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:
- Clinical Chemistry
- Immunoassay
- Molecular Testing
- Microbiology
- Hematology
- Self Monitoring of Blood Glucose (SMBG)
- Point of Care Testing (POCT)
- Coagulation
Key Players covered in the report which has been studied from 3 viewpoints:
- Overview
- Initiatives & Recent Developments
- Revenue
Companies covered in this report:
- Roche Diagnostics
- Sysmex Corporation
- Mindray Medical International Limited
- Shanghai Kehua Bio-Engineering Co. Ltd.
- 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
Methodology
In this report, for analyzing the future trends for the studied market during the forecast period, the publisher has incorporated rigorous statistical and econometric methods, further scrutinized by secondary, primary sources and by in-house experts, supported through their extensive data intelligence repository. The market is studied holistically from both demand and supply-side perspectives. This is carried out to analyze both end-user and producer behavior patterns, in the review period, which affects price, demand and consumption trends. As the study demands to analyze the long-term nature of the market, the identification of factors influencing the market is based on the fundamentality of the study market.
Through secondary and primary researches, which largely include interviews with industry participants, reliable statistics, and regional intelligence, are identified and are transformed to quantitative data through data extraction, and further applied for inferential purposes. The publisher's in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. These analytical tools and models sanitize the data & statistics and enhance the accuracy of their recommendations and advice.
Primary Research
The primary purpose of this phase is to extract qualitative information regarding the market from the key industry leaders. The primary research efforts include reaching out to participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions. The publisher also established professional corporate relations with various companies that allow us greater flexibility for reaching out to industry participants and commentators for interviews and discussions, fulfilling the following functions:
- Validates and improves the data quality and strengthens research proceeds
- Further develop the analyst team’s market understanding and expertise
- Supplies authentic information about market size, share, growth, and forecast
The researcher's primary research interview and discussion panels are typically composed of the most experienced industry members. These participants include, however, are not limited to:
- Chief executives and VPs of leading corporations specific to the industry
- Product and sales managers or country heads; channel partners and top level distributors; banking, investment, and valuation experts
- Key opinion leaders (KOLs)
Secondary Research
The publisher refers to a broad array of industry sources for their secondary research, which typically includes, however, is not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Patent and regulatory databases for understanding of technical & legal developments
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic new articles, webcasts, and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecasts
LOADING...
