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市場調查報告書

心臟標記診斷檢驗市場

Cardiac Marker Diagnostic Testing Markets

出版商 TriMark Publications 商品編碼 220781
出版日期 內容資訊 英文 161 Pages
商品交期: 最快1-2個工作天內
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心臟標記診斷檢驗市場 Cardiac Marker Diagnostic Testing Markets
出版日期: 2016年08月01日 內容資訊: 英文 161 Pages
簡介

每年,全球有1,700萬人因心血管疾病死亡。

本報告提供心臟標記檢驗的體外診斷(IVD)市場相關分析,醫院和診所所使用的臨床檢測設備和試劑,設備,及心臟標記診斷檢驗的未來發展預測等彙整資料,為您概述為以下內容。

第1章 概要

第2章 生物標記的基礎

第3章 心臟標記檢驗市場:市場區隔分析:規模、成長、佔有率

  • 全球心臟標記診斷檢驗市場
  • 美國的心臟標記檢驗市場
  • 歐洲的心臟標記檢驗市場
  • 日本的心臟標記檢驗市場
  • 中國的心臟標記檢驗市場
  • 加拿大的心臟標記檢驗市場
  • 心臟標記檢驗的個別市場

第4章 心血管疾病標記

  • 膽固醇、HDL、LDL
  • 同半胱胺酸
  • 纖維蛋白原
  • C-反應性蛋白質
  • 脂蛋白成分
  • 氧化LDL和HDL

第5章 心臟標記檢驗開發上的問題

  • 遺傳基因檢驗和個人化醫療
  • 預防醫學
  • 患者的安全性和品質
  • 償付
  • 心血管的篩檢編碼
  • 心血管疾病的風險委員會
  • 其他償付問題
  • 院內的即時檢測
  • 衛星設施
  • 檢驗所照護的區域化
  • POCT:最新市場趨勢及促進成長要素
  • 臨床檢驗室改善 (CLIA)
  • 法律規章必要條件
  • 記錄保管和資料管理

第6章 產業的商務趨勢

  • 部門的整合
  • 診斷檢驗成長趨勢
  • 收購、授權合約、內部開發與聯盟
  • 產業領導者及新加入廠商者
  • 心臟標記檢驗的產品檢驗深度
  • 政府的法規
  • 成長的障礙
  • 推動成長力

第7章 重要的技術趨勢

  • 心臟標記診斷檢驗趨勢
  • 心臟生物標記研究
  • 潛在的中風標記
  • 心臟標幟物的未來開發
  • 研究的疑問
  • Lp-PLA2
  • Urotensin

圖表

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目錄
Product Code: TMRCMARK16-0801

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 BNP 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 POC Cardiac Markers
      • 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 Alere
    • 4.1.5.1.2 PTS Diagnostics CardioChek
    • 4.1.5.1.3 Miraculins PreVu POC Skin Cholesterol Test
    • 4.1.5.1.4 Abaxis Piccolo Xpress
    • 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 Oxidized LDL and HDL

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 Cardiovascular Disease Risk Panels
  • 5.7 Other Reimbursement Concerns
    • 5.7.1 Reimbursement for Cardiovascular Disease Risk Factors
  • 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 Industry Leaders and New Entrants
  • 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 ST2
    • 7.1.7 Galectin-3
    • 7.1.6 Emerging POCT Cardiac Marker Testing
  • 7.2 Cardiac Biomarker Research
    • 7.2.1 Glutathione Peroxidase
    • 7.2.2 Antioxidant Biomarkers
    • 7.2.3 Oxidative Biomarkers
    • 7.2.4 Inflammatory Biomarkers
    • 7.2.5 Nitrosative Biomarkers
    • 7.2.6 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

INDEX OF FIGURES

  • Figure 3.1: Market Share of Cardiac Marker Segment
  • Figure 3.2: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2016
  • Figure 3.3: U.S. POC Cardiac Marker Sales, 2011-2021
  • Figure 3.4: Cardiac Marker Market for Diagnostic Testing in Europe, 2011-2021
  • 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: Prevalence of Total Cholesterol Among Adults Aged 20 and Over, by Sex and Age in the U.S., 2011-2014
  • Figure 4.2: Age-Adjusted Trends in Prevalence of High total and low HDL Cholesterol Among Adults Aged over 20 in the U.S., 1999-2014
  • Figure 4.3: Prevalence of Cholesterol Screening in Adults Ages ≥20, U.S.
  • Figure 5.1: CLIA Laboratories by Certificate Types, 2016
  • 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: Biomarkers in Heart Failure
  • Table 2.2: Cardiac Biomarkers of Inflammation and Atherogenesis
  • Table 2.3: Cardiac Biomarkers of Endothelial Function
  • Table 2.4: Cardiac Biomarkers of Thrombosis
  • Table 2.5: Cardiac Biomarkers of Ischemia/Necrosis
  • Table 2.6: Cardiac Biomarkers of Hemodynamic Stress
  • Table 2.7: Cardiac Biomarkers of Heart Failure Mortality
  • Table 2.8: Cardiac Biomarkers of Renal Dysfunction
  • Table 2.9: Cardiac Biomarkers of Metabolic/Lipid Dysregulation
  • Table 2.10: 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, 2010-2021
  • Table 3.4: Cardiac Markers in Clinical Use
  • Table 3.5: Market Share of Cardiac Marker Segment
  • Table 3.6: U.S. Cardiac Marker Market, 2011-2021
  • Table 3.7: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2016
  • Table 3.8: U.S. POC Cardiac Marker Sales, 2015-2021
  • Table 3.9: Spectrum of Patient Care Testing
  • Table 3.9: Cardiac Marker Market for Diagnostic Testing in Europe, 2015-2021
  • 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, 2011-2021
  • Table 3.22: Chinese Cardiac Marker Market, 2011-2021
  • Table 3.23: Canadian Cardiac Marker Market, 2010-2020
  • Table 3.24: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2015
  • 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, 2011-2021
  • Table 3.29: U.S. Cardiac Troponin Marker Market, 2011-2021
  • Table 3.30: Selected POC Cardiac Biomarkers, 2016
  • Table 3.31: Projections in U.S. Sales of POC Cardiac Marker Tests, 2011-2021
  • Table 3.32: Causes of Troponin Elevations
  • Table 3.33: World Revenue from CK-MB Markets, 2011-2021
  • Table 3.34: U.S. Revenue from CK-MB Markets, 2011-2021
  • Table 3.35: World Myoglobin Market Revenues, 2011-2021
  • Table 3.36: U.S. Myoglobin Market Revenues, 2011-2021
  • Table 3.37: BNP Clinical Characteristics
  • Table 3.38: Global Sales of BNP and NT-proBNP assays, 2011-2021
  • Table 3.39: U.S. Sales of BNP and NT-proBNP assays, 2011-2021
  • 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: Cholesterol Levels in Adults
  • Table 4.3: Number of U.S. Cholesterol Tests, 2000-2014
  • Table 4.4: Selected POC Cholesterol Testing Devices, 2016
  • 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 5.1: CPT Codes Lipid Profile and Cholesterol Testing
  • Table 5.2: Financial Comparison for Moderate and Waived CLIA Labs
  • 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: CRP Levels associated with Risk for Cardiovascular Disease
  • Table 7.2: Potential New Stroke Markers
  • Table 7.3: Non-Lipid Markers of CVD
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