Coagulation Diagnostic Testing Markets

  • April 2013
  • -
  • TriMark Publications
  • -
  • 206 pages

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.

Table Of Contents

TABLE OF CONTENTS

1. Overview 10
1.1 Statement of Report 10
1.2 About this Report 11
1.3 Scope of the Report 11
1.4 Objectives 12
1.5 Methodology 12
1.6 Executive Summary 13

2. Introduction to Hemostasis and Blood Coagulation 15
2.1 Vascular Constriction 15
2.2 Platelet Activation and Platelet Plug Formation 15
2.3 Blood Coagulation 16
2.3.1 Coagulation Cascade 16
2.3.2 Current Cell-Based Model for Blood Coagulation 17
2.3.2.1 Initiation of Blood Coagulation 17
2.3.2.2 Amplification of Blood Coagulation 18
2.3.2.3 Propagation of Blood Coagulation 19
2.4 Fibrinolysis 19
2.5 Regulation of Coagulation 20
2.5.1 Tissue Factor Pathway Inhibitor 20
2.5.2 Antithrombin 21
2.5.3 Thrombomodulin and Protein C 22
2.5.4 Protein Z and Protein Z-dependent Protease Inhibitor 22
2.5.5 Prostacyclin 22
2.6 Clinical Significance of Blood Coagulation and Anticoagulants 22
2.6.1 Overview of Bleeding Disorders 23
2.6.2 Overview of Hypercoagulable Disorders 24
2.6.3 Anticoagulation Therapy in Cardiovascular Disease 25
2.7 Overview of Commonly Used Drugs to Regulate Coagulation 27
2.7.1 Heparin (Unfractionated) 28
2.7.2 Low Molecular-Weight Heparin (LMWH) 28
2.7.3 Fondaparinux 29
2.7.4 Warfarin (Coumadin) 29
2.7.5 Direct Factor Xa Inhibitors 29
2.7.6 Direct Thrombin Inhibitors 30
2.7.7 Thrombolytic Agents 31
2.7.8 Antiplatelet Agents 31
2.7.9 Differences Between Antiplatelets and Anticoagulants 33
2.8 Situations Requiring Coagulation Testing 33
2.8.1 Managing Anticoagulation Therapies 33
2.8.1.1 Monitoring Unfrationated Heparin 34
2.8.2.2 Monitoring Low-Molecular Weight Heparin 36
2.8.1.3 Monitoring Warfarin 36
2.8.1.4 Monitoring Direct Factor Xa Inhibitors 38
2.8.1.5 Monitoring Direct Thrombin Inhibitors 38
2.8.1.6 Monitoring Antiplatelet Therapies 39
2.8.1.7 Perioperative Monitoring of Coagulation 41
2.8.1.8 Monitoring of Coagulation During Hemodialysis 41
2.8.2 Diagnosing and Managing Bleeding Disorders 42

3. Overview of Routine and Special Blood Coagulation Tests 44
3.1 Activated Clotting Time (ACT) 44
3.2 Activated Partial Thromboplastin Time 44
3.3 Activated Protein C Resistance 45
3.4 Alpha-2 Plasmin Inhibitor 46
3.5 Antiphospholipid Antibody 47
3.6 Antithrombin (Activity and Antigen) 48
3.7 Bleeding Time 49
3.8 D-Dimer 49
3.9 Ecarin Clotting Time 50
3.10 Euglobulin Lysis 51
3.11 Factor Activity Assays 51
3.11.1 Factor I (Fibrinogen) Assay 53
3.11.2 Factor II 54
3.11.3 Factor III (Tissue Factor) 54
3.11.4 Factor V 55
3.11.5 Factor V Leiden Mutation 55
3.11.6 Factor VII 56
3.11.7 Factor VIII 56
3.11.8 Factor IX 57
3.11.9 Factor X 58
3.11.10 Factor XI 58
3.11.11 Factor XII 59
3.11.12 Factor XIII 59
3.11.13 High Molecular Weight Kininogen 60
3.11.14 Prekallikrein 61
3.12 Factor Inhibitor Assays 61
3.13 Fibrin Degradation Product Assay 62
3.14 Fibrinogen 63
3.15 Heparin anti-Xa 64
3.16 Heparin Induced Thrombocytopenia 65
3.17 Plasminogen Activity 66
3.18 Plasminogen Activator Inhibitor 67
3.19 Platelet Function Tests 67
3.20 Protein C 68
3.21 Protein S 69
3.22 Prothrombin Time 70
3.23 Prothrombin G20210A Mutation 72
3.24 Reptilase Time 72
3.25 Thrombin Time 73
3.26 Viscoelastic Coagulation Tests 74
3.27 von Willebrand Factor 74

4. Understanding the Technologies Used in Coagulation Testing 77
4.1 Mechanical 77
4.1.1 Viscoelastic Tests 77
4.1.1.1 TEG/Thrombelastrograpy 78
4.1.1.2 ROTEM/Rotational Thromboelastrometry 82
4.1.1.3 Sonoclot 85
4.1.1.4 Clinical Applications 88
4.1.2 Photo-Optical Detection 89
4.1.3 Electro-Mechanical and Electromagnetic Mechanical Detection 89
4.2 Immunologic 90
4.3 Chemical (Chromogenic) Assays 90
4.4 Molecular PCR Testing 90
4.5 Potential Interfering Variables Affecting Coagulation Testing 90
4.6 Influence of New Anticoagulants on Coagulation Testing Paradigms 91
4.7 Future Technologies in Coagulation and Antiplatelet Testing 93

5. Market Analysis: Size, Growth, Share, and Competitors 94
5.1 Worldwide Coagulation and Antiplatelet Testing Markets 94
5.1.1 U.S. Market 97
5.1.2 European Market 100
5.1.3 Japanese Market 102
5.1.4 ROW 103
5.2 Market Structure and Competitive Situation 104
5.2.1 Laboratory Testing 104
5.2.2 POC Coagulation Testing 106
5.2.3 Anticoagulation Clinics 108
5.2.4 Anticoagulation Self-Testing and Self-Management 109
5.3 Market Drivers and Restraints 112
5.3.1 Impact of New Oral Anticoagulant Drugs on the Coagulation Testing Market
113
5.4 Market and Technology Trends - A Look Towards the Future 115
5.5 Marketing Approaches 116
5.6 Strategic Recommendations 117
5.7 Recent Industry Activity 118
5.7.1 Roche and Diagnostica Stago Parting Ways in Laboratory Coagulation 118
5.7.2 Roche Acquires Verum Diagnostica GmbH and Expands Coagulation Testing
Product Line 118
5.7.3 Universal Biosensors and Siemens Collaborate on Advanced POC Coagulation
Platform 119
5.7.4 Instrumentation Laboratory and Beckman Coulter concluded their
Cross-Distribution Agreement 119
5.7.5 CoaguChek® XS Personal Recieves Reimbursement Approval for Self-Testing in
Japan 119
5.7.6 Diagnostica Stago Launches Products for Measurement of Rivaroxaban 120
5.7.7 Diagnostic Stago Offers Three Factor VII Detection Methods 120
5.7.8 Diagnostic Stago Offers Three Procoagulant Microparticle Detection Methods
120
5.7.9 Trinity Biotech Sold its Worldwide Coagulation Business to the Stago Group
121
5.7.10 Inverness Medical Innovations Acquired HemoSense, Inc. 121

6. Coagulation Instrumentation and Assays on the Market 122
6.1 Laboratory Coagulation Testing Instruments and Assays 122
6.1.1 American Labor/Lab A.C.M. Inc. 126
6.1.1.1 CD2000 127
6.1.1.2 CoaLab 6000 127
6.1.2 Beckman Coulter 127
6.1.3 Behnk Elektronik 127
6.1.3.1 Thrombolyzer Fully Automated Systems 127
6.1.3.2 Semi-Automated Instruments 128
6.1.4 Bio/Data 129
6.1.4.1 Platelet Aggregation Profiler, Model-PAP 8E 129
6.1.4.2 Aggregation Reagents and Standalone Assay Kits 129
6.1.4.3 Coagulation Reagents and Controls 129
6.1.5 Cepheid 130
6.1.5.1 Xpert® FII andamp; FV 130
6.1.6 Chrono-Log Corp. 130
6.1.6.1 Whole Blood-Optical Lumi-Aggregation System, Models 700-2/700-4 130
6.1.7 Diagnostica Stago 130
6.1.7.1 STA Compact Hemostasis System 130
6.1.7.2 STA Compact CT 131
6.1.7.3 STA Satellite 131
6.1.7.4 STA-R Evolution Expert Series 132
6.1.7.5 STart 4 Hemostasis Analyzer 132
6.1.7.6 Calibrated Automated Thrombogram 132
6.1.8 Helena Laboratories 133
6.1.8.1 AggRAM 133
6.1.8.2 Cascade M and Cascade M-4 133
6.1.9 Hyphen BioMed 134
6.1.9.1 HEMOCLOT Clotting Assays 134
6.1.9.2 BIOPHEN Chromogenic Reagents 134
6.1.9.3 ZYMUTEST ELISA Assays 134
6.1.10 Instrumentation Laboratory 135
6.1.10.1 ACL TOP Family of Hemostasis Testing Systems 135
6.1.10.2 ACL ELITE Series 136
6.1.10.3 ACL AcuStar 136
6.1.11 LABiTec GmbH 136
6.1.11.1 CoaLab 1000 136
6.1.11.2 CoaData 2004/4004 137
6.1.12 Pentapharm 137
6.1.13 Roche 138
6.1.13.1 cobas t 411 and cobas t 611 138
6.1.14 Sekisui Diagnostics 138
6.1.15 Siemens 140
6.1.15.1 Sysmex CA-600 Systems 140
6.1.15.2 Sysmex CA-1500 141
6.1.15.3 Sysmex CA-7000 141
6.1.15.4 BFT II 142
6.1.15.5 BCS XP 143
6.1.16 Sysmex 144
6.1.17 Tcoag 144
6.1.17.1 Destiny Max 144
6.1.17.2 Destiny Plus 144
6.1.17.3 KC1 Delta / KC4 Delta 145
6.1.18 TECO GmbH 145
6.1.18.1 Coatron M1, M2, and M4 145
6.1.18.2 Coatron A4 146
6.1.18.3 Dimex and Dimex Jr. 146
6.2 POC Coagulation Testing Instruments and Assays: Professional and
Self-Testing 147
6.2.1 Abbott 150
6.2.1.1 i-STAT 1 150
6.2.2 Alere 150
6.2.2.1 INRatio/INRatio2 PT INR Monitoring Systems 150
6.2.3 CoaguSense 151
6.2.3.1 Coag-Sense PT/INR Monitoring System 151
6.2.4 Helena Laboratories 151
6.2.4.1 Cascade POC 151
6.2.4.2 Actalyke XL and Actalyke Mini II 151
6.2.4.3 Abrazo 152
6.2.5 ITC 152
6.2.5.1 ProTime Microcoagulation System 152
6.2.5.2 Hemochron Signature Elite and Signature Plus 152
6.2.5.3 Hemochron Response 153
6.2.6 Medtronic 153
6.2.6.1 HMS Plus 153
6.2.6.2 ACT Plus 154
6.2.7 Roche 154
6.2.7.1 CoaguChek XS PT Test System 154
6.2.7.2 CoaguChek XS Plus PT Test System 155
6.2.7.3 CoaguChek XS Pro PT Test System 155
6.2.8 Spartan Bioscience 155
6.2.9 Universal Biosensors 155
6.3 Platelet Function Testing Instruments and Assays 155
6.3.1 Multiplate analyzer 156
6.3.2 Platelet Function Analyzer-100 (PFA-100) 156
6.3.3 Plateletworks Assay 157
6.3.4 Platelet VASP test (PLT-VASP) 157
6.3.5 ROTEM 158
6.3.6 Sonoclot Analyzer 158
6.3.7 TEG 5000 Thromboelastograph Hemostasis Analyzer 159
6.3.8 VerifyNow 159
6.4 Home Monitoring Devices and Assays 159
6.5 New Product Launches and Products in Development 160

7. Market Challenges 162
7.1 Cost Containment 162
7.2 Competition 162
7.3 Patent Protection 162
7.4 Regulatory Constraints 163
7.5 Discontinuation of Warfarin Therapy 163
7.6 Controversies in Guided Antiplatelet Therapy 163
7.6.1 Aspirin Resistance Testing 164
7.6.2 Clopidogrel Resistance Testing 164
7.7 Introduction of New Anticoagulants with No Monitoring Requirements 164

8. Business Trends in Coagulation Testing 166
8.1 Drivers of Coagulation Testing 166
8.2 Industry Consolidation 166
8.3 Healthcare Expenditures and Cost Controls 167
8.4 Changes in Patient Management 167
8.4.1 Testing Recommendations Updates 167
8.4.2 Centers for Medicare and Medicaid Services Impose Penalty on Re-admission
Rates 167
8.5 Regionalization of Laboratory Care 168
8.6 Satellite Facilities 169
8.7 Point-of-Care Coagulation Testing 169
8.7.1 Key Issues in the POC Coagulation Testing Sector 170
8.7.1.1 POC Coagulation Testing is Safe and Effective 170
8.7.1.2 Different POC Techniques Provide Diverse Information Regarding
Coagulation 170
8.7.1.3 Economic Savings Associated with POC Testing 170
8.7.1.4 Effect on Clinical Outcomes 171
8.7.1.5 Connectivity Issues 171
8.7.1.6 Cost Benefits 171
8.7.1.7 Quality Control Issues 172
8.7.1.8 Cross-Contamination 172
8.7.2 Current POC Coagulation Market Trends and Drivers 172
8.7.2.1 Market Drivers 173
8.7.2.2 Market Restraints 174
8.7.2.3 POC Coagulation Testing Assay Market Trends 174
8.7.2.4 POC Coagulation Testing Assay Technology Trends 174
8.7.2.5 POC Coagulation Testing Assay Strategic Recommendations 174
8.7.3 Advantages and Disadvantages of POC Coagulation Testing 175
8.7.3.1 Advantages of POC Coagulation Testing 175
8.7.3.2 Disadvantages to POC Coagulation Testing 176
8.7.4 Key Customer Segments 176
8.7.4.1 Laboratory Testing 176
8.7.4.2 POC Coagulation Testing 177
8.7.4.3 Anticoagulation Clinics 178
8.7.4.4 Anticoagulation Self-Testing and Self-Management 178
8.7.5 Design Criteria For Decentralized Testing Products 179
8.8 Drivers of OTC and Self-Testing Markets 180

9. Regulatory Environment and Insurance Reimbursements 181
9.1 FDA Labeling Requirements 181
9.2 U.S. Government Regulation of Medical Devices 181
9.3 Clinical Laboratory Improvement Act (CLIA) 182
9.3.1 Certification for POC Coagulation Devices 184
9.4 Coagulation Self-Testing Insurance Coverage and Reimbursement 185
9.5 Trends in U.S. Laboratory Testing Reimbursement Practices 185
9.6 Proposed Changes to the European Regulatory Environment 186

10. Company Profiles 188
10.1 Abbott 188
10.2 Accumetrics 191
10.3 Alere 191
10.4 American Labor/Lab A.C.M. Inc. 192
10.5 Beckman Coulter 192
10.6 Bio/Data 196
10.7 BioCytex 197
10.8 Cepheid 197
10.9 Chrono-Log Corp. 198
10.10 CoaguSense 199
10.11 Diagnostica Stago 199
10.12 Haemonetics 199
10.13 Helena Laboratories 199
10.14 HYPEN BioMed 200
10.15 Instrumentation Laboratory 200
10.16 Inverness Medical Innovations 200
10.17 ITC 200
10.18 Behnk Elektronik GmbH andamp; Co. (Kommanditgesellschaft) 200
10.19 LABiTec GmbH 201
10.20 Medtronic 201
10.21 Pentapharm Ltd. (Now Owned by DSM Nutritional Products AG) 202
10.22 Roche 202
10.23 Sekisui Diagnostics (Formerly American Diagnostica, Inc.) 204
10.24 Siemens 204
10.25 Sienco, Inc. 205
10.26 Spartan Bioscience 205
10.27 Sysmex 205
10.28 Tcoag 206
10.29 Technoclone GmbH 206
10.30 Trinity Biotech, Plc. 206
10.31 Universal Biosensors 206


INDEX OF TABLES

Table 2.1: Coagulation Factors 17
Table 2.2: Proteins Involved in Regulating Coagulation 20
Table 2.3: Acquired Hypercoagulable Disorders 24
Table 2.4: Inherited Hypercoagulable Disorders 25
Table 2.5: Common Conditions Requiring Anticoagulation Therapy 25
Table 2.6: Limitations of Traditional Anticoagulants 28
Table 2.7: Desired Characteristics for New Anticoagulants 28
Table 2.8: Properties of FDA-Approved Direct Thrombin Inhibitors 31
Table 2.9: Advantages of Using Anti-Factor Xa Assay to Monitor Unfractionated
Heparin 35
Table 2.10: Disadvantages of Using Anti-Factor Xa Assay to Monitor
Unfractionated Heparin 35
Table 2.11: Recommended Laboratory Evaluations for Suspected Underlying
Hypercoagulable States 43
Table 2.12: Laboratory Results in Various Platelet and Coagulation Disorders 43
Table 4.1: TEG, ROTEM and Sonoclot Assessments of Coagulation Variables 77
Table 4.2: Advantages of Viscoelastic Assays 78
Table 4.3: Disadvantages of Viscoelastic Assays 78
Table 4.4: TEG Reference Ranges for Kaolin-Activated Citrated Whole Blood 80
Table 4.5: TEG Assay Menu 81
Table 4.6: ROTEM Reference Ranges for Citrated Whole Blood Using the In-TEM
Assay 84
Table 4.7: ROTEM Assay Menu 84
Table 4.8: Reference Ranges for Native Whole Blood Using Sonoclot Assays 86
Table 4.9: Sonoclot Assay Menu 87
Table 4.10: Pre-Analytical Variables Affecting Coagulation Testing 90
Table 4.11: Analytical Variables Affecting Coagulation Testing 91
Table 4.12: Influence of Anticoagulants on Routine Coagulation Assays 92
Table 4.13: Influence of Anticoagulants on Thrombophilia Assays 92
Table 5.1: POCT Frequency in Hospitals 107
Table 5.2: Benefits of Anticoagulation Self-Testing 109
Table 5.3: Barriers to Anticoagulation Self-Testing and Self-Management 111
Table 5.4: Key Market Drivers for Coagulation Testing 112
Table 5.5: Market Drivers for Point-of-Care Anticoagulation Testing Market 113
Table 5.6: Key Market Restraints for Coagulation Testing 113
Table 5.7: Market Restraints for Point-of-Care Anticoagulation Testing Market
113
Table 6.1: Coagulation Analyzers - Laboratory 122
Table 6.2: Comparison of IL’s ACL TOP Family of Hemostasis Analyzers 135
Table 6.3: Sysmex CA-600 System Assays 140
Table 6.4: Sysmex CA-1500 System Assays 141
Table 6.5: Sysmex CA-7000 System Assays 142
Table 6.6: BFT II System Assays 143
Table 6.7: BCS XP System Assays 143
Table 6.8: Coagulation Analyzers - POC and Self-Testing Devices 147
Table 6.9: Multiplate Analyzer Assays 156
Table 7.1: Documents for Protecting Intellectual Property Rights 163
Table 8.1: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats in the Coagulation
POC Market 175
Table 9.1: Financial Comparison for Moderate and Waived CLIA Labs 183


INDEX OF FIGURES

Figure 2.1: Coagulation Cascade 16
Figure 2.2: Initiation and Amplification of Blood Coagulation 18
Figure 2.3: Fibrinolysis 19
Figure 2.4: Role of Tissue Factor Pathway Inhibitor 21
Figure 2.5: Role of Antithrombin 21
Figure 2.6: Role of Thrombomodulin and Protein C 22
Figure 4.1: Schematic of TEG Result Parameters 79
Figure 4.2: TEG Analysis Tree - Kaolin Sample Type 80
Figure 4.3: TEG 5000 Thrombelastograph® Hemostasis Analyzer System 81
Figure 4.4: Schematic of ROTEM Result Parameters 83
Figure 4.5: ROTEM delta 84
Figure 4.6: Schematic of ROTEM Result Parameters 86
Figure 4.7: Sonoclot Coagulation andamp; Platelet Function Analyzer 87
Figure 4.8: Photo-Optical Detection System 89
Figure 5.1: Global Revenue Forecasts for Laboratory and POC Coagulation Testing,
2010-2018 94
Figure 5.2: Global Revenue Forecasts for POC Rapid Coagulation Analyzer Systems,
2010-2018 94
Figure 5.3: Market Share for Coagulation POCT Diagnostic Testing Companies
Worldwide, 2013 95
Figure 5.4: Overall Global Market for Anticoagulant Drugs, 2012-2019 96
Figure 5.5: Estimated Market for Diagnostic Assays of Platelet Function,
2013-2018 97
Figure 5.6: U.S. Revenue Forecasts for Laboratory and POC Coagulation Testing,
2010-2018 98
Figure 5.7: U.S. Laboratory Coagulation Testing Customers by Size 98
Figure 5.8: U.S. Market Share of Laboratory Coagulation Testing by Dollar Volume
99
Figure 5.9: U.S. Revenue Forecasts for POC Rapid Coagulation Analyzer Systems,
2010-2018 99
Figure 5.10: U.S. Market for Anticogulant Drugs, 2012-2019 100
Figure 5.11: European Revenue Forecasts for Laboratory and POC Coagulation
Testing, 2010-2018 101
Figure 5.12: European Revenue Forecasts for POC Rapid Coagulation Analyzer
Systems, 2010-2018 101
Figure 5.13: Japanese Revenue Forecasts for Laboratory and POC Coagulation
Testing, 2010-2018 102
Figure 5.14: Japanese Revenue Forecasts for POC Rapid Coagulation Analyzer
Systems, 2010-2018 102
Figure 5.15: ROW Revenue Forecasts for Laboratory and POC Coagulation Testing,
2010-2018 103
Figure 5.16: ROW Revenue Forecasts for POC Rapid Coagulation Analyzer Systems,
2010-2018 103
Figure 5.17: Indian Coagulation Reagents Market - Test Contribution 104

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