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

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May 28, 2013, 07:37 ET

NEW YORK, May 28, 2013 /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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Despite the economic situation and many operational challenges, the POC cardiology product sector is set to achieve growth of 7.8%

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 available much more 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.

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 volume provides...

Market growth forecasts by sector to 2017

Evaluation of 60 companies

Detailed operating environment analysis

All major POC cardiology testing technologies are covered

Coagulation

Platelet function

Cardiac markers

Cholesterol

Companion diagnostics

Products for all user groups

Physician office

Emergency room/A&E

Home testing

About the Author

This report has been researched and written by independent medical market analyst Joanne Maddox. For over 13 years she has played a pivotal role in tracking trends in medical device and equipment markets and companies. A former editor of Medical Device Companies Analysis she has also written The Global Advanced Wound Care Market to 2017; Advances in Molecular Imaging 2013; and, Telemonitoring: Challenges and Opportunities.

About the Publisher

For over 30 years Espicom Business Intelligence, a Business Monitor company, has been a leading provider of key medical device and technology data. Its experienced and knowledgeable authors are uniquely placed to produce this high-quality and thoroughly researched management report. Espicom is part of Business Monitor International.

TABLE OF 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 LANDSCAPE16

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 System27

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 Testing40

Gaining Clinical Evidence41

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

MANUFACTURERS74

COMPANY DIRECTORY 74

SELECTED COMPANY PROFILES 78

Abbott 78

Recent Key Events 78

i-STAT Point-of-Care Products 78

i-STAT Cartridges79

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

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