Reportlinker Adds Point of Care Diagnostics - Players, products & future market prospects
NEW YORK, May 12, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Point of Care Diagnostics - Players, products & future market prospects
The Point Of Care Diagnostics market was worth US$13.7 billion in 2010 and rose by 3% compared with 2009. The market has historically risen at a much stronger rate and this slowdown was due to a stagnation for blood glucose testing due to weak pricing and volumes in the US. Excluding blood glucose, the market rose by 7% in 2010, driven by demand for cardiovascular testing products.
The Point Of Care Diagnostics market was worth US$13.7 billion in 2010 and rose by 3% compared with 2009. The market has historically risen at a much stronger rate and this slowdown was due to a stagnation for blood glucose testing due to weak pricing and volumes in the US. Excluding blood glucose, the market rose by 7% in 2010, driven by demand for cardiovascular testing products.
Annual market growth of 8 to 9% is predicted to 2016 due to a growing interest in the adoption of Point Of Care technologies by both healthcare providers and consumers, and the introduction of new products that enable POC testing for more applications, enhance ease-of-use and improve on the accuracy of current products.
M&A activity increases as big players diversify and manoeuvre for position
Merger and acquisition activity has increased significantly in recent years, with around 15 key transactions taking place since the beginning of 2009. This industry consolidation is changing the dynamics of the market. In particular, Alere has reinforced its dominance of several product segments, acquiring a leading position in the European drug testing market by purchasing Concateno and a strong position in emerging regions with South Korean manufacturer, Standard Diagnostics. Heightened M&A activity is also
increasing investment in new technology as companies with more financial clout enter the sector, although potentially to the detriment of smaller companies.
Theranostics – now it's getting personal
DNA testing for personalised medicine is just one area of innovation exciting the market. The first of many POC DNA analysis systems, Spartan Bioscience's RX CYP2C19, has recently gained European approval to help cardiologists identify patients with impaired metabolism to the popular anti-blood clotting medication, clopidogrel. It represents the first POC system for companion diagnostics, but with the increasing use of targeted biological drugs the sector will be very much a major component of the future POC market.
Outlook for POC sectors...
Blood glucose testing - will continue to be negatively impacted by pricing pressure and weak volume growth in the US, although this will be partly offset by demand in emerging markets for blood glucose meters and the adoption of new technologies such as continuous blood glucose monitoring in developed countries. In addition, the US market may be affected by a proposed tightening of performance standards to address the limitations of some current blood glucose meters. The underlying market fundamentals remain strong, given the rising number of people with diabetes globally.
Infectious diseases - the market is forecast to show improvement in 2011 after declines in 2010 that were mainly the result of unfavourable comparisons with the unusually strong growth seen in 2009 due to the H1N1 pandemic. Some of this improvement is expected to be offset by reduced funding for healthcare programmes in the developing world. The launch of new tests that promise increased accuracy will drive growth in the market.
Clinical chemistry/blood gas analysers - will see stable growth, driven by increasing clinical evidence as to the benefits of the analysers, rising awareness as to their availability and benefits in terms of time and costs, and moves to enhance connectivity.
Cardiac markers - will see strong, sustained growth in the period to 2016, driven by increasing clinical evidence as to the benefits on patient care of these tests and the corresponding growth in adoption rates.
Coagulation - will experience continued strong demand, led by the rising number of patients using anticoagulation therapy, improved reimbursement for the products and
strong patient demand for self-testing products. However, the sector is expected to be reduced, or possibly even eliminated, in the longer-term as new-generation anticoagulants that do not require such monitoring become widely used.
Cancer tests - will see continued stable growth, driven by the use of POC tests in the consumer market and by healthcare providers for cancer screening programmes, particularly faecal occult blood tests for colon cancer screening. Although there have been calls for the tighter regulation of OTC cancer screening tests, it is unlikely measures will be put in place that would hinder consumer demand or restrict sales.
Fertility products - will experience stable growth, despite strong market competition and reduced consumer spending. This will be driven by higher-priced digital products and increased demand for OTC products.
Includes Market Forecasts to 2016
Unique 5-year sales forecasts to 2016 for all major point of care diagnostic sectors
- A comprehensive examination of all POC sectors with current products and pipeline prospects
- Detailed competitive evaluation covering over 150 companies active in the area
Use this report to…
Review the prospects for key POC testing sectors such as blood glucose, pregnancy, infectious disease and cardiovascular
Identify the fastest growing sectors in US$ and % growth to 2016 with our novel forecasts
Evaluate how the market is developing
Know the current size and split of trends in major markets and technology sectors
Contrast and compare the competitive landscape in terms of product offering by POCsector
Understand the commercial, regulatory and clinical drivers and dampeners that will affect each sector's growth and development
Compare and review the research that will shape the market in the future, such as Theranostics and Microfluidics
Table of Contents
Contents
EXECUTIVE SUMMARY1
BACKGROUND.2
The Role Of POC Testing.3
CURRENT MARKET DYNAMICS5
Fig.1: POC Diagnostics in Relation to the IVD Market, 2010.5
Global POC Diagnostics Market by Product Type, 2007-2010 (US$ million).6
Fig.2: Percentage of POC Diagnostics Market by Product, 20107
Fig.3: POC Diagnostics Market by Product, excl. Glucose, 2010.7
Customers of POC Diagnostic Products.8
POC Technologies by Customer Segment9
Fig.4: POC Diagnostics Market by Customer Type, 2010.9
Fig.5: POC Diagnostics Self-Testing Market by Product Type, 201010
Regional Perspective.10
Fig.6: POC Diagnostics Market by Region, 201011
Fig.7: Professional POC Diagnostics Market by Region, 2010.11
Regulatory and Reimbursement Environment. 12
CLIA Waiver12
COMPETITIVE LANDSCAPE14
Market Leaders by POC Product Type14
Key POC Diagnostics Mergers and Acquisitions, 2008-2010.15
GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES.17
Clinical Utility and Accuracy. 17
POC Diagnostics as a Disruptive Technology.18
Connectivity18
Future Technology: Next-Generation POC Diagnostic Products. 19
Summary: Market Drivers, Restraints and Opportunities.20
MARKET OUTLOOK21
Global POC Diagnostics Market by Product Type, 2007-2016E (US$ million)22
Fig.9: POC Diagnostics Market by Product, excl. Glucose, 2016E.23
POC PRODUCTS AND TECHNOLOGIES24
BLOOD GLUCOSE TESTING AND DIABETES24
WHO Diabetes Prevalence, 2000 and 2030.25
Blood Glucose Testing Market Dynamics25
Fig.10: Global Blood Glucose Testing Market, 2005-2016E (US$ billion).26
Fig.11: Blood Glucose Testing Market by Customer Type, 2010.26
Leading Companies' Diabetes Care Sales, 2004-2010 (US$ million)27
Diabetes Self-Testing.27
Conventional Blood Glucose Testing Products and Technologies28
Market-Leading Self-Testing Blood Glucose Meters.29
Abbott's Test Strip Product Recall29
Competing Self-Testing Blood Glucose Meters.29
FDA Warning - GDH-PQQ Test Strips30
New Products 31
77 Electronica's AutoSense31
Abbott's FreeStyle Lite and FreeStyle Freedom Lite Test Strips31
ACON Laboratories' On Call Blood Glucose Monitoring Systems32
AgaMatrix' WaveSense Products.32
Arkray's Glucocard Blood Glucose Monitoring Systems32
Bayer's Contour USB33
Bayer's DIDGET Meter.33
Cambridge Sensors' Microdot+.33
Infopia's Blood Glucose Products.34
LifeScan's New OneTouch Products34
Nova Biomedical's Nova Max Plus35
Roche's Accu-Chek Products .35
sanofi-aventis/AgaMatrix BGStar and iBGStar36
Standard Diagnostics' SD Check Gold and SD Codefree/SmartLink Gold.36
Professional Use Products . 36
Abbott's Precision XceedPro Blood Glucose and ß-Ketone Monitoring System36
AgaMatrix' KeyNote Pro .36
Arkray Assure Blood Glucose Testing Products37
Bayer's Hospital Blood Glucose Monitoring Products37
EKF Diagnostics' Biosen C.38
LifeScan's SureStep Flexx and SureStep Hospital .38
Nova Biomedical's StatStrip Glucose Monitor38
Quest Diagnostics' HemoCue Blood Glucose Testing Systems39
Roche's Accu-Chek Inform II .39
Continuous Glucose Monitoring.39
Clinical Trial Results - Highlighting Benefits and Drawbacks. 40
Reimbursement Issues 40
CGM Competitive Landscape.41
Medtronic's CGM Systems.41
Paradigm Veo .42
Paradigm REAL-Time Revel 42
Guardian REAL-Time System.43
iPro Professional Use Products43
CareLink Pro 3.0 Therapy Management Software43
Clinical Trials44
DexCom's CGM Systems 45
FDA Warning Letter.45
Abbott's FreeStyle Navigator CGM System 46
A Menarini Diagnostics' GlucoDay S. 46
CGM Products in Development 46
DexCom Products 46
Medtronic.47
Sensors for Medicine & Science's SMSI Glucose Sensor47
Via Medical's Via Blood Glucose Monitoring System .47
Next-Generation Blood Glucose Testing . 48
AiMedics' HypoMon . 48
Echo Therapeutics' Symphony tCGM System. 48
Clinical Study Results.49
GluMetrics' GluCath IV-CGM. 50
Integrity Applications' GlucoTrack 50
Lein Applied Diagnostics.51
Medtronic52
MicroCHIPS52
Pepex Biomedical's Trio Products52
OrSense's NBM-200G Non-Invasive Blood Glucose Meter.53
Solianis Monitoring's Multisensor Glucose Monitoring System.53
VeraLight's SCOUT DS 54
HbA1c Testing.54
HbA1c Products.55
ApexBio's A1C Express55
Axis-Shield's Afinion HbA1c and NycoCard HbA1c Tests.55
Bayer's A1CNow Products.56
Bio-Rad's in2it A1C Analyser .56
DiaSys Diagnostic Systems' InnovaStar56
Ceragem Medisys' LabonaCare HbA1c 56
Infopia's Easy/Clover A1c.56
Quotient Diagnostics' Quo-Test.56
Siemens' DCA Vantage Analyser.57
In Development57
Ketone Testing57
POC CARDIOVASCULAR TESTING 59
POC Coagulation Testing.59
Market Dynamics 60
Fig.12: Global POC Coagulation Market, 2007-2016E (US$ million)60
Self-Monitoring Products61
CoaguSense's CoaguSense PT/INR Monitoring System62
Alere's INRatio2 System .62
Nexus Dx's ProTime Systems.62
Roche's CoaguChek XS .62
Professional Use Products 63
Axis-Shield Products63
Helena Laboratories' Cascade POC System.63
Helena Laboratories' Actalyke & MAX-ACT 64
Medtronic's ACT Plus Automated Coagulation Timer System64
Instrumentation Laboratory's GEM PCL Plus64
Nexus Dx's Hemochron Whole Blood Coagulation System.64
Roche's CoaguChek Systems.65
In Development - Bio-AMD's COAG . 66
Platelet Function and Antiplatelet Drug Assessment.66
Clopidogrel Effectiveness Assessment67
Spartan Bioscience's Spartan RX CYP2C19 POC DNA Testing System.67
Accumetrics' VerifyNow System. 68
Clinical Trials68
Helena Laboratories' Plateletworks System. 69
Cardiac Markers.69
POC Testing.70
Fig.13: Global POC Cardiac Marker Testing Market, 2007-2016E (US$ million).72
POC Testing Products. 72
Currently-Available Cardiac Marker POC Tests72
Alere's Heart Check System73
Alere's Triage and Clearview Products.73
bioMérieux VIDAS Emergency Care Products 74
Nexus Dx's POC Cardiovascular Tests 74
Princeton BioMeditech/LifeSign's StatusFirst Tests and DXpress Reader. 74
Mitsubishi Chemical's Pathfast Immunoassay Analyzer75
Response Biomedical's RAMP 200 Platform.75
Randox Laboratories' Evidence Multistat. 76
Roche Cardiac Testing Products 76
Siemens' Stratus CS Analyzer 76
Products in Development.77
Cholesterol Testing.78
Fig.14: Global POC Cholesterol Testing Market, 2007-2016E (US$ million)79
Home Testing 79
Alere's First Check Cholesterol Test79
Akers Biosciences' Tri-Cholesterol Check .79
Chematics Chemcard Cholesterol Test.79
Infopia's Lipid Pro.80
Roche's Accutrend Plus 80
Syntron Bioresearch's Venture Total Cholesterol Test 80
Point-of-Care Diagnostics 2011
Professional Use Products 80
Alere's Cholestech LDX System .80
Jant Pharmacal's LipidPlus Lipid Profile and Glucose Test System80
Polymer Technology Systems' CardioChek.80
Miraculins' PREVU Point of Care Skin Sterol Test.81
MULTI-FUNCTIONAL CLINICAL CHEMISTRY ANALYSERS. 83
Abaxis' Piccolo xpress83
Abbott's i-STAT System. 84
Alfa Wassermann's ACE Clinical Chemistry Systems.85
Audit Diagnostics' Liqui-Stat Wet Chemistry POC System85
Arkray's SpotChem EZ Dry Chemistry .85
Axis-Shield's Afinion POC System.86
Axis-Shield's NycoCard System87
Horiba ABX' ABX Pentra 400 Clinical Chemistry Analyser.87
MagnaBioSciences' MICT.87
Ortho-Clinical Diagnostics' VITROS DT60 II Chemistry System88
OrSense's NBM Products88
NBM-200MP Oximetry 88
NBM 200 Haemoglobin. 89
Probe Scientific MicroEye Blood Analysis Device90
Radiometer's AQT90 FLEX Immunoassay Analyser.90
Randox Laboratories' Evidence Multistat.91
ReLIA Diagnostic Systems' ReLIA System91
Tosoh Bioscience's AIA-360 Immunoassay Analyser.92
In Development 92
Ativa Medical's POC Analyser92
Atonomics' Atolyzer.93
Claros Diagnostics' Claros System93
pes diagnosesysteme' respons IQ94
Infopia's Tele-Diagnostic System.94
POC BLOOD GAS/ELECTROLYTE ANALYSERS 95
Mayo Clinic's Estimated Glomerular Filtration Rate Study.95
Arkray's SpotChem EL Electrolyte Analyser.96
Epocal's epoc.96
Instrumentation Laboratory's GEM Premier Products .97
tBili Assay 97
GEMweb Plus Custom Connectivity. 97
Nexus Dx's IRMA TRUpoint Blood Analysis System.98
Nexus Dx's AVOXimeter Products.98
Nova Biomedical's Products.98
Stat Profile Critical Care Xpress 98
Stat Profile pHOx .98
Nova Biomedical Electrolyte/Chemistry Analysers 99
Statsensor Creatinine Meter. 99
StatStrip Lactate. 99
OPTI Medical Systems' Products 100
Radiometer's Blood Gas Analysers 100
1st automatic. 100
ABL80 FLEX 100
ABL90 FLEX . 101
ABL800 FLEX. 101
ABL5 101
ABL80 FLEX CO-OX CO Oximeter 101
Roche's cobas Blood Gas Analysers102
Siemens' Blood Gas Analyser Range.102
RAPIDLab Analysers. 102
RAPIDPoint Blood Gas Systems 103
RAPIDChem 744/754 Electrolyte and Lithium Testing 103
RAPIDComm Data Management and Connectivity Solution 103
Via Medical's Products 104
POC HAEMATOLOGY AND HAEMOSTASIS PRODUCTS.105
Surgical Coagulation and Haemostasis Management105
Akers Biosciences' PIFA Heparin/PF4 Rapid Assay. 105
PIFA HPF4 POC.106
Haemonetics' TEG Thrombelastograph Hemostasis Analyzer 106
Instrumentation Laboratory's GEM PCL Plus 106
Medtronic's HMS PLUS Haemostasis Management System 107
Pentapharm's ROTEM delta. 107
Sienco's Sonoclot Coagulation & Platelet Function Analyzers 107
Haematology Analysers.108
Beckman Coulter's COULTER AC•T Series . 108
Quest Diagnostics' HemoCue White Blood Cell Analyzer. 108
Horiba ABX' Haematology Analysers 108
ABX Micros ES60108
ABX Micros 60109
ABX Micros CRP 200.109
ABX E-Sat109
ABX Pentra 60C+ .109
Symex' pocH-100i Haematology Analyser 109
Arkray's PocketChem BA Blood Ammonia Meters110
Haemoglobin Systems.110
ACON Laboratories' Mission Hb Hemoglobin Testing System.110
ApexBio's HemoSmart Haemoglobin Screening System.110
Audit Diagnostics' Hb-Stat110
EKF Diagnostics' Hemo-Control and Hemo Speed Products110
Instrumentation Laboratory's IL 682 CO-Oximeter.111
Nexus Dx's Hgb Pro Professional Hemoglobin Testing System.111
Quest Diagnostics' HemoCue Haemoglobin Systems111
HemoCue 201 DM Analyser Whole Blood Systems.111
Stanbio Laboratory's HemoPoint H2 and STAT-Site M Hgb 112
URIT Medical's URIT-12 Hemoglobin Meter112
POC INFECTIOUS DISEASE TESTS.113
Fig.15: Global POC Infectious Disease Testing Market, 2007-2016E (US$ million) 114
POC Influenza Testing114
Performance and Use of Rapid Influenza Tests in the US.114
Flu Detection Products.115
3M Rapid Detection Flu A+B Test/RAMP Influenza A/B Assay 116
Alere's BinaxNOW Influenza A&B Test 116
Alere's Clearview Exact Influenza A & B 116
Becton Dickinson's Directigen EZ Flu A+B test 116
Jant Pharmacal's Accutest Flu Test. 116
Medix Biochemica's Actim Influenza A&B 116
Meridian Bioscience's TRU FLU.117
Mizuho Medy's Quick Chaser Flu A,B.117
OraSure Technologies' OraSure QuickFlu Rapid Flu A+B Test117
Princeton BioMeditech's BioSign Flu A+B 117
Quidel's QuickVue Influenza Tests.117
Remel's Xpect Flu A&B.117
SA Scientific's SAS FluAlert . 118
Sekisui Diagnostics' OSOM Influenza A & B Test 118
Sysmex' POCTEM Influenza A/B 118
Products in Development118
Chembio's DPP Influenza Tests 118
Enigma Diagnostics' Enigma ML Influenza A/B Detection Assay . 118
IQuum's Liat System119
Nexus Dx's Rapid Flu Tests.119
Respiratory Syncytial Virus120
3M's 3M Rapid Detection RSV Test.121
Quidel's QuickVue RSV 10121
Other Respiratory Tests.121
Ani Biotech's Biocard Chlamydia Pneumoniae IgM Test.121
GenBio's ImmunoFLOW Mycoplasma IgM Test.121
In Development - Tyrian Diagnostics' DiagnostIQ 122
POC HIV Testing.122
HIV Prevalence by Region, 2001 and 2009. 123
Market Dynamics.124
Product Highlights.124
Alere's Pima Point-of-Care CD4 Analyser . 124
Alere's SD, Determine and Clearview HIV Tests.125
bioLytical Laboratories' INSTI Kit125
bioMérieux's VIKIA HIV 1/2 HIV Test.125
Bio-Rad's Multispot HIV-1/HIV-2 Rapid Test 126
Calypte Biomedical's Aware HIV-1/2 Tests 126
Chembio Diagnostics' Sure Check (Clearview Complete), STAT PAK (Clearview HIV 1/2 STAT-PAK) and HIV 1/2 STAT PAK DIPSTICK 126
Chembio Diagnostics' Dual Path Platform Technology Products 127
EY Laboratories' InstantCHEK128
Hema Diagnostic Systems128
IND Diagnostic's One-Step Anti-HIV (1+2) Tests 128
Lab21's Biotec Tests129
MedMira's Tests.129
Integrated Medical Innovations' FirstVue HIV Tests.130
OraSure's OraQuick ADVANCE HIV-1/2 130
Trinity Biotech's POC HIV Tests.130
Savyon Diagnostics' HIVSav 1/2/0 Rapid SeroTest. 131
Unimed's FirstSign HIV Duo. 131
YD Diagnostics' AIDScan. 131
Products in Development131
Alere's HIV NAT System. 131
Calypte Biomedical's Aware II (The Ani Platform) 131
Cepheid's GeneXpert System and Xpert HIV Viral Load Test. 132
Daktari Diagnostics' Daktari CD4 132
IQuum's Liat System. 132
OraSure's OraQuick HIV OTC Test 133
POC Hepatitis Tests133
Hepatitis B .133
Hepatitis C. 134
Available Tests 134
Alfa Scientific Designs' Instant-View Tests.134
bioMérieux' VIKIA HBs Ag Test 135
Integrated Medical Innovations' FirstVue Rapid Test Kit 135
OraSure Technologies' OraQuick HCV Rapid Antibody Test 135
Runbio Biotech's One Step Tests136
YD Diagnostics' HepaScan Tests 136
In Development 136
Chembio's DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests . 136
Exalenz Bioscience's BreathID System 137
MedMira's Multiplo Combination HIV/Hepatitis Tests137
POC Tuberculosis Tests.138
Cepheid's Xpert MTB/RIF 139
In Development 139
Chembio's DPP Tuberculosis 139
TwistDx's Recombinase Polymerase Amplification Technology140
Tropical Disease Tests140
Hema Diagnostic Systems' Malaria Tests 140
Lab21's Tropical Disease Tests. 140
Quest Diagnostics' Focus Dengue Rapid Tests141
New Horizons Diagnostics' Cholera and Bengal SMART141
Unimed's FirstSign Typhoid Tandem Test.141
Products in Development141
Chembio's DPP Leptospirosis 141
Chembio's DPP Visceral Leishmaniasis 142
Sexually-Transmitted Diseases and Related Diagnostics142
Ani Biotech's Biocard Candida and Trichomonas Tests 142
Focus Diagnostics' HerpeSelect Express HSV-2 142
Gryphus Diagnostics' BVBLUE 143
Hema Diagnostic Systems' Rapid 1-2-3 Hema Syphilis 143
MagnaBioSciences MICT Chlamydia Test. 143
Mizuho Medy's Quick Chaser TP Ab 143
New Horizons Diagnostics' GonoGen II and TRUST. 143
Quidel's QuickView Chlamydia Test . 143
RunBio Biotech's Tests. 143
Savyon Diagnostics' SavvyCheck 144
Sekisui Diagnostics' OSOM Trichomonas . 144
Products In Development 144
Chembio's DPP Syphilis Tests.144
Randox Laboratories' Lab-on-a-Chip 145
Trinity Biotech's Uni-Gold Legionella Urinary Antigen .145
Group A Streptococcus Tests145
Currently Available POC Tests 145
H. pylori Tests146
Currently Available H. pylori Tests146
Exalenz Bioscience's BreathID System.147
Meretek Diagnostics' BreathTek UBT 148
Mononucleosis Tests148
Currently Available POC Tests148
Rotavirus and Adenoviral Enteritis Tests149
Ani Biotech's Biocard Tests 149
Meridian Bioscience ImmunoCard STAT! Rotavirus 149
Orion Diagnostica's Diarlex, Rotalex and Adenolex Tests. 149
POC C-REACTIVE PROTEIN DIAGNOSTICS. 150
Abaxis' MetLyte Plus CRP and BioChemistry Panel Plus150
Axis-Shield151
Medix Biochemica's Actim CRP.151
Orion Diagnostica's QuikRead and QuikRead go Systems151
In Development.151
LifeAssays' CRP 151
POC CANCER DIAGNOSTICS 152
Fig.16: Global POC Cancer Markers Market, 2007-2016E (US$ million). 152
Prostate Specific Antigen Tests.153
Available Tests 154
Claros Diagnostics' Claros System154
Mediwatch's PSAwatch 155
Occult Blood Testing 155
ACON Laboratories' Mission FOB Reagent Strips 156
Aerscher Diagnostics' HemaPrompt 156
Alere's Tests. 156
Beckman Coulter's Hemoccult Tests 156
Biomerica's EZ Detect 156
Helena Laboratories' ColoCare. 156
Immunostics' Hema-Screen 157
Orion Diagnostica's QuikRead System and Orion Q-flow FOB 157
Princeton BioMeditech's BioSign iFOBTest. 157
Quest Diagnostics' InSure Quik F I T. 157
Quidel's QuickVue iFOB 158
Other Available FOB Tests 158
Gastric Occult Blood Tests. 159
CEA Testing159
Alpha Fetoprotein Testing160
Bladder Cancer Testing160
Alere's Matritech NMP22 BladderChek Test 160
Mediwatch's Bladderwatch BTA Test 160
Novel Products in Development.160
Akers Biosciences' BreathPulmo Health "Check" 160
Balter Medical's Optical Transfer Diagnosis Platform 161
Guided Therapeutics' LightTouch Cervical Cancer Scanner.161
Lung and Oesophageal Cancer162
Infopia's Cancer Diagnosing Sensor. 163
URINALYSIS.164
Fig.17: Global POC Urinalysis Market, 2007-2016E (US$ million)164
Product Highlights - Urine Analysis Test Strips165
Key Products.165
ACON Laboratories' Mission Products. 165
Arkray's Products 166
PocketChem UA166
AUTION ELEVEN166
DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips 166
Diagnostic Test Group's Clarity Urocheck 120 Analyzer 166
Roche's Products. 166
Urisys 1100 Urine Analyser166
Chemstrip Criterion II Analyzer.166
Siemens' Products. 167
Clinitek Advantus Analyser167
Clinitek Status Analyser167
Clinitek Status+.167
Clinitek Status Connect.167
RAPIDComm Data Management and Connectivity Solution 167
New Products 168
77 Elektronika's DocUReader 2 and DocuReader 2 Pro. 168
Urinary Tract Infection Tests.168
ACON Laboratories' Mission UTI Urinary Tract Infection Test Strips 168
Jant Pharmacal's Accutest Uriscreen Rapid UTI Screen Test . 168
Orion Diagnostica's Uricult Dipslide Tests 168
Microalbumin Testing169
Axis-Shield's Afinion ACR Test. 169
Biomerica's Fortel Microalbumin Screening-OTC Test. 169
Orion Diagnostica's QuikRead U-ALB 169
Quest Diagnostics' HemoCue Albumin 201 System.170
Sekisui Diagnostics' OSOM ImmunoDip Urinary Albumin Test170
Siemens' Clinitek Microalbumin Strips170
POC FERTILITY AND PREGNANCY TESTING. 171
Fig.18: Global POC Pregnancy & Fertility Market, 2007-2016E (US$ million). 171
Competitive Landscape - Pregnancy Testing Kits.171
In Development - Bio-AMD's DSR 173
Competitive Landscape - Ovulation Testing Kits173
Competitive Landscape - Menopause Testing Kits.174
SPD Swiss Precision Diagnostics' Consumer Products 174
Mitsubishi Chemical's Pathfast Immunoassay Analyzer.175
ContraVac's SpermCheck Male Fertility Testing Products.175
SpermCheck Fertility 175
SpermCheck Vasectomy176
Labour and Delivery Testing176
Alere's Triage PLGF Assay.176
Amnisure International's AmniSure ROM Test. 177
Medix Biochemica's Actim PROM and Actim Partus. 177
POC DRUGS-OF-ABUSE TESTING. 178
Market Dynamics.178
Currently-Available POC Drugs-of-Abuse Testing Products. 179
DoA Product Highlights 180
Alere's Tests.180
Alfa Scientific Designs' Drug Screen Tests. 181
American Bio Medica's Drug Abuse Tests. 181
Branan Medical's Oratect III and OratectPlus Devices182
Phamatech Drugs of Abuse Tests.182
Randox Laboratories' Evidence Multistat.183
Products in Development. 183
Concateno's New Portable Drug Testing System.183
Alcohol Testing. 184
ACON Laboratories' Alcohol Testing Products184
Alere's Products.184
Akers Biosciences' BreathScan184
BreathScan PRO.184
Chematics' Alco-Screen185
OraSure's Q.E.D. Saliva Alcohol Test185
In Development - TruTouch Technologies' TruTouch 2000 System185
OTHER POC PRODUCTS186
Liver Function Testing186
Exalenz Bioscience's BreathID System 186
Infopia's Pioneer POCT Liver Test Sensor 186
Thyroid Tests.186
Screening Devices Canada's ThyroChek. 186
Akers Biosciences' Lithium "Check" System187
Alere's Triage NGAL Test187
Ani Biotech's Biocard Coeliac Tests.188
bioMérieux' VIDAS B•R•A•H•M•S PCT. Test188
Magellan Biosciences' LeadCare II System.188
Biomerica's Fortel Pet Allergy Tests189
EMERGING TECHNOLOGIES190
Alere's True Rapid Molecular Platform191
Atonomics' Atolyzer.191
Ativa's POC System191
Bio-AMD's MPR192
Cepheid's GeneXpert.192
Xpert MTB/RIF. 193
Xpert HIV Viral Load Test 193
Claros Diagnostics' Claros System194
pes diagnosesysteme' respons IQ.194
Enigma Diagnostics' Enigma ML (Mini Laboratory)195
IQuum's Liat System.195
Liat Assays. 196
Molecular Vision .196
MycroLab.197
Ortho-Clinical Diagnostics' (Johnson & Johnson) Forecast System197
Philips' Magnotech198
Randox Laboratories' Lab-on-a-Chip .199
T2 Biosystems' T2Dx System199
TwistDx' Recombinase Polymerase Amplification Technology 200
Tyrian Diagnostics' DiagnostIQ 201
POC MANUFACTURERS 202
POC COMPANIES DIRECTORY.202
SELECTED COMPANY PROFILES 210
Abaxis.210
Piccolo xpress 210
Litigation with Cepheid211
Financial Performance .211
Abaxis Operating Results, 2005-2010 (US$ million). 211
Latest Results 212
Abbott 213
i-STAT Point-of-Care Products213
Cartridges 213
Diabetes Care.214
FreeStyle Navigator Continuous Glucose Monitoring System. 214
FreeStyle Blood Glucose Monitors and Test Strips 214
Precision Xtra/Optium Xceed System. 214
CoPilot Health Management System. 215
Professional Products. 215
Test Strip Product Recall. 215
Current Alliances 215
CoaguSense 215
Calypte Biomedical 215
Litigation .216
Church & Dwight 216
Bayer. 216
DexCom . 216
Nova Biomedical 216
Financial Performance.217
Abbott Diagnostics Sales, 2005-2010 (US$ million). 217
Fig.19: Percentage of Abbott Diagnostics Revenue by Region, 2010 217
Abbott Diabetes Care Sales by Region, 2005-2010 (US$ million). 218
Fig.20: Percentage of Abbott Diabetes Care Revenue by Region, 2010 218
Accumetrics 219
Recent Key Events 219
Fig.21: Accumetrics Revenue, 2005-2010 (US$ thousand). 219
VerifyNow System. 220
Distribution Agreements 220
ACON Laboratories 222
Recent Key Events222
On Call Blood Glucose Monitoring Systems222
Mission Clinical Chemistry Products 223
Mission Hb Hemoglobin Testing System223
Mission FOB Reagent Strips 223
Urine Analysers and Test Strips.223
Alcohol Testing.223
Akers Bioscienes 224
Recent Key Events224
Current Products.225
PIFA Heparin/PF4 Rapid Assay225
BreathScan226
BreathScan PRO.226
Breath Ketone "Check" 226
Battlefield Blood Transfusion Card227
Lithium "Check" System.227
Tri-Cholesterol Check227
Non Core Products.227
Research and Development 227
BreathPulmo Health "Check"227
Current Alliances and Distribution Agreements.228
Al Tadawi Medical Equip.228
HealthTrust Purchasing Group.228
Fisher HealthCare.228
BreathScan International.228
US Government Service Administration Schedule Contract.228
AFRICA Continental Holdings228
PULSE Health.228
Financial Performance229
Akers Biosciences Operating Results, 2005-2009 (US$ thousands)229
Latest Results229
Alere. 230
Recent Key Events231
POC Professional Diagnostic Products 231
Cardiology.231
Women's Health.232
Infectious Diseases.233
Oncology234
Drugs of Abuse234
Consumer Products234
First Check Consumer Diagnostics Products234
Standard Diagnostics' Blood Glucose Meters235
Research and Development 235
POC Mergers & Acquisitions 235
Standard Diagnostics235
Assets from Unotech Diagnostics.235
Mologic, Jinsung Meditech, Biolinker and Long Chain International Corp236
Genecare, Zycare, Medim and Biosyn236
Concateno .236
ACON Laboratories' Rapid Diagnostics Assets.236
Vision Biotech and Global Diagnostics CC.236
Matria Healthcare237
BBI Holdings .237
Panbio237
Earlier Acquisitions.237
Joint Ventures. 239
SPD Swiss Precision Diagnostics239
Current Alliances. 239
Spartan Bioscience.239
Epocal.239
OraSure Technologies.239
Mediwatch240
Chembio.240
Trinity Biotech.240
ContraVac 240
Litigation.240
OraSure Technologies.240
Financial Performance 241
Alere - Operating Results, 2006-2010 (US$ million). 242
Fig.22: Percentage of Alere's Revenue by Segment, 2010 242
Fig.23: Percentage of Alere's Revenue by Product Type, 2010 242
Fig.24: Percentage of Alere's Revenue by Region, 2010 243
Alere Professional Diagnostics Operating Results, 2006-2010 (US$ million). 243
Alere Consumer Diagnostics Operating Results, 2006-2010 (US$ million) 243
American Bio Medica 244
Recent Key Events244
Drug Abuse Tests.244
Urine Tests.244
Saliva Tests 245
Rapid Reader. 245
Adulteration, Alcohol and Nicotine Products246
Current Alliances.246
Hema Diagnostic Systems246
Financial Performance246
American Bio Medica Operating Results, 2006-2010 (US$ million).246
Arkray.247
Recent Key Events 247
SpotChem EZ Dry Chemistry Analyser . 247
SpotChem EL Electrolyte Analyser 247
PocketChem BA Blood Ammonia Meters.248
Urinalysis.248
DiaScreen 50 Urine Chemistry Analyzer.248
PocketChem UA248
AUTION ELEVEN248
Blood Glucose Self-Testing248
Glucocard Meters 248
Assure Blood Glucose Testing Products 249
Current Alliances.250
ELITech Group250
Nipro.250
MyCareTeam .250
A Menarini Diagnostics.250
Axis-Shield251
Recent Key Events251
Afinion POC System 251
NycoCard 252
Coagulation Products 253
Financial Performance 253
Fig.25: Axis-Shield Revenue by Business Unit, 2010254
Fig.26: Axis-Shield Revenue by Region, 2010255
Axis-Shield - POC Segment Operating Results, 2006-2010 (£ million)255
Axis-Shield - POC Sales by Product Line, 2006-2010 (£ million).255
Fig.27: Axis-Shield POC Sales by Product, 2010256
Fig.28: Axis-Shield Afinion Sales by Region, 2010256
Bayer.257
Blood Glucose Monitoring Systems 257
DIDGET Meter257
Contour USB257
Contour, Contour TS, Contour Link and Breeze 2.258
Elite and Elite XL.258
A1CNow Products258
Current Alliances . 259
Medtronic259
Litigation. 259
Abbott259
Roche Diagnostics259
Financial Performance 259
Bayer Diabetes Care Revenue, 2005-2010 (EUR million)259
Beckman Coulter 260
Rapid Tests260
Hemoccult Tests 260
Gastroccult 260
Haematology Analysers . 261
Biomerica. 262
Home Diagnostic Products 262
Professional Use Products 263
IVAX Diagnostics Distribution Alliance. 263
Financial Performance 263
Biomerica - Operating Results, 2006-2010 (US$ thousand)263
Biomerica - Revenue by Region, 2008-2010 (US$ thousand)264
Fig.29: Percentage of Biomerica's Revenue by Region, 2010.264
Latest Results264
bioMérieux. 265
Emergency Care 265
VIDAS NT-proBNP 265
VIDAS Troponin I Ultra265
VIDAS D-Dimer Exclusion265
VIDAS B•R•A•H•M•S PCT. Test.266
Rapid Infectious Disease Tests266
VIKIA HIV1/2 HIV Test266
VIKIA HBs Ag Hepatitis B Test266
Current Alliances.266
Philips.266
Quidel.267
Sysmex .267
Abaxis.267
ReLIA Diagnostic Systems.267
Roche Diagnostics267
Brahms.267
Financial Performance 267
bioMérieux - Operating Results, 2006-2010 (EUR million)268
Fig.30: Percentage of bioMérieux's Revenue by Product Type, 2010.268
Fig.31: Percentage of bioMérieux's Revenue by Region, 2010269
Bio-Rad Laboratories 270
Point-of-Care HbA1c Testing. 270
TOX/See Drugs-of-Abuse Testing 270
Multispot HIV-1/HIV-2 Rapid Test 270
Current Alliances. 271
Chembio 271
Calypte Biomedical271
Calypte Biomedical272
Aware Rapid Test Product Line. 272
Aware HIV-1/2 OMT (Oral fluid) 273
Aware HIV-1/2 BSP 273
Aware HIV-1/2 U.273
Products in Development - Aware II (The Ani Platform) 273
Current Alliances. 273
Manufacturing Contracts. 274
Financial Performance.274
Calypte Biomedical Operating Results, 2006-2010 (US$ thousands) 274
Fig.32: Percentage of Calypte's Revenue by Product, 9 Months 2010275
Chembio Diagnostics.276
Recent Key Events276
Rapid HIV Tests. 277
Dual Path Platform Technology Products 277
DPP HIV 1/2 Screening Assay.277
DPP HIV 1/2 Confirmatory Test278
Other Tests 278
DPP Technology Products in Development 278
DPP Tuberculosis 278
DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests 279
DPP Influenza .279
DPP Leptospirosis 279
DPP Syphilis Screen & Confirm280
Current Alliances.280
Oswaldo Cruz Foundation of Brazil280
Battelle Memorial Institute.280
Alere.281
US CDC281
Infectious Disease Research Institute281
Bio-Rad Laboratories281
Financial Performance282
Chembio - Operating Results, 2006-2010 (US$ thousands)282
Chembio - Revenue by Type, 2008-2010 (US$ thousand)283
Chembio - Product Sales by Region, 2006-2010 (US$ thousand).283
Fig.33: Percentage of Chembio's Revenue by Type, 2010283
Fig.34: Percentage of Chembio's Product Sales by Region, 2010284
DexCom 285
SEVEN PLUS CGM System285
FDA Warning Letter.285
GlucoClear285
Research and Development286
Current Alliances.286
Edwards Lifesciences286
Insulet.286
Animas.286
Litigation with Abbott 286
Financial Performance 287
DexCom - Operating Results, 2006-2010 (US$ thousands).288
Horiba ABX. 289
Haematology Analysers289
ABX Micros ES60289
ABX Micros 60289
ABX Micros CRP 200.289
ABX E-Sat289
ABX Pentra 60C+ .290
ABX Pentra 400 Clinical Chemistry Analyser.290
Financial Performance290
Fig.35: Percentage of Horiba's Revenue by Division, 2010.290
Horiba Medical Operating Results, 2006-2010 (¥ million)291
Fig.36: Percentage of Horiba Medical's Revenue by Region, 2010291
Instrumentation Laboratory292
Recent Key Events292
POC Critical Care Diagnostics 293
tBili Assay293
GEMweb Plus Custom Connectivity.293
Purchasing Contracts294
LifeScan 295
Recent Key Events295
Blood Glucose Monitoring Products 295
Consumer Products296
Hospital Products.297
Test Strips298
OneTouch Diabetes Management Software 298
DataLink Data Management System299
Current Alliances.299
Medtronic299
Financial Performance299
J&J Diabetes Care Revenue 2005-2010 (US$ million).299
Fig.37: LifeScan Sales by Region, 2010.300
Fig.38: LifeScan Sales, 2004-2010 (US$ million)300
MedMira .301
Recent Key Events301
Rapid Tests 302
Multiplo HIV/HCV.302
Multiplo HBV/HIV/HCV302
HIV Tests.303
Reveal/MiraWell hp Test H. pylori Test304
R&D Activities304
New Combination Tests304
Current Alliances.304
Advance Aid304
Triplex International Biosciences304
VWR International.305
Tri-Star Industries.305
Vitest 305
Shenzhen Kang Sheng Bao Bio-Technology305
Pan American Health Organization305
HealthCare Asia MediTech306
INyDIA Diagnóstico306
Voden Medical Instruments .306
IKXUR306
Financial Performance306
MedMira Operating Results, 2006-2010 (C$ thousands)306
MedMira - Revenue by Region, 2007-2010 (C$ thousands).307
Fig.39: MedMira - Revenue by Region, 2010.307
Latest Results307
Medtronic. 308
CGM Systems.308
Recent Key Events309
Paradigm Veo .309
Paradigm REAL-Time Revel .309
Guardian REAL-Time System. 310
iPro Professional Use Products 310
CareLink Pro 3.0 Therapy Management Software. 310
Blood Glucose Meters 311
Clinical Trials 311
Research and Development 312
Alliances - LifeScan and Bayer 313
Cardiac Surgery POC Products.313
ACT Plus Automated Coagulation Timer System. 313
HMS PLUS Haemostasis Management System 313
Financial Performance.313
Fig.40: Medtronic Diabetes Revenue, 2005-2010 (US$ million). 314
Fig.41: Medtronic Diabetes Revenue by Region, 2010. 314
Fig.42: Medtronic Diabetes Revenue by Product Type, 2010 315
Latest Results . 315
Meridian Bioscience.316
TRU FLU and TRU RSV316
C.difficile Tests.316
ImmunoCard STAT! HpSA H. pylori Test.316
ImmunoCard STAT! Rotavirus316
ImmunoCard STAT! Strep A316
ImmunoCard STAT! MONO317
ImmunoCard STAT! hCG Combo Test.317
Financial Performance.317
Meridian Bioscience Operating Results, 2006-2010 (US$ million) 317
Meridian Biosci
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Nicolas Bombourg
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