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

• Publication date: November 2012
• Report size: 174 pages

The market for Point-of-Care (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 the introduction of new products that enable POC testing for more applications. The benefits are clear. Hospital-based POC diagnostics...

The market for Point-of-Care (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 the introduction of new products that enable POC testing for more applications.

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.

Hospital-based point-of-care technology provides clinical efficiency and life saving benefits:

The integration of IT connectivity and data management features enables POC analysers to communicate with hospital IT systems and electronic patient records in order to increase efficiency, facilitate quality control and reduce the chance of user error.
The development of new technologies that enable DNA analysis and the identification of hospital-acquired infections such as MRSA at the point of care.
The patient experience is improved with shorter waiting times and hospital stays, and lower rates of hospital-acquired infections.
Automated calibration, processing and operation features eliminate the need for medical staff to add reagents or undertake manual handling steps as errors in these areas can impact patient safety and the accuracy of POC test results.

Challenges remain...

Concerns have been raised by laboratory professionals that the decentralisation of hospital testing and 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 and implemented. The counter argument in favour of POC testing is not helped by the lack of a wide clinical evidence base which is needed if POC diagnostics are to prove they provide lab-quality results and benefits in terms of clinical-usefulness, convenience and cost savings.

This new November 2012 report delivers a complete analysis
This new 182-page highly-detailed report Hospital-based Point-of-Care Diagnostics: Products, Players and Outlook to 2017 provides executives with a complete understanding of the issues which are shaping the market and how that will affect its commercial development. This is Volume 2 of a 4-Volume study of the whole POC IVD sector to be published late 2012/early 2013. See overleaf for more details and discounts.

Focus on...
The Competitive Environment

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 (previously Inverness Medical Innovations), 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.


More Information...
Covering all major hospital POC testing technologies

Haematology Analysers
Blood Gas Analysers
Electrolyte Analysers
Cardiac Markers
Multi-functional clinical chemistry analysers
Urinalysis



Use this report to...

Understand the positive and negative trends which are shaping the sector’s operation
Identify which sectors of the hospital POC market 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 by technology and see them in their competitive environment.

In Vitro Diagnostic Industry

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 B•R•A•H•M•S 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