Keywords : POC, immunoassay, POC testing, Cardiac Marker, IVD, Coagulation Test, Haemostasis, Hemostasis analyzer
POC testing can offer clear benefits over laboratory testing. As it is conducted in the presence of or near the patient, results are obtained quickly, enabling healthcare providers to act swiftly to emergencies such as heart attack and provide a diagnosis while the patient is still in the healthcare facility, speeding treatment and reducing visits to the doctor. For patients, self-testing helps users control their condition, reducing the chance o...
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POC testing can offer clear benefits over laboratory testing. As it is conducted in the presence of or near the patient, results are obtained quickly, enabling healthcare providers to act swiftly to emergencies such as heart attack and provide a diagnosis while the patient is still in the healthcare facility, speeding treatment and reducing visits to the doctor. For patients, self-testing helps users control their condition, reducing the chance of complications and improving health, while lowering the time and cost of treating complications, and the need for patients to regularly see their doctor.
Clinical acceptance remains an obstacle
This is a key issue. Healthcare providers need evidence that POC diagnostics provide lab-quality results and benefits in terms of clinical-usefulness, convenience and cost in order to adopt them. Unsurprisingly, concerns have been raised by laboratory professionals about the decentralisation of hospital testing and by doctors about patient and consumer self-testing. In both cases, there is concern that the use of POC products by less skilled users may result in inaccurate diagnoses, leading to resistance to the changes needed for POC products to be widely implemented.
Overcoming these issues will be critical to the POC diagnostic sector if it is to realise its full potential – at present, adoption and usage rates vary widely, and there remains much untapped potential in the worldwide market.
Innovation is making an impact
There is currently much innovation in the market. Products that enable multi-parameter diagnostics using technologies such as microfluidics are a major focus, as are products for personalised medicine. For example, the first POC DNA analysis system, Spartan Bioscience’s RX CYP2C19, has European approval to help identify patients with impaired metabolism to the popular anti-blood clotting medication, clopidogrel.
This new September 2012 report delivers a complete and insightful analysis
This new 130-page highly detailed report – Volume 1 of a 4-volume study of the whole IVD sector to be published this autumn/winter – provides executives with a complete understanding of the issues which are shaping the market and how they will affect its commercial development.
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In Vitro Diagnostic Industry
Contents
MARKET OVERVIEW 1
EXECUTIVE SUMMARY 1
INTRODUCTION 2
POC Cardiovascular POC 2
The Role Of POC Testing in Cardiovascular Care 3
Customers of POC Cardiovascular Diagnostic Products 4
POC Cardiovascular Technologies by Customer Segment 4
Regulatory and Reimbursement Environment 5
CLIA Waiver 5
CURRENT MARKET DYNAMICS 6
Fig 1: POC Diagnostics in Relation to the IVD Market, 2011 6
Fig 2: Percentage of POC Diagnostics Market by Product, 2011 7
Regional Perspective 7
Fig 3: Professional POC Diagnostics Market by Region, 2011 8
POC Cardiovascular Testing Market 8
POC Cardiovascular Diagnostics Market by Product Type, 2007-2011 (US$ million) 9
Fig 4: Cardiac POC Testing Market by Product, 2011 9
GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES 10
The Burden of Cardiovascular Disease 10
POC Diagnostics and the Economy 11
POC Diagnostics as a Disruptive Technology 12
Clinical Utility and Accuracy 12
Connectivity 13
Emerging Technologies 13
Companion Diagnostics 13
Lab-on-a-Chip Devices and Microfluidics 14
Summary: Market Drivers, Restraints and Opportunities 15
COMPETITIVE LANDSCAPE 16
Market Leaders for Cardiovascular POC Testing Products 16
Select POC Diagnostics Companies’ Sales, 2007-2011 (US$ million) 16
Merger and Acquisition Activity 17
Key POC Diagnostics Mergers and Acquisitions, 2008-2011 17
FUTURE MARKET PROSPECTS 18
POC Cardiovascular Testing Market by Product Type, 2011-2017E (US$ million) 19
POC Cardiovascular Testing Market by Product Growth, 2008-2017E (%) 19
POC CARDIOVASCULAR PRODUCTS AND TECHNOLOGIES 20
POC COAGULATION TESTING 20
POC Coagulation Testing Market Dynamics 20
Fig 5: Global POC Coagulation Market, 2007-2017E (US$ million) 21
The Impact of New-Generation Anticoagulants 21
Self-Monitoring Products 23
CoaguSense’s CoaguSense PT/INR Monitoring System 24
Alere’s INRatio2 System 24
International Technidyne Corporation’s ProTime System 24
ProTime Microcoagulation System 24
Roche’s CoaguChek XS 25
Professional Use Products 25
Abbott’s i-STAT System 25
i-STAT Cartridges 26
Alere’s Axis-Shield Products 26
Helena Laboratories’ Cascade POC System 27
Helena Laboratories’ Actalyke & MAX-ACT 27
Medtronic‘s ACT Plus Automated Coagulation Timer System 27
Instrumentation Laboratory’s GEM PCL Plus 27
ITC’s Hemochron Whole Blood Coagulation System 27
Hemochron Signature Elite and Hemochron Signature Plus Microcoagulation System 28
Hemochron Response 28
Radiometer’s AQT90 FLEX Immunoassay Analyser 28
Roche’s CoaguChek Systems 28
CoaguChek XS Pro 29
CoaguChek XS Plus 29
CoaguChek XS 29
CoaguChek Link 29
Products in Development 30
Bio-AMD’s COAG 30
Siemens/Universal Biosensors’ POC Coagulation Tests 30
Surgical Coagulation and Haemostasis Management 31
Akers Biosciences’ PIFA Heparin/PF4 and PIFA PLUSS Rapid Assays 31
Haemonetics’ TEG Thrombelastograph Hemostasis Analyzer 32
Medtronic’s HMS PLUS Haemostasis Management System 32
Pentapharm’s ROTEM delta 33
Sienco’s Sonoclot Coagulation & Platelet Function Analyzers 33
PLATELET FUNCTION AND ANTIPLATELET DRUG ASSESSMENT 34
Clinical Guidelines 34
Accumetrics’ VerifyNow System 35
Clinical Studies 35
Helena Laboratories’ Plateletworks System 36
Clopidogrel Effectiveness Assessment 36
Spartan Bioscience’s Spartan RX CYP2C19 POC DNA Testing System 37
Clinical Studies 37
POC CARDIAC MARKER TESTING 38
PROTECT Study 39
VISION Study 40
POC Testing 40
Gaining Clinical Evidence 41
Market Dynamics 42
Fig 6: Global POC Cardiac Marker Testing Market, 2007-2017E (US$ million) 42
POC Testing Products 43
Currently-Available Cardiac Marker POC Tests 43
Abbott’s i-STAT System 44
Alfa Wassermann’s ACE Clinical Chemistry Systems 45
Alere’s Heart Check System 45
Alere’s Triage and Clearview Products 45
Audit Diagnostics’ DryLab 48
bioMérieux VIDAS and bioNexia Tests 48
Nexus Dx/Samsung’s LABGEO POC Cardiovascular Analysers 48
Mitsubishi Chemical’s Pathfast Immunoassay Analyzer 49
Ortho-Clinical Diagnostics’ VITROS DT60 II Chemistry System 49
Radiometer’s AQT90 FLEX Immunoassay Analyser 49
Randox Laboratories’ Evidence Multistat 50
ReLIA Diagnostic Systems’ ReLIA System 50
Response Biomedical’s RAMP Platform 50
Roche Cardiac Testing Products 52
Siemens’ Stratus CS Analyzer 53
Tosoh Bioscience’s AIA-360 Immunoassay Analyser 53
Products in Development 54
POC CHOLESTEROL TESTING 57
Cholesterol Testing and Preventative Medicine 57
POC Cholesterol Testing Market Dynamics 58
Fig 7: Global POC Cholesterol Testing Market, 2007-2017E (US$ million) 59
Professional Use Products 59
Abaxis’ Piccolo xpress 59
Alere’s Cholestech LDX System 60
Alfa Wassermann’s ACE Clinical Chemistry Systems 60
Arkray’s SpotChem Dry Chemistry Analysers 61
Audit Diagnostics’ Liqui-Stat System 61
Horiba ABX’ Pentra Clinical Chemistry Analysers 61
Jant Pharmacal’s LipidPlus Lipid Profile and Glucose Test System 61
Polymer Technology Systems’ CardioChek PA 62
Miraculins’ PreVu Point of Care Skin Sterol Test 62
Distribution Agreements 63
Samsung’s LABGEO PT10 Clinical Chemistry Analyzer 64
Products in Development 64
Roche and Panasonic Healthcare 64
Home Testing 64
Alere’s First Check Cholesterol Test 64
Akers Biosciences’ Tri-Cholesterol Check 64
Chematics Chemcard Cholesterol Test 65
Infopia’s Lipid Pro 65
Roche’s Accutrend Plus 65
Syntron Bioresearch’s Venture Total Cholesterol Test 65
EMERGING TECHNOLOGIES 65
Ativa Medical’s POC Analyser 66
Atonomics’ Atolyzer 67
Bio-AMD’s MPR 67
Biosensia’s RapiPlex 67
Fiomi Diagnostics (Trinity Biotech) Forecast Technology 68
MagnaBioSciences’ MICT On-Site System 69
Molecular Vision 69
MycroLab 69
OPKO Health’s OPKO Diagnostics Platform 70
Philips’ Minicare 71
Radisens Diagnostics’ POC Platform 72
T2 Biosystems’ T2Dx System 72
T2Hemostasis Assay 73
MANUFACTURERS 74
COMPANY DIRECTORY 74
SELECTED COMPANY PROFILES 78
Abbott 78
Recent Key Events 78
i-STAT Point-of-Care Products 78
i-STAT Cartridges 79
Financial Performance 80
Abbott Point of Care Sales, 2010-2011 (US$ million) 80
Fig 8: Percentage of Abbott Point of Care Revenue by Region, 2011 80
Accumetrics 81
Recent Key Events 81
Fig 9: Accumetrics Revenue, 2005-2011 (US$ thousand) 82
VerifyNow System 82
Distribution Agreements 83
Akers Biosciences 84
Recent Key Events 84
Current Products 85
PIFA Heparin/PF4 and PIFA PLUSS Rapid Assays 85
Tri-Cholesterol Check 85
Current Alliances and Distribution Agreements 86
Al Tadawi Medical Equip/ PharmaNova Medical Equipment 86
Fisher HealthCare 86
Financial Performance 86
Akers Biosciences Operating Results, 2007-2011 (US$ thousands) 87
Fig 10: Percentage of Akers’ Revenue by Product Type, 2011 87
Alere 88
Recent Key Events 89
POC Cardiology Diagnostic Products 89
Triage Cardiac Marker Tests 89
Alere Heart Check System 91
Cholestech LDX 92
INRatio2 System 92
Axis-Shield Products 92
RALS-Plus POC IT Solution 94
Alere Consumer Products 94
POC Mergers & Acquisitions 94
Axis-Shield 94
Medical Automation Systems’ 94
Standard Diagnostics 95
Mologic, Jinsung Meditech, Biolinker and Long Chain International Corp 95
Zycare, Medim and Biosyn 95
ACON Laboratories’ Rapid Diagnostics Assets 95
Matria Healthcare 96
BBI Holdings 96
Other Acquisitions 96
Current Alliances 97
Spartan Bioscience 97
Epocal 97
Financial Performance 97
Alere - Operating Results, 2007-2011 (US$ million) 98
Fig 11: Percentage of Alere’s Revenue by Segment, 2011 98
Fig 12: Percentage of Alere’s Revenue by Region, 2011 99
Alere Professional Diagnostics Operating Results, 2007-2011 (US$ million) 99
Alere Professional Diagnostics Net Sales & Services Revenue, 2007-2011 (US$ million) 99
Fig 13: Alere Professional Diagnostics Net Sales & Services Revenue by Product, 2011 100
Alere Consumer Diagnostics Operating Results, 2007-2011 (US$ million) 100
Latest Results 100
Axis Shield - Financial Performance 101
Fig 14: Axis-Shield Revenue by Business Unit, 2010 102
Fig 15: Axis-Shield Revenue by Region, 2010 102
Axis-Shield - POC Segment Operating Results, 2006-2010 (£ million) 102
Axis-Shield - POC Sales by Product Line, 2006-2010 (£ million) 103
Fig 16: Axis-Shield POC Sales by Product, 2010 103
Fig 17: Axis-Shield Afinion Sales by Region, 2010 103
bioMérieux 104
bioNexia POC Tests 104
VIDAS Tests 104
VIDAS NT-proBNP 104
VIDAS Troponin I Ultra 104
VIDAS D-Dimer Exclusion 105
VIDAS B•R•A•H•M•S PCT Test 105
Current Alliances 105
Uppsala Clinical Research Center 105
Philips 105
Sysmex 106
Abaxis 106
ReLIA Diagnostic Systems 106
Roche Diagnostics 106
Brahms 106
Financial Performance 106
bioMérieux - Operating Results, 2007-2011 (EUR million) 106
Fig 18: Percentage of bioMérieux’ Revenue by Product Type, 2011 107
Fig 19: Percentage of bioMérieux’ Revenue by Region, 2011 107
International Technidyne Corporation 108
Products 108
ProTime Microcoagulation System 108
Hemochron Whole Blood Coagulation System 108
IRMA TRUpoint Blood Analysis System 109
AVOXimeter Whole Blood CO Oximeter and Oximeter 109
Current Alliances 110
Alere 110
Financial Performance 110
International Technidyne Operating Results, 2004-2009 (US$ million) 110
Fig 20: International Technidyne Revenue, 2000-2010 (US$ million) 111
Radiometer (Danaher) 112
Recent Key Events 112
AQT90 FLEX Immunoassay Analyser 112
AQURE POC Management System 113
Financial Performance 113
Fig 21: Radiometer - Revenue by Region, 2010 114
Response Biomedical 115
Recent Key Events 115
RAMP System 116
Cardiac Marker Tests 117
Current Alliances 117
Fisher Scientific 117
Cremascoli 117
O&D Biotech 117
Guangzhou Wondfo Biotech 118
Shionogi 118
Financial Performance 118
Response Biomedical - Operating Results, 2007-2011 (C$ thousand) 118
Response Biomedical - Product Sales by Category, 2009-2011 (C$ thousand) 119
Fig 22: Response Biomedical - Product Sales by Category, 2011 119
Response Biomedical - Revenue by Region, 2009-2011 (C$ thousand) 119
Fig 23: Response Biomedical - Revenue by Region, 2011 120
Latest Results 120
Roche Diagnostics 121
Recent Key Events 121
CoaguChek Systems 122
CoaguChek XS Pro 122
CoaguChek XS Plus 122
CoaguChek XS 122
CoaguChek Link 122
Cardiac Testing Products 123 Device 123
Cardiac Reader 123
TROP T Sensitive Rapid Assay 123
cobas POC IT Solution 124
Current Alliances and Contracts 124
Panasonic Healthcare 124
Eidia (Eisai) 124
Voluntis 124
Radiometer 125
bioMérieux 125
Alere 125
Dade Behring (Siemens) 125
Financial Performance 125
Roche Diagnostics Operating Results, 2010-2011 (SFr million) 126
Fig 24: Roche Diagnostics - Revenue by Product Line, 2011 126
Fig 25: Roche Professional Diagnostics - Revenue by Region, 2011 126
Latest Results 127
Siemens Healthcare 128
Recent Key Events 128
Stratus CS Acute Care Diagnostic System 128
Current Alliances and Supply Contracts 129
Universal Biosensors 129
Premier 129
Roche 129
Financial Performance 129
Latest Results 130
APPENDICES 131
APPENDIX 1 - LIST OF ABBREVIATIONS 131
APPENDIX 2 - REPORT METHODOLOGY 132
