心脏标志物诊断测试市场

心脏标志物诊断测试市场 是由出版商Trimark Publications在2011年11月所出版的。 这份英文市场调查报告书包含139 Pages 价格从美金3400起跳。

简介

每年全球有1,700万人死亡于心血管疾病。

本报告为，分析心脏标志物诊断测试所需之体外诊断（IVD）市场，并汇整医院及诊所使用之临床测试设备、试剂、工具及心脏标志物诊断测试未来发展之预测等，以下列摘要形式阐述。

第1章 概要

第2章 简介

• 全球诊断产品业
• 市场参与阻碍
• 企业评估概要
• 市场展望
• 新的IVD环境中最成功之技术及产品

第3章 心脏标志物测试市场：市场区隔分析：规模、成长、市场占有率

• 全球心脏标志物诊断测试市场
• 美国心脏标志物测试市场
• 欧洲心脏标志物测试市场
• 日本心脏标志物测试市场
• 中国心脏标志物测试市场
• 心脏标志物测试之个别市场

第4章 心血管疾病标志物

• 胆固醇、HDL、LDL
• 同型半胱氨酸
• 纤维蛋白原
• C-反应蛋白
• 脂蛋白分数
• 肺栓塞
• 氧化LDL及HDL
• 中风

第5章 心脏标志物测试开发之问题

• 基因检测及个别化医疗
• 预防医学
• 患者安全和质量
• 偿还
• 心血管疾病
• 糖尿病筛查
• 其他偿还问题
• CPT测试代码和付款
• 医院即时检查
• 实验室保健之合理性
• POCT之要求项目
• 临床实验室改善
• 质量保证问题
• 政治管理
• 法规要求
• 记录保存及数据管理

第6章 产业商务趋势

• 中心之集成
• 诊断测试之成长趋势
• 收购、授权合约、内部开发及合作
• 心脏标志物测试中产品测试之深度
• 政府法规
• 成长阻力
• 成长驱力

第7章 重要技术趋势

• 心脏标志物诊断测试趋势
• 心脏标志物研究
• 中风标志物
• 心血管标志物未来之开发
• 研发之疑问
• Lp-PLA2
• Urotensin

第8章 企业简介

图表

目录

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.

The author of this report holds a Ph.D. in biochemistry from the University of Minnesota, and has had post-doctoral studies at the University of Connecticut School of Medicine. He has taught at Quinnepiac University, the Tufts School of Medicine, and New York Institute of Technology. He has been a senior scientist at DuPont and Pfizer Pharmaceutical Laboratories in drug development and diagnostic testing. He was a leader in the formation and development of Dianon Laboratories, now part of LabCorp. He also has many decades of experience in science writing and as a medical industry analyst and consultant. He has over 40 years of experience in laboratory testing and instrument and reagent development technology as a licensed clinical laboratory director, as well as extensive experience in senior level management positions in biotech and medical service companies.

Company-specific information is obtained mainly from industry trade publications, academic journals, news and research articles, press releases and corporate websites, as well as annual reports for publicly-held firms. Additional sources of information include non-governmental organizations (NGOs) such as the World Health Organization (WHO) and governmental entities such as the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Where possible and practicable, the most recent data available have been used.

Some of the statistical information was taken from Biotechnology Associates' database and from TriMark's private data stores. The information in this study was obtained from sources that we believe to be reliable, but we do not guarantee the accuracy, adequacy or completeness of any information or omission or for the results obtained by the use of such information. Key information from the business literature was used as a basis to conduct dialogue with and obtain expert opinion from market professionals regarding commercial potential and market sizes. Senior managers from major company players were interviewed for part of the information in this report.

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. Introduction

• 2.1. Global Diagnostic Products Industry
• 2.2. Barriers to Entry
• 2.3. Company Evaluation Overview
• 2.4. Market Outlook
• 2.5. Technologies and Products that are the Most Successful in the New IVD Environment

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. Diagnostic Test Categories
  • 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
    • 3.3.2.2. U.K. Competitive Analysis
    • 3.3.2.3. U.K. Market Access
  • 3.3.3. Italy
  • 3.3.4. France
  • 3.3.5. Spain
  • 3.3.6. Belgium
  • 3.3.7. Switzerland
  • 3.3.8. 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. AMI and 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. 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
  • 3.7.7. Albumin
    • 3.7.7.1. Intact Albumin
    • 3.7.7.2. Albumin Cobalt Binding Test
    • 3.7.7.3. Ischemic Modified Albumin
    • 3.7.7.4. 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 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
• 4.2. 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
• 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. Requirements for POCT
  • 5.12.1. Benefits of POCT
  • 5.12.2. 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
    • 6.5.1.1. Importing Medical Devices into the U.S.
    • 6.5.1.2. Exporting Medical Devices from the U.S.
  • 6.5.2. U.K. Regulations
  • 6.5.3. E.U. Regulations
  • 6.5.4. Japanese Regulations
  • 6.5.5. 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. Fatty Acid Binding Protein
  • 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
• 7.2. 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. Roche's Biomarker Strategy
  • 7.5.2. Biomarkers for Unstable Angina
• 7.6. Lp-PLA2
• 7.7. Urotensin

8. Company Profiles

• 8.1. Abbott Laboratories
• 8.2. Alere
• 8.3. Ani Biotech
• 8.4. Axis-Shield
• 8.5. Bayer Corporation
• 8.6. Beckman Coulter (now part of Danaher)
• 8.7. Biosite, Inc. (now a brand of Alere)
• 8.8. Johnson & Johnson
• 8.9. LifeSign
• 8.10. PreMD, Inc.
• 8.11. Randox Laboratories
• 8.12. Response Biomedical
• 8.13. Roche Diagnostics
• 8.14. Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation, and Dade Behring)
• 8.15. Sierra Resources International
• 8.16. Spectral Diagnostics, Inc.

• Figure 2.1: Lab Industry Market Share
• Figure 2.2: Market Share of Major Lab Testing Segments
• Figure 3.1: Worldwide Distribution of IVD Testing, 2010

• Table 2.1: World Population and Growth, 2000-2024
• Table 2.2: Worldwide Market Share IVD Companies
• Table 2.3: Global Clinical Laboratory Market Sales, 1998-2011
• Table 2.4: U.S. In Vitro Central Lab Diagnostic Testing, 2003-2012
• Table 2.5: Global Point of Care Revenues, 2005-2012
• Table 3.1: Cardiac Marker Markets by Country, 2002-2010
• Table 3.2: Total Global Cardiac Marker Market, 2002-2010
• Table 3.3: Overall IVD Testing Market Worldwide, 2010
• Table 3.4: Worldwide Distribution of IVD Testing, 2010
• Table 3.5: Top 12 Countries for IVD Testing Markets, 2010
• Table 3.6: Eight Largest Diagnostic Companies Worldwide, 2010
• Table 3.7: Cardiac Markers
• Table 3.8: Market Share of Cardiac Marker Segment
• Table 3.9: U.S. Cardiac Marker Market, 2001-2010
• Table 3.10: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2010
• Table 3.11: U.S. POC Cardiac Marker Sales, 2001-2010
• Table 3.12: Cardiac Marker Market for Diagnostic Testing in Europe, 2001-2010
• Table 3.13: Regional Comparison of Healthcare and IVD Expenditures
• Table 3.14: German Diagnostics Products Market Sales, 1997-2008
• Table 3.15: German Cardiac Marker Test Market, 2000-2010
• Table 3.16: U.K. Cardiac Marker Market, 2001-2010
• Table 3.17: Major U.K. IVD Manufacturers
• Table 3.18: U.S. IVD Manufacturers Doing Business in the U.K.
• Table 3.19: Other European Companies that Manufacture IVD Products in the U.K.
• Table 3.20: Italian Cardiac Marker Market, 2001-2010
• Table 3.21: French Cardiac Marker Market, 2001-2010
• Table 3.22: Spanish Cardiac Marker Market, 2001-2010
• Table 3.23: Japanese Cardiac Marker Diagnostic Testing Market, 2001-2010
• Table 3.24: Chinese Diagnostics Products Market, 2000-2010
• Table 3.25: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2010
• Table 3.26: Common Causes of Chest Pain
• Table 3.27: Rate of Inappropriate Discharge from the ER for Patients with AMI
• Table 3.28: Continuing Analytical Issues for Implementation of Cardiac Troponin
• Table 3.29: Global Cardiac Troponin Marker Market, 2001-2010
• Table 3.30: U.S. Cardiac Troponin Marker Market, 2001-2010
• Table 3.31: Trends in U.S. Sales of POC Cardiac Marker Tests, 1998-2010
• Table 3.32: World Revenue from CK-MB Markets, 2001-2010
• Table 3.33: U.S. Revenue from CK-MB Markets, 2001-2010
• Table 3.34: World Myoglobin Market Revenues, 2001-2010
• Table 3.35: U.S. Myoglobin Market Revenues, 2001-2010
• Table 3.36: BNP Clinical Characteristics
• Table 3.37: Worldwide Sales of BNP Diagnostic Tests, 2004-2010
• Table 3.38: U.S. Sales of BNP Diagnostic Tests, 2004-2010
• Table 3.39: Analytical Characteristics of Commercial BNP Assays per Manufacturer
• Table 3.40: Analytical Characteristics of Commercial NT-proBNP Assays per Manufacturer
• Table 3.41: Market Share of BNP Assays in the U.S.
• Table 3.42: Market Share of NT-proBNP Assays in the U.S.
• Table 3.43: U.S. Hospital Share Estimates of NP Usage
• Table 4.1: HDL Levels in Adults
• Table 4.2: LDL Levels in Adults
• Table 4.3: LDL Screening Management Rates-Percent of Patient Population, 2004
• Table 4.4: LDL Screening Management Rates-Percent of Patient Population, 2009
• Table 4.5: Number of U.S. Cholesterol Tests, 2000-2010
• Table 4.6: World CRP Market Revenue, 2001-2010
• Table 4.7: U.S. CRP Market Revenue, 2001-2010
• Table 4.8: Clinical Characteristics of D-Dimer
• Table 5.1: POCT in Two Hospitals Cost Analysis with Labor Included
• Table 5.2: Cost Analysis for Glucose Testing: POCT vs. Central Lab
• Table 5.3: POCT Clinical Outcomes in AMI
• Table 7.1: Oxidative Biomarker Research Assay Market Size
• Table 7.2: Non-Lipid Markers of CVD
• Table 8.1: Products Marketed by Abbott in the Diagnostic Market
• Table 3.33: U.S. Revenue from CK-MB Markets, 2001-2010
• Table 3.34: World Myoglobin Market Revenues, 2001-2010
• Table 3.35: U.S. Myoglobin Market Revenues, 2001-2010
• Table 3.36: BNP Clinical Characteristics
• Table 3.37: Worldwide Sales of BNP Diagnostic Tests, 2004-2010
• Table 3.38: U.S. Sales of BNP Diagnostic Tests, 2004-2010
• Table 3.39: Commercial BNP Assays in the U.S.
• Table 3.40: Market Share of BNP Assays in the U.S.
• Table 3.41: Market Share of NT-proBNP Assays in the U.S.
• Table 3.42: Siemens Healthcare Diagnostics Cardiac Marker Assays
• Table 3.43: Cardiac Markers: Sampling Frequency
• Table 3.44: Cardiac Marker Products by LifeSign
• Table 4.1: HDL Levels in Adults
• Table 4.2: LDL Levels in Adults
• Table 4.3: LDL Screening Management Rates-Percent of Patient Population
• Table 4.4: Number of U.S. Cholesterol Tests, 2000-2010
• Table 4.5: World CRP Market Revenue, 2001-2010
• Table 4.6: U.S. CRP Market Revenue, 2001-2010
• Table 4.7: Clinical Characteristics of D-Dimer
• Table 5.1: POCT in Two Hospitals Cost Analysis with Labor Included
• Table 5.2: Cost Analysis for Glucose Testing: POCT vs. Central Lab
• Table 5.3: Financial Comparison for Moderate and Waived CLIA Labs
• Table 5.4: POCT Clinical Outcomes in AMI
• Table 7.1: Oxidative Biomarker Research Assay Market Size
• Table 7.2: Non-Lipid Markers of CVD
• Table 8.1: Products Marketed by Abbott in the Diagnostic Market
• Table 8.2: Products Marketed by Biosite in the Diagnostic Market

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