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

  • January 2013
  • -
  • Espicom Business Intelligence
  • -
  • 178 pages

Rising incidence of diabetes, heart conditions and cancer are underpinning the physician-based POC diagnostic sector’s rapid growth
The market for POC diagnostic products used in the physician’s surgery was worth approximately US$4.1 billion in 2011 with sectors such as cholesterol testing and tumour markers making the best continued growth in the year. All sectors will see sustained growth over the medium term with the market forging ahead to be valued at over US$6 billion by 2017.

In the physician's office, POC diagnostics can play a key role in the diagnosis and ongoing monitoring of acute and chronic illnesses, the detection of some types of cancer, the monitoring of patients on anticoagulation drugs, and for general blood and urine testing. It can also play an important role in enabling preventative medicine, which is intended to help curb the increasing incidence of chronic conditions such as diabetes and cardiovascular disease through early detection and identifying patients with risk factors that mean they are likely to develop such conditions in the future.

There are several key challenges in the market. Currently, many physicians’ offices do not have budgets for in-house diagnostic testing and healthcare funding needs to change in order to provide incentives for doctors to use the products. For this to happen, healthcare providers need evidence that POC diagnostics provide benefits in terms of clinical-usefulness, convenience and cost.


This volume provides...

Market growth forecasts by sector to 2017
Over 100 companies listed with 14 detailed profiles
Detailed operating environment analysis

All major testing technologies are covered

Haemoglobin (HbA1c)
Cholesterol
Coagulation
Tumour marking
C-reactive protein (CRP)
Urinalysis
Haematology & clinical chemistry

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

Physician-based Point of Care Diagnostics: Products, Players and Outlook to 2017
Table of Contents

MARKET OVERVIEW 1
EXECUTIVE SUMMARY 1
INTRODUCTION 2
Physician's Office POC Testing 2
The Role of POC Testing in a Physician's Office 3
Regulatory and Reimbursement Environment 4
CLIA Waiver 4
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
Physician's Office POC Testing Market 8
Addressable Markets for Physician's Office POC Testing, 2007-2011 (US$ million) 10
Fig 4: Addressable Markets for Physician's Office POC Testing, 2011 10
Fig 5: Physician's Office POC Testing Market, 2011 11
GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES 12
POC Diagnostics and the Economy 12
The Burden of Chronic Disease and Preventative Medicine 12
Clinical Utility and Accuracy 14
POC Diagnostics as a Disruptive Technology 14
Emerging Technologies 15
Summary: Market Drivers, Restraints and Opportunities 16
COMPETITIVE LANDSCAPE 17
Market Leaders for Physician's Office POC Testing Products 17
Select POC Diagnostics Companies' Sales, 2007-2011 (US$ million) 17
Merger and Acquisition Activity 17
Key POC Diagnostics Mergers and Acquisitions, 2008-2011 18
FUTURE MARKET PROSPECTS 20
Addressable Markets for Physician's Office POC Testing, 2011-2017E (US$ million) 21
Growth in the Addressable Markets for Physician's Office POC Testing, 2008-2017E (%) 21
Physician's Office POC Testing Market, 2011-2012E (US$ million) 21
Fig 6: Physician's Office POC Testing Market, 2012(E) 22
PHYSICIAN'S OFFICE POC PRODUCTS AND TECHNOLOGIES 23
POC HBA1C TESTING 23
Diabetes Prevalence and Burden to the Healthcare System 23
Fig 7: Diabetes Prevalence by Geographic Region, 2011-2030 23
Diabetes Prevalence for the Top 10 Countries, 2011-2030 (million) 24
Diabetes Management and the Role of HbA1c Testing 25
POC HbA1c Testing Market 27
Fig 8: Global POC HbA1c Testing Market, 2007-2017E (US$ million) 27
POC HbA1c Products 27
ApexBio's A1C Express 27
Alere/Axis-Shield's Afinion HbA1c and NycoCard HbA1c Tests 27
Bayer's A1CNow Products 28
Bio-Rad's in2it A1C Analyser 28
DiaSys Diagnostic Systems' InnovaStar 28
Ceragem Medisys' HbA1c Analysers 29
EKF Diagnostics' Quo-Lab, Quo-Test and Biosen HbA1c Analysers 29
Infopia's Easy/Clover A1c 29
Siemens' DCA Vantage Analyser 29
Tosoh Bioscience's G8 HPLC Analyzer 30
In Development 30
POC CHOLESTEROL TESTING 32
Cholesterol Testing and Preventative Medicine 32
POC Cholesterol Testing Market Dynamics 33
Fig 9: Global POC Cholesterol Testing Market, 2007-2017E (US$ million) 34
Fig:10: POC Cholesterol Testing Market by End User, 2011 34
Available Products 35
Alere's Cholestech LDX System 35
Akers Biosciences' Tri-Cholesterol Check 35
Chematics' Chemcard Cholesterol Test 35
General Life Biotechnology's BeneCheck LipidEx ST 35
Infopia's Lipid Pro 36
Jant Pharmacal's LipidPlus Lipid Profile and Glucose Test System 36
Miraculins' PreVu Point of Care Skin Sterol Test 36
Distribution Agreements 37
Polymer Technology Systems' CardioChek PA 37
Roche's Accutrend Plus 38
Syntron Bioresearch's Venture Total Cholesterol Test 38
Products in Development 38
Roche and Panasonic Healthcare 38
POC COAGULATION TESTING 39
POC Coagulation Testing Market Dynamics 39
Fig 11: Global POC Coagulation Market, 2007-2017E (US$ million) 40
The Impact of New-Generation Anticoagulants 40
Patient Self-Testing and Issues for Doctors 41
CoaguSense's CoaguSense PT/INR Monitoring System 43
Alere's INRatio2 System 43
International Technidyne Corporation's ProTime Microcoagulation System 43
Roche's CoaguChek XS 43
Professional Use Products 44
Alere's Axis-Shield Products 44
Helena Laboratories' Cascade POC System 44
Instrumentation Laboratory's GEM PCL Plus 45
Roche's CoaguChek Systems 45
CoaguChek XS Pro 45
CoaguChek XS Plus 45
CoaguChek XS 45
CoaguChek Link 45
Products in Development 46
Bio-AMD's COAG 46
Siemens/Universal Biosensors' POC Coagulation Tests 46
POC CLINICAL CHEMISTRY AND HAEMATOLOGY PRODUCTS 47
Multi-Functional POC Clinical Chemistry Analysers 47
Handheld POC Analysers Suitable for Use by Physicians 47
Abaxis' Piccolo xpress 47
Abbott's i-STAT System 48
Alere/Axis-Shield's Afinion POC System 49
Alere/Axis-Shield's NycoCard System 49
Benchtop Systems Suitable for Physician's Laboratories 50
Alfa Wassermann's ACE Clinical Chemistry Systems 50
Arkray's SpotChem Systems 50
SpotChem Test Strips 51
Audit Diagnostics' Liqui-Stat System 51
DiaSys Diagnostic Systems' InnovaStar 51
Horiba's ABX Pentra Clinical Chemistry Analysers 52
Ortho-Clinical Diagnostics' VITROS DT60 II Chemistry System 52
Qualigen's FastPack IP System 52
Samsung's LABGEO Clinical Chemistry Analysers 52
Tosoh Bioscience's AIA Immunoassay Analysers 52
POC Haematology and Haemoglobin Analysers 53
POC Haemoglobin Systems 53
POC Analyser Accuracy 53
ACON Laboratories' Mission Hb Hemoglobin Testing Systems 54
ApexBio's HemoSmart Haemoglobin Screening System 54
Audit Diagnostics' Hb-Stat 54
Ceragem Medisys' CERA-CHEK Hb Plus 54
EKF Diagnostics' Products 54
General Life Biotechnology's BeneCheck Hb Hemoglobin Test System 55
OrSense's Glasswing and NBM 200 Systems 55
Quest Diagnostics' HemoCue Haemoglobin Systems 56
URIT Medical's URIT-12 Hemoglobin Meter 57
POC C-REACTIVE PROTEIN DIAGNOSTICS 58
Abaxis' MetLyte Plus CRP and BioChemistry Panel Plus 58
Alere/Axis-Shield 59
bioMerieux bioNexia CRP Test 59
LifeAssays' CRP 59
Medix Biochemica's Actim CRP 59
Orion Diagnostica's QuikRead and QuikRead go Systems 59
POC PHYSICIAN'S OFFICE INFECTIOUS DISEASE TESTS 60
Current Market Dynamics 61
Fig 12: Market for POC Infectious Disease Tests used in a Physician's Office, 2007-2017E (US$ million) 61
POC Influenza Testing 61
Performance and Use of Rapid Influenza Tests in the US 62
CDC Recommendations 62
CDC: Influenza Prevalence and Test Accuracy 63
POC Influenza Testing Market 63
Future Prospects 64
CLIA-Waived Flu Detection Products 64
Alere's Influenza Tests 64
Becton Dickinson's BD Veritor System 64
Quidel's Sofia Analyzer and Sofia Influenza A+B Fluorescent Immunoassays 65
Quidel's QuickVue Influenza Tests 65
SA Scientific's SAS FluAlert 65
Other POC Flu Detection Products 65
bioMerieux' bioNexia Influenza A+B Tests 66
IQuum's Liat Influenza A/B Assay and the Liat Analyzer 66
Jant Pharmacal's Accutest Flu Test 67
Medix Biochemica's Actim Influenza AandB 67
Meridian Bioscience's TRU FLU 67
Mizuho Medy's Quick Chaser Flu A,B 67
OraSure Technologies' OraSure QuickFlu Rapid Flu A+B Test 67
Princeton BioMeditech's BioSign Flu A+B 67
Response Biomedical's Influenza A+B Test 68
Sekisui Diagnostics' OSOM Influenza A and B Test 68
Products in Development 68
Chembio's DPP Influenza Tests 68
Cepheid's GeneXpert 69
Lucigen's Nucleic Acid-Based POC Test 69
Respiratory Syncytial Virus 69
Quidel's Sofia RSV Fluorescent Immunoassay 70
Quidel's QuickVue RSV 10 71
Response Biomedical's RSV Test 71
Other Respiratory Tests 71
Ani Biotech's Biocard Chlamydia Pneumoniae IgM Test 71
GenBio's ImmunoFLOW Mycoplasma IgM Test 72
Group A Streptococcus Tests 72
Currently-Available POC Strep A Tests 73
Quidel's Sofia Strep A Fluorescent Immunoassay 73
H pylori Tests 74
Currently-Available H pylori Tests 74
Exalenz Bioscience's BreathID System 75
Otsuka America Pharmaceutical's BreathTek UBT 75
Mononucleosis Tests 76
Currently-Available POC Mono Tests 76
Rotavirus and Adenoviral Enteritis Tests 76
Ani Biotech's Biocard Tests 76
Meridian Bioscience ImmunoCard STAT! Rotavirus 77
Nicox/Rapid Pathogen Screening's AdenoPlus 77
Orion Diagnostica's Diarlex, Rotalex and Adenolex Tests 77
Women's Heath Diagnostics 77
Ani Biotech's Biocard Candida and Trichomonas Tests 77
Gryphus Diagnostics' BVBLUE 77
Quidel's QuickView Chlamydia Test 78
RunBio Biotech's Tests 78
Savyon Diagnostics' SavvyCheck 78
POC TUMOUR MARKER TESTING 79
Fig 13: Global POC Tumour Markers Market, 2007-2017E (US$ million) 79
Prostate Specific Antigen Tests 80
Available Tests 81
Mediwatch's PSAwatch 81
OPKO Health's OPKO Diagnostics Platform 82
Occult Blood Testing 82
ACON Laboratories' Mission FOB Reagent Strips 83
Aerscher Diagnostics' HemaPrompt 83
Alere's Tests 83
Beckman Coulter's Hemoccult Tests 83
Biomerica's EZ Detect 83
bioMerieux' bioNexia FOBplus 84
Helena Laboratories' ColoCare 84
Immunostics' Hema-Screen 84
Orion Diagnostica's QuikRead System and Orion Q-flow FOB 84
Princeton BioMeditech's BioSign iFOBTest 84
Quest Diagnostics' InSure Quik F I T 85
Quidel's QuickVue iFOB 85
Other Available FOB Tests 86
Gastric Occult Blood Tests 86
CEA Testing 87
Alpha Fetoprotein Testing 87
Bladder Cancer Testing 87
Alere's Matritech NMP22 BladderChek Test 88
bioMerieux' bioNexia BTA 88
Mediwatch's Bladderwatch BTA Test 88
Novel Products in Development 88
Bioscience Ventures/ Serascience's POC Myeloma Test 88
Guided Therapeutics' Non-Invasive Cancer Diagnostic Products 88
LuViva Advanced Cervical Scan 88
Oesophageal and Other Cancer Detection 89
Infopia's Cancer Diagnosing Sensor 90
POC URINALYSIS TESTING 91
Fig 9: Global POC Urinalysis Market, 2007-2017E (US$ million) 92
Key Urine Analysis Test Strips 92
Product Highlights 92
77 Elektronika's DocUReader 2 and DocuReader 2 Pro 92
ACON Laboratories' Mission Products 93
Arkray's Products 93
PocketChem UA 93
AUTION ELEVEN 93
DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips 93
Roche's Products 93
Urisys 1100 Urine Analyser 93
Chemstrip Criterion II Analyzer 94
Chemstrips/Combur-Test Strips 94
Siemens' Products 94
Clinitek Status+ 94
Clinitek Status Connect 94
Multistix10 SG Reagent Strips 94
RAPIDComm Data Management and Connectivity Solution 95
Microalbumin Testing 95
Axis-Shield's Afinion ACR Test 95
Biomerica's Fortel Microalbumin Screening-OTC Test 96
Orion Diagnostica's QuikRead U-ALB 96
Quest Diagnostics' HemoCue Albumin 201 System 96
Sekisui Diagnostics' OSOM ImmunoDip Urinary Albumin Test 96
Siemens' Clinitek Microalbumin Strips 96
OTHER PRODUCTS 97
Alere Heart Check System for Heart Failure Monitoring 97
Liver Function Testing 97
Exalenz Bioscience's BreathID System 97
BreathID Methacetin Breath Test 98
Infopia's Pioneer POCT Liver Test Sensor 98
Thyroid Tests 98
Jant Pharmacal's Accutest TSH 98
Screening Devices Canada's ThyroChek 98
Ani Biotech's Biocard Coeliac Tests 99
Rapid Pathogen Screening's InflammaDry 99
Products in Development 100
Akers Biosciences' BreathPulmo Health Check and Breath Asthma Check 100
POC Breath Asthma Check 100
EMERGING TECHNOLOGIES 101
Applied Nanodetectors' Sensor Array Platform 101
Ativa Medical's POC System 101
Bio-AMD's MPR 102
Biosensia's RapiPlex 102
Cepheid's GeneXpert 103
MagnaBioSciences' MICT On-Site System 104
Molecular Vision 104
MycroLab 105
OPKO Health's OPKO Diagnostics Platform 106
pes diagnosesysteme' respons IQ 106
Philips' Minicare 107
Radisens Diagnostics' POC Platform 108
T2 Biosystems' T2Dx System 108
T2Hemostasis Assay 109
Tyrian Diagnostics' DiagnostIQ 110
MANUFACTURERS 111
COMPANY DIRECTORY 111
SELECTED COMPANY PROFILES 117
Abaxis 117
Piccolo xpress 117
Financial Performance 118
Abaxis Operating Results, 2007-2012 (US$ million) 118
Latest Results 118
Akers Biosciences 119
Recent Key Events 119
Current Products 120
PIFA Heparin/PF4 and PIFA PLUSS Rapid Assays 120
Tri-Cholesterol Check 120
Research and Development 121
BreathPulmo Health Check 121
POC Breath Asthma Check 121
Current Alliances and Distribution Agreements 121
PULSE Health 121
Al Tadawi Medical Equip/PharmaNova Medical Equipment 122
Fisher HealthCare 122
US Government Service Administration Schedule Contract 122
Financial Performance 122
Akers Biosciences Operating Results, 2007-2011 (US$ thousands) 123
Fig 15: Percentage of Akers' Revenue by Product Type, 2011 123
Alere 124
Recent Key Events 124
POC Cardiology Diagnostic Products 125
Alere Heart Check System 125
Cholestech LDX 125
INRatio2 System 125
Axis-Shield POC Products 125
Afinion POC System 126
NycoCard 126
Coagulation Products 127
POC Oncology Products 127
POC Infectious Disease Tests 127
POC Mergers and Acquisitions 128
Axis-Shield 128
Medical Automation Systems'128
Standard Diagnostics 128
Assets from Unotech Diagnostics 128
Mologic, Jinsung Meditech, Biolinker and Long Chain International Corp 128
Zycare, Medim and Biosyn 129
ACON Laboratories' Rapid Diagnostics Assets 129
Matria Healthcare 129
BBI Holdings 129
Other Acquisitions 129
Agreements 130
EKF Diagnostics 130
Spartan Bioscience 130
Financial Performance 131
Alere - Operating Results, 2007-2011 (US$ million) 132
Fig 16: Percentage of Alere's Revenue by Segment, 2011 132
Fig 17: Percentage of Alere's Revenue by Region, 2011 132
Alere Professional Diagnostics: Operating Results, 2007-2011 (US$ million) 133
Alere Professional Diagnostics: Net Sales and Services Revenue, 2007-2011 (US$ million) 133
Fig 18: Alere Professional Diagnostics: Net Sales and Services Revenue by Product, 2011 133
Latest Results 133
Axis Shield - Financial Performance 134
Fig 19: Axis-Shield Revenue by Business Unit, 2010 135
Fig 20: Axis-Shield Revenue by Region, 2010 135
Axis-Shield - POC Segment Operating Results, 2006-2010 (£ million) 135
Axis-Shield - POC Sales by Product Line, 2006-2010 (£ million) 136
Fig 21: Axis-Shield POC Sales by Product, 2010 136
Fig 22: Axis-Shield Afinion Sales by Region, 2010 136
Arkray 137
Recent Key Events 137
POC Testing Products 137
SpotChem EZ Dry Chemistry Analyser 137
SpotChem D-Concept 138
SpotChem CL SB-1440 Automatic Blood Cell Counter 138
PocketChem BA Blood Ammonia Meters 138
Urinalysis 139
Current Alliances 139
ELITech Group 139
Beckman Coulter (Danaher) 140
POC Products 140
Hemoccult Tests 140
Gastroccult 141
International Technidyne Corporation 142
Products 142
ProTime Coagulation Systems 142
Hemochron Whole Blood Coagulation System 142
Current Alliances 143
Roche 143
Financial Performance 143
International Technidyne Operating Results, 2004-2009 (US$ million) 144
Fig 23: International Technidyne Revenue, 2000-2010 (US$ million) 144
Orion Diagnostica 145
QuikRead 101 System 145
QuikRead go 145
Uricult Dipslide Tests 146
Rotaviral and Adenoviral Enteritis Tests 146
Financial Performance 147
Orion Diagnostica - Operating Results, 2007-2011 (EUR million) 147
Meridian Bioscience 148
TRU FLU and TRU RSV 148
ImmunoCard STAT! HpSA H pylori Test 148
ImmunoCard STAT! Rotavirus 148
ImmunoCard STAT! Strep A 148
ImmunoCard STAT! MONO 148
ImmunoCard STAT! hCG Combo Test 149
Financial Performance 149
Meridian Bioscience - Operating Results, 2008-2012 (US$ million) 149
Meridian Bioscience - Third-Party Sales by Segment, 2008-2012 (US$ million) 149
Meridian Bioscience - Operating Income by Segment, 2008-2012 (US$ million) 149
Fig 24: Meridian Bioscience - Revenue by Segment, 2012 150
Meridian Bioscience - European Diagnostics Sales by Country, 2006-2011 (US$ million) 150
Outlook 150
Quest Diagnostics 151
HemoCue Products 151
Haemoglobin Systems 151
HemoCue Albumin 201 System 152
HemoCue White Blood Cell Analyzer 152
HemoCue WBC DIFF 153
HemoCue Basic Data Management and Connectivity Software 153
Enterix Products 153
InSure Quik F I T Fecal Immunochemical Test 153
Litigation with EKF Diagnostics 154
Financial Performance 154
Quest Diagnostics - Operating Results, 2007-2011 (US$ million) 155
Quest Diagnostics - Sales and Earnings by Category, 2007-2011 (US$ million) 155
Fig 25: Quest Diagnostics - Revenue by Division, 2011 155
Latest Results and Outlook 155
Quidel 157
Recent Key Events 157
Sofia Analyzer and the Sofia Influenza A+B Fluorescent Immunoassay 157
QuickVue Rapid Tests 158
QuickVue Influenza Tests 158
QuickVue Group A Strep Tests 158
QuickVue RSV Tests 158
QuickVue+ Infectious Mononucleosis 159
QuickVue iFOB 159
QuickVue H Pylori gII Test 159
Financial Performance 159
Quidel - Operating Results, 2007-2011 (US$ million) 160
Quidel - Revenue by Product Type, 2008-2011 (US$ million) 160
Fig 26: Quidel - Revenue by Product Type, 2011 160
Fig 27: Quidel - Infectious Disease Revenue, 2005-2011 (US$ million) 161
Quidel - Revenue by Region, 2005-2011 (US$ million) 161
Fig 28: Quidel - Revenue by Region, 2011 161
Latest Results 162
Roche Diagnostics 163
Recent Key Events 163
CoaguChek Systems 164
CoaguChek XS Pro 164
CoaguChek XS Plus 164
CoaguChek XS 164
CoaguChek Link 164
Urinalysis 165
Urisys 1100 Urine Analyser 165
Chemstrip Criterion II Analyzer 165
Chemstrips/Combur-Test Strips 165
Current Alliances and Contracts 165
Panasonic Healthcare 165
Voluntis 166
Financial Performance 166
Roche Diagnostics Operating Results, 2010-2011 (SFr million)166
Fig 29: Roche Diagnostics - Revenue by Product Line, 2011 167
Fig 30: Roche Professional Diagnostics - Revenue by Region, 2011 167
Latest Results 167
Sekisui Diagnostics 168
Point of Care Tests 168
OSOM RSV/Adenovirus Rapid Test 168
OSOM Influenza A and B Test 168
OSOM H pylori 168
OSOM Ultra Strep A 168
OSOM Strep A 169
OSOM Mono 169
OSOM Trichomonas Rapid Test 169
OSOM BVBLUE Test 169
OSOM ImmunoDip Urinary Albumin Test 169
OSOM Pregnancy Tests 169
Siemens Healthcare 170
Products 170
Diabetes Testing - DCA Vantage Analyser 170
Urinlysis Products 171
RAPIDComm Data Management and Connectivity Solution 172
Current Alliances and Supply Contracts 172
Universal Biosensors 172
Premier 173
Roche 173
Financial Performance 173
Latest Results173
Thermo Fisher Scientific 174
Sure-Vue Tests 174
Remel's Xpect Tests 174
APPENDICES 175
APPENDIX 1 - LIST OF ABBREVIATIONS 175
APPENDIX 2 - REPORT METHODOLOGY 176
Sources 176
Market forecasts 177

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