China In-Vitro Diagnostics (IVD) Market, Company Analysis & Forecast To 2022

China In-Vitro Diagnostics (IVD) market is likely to more than triple by 2022 from its current level in 2016. 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 In-Vitro Diagnostics (IVD) market is likely to more than triple by 2022 from its current level in 2016. 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. With an aging population, a rapidly growing middle class and a government encouraging preventive care, China IVD market is slated to show substantial growth in the future. 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 is the leading segment in China IVD market. Immunoassay is likely to maintain its dominant position in the forecasting period as well. Clinical Chemistry holds the 2nd position in China IVD market being followed by Molecular Testing. SMBG market accounted for XXX percent market share in 2016. Microbiology and Hematology segments are competing closely with each other to grab maximum share of the pie.

China IVD Market Company Analysis: In China IVD market, Roche Diagnostics is the leader with XXX percent market share in 2016. Sysmex Corporation and Mindary Medical are other top two players in the China IVD market. At present, many local players are present in China IVD market and their combined market share was XXX percent in 2016. 

This is the 2nd edition report on China IVD Market by iGATE RESEARCH. The report titled “China In-Vitro Diagnostics (IVD) Market, Company Analysis & Forecast to 2022” studies in detail the China IVD Market - Application Segment Wise, Company Sales, Registration & Regulatory Status in China IVD & Driving Factors and Challenges for China IVD Market.    

This 100 Page report with 34 Figures and 3 Tables has been analyzed from 8 View Points:

1) China IVD Market and Forecast (2007 - 2022)
2) China IVD Segment Wise Market & Forecast (2007 - 2022)
3) Development Environment and Regulatory Status in China IVD market 
4) Company Wise IVD Sales & Forecast (2010 - 2022)
5) Registration for In Vitro Diagnostic Reagents in China
6) Regulatory History/Status/Trends in China IVD Market
7) Profiles of Select Private Clinical Labs and Diagnostic Services Companies
8) China IVD Industry Drivers & Challenges

China IVD Market - 8 Application Segments Covered

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 

Company Wise IVD Sales & Forecast 

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 (2007 - 2022) 

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 (2007 - 2022) 

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. China IVD Market - Company Wise Sales Analysis (2010 - 2022)
 
7.1 Roche Diagnostic - China IVD Sales and Forecast
7.2 Abbott Laboratories - China IVD Sales and Forecast
7.3 Sysmex Corporation - China IVD Sales and Forecast
7.4 Mindray Medical International Limited - China IVD Sales and Forecast
7.5 Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
7.6 Others - China IVD Sales and Forecast

8. Profiles of Select Private Clinical Labs and Diagnostic Services Companies

8.1 Zhejiang Di’an Diagnostics Technology Co., Ltd. 

8.1.1 Company Overview
8.1.2 Products and Services Offered by Di’an

8.2 ADICON Clinical Laboratories (Privately held) 

8.2.1 Company Overview
8.2.2 Products and Services Offered by ADICON

8.3 Guangzhou Kingmed Diagnostics Center Co. Ltd. 

8.3.1 Company Overview
8.3.2 Products and Services Offered by Kingmed

8.4 Kindstar Global (Privately held) 

8.4.1 Company Overview
8.4.2 Products and Services Offered by Kindstar

8.5 BGI-Shenzhen

8.5.1 Company Overview
8.5.2 BGI’s Innovative Approach

8.6 OriGene Technologies

8.6.1 Company Overview
8.6.2 Products and Services Offered by OriGene

9. China IVD Industry Drivers

9.1 Government Efforts to Regulate Laboratory testing
9.2 Increasing Number of Private Hospitals & Independent Testing Laboratories
9.3 Chinese Government Policies Encourage Investment in IVD

10. China IVD Industry Challenge

10.1 Lack of Expertise in Advanced Technology in the Local Companies
10.2 Price Pressures Limits the Participation of Multinational IVD Companies in the China IVD Market
10.3 Reimbursement Rates of Different Products Varies in Different Provinces

List of Figure:

Figure 2-1: China - IVD Market (Million US$), 2007 - 2016
Figure 2-2: China - Forecast for IVD Market (Million US$), 2017 - 2022
Figure 2-3: China IVD Market - Company Share (Percent), 2010 - 2016
Figure 2-4: China IVD Market - Forecast for Company Share (Percent), 2017 - 2022

Figure 3-1: China - Clinical Chemistry Market (Million US$), 2007 - 2016
Figure 3-2: China - Forecast for Clinical Chemistry Market (Million US$), 2017 - 2022
Figure 3-3: China - Immunoassay Market (Million US$), 2007 - 2016
Figure 3-4: China - Forecast for Immunoassay Market (Million US$), 2017 - 2022
Figure 3-5: China - Hematology Market (Million US$), 2007 - 2016
Figure 3-6: China - Forecast for Hematology Market (Million US$), 2017 - 2022
Figure 3-7: China - Coagulation Market (Million US$), 2007 - 2016
Figure 3-8: China - Forecast for Coagulation Market (Million US$), 2017 - 2022
Figure 3-9: China - Microbiology Market (Million US$), 2007 - 2016
Figure 3-10: China - Forecast for Microbiology Market (Million US$), 2017 - 2022
Figure 3-11: China - Molecular Testing Market (Million US$), 2007 - 2016
Figure 3-12: China - Forecast for Molecular Testing Market (Million US$), 2017 - 2022
Figure 3-13: China - SMBG Market (Million US$), 2007 - 2016
Figure 3-14: China - Forecast for SMBG Market (Million US$), 2017 - 2022
Figure 3-15: China - POCT Market (Million US$), 2007 - 2016
Figure 3-16: China - Forecast for POCT Market (Million US$), 2017 - 2022

Figure 7-1: Roche Diagnostic - China IVD Revenue (Million US$), 2010-2016
Figure 7-2: Roche Diagnostic - Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 7-3: Abbott Laboratories - China IVD Revenue (Million US$), 2010 - 2016
Figure 7-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 7-5: Sysmex Corporation - China IVD Revenue (Million US$), 2010 - 2016
Figure 7-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 7-7: Mindray Medical - China IVD Revenue (Million US$), 2010 - 2016
Figure 7-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 7-9: Shanghai Kehua - China IVD Revenue (Million US$), 2010 - 2016
Figure 7-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 7-11: Others - China IVD Revenue (Million US$), 2010 - 2016
Figure 7-12: Others - Forecast for China IVD Revenue (Million US$), 2017 - 2022

Figure 8-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012

Figure 9-1: China - Healthcare Spending and Forecast (Billion US$), 2011 - 2020

List of Tables:

Table 2-1: China - IVD Market Share (Percent), 2007 - 2016
Table 2-2: China - Forecast for IVD Market Share (Percent), 2017 - 2022

Table 9-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China