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China in Vitro Diagnostics Market, Size, Forecast 2022-2027, Industry Trends, Growth, Share, Impact of COVID-19, Company Analysis

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    Report

  • 155 Pages
  • February 2022
  • Region: China
  • Renub Research
  • ID: 5546180
China In-vitro diagnostics (IVD) Market is central to the provision of healthcare globally and is estimated to be US$ 18.9 Billion in 2027. Besides, China is the largest clinical laboratory market in Asia and one of the world's fastest-growing medical realms. Remarkably, over the past years, the rate of Chinese economic growth has been impressive, setting lucrative growth in GDP per year. In addition, the Chinese IVD landscape has historically been controlled by large international providers, with few domestic instrumentation and assay suppliers. Further, looking for a change, the start-up company sees the evolution of diagnostic platforms and assays presenting rapid detection for a wide range of blood-based markers.

China In-Vitro Diagnostics Industry is expanding with double-digit CAGR of 16.9% during 2021-2027


The Chinese IVDs industry is growing for years and has a significant global research and production base. In China, there is a solid clinical demand for the continuous development of IVD enterprises. However, new diagnostic requirements are constantly emerging, requiring clinical laboratories to carry out further testing projects and IVD enterprises to devise new technologies and products. Further, with the improved living standards of the Chinese people and the aging speed of the Chinese population, the demand for family health management is increasing; this avenue will thus become an important growth point for in vitro diagnostics enterprises.

How Coronavirus Benefited China In-Vitro Diagnostics Market Growth Trends


COVID-19 has further accelerated the growth of In-vitro diagnostics industry in China. As China has maintained the zero COVID policy, so in order to achieve that large number of PCR testing and Rapid Antigen tests needs to be performed. Due to COVID variants like Alpha, Beta, Gamma Delta, Delta Plus, and recently Omnicorn, the PCR test and Rapid Antigen tests will keep on happening in huge numbers. According to the publisher, the China In-Vitro Diagnostics Market Size was US$ 7.4 Billion in 2021.

Molecular Diagnostics Segment Registers Strong Growth in the Chinese in Vitro Diagnostics Market


In our report, By Segments - China in Vitro Diagnostics Market has been categorized into clinical chemistry, Immunoassay, Molecular Diagnostic, Microbiology, Haematology, and Self-Monitoring of Blood Glucose (SMBG), Point of Care Testing (POCT), and Coagulation. In IVD, one of the most valuable advances has been in the form of molecular diagnostic tools. As per our analysis, the polymerase chain reaction is the most conventional forefront of molecular diagnostics.

Besides, the real-time PCR products simultaneously detect viruses, bacteria, fungi, and parasites, allowing molecular laboratories to lower costs and drive better outcomes in molecular diagnostics. Remarkably, molecular diagnostic tests are used to detect specific sequences in DNA or RNA (including single nucleotide polymorphism (SNP), deletions, rearrangements, insertions, and others) that may or may not be associated with any disease.

Key Players in the Chinese IVD Market


Major international IVD companies already have a substantial presence in the Chinese market and represent potential competitive barriers to prospective market entrants. The key players include Roche Diagnostics, Sysmex Corporation, Bio-Rad Laboratories Inc., Shanghai Kehua Bio-Engineering Co. Ltd., Abbott Laboratories, Danaher Corporation, and BioMerieux SA.

The companies enjoy significantly greater financial resources to afford costs associated with product certification, clinical trials, and agent representation. Additionally, these companies can make the acquisitions necessary to establish direct distribution and local manufacturing operations.

This research report titled “China In-Vitro Diagnostics (IVD) Market, By Segment [Clinical Chemistry, Immunoassay, Molecular Diagnostic, Microbiology, Hematology, Self-Monitoring of Blood Glucose (SMBG), Point of Care Testing (POCT), Coagulation], Companies (Roche Diagnostics, Sysmex Corporation, Bio-Rad Laboratories Inc., Shanghai Kehua Bio-Engineering Co. Ltd., Abbott Laboratories, Danaher Corporation, and BioMerieux SA)” studies the China IVD Industry.

Segments - China in Vitro Diagnostics Market has been covered 8 viewpoints:


  • Clinical Chemistry Market
  • Immunoassay Market
  • Molecular Diagnostic Market
  • Microbiology Market
  • Hematology Market
  • Self-Monitoring of Blood Glucose (SMBG) Market
  • Point of Care Testing (POCT) Market
  • Coagulation Market

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


  • Overview
  • Initiatives & Recent Developments
  • Revenue

Company Analysis:


  • Roche Diagnostics
  • Sysmex Corporation
  • Bio-Rad Laboratories Inc.
  • Shanghai Kehua Bio-Engineering Co. Ltd.
  • Abbott Laboratories
  • Danaher Corporation
  • BioMerieux SA

Table of Contents

1. Introduction2. Research Methodology3. Executive Summary
4. Market Dynamics
4.1 Growth Drivers
4.2 Challenges
5. China In-Vitro Diagnostics Market
6. Market Share -China in Vitro Diagnostics
6.1 By Segment
7. Segments - China in Vitro Diagnostics Market
7.1 Clinical Chemistry Market
7.2 Immunoassay Market
7.3 Molecular Diagnostic Market
7.4 Microbiology Market
7.5 Hematology Market
7.6 Self-Monitoring of Blood Glucose (SMBG) Market
7.7 Point of Care Testing (POCT) Market
7.8 Coagulation Market
8. Development Environment of Chinese IVD Industry
8.1 Healthcare Reforms
8.2 Improving Quality at Grass-Root Level
8.3 Embracing Technology
9. China: Health Insurance and Reimbursement Policies
9.1 Health Insurance System
9.1.1 Basic Medical Insurance
9.1.2 Insurance for Other Groups
9.1.3 Rural Medical Insurance
9.1.4 Private Health Insurance
9.2 Reimbursement Rules
9.2.1 Device Reimbursement
9.2.2 Reimbursement for In-Vitro Diagnostics (IVDs)
10. Registration of In Vitro Diagnostic Reagents in China
10.1 Registration and Filing
10.2 Filing Obligation for Clinical Trials
10.3 Clinical Trial Institutions
10.4 Elimination of IVD Loophole for Research
10.5 Change of Manufacturing Address
10.6 Change of Main Supplier of an Antigen or Antibody
10.7 Update on China In-Vitro Diagnostics Registration
10.7.1 IVD Product Registration in China
10.7.2 China IVD Type Testing Process
10.7.3 Clinical Trials for IVD Products in China
11. Medical Devices and Reagents Class Registration in China
11.1 Process of Medical Device Registration in China
11.2 Classification of In-vitro Diagnostic Reagents in China
11.2.1 Class III: Highest Risk
11.2.2 Class II: Medium Risk
11.2.3 Class I: Lower Risk
11.3 China In-Vitro Diagnostics Reagents
11.3.1 Blood Screening Reagents - Drug Administration
11.3.2 Varieties of Blood Screening Reagents
11.3.3 Blood Screening Reagent Test
11.3.4 Nucleic Acid Detection Kits for Blood Screening
11.3.5 Radioactive Reagents - Drug Administration
11.3.6 Diagnostic Reagents - Medical Devices Management
12. Porters Five Forces
12.1 Overview
12.2 Bargaining Power of Buyers
12.3 Bargaining Power of Suppliers
12.4 Degree of Competition
12.5 Threat of New Entrants
12.6 Threat of Substitutes
13. Company Analysis
13.1 Roche Diagnostics
13.1.1 Overviews
13.1.2 Recent Developments
13.1.3 Revenues
13.2 Sysmex Corporation
13.2.1 Overviews
13.2.2 Recent Developments
13.2.3 Revenues
13.3 Bio-Rad Laboratories Inc.
13.3.1 Overviews
13.3.2 Recent Developments
13.3.3 Revenues
13.4 Shanghai Kehua Bio-Engineering Co. Ltd.
13.4.1 Overviews
13.4.2 Recent Developments
13.4.3 Revenues
13.5 Abbott Laboratories
13.5.1 Overviews
13.5.2 Recent Developments
13.5.3 Revenues
13.6 Danaher Corporation
13.6.1 Overviews
13.6.2 Recent Developments
13.6.3 Revenues
13.7 BioMerieux SA
13.7.1 Overviews
13.7.2 Recent Developments
13.7.3 Revenues
14. Profiles of Select Private Clinical Labs and Diagnostic Services Companies
14.1 Zhejiang Di’an Diagnostics Technology Co., Ltd.
14.1.1 Products and Services Offered by Di’an
14.2 ADICON Clinical Laboratories (Privately held)
14.2.1 Products and Services Offered by ADICON
14.3 Guangzhou Kingmed Diagnostics Center Co. Ltd.
14.3.1 Products and Services Offered by Kingmed
14.4 Kindstar Global (Privately held)
14.4.1 Products and Services Offered by Kindstar
14.5 BGI-Shenzhen
14.5.1 BGI’s Innovative Approach
14.6 OriGene Technologies
14.6.1 Products and Services Offered by OriGene
List of Figures
Figure 01: China In-Vitro Diagnostics Market (Million US$), 2016 - 2021
Figure 02: Forecast for - China In-Vitro Diagnostics Market (Million US$), 2022 - 2027
Figure 03: Segments - Clinical Chemistry Market (Million US$), 2016 - 2021
Figure 04: Segments - Forecast for Clinical Chemistry Market (Million US$), 2022 - 2027
Figure 05: Segments - Immunoassay Market (Million US$), 2016 - 2021
Figure 06: Segments - Forecast for Immunoassay Market (Million US$), 2022 - 2027
Figure 07: Segments - Molecular Diagnostic Market (Million US$), 2016 - 2021
Figure 08: Segments - Forecast for Molecular Diagnostic Market (Million US$), 2022 - 2027
Figure 09: Segments - Microbiology Market (Million US$), 2016 - 2021
Figure 10: Segments - Forecast for Microbiology Market (Million US$), 2022 - 2027
Figure 11: Segments - Hematology Market (Million US$), 2016 - 2021
Figure 12: Segments - Forecast for Hematology Market (Million US$), 2022 - 2027
Figure 13: Segments - Self-Monitoring of Blood Glucose (SMBG) Market (Million US$), 2016 - 2021
Figure 14: Segments - Forecast for Self-Monitoring of Blood Glucose (SMBG) Market (Million US$), 2022 - 2027
Figure 15: Segments - Point of Care Testing (POCT) Market (Million US$), 2016 - 2021
Figure 16: Segments - Forecast for Point of Care Testing (POCT) Market (Million US$), 2022 - 2027
Figure 17: Segments - Coagulation Market (Million US$), 2016 - 2021
Figure 18: Segments - Forecast for Coagulation Market (Million US$), 2022 - 2027
Figure 19: Roche Diagnostics - Global Revenue (Million US$), 2016 - 2021
Figure 20: Roche Diagnostics - Forecast for Global Revenue (Million US$), 2022 - 2027
Figure 21: Sysmex Corporation - Global Revenue (Million US$), 2016 - 2021
Figure 22: Sysmex Corporation - Forecast for Global Revenue (Million US$), 2022 - 2027
Figure 23: Bio-Rad Laboratories Inc. - Global Revenue (Million US$), 2016 - 2021
Figure 24: Bio-Rad Laboratories Inc. - Forecast for Global Revenue (Million US$), 2022 - 2027
Figure 25: Shanghai Kehua Bio-Engineering Co. Ltd. - Global Revenue (Million US$), 2016 - 2021
Figure 26: Shanghai Kehua Bio-Engineering Co. Ltd. - Forecast for Global Revenue (Million US$), 2022 - 2027
Figure 27: Abbott Laboratories - Global Revenue (Million US$), 2016 - 2021
Figure 28: Abbott Laboratories - Forecast for Global Revenue (Million US$), 2022 - 2027
Figure 29: Danaher Corporation - Global Revenue (Million US$), 2016 - 2021
Figure 30: Danaher Corporation - Forecast for Global Revenue (Million US$), 2022 - 2027
Figure 31: BioMerieux SA - Global Revenue (Million US$), 2016 - 2021
Figure 32: BioMerieux SA - Forecast for Global Revenue (Million US$), 2022 - 2027
List of Tables
Table 01: China - In-Vitro Diagnostics Market Share by Segment (Percent), 2016 - 2021
Table 02: China - Forecast for In-Vitro Diagnostics Market Share by Segment (Percent), 2022 - 2027

Companies Mentioned

  • Abbott Laboratories
  • ADICON Clinical Laboratories (Privately held)
  • BGI-Shenzhen
  • BioMerieux SA
  • Bio-Rad Laboratories Inc.
  • Danaher Corporation
  • Guangzhou Kingmed Diagnostics Center Co. Ltd.
  • Kindstar Global (Privately held)
  • OriGene Technologies
  • Roche Diagnostics
  • Shanghai Kehua Bio-Engineering Co. Ltd.
  • Sysmex Corporation
  • Zhejiang Di’an Diagnostics Technology Co., Ltd.

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
 

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