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China In-Vitro Diagnostics (IVD) Market, Forecast, Companies Analysis, Registration Rules

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Date: 15-May-2017
No. of pages: 101
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China In-vitro diagnostics market is expected to be triple its market size by the end of 2022 from its market size in 2016. China In-Vitro Diagnostics sector is expected to grow with a double digit CAGR of 19.01% in future. With such a huge growth rate China is poised to become the world’s largest In–vitro Diagnostics (IVD) Market in the next few years for both domestic and foreign IVD products. The In–Vitro Diagnostics (IVD) Market in China has been growing rapidly over the past few years and is expected to grow steadily in the coming future, with major growth potential in segments such as contagious disease testing, chronic disease testing and diagnosis in early stages of disease.

China In-Vitro Diagnostics (IVD) – Segment Analysis

Immunoassay has the highest market share in China IVD market, but after 2018 its market share will decline. China Microbiology Market has grown approximately 4 times in 2016 compared to its market value in 2007. China Molecular Testing Market is expected to grow almost five times in future from its present market. Contribution of Point of Care Testing (POCT) market is low compared to Hematology Market, Coagulation Market and Self Monitoring of Blood Glucose (SMBG) Market. Other segments such as Molecular testing, Clinical Chemistry and Microbiology are poised to be remarkable expansion in the near future. Roche is the leading company in the China IVD market.

Factors Driving the Growth of In-Vitro Diagnostics (IVD) in China

Some of the key factors driving the growth of China IVD market are the rising incidences of chronic lifestyle diseases, public health awareness, growing aging population, demand of tests in rural areas stimulated by the healthcare reform plan, increasing demand from the middle class for high–end products and an increase in the number of hospitals and independent clinical laboratories.

China In-Vitro Diagnostics (IVD) Market, Forecast, Companies Analysis, Registration Rules is the 5th edition report on In-Vitro Diagnostics by Renub Research. This presents a detailed account of In-Vitro Diagnostics Market, its 8 Segments Market, Companies In-Vitro Diagnostics Sales in China, Registration of In-Vitro Diagnostics in China.  

This 101 Page report with 36 Figures and 2 Tables studies the China IVD market from 6 view points:


  • Market and Forecast

  • Segment Wise Market & Forecast

  • Development Environment & Regulatory Status in China IVD market

  • Company Wise IVD Sales & Forecast  

  • Growth Drivers for China In-Vitro Diagnostics

  • Challenges for China In-Vitro Diagnostics


China IVD Market – Segment Analysis (2007 – 2022)


  • Clinical Chemistry Market & Forecast

  • Immunoassay Market & Forecast

  • Hematology Market & Forecast

  • Coagulation Market & Forecast

  • Microbiology Market & Forecast

  • Molecular Testing Market & Forecast

  • Self Monitoring of Blood Glucose (SMBG) Market & Forecast

  • Point of Care Testing (POCT) Market & Forecast


China IVD – Companies Sales Analysis (2011 – 2022)


  • Roche Diagnostics

  • Sysmex Corporation

  • Mindray Medical International Limited

  • Shanghai Kehua Bio-Engineering Co. Ltd.

  • Abbott Laboratories

  • 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

China In-Vitro Diagnostics (IVD) Market, Forecast, Companies Analysis, Registration Rules

Table of Contents

1. Executive Summary

2. China IVD Market & Market Share (2007 – 2022)
2.1 China IVD Market (2007 – 2022)
2.2 China IVD Market Share (2007 – 2022)

3. China IVD Companies Market Share (2011 – 2022)

4. China IVD Market by Segments (2007 – 2022)
4.1 China Clinical Chemistry Market & Forecast
4.2 China Immunoassay Market & Forecast
4.3 China Hematology Market & Forecast
4.4 China Coagulation Market (2007 – 2022)
4.5 China Microbiology Market & Forecast
4.6 China Molecular Testing Market & Forecast
4.7 China Self Monitoring of Blood Glucose (SMBG) Market & Forecast
4.8 China Point of Care Testing (POCT) Market & Forecast

5. Development Environment of Chinese IVD Industry
5.1 Healthcare Reforms
5.2 Improving Quality at Grass-Root Level
5.3 Embracing Technology

6. China: Health Insurance and Reimbursement Policies (New)
6.1 Health Insurance System
6.1.1 Basic Medical Insurance
6.1.2 Insurance for Other Groups
6.1.3 Rural Medical Insurance
6.1.4 Private Health Insurance
6.2 Reimbursement Rules
6.2.1 Device Reimbursement
6.2.2 Reimbursement for In-Vitro Diagnostics (IVDs)

7. Registration of 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 Update on China In-Vitro Diagnostics Registration
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. Medical Devices and Reagents Class Registration in China
8.1 Process of Medical Device Registration in China
8.2 Classification of In-vitro Diagnostic Reagents in China
8.2.1 Class III: Highest Risk
8.2.2 Class II: Medium Risk
8.2.3 Class I: Lower Risk
8.3 China In-Vitro Diagnostics Reagents
8.3.1 Blood Screening Reagents — Drug Administration
8.3.2 Varieties of Blood Screening Reagents
8.3.3 Blood Screening Reagent Test
8.3.4 Nucleic Acid Detection Kits for Blood Screening
8.3.5 Radioactive Reagents — Drug Administration
8.3.6 Diagnostic Reagents - Medical Devices Management

9. China IVD Industry Drivers
9.1 Increasing Demand from Middle Class for High Quality Healthcare Products
9.2 Rising Incidences of Lifestyle Diseases in China
9.3 Growth in Private Hospitals & Independent Diagnostic Centers
9.3.1 Increasing the Number of Hospital Beds across all Medical Institutions

10. China IVD Industry Challenges
10.1 Chinese Local Firms Lack of Expertise in Advanced Technology
10.2 Cost Factor Restricts the Contribution of Global IVD Companies in the Chinese IVD Market
10.3 Reimbursement Rates varies from Province to Province in China
10.3.1 Chinese Government Regulating Laboratory Testing in China

11. China IVD Market – Company Sales Analysis (2011 – 2022)
11.1 Roche Diagnostics - China IVD Sales & Forecast
11.2 Sysmex Corporation - China IVD Sales & Forecast
11.3 Mindray Medical International Limited - China IVD Sales & Forecast
11.4 Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
11.5 Abbott Laboratories - China IVD Sales & Forecast
11.6 Others - China IVD Sales & Forecast (2011 – 2022)

12. Profiles of Select Private Clinical Labs and Diagnostic Services Companies
12.1 Zhejiang Di’an Diagnostics Technology Co., Ltd.
12.1.1 Products and Services Offered by Di’an
12.2 ADICON Clinical Laboratories (Privately held)
12.2.1 Products and Services Offered by ADICON
12.3 Guangzhou Kingmed Diagnostics Center Co. Ltd.
12.3.1 Products and Services Offered by Kingmed
12.4 Kindstar Global (Privately held)
12.4.1 Products and Services Offered by Kindstar
12.5 BGI-Shenzhen
12.5.1 BGI’s Innovative Approach
12.6 OriGene Technologies
12.6.1 Products and Services Offered by OriGene

List of Table:

Table 7‑1: Registration Type
Table 8‑1: Number of hospital beds for every 1,000 people

List of Figures:

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 Share (Percent), 2007 – 2016
Figure 2‑4: China – Forecast for IVD Market Share (Percent), 2017 – 2022
Figure 3‑1: China – IVD Market Players Share (Percent), 2011 – 2016
Figure 3‑2: China – Forecast for IVD Market Players Share (Percent), 2017 – 2022
Figure 4‑1: China – Clinical Chemistry Market (Million US$), 2007 – 2016
Figure 4‑2: China – Forecast for Clinical Chemistry Market (Million US$), 2017 – 2022
Figure 4‑3: China – Immunoassay Market (Million US$), 2007 – 2016
Figure 4‑4: China – Forecast for Immunoassay Market (Million US$), 2017 – 2022
Figure 4‑5: China – Hematology Market (Million US$), 2007 – 2016
Figure 4‑6: China – Forecast for Hematology Market (Million US$), 2017 – 2022
Figure 4‑7: China – Coagulation Market (Million US$), 2007 – 2016
Figure 4‑8: China – Forecast for Coagulation Market (Million US$), 2017 – 2022
Figure 4‑9: China – Microbiology Market (Million US$), 2007 – 2016
Figure 4‑10: China – Forecast for Microbiology Market (Million US$), 2017 – 2022
Figure 4‑11: China – Molecular Testing Market (Million US$), 2007 – 2016
Figure 4‑12: China – Forecast for Molecular Testing Market (Million US$), 2017 – 2022
Figure 4‑13: China – SMBG Market (Million US$), 2007 – 2016
Figure 4‑14: China – Forecast for SMBG Market (Million US$), 2017 – 2022
Figure 4‑15: China – POCT Market (Million US$), 2007 – 2016
Figure 4‑16: China – Forecast for POCT Market (Million US$), 2017 – 2022
Figure 7‑1: Process of Medical Device Registration in China
Figure 7‑2: In-vitro Diagnostic System Applied for Market Approval in China
Figure 8‑1: China – Healthcare Spending (Billion US$), 2011 & 2020
Figure 10‑1: Roche Diagnostics – China IVD Revenue (Million US$), 2011 - 2016
Figure 10‑2: Roche Diagnostics – Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 10‑3: Sysmex Corporation – China IVD Revenue (Million US$), 2011 - 2016
Figure 10‑4: Sysmex Corporation – Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 10‑5: Mindray Medical – China IVD Revenue (Million US$), 2011 - 2016
Figure 10‑6: Mindray Medical – Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 10‑7: Shanghai Kehua – China IVD Revenue (Million US$), 2011 - 2016
Figure 10‑8: Shanghai Kehua – Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 10‑9: Others – China IVD Revenue (Million US$), 2011 - 2016
Figure 10‑10: Others – Forecast for China IVD Revenue (Million US$), 2017 - 2022
Figure 11‑1: Kindstar – Collaboration with hospitals in China (Number), 2006-2013

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