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中国の体外診断 (IVD) 市場:予測、企業分析、登録ルール

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

発行 Renub Research 商品コード 320308
出版日 ページ情報 英文 101 Pages; 36 Figures; 2 Tables
納期: 即日から翌営業日
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中国の体外診断 (IVD) 市場:予測、企業分析、登録ルール China In Vitro Diagnostics (IVD) Market, Forecast, Companies Analysis, Registration Rules
出版日: 2017年05月15日 ページ情報: 英文 101 Pages; 36 Figures; 2 Tables
概要

中国の体外診断 (IVD) 市場は、2022年末までに、2016年の市場規模の3倍まで拡大すると見込まれています。市場は、CAGR (複合年間成長率) で、19.01%の成長が予測されています。

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、セグメント別の市場・予測、発展環境と規制状況、企業別の売上高・予測、成長促進要因、課題など、体系的な情報を提供しています。

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

  • 中国のIVD市場
  • 中国のIVD市場シェア

第3章 中国のIVD企業の市場シェア

第4章 中国のIVD市場:セグメント別

  • 中国の臨床化学市場・予測
  • 中国のイムノアッセイ市場・予測
  • 中国の血液学市場・予測
  • 中国の凝固市場・予測
  • 中国の微生物学市場・予測
  • 中国の分子検査市場・予測
  • 中国の血糖セルフモニタリング (SMBG) 市場・予測
  • 中国のポイントオブケア (POCT) 市場・予測

第5章 中国のIVD産業の発展環境

  • 医療改革
  • 一般大衆レベルの品質の向上
  • 技術の活用

第6章 中国:健康保険と償還政策

  • 健康保険制度
  • 償還ルール

第7章 中国のIVD試薬の登録

第8章 中国の医療機器・試薬クラスの登録

第9章 中国のIVD産業の促進要因

  • 中産階級による高品質医療製品への需要増加
  • 中国における生活習慣病の急増
  • 民間病院・独立系診断センターの成長

第10章 中国のIVD産業の課題

  • 現地企業における先進技術の専門知識の不足
  • コスト要因が世界のIVD企業の貢献を抑制
  • 省ごとに異なる償還率

第11章 中国のIVD市場:企業別の売上高分析

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

第12章 主要な民間臨床ラボ・診断サービス企業のプロファイル

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

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目次

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 by Renub Research. 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)

Table of Contents

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 Table:

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