Hospital-based Point of Care Diagnostics: Products, Players and Outlook to 2017

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Date: 12-Nov-2012
No. of pages: 174
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Clinical and patient benefits are driving the hospital-based point-of-care product sector which achieved growth of 7.5% in 2011.

The market for POC diagnostic products used in a hospital setting was worth approximately US$2.9 billion in 2011 with sectors such as cardiac markers making double digit growth in the year. There is growing interest in the adoption of POC technologies, strong demand in emerging markets, and new products that enable POC testing for more applications are being introduced.

The benefits are clear. Hospital-based POC diagnostics offer healthcare providers an opportunity to improve the quality of patient care while saving time and reducing costs. A faster diagnosis can mean a faster medical intervention, potentially avoiding the need to admit a patient into hospital and the costs incurred as a result, while also freeing up that hospital bed.

It’s not all plain sailing. Concerns have been raised by laboratory professionals that the use of POC products by less skilled users may result in inaccurate diagnoses. This has strengthened resistance to the changes needed for POC products to be widely adopted. The counter argument is not helped by the lack of a wide clinical evidence base which proves POC diagnostics deliver lab-quality results and benefit from being convenient and cost-effective.

There are around 80 companies active in the hospital POC diagnostics market, although many are development-stage or have limited product portfolios. The market is currently dominated by Alere, Abbott, Radiometer, Roche and Siemens. Currently, Abbott, Radiometer, Roche and Siemens have strong positions in the markets for clinical chemistry and blood gas analysis; Abbott, Alere and Roche are leaders for POC cardiac marker testing; and Beckman Coulter, Quest Diagnostics, Horiba and Sysmex are key companies in POC haematology diagnostics.

This volume provides…

  • Market growth forecasts by sector to 2017
  • Directory of 80 companies with 16 detailed profiles
  • Detailed operating environment analysis

All major POC hospital-based testing technologies are covered

  • Haematology analysers
  • Blood Gas analysers
  • Electrolyte analysers
  • Cardiac markers
  • Multi-functional clinical chemistry analysers
  • Urinalysis

Hospital-based Point of Care Diagnostics: Products, Players and Outlook to 2017

Table Of Contents

Executive Summary 1

Introduction  2
POC Testing in a Hospital Setting 2

Current Market Dynamics 4
Fig.1: POC Diagnostics in Relation to the IVD Market, 2011 4
Fig.2: Percentage of POC Diagnostics Market by Product, 2011  5
Regional Perspective  5
Fig.3: Professional POC Diagnostics Market by Region, 2011  6
Regulatory and Reimbursement Environment 6
CLIA Waiver  6
Hospital POC Testing Market 7
Hospital POC Testing Market by Product Type, 2007-2011 (US$ million) 8
Fig.4: Hospital POC Testing Market by Product Type, 2011  8

Competitive Landscape 9
Select POC Diagnostics Companies’ Sales, 2007-2011 (US$ million)  9
Market Leaders by Hospital POC Testing Product Type 9
Merger and Acquisition Activity 10
Key Hospital POC Diagnostics Mergers and Acquisitions, 2008-2012  10

Growth Drivers, Restraints And Future Opportunities 12
Clinical Utility and Accuracy 12
Connectivity  12
POC Diagnostics as a Disruptive Technology  13
POC Diagnostics and the Economy  14
Future Technology: Next-Generation POC Diagnostic Products 14
Lab-on-a-Chip Devices and Microfluidics  14
Detecting Hospital-Acquired Infections  15
Summary: Market Drivers, Restraints and Opportunities 16

Future Market Prospects 17
Hospital POC Testing Market by Product Type, 2011-2017E (US$ million) 17
Hospital POC Testing Market by Product Growth, 2008-2017E (%)  18
Fig.5: Predicted Hospital POC Testing Market by Product, 2017 18

Hospital POC Testing Products And Technologies 19
Multi-Functional Clinical Chemistry Analysers 19
Abaxis’ Piccolo xpress  19
Abbott’s i-STAT System 20
Alfa Wassermann’s ACE Clinical Chemistry Systems  21
Arkray’s SpotChem Systems 22
SpotChem Test Strips  22
Audit Diagnostics’ Liqui-Stat and DryLab Systems 22
DiaSys Diagnostic Systems’ InnovaStar 23
Horiba’s ABX Pentra Clinical Chemistry Analysers 23
Ortho-Clinical Diagnostics’ VITROS DT60 II Chemistry System  23
Radiometer’s AQT90 FLEX Immunoassay Analyser 24
Randox Laboratories’ Evidence Multistat 24
Samsung’s LABGEO Clinical Chemistry Analysers 25
Tosoh Bioscience’s AIA Immunoassay Analysers  25

POC Blood Gas/Electrolyte Analysers  27
Fig.6: POC Clinical Chemistry Market, 2007-2017E (US$ million)  27
Arkray’s SpotChem EL Electrolyte Analyser  28
Epocal’s ePOC Blood Analysis System 28
Instrumentation Laboratory’s GEM Premier Products  29
tBili Assay 29
GEMweb Plus  29
ITC’s IRMA TRUpoint Blood Analysis System 30
ITC’s AVOXimeter Products 30
Nova Biomedical’s Critical Care Analysers 30
pHOx Ultra Blood Gas Analyser 30
Stat Profile pHOx  31
Stat Profile Critical Care Xpress  31
Nova Electrolyte/Chemistry Analysers 31
Hand-Held Analysers  32
OPTI Medical Systems’ Products 32
Radiometer’s Blood Gas Analysers  32
1st automatic  32
ABL90 FLEX  33
ABL800 FLEX  33
Avoid Errors App  34
Roche’s cobas Blood Gas Analysers 34
Siemens’ Blood Gas Analyser Range 35
RAPIDPoint Analysers 35
RAPIDLab Analysers  36
RAPIDChem 744/754 Electrolyte and Lithium Testing 36
RAPIDComm Data Management and Connectivity Solution 36
Via Medical’s Products  37

POC Haematology And Haemostasis Products  38
Fig.7: Global POC Haematotolgy Market, 2007-2017E (US$ million)  38
Haematology Analysers 39
Beckman Coulter’s COULTER AC•T Series  39
Horiba’s Haematology Analysers 39
Samsung’s LABGEO HC10  41
Sysmex’ pocH-100i Haematology Analyser 41
POC Haemoglobin Systems 41
POC Analyser Accuracy  42
Available Products 43
Arkray’s PocketChem BA Blood Ammonia Meters 48
Surgical Coagulation and Haemostasis Management  48
Akers Biosciences’ PIFA Heparin/PF4 and PIFA PLUSS Rapid Assays  49
Haemonetics’ TEG Thrombelastograph Hemostasis Analyzer 49
Medtronic’s HMS PLUS Haemostasis Management System  50
Pentapharm’s ROTEM delta 50
Sienco’s Sonoclot Coagulation & Platelet Function Analyzers 50
Platelet Function Assessment  51
Clinical Guidelines 51
Accumetrics’ VerifyNow System  52
Helena Laboratories’ Plateletworks System 53

POC Cardiac Marker Testing 54
PROTECT Study  55
VISION Study  56
POC Testing  56
Gaining Clinical Evidence  57
Market Dynamics 58
Fig.6: Global POC Cardiac Marker Testing Market, 2007-2017E (US$ million)  58
POC Testing Products 59
Currently-Available Cardiac Marker POC Tests  59

POC Urinalysis  69
Fig.9: Global POC Urinalysis Market, 2007-2017E (US$ million)  69
Key Urine Analysis Test Strips  70
Product Highlights 70
77 Elektronika’s DocUReader 2 and DocuReader 2 Pro  70
ACON Laboratories’ Mission Products 70
Arkray’s Products 71
Roche’s Products 71
Siemens’ Products 72

Other POC Products 74
Labour and Delivery Testing 74
Alere’s Triage PLGF Assay  74
Amnisure International’s AmniSure ROM Test 75
Medix Biochemica’s Actim PROM and Actim Partus 75
Liver Function Testing  76
Exalenz Bioscience’s BreathID System 76
Infopia’s Pioneer POCT Liver Test Sensor  76
Alere’s Triage NGAL Test  77
bioMérieux’ VIDAS BRAHMS PCT. Test 77
Magellan Biosciences’ LeadCare II System 78
Medix Biochemica’s Actim Pancreatitis  78
Products in Development 78
Akers Biosciences’ BreathPulmo Health Check and Breath Asthma Check 78

Emerging Technologies 80
Applied Nanodetectors’ Sensor Array Platform 80
Atonomics’ Atolyzer  80
Ativa Medical’s POC System 81
Bio-AMD’s MPR  81
Biosensia’s RapiPlex  82
Fiomi Diagnostics (Trinity Biotech) Forecast Technology  82
MagnaBioSciences’ MICT On-Site System 83
Micronics’ ABORhCard and ABO-XM Card 83
Molecular Vision  84
MycroLab 84
OPKO Health’s OPKO Diagnostics Platform 85
pes diagnosesysteme’ respons IQ  86
Philips’ Minicare  86
Radisens Diagnostics’ POC Platform 87
T2 Biosystems’ T2Dx System 88
T2Hemostasis Assay  89
Tyrian Diagnostics’ DiagnostIQ 89
Hospital-Acquired Infection Testing 90
Cepheid’s GeneXpert  91
Atlas Genetics’ POC System  92
BioFire Diagnostics’ FilmArray System 92
Immunexpress’ SeptiCyte Technology 93
Rheonix’ EncompassMDx Platform 94

Hospital POC Testing Manufacturers 95

Company Directory  95

Selected Company Profiles 100
Abaxis  100
Piccolo xpress 100
Financial Performance 101
Abaxis Operating Results, 2007-2012 (US$ million) 101
Abbott  102
Recent Key Events  102
i-STAT Point of Care Products  102
Alliance with Abaxis  104
Financial Performance  104
Abbott Point of Care Sales, 2010-2011 (US$ million)  104
Fig.10: Percentage of Abbott Point of Care Revenue by Region, 2011 104
Accumetrics  105
Recent Key Events  105
Fig.11: Accumetrics Revenue, 2005-2011 (US$ thousand)  105
VerifyNow System 106
Distribution Agreements  107
Akers Biosciences  108
Recent Key Events  108
Current Products 109
Research and Development 109
Current Alliances and Distribution Agreements  110
Financial Performance  111
Akers Biosciences Operating Results, 2007-2011 (US$ thousands) 111
Fig.12: Percentage of Akers’ Revenue by Product Type, 2011  112
Alere 113
Recent Key Events 113
POC Cardiology Diagnostic Products 114
Women’s Health 116
RALS-Plus POC IT Solution  116
POC Mergers & Acquisitions 117
Current Alliances 119
Financial Performance  120
Alere - Operating Results, 2007-2011 (US$ million) 121
Fig.13: Percentage of Alere’s Revenue by Segment, 2011 121
Fig.14: Percentage of Alere’s Revenue by Region, 2011  121
Alere Professional Diagnostics Operating Results, 2007-2011 (US$ million) 122
Professional Diagnostics Net Sales & Services Revenue, 2007-2011 (US$ million)  122
Fig.15: Alere Professional Diagnostics Net Sales & Services Revenue by Product, 2011 122
Alere Consumer Diagnostics Operating Results, 2007-2011 (US$ million) 122
Arkray  124
Recent Key Events 124
POC Testing Products 124
Current Alliances 126
bioMérieux  127
bioNexia POC Tests  127
VIDAS Tests  127
Current Alliances 128
Financial Performance  129
bioMérieux - Operating Results, 2007-2011 (EUR million)  129
Fig.16: Percentage of bioMérieux’ Revenue by Product Type, 2011  130
Fig.17: Percentage of bioMérieux’s Revenue by Region, 2011 130
Horiba Medical  131
Recent Key Events 132
Haematology Analysers  132
ABX Pentra 400 Clinical Chemistry Analyser  134
Pentra C200 Clinical Chemistry Analyser  134
Financial Performance  134
Fig.18: Percentage of Horiba’s Revenue by Division, 2011 134
Horiba Medical - Operating Results, 2007-2011 (¥ million)  135
Fig.19: Percentage of Horiba Medical’s Revenue by Region, 2011 135
Fig.20: Percentage of Horiba Medical’s Revenue by Product Type, 2011 135
Instrumentation Laboratory  137
Recent Key Events 137
POC Critical Care Diagnostics  137
Purchasing Contracts 138
International Technidyne Corporation 139
Products 139
Current Alliances 140
Financial Performance 140
International Technidyne Operating Results, 2004-2009 (US$ million) 141
Fig.21: International Technidyne Revenue, 2000-2010 (US$ million)  141
Nova Biomedical  142
Critical Care Analysers  142
Hand-Held Analysers 143
Quest Diagnostics 144
HemoCue Products  144
Litigation with EKF Diagnostics  146
Financial Performance  146
Quest Diagnostics - Operating Results, 2007-2011 (US$ million) 147
Quest Diagnostics - Sales and Earnings by Category, 2007-2011 (US$ million)  147
Fig.22: Quest Diagnostics - Revenue by Division, 2011  147
Radiometer (Danaher) 149
Recent Key Events  149
AQT90 FLEX Immunoassay Analyser  150
Blood Gas Analysers  150
AQURE POC Management System 152
RADIANCE IT system  152
Current Alliances 152
Financial Performance  153
Fig.23: Radiometer - Revenue by Region, 2010 153
Response Biomedical  154
Recent Key Events  154
RAMP System 155
Current Alliances 156
Financial Performance  157
Response Biomedical - Operating Results, 2007-2011 (C$ thousands) 157
Response Biomedical - Product Sales by Category, 2009-2011 (C$ thousands)  158
Fig.24: Response Biomedical - Product Sales by Category, 2011  158
Response Biomedical - Revenue by Region, 2009-2011 (C$ thousands)  158
Fig.25: Response Biomedical - Revenue by Region, 2011 159
Roche Diagnostics  160
Recent Key Events  160
Cardiac Testing Products 161
cobas Blood Gas Analysers  161
Urinalysis 162
cobas POC IT Solution 162
Current Alliances and Contracts  163
Financial Performance  163
Roche Diagnostics Operating Results, 2010-2011 (SFr million) 164
Fig.26: Roche Diagnostics - Revenue by Product Line, 2011  164
Fig.27: Roche Professional Diagnostics - Revenue by Region, 2011  164
Siemens Healthcare Diagnostics  166
Recent Key Events  166
Blood Gas Analyser Range 166
Urinalysis 168
Cardiology - Stratus CS Analyzer 169
RAPIDComm Data Management and Connectivity Solution 170
Current Alliances and Supply Contracts  170
Financial Performance  170

Appendices  172

Appendix 1 - List Of Abbreviations 172
Appendix 2 - Report Methodology  173

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