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

http://www.reportlinker.com/p0192428/Point-of-Care-Diagnostics---Players-products--future-market-prospects.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

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
Reportlinker
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