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市場調査レポート

血液凝固診断検査市場

Coagulation Diagnostic Testing Markets

発行 TriMark Publications 商品コード 268537
出版日 ページ情報 英文 206 Pages
納期: 即日から翌営業日
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血液凝固診断検査市場 Coagulation Diagnostic Testing Markets
出版日: 2013年04月01日 ページ情報: 英文 206 Pages
概要

血液凝固検査はラボ検査およびポイントオブケア(POC)検査の双方を含め、当分の間、体外診断市場の最も重要なセグメントのひとつとなる見込みです。

当レポートでは、血液凝固および抗血小板物質検査市場について包括的に調査し、同領域で用いられている新しい技術、現在の製品ライン、製造または開発中の装置、および検査用試薬について分析しており、米国・世界における売上額、市場規模・成長影響因子の分析、主要企業のプロファイルなどをまとめ、概略下記の内容でお届けいたします。

第1章 概要

第2章 止血・血液凝固のイントロダクション

  • 血管収縮
  • 血小板活性化・血小板血栓形成
  • 血液凝固
  • 線維素溶解
  • 凝固の調整
  • 血液凝固・抗凝血剤の臨床的な意義
  • 血液凝固の調整によく使用される薬剤の概要
  • 血液凝固検査が求められる状況

第3章 定期的・特殊血液凝固検査の概要

  • 活性凝固時間(ACT)
  • 活性化部分トロンボプラスチン時間(APTT)
  • 活性化プロテインC抵抗
  • α2プラスミン阻害剤
  • 抗リン脂質抗体
  • アンチトロンビン(活性および抗原)
  • 出血時間
  • D-ダイマー
  • エカリン凝固時間(ECT)
  • オイグロブリン溶解
  • 因子活性アッセイ
  • 因子阻害アッセイ
  • フィブリン分解生成物アッセイ
  • フィブリノゲン
  • ヘパリン抗第10因子活性(anti-Xa)
  • ヘパリン起因性血小板減少症
  • プラスミノーゲン活性
  • プラスミノーゲン活性化因子阻害剤
  • 血小板機能検査
  • プロテインC
  • プロテインS
  • プロトロンビン時間(PT)
  • プロトロンビンG20210A変異体
  • レプチラーゼ時間
  • トロンビン時間
  • 粘弾性凝固検査
  • フォンヴィレブランド因子

第4章 血液凝固検査に用いられる技術の理解

  • 機械
  • 免疫学
  • 化学(発色)アッセイ
  • 分子PCR試験
  • 血液凝固検査に影響するプロテイン干渉変異体
  • 血液凝固検査パラダイムに関する新抗凝血剤の影響
  • 将来の血液凝固・抗血小板物質検査技術

第5章 市場分析:規模・成長・シェア・コンペティター

  • 世界の血液凝固・抗血小板物質検査市場
  • 市場構造・競合状況
  • 市場成長促進因子・抑制因子
  • 将来の市場・技術動向展望
  • マーケティングアプローチ
  • 戦略的提案
  • 近年の業界活動

第6章 市販の血液凝固装置およびアッセイ

  • ラボ用凝固検査装置・アッセイ
  • POC凝固検査装置・アッセイ:専門・セルフテスト
  • 血小板機能検査装置・アッセイ
  • 在宅モニタリングデバイス・アッセイ
  • 新製品発売・開発中の製品

第7章 市場課題

  • コスト抑制
  • 競合
  • 特許保護
  • 規制の抑制
  • ワルファリン治療の中断
  • モニタリング要件の無い新抗凝固薬の投入

第8章 血液凝固検査の事業動向

  • 凝固検査の促進因子
  • 産業統合
  • 医療費およびコスト抑制
  • 患者管理の変化
  • ラボケアの地域化
  • サテライト施設
  • ポイントオブケア(POC)凝固検査
  • OTCおよびセルフテスト市場の促進因子

第9章 規制環境および保険償還

  • FDAのラベリング要件
  • 米国政府の医療装置規制
  • 臨床検査機関改善修正法(CLIA)
  • 血液凝固セルフテスト保険の適用範囲・償還
  • 米国におけるラボ検査償還実施の動向
  • 欧州規制環境の予測される予測

第10章 企業プロファイル

図表インデックス

目次
Product Code: TMRCDT13-0401

Abstract

Coagulation testing, which encompasses both laboratory and point of care (POC) testing, will continue to be one of the most important segments of the in vitro diagnostics market for the foreseeable future. Many of the new models of laboratory coagulation testing devices and reagents, which are dominated by prothrombin time (PT) and activated partial thromboplastin time (aPTT), will include upgrades such as greater automation and the integration of more esoteric coagulation tests such as D-dimer and antiphospholipid assays. This TriMark Publications report provides a comprehensive examination of the coagulation and antiplatelet testing market. It examines the available and emerging technologies being utilized by the coagulation and antiplatelet testing field and describes the current product lines of almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for coagulation and antiplatelet testing. Moreover, the study defines the dollar volume of sales, both in the U.S. and worldwide, and analyzes the factors that influence the size and growth of the market. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market data are also included.

METHODOLOGY

The author of this report holds a Master's in immunology and has substantial experience in science writing and as a medical industry analyst. She also has many years of laboratory experience and has conducted laboratory testing and instrument and reagent development for biotech companies. The senior editor of this report holds a Ph.D. in biochemistry from the University of Minnesota and has had post-doctoral experience at the University of Connecticut School of Medicine. He has taught at Quinnipiac University and the Tufts School of Medicine, and has been a senior scientist at Pfizer Pharmaceutical Laboratories in drug development. He also has many decades of experience in science writing and as a medical industry analyst. He has over 30 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.

Primary Sources

TriMark collects information from hundreds of Database Tables and many comprehensive multi-client research projects, as well as Sector Snapshots that it publishes annually. TriMark extracts relevant data and analytics from its research as part of this data collection.

Secondary Sources

TriMark uses research publications, journals, magazines, newspapers, newsletters, industry reports, investment research reports, trade and industry association reports, government-affiliated trade releases and other published information as part of its secondary research materials. The information is then analyzed and translated by the Industry Research Group into a TriMark study. The Editorial Group reviews the complete package with product and market forecasts, critical industry trends, threats and opportunities, competitive strategies and market share determinations.

Table of Contents

1. Overview

  • 1.1. Statement of Report
  • 1.2. About this Report
  • 1.3. Scope of the Report
  • 1.4. Objectives
  • 1.5. Methodology
  • 1.6. Executive Summary

2. Introduction to Hemostasis and Blood Coagulation

  • 2.1. Vascular Constriction
  • 2.2. Platelet Activation and Platelet Plug Formation
  • 2.3. Blood Coagulation
    • 2.3.1. Coagulation Cascade
    • 2.3.2. Current Cell-Based Model for Blood Coagulation
      • 2.3.2.1. Initiation of Blood Coagulation
      • 2.3.2.2. Amplification of Blood Coagulation
      • 2.3.2.3. Propagation of Blood Coagulation
  • 2.4. Fibrinolysis
  • 2.5. Regulation of Coagulation
    • 2.5.1. Tissue Factor Pathway Inhibitor
    • 2.5.2. Antithrombin
    • 2.5.3. Thrombomodulin and Protein C
    • 2.5.4. Protein Z and Protein Z-dependent Protease Inhibitor
    • 2.5.5. Prostacyclin
  • 2.6. Clinical Significance of Blood Coagulation and Anticoagulants
    • 2.6.1. Overview of Bleeding Disorders
    • 2.6.2. Overview of Hypercoagulable Disorders
    • 2.6.3. Anticoagulation Therapy in Cardiovascular Disease
  • 2.7. Overview of Commonly Used Drugs to Regulate Coagulation
    • 2.7.1. Heparin (Unfractionated)
    • 2.7.2. Low Molecular-Weight Heparin (LMWH)
    • 2.7.3. Fondaparinux
    • 2.7.4. Warfarin (Coumadin)
    • 2.7.5. Direct Factor Xa Inhibitors
    • 2.7.6. Direct Thrombin Inhibitors
    • 2.7.7. Thrombolytic Agents
    • 2.7.8. Antiplatelet Agents
    • 2.7.9. Differences Between Antiplatelets and Anticoagulants
  • 2.8. Situations Requiring Coagulation Testing
    • 2.8.1. Managing Anticoagulation Therapies
      • 2.8.1.1. Monitoring Unfrationated Heparin
      • 2.8.2.2. Monitoring Low-Molecular Weight Heparin
      • 2.8.1.3. Monitoring Warfarin
      • 2.8.1.4. Monitoring Direct Factor Xa Inhibitors
      • 2.8.1.5. Monitoring Direct Thrombin Inhibitors
      • 2.8.1.6. Monitoring Antiplatelet Therapies
      • 2.8.1.7. Perioperative Monitoring of Coagulation
      • 2.8.1.8. Monitoring of Coagulation During Hemodialysis
    • 2.8.2. Diagnosing and Managing Bleeding Disorders

3. Overview of Routine and Special Blood Coagulation Tests

  • 3.1. Activated Clotting Time (ACT)
  • 3.2. Activated Partial Thromboplastin Time
  • 3.3. Activated Protein C Resistance
  • 3.4. Alpha-2 Plasmin Inhibitor
  • 3.5. Antiphospholipid Antibody
  • 3.6. Antithrombin (Activity and Antigen)
  • 3.7. Bleeding Time
  • 3.8. D-Dimer
  • 3.9. Ecarin Clotting Time
  • 3.10. Euglobulin Lysis
  • 3.11. Factor Activity Assays
    • 3.11.1. Factor I (Fibrinogen) Assay
    • 3.11.2. Factor II
    • 3.11.3. Factor III (Tissue Factor)
    • 3.11.4. Factor V
    • 3.11.5. Factor V Leiden Mutation
    • 3.11.6. Factor VII
    • 3.11.7. Factor VIII
    • 3.11.8. Factor IX
    • 3.11.9. Factor X
    • 3.11.10. Factor XI
    • 3.11.11. Factor XII
    • 3.11.12. Factor XIII
    • 3.11.13. High Molecular Weight Kininogen
    • 3.11.14. Prekallikrein
  • 3.12. Factor Inhibitor Assays
  • 3.13. Fibrin Degradation Product Assay
  • 3.14. Fibrinogen
  • 3.15. Heparin anti-Xa
  • 3.16. Heparin Induced Thrombocytopenia
  • 3.17. Plasminogen Activity
  • 3.18. Plasminogen Activator Inhibitor
  • 3.19 Platelet Function Tests
  • 3.20. Protein C
  • 3.21. Protein S
  • 3.22. Prothrombin Time
  • 3.23. Prothrombin G20210A Mutation
  • 3.24. Reptilase Time
  • 3.25. Thrombin Time
  • 3.26. Viscoelastic Coagulation Tests
  • 3.27. von Willebrand Factor

4. Understanding the Technologies Used in Coagulation Testing

  • 4.1. Mechanical
    • 4.1.1. Viscoelastic Tests
      • 4.1.1.1. TEG/Thrombelastrograpy
      • 4.1.1.2. ROTEM/Rotational Thromboelastrometry
      • 4.1.1.3. Sonoclot
      • 4.1.1.4. Clinical Applications
    • 4.1.2. Photo-Optical Detection
    • 4.1.3. Electro-Mechanical and Electromagnetic Mechanical Detection
  • 4.2. Immunologic
  • 4.3. Chemical (Chromogenic) Assays
  • 4.4. Molecular PCR Testing
  • 4.5. Potential Interfering Variables Affecting Coagulation Testing
  • 4.6. Influence of New Anticoagulants on Coagulation Testing Paradigms
  • 4.7. Future Technologies in Coagulation and Antiplatelet Testing

5. Market Analysis: Size, Growth, Share, and Competitors

  • 5.1. Worldwide Coagulation and Antiplatelet Testing Markets
    • 5.1.1. U.S. Market
    • 5.1.2. European Market
    • 5.1.3. Japanese Market
    • 5.1.4. ROW
  • 5.2. Market Structure and Competitive Situation
    • 5.2.1. Laboratory Testing
    • 5.2.2. POC Coagulation Testing
    • 5.2.3. Anticoagulation Clinics
    • 5.2.4. Anticoagulation Self-Testing and Self-Management
  • 5.3. Market Drivers and Restraints
    • 5.3.1. Impact of New Oral Anticoagulant Drugs on the Coagulation Testing Market
  • 5.4. Market and Technology Trends A Look Towards the Future
  • 5.5. Marketing Approaches
  • 5.6. Strategic Recommendations
  • 5.7. Recent Industry Activity
    • 5.7.1. Roche and Diagnostica Stago Parting Ways in Laboratory Coagulation
    • 5.7.2. Roche Acquires Verum Diagnostica GmbH and Expands Coagulation Testing Product Line
    • 5.7.3. Universal Biosensors and Siemens Collaborate on Advanced POC Coagulation Platform
    • 5.7.4. Instrumentation Laboratory and Beckman Coulter concluded their Cross-Distribution Agreement
    • 5.7.5. CoaguChek® XS Personal Recieves Reimbursement Approval for Self-Testing in Japan
    • 5.7.6. Diagnostica Stago Launches Products for Measurement of Rivaroxaban
    • 5.7.7. Diagnostic Stago Offers Three Factor VII Detection Methods
    • 5.7.8. Diagnostic Stago Offers Three Procoagulant Microparticle Detection Methods
    • 5.7.9. Trinity Biotech Sold its Worldwide Coagulation Business to the Stago Group
    • 5.7.10. Inverness Medical Innovations Acquired HemoSense, Inc.

6. Coagulation Instrumentation and Assays on the Market

  • 6.1. Laboratory Coagulation Testing Instruments and Assays
    • 6.1.1. American Labor/Lab A.C.M. Inc.
      • 6.1.1.1. CD2000
      • 6.1.1.2. CoaLab 6000
    • 6.1.2. Beckman Coulter
    • 6.1.3. Behnk Elektronik
      • 6.1.3.1. Thrombolyzer Fully Automated Systems
      • 6.1.3.2. Semi-Automated Instruments
    • 6.1.4. Bio/Data
      • 6.1.4.1. Platelet Aggregation Profiler, Model-PAP 8E
      • 6.1.4.2. Aggregation Reagents and Standalone Assay Kits
      • 6.1.4.3. Coagulation Reagents and Controls
    • 6.1.5. Cepheid
      • 6.1.5.1. Xpert® FII & FV
    • 6.1.6. Chrono-Log Corp.
      • 6.1.6.1. Whole Blood-Optical Lumi-Aggregation System, Models 700-2/700-4
    • 6.1.7. Diagnostica Stago
      • 6.1.7.1. STA Compact Hemostasis System
      • 6.1.7.2. STA Compact CT
      • 6.1.7.3. STA Satellite
      • 6.1.7.4. STA-R Evolution Expert Series
      • 6.1.7.5. STart 4 Hemostasis Analyzer
      • 6.1.7.6. Calibrated Automated Thrombogram
    • 6.1.8. Helena Laboratories
      • 6.1.8.1. AggRAM
      • 6.1.8.2. Cascade M and Cascade M-4
    • 6.1.9. Hyphen BioMed
      • 6.1.9.1. HEMOCLOT Clotting Assays
      • 6.1.9.2. BIOPHEN Chromogenic Reagents
      • 6.1.9.3. ZYMUTEST ELISA Assays
    • 6.1.10. Instrumentation Laboratory
      • 6.1.10.1. ACL TOP Family of Hemostasis Testing Systems
      • 6.1.10.2. ACL ELITE Series
      • 6.1.10.3. ACL AcuStar
    • 6.1.11. LABiTec GmbH
      • 6.1.11.1. CoaLab 1000
      • 6.1.11.2. CoaData 2004/4004
    • 6.1.12. Pentapharm
    • 6.1.13. Roche
      • 6.1.13.1. cobas t 411 and cobas t 611
    • 6.1.14. Sekisui Diagnostics
    • 6.1.15. Siemens
      • 6.1.15.1. Sysmex CA-600 Systems
      • 6.1.15.2. Sysmex CA-1500
      • 6.1.15.3. Sysmex CA-7000
      • 6.1.15.4. BFT II
      • 6.1.15.5. BCS XP
    • 6.1.16. Sysmex
    • 6.1.17. Tcoag
      • 6.1.17.1. Destiny Max
      • 6.1.17.2. Destiny Plus
      • 6.1.17.3. KC1 Delta / KC4 Delta
    • 6.1.18. TECO GmbH
      • 6.1.18.1. Coatron M1, M2, and M4
      • 6.1.18.2. Coatron A4
      • 6.1.18.3. Dimex and Dimex Jr.
  • 6.2. POC Coagulation Testing Instruments and Assays: Professional and Self-Testing
    • 6.2.1. Abbott
      • 6.2.1.1. i-STAT 1
    • 6.2.2. Alere
      • 6.2.2.1. INRatio/INRatio2 PT INR Monitoring Systems
    • 6.2.3. CoaguSense
      • 6.2.3.1. Coag-Sense PT/INR Monitoring System
    • 6.2.4. Helena Laboratories
      • 6.2.4.1. Cascade POC
      • 6.2.4.2. Actalyke XL and Actalyke Mini II
      • 6.2.4.3. Abrazo
    • 6.2.5. ITC
      • 6.2.5.1. ProTime Microcoagulation System
      • 6.2.5.2. Hemochron Signature Elite and Signature Plus
      • 6.2.5.3. Hemochron Response
    • 6.2.6. Medtronic
      • 6.2.6.1. HMS Plus
      • 6.2.6.2. ACT Plus
    • 6.2.7. Roche
      • 6.2.7.1. CoaguChek XS PT Test System
      • 6.2.7.2. CoaguChek XS Plus PT Test System
      • 6.2.7.3. CoaguChek XS Pro PT Test System
    • 6.2.8. Spartan Bioscience
    • 6.2.9. Universal Biosensors
  • 6.3. Platelet Function Testing Instruments and Assays
    • 6.3.1. Multiplate analyzer
    • 6.3.2. Platelet Function Analyzer-100 (PFA-100)
    • 6.3.3. Plateletworks Assay
    • 6.3.4. Platelet VASP test (PLT-VASP)
    • 6.3.5. ROTEM
    • 6.3.6. Sonoclot Analyzer
    • 6.3.7. TEG 5000 Thromboelastograph Hemostasis Analyzer
    • 6.3.8. VerifyNow
  • 6.4. Home Monitoring Devices and Assays
  • 6.5. New Product Launches and Products in Development

7. Market Challenges

  • 7.1. Cost Containment
  • 7.2. Competition
  • 7.3. Patent Protection
  • 7.4. Regulatory Constraints
  • 7.5. Discontinuation of Warfarin Therapy
  • 7.6. Controversies in Guided Antiplatelet Therapy
    • 7.6.1. Aspirin Resistance Testing
    • 7.6.2. Clopidogrel Resistance Testing
  • 7.7. Introduction of New Anticoagulants with No Monitoring Requirements

8. Business Trends in Coagulation Testing

  • 8.1. Drivers of Coagulation Testing
  • 8.2. Industry Consolidation
  • 8.3. Healthcare Expenditures and Cost Controls
  • 8.4. Changes in Patient Management
    • 8.4.1. Testing Recommendations Updates
    • 8.4.2. Centers for Medicare and Medicaid Services Impose Penalty on Re-admission Rates
  • 8.5. Regionalization of Laboratory Care
  • 8.6. Satellite Facilities
  • 8.7. Point-of-Care Coagulation Testing
    • 8.7.1. Key Issues in the POC Coagulation Testing Sector
      • 8.7.1.1. POC Coagulation Testing is Safe and Effective
      • 8.7.1.2. Different POC Techniques Provide Diverse Information Regarding Coagulation
      • 8.7.1.3. Economic Savings Associated with POC Testing
      • 8.7.1.4. Effect on Clinical Outcomes
      • 8.7.1.5. Connectivity Issues
      • 8.7.1.6. Cost Benefits
      • 8.7.1.7. Quality Control Issues
      • 8.7.1.8. Cross-Contamination
    • 8.7.2. Current POC Coagulation Market Trends and Drivers
      • 8.7.2.1. Market Drivers
      • 8.7.2.2. Market Restraints
      • 8.7.2.3. POC Coagulation Testing Assay Market Trends
      • 8.7.2.4. POC Coagulation Testing Assay Technology Trends
      • 8.7.2.5. POC Coagulation Testing Assay Strategic Recommendations
    • 8.7.3. Advantages and Disadvantages of POC Coagulation Testing
      • 8.7.3.1. Advantages of POC Coagulation Testing
      • 8.7.3.2. Disadvantages to POC Coagulation Testing
    • 8.7.4. Key Customer Segments
      • 8.7.4.1. Laboratory Testing
      • 8.7.4.2. POC Coagulation Testing
      • 8.7.4.3. Anticoagulation Clinics
      • 8.7.4.4. Anticoagulation Self-Testing and Self-Management
    • 8.7.5. Design Criteria For Decentralized Testing Products
  • 8.8. Drivers of OTC and Self-Testing Markets

9. Regulatory Environment and Insurance Reimbursements

  • 9.1. FDA Labeling Requirements
  • 9.2. U.S. Government Regulation of Medical Devices
  • 9.3. Clinical Laboratory Improvement Act (CLIA)
    • 9.3.1. Certification for POC Coagulation Devices
  • 9.4. Coagulation Self-Testing Insurance Coverage and Reimbursement
  • 9.5. Trends in U.S. Laboratory Testing Reimbursement Practices
  • 9.6. Proposed Changes to the European Regulatory Environment

10. Company Profiles

  • 10.1. Abbott
  • 10.2. Accumetrics
  • 10.3. Alere
  • 10.4. American Labor/Lab A.C.M. Inc.
  • 10.5. Beckman Coulter
  • 10.6. Bio/Data
  • 10.7. BioCytex
  • 10.8. Cepheid
  • 10.9. Chrono-Log Corp.
  • 10.10. CoaguSense
  • 10.11. Diagnostica Stago
  • 10.12. Haemonetics
  • 10.13. Helena Laboratories
  • 10.14. HYPEN BioMed
  • 10.15. Instrumentation Laboratory
  • 10.16. Inverness Medical Innovations
  • 10.17. ITC
  • 10.18. Behnk Elektronik GmbH & Co. (Kommanditgesellschaft)
  • 10.19. LABiTec GmbH
  • 10.20. Medtronic
  • 10.21. Pentapharm Ltd. (Now Owned by DSM Nutritional Products AG)
  • 10.22. Roche
  • 10.23. Sekisui Diagnostics (Formerly American Diagnostica, Inc.)
  • 10.24. Siemens
  • 10.25. Sienco, Inc.
  • 10.26. Spartan Bioscience
  • 10.27. Sysmex
  • 10.28. Tcoag
  • 10.29. Technoclone GmbH
  • 10.30. Trinity Biotech, Plc.
  • 10.31. Universal Biosensors

INDEX OF TABLES

  • Table 2.1: Coagulation Factors
  • Table 2.2: Proteins Involved in Regulating Coagulation
  • Table 2.3: Acquired Hypercoagulable Disorders
  • Table 2.4: Inherited Hypercoagulable Disorders
  • Table 2.5: Common Conditions Requiring Anticoagulation Therapy
  • Table 2.6: Limitations of Traditional Anticoagulants
  • Table 2.7: Desired Characteristics for New Anticoagulants
  • Table 2.8: Properties of FDA-Approved Direct Thrombin Inhibitors
  • Table 2.9: Advantages of Using Anti-Factor Xa Assay to Monitor Unfractionated Heparin
  • Table 2.10: Disadvantages of Using Anti-Factor Xa Assay to Monitor Unfractionated Heparin
  • Table 2.11: Recommended Laboratory Evaluations for Suspected Underlying Hypercoagulable States
  • Table 2.12: Laboratory Results in Various Platelet and Coagulation Disorders
  • Table 4.1: TEG, ROTEM and Sonoclot Assessments of Coagulation Variables
  • Table 4.2: Advantages of Viscoelastic Assays
  • Table 4.3: Disadvantages of Viscoelastic Assays
  • Table 4.4: TEG Reference Ranges for Kaolin-Activated Citrated Whole Blood
  • Table 4.5: TEG Assay Menu
  • Table 4.6: ROTEM Reference Ranges for Citrated Whole Blood Using the In-TEM Assay
  • Table 4.7: ROTEM Assay Menu
  • Table 4.8: Reference Ranges for Native Whole Blood Using Sonoclot Assays
  • Table 4.9: Sonoclot Assay Menu
  • Table 4.10: Pre-Analytical Variables Affecting Coagulation Testing
  • Table 4.11: Analytical Variables Affecting Coagulation Testing
  • Table 4.12: Influence of Anticoagulants on Routine Coagulation Assays
  • Table 4.13: Influence of Anticoagulants on Thrombophilia Assays
  • Table 5.1: POCT Frequency in Hospitals
  • Table 5.2: Benefits of Anticoagulation Self-Testing
  • Table 5.3: Barriers to Anticoagulation Self-Testing and Self-Management
  • Table 5.4: Key Market Drivers for Coagulation Testing
  • Table 5.5: Market Drivers for Point-of-Care Anticoagulation Testing Market
  • Table 5.6: Key Market Restraints for Coagulation Testing
  • Table 5.7: Market Restraints for Point-of-Care Anticoagulation Testing Market
  • Table 6.1: Coagulation Analyzers Laboratory
  • Table 6.2: Comparison of ILツ痴 ACL TOP Family of Hemostasis Analyzers
  • Table 6.3: Sysmex CA-600 System Assays
  • Table 6.4: Sysmex CA-1500 System Assays
  • Table 6.5: Sysmex CA-7000 System Assays
  • Table 6.6: BFT II System Assays
  • Table 6.7: BCS XP System Assays
  • Table 6.8: Coagulation Analyzers POC and Self-Testing Devices
  • Table 6.9: Multiplate Analyzer Assays
  • Table 7.1: Documents for Protecting Intellectual Property Rights
  • Table 8.1: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market
  • Table 9.1: Financial Comparison for Moderate and Waived CLIA Labs

INDEX OF FIGURES

  • Figure 2.1: Coagulation Cascade
  • Figure 2.2: Initiation and Amplification of Blood Coagulation
  • Figure 2.3: Fibrinolysis
  • Figure 2.4: Role of Tissue Factor Pathway Inhibitor
  • Figure 2.5: Role of Antithrombin
  • Figure 2.6: Role of Thrombomodulin and Protein C
  • Figure 4.1: Schematic of TEG Result Parameters
  • Figure 4.2: TEG Analysis Tree Kaolin Sample Type
  • Figure 4.3: TEG 5000 Thrombelastograph® Hemostasis Analyzer System
  • Figure 4.4: Schematic of ROTEM Result Parameters
  • Figure 4.5: ROTEM delta
  • Figure 4.6: Schematic of ROTEM Result Parameters
  • Figure 4.7: Sonoclot Coagulation & Platelet Function Analyzer
  • Figure 4.8: Photo-Optical Detection System
  • Figure 5.1: Global Revenue Forecasts for Laboratory and POC Coagulation Testing, 2010-2018
  • Figure 5.2: Global Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2010-2018
  • Figure 5.3: Market Share for Coagulation POCT Diagnostic Testing Companies Worldwide, 2013
  • Figure 5.4: Overall Global Market for Anticoagulant Drugs, 2012-2019
  • Figure 5.5: Estimated Market for Diagnostic Assays of Platelet Function, 2013-2018
  • Figure 5.6: U.S. Revenue Forecasts for Laboratory and POC Coagulation Testing, 2010-2018
  • Figure 5.7: U.S. Laboratory Coagulation Testing Customers by Size
  • Figure 5.8: U.S. Market Share of Laboratory Coagulation Testing by Dollar Volume
  • Figure 5.9: U.S. Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2010-2018
  • Figure 5.10: U.S. Market for Anticogulant Drugs, 2012-2019
  • Figure 5.11: European Revenue Forecasts for Laboratory and POC Coagulation Testing, 2010-2018
  • Figure 5.12: European Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2010-2018
  • Figure 5.13: Japanese Revenue Forecasts for Laboratory and POC Coagulation Testing, 2010-2018
  • Figure 5.14: Japanese Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2010-2018
  • Figure 5.15: ROW Revenue Forecasts for Laboratory and POC Coagulation Testing, 2010-2018
  • Figure 5.16: ROW Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2010-2018
  • Figure 5.17: Indian Coagulation Reagents Market Test Contribution
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