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市場調查報告書

中國的體外診斷 (IVD) 市場,企業分析及預測

China In-Vitro Diagnostics (IVD) Market, Company Analysis & Forecast to 2022

出版商 iGate Research Pvt Ltd 商品編碼 511190
出版日期 內容資訊 英文 100 Pages
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中國的體外診斷 (IVD) 市場,企業分析及預測 China In-Vitro Diagnostics (IVD) Market, Company Analysis & Forecast to 2022
出版日期: 2017年06月05日 內容資訊: 英文 100 Pages
簡介

本報告提供中國的體外診斷 (IVD) 市場相關調查,市場的成果與預測,各市場區隔的市場成果與預測,開發環境與法規情形,各企業的銷售額與預測,IVD試劑的登記情形,主要的民間臨床實驗室、診斷服務企業簡介,及市場促進要素與課題等相關彙整。

第1章 摘要整理

第2章 中國的IVD市場、市場佔有率分析

  • 中國的IVD市場、預測
  • 中國的IVD市場佔有率、預測
  • 中國的IVD企業佔有率、預測

第3章 中國的IVD:各市場區隔的市場、預測

  • 中國的臨床化學市場、預測
  • 中國的免疫檢測市場、預測
  • 中國的血液學市場、預測
  • 中國的凝固市場、預測
  • 中國的微生物學市場、預測
  • 中國的分子檢驗市場、預測
  • 中國的血糖自我監測 (SMBG) 市場、預測
  • 中國的就地檢驗 (POCT) 市場、預測

第4章 中國的IVD產業的發展環境

  • 政府的醫療制度改革
  • 政府的國民支援政策
  • 醫院升級的必要條件

第5章 體外診斷劑登記管理簡介

  • 中國的體外診斷劑的分類
  • 中國的IVD市場上法規的歷史
  • 中國的IVD市場上法規情形
  • 中國的IVD市場上法規趨勢

第6章 中國的體外診斷劑的登記

  • 登記、申請
  • 臨床實驗的申請義務
  • 臨床實驗設施
  • 消除研究的IVD的漏洞
  • 產地的變化
  • 抗原或抗體的主要供應商的變化
  • 中國的體外診斷登記的更新

第7章 中國的IVD市場:各企業的銷售額分析

  • Roche Diagnostic:中國的IVD銷售額、預測
  • Abbott Laboratories:中國的IVD銷售額、預測
  • Sysmex Corporation:中國的IVD銷售額、預測
  • Mindray Medical International Limited:中國的IVD銷售額、預測
  • Shanghai Kehua Bio-Engineering Co. Ltd.:中國的IVD銷售額、預測
  • 其他:中國的IVD銷售額、預測

第8章 主要民間臨床實驗室、診斷服務企業簡介

  • Zhejiang Di'an Diagnostics Technology Co., Ltd.
  • ADICON Clinical Laboratories (Privately held)
  • Guangzhou Kingmed Diagnostics Center Co. Ltd.
  • Kindstar Global (Privately held)
  • BGI-Shenzhen
  • OriGene Technologies
    • 企業概要
    • 產品與服務

第9章 中國的IVD產業上促進要素

  • 限制實驗室檢驗的政府的配合措施
  • 民間醫院 & 獨立型檢驗實驗室的增加
  • 中國政府的政策IVD的投資

第10章 中國的IVD產業上課題

  • 國內企業中先進技術的專家不足
  • 價格壓力抑制中國的IVD市場上多國籍IVD企業的進入
  • 各產品的醫療費償付率,依地區 (省) 而有各式各樣

圖表一覽

目錄

China In-Vitro Diagnostics (IVD) market is likely to more than triple by 2022 from its current level in 2016. China represents one of the largest clinical laboratory markets in the Asia-Pacific region, and the fastest growing among the top ten IVD country markets. With an aging population, a rapidly growing middle class and a government encouraging preventive care, China IVD market is slated to show substantial growth in the future. China's quickly aging population means the country is experiencing an explosion of chronic conditions such as diabetes, heart disease and cancer. All of these conditions can be diagnosed and monitored using IVD products. Further, the average Chinese consumer is now willing and able to pay more for healthcare than a decade years ago. Hence, China has the potential for more dramatic growth in the future.

China IVD Market Segment Wise Analysis: Immunoassay is the leading segment in China IVD market. Immunoassay is likely to maintain its dominant position in the forecasting period as well. Clinical Chemistry holds the 2nd position in China IVD market being followed by Molecular Testing. SMBG market accounted for XXX percent market share in 2016. Microbiology and Hematology segments are competing closely with each other to grab maximum share of the pie.

China IVD Market Company Analysis: In China IVD market, Roche Diagnostics is the leader with XXX percent market share in 2016. Sysmex Corporation and Mindary Medical are other top two players in the China IVD market. At present, many local players are present in China IVD market and their combined market share was XXX percent in 2016.

This is the 2nd edition report on China IVD Market by iGATE RESEARCH. The report titled "China In-Vitro Diagnostics (IVD) Market, Company Analysis & Forecast to 2022" studies in detail the China IVD Market - Application Segment Wise, Company Sales, Registration & Regulatory Status in China IVD & Driving Factors and Challenges for China IVD Market.

This 100 Page report with 34 Figures and 3 Tables has been analyzed from 8 View Points:

  • 1) China IVD Market and Forecast (2007 - 2022)
  • 2) China IVD Segment Wise Market & Forecast (2007 - 2022)
  • 3) Development Environment and Regulatory Status in China IVD market
  • 4) Company Wise IVD Sales & Forecast (2010 - 2022)
  • 5) Registration for In Vitro Diagnostic Reagents in China
  • 6) Regulatory History/Status/Trends in China IVD Market
  • 7) Profiles of Select Private Clinical Labs and Diagnostic Services Companies
  • 8) China IVD Industry Drivers & Challenges

China IVD Market - 8 Application Segments Covered

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

Company Wise IVD Sales & Forecast

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

Data Source

iGATE RESEARCH employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. This report is built by using data and information sourced from Proprietary Information Database, Primary and Secondary Research Methodologies, and In house analysis by iGATE Research dedicated team of qualified professionals with deep industry experience and expertise.

Research Methodologies

Primary Research Methodologies: Questionnaires, Surveys, Interviews with Individuals, Small Groups, Telephonic Interview, etc.

Secondary Research Methodologies: Printable and Non-printable sources, Newspaper, Magazine and Journal Content, Government and NGO Statistics, white Papers, Information on the Web, Information from Agencies Such as Industry Bodies, Companies Annual Report, Government Agencies, Libraries and Local Councils and a large number of Paid Databases.

Table of Contents

1. Executive Summary

2. China IVD Market and Market Share Analysis (2007 - 2022)

  • 2.1 China IVD Market and Forecast
  • 2.2 China IVD Market Share and Forecast
  • 2.3 China IVD Company Share and Forecast

3. China IVD - Segments Wise Market and Forecast (2007 - 2022)

  • 3.1 China Clinical Chemistry Market and Forecast
  • 3.2 China Immunoassay Market and Forecast
  • 3.3 China Hematology Market and Forecast
  • 3.4 China Coagulation Market and Forecast
  • 3.5 China Microbiology Market and Forecast
  • 3.6 China Molecular Testing Market and Forecast
  • 3.7 China Self Monitoring of Blood Glucose (SMBG) Market and Forecast
  • 3.8 China Point of Care Testing (POCT) Market and Forecast

4. Development Environment of Chinese IVD Industry

  • 4.1 State Healthcare Reforms
  • 4.2 State Citizen-Benefiting Policies
  • 4.3 Requirements of Hospital Upgrading

5. Profile of In-vitro Diagnostic Reagents Registration Control

  • 5.1 Classification of In-vitro Diagnostic Reagents in China
    • 5.1.1 Class III: Highest Risk
    • 5.1.2 Class II: Medium Risk
    • 5.1.3 Class I: Lower Risk
  • 5.2 Regulatory History in China IVD Market
  • 5.3 Regulatory Status in China IVD Market
    • 5.3.1 Blood Screening Reagents - Drug Administration
    • 5.3.2 Varieties of Blood Screening Reagents
    • 5.3.3 Blood Screening Reagent Test
    • 5.3.4 Nucleic Acid Detection Kits for Blood Screening
    • 5.3.5 Radioactive reagents - Drug Administration
    • 5.3.6 Diagnostic Reagents - Medical Devices Management
  • 5.4 Regulatory Trend in China IVD Market
    • 5.4.1 Blood Screening Reagents Belonging
    • 5.4.2 Quality Improvement
    • 5.4.3 Pre-Evaluation of Registration Standards

6. Registration for In Vitro Diagnostic Reagents in China

  • 6.1 Registration and Filing
  • 6.2 Filing Obligation for Clinical Trials
  • 6.3 Clinical Trial Institutions
  • 6.4 Elimination of IVD Loophole for Research
  • 6.5 Change of Manufacturing Address
  • 6.6 Change of Main Supplier of An Antigen or Antibody
  • 6.7 China In Vitro Diagnostics Registration Update
    • 6.7.1 IVD Product Registration in China
    • 6.7.2 China IVD Type Testing Process
    • 6.7.3 Clinical Trials for IVD Products in China

7. China IVD Market - Company Wise Sales Analysis (2010 - 2022)

  • 7.1 Roche Diagnostic - China IVD Sales and Forecast
  • 7.2 Abbott Laboratories - China IVD Sales and Forecast
  • 7.3 Sysmex Corporation - China IVD Sales and Forecast
  • 7.4 Mindray Medical International Limited - China IVD Sales and Forecast
  • 7.5 Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
  • 7.6 Others - China IVD Sales and Forecast

8. Profiles of Select Private Clinical Labs and Diagnostic Services Companies

  • 8.1 Zhejiang Di'an Diagnostics Technology Co., Ltd.
    • 8.1.1 Company Overview
    • 8.1.2 Products and Services Offered by Di'an
  • 8.2 ADICON Clinical Laboratories (Privately held)
    • 8.2.1 Company Overview
    • 8.2.2 Products and Services Offered by ADICON
  • 8.3 Guangzhou Kingmed Diagnostics Center Co. Ltd.
    • 8.3.1 Company Overview
    • 8.3.2 Products and Services Offered by Kingmed
  • 8.4 Kindstar Global (Privately held)
    • 8.4.1 Company Overview
    • 8.4.2 Products and Services Offered by Kindstar
  • 8.5 BGI-Shenzhen
    • 8.5.1 Company Overview
    • 8.5.2 BGI's Innovative Approach
  • 8.6 OriGene Technologies
    • 8.6.1 Company Overview
    • 8.6.2 Products and Services Offered by OriGene

9. China IVD Industry Drivers

  • 9.1 Government Efforts to Regulate Laboratory testing
  • 9.2 Increasing Number of Private Hospitals & Independent Testing Laboratories
  • 9.3 Chinese Government Policies Encourage Investment in IVD

10. China IVD Industry Challenge

  • 10.1 Lack of Expertise in Advanced Technology in the Local Companies
  • 10.2 Price Pressures Limits the Participation of Multinational IVD Companies in the China IVD Market
  • 10.3 Reimbursement Rates of Different Products Varies in Different Provinces

List of Figure:

  • 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 - Company Share (Percent), 2010 - 2016
  • Figure 2-4: China IVD Market - Forecast for Company Share (Percent), 2017 - 2022
  • Figure 3-1: China - Clinical Chemistry Market (Million US$), 2007 - 2016
  • Figure 3-2: China - Forecast for Clinical Chemistry Market (Million US$), 2017 - 2022
  • Figure 3-3: China - Immunoassay Market (Million US$), 2007 - 2016
  • Figure 3-4: China - Forecast for Immunoassay Market (Million US$), 2017 - 2022
  • Figure 3-5: China - Hematology Market (Million US$), 2007 - 2016
  • Figure 3-6: China - Forecast for Hematology Market (Million US$), 2017 - 2022
  • Figure 3-7: China - Coagulation Market (Million US$), 2007 - 2016
  • Figure 3-8: China - Forecast for Coagulation Market (Million US$), 2017 - 2022
  • Figure 3-9: China - Microbiology Market (Million US$), 2007 - 2016
  • Figure 3-10: China - Forecast for Microbiology Market (Million US$), 2017 - 2022
  • Figure 3-11: China - Molecular Testing Market (Million US$), 2007 - 2016
  • Figure 3-12: China - Forecast for Molecular Testing Market (Million US$), 2017 - 2022
  • Figure 3-13: China - SMBG Market (Million US$), 2007 - 2016
  • Figure 3-14: China - Forecast for SMBG Market (Million US$), 2017 - 2022
  • Figure 3-15: China - POCT Market (Million US$), 2007 - 2016
  • Figure 3-16: China - Forecast for POCT Market (Million US$), 2017 - 2022
  • Figure 7-1: Roche Diagnostic - China IVD Revenue (Million US$), 2010-2016
  • Figure 7-2: Roche Diagnostic - Forecast for China IVD Revenue (Million US$), 2017 - 2022
  • Figure 7-3: Abbott Laboratories - China IVD Revenue (Million US$), 2010 - 2016
  • Figure 7-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2017 - 2022
  • Figure 7-5: Sysmex Corporation - China IVD Revenue (Million US$), 2010 - 2016
  • Figure 7-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2017 - 2022
  • Figure 7-7: Mindray Medical - China IVD Revenue (Million US$), 2010 - 2016
  • Figure 7-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2017 - 2022
  • Figure 7-9: Shanghai Kehua - China IVD Revenue (Million US$), 2010 - 2016
  • Figure 7-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2017 - 2022
  • Figure 7-11: Others - China IVD Revenue (Million US$), 2010 - 2016
  • Figure 7-12: Others - Forecast for China IVD Revenue (Million US$), 2017 - 2022
  • Figure 8-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012
  • Figure 9-1: China - Healthcare Spending and Forecast (Billion US$), 2011 - 2020

List of Tables:

  • Table 2-1: China - IVD Market Share (Percent), 2007 - 2016
  • Table 2-2: China - Forecast for IVD Market Share (Percent), 2017 - 2022
  • Table 9-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China
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