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China IVD Market, Share, Trends, Regulations, Reimbursement & Key Players Analysis - Forecast to 2025

  • Published Date : February 2019
  • Pages : 106
  • Type : Diagnostics

China In-Vitro Diagnostics (IVD) market is likely to exceed US$ 15 Billion mark by 2025. 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 In-Vitro Diagnostics (IVD) market is likely to exceed US$ 15 Billion mark by 2025. 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. 

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 is expanding its business portfolio in China, such as by entering the immunochemistry field there in 2015.

• At present, many local players are present in China IVD market and their combined market share is likely to exceed 54 percent by 2025. 

iGATE RESEARCH report titled “China IVD Market, Share, Trends, Regulations, Reimbursement & Key Players Analysis - Forecast to 2025” provides a comprehensive analysis of the China In-Vitro Diagnostics (IVD) Market.

This 106 Page report with 34 Figures and 3 Tables has been analyzed from 10 View Points:

1) China IVD Market and Forecast (2009 - 2025)
2) China IVD Market Share and Forecast (2009 - 2025)
3) China IVD Market & Forecast – By Segment (2009 - 2025)
4) Development Environment and Regulatory Status in China IVD market 
5) China IVD Market & Forecast – Key Players Sales Analysis (2010 - 2025)
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) 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 Diagnostic
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

• Zhejiang Di’an Diagnostics Technology Co., Ltd
• ADICON Clinical Laboratories
• Guangzhou Kingmed Diagnostics Center Co. Ltd.
• Kindstar Global (Privately held)
• BGI-Shenzhen (Privately held)
• OriGene Technologies (Privately held)

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. China IVD Market and Market Share Analysis (2009 - 2025) 

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 (2009 - 2025) 

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 - 2025) 

8.1 Roche Diagnostic - 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 Figures:

Figure 2-1: China - IVD Market (Million US$), 2009 - 2018
Figure 2-2: China - Forecast for IVD Market (Million US$), 2019 - 2025
Figure 2-3: China IVD Market - Company Share (Percent), 2009 - 2018
Figure 2-4: China IVD Market - Forecast for Company Share (Percent), 2019 - 2025

Figure 3-1: China - Clinical Chemistry Market (Million US$), 2009 - 2018
Figure 3-2: China - Forecast for Clinical Chemistry Market (Million US$), 2019 - 2025
Figure 3-3: China - Immunoassay Market (Million US$), 2009 - 2018
Figure 3-4: China - Forecast for Immunoassay Market (Million US$), 2019 - 2025
Figure 3-5: China - Hematology Market (Million US$), 2009 - 2018
Figure 3-6: China - Forecast for Hematology Market (Million US$), 2019 - 2025
Figure 3-7: China - Coagulation Market (Million US$), 2009 - 2018
Figure 3-8: China - Forecast for Coagulation Market (Million US$), 2019 - 2025
Figure 3-9: China - Microbiology Market (Million US$), 2009 - 2018
Figure 3-10: China - Forecast for Microbiology Market (Million US$), 2019 - 2025
Figure 3-11: China - Molecular Testing Market (Million US$), 2009 - 2018
Figure 3-12: China - Forecast for Molecular Testing Market (Million US$), 2019 - 2025
Figure 3-13: China - SMBG Market (Million US$), 2009 - 2018
Figure 3-14: China - Forecast for SMBG Market (Million US$), 2019 - 2025
Figure 3-15: China - POCT Market (Million US$), 2009 - 2018
Figure 3-16: China - Forecast for POCT Market (Million US$), 2019 - 2025

Figure 8-1: Roche Diagnostic - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-2: Roche Diagnostic - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-3: Abbott Laboratories - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-5: Sysmex Corporation - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-7: Mindray Medical - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-9: Shanghai Kehua - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2019 - 2025
Figure 8-11: Others - China IVD Revenue (Million US$), 2010 - 2018
Figure 8-12: Others - Forecast for China IVD Revenue (Million US$), 2019 - 2025

Figure 9-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012
Figure 10-1: China - Healthcare Spending and Forecast (Billion US$), 2011 - 2020

List of Tables:

Table 2-1: China - IVD Market Share (Percent), 2009 - 2018
Table 2-2: China - Forecast for IVD Market Share (Percent), 2019 - 2025

Table 10-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China

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