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体外診断 (IVD) の中国市場 - 規模、シェア、動向、規制、償還、主要企業分析:2026年までの予測

China In-Vitro Diagnostics (IVD) Market, Size, Share, Trends, Regulations, Reimbursement & Key Players Analysis - Forecast to 2026

発行 iGate Research Pvt Ltd 商品コード 927572
出版日 ページ情報 英文 108 Pages
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体外診断 (IVD) の中国市場 - 規模、シェア、動向、規制、償還、主要企業分析:2026年までの予測 China In-Vitro Diagnostics (IVD) Market, Size, Share, Trends, Regulations, Reimbursement & Key Players Analysis - Forecast to 2026
出版日: 2020年03月09日 ページ情報: 英文 108 Pages
概要

中国の体外診断 (IVD) 市場は、2026年までに約176億米ドルに達する見込みです。中国は、アジア太平洋地域で最大の臨床検査市場の1つで、IVDの上位10ヶ国市場の中でも最も急成長しています。

当レポートでは、中国の体外診断 (IVD) 市場について調査分析し、市場と予測、市場シェアと予測、セグメント別の市場分析、規制情勢、主要企業などについて、体系的な情報を提供しています。

目次

第1章 エグゼクティブサマリー

第2章 中国のIVD市場と市場シェア分析

  • 中国のIVD市場と予測
  • 中国のIVD市場シェアと予測
  • 中国のIVD企業シェアと予測

第3章 中国のIVD - セグメント別の市場と予測

  • 中国の臨床化学市場と予測
  • 中国のイムノアッセイ市場と予測
  • 中国の血液学市場と予測
  • 中国の凝固市場と予測
  • 中国の微生物学市場と予測
  • 中国の分子検査市場と予測
  • 中国の血糖自己測定 (SMBG) 市場と予測
  • 中国のポイントオブケア検査 (POCT) 市場と予測

第4章 中国のIVD産業の開発環境

  • 省別の医療制度改革
  • 省別の市民利益政策
  • 病院整備の要件

第5章 IVD試薬の登録管理のプロファイル

  • 中国のIVD試薬の分類
  • 中国のIVD市場における規制の歴史
  • 中国のIVD市場における規制状況
  • 中国のIVD市場における規制動向

第6章 中国のIVD試薬の登録

  • 登録と申告
  • 臨床試験の申告義務
  • 臨床試験機関
  • 調査に対するIVDの抜け道の除外
  • 製造拠点の変更
  • 抗原または抗体の主要サプライヤーの変更
  • 中国のIVDの登録

第7章 中国のIVD製品の償還

第8章 中国のIVD市場 - 主要企業の販売分析

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

第9章 主要な民間臨床機関・診断サービス企業のプロファイル

  • Diagnostics Group Co. Ltd.
  • ADICON Clinical Laboratories
  • Guangzhou Kingmed Diagnostics Center Co. Ltd.
  • Kindstar Global
  • BGI-Shenzhen
  • OriGene Technologies

第10章 中国のIVD産業の促進要因

第11章 中国のIVD産業の課題

目次

China In-Vitro Diagnostics (IVD) market is likely to reach around US$ 17.6 Billion by 2026. 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. Historically, large multinational companies have dominated IVD market in China; today, domestic companies such as Shanghai Kehua Bio-Engineering (KHB) being one of the largest - are now gaining market share.

China is a large and fast-growing in vitro diagnostics (IVD) market - in fact, only second to the United States in terms of value. 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 captures maximum share of the China IVD market.
  • Clinical Chemistry holds the 2nd position in China IVD market being followed by Molecular Testing.
  • The molecular testing market in China is expected to show double digits growth rate during the forecast period.
  • China SMBG market is dominated by foreign IVD companies such as Roche.
  • Microbiology and Hematology segments are competing closely with each other to grab maximum share of the pie.
  • Point of Care Testing accounts for least share of the China IVD market.

China IVD Market Company Analysis

  • Roche captures maximum share of the China IVD market.
  • Sysmex Corporation and Mindary Medical are other top two players in the China IVD market.
  • Sysmex has built a robust infrastructure in China, working with more than 200 sales distributors to provide products and services throughout the country.
  • In Abbott's worldwide diagnostics business, sales growth over the last three years reflected the acquisition of Alere in October of 2017.
  • At present, many local players are present in China IVD market and their combined market share is likely to exceed 60 percent by 2026.

iGATE RESEARCH report titled "China In-Vitro Diagnostics (IVD) Market, Size, Share, Trends, Regulations, Reimbursement & Key Players Analysis - Forecast to 2026" provides a comprehensive analysis of the China In-Vitro Diagnostics (IVD Market.

This 108 Page report with 34 Figures and 3 Tables has been analyzed from 10 View Points:

  • 1) China IVD Market and Forecast (2010 - 2026)
  • 2) China IVD Market Share and Forecast (2010 - 2026)
  • 3) China IVD Market & Forecast - By Segment (2010 - 2026)
  • 4) Development Environment and Regulatory Status in China IVD market
  • 5) China IVD Market & Forecast - Key Players Sales Analysis (2010 - 2026)
  • 6) Registration for In Vitro Diagnostic Reagents in China
  • 7) Regulatory History/Status/Trends in China IVD Market
  • 8) Reimbursement of IVD Products in China
  • 9) Profiles of Select Private Clinical Labs and Diagnostic Services Companies
  • 10) China IVD Industry Drivers & Challenges

China IVD Market - By Application Segments

  • 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

China IVD Sales & Forecast - Key Players Analysis

  • 1. Roche Diagnostics
  • 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

  • Dian Diagnostics Group Co. Ltd. (Formerly Zhejiang Di'an Diagnostics Technology Co., Ltd.)
  • ADICON Clinical Laboratories
  • Guangzhou Kingmed Diagnostics Center Co. Ltd.
  • Kindstar Global
  • BGI-Shenzhen
  • OriGene Technologies

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 (2010 - 2026)

  • 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 (2010 - 2026)

  • 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. Reimbursement of IVD Products in China

8. China IVD Market - Key Players Sales Analysis (2010 - 2026)

  • 8.1 Roche Diagnostics - China IVD Sales and Forecast
  • 8.2 Abbott Laboratories - China IVD Sales and Forecast
  • 8.3 Sysmex Corporation - China IVD Sales and Forecast
  • 8.4 Mindray Medical International Limited - China IVD Sales and Forecast
  • 8.5 Shanghai Kehua Bio-Engineering Co. Ltd. - China IVD Sales & Forecast
  • 8.6 Others - China IVD Sales and Forecast

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

  • 9.1 Dian Diagnostics Group Co. Ltd. (Formerly Zhejiang Di'an Diagnostics Technology Co., Ltd.)
    • 9.1.1 Company Overview
    • 9.1.2 Products and Services Offered by Di'an
  • 9.2 ADICON Clinical Laboratories (Privately held)
    • 9.2.1 Company Overview
    • 9.2.2 Products and Services Offered by ADICON
  • 9.3 Guangzhou Kingmed Diagnostics Center Co. Ltd.
    • 9.3.1 Company Overview
    • 9.3.2 Products and Services Offered by Kingmed
  • 9.4 Kindstar Global (Privately held)
    • 9.4.1 Company Overview
    • 9.4.2 Products and Services Offered by Kindstar
  • 9.5 BGI-Shenzhen
    • 9.5.1 Company Overview
    • 9.5.2 BGI's Innovative Approach
  • 9.6 OriGene Technologies
    • 9.6.1 Company Overview
    • 9.6.2 Products and Services Offered by OriGene

10. China IVD Industry Drivers

  • 10.1 Government Efforts to Regulate Laboratory testing
  • 10.2 Increasing Number of Private Hospitals & Independent Testing Laboratories
  • 10.3 Chinese Government Policies Encourage Investment in IVD

11. China IVD Industry Challenge

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

List of Figures:

  • Figure 2-1: China - IVD Market (Million US$), 2010 - 2019
  • Figure 2-2: China - Forecast for IVD Market (Million US$), 2020 - 2026
  • Figure 2-3: China IVD Market - Company Share (Percent), 2010 - 2019
  • Figure 2-4: China IVD Market - Forecast for Company Share (Percent), 2020 - 2026
  • Figure 3-1: China - Clinical Chemistry Market (Million US$), 2010 - 2019
  • Figure 3-2: China - Forecast for Clinical Chemistry Market (Million US$), 2020 - 2026
  • Figure 3-3: China - Immunoassay Market (Million US$), 2010 - 2019
  • Figure 3-4: China - Forecast for Immunoassay Market (Million US$), 2020 - 2026
  • Figure 3-5: China - Hematology Market (Million US$), 2010 - 2019
  • Figure 3-6: China - Forecast for Hematology Market (Million US$), 2020 - 2026
  • Figure 3-7: China - Coagulation Market (Million US$), 2010 - 2019
  • Figure 3-8: China - Forecast for Coagulation Market (Million US$), 2020 - 2026
  • Figure 3-9: China - Microbiology Market (Million US$), 2010 - 2019
  • Figure 3-10: China - Forecast for Microbiology Market (Million US$), 2020 - 2026
  • Figure 3-11: China - Molecular Testing Market (Million US$), 2010 - 2019
  • Figure 3-12: China - Forecast for Molecular Testing Market (Million US$), 2020 - 2026
  • Figure 3-13: China - SMBG Market (Million US$), 2010 - 2019
  • Figure 3-14: China - Forecast for SMBG Market (Million US$), 2020 - 2026
  • Figure 3-15: China - POCT Market (Million US$), 2010 - 2019
  • Figure 3-16: China - Forecast for POCT Market (Million US$), 2020 - 2026
  • Figure 8-1: Roche Diagnostics - China IVD Revenue (Million US$), 2010 - 2019
  • Figure 8-2: Roche Diagnostics - Forecast for China IVD Revenue (Million US$), 2020 - 2026
  • Figure 8-3: Abbott Laboratories - China IVD Revenue (Million US$), 2010 - 2019
  • Figure 8-4: Abbott Laboratories - Forecast for China IVD Revenue (Million US$), 2020 - 2026
  • Figure 8-5: Sysmex Corporation - China IVD Revenue (Million US$), 2010 - 2019
  • Figure 8-6: Sysmex Corporation - Forecast for China IVD Revenue (Million US$), 2020 - 2026
  • Figure 8-7: Mindray Medical - China IVD Revenue (Million US$), 2010 - 2019
  • Figure 8-8: Mindray Medical - Forecast for China IVD Revenue (Million US$), 2020 - 2026
  • Figure 8-9: Shanghai Kehua - China IVD Revenue (Million US$), 2010 - 2019
  • Figure 8-10: Shanghai Kehua - Forecast for China IVD Revenue (Million US$), 2020 - 2026
  • Figure 8-11: Others - China IVD Revenue (Million US$), 2010 - 2019
  • Figure 8-12: Others - Forecast for China IVD Revenue (Million US$), 2020 - 2026
  • Figure 9-1: Kindstar - Collaboration with Hospitals in China (Number), 2006 - 2012
  • Figure 10-1: China - Healthcare Spending and Forecast (Billion US$), 2011 - 2020

List of Tables:

  • Table 2-1: China - IVD Market Share (Percent), 2010 - 2019
  • Table 2-2: China - Forecast for IVD Market Share (Percent), 2020 - 2026
  • Table 10-1: China Food and Drug Administration - Regulation and Impact for Medical Device and IVD Manufacturers Selling in China