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

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SOURCE Reportlinker

NEW YORK, March 28, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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

http://www.reportlinker.com/p01081137/Physician-based-Point-of-Care-Diagnostics-Products-Players-and-Outlook-to-2017 .html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

The market for Point-of-Care (POC) diagnostic products used in the physician's surgery was worth approximately US$1.7 billion in 2011 with sectors such as cholesterol testing and tumour markers making the best continued growth in the year. All sectors will see sustained growth over the medium term, with the total addressable market for products that can be potentially used in a physician's office forging ahead to be valued at over US$6.1 billion by 2017.

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

The benefits for clinicians, patients and health payers are clear. Physician-based testing provides rapid POC diagnosis and faster medical intervention. Healthcare providers are looking for new ways of improving patient outcomes, which in turn reduces the need for more expensive patient care, medications and hospital stays, as well as reducing costs and managing a larger number of patients without increasing staffing levels or numbers of hospital beds.

Challenges remain...

There are several key challenges in the market. Currently, many physicians' offices do not have budgets for in-house diagnostic testing and healthcare funding needs to change in order to provide incentives for doctors to use the products. For this to happen, healthcare providers need evidence that POC diagnostics provide benefits in terms of clinical-usefulness, convenience and cost in order to adopt them. In addition, concerns have also been raised about the accuracy of some POC tests used to diagnose conditions such as influenza. For infectious disease testing, the ongoing development of POC PCR and DNA-based systems is expected to improve on currently-available products. These devices could represent a significant market opportunity for manufacturers, should they be able to reduce the testing time and price point of the products to something suitable for and attractive to physicians. This new January 2013 report delivers a complete analysis

This new 178-page highly-detailed report Physician-based Point-of-Care Diagnostics: Products, Players and Outlook to 2017 provides executives with a complete understanding of the issues which are shaping the market and how they will affect its commercial and clinical development. This is Volume 3 of a 4-Volume study of the whole POC IVD sector to be published late 2012/early 2013. Contents

MARKET OVERVIEW 1

EXECUTIVE SUMMARY .1

INTRODUCTION 2

Physician's Office POC Testing .2

The Role of POC Testing in a Physician's Office 3

Regulatory and Reimbursement Environment 4

CLIA Waiver 4

CURRENT MARKET DYNAMICS 6

Fig.1: POC Diagnostics in Relation to the IVD Market, 2011 6

Fig.2: Percentage of POC Diagnostics Market by Product, 2011 7

Regional Perspective 7

Fig.3: Professional POC Diagnostics Market by Region, 2011 8

Physician's Office POC Testing Market 8

Addressable Markets for Physician's Office POC Testing, 2007-2011 (US$ million) 10

Fig.4: Addressable Markets for Physician's Office POC Testing, 2011 10

Fig.5: Physician's Office POC Testing Market, 2011 .11

GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES .12

POC Diagnostics and the Economy 12

The Burden of Chronic Disease and Preventative Medicine .12

Clinical Utility and Accuracy 14

POC Diagnostics as a Disruptive Technology 14

Emerging Technologies 15

Summary: Market Drivers, Restraints and Opportunities 16

COMPETITIVE LANDSCAPE .17

Market Leaders for Physician's Office POC Testing Products 17

Select POC Diagnostics Companies' Sales, 2007-2011 (US$ million) 17

Merger and Acquisition Activity .17

Key POC Diagnostics Mergers and Acquisitions, 2008-2011 18

FUTURE MARKET PROSPECTS 20

Addressable Markets for Physician's Office POC Testing, 2011-2017E (US$ million) 21

Growth in the Addressable Markets for Physician's Office POC Testing, 2008-2017E (%) .21

Physician's Office POC Testing Market, 2011-2012E (US$ million) .21

Fig.6: Physician's Office POC Testing Market, 2012(E) 22

PHYSICIAN'S OFFICE POC PRODUCTS AND TECHNOLOGIES .23

POC HBA1C TESTING 23

Diabetes Prevalence and Burden to the Healthcare System 23

Fig.7: Diabetes Prevalence by Geographic Region, 2011-2030 23

Diabetes Prevalence for the Top 10 Countries, 2011-2030 (million) .24

Diabetes Management and the Role of HbA1c Testing 25

POC HbA1c Testing Market .27

Fig.8: Global POC HbA1c Testing Market, 2007-2017E (US$ million) 27

POC HbA1c Products 27

ApexBio's A1C Express 27

Alere/Axis-Shield's Afinion HbA1c and NycoCard HbA1c Tests 27

Bayer's A1CNow Products .28

Bio-Rad's in2it A1C Analyser 28

DiaSys Diagnostic Systems' InnovaStar 28

Ceragem Medisys' HbA1c Analysers .29

EKF Diagnostics' Quo-Lab, Quo-Test and Biosen HbA1c Analysers 29

Infopia's Easy/Clover A1c 29

Siemens' DCA Vantage Analyser 29

Tosoh Bioscience's G8 HPLC Analyzer 30

In Development 30

POC CHOLESTEROL TESTING 32

Cholesterol Testing and Preventative Medicine .32

POC Cholesterol Testing Market Dynamics 33

Fig.9: Global POC Cholesterol Testing Market, 2007-2017E (US$ million) .34

Fig:10: POC Cholesterol Testing Market by End User, 2011 .34

Available Products .35

Alere's Cholestech LDX System 35

Akers Biosciences' Tri-Cholesterol Check 35

Chematics' Chemcard Cholesterol Test 35

General Life Biotechnology's BeneCheck LipidEx ST 35

Infopia's Lipid Pro 36

Jant Pharmacal's LipidPlus Lipid Profile and Glucose Test System .36

Miraculins' PreVu Point of Care Skin Sterol Test .36

Distribution Agreements .37

Polymer Technology Systems' CardioChek PA .37

Roche's Accutrend Plus 38

Syntron Bioresearch's Venture Total Cholesterol Test 38

Products in Development 38

Roche and Panasonic Healthcare 38

POC COAGULATION TESTING 39

POC Coagulation Testing Market Dynamics 39

Fig.11: Global POC Coagulation Market, 2007-2017E (US$ million) 40

The Impact of New-Generation Anticoagulants 40

Patient Self-Testing and Issues for Doctors .41

CoaguSense's CoaguSense PT/INR Monitoring System .43

Alere's INRatio2 System .43

International Technidyne Corporation's ProTime Microcoagulation System .43

Roche's CoaguChek XS 43

Professional Use Products . 44

Alere's Axis-Shield Products .44

Helena Laboratories' Cascade POC System 44

Instrumentation Laboratory's GEM PCL Plus 45

Roche's CoaguChek Systems 45

CoaguChek XS Pro .45

CoaguChek XS Plus 45

CoaguChek XS .45

CoaguChek Link 45

Products in Development . 46

Bio-AMD's COAG 46

Siemens/Universal Biosensors' POC Coagulation Tests .46

POC CLINICAL CHEMISTRY AND HAEMATOLOGY PRODUCTS .47

Multi-Functional POC Clinical Chemistry Analysers 47

Handheld POC Analysers Suitable for Use by Physicians 47

Abaxis' Piccolo xpress 47

Abbott's i-STAT System 48

Alere/Axis-Shield's Afinion POC System 49

Alere/Axis-Shield's NycoCard System .49

Benchtop Systems Suitable for Physician's Laboratories .50

Alfa Wassermann's ACE Clinical Chemistry Systems .50

Arkray's SpotChem Systems .50

SpotChem Test Strips 51

Audit Diagnostics' Liqui-Stat System .51

DiaSys Diagnostic Systems' InnovaStar .51

Horiba's ABX Pentra Clinical Chemistry Analysers 52

Ortho-Clinical Diagnostics' VITROS DT60 II Chemistry System 52

Qualigen's FastPack IP System 52

Samsung's LABGEO Clinical Chemistry Analysers 52

Tosoh Bioscience's AIA Immunoassay Analysers .52

POC Haematology and Haemoglobin Analysers 53

POC Haemoglobin Systems 53

POC Analyser Accuracy .53

ACON Laboratories' Mission Hb Hemoglobin Testing Systems 54

ApexBio's HemoSmart Haemoglobin Screening System .54

Audit Diagnostics' Hb-Stat .54

Ceragem Medisys' CERA-CHEK Hb Plus .54

EKF Diagnostics' Products 54

General Life Biotechnology's BeneCheck Hb Hemoglobin Test System .55

OrSense's Glasswing and NBM 200 Systems 55

Quest Diagnostics' HemoCue Haemoglobin Systems 56

URIT Medical's URIT-12 Hemoglobin Meter 57

POC C-REACTIVE PROTEIN DIAGNOSTICS 58

Abaxis' MetLyte Plus CRP and BioChemistry Panel Plus .58

Alere/Axis-Shield 59

bioMérieux bioNexia CRP Test .59

LifeAssays' CRP 59

Medix Biochemica's Actim CRP 59

Orion Diagnostica's QuikRead and QuikRead go Systems 59

POC PHYSICIAN'S OFFICE INFECTIOUS DISEASE TESTS 60

Current Market Dynamics 61

Fig.12: Market for POC Infectious Disease Tests used in a Physician's Office, 2007-2017E (US$ million) 61

POC Influenza Testing 61

Performance and Use of Rapid Influenza Tests in the US .62

CDC Recommendations 62

CDC: Influenza Prevalence and Test Accuracy 63

POC Influenza Testing Market .63

Future Prospects .64

CLIA-Waived Flu Detection Products 64

Alere's Influenza Tests 64

Becton Dickinson's BD Veritor System 64

Quidel's Sofia Analyzer and Sofia Influenza A+B Fluorescent Immunoassays .65

Quidel's QuickVue Influenza Tests 65

SA Scientific's SAS FluAlert .65

Other POC Flu Detection Products 65

bioMérieux' bioNexia Influenza A+B Tests 66

IQuum's Liat Influenza A/B Assay and the Liat Analyzer .66

Jant Pharmacal's Accutest Flu Test 67

Medix Biochemica's Actim Influenza A&B .67

Meridian Bioscience's TRU FLU .67

Mizuho Medy's Quick Chaser Flu A,B 67

OraSure Technologies' OraSure QuickFlu Rapid Flu A+B Test 67

Princeton BioMeditech's BioSign Flu A+B 67

Response Biomedical's Influenza A+B Test 68

Sekisui Diagnostics' OSOM Influenza A & B Test 68

Products in Development 68

Chembio's DPP Influenza Tests .68

Cepheid's GeneXpert .69

Lucigen's Nucleic Acid-Based POC Test .69

Respiratory Syncytial Virus 69

Quidel's Sofia RSV Fluorescent Immunoassay 70

Quidel's QuickVue RSV 10 71

Response Biomedical's RSV Test .71

Other Respiratory Tests 71

Ani Biotech's Biocard Chlamydia Pneumoniae IgM Test .71

GenBio's ImmunoFLOW Mycoplasma IgM Test 72

Group A Streptococcus Tests .72

Currently-Available POC Strep A Tests .73

Quidel's Sofia Strep A Fluorescent Immunoassay 73

H. pylori Tests 74

Currently-Available H. pylori Tests 74

Exalenz Bioscience's BreathID System 75

Otsuka America Pharmaceutical's BreathTek UBT .75

Mononucleosis Tests .76

Currently-Available POC Mono Tests 76

Rotavirus and Adenoviral Enteritis Tests 76

Ani Biotech's Biocard Tests .76

Meridian Bioscience ImmunoCard STAT! Rotavirus .77

Nicox/Rapid Pathogen Screening's AdenoPlus .77

Orion Diagnostica's Diarlex, Rotalex and Adenolex Tests 77

Women's Heath Diagnostics 77

Ani Biotech's Biocard Candida and Trichomonas Tests 77

Gryphus Diagnostics' BVBLUE 77

Quidel's QuickView Chlamydia Test 78

RunBio Biotech's Tests .78

Savyon Diagnostics' SavvyCheck 78

POC TUMOUR MARKER TESTING 79

Fig.13: Global POC Tumour Markers Market, 2007-2017E (US$ million) 79

Prostate Specific Antigen Tests 80

Available Tests 81

Mediwatch's PSAwatch 81

OPKO Health's OPKO Diagnostics Platform 82

Occult Blood Testing .82

ACON Laboratories' Mission FOB Reagent Strips .83

Aerscher Diagnostics' HemaPrompt 83

Alere's Tests .83

Beckman Coulter's Hemoccult Tests 83

Biomerica's EZ Detect 83

bioMérieux' bioNexia FOBplus 84

Helena Laboratories' ColoCare 84

Immunostics' Hema-Screen .84

Orion Diagnostica's QuikRead System and Orion Q-flow FOB 84

Princeton BioMeditech's BioSign iFOBTest 84

Quest Diagnostics' InSure Quik F I T 85

Quidel's QuickVue iFOB .85

Other Available FOB Tests .86

Gastric Occult Blood Tests 86

CEA Testing .87

Alpha Fetoprotein Testing 87

Bladder Cancer Testing 87

Alere's Matritech NMP22 BladderChek Test .88

bioMérieux' bioNexia BTA .88

Mediwatch's Bladderwatch BTA Test 88

Novel Products in Development .88

Bioscience Ventures/ Serascience's POC Myeloma Test .88

Guided Therapeutics' Non-Invasive Cancer Diagnostic Products 88

LuViva Advanced Cervical Scan 88

Oesophageal and Other Cancer Detection .89

Infopia's Cancer Diagnosing Sensor 90

POC URINALYSIS TESTING 91

Fig.9: Global POC Urinalysis Market, 2007-2017E (US$ million) 92

Key Urine Analysis Test Strips .92

Product Highlights .92

77 Elektronika's DocUReader 2 and DocuReader 2 Pro 92

ACON Laboratories' Mission Products .93

Arkray's Products 93

PocketChem UA 93

AUTION ELEVEN 93

DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips .93

Roche's Products .93

Urisys 1100 Urine Analyser .93

Chemstrip Criterion II Analyzer .94

Chemstrips/Combur-Test Strips 94

Siemens' Products 94

Clinitek Status+ 94

Clinitek Status Connect 94

Multistix10 SG Reagent Strips 94

RAPIDComm Data Management and Connectivity Solution .95

Microalbumin Testing 95

Axis-Shield's Afinion ACR Test .95

Biomerica's Fortel Microalbumin Screening-OTC Test 96

Orion Diagnostica's QuikRead U-ALB .96

Quest Diagnostics' HemoCue Albumin 201 System 96

Sekisui Diagnostics' OSOM ImmunoDip Urinary Albumin Test .96

Siemens' Clinitek Microalbumin Strips .96

OTHER PRODUCTS .97

Alere Heart Check System for Heart Failure Monitoring 97

Liver Function Testing 97

Exalenz Bioscience's BreathID System 97

BreathID Methacetin Breath Test .98

Infopia's Pioneer POCT Liver Test Sensor 98

Thyroid Tests .98

Jant Pharmacal's Accutest TSH .98

Screening Devices Canada's ThyroChek .98

Ani Biotech's Biocard Coeliac Tests 99

Rapid Pathogen Screening's InflammaDry 99

Products in Development 100

Akers Biosciences' BreathPulmo Health Check and Breath Asthma Check 100

POC Breath Asthma Check 100

EMERGING TECHNOLOGIES .101

Applied Nanodetectors' Sensor Array Platform 101

Ativa Medical's POC System .101

Bio-AMD's MPR .102

Biosensia's RapiPlex 102

Cepheid's GeneXpert .103

MagnaBioSciences' MICT On-Site System 104

Molecular Vision 104

MycroLab 105

OPKO Health's OPKO Diagnostics Platform 106

pes diagnosesysteme' respons IQ 106

Philips' Minicare 107

Radisens Diagnostics' POC Platform 108

T2 Biosystems' T2Dx System 108

T2Hemostasis Assay 109

Tyrian Diagnostics' DiagnostIQ 110

MANUFACTURERS 111

COMPANY DIRECTORY 111

SELECTED COMPANY PROFILES .117

Abaxis 117

Piccolo xpress 117

Financial Performance 118

Abaxis Operating Results, 2007-2012 (US$ million) 118

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