Point of Care Diagnostics: Players, Products & Future Market Prospects

Date: May 4, 2011
Pages: 396
US$ 2,265.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: P2399594A8EEN

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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 Role Of POC Testing
    Fig.1: POC Diagnostics in Relation to the IVD Market, 2010
    Global POC Diagnostics Market by Product Type, 2007-2010 (US$ million)
    Fig.2: Percentage of POC Diagnostics Market by Product, 2010
    Fig.3: POC Diagnostics Market by Product, excl. Glucose, 2010
  Customers of POC Diagnostic Products
    POC Technologies by Customer Segment
    Fig.4: POC Diagnostics Market by Customer Type, 2010
    Fig.5: POC Diagnostics Self-Testing Market by Product Type, 2010
Regional Perspective
    Fig.6: POC Diagnostics Market by Region, 2010
    Fig.7: Professional POC Diagnostics Market by Region, 2010
  Regulatory and Reimbursement Environment
    CLIA Waiver


Market Leaders by POC Product Type
Key POC Diagnostics Mergers and Acquisitions, 2008-2010


Clinical Utility and Accuracy
POC Diagnostics as a Disruptive Technology
Future Technology: Next-Generation POC Diagnostic Products
  Summary: Market Drivers, Restraints and Opportunities


Global POC Diagnostics Market by Product Type, 2007-2016E (US$ million)
Fig.9: POC Diagnostics Market by Product, excl. Glucose, 2016E



  WHO Diabetes Prevalence, 2000 and 2030
Blood Glucose Testing Market Dynamics
  Fig.10: Global Blood Glucose Testing Market, 2005-2016E (US$ billion)
  Fig.11: Blood Glucose Testing Market by Customer Type, 2010
  Leading Companies’ Diabetes Care Sales, 2004-2010 (US$ million)
Diabetes Self-Testing
Conventional Blood Glucose Testing Products and Technologies
  Market-Leading Self-Testing Blood Glucose Meters
  Abbott’s Test Strip Product Recall
  Competing Self-Testing Blood Glucose Meters
  FDA Warning - GDH-PQQ Test Strips
  New Products
    Abbott’s FreeStyle Lite and FreeStyle Freedom Lite Test Strips
    ACON Laboratories’ On Call Blood Glucose Monitoring Systems
    AgaMatrix’ WaveSense Products
    Arkray’s Glucocard Blood Glucose Monitoring Systems
    Bayer’s Contour USB
    Bayer’s DIDGET Meter
    Cambridge Sensors’ Microdot+
    Infopia’s Blood Glucose Products
    Point-of-Care Diagnostics 2011
    Table of Contents Point-of-Care Diagnostics 2011
    LifeScan’s New OneTouch Products
    Nova Biomedical’s Nova Max Plus
    Roche’s Accu-Chek Products
    sanofi-aventis/AgaMatrix BGStar and iBGStar
    Standard Diagnostics’ SD Check Gold and SD Codefree/SmartLink Gold
Professional Use Products
  Abbott’s Precision XceedPro Blood Glucose and ß-Ketone Monitoring System
  AgaMatrix’ KeyNote Pro
  Arkray Assure Blood Glucose Testing Products
  Bayer’s Hospital Blood Glucose Monitoring Products
  EKF Diagnostics’ Biosen C
  LifeScan’s SureStep Flexx and SureStep Hospital
  Nova Biomedical’s StatStrip Glucose Monitor
  Quest Diagnostics’ HemoCue Blood Glucose Testing Systems
  Roche’s Accu-Chek Inform II
Continuous Glucose Monitoring
  Clinical Trial Results - Highlighting Benefits and Drawbacks
  Reimbursement Issues
  CGM Competitive Landscape
  Medtronic’s CGM Systems
    Paradigm Veo
    Paradigm REAL-Time Revel
    Guardian REAL-Time System
    iPro Professional Use Products
    CareLink Pro 3.0 Therapy Management Software
    Clinical Trials
  DexCom’s CGM Systems
    FDA Warning Letter
  Abbott’s FreeStyle Navigator CGM System
  A Menarini Diagnostics’ GlucoDay S
  CGM Products in Development
    DexCom Products
    Sensors for Medicine & Science’s SMSI Glucose Sensor
    Via Medical’s Via Blood Glucose Monitoring System
Next-Generation Blood Glucose Testing
  AiMedics’ HypoMon
  Echo Therapeutics’ Symphony tCGM System
    Clinical Study Results
  GluMetrics’ GluCath IV-CGM
  Integrity Applications’ GlucoTrack
  Lein Applied Diagnostics
  Pepex Biomedical’s Trio Products
  OrSense’s NBM-200G Non-Invasive Blood Glucose Meter
  Solianis Monitoring’s Multisensor Glucose Monitoring System
  VeraLight’s SCOUT DS
HbA1c Testing
  HbA1c Products
    ApexBio’s A1C Express
    Axis-Shield’s Afinion HbA1c and NycoCard HbA1c Tests
    Bayer’s A1CNow Products
    Bio-Rad’s in2it A1C Analyser
    DiaSys Diagnostic Systems’ InnovaStar
    Point-of-Care Diagnostics 2011 Table of Contents
    Ceragem Medisys’ LabonaCare HbA1c
    Infopia’s Easy/Clover A1c
    Quotient Diagnostics’ Quo-Test
    Siemens’ DCA Vantage Analyser
    In Development
  Ketone Testing


  POC Coagulation Testing
    Market Dynamics
    Fig.12: Global POC Coagulation Market, 2007-2016E (US$ million)
    Self-Monitoring Products
      CoaguSense’s CoaguSense PT/INR Monitoring System
      Alere’s INRatio2 System
      Nexus Dx’s ProTime Systems
      Roche’s CoaguChek XS
    Professional Use Products
      Axis-Shield Products
      Helena Laboratories’ Cascade POC System
      Helena Laboratories’ Actalyke & MAX-ACT
      Medtronic‘s ACT Plus Automated Coagulation Timer System
      Instrumentation Laboratory’s GEM PCL Plus
      Nexus Dx’s Hemochron Whole Blood Coagulation System
    Roche’s CoaguChek Systems
  In Development - Bio-AMD’s COAG
  Platelet Function and Antiplatelet Drug Assessment
    Clopidogrel Effectiveness Assessment
      Spartan Bioscience’s Spartan RX CYP2C19 POC DNA Testing System
    Accumetrics’ VerifyNow System
      Clinical Trials
  Helena Laboratories’ Plateletworks System
Cardiac Markers
  POC Testing
  Fig.13: Global POC Cardiac Marker Testing Market, 2007-2016E (US$ million)
  POC Testing Products
  Currently-Available Cardiac Marker POC Tests
    Alere’s Heart Check System
    Alere’s Triage and Clearview Products
    bioMérieux VIDAS Emergency Care Products
    Nexus Dx’s POC Cardiovascular Tests
    Princeton BioMeditech/LifeSign’s StatusFirst Tests and DXpress Reader
    Mitsubishi Chemical’s Pathfast Immunoassay Analyzer
    Response Biomedical’s RAMP 200 Platform
    Randox Laboratories’ Evidence Multistat
    Roche Cardiac Testing Products
    Siemens’ Stratus CS Analyzer
    Products in Development
Cholesterol Testing
  Fig.14: Global POC Cholesterol Testing Market, 2007-2016E (US$ million)
  Home Testing
    Alere’s First Check Cholesterol Test
    Akers Biosciences’ Tri-Cholesterol Check
    Chematics Chemcard Cholesterol Test
Infopia’s Lipid Pro
    Roche’s Accutrend Plus
    Syntron Bioresearch’s Venture Total Cholesterol Test
Point-of-Care Diagnostics 2011
  Professional Use Products
  Alere’s Cholestech LDX System
  Jant Pharmacal’s LipidPlus Lipid Profile and Glucose Test System
  Polymer Technology Systems’ CardioChek
Miraculins’ PREVU Point of Care Skin Sterol Test


Abaxis’ Piccolo xpress
Abbott’s i-STAT System
Alfa Wassermann’s ACE Clinical Chemistry Systems
Audit Diagnostics’ Liqui-Stat Wet Chemistry POC System
Arkray’s SpotChem EZ Dry Chemistry
Axis-Shield’s Afinion POC System
Axis-Shield’s NycoCard System
Horiba ABX’ ABX Pentra 400 Clinical Chemistry Analyser
MagnaBioSciences’ MICT
Ortho-Clinical Diagnostics' VITROS DT60 II Chemistry System
OrSense’s NBM Products
  NBM-200MP Oximetry
  NBM 200 Haemoglobin
Probe Scientific MicroEye Blood Analysis Device
Radiometer’s AQT90 FLEX Immunoassay Analyser
Randox Laboratories’ Evidence Multistat
ReLIA Diagnostic Systems’ ReLIA System
Tosoh Bioscience’s AIA-360 Immunoassay Analyser
  In Development
    Ativa Medical’s POC Analyser
    Atonomics’ Atolyzer
    Claros Diagnostics’ Claros System
    pes diagnosesysteme’ respons IQ
    Infopia’s Tele-Diagnostic System


Mayo Clinic’s Estimated Glomerular Filtration Rate Study
Arkray’s SpotChem EL Electrolyte Analyser
Epocal’s epoc
Instrumentation Laboratory’s GEM Premier Products
  tBili Assay
  GEMweb Plus Custom Connectivity
Nexus Dx’s IRMA TRUpoint Blood Analysis System
Nexus Dx’s AVOXimeter Products
Nova Biomedical’s Products
  Stat Profile Critical Care Xpress
    Stat Profile pHOx
  Nova Biomedical Electrolyte/Chemistry Analysers
  Statsensor Creatinine Meter
  StatStrip Lactate
OPTI Medical Systems’ Products
  Radiometer’s Blood Gas Analysers
  ABL80 FLEX CO-OX CO Oximeter
Roche’s cobas Blood Gas Analysers
Siemens’ Blood Gas Analyser Range
  Point-of-Care Diagnostics 2011 Table of Contents
  RAPIDLab Analysers
  RAPIDPoint Blood Gas Systems
  RAPIDChem 744/754 Electrolyte and Lithium Testing
  RAPIDComm Data Management and Connectivity Solution
  Via Medical’s Products


Surgical Coagulation and Haemostasis Management
  Akers Biosciences’ PIFA Heparin/PF4 Rapid Assay
  Haemonetics’ TEG Thrombelastograph Hemostasis Analyzer
    Instrumentation Laboratory’s GEM PCL Plus
  Medtronic’s HMS PLUS Haemostasis Management System
  Pentapharm’s ROTEM delta
  Sienco’s Sonoclot Coagulation & Platelet Function Analyzers
Haematology Analysers
  Beckman Coulter’s COULTER AC•T Series
  Quest Diagnostics’ HemoCue White Blood Cell Analyzer
  Horiba ABX’ Haematology Analysers
    ABX Micros ES60
    ABX Micros
    ABX Micros CRP
    ABX E-Sat
    ABX Pentra 60C+
  Symex’ pocH-100i Haematology Analyser
Arkray’s PocketChem BA Blood Ammonia Meters
Haemoglobin Systems
  ACON Laboratories’ Mission Hb Hemoglobin Testing System
  ApexBio’s HemoSmart Haemoglobin Screening System
  Audit Diagnostics’ Hb-Stat
  EKF Diagnostics’ Hemo-Control and Hemo Speed Products
  Instrumentation Laboratory’s IL 682 CO-Oximeter
  Nexus Dx’s Hgb Pro Professional Hemoglobin Testing System
  Quest Diagnostics’ HemoCue Haemoglobin Systems
    HemoCue 201 DM Analyser Whole Blood Systems
Stanbio Laboratory’s HemoPoint H2 and STAT-Site M Hgb
  URIT Medical’s URIT-12 Hemoglobin Meter


  Fig.15: Global POC Infectious Disease Testing Market, 2007-2016E (US$ million)
POC Influenza Testing
  Performance and Use of Rapid Influenza Tests in the US
  Flu Detection Products
    Alere’s BinaxNOW Influenza A&B Test
    Alere’s Clearview Exact Influenza A & B
    Becton Dickinson’s Directigen EZ Flu A+B test
    Jant Pharmacal’s Accutest Flu Test
    Medix Biochemica’s Actim Influenza A&B
    Meridian Bioscience’s TRU FLU
    Mizuho Medy’s Quick Chaser Flu A,B
    OraSure Technologies’ OraSure QuickFlu Rapid Flu A+B Test
    Princeton BioMeditech’s BioSign Flu A+B
    Quidel’s QuickVue Influenza Tests
    Remel’s Xpect Flu A&B
    SA Scientific’s SAS FluAlert
    Sekisui Diagnostics’ OSOM Influenza A & B Test
    Sysmex’ POCTEM Influenza A/B
  Products in Development
    Chembio’s DPP Influenza Tests
    Enigma Diagnostics’ Enigma ML Influenza A/B Detection Assay
    IQuum’s Liat System
    Nexus Dx’s Rapid Flu Tests
Respiratory Syncytial Virus
  Quidel’s QuickVue RSV
Other Respiratory Tests
  Ani Biotech’s Biocard Chlamydia Pneumoniae IgM Test
  GenBio’s ImmunoFLOW Mycoplasma IgM Test
  In Development - Tyrian Diagnostics’ DiagnostIQ
POC HIV Testing
  HIV Prevalence by Region, 2001 and 2009
  Market Dynamics
  Product Highlights
    Alere’s Pima Point-of-Care CD4 Analyser
    Alere’s SD, Determine and Clearview HIV Tests
    bioLytical Laboratories’ INSTI Kit
    bioMérieux’s VIKIA HIV 1/2 HIV Test
    Bio-Rad’s Multispot HIV-1/HIV-2 Rapid Test
    Calypte Biomedical’s Aware HIV-1/2 Tests
    Chembio Diagnostics’ Sure Check (Clearview Complete), STAT PAK (Clearview HIV 1/2 STAT-PAK) and HIV 1/2 STAT PAK DIPSTICK �
  Chembio Diagnostics’ Dual Path Platform Technology Products
    EY Laboratories’ InstantCHEK
    Hema Diagnostic Systems
    IND Diagnostic’s One-Step Anti-HIV (1+2) Tests
    Lab21’s Biotec Tests
    MedMira’s Tests
    Integrated Medical Innovations’ FirstVue HIV Tests
    OraSure’s OraQuick ADVANCE HIV-1/2
    Trinity Biotech’s POC HIV Tests
    Savyon Diagnostics’ HIVSav 1/2/0 Rapid SeroTest
    Unimed’s FirstSign HIV Duo
    YD Diagnostics’ AIDScan
  Products in Development
    Alere’s HIV NAT System
    Calypte Biomedical’s Aware II (The Ani Platform)
  Cepheid’s GeneXpert System and Xpert HIV Viral Load Test
    Daktari Diagnostics’ Daktari CD4
    IQuum’s Liat System
    OraSure’s OraQuick HIV OTC Test
POC Hepatitis Tests
  Hepatitis B
  Hepatitis C
  Available Tests
    Alfa Scientific Designs’ Instant-View Tests
    bioMérieux‘ VIKIA HBs Ag Test
    Integrated Medical Innovations’ FirstVue Rapid Test Kit
    OraSure Technologies’ OraQuick HCV Rapid Antibody Test
    Runbio Biotech’s One Step Tests
    YD Diagnostics’ HepaScan Tests
In Development
  Chembio’s DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests
  Exalenz Bioscience’s BreathID System
MedMira’s Multiplo Combination HIV/Hepatitis Tests
POC Tuberculosis Tests
  Cepheid’s Xpert MTB/RIF
  In Development
    Chembio’s DPP Tuberculosis
    TwistDx’s Recombinase Polymerase Amplification Technology
Tropical Disease Tests
  Hema Diagnostic Systems’ Malaria Tests
  Lab21’s Tropical Disease Tests
  Quest Diagnostics’ Focus Dengue Rapid Tests
  New Horizons Diagnostics’ Cholera and Bengal SMART
  Unimed’s FirstSign Typhoid Tandem Test
  Products in Development
    Chembio’s DPP Leptospirosis
    Chembio’s DPP Visceral Leishmaniasis
Sexually-Transmitted Diseases and Related Diagnostics
  Ani Biotech’s Biocard Candida and Trichomonas Tests
  Focus Diagnostics’ HerpeSelect Express HSV-2
  Gryphus Diagnostics’ BVBLUE
  Hema Diagnostic Systems’ Rapid 1-2-3 Hema Syphilis
  MagnaBioSciences MICT Chlamydia Test
  Mizuho Medy’s Quick Chaser TP Ab
  New Horizons Diagnostics’ GonoGen II and TRUST
  Quidel’s QuickView Chlamydia Test
  RunBio Biotech’s Tests
  Savyon Diagnostics’ SavvyCheck
  Sekisui Diagnostics’ OSOM Trichomonas
  Products In Development
    Chembio’s DPP Syphilis Tests
    Randox Laboratories’ Lab-on-a-Chip
Trinity Biotech’s Uni-Gold Legionella Urinary Antigen
Group A Streptococcus Tests
  Currently Available POC Tests
H. pylori Tests
  Currently Available H. pylori Tests
  Exalenz Bioscience’s BreathID System
  Meretek Diagnostics’ BreathTek UBT
Mononucleosis Tests
  Currently Available POC Tests
Rotavirus and Adenoviral Enteritis Tests
  Ani Biotech’s Biocard Tests
  Meridian Bioscience ImmunoCard STAT! Rotavirus
  Orion Diagnostica’s Diarlex, Rotalex and Adenolex Tests


Abaxis’ MetLyte Plus CRP and BioChemistry Panel Plus
Medix Biochemica’s Actim CRP
Orion Diagnostica’s QuikRead and QuikRead go Systems
In Development
  LifeAssays’ CRP


  Fig.16: Global POC Cancer Markers Market, 2007-2016E (US$ million)
Prostate Specific Antigen Tests
  Available Tests
  Claros Diagnostics’ Claros System
  Mediwatch’s PSAwatch
Occult Blood Testing
  ACON Laboratories’ Mission FOB Reagent Strips
  Aerscher Diagnostics’ HemaPrompt
  Alere’s Tests
  Beckman Coulter’s Hemoccult Tests
  Biomerica’s EZ Detect
  Helena Laboratories’ ColoCare
  Immunostics’ Hema-Screen
  Orion Diagnostica’s QuikRead System and Orion Q-flow FOB
  Princeton BioMeditech’s BioSign iFOBTest
  Quest Diagnostics’ InSure Quik F I T
  Quidel’s QuickVue iFOB
  Other Available FOB Tests
  Gastric Occult Blood Tests
CEA Testing
Alpha Fetoprotein Testing
Bladder Cancer Testing
  Alere’s Matritech NMP22 BladderChek Test
  Mediwatch’s Bladderwatch BTA Test
Novel Products in Development
  Akers Biosciences’ BreathPulmo Health “Check”
  Balter Medical’s Optical Transfer Diagnosis Platform
  Guided Therapeutics’ LightTouch Cervical Cancer Scanner
    Lung and Oesophageal Cancer
Infopia’s Cancer Diagnosing Sensor


  Fig.17: Global POC Urinalysis Market, 2007-2016E (US$ million)
  Product Highlights - Urine Analysis Test Strips
Key Products
  ACON Laboratories’ Mission Products
  Arkray’s Products
    PocketChem UA
    DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips
    Diagnostic Test Group’s Clarity Urocheck 120 Analyzer
Roche’s Products
  Urisys 1100 Urine Analyser
  Chemstrip Criterion II Analyzer
Siemens’ Products
  Clinitek Advantus Analyser
  Clinitek Status Analyser
  Clinitek Status+
  Clinitek Status Connect
  RAPIDComm Data Management and Connectivity Solution
New Products
Urinary Tract Infection Tests
  ACON Laboratories’ Mission UTI Urinary Tract Infection Test Strips
  Jant Pharmacal’s Accutest Uriscreen Rapid UTI Screen Test
  Orion Diagnostica’s Uricult Dipslide Tests
Microalbumin Testing
  Axis-Shield’s Afinion ACR Test
  Biomerica’s Fortel Microalbumin Screening-OTC Test
  Orion Diagnostica’s QuikRead U-ALB
  Quest Diagnostics’ HemoCue Albumin 201 System
  Sekisui Diagnostics’ OSOM ImmunoDip Urinary Albumin Test
  Siemens’ Clinitek Microalbumin Strips


  Fig.18: Global POC Pregnancy & Fertility Market, 2007-2016E (US$ million)
Competitive Landscape - Pregnancy Testing Kits
  In Development - Bio-AMD’s DSR
Competitive Landscape - Ovulation Testing Kits
Competitive Landscape - Menopause Testing Kits
SPD Swiss Precision Diagnostics’ Consumer Products
Mitsubishi Chemical’s Pathfast Immunoassay Analyzer
ContraVac’s SpermCheck Male Fertility Testing Products
  SpermCheck Fertility
  SpermCheck Vasectomy
Labour and Delivery Testing
  Alere’s Triage PLGF Assay
  Amnisure International’s AmniSure ROM Test
  Medix Biochemica’s Actim PROM and Actim Partus


Market Dynamics
Currently-Available POC Drugs-of-Abuse Testing Products
DoA Product Highlights
  Alere’s Tests
  Alfa Scientific Designs’ Drug Screen Tests
  American Bio Medica’s Drug Abuse Tests
  Branan Medical’s Oratect III and OratectPlus Devices
  Phamatech Drugs of Abuse Tests
  Randox Laboratories’ Evidence Multistat
Products in Development
  Concateno’s New Portable Drug Testing System
Alcohol Testing
  ACON Laboratories' Alcohol Testing Products
  Alere’s Products
  kers Biosciences’ BreathScan
  BreathScan PRO
  Chematics’ Alco-Screen
  OraSure’s Q.E.D. Saliva Alcohol Test
  In Development - TruTouch Technologies’ TruTouch 2000 System


Liver Function Testing
  Exalenz Bioscience’s BreathID System
  Infopia’s Pioneer POCT Liver Test Sensor
Thyroid Tests
  Screening Devices Canada’s ThyroChek
Akers Biosciences’ Lithium “Check” System
Alere’s Triage NGAL Test
Ani Biotech’s Biocard Coeliac Tests
bioMérieux’ VIDAS B·R·A·H·M·S PCT. Test
Magellan Biosciences’ LeadCare II System
Biomerica’s Fortel Pet Allergy Tests


Alere’s True Rapid Molecular Platform
Atonomics’ Atolyzer
Ativa's POC System
Cepheid’s GeneXpert
  Xpert MTB/RIF
  Xpert HIV Viral Load Test
Claros Diagnostics’ Claros System
pes diagnosesysteme’ respons IQ
Enigma Diagnostics’ Enigma ML (Mini Laboratory)
IQuum’s Liat System
  Liat Assays
Molecular Vision
Ortho-Clinical Diagnostics’ (Johnson & Johnson) Forecast System
Philips’ Magnotech
Randox Laboratories’ Lab-on-a-Chip
T2 Biosystems’ T2Dx System
TwistDx’ Recombinase Polymerase Amplification Technology
Tyrian Diagnostics’ DiagnostIQ


    Piccolo xpress
    Litigation with Cepheid
    Financial Performance
    Abaxis Operating Results, 2005-2010 (US$ million)
      Latest Results
  i-STAT Point-of-Care Products
Diabetes Care
  FreeStyle Navigator Continuous Glucose Monitoring System
  FreeStyle Blood Glucose Monitors and Test Strips
  Precision Xtra/Optium Xceed System
  CoPilot Health Management System
  Professional Products
  Test Strip Product Recall
Current Alliances
  Calypte Biomedical
  Church & Dwight
  Nova Biomedical
Financial Performance
Abbott Diagnostics Sales, 2005-2010 (US$ million)
Fig.19: Percentage of Abbott Diagnostics Revenue by Region, 2010
Abbott Diabetes Care Sales by Region, 2005-2010 (US$ million)
Fig.20: Percentage of Abbott Diabetes Care Revenue by Region, 2010
  Recent Key Events
  Fig.21: Accumetrics Revenue, 2005-2010 (US$ thousand)
  VerifyNow System
  Distribution Agreements
ACON Laboratories
  Recent Key Events
On Call Blood Glucose Monitoring Systems
Mission Clinical Chemistry Products
  Mission Hb Hemoglobin Testing System
  Mission FOB Reagent Strips
  Urine Analysers and Test Strips
Alcohol Testing
Akers Bioscienes
  Recent Key Events
    Current Products
    PIFA Heparin/PF4 Rapid Assay
    BreathScan PRO
    Breath Ketone “Check”
    Battlefield Blood Transfusion Card
    Lithium “Check” System
    Tri-Cholesterol Check
    Non Core Products
  Research and Development
    BreathPulmo Health “Check”
  Current Alliances and Distribution Agreements
    Al Tadawi Medical Equip
    HealthTrust Purchasing Group
    Fisher HealthCare
    BreathScan International
    US Government Service Administration Schedule Contract
    AFRICA Continental Holdings
    PULSE Health
Financial Performance
  Akers Biosciences Operating Results, 2005-2009 (US$ thousands)
    Latest Results
  Recent Key Events
  POC Professional Diagnostic Products
    Women’s Health
    Infectious Diseases
    Drugs of Abuse
Consumer Products
  First Check Consumer Diagnostics Products
  Standard Diagnostics’ Blood Glucose Meters
Research and Development
POC Mergers & Acquisitions
  Standard Diagnostics
  Assets from Unotech Diagnostics
  Mologic, Jinsung Meditech, Biolinker and Long Chain International Corp
  Genecare, Zycare, Medim and Biosyn
  ACON Laboratories’ Rapid Diagnostics Assets
  Vision Biotech and Global Diagnostics CC
  Matria Healthcare
  BBI Holdings
  Earlier Acquisitions
Joint Ventures
  SPD Swiss Precision Diagnostics
Current Alliances
  Spartan Bioscience
  OraSure Technologies
  Trinity Biotech
  OraSure Technologies
Financial Performance
  Alere - Operating Results, 2006-2010 (US$ million)
  Fig.22: Percentage of Alere’s Revenue by Segment, 2010
  Fig.23: Percentage of Alere’s Revenue by Product Type, 2010
  Fig.24: Percentage of Alere’s Revenue by Region, 2010
  Alere Professional Diagnostics Operating Results, 2006-2010 (US$ million)
  Alere Consumer Diagnostics Operating Results, 2006-2010 (US$ million)
American Bio Medica
  Recent Key Events
  Drug Abuse Tests
    Urine Tests
    Saliva Tests
    Rapid Reader
    Adulteration, Alcohol and Nicotine Products
Current Alliances
  Hema Diagnostic Systems
Financial Performance
American Bio Medica Operating Results, 2006-2010 (US$ million)
  Recent Key Events
  SpotChem EZ Dry Chemistry Analyser
  SpotChem EL Electrolyte Analyser
  PocketChem BA Blood Ammonia Meters
    DiaScreen 50 Urine Chemistry Analyzer
    PocketChem UA
Blood Glucose Self-Testing
  Glucocard Meters
  Assure Blood Glucose Testing Products
Current Alliances
  ELITech Group
  A Menarini Diagnostics
  Recent Key Events
  Afinion POC System
  Coagulation Products
  Financial Performance
  Fig.25: Axis-Shield Revenue by Business Unit, 2010
  Fig.26: Axis-Shield Revenue by Region, 2010
  Axis-Shield - POC Segment Operating Results, 2006-2010 (£ million)
  Axis-Shield - POC Sales by Product Line, 2006-2010 (£ million)
  Fig.27: Axis-Shield POC Sales by Product, 2010
  Fig.28: Axis-Shield Afinion Sales by Region, 2010
  Blood Glucose Monitoring Systems
    DIDGET Meter
    Contour USB
    Contour, Contour TS, Contour Link and Breeze
    Elite and Elite XL
  A1CNow Products
  Current Alliances
    Roche Diagnostics
  Financial Performance
  Bayer Diabetes Care Revenue, 2005-2010 (EUR million)
Beckman Coulter
  Rapid Tests
    Hemoccult Tests
  Haematology Analysers
  Home Diagnostic Products
  Professional Use Products
  IVAX Diagnostics Distribution Alliance
  Financial Performance
  Biomerica - Operating Results, 2006-2010 (US$ thousand)
  Biomerica - Revenue by Region, 2008-2010 (US$ thousand)
  Fig.29: Percentage of Biomerica’s Revenue by Region, 2010
    Latest Results
  Emergency Care
    VIDAS Troponin I Ultra
    VIDAS D-Dimer Exclusion
    VIDAS B·R·A·H·M·S PCT. Test
Rapid Infectious Disease Tests
  VIKIA HBs Ag Hepatitis B Test
Current Alliances
  ReLIA Diagnostic Systems
  Roche Diagnostics
Financial Performance
  bioMérieux - Operating Results, 2006-2010 (EUR million)
  Fig.30: Percentage of bioMérieux’s Revenue by Product Type, 2010
  Fig.31: Percentage of bioMérieux’s Revenue by Region, 2010
Bio-Rad Laboratories
Point-of-Care HbA1c Testing
TOX/See Drugs-of-Abuse Testing
Multispot HIV-1/HIV-2 Rapid Test
Current Alliances
  Calypte Biomedical
Calypte Biomedical
  Aware Rapid Test Product Line
    Aware HIV-1/2 OMT (Oral fluid)
    Aware HIV-1/2 BSP
    Aware HIV-1/2 U
Products in Development - Aware II (The Ani Platform)
Current Alliances
  Manufacturing Contracts
Financial Performance
Calypte Biomedical Operating Results, 2006-2010 (US$ thousands)
Fig.32: Percentage of Calypte’s Revenue by Product, 9 Months 2010
Chembio Diagnostics
  Recent Key Events
  Rapid HIV Tests
  Dual Path Platform Technology Products
    DPP HIV 1/2 Screening Assay
    DPP HIV 1/2 Confirmatory Test
Other Tests
  DPP Technology Products in Development
  DPP Tuberculosis
  DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests
  DPP Influenza
  DPP Leptospirosis
  DPP Syphilis Screen & Confirm
Current Alliances
  Oswaldo Cruz Foundation of Brazil
  Battelle Memorial Institute
  Infectious Disease Research Institute
  Bio-Rad Laboratories
Financial Performance
  Chembio - Operating Results, 2006-2010 (US$ thousands)
  Chembio - Revenue by Type, 2008-2010 (US$ thousand)
  Chembio - Product Sales by Region, 2006-2010 (US$ thousand)
  Fig.33: Percentage of Chembio’s Revenue by Type, 2010
  Fig.34: Percentage of Chembio’s Product Sales by Region, 2010
    FDA Warning Letter
  Research and Development
  Current Alliances
    Edwards Lifesciences
Litigation with Abbott
Financial Performance
DexCom - Operating Results, 2006-2010 (US$ thousands)
Horiba ABX
  Haematology Analysers
    ABX Micros ES60
    ABX Micros
    ABX Micros CRP
    ABX E-Sat
    ABX Pentra 60C+
ABX Pentra 400 Clinical Chemistry Analyser
Financial Performance
  Fig.35: Percentage of Horiba’s Revenue by Division, 2010
  Horiba Medical Operating Results, 2006-2010 (¥ million)
  Fig.36: Percentage of Horiba Medical’s Revenue by Region, 2010
Instrumentation Laboratory
  Recent Key Events
  POC Critical Care Diagnostics
    tBili Assay
    GEMweb Plus Custom Connectivity
Purchasing Contracts
  Recent Key Events
Blood Glucose Monitoring Products
  Consumer Products
  Hospital Products
  Test Strips
OneTouch Diabetes Management Software
DataLink Data Management System
Current Alliances
    Financial Performance
    J&J Diabetes Care Revenue 2005-2010 (US$ million)
    Fig.37: LifeScan Sales by Region, 2010
    Fig.38: LifeScan Sales, 2004-2010 (US$ million)
  Recent Key Events
  Rapid Tests
    Multiplo HIV/HCV
    Multiplo HBV/HIV/HCV
    HIV Tests
    Reveal/MiraWell hp Test H. pylori Test
R&D Activities
  New Combination Tests
Current Alliances
  Advance Aid
  Triplex International Biosciences
  VWR International
  Tri-Star Industries
  Shenzhen Kang Sheng Bao Bio-Technology
  Pan American Health Organization
  HealthCare Asia MediTech
  INyDIA Diagnóstico
  Voden Medical Instruments
Financial Performance
  MedMira Operating Results, 2006-2010 (C$ thousands)
  MedMira - Revenue by Region, 2007-2010 (C$ thousands)
  Fig.39: MedMira - Revenue by Region, 2010
  Latest Results
  CGM Systems
Recent Key Events
  Paradigm Veo
  Paradigm REAL-Time Revel
  Guardian REAL-Time System
  iPro Professional Use Products
  CareLink Pro 3.0 Therapy Management Software
  Blood Glucose Meters
  Clinical Trials
  Research and Development
  Alliances - LifeScan and Bayer
Cardiac Surgery POC Products
  ACT Plus Automated Coagulation Timer System
  HMS PLUS Haemostasis Management System
Financial Performance
Fig.40: Medtronic Diabetes Revenue, 2005-2010 (US$ million)
Fig.41: Medtronic Diabetes Revenue by Region, 2010
Fig.42: Medtronic Diabetes Revenue by Product Type, 2010
  Latest Results
Meridian Bioscience
  C.difficile Tests
  ImmunoCard STAT! HpSA H. pylori Test
  ImmunoCard STAT! Rotavirus
  ImmunoCard STAT! Strep A
  ImmunoCard STAT! MONO
  ImmunoCard STAT! hCG Combo Test
  Financial Performance
  Meridian Bioscience Operating Results, 2006-2010 (US$ million)
  Meridian Bioscience - Third-Party Sales by Segment, 2006-2010 (US$ million)
  Meridian Bioscience - Operating Income by Segment, 2006-2010 (US$ million)
  Fig.43: Meridian Bioscience - Revenue by Segment, 2010
  Meridian Bioscience - European Diagnostics Sales by Country, 2005-2010 (US$ million)
    Latest Results and Outlook
Nexus Dx
  Recent Key Events
  ProTime Coagulation Systems
  Hemochron Whole Blood Coagulation System
  IRMA TRUpoint Blood Analysis System
  AVOXimeter Whole Blood CO Oximeter and Oximeter
  Hgb Pro Professional Hemoglobin Testing System
  POC Cardiovascular Tests
Products in Development
Current Alliances
  Medical Automation Systems
Financial Performance - ITC
  International Technidyne Operating Results, 2004-2009 (US$ million)
  Fig.44: International Technidyne Revenue, 2000-2010 (US$ million)
Nipro Diagnostics
  TRUEtest Test Strips
  TRUE2go and TRUEresult
  TRUEmanager Diabetes Management Software
  Current Alliances
Financial Performance
Home Diagnostics - Operating Results, 2004-2008 (US$ million)
Home Diagnostics - Revenue by Source, 2006-2008 (US$ million)
Fig.45: Percentage of Home Diagnostics’ Revenue by Source, 2008
Nova Biomedical
  Recent Key Events
  StatStrip Hospital Blood Glucose Analysers
  Statsensor Creatinine Meter
  StatStrip Lactate
  Whole Blood Stat Testing
    Stat Profile Critical Care Xpress
    Stat Profile pHOx
Nova Electrolyte/Chemistry Analysers
  Self-Testing Blood Glucose Analysers
  Nova Max Plus
  Nova Max Link
Current Alliances and Contracts
  HealthTrust Purchasing Group
  Roche Diagnostics
OraSure Technologies
  Recent Key Events
  OraQuick Rapid Test Platform
    OraQuick HCV Rapid Antibody Test
    OraQuick ADVANCE HIV-1/2
OraSure QuickFlu Rapid Flu A+B Test
Q.E.D. Saliva Alcohol Test
Products in Development
Current Alliances and Licensing Agreements
  Princeton BioMeditech
  Ortho-Clinical Diagnostics
Financial Performance
  OraSure - Operating Results, 2006-2010 (US$ million)
  OraSure Infectious Disease Testing Sales, 2009-2010 (US$ thousands)
  Fig.46: OraSure - Revenue by Business Area, 2010
  Fig.47: OraQuick HIV Revenue by Region, 2010
Orion Diagnostica
  QuikRead System
  QuikRead go
  Uricult Dipslide Tests
  Rotaviral and Adenoviral Enteritis Tests
  Orion Q-flow FOB
  Financial Performance
  Orion Diagnostica - Operating Results, 2006-2010 (EUR million)
  NBM-200MP Multi-Parameter Sensor
    NBM-200MP Oximetry
    NBM 200 Haemoglobin
    In Development - NBM-200G Blood Glucose Meter
  Drugs of Abuse Tests
    At Home Drug Test
    QuickScreen Plus
    QuickScreen Cup
    QuickScreen Dipsticks and Cassettes
  Pregnancy and Fertility Testing
Quest Diagnostics
  HemoCue Products
    Haemoglobin Systems
    Blood Glucose Testing
    HemoCue Albumin 201 System
    HemoCue White Blood Cell Analyzer
  Enterix Products
    InSure Quik F I T Fecal Immunochemical Test
  Focus Diagnostics’ POC Products
    HerpeSelect Express HSV-2
    Focus Dengue Rapid Tests
  Current Alliances
  Financial Performance
  Quest Diagnostics - Operating Results, 2006-2010 (US$ million)
  Quest Diagnostics - Sales and Earnings by Category, 2006-2010 (US$ million)
  Fig.48: Quest Diagnostics - Revenue by Division, 2010
  Fig.49: Quest Diagnostics - Revenue by Product Type, 2010
  Recent Key Events
  Infectious Disease Tests
    QuickVue Influenza Tests
    QuickVue Group A Strep Tests
    QuickVue RSV Tests
    QuickVue+ Infectious Mononucleosis
Reproductive and Women’s Health
QuickVue iFOB
QuickVue H. Pylori gII Test
Current Alliances
  Financial Performance
  Quidel Operating Results, 2006-2010 (US$ million)
  Quidel - Revenue by Product Type, 2008-2010 (US$ million)
  Fig.50: Quidel - Revenue by Product Type, 2010
  Fig.51: Quidel Infectious Disease Revenue, 2005-2010 (US$ million)
  Quidel - Revenue by Region, 2005-2010 (US$ million)
  Fig.52: Quidel - Revenue by Region, 2010
Radiometer (Danaher)
  Recent Key Events
  AQT90 FLEX Immunoassay Analyser
  Blood Gas Analysers
    ABL80 FLEX
    ABL90 FLEX
    ABL800 FLEX
  ABL80 FLEX CO-OX CO Oximeter
Quality Control
Current Alliances
    Medical Automation Systems
  Financial Performance
  Fig.53: Radiometer - Revenue by Region, 2010
Response Biomedical
  Recent Key Events
  RAMP System
    Respiratory Syncytial Virus Test
    RAMP NT-proBNP Test
    Other Cardiac Markers
  Current Alliances
    Guangzhou Wondfo Biotech
    O&D Biotech
  Financial Performance
  Response Biomedical - Operating Results, 2006-2010 (C$ thousands)
  Response Biomedical - Product Sales by Category, 2009-2010 (C$ thousands)
  Fig.54: Response Biomedical - Product Sales by Category, 2010
  Response Biomedical - Revenue by Region, 2006-2010 (C$ thousands)
  Fig.55: Response Biomedical - Revenue by Region, 2010
Roche Diagnostics
  Recent Key Events
  Professional Diagnostic Products
    CoaguChek Systems
    Cardiac Testing Products
    cobas Blood Gas Analysers
    Hospital Blood Glucose Monitoring
Diabetes Care
  Blood Glucose Monitoring Products
  Data Management Tools
cobas POC IT Solution
Current Alliances and Contracts
  Sanko Junyaku (Eisai)
  Premier Purchasing Partners
  Response Biomedical
  Dade Behring (Siemens)
    Nova Biomedical
  Financial Performance
  Roche Diagnostics Operating Results, 2006-2010 (SFr million)
  Roche Diagnostics Sales by Product Line, 2007-2010 (SFr million)
  Roche Diagnostics Sales by Region, 2007-2010 (SFr million)
  Fig.56: Roche Diagnostics - Revenue by Product Line, 2010
  Fig.57: Roche Diagnostics - Revenue by Region, 2010
  Fig.58: Roche Diabetes Care - Revenue by Region, 2010
Sekisui Diagnostics
  Point of Care Tests
    OSOM C. difficile Toxin A/B Test
    OSOM Influenza A & B Test
    OSOM H. pylori
    OSOM Ultra Strep A
    OSOM Strep A
    OSOM Mono
    OSOM Trichomonas Rapid Test
    OSOM ImmunoDip Urinary Albumin Test
    OSOM Pregnancy Tests
Siemens Healthcare
  Recent Key Events
    RAPIDLab Analysers
    RAPIDPoint Blood Gas Systems
    RAPIDChem 744/754 Electrolyte and Lithium Testing
  Clinitek Advantus Analyzer
  Clinitek Status Analyser
  Clinitek Status+
  Clinitek Status Connect
  Multistix10 SG Reagent Strips
  Clinitek Microalbumin Strips
  Clinitest hCG Pregnancy Test
RAPIDComm Data Management and Connectivity Solution
Diabetes Testing - DCA Vantage Analyser
Cardiology - Stratus CS Analyzer
Current Alliances and Supply Contracts
  Financial Performance
Thermo Fisher Scientific
  Sure-Vue Tests
  Remel’s Xpect Tests
Trinity Biotech
  POC HIV Tests
    Uni-Gold Recombigen HIV
Uni-Gold Legionella Urinary Antigen (LUA)
Current Alliances
Financial Performance
Trinity Biotech Operating Results, 2006-2010 (US$ million)
Trinity Biotech - Sales by Product Line, 2006-2010 (US$ million)


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