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China In-Vitro Diagnostics (IVD) Market, Impact of COVID-19, Size, Share, Regulations, Reimbursement, Major Deals, Key Players Analysis, Trends & Recent Developments - Forecast to 2028

  • Published Date : March, 2022
  • Pages : 263
  • Type : Diagnostics

China In-Vitro Diagnostics (IVD) market is predicted to reach US$ 21 Billion by 2028. In China, COVID–19 disease has infected around 147,437 people, and the death toll has reached 4,638. Maximum testing and quick hospitalization are key components for flattening the curve. In this scenario, the in-vitro diagnostics forms the crux of increased testing.

China In-Vitro Diagnostics (IVD) market is predicted to reach US$ 21 Billion by 2028. 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.  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 2022 by offering medical and health services. Such initiatives by the government are expected to boost market growth during the forecast period. 

Impact of COVID-19 on China In-Vitro Diagnostics Market 
 
The COVID–19 outbreak has become a global stress test. As the number of people infected with the virus continues to rise around the world, uncertainties about global economic growth increases. The COVID–19 disease has infected around 486 Million people worldwide. Globally the death toll has reached 6,157,201 according to the latest statistics from the Worldometers (as of March 30, 2022). In China, COVID–19 disease has infected around 147,437 people (as of March 30, 2022), and the death toll has reached 4,638. The clouds of the new coronavirus threat loom over the world and continue to create havoc in the lives of millions of people. Maximum testing and quick hospitalization are key components for flattening the curve. 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, being followed by Clinical Chemistry segment.

• Molecular Testing stands at the 3rd spot and its market share is expected to rise throughout the forecast period, due to steady demand of polymerase chain reaction (PCR) products in China IVD market.

• 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, followed by Sysmex Corporation. 

• Shanghai Kehua Bio-Engineering Co. Ltd. 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 four years reflected the acquisition of Alere in October of 2017.

• In March 2022, Mindray, a global leading medical solution provider, has launched the new BC-700 Series, a revolutionary hematology analyzer series that incorporates both complete blood count (CBC) and erythrocyte sedimentation rate (ESR) tests.

• 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. 
 

iGATE RESEARCH report titled “China In-Vitro Diagnostics (IVD) Market, Impact of COVID-19, Size, Share, Regulations, Reimbursement, Major Deals, Key Players Analysis, Trends & Recent Developments - Forecast to 2028” provides a comprehensive analysis of the China In-Vitro Diagnostics (IVD) Market.

This 263 Page report with 33 Figures and 3 Tables has been analyzed from 13 View Points:

1) China IVD Market and Forecast (2010 - 2028)
2) Impact of COVID-19 on China IVD Market 
3) China IVD Market Share and Forecast (2010 - 2028)
4) China IVD Market & Forecast – By Segment (2010 - 2028)
5) Development Environment and Regulatory Status in China IVD market 
6) China IVD Market & Forecast – Key Players Sales Analysis (2010 - 2027)
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) IVD Market – Recent Developments
12) IVD Market – Major Deals
13) China IVD Industry Drivers & Challenges


China IVD Market – By Application Segment 

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. Bio–Rad Laboratories, Inc
7. Danaher Corporation
8. Biomerieux
9. 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.

1. Executive Summary

2. Impact of COVID-19 on China IVD Market

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

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 - 2028) 

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 - 2027) 

9.1 Roche Diagnostics

9.1.1 Business Overview
9.1.2 Roche Diagnostics - China IVD Sales and Forecast
9.1.3 Recent Initiatives/ Strategy/ Developments

9.2 Abbott Laboratories

9.2.1 Business Overview
9.2.2 Abbott Laboratories - China IVD Sales and Forecast
9.2.3 Recent Initiatives/ Strategy/ Developments

9.3 Sysmex Corporation

9.3.1 Business Overview
9.3.2 Sysmex Corporation - China IVD Sales and Forecast
9.3.3 Recent Initiatives/ Strategy/ Developments

9.4 Mindray Medical International Limited

9.4.1 Business Overview
9.4.2 Mindray Medical International Limited - China IVD Sales and Forecast
9.4.3 Recent Initiatives/ Strategy/ Developments

9.5 Shanghai Kehua Bio-Engineering Co. Ltd. 

9.5.1 Business Overview
9.5.2 Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
9.5.3 Recent Initiatives/ Strategy/ Developments

9.6 Bio–Rad Laboratories, Inc

9.6.1 Business Overview
9.6.2 Recent Initiatives/ Strategy/ Developments

9.7 Danaher Corporation

9.7.1 Business Overview
9.7.2 Recent Initiatives/ Strategy/ Developments

9.8 Biomerieux

9.8.1 Business Overview
9.8.2 Recent Initiatives/ Strategy/ Developments

9.9 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 – Recent Developments

12. IVD Market – Major Deals

12.1 2022
12.2 2021
12.3 2020
12.4 2019
12.5 2018
12.6 2017
12.7 2016

13. China IVD Market - Driving Factors

13.1 Government Efforts to Regulate Laboratory testing
13.2 Healthy China 2030 Initiatives to Fuel China IVD Market
13.3 Increasing Number of Private Hospitals & Independent Testing Laboratories
13.4 Chinese Government Policies Encourage Investment in IVD
13.5 Technology Advancement Spurring the IVD Market
13.6 High Prevalence of Chronic and Infectious Diseases

14. China IVD Market - Challenges

14.1 Lack of Expertise in Advanced Technology in the Local Companies
14.2 Price Pressures Limits Participation of Multinational IVD Companies in China IVD Market
14.3 Reimbursement Rates of Different Products Varies in Different Provinces
14.4 Operational Barriers Faced in Conducting Diagnostic Tests

List of Figures:

Figure 3-1: China - IVD Market (Million US$), 2010 - 2021
Figure 3-2: China - Forecast for IVD Market (Million US$), 2022 - 2028
Figure 3-3: China IVD Market - Company Share (Percent), 2010 - 2021
Figure 3-4: China IVD Market - Forecast for Company Share (Percent), 2022 - 2028

Figure 4-1: China - Clinical Chemistry Market (Million US$), 2010 - 2021
Figure 4-2: China - Forecast for Clinical Chemistry Market (Million US$), 2022 - 2028
Figure 4-3: China - Immunoassay Market (Million US$), 2010 - 2021
Figure 4-4: China - Forecast for Immunoassay Market (Million US$), 2022 - 2028
Figure 4-5: China - Hematology Market (Million US$), 2010 - 2021
Figure 4-6: China - Forecast for Hematology Market (Million US$), 2022 - 2028
Figure 4-7: China - Coagulation Market (Million US$), 2010 - 2021
Figure 4-8: China - Forecast for Coagulation Market (Million US$), 2022 - 2028
Figure 4-9: China - Microbiology Market (Million US$), 2010 - 2021
Figure 4-10: China - Forecast for Microbiology Market (Million US$), 2022 - 2028
Figure 4-11: China - Molecular Testing Market (Million US$), 2010 - 2021
Figure 4-12: China - Forecast for Molecular Testing Market (Million US$), 2022 - 2028
Figure 4-13: China - SMBG Market (Million US$), 2010 - 2021
Figure 4-14: China - Forecast for SMBG Market (Million US$), 2022 - 2028
Figure 4-15: China - POCT Market (Million US$), 2010 - 2021
Figure 4-16: China - Forecast for POCT Market (Million US$), 2022 - 2028

Figure 9-1: Roche Diagnostics - China IVD Revenue (Million US$), 2010 - 2021
Figure 9-2: Roche Diagnostics - Forecast for China IVD Revenue (Million US$), 2022 - 2027
Figure 9-3: Abbott Laboratories - China IVD Revenue (Million US$), 2010 - 2021
Figure 9-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2022 - 2027
Figure 9-5: Sysmex Corporation - China IVD Revenue (Million US$), 2010 – 2021
Figure 9-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2022 - 2027
Figure 9-7: Mindray Medical - China IVD Revenue (Million US$), 2010 - 2021
Figure 9-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2022 - 2027
Figure 9-9: Shanghai Kehua - China IVD Revenue (Million US$), 2010 - 2021
Figure 9-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2022 - 2027
Figure 9-11: Others - China IVD Revenue (Million US$), 2010 - 2021
Figure 9-12: Others - Forecast for China IVD Revenue (Million US$), 2022 - 2027

Figure 10-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012

List of Tables:

Table 3-1: China - IVD Market Share (Percent), 2010 - 2021
Table 3-2: China - Forecast for IVD Market Share (Percent), 2022 - 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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