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

  • ID: 4267401
  • Report
  • May 2017
  • Region: China
  • 101 Pages
  • Renub Research
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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

FEATURED COMPANIES

  • Abbott Laboratories
  • Roche Diagnostics
  • Sysmex Corporation
  • MORE

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. 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:

1) Market and Forecast
2) Segment Wise Market & Forecast
3) Development Environment & Regulatory Status in China IVD market
4) Company Wise IVD Sales & Forecast
5) Growth Drivers for China In-Vitro Diagnostics
6) Challenges for China In-Vitro Diagnostics

China IVD Market - Segment Analysis (2007 - 2022):

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

China IVD - Companies Sales Analysis (2011 - 2022):

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

Note: This report offers 10% free customization.
Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Abbott Laboratories
  • Roche Diagnostics
  • Sysmex Corporation
  • MORE

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 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

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

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  • Abbott Laboratories
  • Mindray Medical International Limited
  • Roche Diagnostics
  • Shanghai Kehua Bio-Engineering Co. Ltd.
  • Sysmex Corporation
Note: Product cover images may vary from those shown
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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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