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Coagulation Diagnostic Testing Markets

  • ID: 2527909
  • Report
  • April 2013
  • Region: Global
  • 206 Pages
  • TriMark Publications
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Coagulation Testing Market to Jump to Over $1.9 Billion by 2018


  • Abbott
  • Bio/Data
  • CoaguSense
  • HYPEN BioMed
  • Roche
  • Sysmex
  • MORE
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.
Note: Product cover images may vary from those shown
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  • Abbott
  • Bio/Data
  • CoaguSense
  • HYPEN BioMed
  • Roche
  • Sysmex
  • MORE
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 Initiation of Blood Coagulation Amplification of Blood Coagulation 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 Monitoring Unfrationated Heparin Monitoring Low-Molecular Weight Heparin Monitoring Warfarin Monitoring Direct Factor Xa Inhibitors Monitoring Direct Thrombin Inhibitors Monitoring Antiplatelet Therapies Perioperative Monitoring of Coagulation 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 TEG/Thrombelastrograpy ROTEM/Rotational Thromboelastrometry Sonoclot 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. CD2000 CoaLab 6000
6.1.2 Beckman Coulter
6.1.3 Behnk Elektronik Thrombolyzer Fully Automated Systems Semi-Automated Instruments
6.1.4 Bio/Data Platelet Aggregation Profiler, Model-PAP 8E Aggregation Reagents and Standalone Assay Kits Coagulation Reagents and Controls
6.1.5 Cepheid Xpert- FII & FV
6.1.6 Chrono-Log Corp. Whole Blood-Optical Lumi-Aggregation System, Models 700-2/700-4
6.1.7 Diagnostica Stago STA Compact Hemostasis System STA Compact CT STA Satellite STA-R Evolution Expert Series STart 4 Hemostasis Analyzer Calibrated Automated Thrombogram
6.1.8 Helena Laboratories AggRAM Cascade M and Cascade M-4
6.1.9 Hyphen BioMed HEMOCLOT Clotting Assays BIOPHEN Chromogenic Reagents ZYMUTEST ELISA Assays
6.1.10 Instrumentation Laboratory ACL TOP Family of Hemostasis Testing Systems ACL ELITE Series ACL AcuStar
6.1.11 LABiTec GmbH CoaLab 1000 CoaData 2004/4004
6.1.12 Pentapharm
6.1.13 Roche cobas t 411 and cobas t 611
6.1.14 Sekisui Diagnostics
6.1.15 Siemens Sysmex CA-600 Systems Sysmex CA-1500 Sysmex CA-7000 BFT II BCS XP
6.1.16 Sysmex
6.1.17 Tcoag Destiny Max Destiny Plus KC1 Delta / KC4 Delta
6.1.18 TECO GmbH Coatron M1, M2, and M4 Coatron A4 Dimex and Dimex Jr.
6.2 POC Coagulation Testing Instruments and Assays: Professional and Self-Testing
6.2.1 Abbott i-STAT 1
6.2.2 Alere INRatio/INRatio2 PT INR Monitoring Systems
6.2.3 CoaguSense Coag-Sense PT/INR Monitoring System
6.2.4 Helena Laboratories Cascade POC Actalyke XL and Actalyke Mini II Abrazo
6.2.5 ITC ProTime Microcoagulation System Hemochron Signature Elite and Signature Plus Hemochron Response
6.2.6 Medtronic HMS Plus ACT Plus
6.2.7 Roche CoaguChek XS PT Test System CoaguChek XS Plus PT Test System 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 POC Coagulation Testing is Safe and Effective Different POC Techniques Provide Diverse Information Regarding Coagulation Economic Savings Associated with POC Testing Effect on Clinical Outcomes Connectivity Issues Cost Benefits Quality Control Issues Cross-Contamination
8.7.2 Current POC Coagulation Market Trends and Drivers Market Drivers Market Restraints POC Coagulation Testing Assay Market Trends POC Coagulation Testing Assay Technology Trends POC Coagulation Testing Assay Strategic Recommendations
8.7.3 Advantages and Disadvantages of POC Coagulation Testing Advantages of POC Coagulation Testing Disadvantages to POC Coagulation Testing
8.7.4 Key Customer Segments Laboratory Testing POC Coagulation Testing Anticoagulation Clinics 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


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- s 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


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
Note: Product cover images may vary from those shown
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- Abbott
- Accumetrics
- Alere
- American Labor/Lab A.C.M. Inc.
- Beckman Coulter
- Behnk Elektronik GmbH & Co. (Kommanditgesellschaft)
- Bio/Data
- BioCytex
- Cepheid
- Chrono-Log Corp.
- CoaguSense
- Diagnostica Stago
- HYPEN BioMed
- Haemonetics
- Helena Laboratories
- Instrumentation Laboratory
- Inverness Medical Innovations
- LABiTec GmbH
- Medtronic
- Pentapharm Ltd. (Now Owned by DSM Nutritional Products AG)
- Roche
- Sekisui Diagnostics (Formerly American Diagnostica, Inc.)
- Siemens
- Sienco, Inc.
- Spartan Bioscience
- Sysmex
- Tcoag
- Technoclone GmbH
- Trinity Biotech, Plc.
- Universal Biosensors
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown