China In-Vitro Diagnostics (IVD) market is predicted to exceed US$ 21 Billion by 2027. China is a large and fast-growing in vitro diagnostics (IVD) market - in fact, only second to the United States in terms of value. 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 represents one of the largest clinical laboratory markets in the Asia-Pacific region, and the fastest growing among the top ten IVD country markets. 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.
Impact of COVID-19 on China In-Vitro Diagnostics Market
The COVID-19 outbreak has become a global stress test. The disease has infected around 165 Million people worldwide. Globally the death toll has reached 3,412,045 according to the latest statistics from the Worldometers (as of May 18, 2021). The number is still growing, and the duration of the pandemic is still difficult to predict. In China, COVID-19 disease has infected around 90,894 people (as of May 18, 2021), and the death toll has reached 4,636. The COVID-19 outbreak has created a sense of urgency and panic among people globally. In this scenario, the in-vitro diagnostics forms the crux of increased testing. Manufacturers in the in-vitro diagnostic market are focusing on developing novel technologies for maximum testing within a minimum period. For instance, in April 2021, Sysmex Corporation obtained in vitro diagnostic approval for the manufacturing and marketing of the DetectAmp SARS-CoV-2 RT-PCR Kit, a SARS coronavirus nucleic acid kit that detects the RNA of the novel coronavirus (SARS-CoV-2). The novel coronavirus has accelerated the research and development activities in the in-vitro diagnostics market. Development and production in maximum numbers is the need of the hour. Therefore, quick approvals are proving to be the cherry on the cake for the growth of the in-vitro diagnostic market.
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.
- The China Coagulation market is expected to almost double by 2026 from current figure.
- 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 Abbott Laboratories are the other top two players in the China IVD market.
- Sysmex has built a robust infrastructure in China, working with more than 400 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 65 percent by 2026.
iGATE RESEARCH report titled "China In-Vitro Diagnostics (IVD) Market, Impact of COVID-19, Size, Share, Trends, Regulations, Reimbursement, Major Deals & Key Players Analysis - Forecast to 2027" provides a comprehensive analysis of the China In-Vitro Diagnostics (IVD Market.
This 150 Page report with 34 Figures and 3 Tables has been analyzed from 11 View Points:
1) China IVD Market and Forecast (2010 - 2027)
2) Impact of COVID-19 on China IVD Market
3) China IVD Market Share and Forecast (2010 - 2027)
4) China IVD Market & Forecast - By Segment (2010 - 2027)
5) Development Environment and Regulatory Status in China IVD market
6) China IVD Market & Forecast - Key Players Sales Analysis (2010 - 2026)
7) Registration for In Vitro Diagnostic Reagents in China
8) Regulatory History/Status/Trends in China IVD Market
9) Reimbursement of IVD Products in China
10) Profiles of Select Private Clinical Labs and Diagnostic Services Companies
11) China IVD Industry Drivers & Challenges
China IVD Market - By Application Segments
1. Clinical Chemistry Market
2. Immunoassay Market
3. Hematology Market
4. Coagulation Market
5. Microbiology Market
6. Molecular Testing Market
7. Self-Monitoring of Blood Glucose (SMBG) Market
8. Point of Care Testing (POCT) Market
China IVD Sales & Forecast - Key Players Analysis
1. Roche Diagnostics
2. Abbott Laboratories
3. Sysmex Corporation
4. Mindray Medical International Limited
5. Shanghai Kehua Bio-Engineering Co. Ltd.
6. 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
iGATE RESEARCH 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 Proprietary Information Database, Primary and Secondary Research Methodologies, and In house analysis by iGATE Research dedicated team of qualified professionals with deep industry experience and expertise.
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.
Table of Contents
1. Executive Summary
2. Impact of COVID-19 on China IVD Market
3. China IVD Market and Market Share Analysis (2010 - 2027)
3.1 China IVD Market and Forecast
3.2 China IVD Market Share and Forecast
3.3 China IVD Company Share and Forecast
4. China IVD - Segments Wise Market and Forecast (2010 - 2027)
4.1 China Clinical Chemistry Market and Forecast
4.2 China Immunoassay Market and Forecast
4.3 China Hematology Market and Forecast
4.4 China Coagulation Market and Forecast
4.5 China Microbiology Market and Forecast
4.6 China Molecular Testing Market and Forecast
4.7 China Self-Monitoring of Blood Glucose (SMBG) Market and Forecast
4.8 China Point of Care Testing (POCT) Market and Forecast
5. Development Environment of Chinese IVD Industry
5.1 State Healthcare Reforms
5.2 State Citizen-Benefiting Policies
5.3 Requirements of Hospital Upgrading
5.4 Healthy China 2030
6. Profile of In-vitro Diagnostic Reagents Registration Control
6.1 Classification of In-vitro Diagnostic Reagents in China
6.1.1 Class III: Highest Risk
6.1.2 Class II: Medium Risk
6.1.3 Class I: Lower Risk
6.2 Regulatory History in China IVD Market
6.3 Regulatory Status in China IVD Market
6.3.1 Blood Screening Reagents - Drug Administration
6.3.2 Varieties of Blood Screening Reagents
6.3.3 Blood Screening Reagent Test
6.3.4 Nucleic Acid Detection Kits for Blood Screening
6.3.5 Radioactive reagents - Drug Administration
6.3.6 Diagnostic Reagents - Medical Devices Management
6.4 Regulatory Trend in China IVD Market
6.4.1 Blood Screening Reagents Belonging
6.4.2 Quality Improvement
6.4.3 Pre-Evaluation of Registration Standards
7. Registration for In Vitro Diagnostic Reagents in China
7.1 Registration and Filing
7.2 Filing Obligation for Clinical Trials
7.3 Clinical Trial Institutions
7.4 Elimination of IVD Loophole for Research
7.5 Change of Manufacturing Address
7.6 Change of Main Supplier of An Antigen or Antibody
7.7 China In Vitro Diagnostics Registration Update
7.7.1 IVD Product Registration in China
7.7.2 China IVD Type Testing Process
7.7.3 Clinical Trials for IVD Products in China
8. Reimbursement of IVD Products in China
9. China IVD Market - Key Players Sales Analysis (2010 - 2026)
9.1 Roche Diagnostics - China IVD Sales and Forecast
9.2 Abbott Laboratories - China IVD Sales and Forecast
9.3 Sysmex Corporation - China IVD Sales and Forecast
9.4 Mindray Medical International Limited - China IVD Sales and Forecast
9.5 Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
9.6 Others - China IVD Sales and Forecast
10. Profiles of Select Private Clinical Labs and Diagnostic Services Companies
10.1 Dian Diagnostics Group Co. Ltd. (Formerly Zhejiang Di'an Diagnostics Technology Co., Ltd.)
10.1.1 Company Overview
10.1.2 Products and Services Offered by Di'an
10.2 ADICON Clinical Laboratories (Privately held)
10.2.1 Company Overview
10.2.2 Products and Services Offered by ADICON
10.3 Guangzhou KingMed Diagnostics Center Co. Ltd.
10.3.1 Company Overview
10.3.2 Products and Services Offered by KingMed
10.4 Kindstar Global (Privately held)
10.4.1 Company Overview
10.4.2 Products and Services Offered by Kindstar
10.5 BGI-Shenzhen
10.5.1 Company Overview
10.5.2 BGI's Innovative Approach
10.6 OriGene Technologies
10.6.1 Company Overview
10.6.2 Products and Services Offered by OriGene
11. IVD Market - Major Deals
11.1 2021
11.2 2020
11.3 2019
11.4 2018
11.5 2017
11.6 2016
12. China IVD Industry Drivers
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
13. China IVD Industry Challenge
13.1 Lack of Expertise in Advanced Technology in the Local Companies
13.2 Price Pressures Limits the Participation of Multinational IVD Companies in the China IVD Market
13.3 Reimbursement Rates of Different Products Varies in Different Provinces
List of Tables:
Table 3-1: China - IVD Market Share (Percent), 2010 - 2020
Table 3-2: China - Forecast for IVD Market Share (Percent), 2021 - 2027
Table 12-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China
List of Figures:
Figure 3-1: China - IVD Market (Million US$), 2010 - 2020
Figure 3-2: China - Forecast for IVD Market (Million US$), 2021 - 2027
Figure 3-3: China IVD Market - Company Share (Percent), 2010 - 2020
Figure 3-4: China IVD Market - Forecast for Company Share (Percent), 2021 - 2026
Figure 4-1: China - Clinical Chemistry Market (Million US$), 2010 - 2020
Figure 4-2: China - Forecast for Clinical Chemistry Market (Million US$), 2021 - 2027
Figure 4-3: China - Immunoassay Market (Million US$), 2010 - 2020
Figure 4-4: China - Forecast for Immunoassay Market (Million US$), 2021 - 2027
Figure 4-5: China - Hematology Market (Million US$), 2010 - 2020
Figure 4-6: China - Forecast for Hematology Market (Million US$), 2021 - 2027
Figure 4-7: China - Coagulation Market (Million US$), 2010 - 2020
Figure 4-8: China - Forecast for Coagulation Market (Million US$), 2021 - 2027
Figure 4-9: China - Microbiology Market (Million US$), 2010 - 2020
Figure 4-10: China - Forecast for Microbiology Market (Million US$), 2021 - 2027
Figure 4-11: China - Molecular Testing Market (Million US$), 2010 - 2020
Figure 4-12: China - Forecast for Molecular Testing Market (Million US$), 2021 - 2027
Figure 4-13: China - SMBG Market (Million US$), 2010 - 2020
Figure 4-14: China - Forecast for SMBG Market (Million US$), 2021 - 2027
Figure 4-15: China - POCT Market (Million US$), 2010 - 2020
Figure 4-16: China - Forecast for POCT Market (Million US$), 2021 - 2027
Figure 9-1: Roche Diagnostics - China IVD Revenue (Million US$), 2010 - 2020
Figure 9-2: Roche Diagnostics - Forecast for China IVD Revenue (Million US$), 2021 - 2026
Figure 9-3: Abbott Laboratories - China IVD Revenue (Million US$), 2010 - 2020
Figure 9-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2021 - 2026
Figure 9-5: Sysmex Corporation - China IVD Revenue (Million US$), 2010 - 2020
Figure 9-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2021 - 2026
Figure 9-7: Mindray Medical - China IVD Revenue (Million US$), 2010 - 2020
Figure 9-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2021 - 2026
Figure 9-9: Shanghai Kehua - China IVD Revenue (Million US$), 2010 - 2020
Figure 9-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2021 - 2026
Figure 9-11: Others - China IVD Revenue (Million US$), 2010 - 2020
Figure 9-12: Others - Forecast for China IVD Revenue (Million US$), 2021 - 2026
Figure 10-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012
Figure 11-1: China - Healthcare Spending and Forecast (Billion US$), 2011 - 2020e
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