MARKET OVERVIEW
EXECUTIVE SUMMARY
INTRODUCTION
Physicians Office POC Testing
The Role of POC Testing in a Physicians Office
Regulatory and Reimbursement Environment
CLIA Waiver
CURRENT MARKET DYNAMICS
Fig 1: POC Diagnostics in Relation to the IVD Market, 2011
Fig 2: Percentage of POC Diagnostics Market by Product, 2011
Regional Perspective
Fig 3: Professional POC Diagnostics Market by Region, 2011
Physicians Office POC Testing Market
Addressable Markets for Physicians Office POC Testing, 2007-2011 (US$ million)
Fig 4: Addressable Markets for Physicians Office POC Testing, 2011
Fig 5: Physicians Office POC Testing Market, 2011
GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES
POC Diagnostics and the Economy
The Burden of Chronic Disease and Preventative Medicine
Clinical Utility and Accuracy
POC Diagnostics as a Disruptive Technology
Emerging Technologies
Summary: Market Drivers, Restraints and Opportunities
COMPETITIVE LANDSCAPE
Market Leaders for Physicians Office POC Testing Products
Select POC Diagnostics Companies Sales, 2007-2011 (US$ million)
Merger and Acquisition Activity
Key POC Diagnostics Mergers and Acquisitions, 2008-2011
FUTURE MARKET PROSPECTS
Addressable Markets for Physicians Office POC Testing, 2011-2017E (US$ million)
Growth in the Addressable Markets for Physicians Office POC Testing, 2008-2017E (%)
Physicians Office POC Testing Market, 2011-2012E (US$ million)
Fig 6: Physicians Office POC Testing Market, 2012(E)
PHYSICIANS OFFICE POC PRODUCTS AND TECHNOLOGIES
POC HBA1C TESTING
Diabetes Prevalence and Burden to the Healthcare System
Fig 7: Diabetes Prevalence by Geographic Region, 2011-2030
Diabetes Prevalence for the Top 10 Countries, 2011-2030 (million)
Diabetes Management and the Role of HbA1c Testing
POC HbA1c Testing Market
Fig 8: Global POC HbA1c Testing Market, 2007-2017E (US$ million)
POC HbA1c Products
ApexBios A1C Express
Alere/Axis-Shields Afinion HbA1c and NycoCard HbA1c Tests
Bayers A1CNow Products
Bio-Rads in2it A1C Analyser
DiaSys Diagnostic Systems InnovaStar
Ceragem Medisys HbA1c Analysers
EKF Diagnostics Quo-Lab, Quo-Test and Biosen HbA1c Analysers
Infopias Easy/Clover A1c
Siemens DCA Vantage Analyser
Tosoh Biosciences G8 HPLC Analyzer
In Development
POC CHOLESTEROL TESTING
Cholesterol Testing and Preventative Medicine
POC Cholesterol Testing Market Dynamics
Fig 9: Global POC Cholesterol Testing Market, 2007-2017E (US$ million)
Fig:10: POC Cholesterol Testing Market by End User, 2011
Available Products
Aleres Cholestech LDX System
Akers Biosciences Tri-Cholesterol Check
Chematics Chemcard Cholesterol Test
General Life Biotechnologys BeneCheck LipidEx ST
Infopias Lipid Pro
Jant Pharmacals LipidPlus Lipid Profile and Glucose Test System
Miraculins PreVu Point of Care Skin Sterol Test
Distribution Agreements
Polymer Technology Systems CardioChek PA
Roches Accutrend Plus
Syntron Bioresearchs Venture Total Cholesterol Test
Products in Development
Roche and Panasonic Healthcare
POC COAGULATION TESTING
POC Coagulation Testing Market Dynamics
Fig 11: Global POC Coagulation Market, 2007-2017E (US$ million)
The Impact of New-Generation Anticoagulants
Patient Self-Testing and Issues for Doctors
CoaguSenses CoaguSense PT/INR Monitoring System
Aleres INRatio2 System
International Technidyne Corporations ProTime Microcoagulation System
Roches CoaguChek XS
Professional Use Products
Aleres Axis-Shield Products
Helena Laboratories Cascade POC System
Instrumentation Laboratorys GEM PCL Plus
Roches CoaguChek Systems
CoaguChek XS Pro
CoaguChek XS Plus
CoaguChek XS
CoaguChek Link
Products in Development
Bio-AMDs COAG
Siemens/Universal Biosensors POC Coagulation Tests
POC CLINICAL CHEMISTRY AND HAEMATOLOGY PRODUCTS
Multi-Functional POC Clinical Chemistry Analysers
Handheld POC Analysers Suitable for Use by Physicians
Abaxis Piccolo xpress
Abbotts i-STAT System
Alere/Axis-Shields Afinion POC System
Alere/Axis-Shields NycoCard System
Benchtop Systems Suitable for Physicians Laboratories
Alfa Wassermanns ACE Clinical Chemistry Systems
Arkrays SpotChem Systems
SpotChem Test Strips
Audit Diagnostics Liqui-Stat System
DiaSys Diagnostic Systems InnovaStar
Horibas ABX Pentra Clinical Chemistry Analysers
Ortho-Clinical Diagnostics VITROS DT60 II Chemistry System
Qualigens FastPack IP System
Samsungs LABGEO Clinical Chemistry Analysers
Tosoh Biosciences AIA Immunoassay Analysers
POC Haematology and Haemoglobin Analysers
POC Haemoglobin Systems
POC Analyser Accuracy
ACON Laboratories Mission Hb Hemoglobin Testing Systems
ApexBios HemoSmart Haemoglobin Screening System
Audit Diagnostics Hb-Stat
Ceragem Medisys CERA-CHEK Hb Plus
EKF Diagnostics Products
General Life Biotechnologys BeneCheck Hb Hemoglobin Test System
OrSenses Glasswing and NBM 200 Systems
Quest Diagnostics HemoCue Haemoglobin Systems
URIT Medicals URIT-12 Hemoglobin Meter
POC C-REACTIVE PROTEIN DIAGNOSTICS
Abaxis MetLyte Plus CRP and BioChemistry Panel Plus
Alere/Axis-Shield
bioMérieux bioNexia CRP Test
LifeAssays CRP
Medix Biochemicas Actim CRP
Orion Diagnosticas QuikRead and QuikRead go Systems
POC PHYSICIANS OFFICE INFECTIOUS DISEASE TESTS
Current Market Dynamics
Fig 12: Market for POC Infectious Disease Tests used in a Physicians Office, 2007-2017E (US$ million)
POC Influenza Testing
Performance and Use of Rapid Influenza Tests in the US
CDC Recommendations
CDC: Influenza Prevalence and Test Accuracy
POC Influenza Testing Market
Future Prospects
CLIA-Waived Flu Detection Products
Aleres Influenza Tests
Becton Dickinsons BD Veritor System
Quidels Sofia Analyzer and Sofia Influenza A+B Fluorescent Immunoassays
Quidels QuickVue Influenza Tests
SA Scientifics SAS FluAlert
Other POC Flu Detection Products
bioMérieux bioNexia Influenza A+B Tests
IQuums Liat Influenza A/B Assay and the Liat Analyzer
Jant Pharmacals Accutest Flu Test
Medix Biochemicas Actim Influenza A&B
Meridian Biosciences TRU FLU
Mizuho Medys Quick Chaser Flu A,B
OraSure Technologies OraSure QuickFlu Rapid Flu A+B Test
Princeton BioMeditechs BioSign Flu A+B
Response Biomedicals Influenza A+B Test
Sekisui Diagnostics OSOM Influenza A & B Test
Products in Development
Chembios DPP Influenza Tests
Cepheids GeneXpert
Lucigens Nucleic Acid-Based POC Test
Respiratory Syncytial Virus
Quidels Sofia RSV Fluorescent Immunoassay
Quidels QuickVue RSV 10
Response Biomedicals RSV Test
Other Respiratory Tests
Ani Biotechs Biocard Chlamydia Pneumoniae IgM Test
GenBios ImmunoFLOW Mycoplasma IgM Test
Group A Streptococcus Tests
Currently-Available POC Strep A Tests
Quidels Sofia Strep A Fluorescent Immunoassay
H pylori Tests
Currently-Available H pylori Tests
Exalenz Biosciences BreathID System
Otsuka America Pharmaceuticals BreathTek UBT
Mononucleosis Tests
Currently-Available POC Mono Tests
Rotavirus and Adenoviral Enteritis Tests
Ani Biotechs Biocard Tests
Meridian Bioscience ImmunoCard STAT! Rotavirus
Nicox/Rapid Pathogen Screenings AdenoPlus
Orion Diagnosticas Diarlex, Rotalex and Adenolex Tests
Womens Heath Diagnostics
Ani Biotechs Biocard Candida and Trichomonas Tests
Gryphus Diagnostics BVBLUE
Quidels QuickView Chlamydia Test
RunBio Biotechs Tests
Savyon Diagnostics SavvyCheck
POC TUMOUR MARKER TESTING
Fig 13: Global POC Tumour Markers Market, 2007-2017E (US$ million)
Prostate Specific Antigen Tests
Available Tests
Mediwatchs PSAwatch
OPKO Healths OPKO Diagnostics Platform
Occult Blood Testing
ACON Laboratories Mission FOB Reagent Strips
Aerscher Diagnostics HemaPrompt
Aleres Tests
Beckman Coulters Hemoccult Tests
Biomericas EZ Detect
bioMérieux bioNexia FOBplus
Helena Laboratories ColoCare
Immunostics Hema-Screen
Orion Diagnosticas QuikRead System and Orion Q-flow FOB
Princeton BioMeditechs BioSign iFOBTest
Quest Diagnostics InSure Quik F I T
Quidels QuickVue iFOB
Other Available FOB Tests
Gastric Occult Blood Tests
CEA Testing
Alpha Fetoprotein Testing
Bladder Cancer Testing
Aleres Matritech NMP22 BladderChek Test
bioMérieux bioNexia BTA
Mediwatchs Bladderwatch BTA Test
Novel Products in Development
Bioscience Ventures/ Serasciences POC Myeloma Test
Guided Therapeutics Non-Invasive Cancer Diagnostic Products
LuViva Advanced Cervical Scan
Oesophageal and Other Cancer Detection
Infopias Cancer Diagnosing Sensor
POC URINALYSIS TESTING
Fig 9: Global POC Urinalysis Market, 2007-2017E (US$ million)
Key Urine Analysis Test Strips
Product Highlights
77 Elektronikas DocUReader 2 and DocuReader 2 Pro
ACON Laboratories Mission Products
Arkrays Products
PocketChem UA
AUTION ELEVEN
DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips
Roches Products
Urisys 1100 Urine Analyser
Chemstrip Criterion II Analyzer
Chemstrips/Combur-Test Strips
Siemens Products
Clinitek Status+
Clinitek Status Connect
Multistix10 SG Reagent Strips
RAPIDComm Data Management and Connectivity Solution
Microalbumin Testing
Axis-Shields Afinion ACR Test
Biomericas Fortel Microalbumin Screening-OTC Test
Orion Diagnosticas QuikRead U-ALB
Quest Diagnostics HemoCue Albumin 201 System
Sekisui Diagnostics OSOM ImmunoDip Urinary Albumin Test
Siemens Clinitek Microalbumin Strips
OTHER PRODUCTS
Alere Heart Check System for Heart Failure Monitoring
Liver Function Testing
Exalenz Biosciences BreathID System
BreathID Methacetin Breath Test
Infopias Pioneer POCT Liver Test Sensor
Thyroid Tests
Jant Pharmacals Accutest TSH
Screening Devices Canadas ThyroChek
Ani Biotechs Biocard Coeliac Tests
Rapid Pathogen Screenings InflammaDry
Products in Development
Akers Biosciences BreathPulmo Health Check and Breath Asthma Check
POC Breath Asthma Check
EMERGING TECHNOLOGIES
Applied Nanodetectors Sensor Array Platform
Ativa Medicals POC System
Bio-AMDs MPR
Biosensias RapiPlex
Cepheids GeneXpert
MagnaBioSciences MICT On-Site System
Molecular Vision
MycroLab
OPKO Healths OPKO Diagnostics Platform
pes diagnosesysteme respons IQ
Philips Minicare
Radisens Diagnostics POC Platform
T2 Biosystems T2Dx System
T2Hemostasis Assay
Tyrian Diagnostics DiagnostIQ
MANUFACTURERS
COMPANY DIRECTORY
SELECTED COMPANY PROFILES
Abaxis
Piccolo xpress
Financial Performance
Abaxis Operating Results, 2007-2012 (US$ million)
Latest Results
Akers Biosciences
Recent Key Events
Current Products
PIFA Heparin/PF4 and PIFA PLUSS Rapid Assays
Tri-Cholesterol Check
Research and Development
BreathPulmo Health Check
POC Breath Asthma Check
Current Alliances and Distribution Agreements
PULSE Health
Al Tadawi Medical Equip/PharmaNova Medical Equipment
Fisher HealthCare
US Government Service Administration Schedule Contract
Financial Performance
Akers Biosciences Operating Results, 2007-2011 (US$ thousands)
Fig 15: Percentage of Akers Revenue by Product Type, 2011
Alere
Recent Key Events
POC Cardiology Diagnostic Products
Alere Heart Check System
Cholestech LDX
INRatio2 System
Axis-Shield POC Products
Afinion POC System
NycoCard
Coagulation Products
POC Oncology Products
POC Infectious Disease Tests
POC Mergers & Acquisitions
Axis-Shield
Medical Automation Systems
Standard Diagnostics
Assets from Unotech Diagnostics
Mologic, Jinsung Meditech, Biolinker and Long Chain International Corp
Zycare, Medim and Biosyn
ACON Laboratories Rapid Diagnostics Assets
Matria Healthcare
BBI Holdings
Other Acquisitions
Agreements
EKF Diagnostics
Spartan Bioscience
Financial Performance
Alere - Operating Results, 2007-2011 (US$ million)
Fig 16: Percentage of Aleres Revenue by Segment, 2011
Fig 17: Percentage of Aleres Revenue by Region, 2011
Alere Professional Diagnostics: Operating Results, 2007-2011 (US$ million)
Alere Professional Diagnostics: Net Sales & Services Revenue, 2007-2011 (US$ million)
Fig 18: Alere Professional Diagnostics: Net Sales & Services Revenue by Product, 2011
Latest Results
Axis Shield - Financial Performance
Fig 19: Axis-Shield Revenue by Business Unit, 2010
Fig 20: 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 21: Axis-Shield POC Sales by Product, 2010
Fig 22: Axis-Shield Afinion Sales by Region, 2010
Arkray
Recent Key Events
POC Testing Products
SpotChem EZ Dry Chemistry Analyser
SpotChem D-Concept
SpotChem CL SB-1440 Automatic Blood Cell Counter
PocketChem BA Blood Ammonia Meters
Urinalysis
Current Alliances
ELITech Group
Beckman Coulter (Danaher)
POC Products
Hemoccult Tests
Gastroccult
International Technidyne Corporation
Products
ProTime Coagulation Systems
Hemochron Whole Blood Coagulation System
Current Alliances
Roche
Financial Performance
International Technidyne Operating Results, 2004-2009 (US$ million)
Fig 23: International Technidyne Revenue, 2000-2010 (US$ million)
Orion Diagnostica
QuikRead 101 System
QuikRead go
Uricult Dipslide Tests
Rotaviral and Adenoviral Enteritis Tests
Financial Performance
Orion Diagnostica - Operating Results, 2007-2011 (EUR million)
Meridian Bioscience
TRU FLU and TRU RSV
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, 2008-2012 (US$ million)
Meridian Bioscience - Third-Party Sales by Segment, 2008-2012 (US$ million)
Meridian Bioscience - Operating Income by Segment, 2008-2012 (US$ million)
Fig 24: Meridian Bioscience - Revenue by Segment, 2012
Meridian Bioscience - European Diagnostics Sales by Country, 2006-2011 (US$ million)
Outlook
Quest Diagnostics
HemoCue Products
Haemoglobin Systems
HemoCue Albumin 201 System
HemoCue White Blood Cell Analyzer
HemoCue WBC DIFF
HemoCue Basic Data Management and Connectivity Software
Enterix Products
InSure Quik F I T Fecal Immunochemical Test
Litigation with EKF Diagnostics
Financial Performance
Quest Diagnostics - Operating Results, 2007-2011 (US$ million)
Quest Diagnostics - Sales and Earnings by Category, 2007-2011 (US$ million)
Fig 25: Quest Diagnostics - Revenue by Division, 2011
Latest Results and Outlook
Quidel
Recent Key Events
Sofia Analyzer and the Sofia Influenza A+B Fluorescent Immunoassay
QuickVue Rapid Tests
QuickVue Influenza Tests
QuickVue Group A Strep Tests
QuickVue RSV Tests
QuickVue+ Infectious Mononucleosis
QuickVue iFOB
QuickVue H Pylori gII Test
Financial Performance
Quidel - Operating Results, 2007-2011 (US$ million)
Quidel - Revenue by Product Type, 2008-2011 (US$ million)
Fig 26: Quidel - Revenue by Product Type, 2011
Fig 27: Quidel - Infectious Disease Revenue, 2005-2011 (US$ million)
Quidel - Revenue by Region, 2005-2011 (US$ million)
Fig 28: Quidel - Revenue by Region, 2011
Latest Results
Roche Diagnostics
Recent Key Events
CoaguChek Systems
CoaguChek XS Pro
CoaguChek XS Plus
CoaguChek XS
CoaguChek Link
Urinalysis
Urisys 1100 Urine Analyser
Chemstrip Criterion II Analyzer
Chemstrips/Combur-Test Strips
Current Alliances and Contracts
Panasonic Healthcare
Voluntis
Financial Performance
Roche Diagnostics Operating Results, 2010-2011 (SFr million)
Fig 29: Roche Diagnostics - Revenue by Product Line, 2011
Fig 30: Roche Professional Diagnostics - Revenue by Region, 2011
Latest Results
Sekisui Diagnostics
Point of Care Tests
OSOM RSV/Adenovirus Rapid Test
OSOM Influenza A & B Test
OSOM H pylori
OSOM Ultra Strep A
OSOM Strep A
OSOM Mono
OSOM Trichomonas Rapid Test
OSOM BVBLUE Test
OSOM ImmunoDip Urinary Albumin Test
OSOM Pregnancy Tests
Siemens Healthcare
Products
Diabetes Testing - DCA Vantage Analyser
Urinlysis Products
RAPIDComm Data Management and Connectivity Solution
Current Alliances and Supply Contracts
Universal Biosensors
Premier
Roche
Financial Performance
Latest Results
Thermo Fisher Scientific
Sure-Vue Tests
Remels Xpect Tests
APPENDICES
APPENDIX 1 - LIST OF ABBREVIATIONS
APPENDIX 2 - REPORT METHODOLOGY
Sources
Market forecasts
