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China In Vitro Diagnostics (IVD) Market, By Segment (Clinical Chemistry, Immunoassay, Molecular Testing, Microbiology, Hematology, SMBG, POCT, Coagulation) and Companies

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  • January 2021
  • Region: China
  • Renub Research
  • ID: 5231631

In China, the in vitro diagnostic industry has evolved since the 1980s, and now the key players are manufacturing from single and straight forward products to complete industrial chains. The 21st century brought a rapid development in China's IVD industry, where all the tools such as reagents and instruments are produced in-house. The increasing number of test volumes related to clinical chemistry, immunoassay, haematology, coagulation and microbiology are in high demand. They are acting as a catalysing role for the growth of the China IVD industry. According to this report, China's In Vitro Diagnostics Market will be USD 22.3 Billion by 2026.

The major growth drivers for China's IVD industry are increasing demand from the middle class for high-quality healthcare products, and rising incidences of lifestyle diseases. In China, there has been massive expenditure in every healthcare segment in the areas of pharmaceuticals, medical devices, and traditional Chinese medicines. The significant barriers for China's IVD industry is the lagging by local manufacturers in the adoption of advanced technology.

In October 2020, Roche diagnostics launched the product "Roche’s Tecentriq" with Avastin which was approved by CFDA for the treatment of liver cancer. The outbreak of Covid-19 has impacted IVD products by playing a vital role in the diagnosis of coronavirus symptoms.

This report studies the China IVD Industry and is broken down as follows:

By Segment - The Report Studies the Market of the following 8 Categories:

  1. Clinical Chemistry
  2. Immunoassay
  3. Molecular Testing
  4. Microbiology
  5. Hematology
  6. Self Monitoring of Blood Glucose (SMBG)
  7. Point of Care Testing (POCT)
  8. Coagulation

Key Players covered in the report which has been studied from 3 viewpoints:

  1. Overview
  2. Initiatives & Recent Developments
  3. Revenue

Companies covered in this report:

  1. Roche Diagnostics
  2. Sysmex Corporation
  3. Mindray Medical International Limited
  4. Shanghai Kehua Bio-Engineering Co. Ltd.
  5. Abbott Laboratories

Table of Contents

1.    Introduction

2.    Executive Summary

3.    Market Dynamics
3.1    Growth Drivers
3.2    Challenges

4.    China IVD Market

5.    Market Share
5.1    By Segments

6.    Segments - China's IVD Market
6.1    Clinical Chemistry Market
6.2    Immunoassay Market
6.3    Molecular Diagnostic Market
6.4    Microbiology Market
6.5    Hematology Market
6.6    Self Monitoring of Blood Glucose (SMBG) Market
6.7    Point of Care Testing (POCT) Market
6.8    Coagulation Market

7.    Development Environment of the Chinese IVD Industry
7.1    Healthcare Reforms
7.2    Improving Quality at Grass-Root Level
7.3    Embracing Technology

8.    China: Health Insurance and Reimbursement Policies
8.1    Health Insurance System
8.1.1    Basic Medical Insurance
8.1.2    Insurance for Other Groups
8.1.3    Rural Medical Insurance
8.1.4    Private Health Insurance
8.2    Reimbursement Rules
8.2.1    Device Reimbursement
8.2.2    Reimbursement for In-Vitro Diagnostics (IVDs)

9.    Registration of In Vitro Diagnostic Reagents in China
9.1    Registration and Filing
9.2    Filing Obligation for Clinical Trials
9.3    Clinical Trial Institutions
9.4    Elimination of IVD Loophole for Research
9.5    Change of Manufacturing Address
9.6    Change of Main Supplier of an Antigen or Antibody
9.7    Update on China In-Vitro Diagnostics Registration
9.7.1    IVD Product Registration in China
9.7.2    China IVD Type Testing Process
9.7.3    Clinical Trials for IVD Products in China

10.    Medical Devices and Reagents Class Registration in China
10.1    Process of Medical Device Registration in China
10.2    Classification of In-vitro Diagnostic Reagents in China
10.2.1    Class III: Highest Risk    
10.2.2    Class II: Medium Risk
10.2.3    Class I: Lower Risk
10.3    China In-Vitro Diagnostics Reagents
10.3.1    Blood Screening Reagents - Drug Administration
10.3.2    Varieties of Blood Screening Reagents
10.3.3    Blood Screening Reagent Test
10.3.4    Nucleic Acid Detection Kits for Blood Screening
10.3.5    Radioactive Reagents - Drug Administration
10.3.6    Diagnostic Reagents - Medical Devices Management

11.    Company Sales Analysis
11.1    Roche Diagnostics
11.1.1    Overview
11.1.2    Initiatives & Recent Developments
11.1.3    Sales Revenue
11.2    Sysmex Corporation
11.2.1    Overview
11.2.2    Initiatives & Recent Developments
11.2.3    Sales Revenue
11.3    Mindray Medical International Limited
11.3.1    Overview
11.3.2    Initiatives & Recent Developments
11.3.3    Sales Revenue
11.4    Shanghai Kehua Bio-Engineering Co. Ltd.
11.4.1    Overview
11.4.2    Initiatives & Recent Developments
11.4.3    Sales Revenue
11.5    Abbott Laboratories
11.5.1    Overview
11.5.2    Initiatives & Recent Developments
11.5.3    Sales Revenue

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 Figures:

Figure 3-1: China – Healthcare Spending (Billion US$), 2011 & 2020
Figure 4-1: China – IVD Market (Billion US$), 2014 – 2020
Figure 4-2: China – Forecast for IVD Market (Billion US$), 2021 – 2026
Figure 5-1: China – IVD Market Share by Segments (Percent), 2014 – 2020
Figure 5-2: China – Forecast for IVD Market Share by Segments (Percent), 2021 – 2026
Figure 6-1: China IVD – Clinical Chemistry Market (Million US$), 2014 – 2020
Figure 6-2: China IVD – Forecast for Clinical Chemistry Market (Million US$), 2021 – 2026
Figure 6-3: China IVD – Immunoassay Market (Million US$), 2014 – 2020
Figure 6-4: China IVD – Forecast for Immunoassay Market (Million US$), 2021 – 2026
Figure 6-5: China IVD – Molecular Testing Market (Million US$), 2014 – 2020
Figure 6-6: China IVD – Forecast for Molecular Testing Market (Million US$), 2021 – 2026
Figure 6-7: China IVD – Microbiology Market (Million US$), 2014 – 2020
Figure 6-8: China IVD – Forecast for Microbiology Market (Million US$), 2021 – 2026
Figure 6-9: China – Hematology Market (Million US$), 2014 – 2020
Figure 6-10: China – Forecast for Hematology Market (Million US$), 2021 – 2026
Figure 6-11: China IVD – SMBG Market (Million US$), 2014 – 2020
Figure 6-12: China IVD – Forecast for SMBG Market (Million US$), 2021 – 2026
Figure 6-13: China IVD – POCT Market (Million US$), 2014 – 2020
Figure 6-14: China IVD – Forecast for POCT Market (Million US$), 2021 – 2026
Figure 6-15: China IVD – Coagulation Market (Million US$), 2014 – 2020
Figure 6-16: China IVD – Forecast for Coagulation Market (Million US$), 2021 – 2026
Figure 10-1: Process of Medical Device Registration in China
Figure 10-2: In-vitro Diagnostic System Applied for Market Approval in China
Figure 11-1: Roche Diagnostics – China IVD Revenue (Million US$), 2014 - 2020
Figure 11-2: Roche Diagnostics – Forecast for China IVD Revenue (Million US$), 2021 - 2026
Figure 11-3: Sysmex Corporation – China IVD Revenue (Million US$), 2014 - 2020
Figure 11-4: Sysmex Corporation – Forecast for China IVD Revenue (Million US$), 2021 - 2027
Figure 11-5: Qiagen – China IVD Revenue (Million US$), 2014 - 2020
Figure 11-6: Qiagen – Forecast for China IVD Revenue (Million US$), 2021 - 2027
Figure 11-7: Shanghai Kehua – China IVD Revenue (Million US$), 2016 - 2020
Figure 11-8: Shanghai Kehua – Forecast for China IVD Revenue (Million US$), 2021 - 2027
Figure 11-9: Abbott Laboratories – China IVD Revenue (Million US$), 2014 - 2020
Figure 11-10: Abbott Laboratories – Forecast for China IVD Revenue (Million US$), 2021 - 2027
Figure 12-1: Kindstar – Collaboration with hospitals in China (Number), 2006-2013List of Tables:

Table 3-1: Number of hospital beds for every 1,000 people
Table 10-1:Registration Type, 2016

Companies Mentioned

  • Abbott Laboratories
  • Mindray Medical International Limited
  • Roche Diagnostics
  • Shanghai Kehua Bio-Engineering Co. Ltd.
  • Sysmex Corporation



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