can reveal a pharmaceutical's solubility and can predict The medication's ability to reach a specific target within The body. Testing may even reveal contamination in The manufacturing production process or highlight other,......
  • Global Pharmaceutical Testing Services Market Growth (Status and Outlook) 2024-2030
    Published: 04-Jan-2024        Price: US 3660 Onwards        Pages: 156
    According to our LPI (LP Information) latest study, the global Pharmaceutical Testing Services market size was valued at US$ 3398.6 million in 2023. With growing demand in downstream market, the Pharmaceutical Testing Services is forecast to a readjusted size of US$ 7008.4 million by 2030 with a CAGR of 10.9% during review period. The research report highlights the growth potential of the global Pharmaceutical Testing Services market. Pharmaceutical Testing Services are expected to show ......
  • Global Helicobacter Pylori Diagnostics Market Growth (Status and Outlook) 2024-2030
    Published: 04-Jan-2024        Price: US 3660 Onwards        Pages: 109
    According to our LPI (LP Information) latest study, the global Helicobacter Pylori Diagnostics market size was valued at US$ 624.1 million in 2023. With growing demand in downstream market, the Helicobacter Pylori Diagnostics is forecast to a readjusted size of US$ 1040.4 million by 2030 with a CAGR of 7.6% during review period. The research report highlights the growth potential of the global Helicobacter Pylori Diagnostics market. Helicobacter Pylori Diagnostics are expected to show st......
  • Global Laboratory-developed Testing Market Growth (Status and Outlook) 2024-2030
    Published: 04-Jan-2024        Price: US 3660 Onwards        Pages: 110
    According to our LPI (LP Information) latest study, the global Laboratory-developed Testing market size was valued at US$ 3442.2 million in 2023. With growing demand in downstream market, the Laboratory-developed Testing is forecast to a readjusted size of US$ 4512 million by 2030 with a CAGR of 3.9% during review period. The research report highlights the growth potential of the global Laboratory-developed Testing market. Laboratory-developed Testing are expected to show stable growth i......
  • Global Laboratory-developed Testing Market 2024 by Company, Regions, Type and Application, Forecast to 2030
    Published: 01-Jan-2024        Price: US 3480 Onwards        Pages: 109
    According to our (Global Info Research) latest study, the global Laboratory-developed Testing market size was valued at USD 3620.6 million in 2023 and is forecast to a readjusted size of USD 4649.1 million by 2030 with a CAGR of 3.6% during review period. Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests-now commonly referred to as laboratory-developed tests (LDTs)-are subject to the same regulatory oversight as other in vit......
  • Global Pharmaceutical Testing Services Market 2024 by Company, Regions, Type and Application, Forecast to 2030
    Published: 01-Jan-2024        Price: US 3480 Onwards        Pages: 151
    According to our (Global Info Research) latest study, the global Pharmaceutical Testing Services market size was valued at USD 3574.8 million in 2023 and is forecast to a readjusted size of USD 6987.8 million by 2030 with a CAGR of 10.0% during review period. Pharmaceutical Testing Service is often used to identify the chemical composition and molecular structure of each individual substance contained in a medication. This knowledge provides insight into a drug's performance and s......
  • Global TB Diagnostic Industry Research Report, In-depth Analysis of Current Status and Outlook of Key Countries 2023-2028
    Published: 28-Dec-2023        Price: US 3380 Onwards        Pages: 116
    Market Overview of Global TB Diagnostic market: According to our latest research, the global TB Diagnostic market looks promising in the next 5 years. As of 2022, the global TB Diagnostic market was estimated at USD XX million, and it's anticipated to reach USD XX million in 2028, with a CAGR of XX% during the forecast years. This report covers a research time span from 2018 to 2028, and presents a deep and comprehensive analysis of the global TB Diagnostic market, with a sys......
  • IVD Products - Global Market Insights and Sales Trends 2024
    Published: 27-Dec-2023        Price: US 3350 Onwards        Pages: 124
    This report provides market insight on the different segments, by manufacturers, by Type, by Application. Market size and forecast (2018-2029) has been provided in the report. The primary objectives of this report are to provide 1) global market size and forecasts, growth rates, market dynamics, industry structure and developments, market situation, trends; 2) global market share and ranking By Company; 3) comprehensive presentation of the global market for IVD Products, with both quantitative a......
    • SERVICES
    Value for Money
    We believe in "optimum utilization of available budget and resources". While servicing our clients' (your) market research requirements, we keep the same approach in focus to help you get the best value for your $$s.
    Ever Growing Inventory
    Ranging from the smallest feasible / required data (datasheets, data facts, SWOT analysis, company profiles, etc) to full research reports that help you make decisions, our inventory is updated almost on a daily basis with the latest industry reports from domain experts that track more than 5000 niche sectors.
    One Stop Solution
    Need a custom research report on medical devices market? Require all available business intelligence on 3D printing industry? Exploring F&B sector of a particular country/region? RnRMarketResearch.com is your one-stop-solution to all market intelligence needs. We not only offer custom research and consulting services, we also "bundle" reports to meet your needs and help you fetch the data analysis you require for your business.
    Dedicated Client Engagement
    Not limited to only "finding" relevant reports for you, our client engagement team dedicates its efforts to understand your "business need" and accordingly maps available research data to help you move forward. Call "your" client engagement executive any time of your day and get your questions answered in order to make the correct business decision.
    Saving Time and Efforts
    Simply share your research requirement details with us and let us do all the hard work to find required intelligence for you. When you add up our "one stop solution" and "dedicated client engagement" services mentioned above, you obviously know the time and effort saving you do by working with us.
    Payment Flexibility
    Working with Fortune 500 organizations, we understand the importance of being flexible for payments. Share your payment terms with us and we will surely match up to them to ensure you get access to required business intelligence data without having to wait for the payment to be done.
    Post-Purchase Research Support
    Have questions after reading a report / datasheet bought through us? Not sure about the methodology used for data available in the research? Talk to us / Share your questions with us and if required, we will connect you with the analyst(s)/author(s) of the report(s) and ensure you get satisfactory answers for the same. Need more data / analysis / report(s) on the topic of your research/project? The RnRMarketResearch.com team is here for you 24X7 to support you with your post-purchase requirements. Subscription Offers & Packages (Get in touch with us for more details - [email protected] / +1 888 391 5441 )
    • Ad Hoc
    • Pay - as - you - go / Bucket Subscriptions
    • Fixed Cost for #of reports
    • Customize / Personalize as per your needs