Cardiology Point of Care Diagnostics: Products, players & outlook to 2017

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Dec 13, 2012, 10:38 ET

NEW YORK, Dec. 13, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Cardiology Point of Care Diagnostics: Products, players & outlook to 2017
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A comprehensive global market report on this high-growth sector

The POC cardiology diagnostics market was worth over US$2 billion in 2011 and rose by 9% compared with 2010. This was driven by a growing interest in the adoption of POC technologies by both healthcare providers and patients at home, as well as the introduction of new products that enable POC testing for more applications, enhance ease-of-use and improve on current products.

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.

Get the best from your investment! Pdf or print formats and the brilliant Espicom Interactive included at no extra cost! Customers can choose print or pdf format but all get access via Espicom Interactive. Customers will really benefit from accessing this report's rich content through Espicom Interactive by...
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Covering all major POC cardiology testing technologies

Coagulation
Platelet Function
Cardiac Markers
Cholesterol
Companion Diagnostics

Products for all user groups

Physician Office
Emergency Room/A&E
Home Testing

Use this report to...

Understand the trends which are shaping the sector's operation
Identify which sectors offer the greatest growth potential over the next 5 years
Highlight the emerging companies in the industry with novel technology
Evaluate the competitive landscape and identify the companies to watch
Know who's striking strategic and tactical partnerships
Monitor M&A activity and the changing competitive landscape
Identify the leading products

Focus on... Mergers & Acquisitions

M&A activity has increased significantly in recent years and this industry consolidation is changing the dynamics of the market, potentially to the detriment of smaller companies. In particular, Alere has reinforced its industry dominance with several key acquisitions in the past five years, including HemoSense, Cholestech and Biosite. In 2011, it acquired Axis-Shield, a company with POC sales of nearly £50 million in 2010, and Medical Automation Systems, the market leader in POC IT connectivity solutions.

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 Environment5
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, 20119
GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES10
The Burden of Cardiovascular Disease10
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 PROSPECTS18
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 Products23
CoaguSense's CoaguSense PT/INR Monitoring System.24
Alere's INRatio2 System .24
International Technidyne Corporation's ProTime System24
ProTime Microcoagulation System.24
Roche's CoaguChek XS ..25
Professional Use Products ..25
Abbott's i-STAT System25
i-STAT Cartridges26
Alere's Axis-Shield Products26
Helena Laboratories' Cascade POC System.27
Helena Laboratories' Actalyke & MAX-ACT 27
September iii
Cardiology Point-of-Care DiagnosticsTable of Contents
iv ©Espicom Business Intelligence September 2012
Cardiology Point-of-Care Diagnostics
Medtronic's ACT Plus Automated Coagulation Timer System..27
Instrumentation Laboratory's GEM PCL Plus.27
ITC's Hemochron Whole Blood Coagulation System27
Hemochron Signature Elite and Hemochron Signature Plus Microcoagulation System .28
Hemochron Response28
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 Guidelines34
Accumetrics' VerifyNow System .35
Clinical Studies .35
Helena Laboratories' Plateletworks System36
Clopidogrel Effectiveness Assessment36
Spartan Bioscience's Spartan RX CYP2C19 POC DNA Testing System .37
Clinical Studies ..37
POC CARDIAC MARKER TESTING38
PROTECT Study.39
VISION Study. 40
POC Testing..40
Gaining Clinical Evidence..41
Market Dynamics42
Fig.6: Global POC Cardiac Marker Testing Market, 2007-2017E (US$ million) 42
POC Testing Products. 43
Currently-Available Cardiac Marker POC Tests43
Abbott's i-STAT System.44
Alfa Wassermann's ACE Clinical Chemistry Systems45
Alere's Heart Check System45
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 Analyzer49
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 System50
Response Biomedical's RAMP Platform..50
Roche Cardiac Testing Products..52
Siemens' Stratus CS Analyzer53
Tosoh Bioscience's AIA-360 Immunoassay Analyser53
Products in Development54
POC CHOLESTEROL TESTING
Cholesterol Testing and Preventative Medicine57
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 Analysers61
Audit Diagnostics' Liqui-Stat System61
Horiba ABX' Pentra Clinical Chemistry Analysers61
Jant Pharmacal's LipidPlus Lipid Profile and Glucose Test System61
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 Analyser66
Atonomics' Atolyzer67
Bio-AMD's MPR..67
Biosensia's RapiPlex ..67
Fiomi Diagnostics (Trinity Biotech) Forecast Technology68
MagnaBioSciences' MICT On-Site System.69
Molecular Vision ..69
MycroLab69
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, 201180
Accumetrics .81
Recent Key Events..81
Fig.9: Accumetrics Revenue, 2005-2011 (US$ thousand)..82
VerifyNow System. 82
Distribution Agreements. 83
Akers Biosciences 84vi ©Espicom Business Intelligence September 2012
Table of Contents Cardiology Point-of-Care Diagnostics
Recent Key Events..84
Current Products 85
PIFA Heparin/PF4 and PIFA PLUSS Rapid Assays85
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 Tests89
Alere Heart Check System91
Cholestech LDX..92
INRatio2 System92
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 Healthcare96
BBI Holdings ..96
Other Acquisitions96
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 Performance101
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, 2010103
Fig.17: Axis-Shield Afinion Sales by Region, 2010103
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..106
ReLIA Diagnostic Systems.106
Roche Diagnostics.106
Brahms106
Financial Performance 106
bioMérieux - Operating Results, 2007-2011 (EUR million).106
Fig.18: Percentage of bioMerieux' Revenue by Product Type, 2011107
Fig.19: Percentage of bioMerieux' Revenue by Region, 2011107
International Technidyne Corporation 108
Products. 108
ProTime Microcoagulation System.108
Hemochron Whole Blood Coagulation System108
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, 2010114
Response Biomedical..115
Recent Key Events.115
RAMP System..116
Cardiac Marker Tests.117
Current Alliances..117
Fisher Scientific117
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, 2011120
Latest Results..120
Roche Diagnostics .121
Recent Key Events121
CoaguChek Systems. 122
CoaguChek XS Pro 122
CoaguChek XS Plus ..122
CoaguChek XS .122
CoaguChek Link..122
Cardiac Testing Products.. 123viii ©Espicom Business Intelligence September 2012
Table of Contents Cardiology Point-of-Care Diagnostics
cobas h 232 Portable Cardiac Testing Device.123
Cardiac Reader 123
TROP T Sensitive Rapid Assay.123
cobas POC IT Solution124
Current Alliances and Contracts124
Panasonic Healthcare .124
Eidia (Eisai)124
Voluntis124
Radiometer ..125
bioMerieux125
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 Events128
Stratus CS Acute Care Diagnostic System 128
Current Alliances and Supply Contracts. 129
Universal Biosensors129
Premier129
Roche129
Financial Performance ... 129
Latest Results..130
APPENDICES 131
APPENDIX 1 - LIST OF ABBREVIATIONS.. 131
APPENDIX 2 - REPORT METHODOLOGY. 132