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市場調査レポート

MediPoint:急性冠症候群(ACS)診断用心臓バイオマーカー:米国市場の分析と予測

MediPoint: Diagnostic Cardiac Biomarkers for Acute Coronary Syndromes - US Analysis and Market Forecasts

発行 GlobalData 商品コード 270249
出版日 ページ情報 英文 137 Pages
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MediPoint:急性冠症候群(ACS)診断用心臓バイオマーカー:米国市場の分析と予測 MediPoint: Diagnostic Cardiac Biomarkers for Acute Coronary Syndromes - US Analysis and Market Forecasts
出版日: 2013年04月30日 ページ情報: 英文 137 Pages
概要

当レポートでは、米国における急性冠症候群(以下ACS)の診断用の心臓バイオマーカーの市場について分析し、疾患の概要や、現在の各種検査方法・バイオマーカーの特色と市場動向(過去3年間の実績値と今後7年間の予測値)、アンメットニーズ、開発中の製品のパイプライン分析、関連産業の全体的動向、主要企業のプロファイルと製品構成、米国の全体的な市場構造などを調査して、その結果を概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 急性冠症候群(虚血症候群、ACS)
  • 生体構造・生理機能
  • 病態
  • 臨床所見
    • 兆候
    • 診断
  • 臨床転帰
    • 治療オプション
    • 治療パラダイム
  • 疫学
  • 経済的影響

第4章 競争環境

  • 概要
  • 心筋トロポニン
    • 概要
    • 臨床適用と有用性
    • 市場普及率
    • SWOT分析
  • クレアチンキナーゼ-MB (CK-MB)
    • 概要
    • 臨床適用と有用性
    • 市場普及率
    • SWOT分析
  • ミオグロビン
    • 概要
    • 臨床適用と有用性
    • 市場普及率
    • SWOT分析
  • ポイントオブケア(POC)
    • 概要
    • 臨床適用と有用性
    • 市場普及率
    • SWOT分析

第5章 アンメットニーズ

  • 概要
  • 早期診断
  • 特殊性と偽陽性
  • 生化学検定の結果の解釈
  • 心筋虚血向けマーカー
  • トロポニン検定の感度

第6章 パイプライン製品

  • 概要
  • BAG3 (Biouniversia)
  • CAVARISK (Cavadis)
  • CardioScore (BG Medicine)
  • 末梢循環血管内皮細胞
  • Copeptin (Thermo Scientific)
  • 心臓由来脂肪酸結合蛋白(H-FABP)
  • MIRISK VPの評価 (Aviir)
  • 最新の早期検査
    • 心臓診断検定 (Prevencio/University of Pittsburgh)
    • センチネル心血管疾患(CVD) (GeneNews)
    • SomaScanによる心血管検定 (SomaLogic)

第7章 産業概要

  • ACS向け診断バイオマーカー検査の経口
  • 市場へのアクセス
  • 医療費償還の傾向
  • 規制環境
    • 新たな検査方法の認証
    • 製品のリコール

第8章 既存・新規企業

  • 概要
  • 企業戦略の傾向
  • Abbott Diagnostics
  • Alere
  • Beckman Coulter
  • bioMerieux
  • 三菱化学メディエンス
  • Ortho-Clinical Diagnostics
  • Radiometer Medical
  • Randox Laboratories
  • Response Biomedical
  • Roche Diagnostics
  • Siemens Healthcare
  • Thermo Scientific

第9章 市場の促進要因・機会・障壁

  • 市場促進要因
    • パイプライン・バイオマーカー検査の導入
    • ポイントオブケア(POC)検査の導入増加
  • 市場機会
    • トポロニン検定の感度の高さ
    • トポロニンPOC検定の感度の拡張
    • ACSの早期診断のための新たなパイプライン検査
  • 市場の障壁
    • 米国でのACS発症件数の減少
    • 米国でのトロポニン検査の飽和化
    • 検査パネルからのCK-MBおよびミオグロビンの除去
    • 医療費償還

第10章 国の見通しと予測

  • 市場概要
  • 米国

第11章 付録

図表一覧

目次
Product Code: GDME1027CFR

Summary

In the US, the ACS in vitro diagnostics market is dominated by a single biomarker test, cardiac troponins. However, this market remains of high interest due to advancements in assay sensitivity both on laboratory and point-of-care platforms. GlobalData expects these advancements to have an impact on other diagnostic tests such as creatine kinase-MB isoenzyme and myoglobin. Furthermore, the emergence of pipeline biomarker tests will change the landscape of ACS in vitro diagnostic testing and is expected to provide enhancements in the early diagnosis of the disease.

Acute coronary syndrome (ACS) consists of two major diseases, myocardial infarction (MI) and unstable angina, with the former being one of the major killers in the mature markets. Though the incidence of ACS is either in decline or steady across the US and European countries, millions of ACS and suspected ACS patients still visit emergency rooms every year with symptoms such as chest pain, and these patients are typically assessed with in vitro diagnostic cardiac biomarker tests. The ACS diagnostic cardiac biomarker reagents market is dominated by the cardiac troponins, the gold-standard biomarkers for the diagnosis of MI.

Scope

  • An overview of ACS, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized US ACS in vitro diagnostic testing reagents market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
  • Investigation of current and future market competition for diagnostic cardiac biomarkers for ACS
  • Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
  • Competitor assessment including device approval analysis and device sales forecasts.
  • Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
  • Analysis of unmet needs within the market and opportunities for future players.
  • Technology trends evaluation to assess strength of pipeline.
  • An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
  • Company profiles including business description, financial overview and SWOT analysis.
  • Coverage of key market players.
  • Strategic assessment of the diagnostic cardiac biomarkers for ACS sector through market impact analysis, future market scenario and company analysis.
  • Direct quotes from Key Opinion Leaders (KOL) as well as cardiologists

Reasons to buy

  • Understand the trends shaping and driving the US diagnostic cardiac biomarkers for ACS.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in the US diagnostic cardiac biomarkers for ACS Market through 2018.
  • Quantify candidate patient populations to better design product pricing & launch plans.
  • Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
  • Perform benchmarking analysis of growth opportunities against currently marketed products.
  • Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
  • Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.
  • Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
  • What's the next big thing in US diagnostic cardiac biomarkers for ACS market landscape? Identify, understand and capitalize.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst

3. Disease Overview

  • 3.1. Acute Coronary Syndromes
  • 3.2. Anatomy and Physiology
  • 3.3. Pathophysiology
  • 3.4. Clinical Presentation
    • 3.4.1. Symptoms
    • 3.4.2. Diagnosis
  • 3.5. Clinical Outcomes
    • 3.5.1. Treatment Options
    • 3.5.2. Treatment Paradigm
  • 3.6. Epidemiology
  • 3.7. Economic Impact

4. Competitive Assessment

  • 4.1. Overview
  • 4.2. Cardiac Troponins
    • 4.2.1. Overview
    • 4.2.2. Clinical Application and Utility
    • 4.2.3. Market Penetration
    • 4.2.4. SWOT Analysis
  • 4.3. Creatine Kinase-MB
    • 4.3.1. Overview
    • 4.3.2. Clinical Application and Utility
    • 4.3.3. Market Penetration
    • 4.3.4. SWOT Analysis
  • 4.4. Myoglobin
    • 4.4.1. Overview
    • 4.4.2. Clinical Application and Utility
    • 4.4.3. Market Penetration
    • 4.4.4. SWOT Analysis
  • 4.5. Point-of-Care
    • 4.5.1. Overview
    • 4.5.2. Clinical Application and Utility
    • 4.5.3. Market Penetration
    • 4.5.4. SWOT Analysis

5. Unmet Needs

  • 5.1. Overview
  • 5.2. Earlier Diagnosis
  • 5.3. Specificity and False Positives
  • 5.4. Interpretation of Biochemical Assay Results
  • 5.5. Markers for Myocardial Ischemia
  • 5.6. Troponin Assay Sensitivity

6. Pipeline Products

  • 6.1. Overview
  • 6.2. BAG3 (Biouniversia)
    • 6.2.1. Overview
    • 6.2.2. SWOT Analysis
  • 6.3. CAVARISK (Cavadis)
    • 6.3.1. Overview
    • 6.3.2. SWOT Analysis
  • 6.4. CardioScore (BG Medicine)
    • 6.4.1. Overview
    • 6.4.2. SWOT Analysis
  • 6.5. Circulating Endothelial Cells
    • 6.5.1. Overview
    • 6.5.2. SWOT Analysis
  • 6.6. Copeptin (Thermo Scientific)
    • 6.6.1. Overview
    • 6.6.2. SWOT Analysis
  • 6.7. Heart-Type Fatty Acid Binding Protein
    • 6.7.1. Overview
    • 6.7.2. SWOT Analysis
  • 6.8. MIRISK VP Assessment (Aviir)
    • 6.8.1. Overview
    • 6.8.2. SWOT Analysis
  • 6.9. Early Emerging Tests
    • 6.9.1. Heart Diagnostic Assay (Prevencio/University of Pittsburgh)
    • 6.9.2. Sentinel CVD (GeneNews)
    • 6.9.3. SomaScan Cardiovascular Assay (SomaLogic)

7. Industry Overview

  • 7.1. ACS Diagnostic Biomarker Testing Trends
  • 7.2. Market Access
  • 7.3. Reimbursement Trends
  • 7.4. Regulatory Environment
    • 7.4.1. Approval of New Tests
    • 7.4.2. Product Recalls

8. Current and Future Players

  • 8.1. Overview
  • 8.2. Trends in Corporate Strategy
  • 8.3. Abbott Diagnostics
    • 8.3.1. Overview
    • 8.3.2. Portfolio Assessment
  • 8.4. Alere
    • 8.4.1. Overview
    • 8.4.2. Portfolio Assessment
  • 8.5. Beckman Coulter
    • 8.5.1. Overview
    • 8.5.2. Portfolio Assessment
  • 8.6. bioMerieux
    • 8.6.1. Overview
    • 8.6.2. Portfolio Assessment
  • 8.7. Mitsubishi Chemical Medience Corporation
    • 8.7.1. Overview
    • 8.7.2. Portfolio Assessment
  • 8.8. Ortho-Clinical Diagnostics
    • 8.8.1. Overview
    • 8.8.2. Portfolio Assessment
  • 8.9. Radiometer Medical
    • 8.9.1. Overview
    • 8.9.2. Portfolio Assessment
  • 8.10. Randox Laboratories
    • 8.10.1. Overview
    • 8.10.2. Portfolio Assessment
  • 8.11. Response Biomedical
    • 8.11.1. Overview
    • 8.11.2. Portfolio Assessment
  • 8.12. Roche Diagnostics
    • 8.12.1. Overview
    • 8.12.2. Portfolio Assessment
  • 8.13. Siemens Healthcare
    • 8.13.1. Overview
    • 8.13.2. Portfolio Assessment
  • 8.14. Thermo Scientific
    • 8.14.1. Overview
    • 8.14.2. Portfolio Assessment

9. Market Drivers and Opportunities and Barriers

  • 9.1. Market Drivers
    • 9.1.1. Uptake of Pipeline Biomarker Tests
    • 9.1.2. Increasing Adoption of POC Testing
  • 9.2. Market Opportunities
    • 9.2.1. High-Sensitivity Troponin Assays
    • 9.2.2. Enhancement in Sensitivity of Troponin POC Assays
    • 9.2.3. New Pipeline Tests for Early Diagnosis of ACS
  • 9.3. Market Barriers
    • 9.3.1. Decreasing Numbers of ACS Cases in the US
    • 9.3.2. Saturation of Troponin Testing in the US
    • 9.3.3. Removal of CK-MB and Myoglobin from Testing Panels
    • 9.3.4. Reimbursement

10. Country Outlooks and Forecasts

  • 10.1. Market Overview
  • 10.2. US

11. Appendix

  • 11.1. Bibliography
  • 11.2. Abbreviations
  • 11.3. Research Methodology
    • 11.3.1. Overview
    • 11.3.2. Coverage
    • 11.3.3. Secondary Research
    • 11.3.4. Forecast Methodology
  • 11.4. Primary Research
  • 11.5. Physicians and Specialists Included in this Study
  • 11.6. About the Authors
    • 11.6.1. Analysts
    • 11.6.2. Global Head of Healthcare
  • 11.7. About MediPoint
  • 11.8. About GlobalData
  • 11.9. Contact Us
  • 11.10. Disclaimer

List of Tables

  • Table 1: Risk Factors Associated with ACS
  • Table 2: Properties of Common ACS and MI Diagnostic Biomarkers
  • Table 3: Diagnosis and Risk Stratification of ACS
  • Table 4: Common PCI Periprocedural Antithrombotic Drugs
  • Table 5: Common Drugs for Fibrinolysis
  • Table 6: Common Drugs for the Treatment of NSTEMI and UA
  • Table 7: Description of Direct and Indirect Economic Costs
  • Table 8: Economic Impact ($bn) of CAD in the US, 2009 to 2018
  • Table 9: Product Profile - Cardiac Troponins
  • Table 10: Cardiac Troponin Concentrations of Selected Current Troponin Assays
  • Table 11: Cardiac Troponin Concentrations of Selected High-Sensitivity Troponin Assays
  • Table 12: Cardiac Troponins SWOT Analysis
  • Table 13: Product Profile - Creatine Kinase-MB
  • Table 14: Creatine Kinase-MB SWOT Analysis
  • Table 15: Product Profile - Myoglobin
  • Table 16: Myoglobin SWOT Analysis
  • Table 17: Product Profile - Point-of-Care Testing
  • Table 18: Cardiac Troponin Concentrations of POC Troponin Assays
  • Table 19: Point-of-Care Cardiac Panel SWOT Analysis
  • Table 20: ACS Cardiac Biomarker Product Pipeline
  • Table 21: BAG3 SWOT Analysis
  • Table 22: CAVARISK SWOT Analysis
  • Table 23: CardioScore SWOT Analysis
  • Table 24: Circulating Endothelial Cells SWOT Analysis
  • Table 25: Copeptin SWOT Analysis
  • Table 26: Heart-Type Fatty Acid Binding Protein SWOT Analysis
  • Table 27: MIRISK VP SWOT Analysis
  • Table 28: Company Profile - Abbott Diagnostics
  • Table 29: Abbott Diagnostics SWOT Analysis, 2013
  • Table 30: Company Profile - Alere
  • Table 31: Alere SWOT Analysis, 2013
  • Table 32: Company Profile - Beckman Coulter
  • Table 33: Beckman Coulter SWOT Analysis, 2013
  • Table 34: Company Profile - bioMerieux
  • Table 35: bioMerieux SWOT Analysis, 2013
  • Table 36: Company Profile - Mitsubishi Chemical Medience Corporation
  • Table 37: Mitsubishi Chemical Medience Corporation SWOT Analysis, 2013
  • Table 38: Company Profile - Ortho-Clinical Diagnostics
  • Table 39: Ortho-Clinical Diagnostics SWOT Analysis, 2013
  • Table 40: Company Profile - Radiometer Medical
  • Table 41: Radiometer Medical SWOT Analysis, 2013
  • Table 42: Company Profile - Randox Laboratories
  • Table 43: Randox Laboratories SWOT Analysis, 2013
  • Table 44: Company Profile - Response Biomedical
  • Table 45: Response Biomedical SWOT Analysis, 2013
  • Table 46: Company Profile - Roche Diagnostics
  • Table 47: Roche Diagnostics SWOT Analysis, 2013
  • Table 48: Company Profile - Siemens Healthcare
  • Table 49: Siemens Healthcare SWOT Analysis, 2013
  • Table 50: Company Profile - Thermo Scientific
  • Table 51: Thermo Scientific SWOT Analysis, 2013
  • Table 52: Major Events Affecting the US ACS In Vitro Diagnostics Market
  • Table 53: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the US, ($m), 2009-2018

List of Figures

  • Figure 1: Anatomy of the Human Heart
  • Figure 2: Heart Muscle Damage, Atherosclerosis and Thrombosis
  • Figure 3: Strategy for Evaluating ACS
  • Figure 4: Treatment and Management of ACS
  • Figure 5: Annual Number of ACS Cases in the US, 2009?2018
  • Figure 6: Direct and Indirect Costs ($bn) of CAD in the US, 2011 to 2018
  • Figure 7: US Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012
  • Figure 8: Estimated US ACS Diagnostic Biomarker Testing Volumes, 2009 to 2018
  • Figure 9: US Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018
  • Figure 10: US Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018
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