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市場調査レポート

心臓マーカー診断検査市場

Cardiac Marker Diagnostic Testing Markets

発行 TriMark Publications 商品コード 220781
出版日 ページ情報 英文 196 Pages
納期: 即日から翌営業日
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心臓マーカー診断検査市場 Cardiac Marker Diagnostic Testing Markets
出版日: 2015年01月01日 ページ情報: 英文 196 Pages
担当者のコメント
TriMark Publicationsは、米国ニューヨークに本社を置く医療分野専門の市場調査会社です。世界市場の中でもアメリカ市場の分析を得意としています。比較的短いスパンで情報が更新されることから、最新データが網羅されているとして継続的に購入されるお客様が多い出版社の一つです。当レポートでは、2010年から2020年までの世界12カ国における心臓マーカー市場の実績および予測値をお届けしております。
概要

毎年、世界で1,700万人が心血管疾患で死亡しています。

当レポートでは、心臓マーカー検査のための体外診断(IVD)市場を分析し、病院やクリニックで用いられる臨床測定装置や試薬、備品、および心臓マーカー診断検査の将来的発展予測などをまとめてお届けいたします。

第1章 概要

第2章 バイオマーカーの基礎

第3章 心臓マーカー検査市場:市場セグメント分析:規模、成長、シェア

  • 世界の心臓マーカー診断検査市場
  • 米国の心臓マーカー検査市場
  • 欧州の心臓マーカー検査市場
  • 日本の心臓マーカー検査市場
  • 中国の心臓マーカー検査市場
  • カナダの心臓マーカー検査市場
  • 心臓マーカー検査の個別市場

第4章 心血管疾患マーカー

  • コレステロール、HDL、LDL
  • ホモシステイン
  • フィブリノゲン
  • C-反応性タンパク質
  • リポタンパク分画
  • 肺塞栓
  • 酸化LDLとHDL
  • 脳梗塞

第5章 心臓マーカー検査開発上の問題

  • 遺伝子検査と個別化医療
  • 予防医学
  • 患者の安全性と品質
  • 償還
  • 心血管疾患スクリーニングコード
  • 糖尿病スクリーニング
  • その他の償還問題
  • CPT検査コードと支払い学
  • 院内での即時検査
  • 衛星施設
  • 検査所ケアの地域化
  • POCT:最新市場動向および成長促進因子
  • 臨床検査室改善 (CLIA)
  • 法規制要件
  • 記録保管とデータ管理

第6章 業界のビジネス動向

  • セクターの統合
  • 診断検査成長動向
  • 買収、ライセンス契約、内部開発と提携
  • 心臓マーカー検査における製品検査の複雑さ
  • 政府の規制
  • 成長の障壁
  • 成長の促進力

第7章 重要な技術動向

  • 心臓マーカー診断検査動向
  • 心臓バイオマーカー研究
  • 潜在的脳卒中マーカー
  • 心血管マーカーの将来の開発
  • 研究における疑問
  • Lp-PLA2
  • Urotensin

第8章 企業プロファイル

図表

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目次
Product Code: TMRCMARK15-0701

Cardiac marker diagnostic testing measures the concentration of certain proteins, i.e., biomarkers, which indicate the presence or severity of cardiovascular disease (CVD). Among the most prevalent CVDs are sudden cardiac arrest (SCA), acute myocardial infarction (AMI), congestive heart failure (CHF) and atherosclerosis. Every year, an estimated 17 million people worldwide die from a CVD. This TriMark Publications report describes the specific market segment of the in vitro diagnostics (IVD) market devoted to cardiac marker testing, including size; growth; industry trends; product development and investment; and clinical measurement devices, reagents and supplies. Highly-attractive cardiac marker areas of growth covered in this review include: the cardiac rapid assay market, troponins, Creatine kinase-myocardial band (CK-MB) and brain natriuretic peptide (BNP) testing. Also examined are heart failure, myoglobin, homocysteine (Hcy), C-reactive protein (CRP), pulmonary embolism (PE) (D-dimer test), low-density and high-density lipoproteins (LDL and HDL), stroke, cardiac enzymes, albumin, cardiac markers used in clinical decisions, cardiac markers in renal failure, cardiac panels and point of care (POC) cardiac markers. This study also provides a thorough analysis of the companies known to be marketing, manufacturing or developing cardiac marker products in the U.S. and worldwide, as well as detailed tables, charts and figures covering the U.S., Europe and Asia markets.

Table of Contents

1. Overview

  • 1.1. Statement of Report
  • 1.2. Objectives of This Report
  • 1.3. Scope of This Report
  • 1.4. Methodology
  • 1.5. Executive Summary

2. The Basics of Biomarkers

3. Cardiac Marker Testing Markets: Market Segment Analysis: Size, Growth and Share

  • 3.1. Global Cardiac Marker Diagnostic Testing Markets
    • 3.1.1. Clinical Utility of Cardiac Markers
    • 3.1.2. Market Drivers in the Cardiac Marker Diagnostics Testing Sector
    • 3.1.3. Market Restraints in Cardiac Marker Testing Segment
    • 3.1.4. Principal Market Segments for Cardiac Marker Testing
    • 3.1.5. Key Players in the Cardiac Marker Diagnostics Testing Segment
    • 3.1.6. Cardiac Marker Testing Sector Analysis
  • 3.2. U.S. Cardiac Marker Testing Market
    • 3.2.1. Market Overview
    • 3.2.2. Cardiac Diagnostic Test Segments
    • 3.2.3. U.S. Hospital POC Cardiac Markers
  • 3.3. European Cardiac Marker Diagnostic Test Market
    • 3.3.1. German Diagnostic Markets
    • 3.3.2. U.K. Diagnostic Testing Market
      • 3.3.2.1. U.K. Market Statistics
    • 3.3.3. Italy
    • 3.3.4. France
    • 3.3.5. Spain
    • 3.3.6. Benelux
    • 3.3.7. Scandinavia
    • 3.3.8. Switzerland
    • 3.3.9. Barriers to Entry to European Market
  • 3.4. Japanese Diagnostic Testing Market
  • 3.5. Chinese Diagnostic Testing Market
  • 3.6. Canadian Diagnostic Market
  • 3.7. Cardiac Marker Testing Individual Markets
    • 3.7.1. Clinical Overview
    • 3.7.2. Cardiac Acute Disease Markers
    • 3.7.3. Market Overview
      • 3.7.3.1. Troponins
      • 3.7.3.2. Market Size and Growth Projections
      • 3.7.3.3. Clinical Use of Cardiac Troponins
      • 3.7.3.4. TnI and TnT Market Drivers
      • 3.7.3.5. TnI and TnT Market Restraints
    • 3.7.4. CK-MB and Cardiac Enzymes
      • 3.7.4.1. Creatine Kinase (CK) Enzymes
      • 3.7.4.2. Market Size and Growth Projections
      • 3.7.4.3. CK-MB: Market Drivers
      • 3.7.4.4. CK-MB: Market Restraints
    • 3.7.5. Myoglobin
      • 3.7.5.1. Market Size and Growth Projections
      • 3.7.5.2. Clinical Use of Myoglobin
      • 3.7.5.3. Myoglobin Market Drivers
      • 3.7.5.4. Myoglobin Market Restraints
    • 3.7.6. Natriuretic Peptides
      • 3.7.6.1. Market Overview
      • 3.7.6.2. Market Size and Growth Projections
      • 3.7.6.3. Commercial Assays for BNP and NT-proBNP
      • 3.7.6.4. Competitive Landscape
      • 3.7.6.5. BNP Test Market Share
      • 3.7.6.6. Clinical Applications of BNP/NT-proBNP
      • 3.7.6.7. BNP NT-proBNP Market Drivers
      • 3.7.6.8. BNP NT-proBNP Market Restraints
      • 3.7.6.9. Future Projections and Trends of NP Testing
      • 3.7.6.10. Future Use of BNP
    • 3.7.7. Albumin
      • 3.7.7.1. Ischemic Modified Albumin (IMA)
      • 3.7.7.2. Microalbuminuria
    • 3.7.8. Key Players in Cardiac Markers
    • 3.7.9. Evaluation of Cardiac Markers
    • 3.7.10. Cardiac Markers Use in Clinical Decisions
    • 3.7.11. Status of Cardiac Markers in the ER
    • 3.7.12. Cardiac Markers in Renal Failure
    • 3.7.13. Troponins in Non-Ischemic Heart Disease
    • 3.7.14. Market Restraints
    • 3.7.15. Market Drivers
    • 3.7.16. Cardiac Panels
    • 3.7.17. POC Cardiac Markers
      • 3.7.17.1. Market Size and Growth Rate
      • 3.7.17.2. Market Restraints
      • 3.7.17.3. The Next Wave

4. Cardiovascular Disease Markers

  • 4.1. Cholesterol, HDL and LDL
    • 4.1.1. Cholesterol Testing Market Forecasts
    • 4.1.2. Cholesterol Testing Market Growth Drivers
    • 4.1.3. Market Outlook: U.S. Market Analysis
    • 4.1.4. Trends and Issues
    • 4.1.5. Key Players in the Cholesterol Kit Market
      • 4.1.5.1. Review of Cholesterol Kit Company Products
        • 4.1.5.1.1. Cholestech (Now Alere)
        • 4.1.5.1.2. PTS Diagnostics CardioChek
        • 4.1.5.1.3. Miraculins PREVUE POC Skin Cholesterol Test
        • 4.1.5.1.4. Abaxis Piccolo Express
      • 4.1.5.2. Product Comparison of Leading Suppliers
  • 4.2. Homocysteine
  • 4.3. Fibrinogen
  • 4.4. C-Reactive Protein
  • 4.5. Lipoprotein Fractions
  • 4.6. Pulmonary Embolism (D-Dimer Test)
  • 4.7. Oxidized LDL and HDL
  • 4.8. Stroke

5. Cardiac Marker Testing Development Issues

  • 5.1. Genetic Testing and Personalized Medicine
  • 5.2. Preventive Medicine
  • 5.3. Patient Safety and Quality Measures
  • 5.4. Reimbursement
  • 5.5. Cardiovascular Screening Codes
  • 5.6. Screening for Diabetes
  • 5.7. Other Reimbursement Concerns
    • 5.7.1. Reimbursement for Routine Venipuncture
    • 5.7.2. Japanese Reimbursements for Medical Devices
  • 5.8. CPT Test Codes and Payment Amounts
  • 5.9. Rapid Near-Patient Testing in Hospitals
  • 5.10. Satellite Facilities
  • 5.11. Regionalization of Laboratory Care
  • 5.12. POCT: Current Market Trends and Drivers
    • 5.12.1. Effectiveness of POCT
    • 5.12.2. New Growth Areas for POCT
    • 5.12.3. Advantages of POCT in a Clinical Setting
    • 5.12.4. Shifts from Central Lab Testing to POCT
    • 5.12.5. Turnaround Time for POCT
  • 5.13. Clinical Laboratory Improvement Amendments (CLIA)
  • 5.14. Regulatory Requirements
  • 5.15. Record-Keeping and Data Management
    • 5.15.1. Effectiveness of Clinical Outcomes

6. Business Trends in the Industry

  • 6.1. Sector Consolidation
  • 6.2. Diagnostic Testing Growth Trends
  • 6.3. Acquisition, License Agreements, Internal Development and Partnerships
  • 6.4. Product Testing Depth in Cardiac Marker Testing
  • 6.5. Government Regulation
    • 6.5.1. U.S. Regulation
    • 6.5.2. CLIA Regulations
    • 6.5.3. Clinical Laboratory Improvement Act
    • 6.5.4. State Licensing for Service Laboratories
    • 6.5.5. IVDMIAs
    • 6.5.6. FDA Draft Guidance on In Vitro Companion Diagnostic Devices
    • 6.5.7. 510(k) Clearance
    • 6.5.8. Pre-Market Approval
      • 6.5.8.1. Pre-Market Approval Application
      • 6.5.8.2. Importing Medical Devices into the U.S.
      • 6.5.8.3. Exporting Medical Devices from the U.S.
    • 6.5.9. E.U. Regulations
    • 6.5.10. Japanese Regulations
    • 6.5.11. Chinese Regulations
  • 6.6. Barriers to Growth
  • 6.7. Drivers of Growth

7. Important Technology Trends

  • 7.1. Trends in Cardiac Marker Diagnostic Testing
    • 7.1.1. Free Fatty Acids and Fatty Acid Binding Proteins
    • 7.1.2. Glycogen Phosphorylase Isoenzyme BB
    • 7.1.3. S-100 Protein
    • 7.1.4. Cobalt-Binding Albumin
    • 7.1.5. Myosin Light Chains
    • 7.1.6. Emerging POCT Cardiac Marker Testing
  • 7.2. Cardiac Biomarker Research
    • 7.2.1. Myeloperoxidase
    • 7.2.2. Glutathione Peroxidase
    • 7.2.3. Antioxidant Biomarkers
    • 7.2.4. Oxidative Biomarkers
    • 7.2.5. Inflammatory Biomarkers
    • 7.2.6. Nitrosative Biomarkers
    • 7.2.7. Hemostatic Biomarkers
  • 7.3. Potential Stroke Markers
    • 7.3.1. Pharmacogenomics: Cardiovascular Drugs and Proteomic Markers
    • 7.3.2. Cardiac Proteomics
    • 7.3.3. Drivers for Cardiovascular Proteomic Markers
    • 7.3.4. Barriers to Cardiovascular Proteomic Markers
  • 7.4. Future Developments for Cardiovascular Markers
  • 7.5. Research Questions
    • 7.5.1. Biomarker Development Strategies
    • 7.5.2. Biomarkers for Unstable Angina
  • 7.6. Lp-PLA2
  • 7.7. Urotensin

8. Company Profiles

  • 8.1. Abbott Laboratories and SWOT Analysis
  • 8.2. Alere and SWOT Analysis
  • 8.3. Beckman Coulter (now part of Danaher)
  • 8.4. bioMérieux
  • 8.5. Biosite, Inc. (now a brand of Alere)
  • 8.6. CardioGenics
  • 8.7. Chek Diagnostics
  • 8.8. diaDexus and SWOT Analysis
  • 8.9. Health-Chem Diagnostics (HCD)
  • 8.10. Ortho-Clinical Diagnostics, Inc. and SWOT Analysis
  • 8.11. LifeSign, LLC
  • 8.12. PreMD, Inc.
  • 8.13. PTS Diagnostics
  • 8.14. Randox Laboratories Ltd.
  • 8.15. Response Biomedical
  • 8.16. Radiometer Medical
  • 8.17. Roche Diagnostics
  • 8.18. Sanyo Chemical Industries Ltd.
  • 8.19. Siemens Healthcare Diagnostics
  • 8.20. Sierra Resources International
  • 8.21. Spectral Diagnostics, Inc.
  • 8.22. Shionogi & Co., Ltd.

INDEX OF FIGURES

  • Figure 3.1: Market Share of Cardiac Marker Segment
  • Figure 3.2: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2014
  • Figure 3.3: U.S. POC Cardiac Marker Sales, 2010-2020
  • Figure 3.4: Cardiac Marker Market for Diagnostic Testing in Europe, 2010-2020
  • Figure 3.5: Cardiac Marker POCT Troponin Market Share by Product Type
  • Figure 3.6: Cardiac Marker POCT BNP Market Share by Product Type
  • Figure 4.1: Age-Adjusted Prevalence of High LDL Cholesterol Among Adults Aged 40-74, by Sex and Age in the U.S., 1976-2010
  • Figure 4.2: Age-Adjusted Trends in Prevalence of High LDL Cholesterol, Use of Cholesterol-Lowering Medications, and Low Saturated-Fat Intake Among Adults Aged 40-74 in the U.S., 1976-2010
  • Figure 5.1: CLIA Laboratories by Certificate Types
  • Figure 6.1: Current Conformity Assessment Route, Annexes and Quality System Standards by IVD Device Category
  • Figure 6.2: The Chinese Healthcare System

INDEX OF TABLES

  • Table 2.1: Cardiac Biomarkers of Inflammation and Atherogenesis
  • Table 2.2: Cardiac Biomarkers of Endothelial Function
  • Table 2.3: Cardiac Biomarkers of Thrombosis
  • Table 2.4: Cardiac Biomarkers of Ischemia/Necrosis
  • Table 2.5: Cardiac Biomarkers of Hemodynamic Stress
  • Table 2.6: Cardiac Biomarkers of Heart Failure Mortality
  • Table 2.7: Cardiac Biomarkers of Renal Dysfunction
  • Table 2.8: Cardiac Biomarkers of Metabolic/Lipid Dysregulation
  • Table 2.9: Cardiac Biomarkers of Brain Damage
  • Table 3.1: Cardiac Marker Markets by Country and Region, 2010-2020
  • Table 3.2: Cardiac Marker Markets by Country and Region, 2010-2020
  • Table 3.3: Total Global Cardiac Marker Market, 2010-2020
  • Table 3.4: Most Clinically Used Cardiac Markers
  • Table 3.5: Market Share of Cardiac Marker Segment
  • Table 3.6: U.S. Cardiac Marker Market, 2010-2020
  • Table 3.7: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2014
  • Table 3.8: U.S. POC Cardiac Marker Sales, 2010-2020
  • Table 3.9: Cardiac Marker Market for Diagnostic Testing in Europe, 2010-2020
  • Table 3.10: Regional Comparison of Healthcare and IVD Expenditures
  • Table 3.11: German IVD Diagnostics Products Market Sales, 2010-2020
  • Table 3.12: German Cardiac Marker Test Market, 2010-2020
  • Table 3.13: U.K. IVD Diagnostics Products Market Sales, 2010-2020
  • Table 3.14: U.K. Cardiac Marker Market, 2010-2020
  • Table 3.15: Italian Cardiac Marker Market, 2010-2020
  • Table 3.16: French Cardiac Marker Market, 2010-2020
  • Table 3.17: Spanish Cardiac Marker Market, 2010-2020
  • Table 3.18: Benelux Cardiac Marker Market, 2010-2020
  • Table 3.19: Scandinavian Cardiac Marker Market, 2010-2020
  • Table 3.20: Swiss Cardiac Marker Market, 2010-2020
  • Table 3.21: Japanese Cardiac Marker Diagnostic Testing Market, 2010-2020
  • Table 3.22: Chinese Cardiac Marker Market, 2010-2020
  • Table 3.23: Canadian Cardiac Marker Market, 2010-2020
  • Table 3.24: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2014
  • Table 3.25: Common Causes of Chest Pain
  • Table 3.26: Rate of Inappropriate Discharge from the ER for Patients with AMI, 1984-2014
  • Table 3.27: Continuing Analytical Issues for Implementation of Cardiac Troponin
  • Table 3.28: Global Cardiac Troponin Marker Market, 2010-2020
  • Table 3.29: U.S. Cardiac Troponin Marker Market, 2010-2020
  • Table 3.30: Selected POC Cardiac Biomarkers, 2014
  • Table 3.31: Projections in U.S. Sales of POC Cardiac Marker Tests, 2010-2020
  • Table 3.32: Causes of Troponin Elevations
  • Table 3.33: World Revenue from CK-MB Markets, 2010-2020
  • Table 3.34: U.S. Revenue from CK-MB Markets, 2010-2020
  • Table 3.35: World Myoglobin Market Revenues, 2010-2020
  • Table 3.36: U.S. Myoglobin Market Revenues, 2010-2020
  • Table 3.37: BNP Clinical Characteristics
  • Table 3.38: Global Sales of BNP and NT-proBNP assays, 2010-2020
  • Table 3.39: U.S. Sales of BNP and NT-proBNP assays, 2010-2020
  • Table 3.40: FDA Approved BNP Assays
  • Table 3.41: FDA Approved NT-proBNP Assays
  • Table 3.42: Analytical Characteristics of Commercial BNP Assays per Manufacturer
  • Table 3.43: Analytical Characteristics of Commercial NT-proBNP Assays per Manufacturer
  • Table 3.44: Market Share of BNP Assays in the U.S. by Instrument
  • Table 3.45: Market Share of NT-proBNP Assays in the U.S. by Instrument
  • Table 3.46: U.S. Hospital Share Estimates of NP Usage
  • Table 3.47: CHF National Hospital Discharge Survey, 2000-2010
  • Table 3.48: BNP NT-pro BNP Market Drivers
  • Table 3.49: BNP NT-pro BNP Market Restraints
  • Table 3.50: Trends in Cardiovascular Testing in Primary Care, U.S. and Globally
  • Table 3.51: The Clinical Advantages of Ischemia Modified Albumin
  • Table 3.52: Analytical Advantages of IMA
  • Table 3.53: Analytical Disadvantages of IMA
  • Table 4.1: HDL Levels in Adults
  • Table 4.2: LDL Levels in Adults
  • Table 4.3: Number of U.S. Cholesterol Tests, 2000-2014
  • Table 4.4: Selected POC Cholesterol Testing Devices, 2014
  • Table 4.5: World CRP Market Revenue, 2010-2020
  • Table 4.6: U.S. CRP Market Revenue, 2010-2020
  • Table 4.7: Clinical Characteristics of CRP
  • Table 4.8: Clinical Characteristics of D-Dimer
  • Table 5.1: CPT Codes Lipid Profile and Cholesterol Testing
  • Table 5.2: Financial Comparison for Moderate and Waived CLIA Labs
  • Table 5.3: POCT Clinical Outcomes in AMI
  • Table 6.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business
  • Table 6.2: Strengths of the 510k Process
  • Table 6.3: Drawbacks of the 510k Process
  • Table 6.4: Number of Healthcare Institutions According to Ownership China, 2010
  • Table 6.5: Total Number of Hospitals by Ranking China, 2010
  • Table 6.6: POC Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact
  • Table 6.7: Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact
  • Table 7.1: Oxidative Biomarker Research Assay Market Size
  • Table 7.2: Potential New Stroke Markers
  • Table 7.3: Non-Lipid Markers of CVD
  • Table 8.1: Alere Professional Diagnostics
  • Table 8.2: Alere, Inc. Financial Figures-Net Sales by Business Sector, 2011-2013
  • Table 8.3: Alere, Inc. Financial Figures-Net Sales by Geographic Region, 2011-2013
  • Table 8.4: Roche Group Financial Figures-Net Sales by Business Sector, 2009-2013
  • Table 8.5: Roche Group Financial Figures-Net Sales by Geographic Region, 2012 and 2013 for the Diagnostics Division
  • Table 8.6: Roche Group Financial Figures-Net Sales by Sub-Division, 2011-2013 192
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