Infectious Diseases Point of Care Diagnostics - Products, Players and Outlook to 2017

Mar 28, 2013, 14:05 ET from Reportlinker

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

Infectious Diseases Point of Care Diagnostics - Products, Players and Outlook to 2017

With the variable impact of influenza testing and much product innovation, POC diagnostics for infectious diseases is a wide area of high-growth opportunities

The market for Point-of-Care (POC) diagnostic products used in infectious diseases is expected to exceed US$1.8 billion by 2017, with year-on-year double digit growth from 2013 onwards. But there is a twist...

One of the largest segments within POC infectious disease diagnostics is influenza testing (US$180 million in 2011) and the overall value of the sector is influenced by the demand for tests during the critical influenza season. For example, the market rose rapidly in 2009 as a result of increased demand brought about by the pandemic H1N1 virus, declined in 2010 when there was a weak influenza season and rose again in 2011 when rates of influenza were higher. The fragmented nature of the sector, along with variable factors such as the level of influenza testing, means any assessment of the market requires a detailed appreciation of the products and players driving growth.

Competitive landscape: plenty of room for expansion?

There are 80+ companies active in the POC infectious disease sector. Alere, with 2012 revenues of US$2.4 billion of which US$565 million were due to infectious disease tests, is clearly the market leader, providing tests across all major product sectors. Alere's success has been built, in part, due to an aggressive acquisition strategy. Could that route be taken by others?

Consolidation through mergers and acquisitions is likely to continue in the POC diagnostics market in the future, while some development-stage companies are likely to fail. In light of the current economic situation, there remain good opportunities for companies with cash or financing available to them to add to their POC operations, both through acquisitions and by licensing technologies from companies that cannot afford to commercialise them themselves.

Wide applications in different geographical settings

The market for POC infectious disease testing can be broadly divided into testing in the developed world, and testing in emerging and developing countries. In the developed world, POC testing is most frequently conducted in professional healthcare settings, where it facilitates faster diagnosis and treatment than lab-based testing. Demand in the developed world varies significantly, with the US a strong adopter of the technology and Japan also frequently using POC influenza testing products. However, testing in Europe continues to be conducted mainly in central labs and the POC market is underpenetrated, hence an area of good opportunity.

POC can also have a big impact in emerging markets. With access to central lab testing often being sparse or non-existent, particularly in remote areas, POC testing can determine diagnosis at the point of need and is playing a key role in reducing the prevalence of diseases such as HIV and Malaria.



The Role Of POC Testing in Infectious Disease Diagnostics and Surveillance 2

POC Infectious Disease Testing Products 3

Customers of POC Infectious Disease Tests 3

Regulatory and Reimbursement Environment .4

CLIA Waiver 4


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

POC Infectious Disease Testing Market .8

Fig.4: POC Infectious Disease Testing Market, 2007-2011 (US$ million) 9

Fig:5: POC Infectious Disease Testing Market by Product Type, 2011 (%) 10


Select POC Diagnostics Companies' Sales, 2007-2011 (US$ million) .11

POC Infectious Disease Competitors .11

Market Leaders for POC Infectious Disease Testing Products 12

Select Companies' Infectious Disease Testing Sales, 2008-2011 (US$ million) .12

Fig:6: POC Infectious Disease Testing Market Shares by Competitor, 2011 (%) .12

Merger and Acquisition Activity 12

Key POC Infectious Disease Testing Mergers and Acquisitions, 2008-2012 .13


Clinical Utility and Accuracy .15

Expanded Access to Screening in the US .16

POC Diagnostics as a Disruptive Technology .16

Future Technology: Next-Generation POC Diagnostic Products .17

Detecting Hospital-Acquired Infections .17

Summary: Market Drivers, Restraints and Opportunities 18


Fig.7: POC Infectious Disease Testing Market, 2011-2017E (US$ million) 20

Fig.8: POC Infectious Disease Testing Market Growth Rates, 2008-2017E (US$ million) 20



POC Influenza Testing .21

Performance and Use of Rapid Influenza Tests in the US .21

CDC Recommendations .22

CDC: Influenza Prevalence and Test Accuracy .22

POC Influenza Testing Market .22

Future Prospects 23

CLIA-Waived Flu Detection Products .24

Alere's Influenza Tests 24

Alverix/Becton Dickinson's BD Veritor System 24

Quidel's Sofia Analyzer and Sofia Influenza A+B Fluorescent Immunoassays 25

Quidel's QuickVue Influenza Tests .25

SA Scientific's SAS FluAlert 25

Other POC Flu Detection Products .25

bioMérieux' bioNexia Influenza A+B Tests .26

IQuum's Liat Influenza A/B Assay and the Liat Analyzer 26

Jant Pharmacal's Accutest Flu Test 27

Medix Biochemica's Actim Influenza A&B .27

Meridian Bioscience's TRU FLU .27

Mizuho Medy's Quick Chaser Flu A,B 27

OraSure Technologies' OraSure QuickFlu Rapid Flu A+B Test 27

Princeton BioMeditech's BioSign Flu A+B .27

Response Biomedical's Influenza A+B Test 28

Sekisui Diagnostics' OSOM Influenza A & B Test .28

Products in Development .28

Alere's iNAT System .28

Chembio's DPP Influenza Tests .28

Cepheid's GeneXpert .29

Enigma Diagnostics .29

Enigma ML (Mini Laboratory) 30

Lucigen's Nucleic Acid-Based POC Test 31

Respiratory Syncytial Virus Testing .31

Alverix/BD's BD Veritor System .32

Quidel's Sofia RSV Fluorescent Immunoassay .32

Quidel's QuickVue RSV 10 33

Response Biomedical's RSV Test .33

BioFire Diagnostics' FilmArray System 33

FilmArray Respiratory Panel .34

Other Respiratory Tests 34

Ani Biotech's Biocard Chlamydia Pneumoniae IgM Test 34

GenBio's ImmunoFLOW Mycoplasma IgM Test 34

Trinity Biotech's Uni-Gold Tests 35


Group A Streptococcus Tests 36

Currently Available POC Tests 36

Quidel's Sofia Strep A Fluorescent Immunoassay .37

H. pylori Tests .37

Currently Available H. pylori Tests .38

Exalenz Bioscience's BreathID System .38

Otsuka America Pharmaceutical's BreathTek UBT .39

Mononucleosis Tests .39

Currently Available POC Tests 39

Rotavirus and Adenoviral Enteritis Tests 40

Ani Biotech's Biocard Tests .40

Meridian Bioscience ImmunoCard STAT! Rotavirus 40

Nicox/Rapid Pathogen Screening's AdenoPlus .40

Orion Diagnostica's Diarlex, Rotalex and Adenolex Tests .40

Other Products 41

Ani Biotech's Biocard Candida and Trichomonas Tests .41

Gryphus Diagnostics' BVBLUE 41

Medix Biochemica's Actim Noro 41


Fig.9: HIV Prevalence, 2001-2011 (millions) 42

Fig.10: HIV Prevalence by Region, 2011 43

Fig.11: Number of New HIV Infections, 2001-2011 (million) 43

Fig.12: New HIV Infections by Region, 2011 44

Efforts to Combat HIV 44

Screening in the US 44

The Role of POC Testing 45

Market Dynamics 46

Fig:13: Global POC HIV Testing Market Shares by Company, 2011 .47

Fig:14: US POC HIV Testing Market Shares by Company, 2011 47

Rapid HIV Tests . 48

Currently Available POC Tests 48

CLIA-Waived Tests 49

bioLytical Laboratories' INSTI Rapid HIV-1 Antibody Test 49

Chembio Diagnostics' Lateral Flow HIV Tests .49

Fig.15: Chembio: HIV Lateral Flow Test Sales, 2008-2011 (US$ thousands) .50

OraSure Technologies' OraQuick Rapid Test Platform 50

OraSure's POC HIV Testing Sales, 2010-2011 (US$ thousands) .50

Fig.16: OraSure's OraQuick HIV Revenue by Region, 2011 51

Trinity Biotech's POC HIV Tests 51

Non-CLIA-Waived Tests 52

Alere's SD, Determine and Clearview HIV Tests 52

bioMérieux's VIKIA HIV 1/2 HIV Test .52

Bio-Rad's Multispot HIV-1/HIV-2 Rapid Test .52

Calypte Biomedical's Aware HIV-1/2 Tests 52

Fig.17: Calypte Biomedical: Aware Rapid HIV Test Sales, 2009-2011 (US$ thousands) 53

Chembio's Dual Path Platform Technology Products 53

FirstVue HIV Tests 54

Hema Diagnostic Systems 55

IND Diagnostic's One-Step Anti-HIV (1+2) Tests .55

Lab21's Biotec Tests .55

MedMira's Reveal HIV Tests 55

Savyon Diagnostics' HIVSav 1/2/0 Rapid SeroTest .56

Unimed's FirstSign HIV Duo 57

Products in Development 57

Alere's NAT Analyzer .57

Calypte Biomedical's Aware II (The Ani Platform) 57

Cepheid's GeneXpert System and Xpert HIV Viral Load Test 57


IQuum's Liat System 58

MedMira's Dual HIV Test .58

POC CD4 Testing 59

Alere's Pima Point-of-Care CD4 Analyser .59

In Development - Daktari Diagnostics' Daktari CD4 .59


Hepatitis B .61

Hepatitis C 61

HCV Screening in the US .62

POC HCV Testing 63

POC and Rapid HCV Tests: Sensitivity & Specificity .63

Available POC Tests 64

Key Rapid Tests .65

Alfa Scientific Designs' Instant-View Tests .65

bioMérieux's VIKIA HBs Ag Test 65

FirstVue's Hepatitis Rapid Test Kits .66

OraSure Technologies' OraQuick HCV Rapid Antibody Test .66

OraSure's POC HCV Testing Sales, 2010-2011 (US$ thousands) 66

Fig.18: OraQuick HCV Revenue by Region, 2011 .67

Runbio Biotech's One Step Tests .67

In Development .67

bioLytical Laboratories' INSTI Test 67

Chembio Diagnostics' DPP HCV Test 68

MedMira's Rapid Tests 68


TB and HIV 70

MedMira's Multiplo Rapid Tests .70

Multiplo HIV/HCV 70Multiplo HBV/HIV/HCV .71Multiplo TP/HIV 71Products in Development 71Chembio Diagnostics' DPP Syphilis/HIV Combination Test .71MedMira's Development Products 71POC TUBERCULOSIS TESTING .72Multidrug-Resistant TB .72TB and HIV 73POC TB Testing 73Cepheid's Xpert MTB/RIF 74Concessionary Pricing 75Alere's Determine TB LAM Ag Test 75Products In Development .76Alere/TwistDx's Recombinase Polymerase Amplification Technology .76Applied Nanodetectors and the London School of Hygiene & Tropical Medicine 76Chembio's DPP Tuberculosis Test .76Enigma Diagnostics' Enigma ML (Mini Laboratory) 77POC SEXUALLY-TRANSMITTED INFECTION TESTING 78STI Testing and the Role of POC Diagnostics 78POC STI Diagnostic Products 79Currently Available POC Tests 79Ani Biotech's Biocard Candida and Trichomonas Tests 80Focus Diagnostics' HerpeSelect Express HSV-2 80Gryphus Diagnostics' BVBLUE .80Hema Diagnostic Systems' Rapid 1-2-3 Hema Syphilis 80MedMira's Reveal TP Rapid Syphilis Test .80Quidel's QuickView Chlamydia Test .80RunBio Biotech's Tests 81Savyon Diagnostics' SavvyCheck .81Sekisui Diagnostics' OSOM Tests .81Trinity Biotech's Uni-Gold HSV-2 Rapid Test .81Products In Development .81Atlas Genetics' POC System 81bioLytical Laboratories' INSTI Test 82Chembio's DPP Syphilis Tests 82GenBio's ImmunoFLOW Herpes Simplex Virus Test .83Randox Laboratories' Lab-on-a-Chip 83POC TROPICAL DISEASE TESTS .85Common Tropical Diseases .85Malaria .85Dengue Fever .85Leptospirosis 86Visceral Leishmaniasis .86Typhoid .86POC Testing 87Currently Available POC Tests 88Alere's Standard Diagnostics Tests .88SD BIOLINE HAT .88Hema Diagnostic Systems' Malaria and Typhoid Tests 89Lab21's Tropical Disease Tests 89Quest Diagnostics' Focus Dengue Rapid Tests .89Products in Development .90Chembio's DPP Leptospirosis .90Chembio's DPP Visceral Leishmaniasis .90EMERGING TECHNOLOGIES .91POC Hospital-Acquired Infection Testing .91Available Products and Developments .93New-Generation POC Diagnostic Platform Technologies .93Alere's POC Molecular Diagnostics Technologies 93Ionian Technologies' Nicking Enzyme Amplification Reaction Technology 94TwistDx' Recombinase Polymerase Amplification Technology .94Atlas Genetics' POC System 94Atonomics' Atolyzer .95Bio-AMD's MPR and DSR .96BioFire Diagnostics' FilmArray System .97FilmArray Blood Culture ID Panel .97FilmArray GI Panel .97Biosensia's RapiPlex 98Cepheid's GeneXpert .98pes diagnosesysteme' respons IQ .99Enigma Diagnostics' Products .100Enigma ML (Mini Laboratory) 100ResonSense Technology .101Fiomi Diagnostics (Trinity Biotech) Forecast Technology 102Immunexpress' SeptiCyte Technology 102IQuum's Liat System .103Liat Assays .104Lucigen's Nucleic Acid-Based POC Tests 104MycroLab 105OPKO Health's OPKO Diagnostics Platform 106Philips' Minicare .106Radisens Diagnostics' POC Platform 107Randox Laboratories' Lab-on-a-Chip 107ReLIA Diagnostic Systems' ReLIA System 108Rheonix' EncompassMDx Platform 108T2 Biosystems' T2Dx System 108Infectious Diseases 109Tyrian Diagnostics' DiagnostIQ 110POC MANUFACTURERS .111POC COMPANY DIRECTORY 111SELECTED COMPANY PROFILES 115Alere 115Recent Key Events 116POC Infectious Disease Tests .116New Products 116Standard Diagnostics' Tests .117Research and Development 118Infectious Diease Mergers & Acquisitions 118Ionian Technologies 118TwistDx 118Standard Diagnostics .119Mologic, Jinsung Meditech, Biolinker and Long Chain International Corp .119ACON Laboratories' Rapid Diagnostics Assets .119Matria Healthcare 119BBI Holdings 119Other Acquisitions .120Contracts and Alliances .120OraSure Technologies .120Chembio 120Trinity Biotech .121Financial Performance .121Alere - Operating Results, 2007-2011 (US$ million) .121Fig.19: Percentage of Alere's Revenue by Segment, 2011 .122Fig.20: Percentage of Alere's Revenue by Region, 2011 .122Alere Professional Diagnostics: Operating Results, 2007-2011 (US$ million) 122Alere Professional Diagnostics: Net Sales & Services Revenue, 2007-2011 (US$ million) .123Fig.21: Alere Professional Diagnostics: Net Sales & Services Revenue by Product, 2011 .123Latest Results .123Calypte Biomedical .124Aware Rapid Test Product Line .124Aware HIV-1/2 OMT (Oral fluid) .125Aware HIV-1/2 Oral OTC 125Products in Development - Aware II (The Ani Platform) 125Current Alliances 125Manufacturing Contracts .126Financial Performance 126Calypte Biomedical: Operating Results, 2007-2011 (US$ thousands) 126Calypte Biomedical: Revenue by Product Line, 2009-2011 (US$ thousands) .127Fig.22: Calypte Biomedical: Percentage of Revenue by Product Line, 2011 127Latest Results 127Chembio Diagnostics 128Recent Key Events 129Lateral Flow Rapid HIV Tests 129Dual Path Platform Technology Products 130DPP HIV 1/2 Assay .130DPP HIV 1/2 Confirmatory Test .130Other Tests .131Research and Development .131SURE CHECK HIV OTC 131DPP Technology Products in Development 131Current Alliances and Contracts .133Battelle Memorial Institute 133Oswaldo Cruz Foundation of Brazil 133National Institutes of Health 134Alere 134Infectious Disease Research Institute .134Bio-Rad Laboratories 134Financial Performance .135Chembio - Operating Results, 2007-2011 (US$ thousands) .135Chembio - Revenue by Type, 2008-2011 (US$ thousand) 136Chembio - Product Sales by Region, 2010-2011 (US$ thousand) 136Fig.23: Percentage of Chembio's Revenue by Type, 2011 .136Fig.24: Percentage of Chembio's Product Sales by Region, 2011 137Latest Results 137MedMira 138Recent Key Events 139Rapid Tests 139Multiplo HIV/HCV 139Multiplo HBV/HIV/HCV 140Multiplo TP/HIV .140Reveal HIV Tests 140Reveal TP Rapid Syphilis Test 141Reveal/MedMira hp Test H. pylori Test 141R&D Activities .141Dual HIV Test .142Current Alliances 142United States Army .142Advance Aid .143Triplex International Biosciences 143VWR International 143Vitest .143Financial Performance 143MedMira - Operating Results, 2008-2012 (C$ thousands) 144MedMira - Revenue by Region, 2007-2012 (C$ thousands) .144Fig.25: MedMira - Revenue by Region, 2012 .145Latest Results 145Meridian Bioscience 146TRU FLU and TRU RSV 146ImmunoCard STAT! HpSA H. pylori Test .146ImmunoCard STAT! Rotavirus 146ImmunoCard STAT! Strep A 146ImmunoCard STAT! MONO .146ImmunoCard STAT! hCG Combo Test .147Financial Performance .147Meridian Bioscience - Operating Results, 2008-2012 (US$ million) .147Meridian Bioscience - Third-Party Sales by Segment, 2008-2012 (US$ million) .147Meridian Bioscience - Operating Income by Segment, 2008-2012 (US$ million) 147Fig.26: Meridian Bioscience - Revenue by Segment, 2012 .148Meridian Bioscience - European Diagnostics Sales by Country, 2006-2011 (US$ million) 148Outlook 148OraSure Technologies .149Recent Key Events 149OraQuick Rapid Test Platform 149OraSure's OraQuick ADVANCE HIV Test 149OraSure's OraQuick In-Home HIV Test 150OraQuick HCV Rapid Antibody Test .150OraSure QuickFlu Rapid Flu A+B Test .150Products in Development .150Current Alliances and Licensing Agreements .150Princeton BioMeditech .150Alere 151Merck .151Ortho-Clinical Diagnostics 151Financial Performance .151OraSure - Operating Results, 2007-2011 (US$ million) 152Fig.27: OraSure - Revenue by Business Area, 2011 .152OraSure Infectious Disease Testing Sales, 2010-2011 (US$ thousands) .153Fig.28: OraQuick HIV Revenue by Region, 2011 .153Fig.29: OraQuick HCV Revenue by Region, 2011 153Latest Results and Outlook .154Quest Diagnostics 155Focus Diagnostics' POC Products 155HerpeSelect Express HSV-2 .155Focus Dengue Rapid Tests 156Financial Performance 156Quest Diagnostics - Operating Results, 2007-2011 (US$ million) 157Quest Diagnostics - Sales and Earnings by Category, 2007-2011 (US$ million) 157Fig.30: Quest Diagnostics - Revenue by Division, 2011 157Latest Results and Outlook .157Quidel 159Recent Key Events 159Sofia Analyzer and the Sofia Influenza A+B Fluorescent Immunoassay .159QuickVue Rapid Tests 160QuickVue Influenza Tests 160QuickVue Group A Strep Tests .160QuickVue RSV Tests .160QuickVue+ Infectious Mononucleosis 161QuickVue H. Pylori gII Test 161Financial Performance .161Quidel - Operating Results, 2007-2011 (US$ million) .161Quidel - Revenue by Product Type, 2008-2011 (US$ million) .162Fig.31: Quidel - Revenue by Product Type, 2011 .162Fig.32: Quidel - Infectious Disease Revenue, 2005-2011 (US$ million) 162Quidel - Revenue by Region, 2005-2011 (US$ million) 163Fig.33: Quidel - Revenue by Region, 2011 .163Latest Results and Outlook .163Sekisui Diagnostics .164Point of Care Tests 164OSOM RSV/Adenovirus Rapid Test .164OSOM Influenza A & B Test .164OSOM H. pylori 164OSOM Ultra Strep A .164OSOM Strep A 165OSOM Mono 165OSOM Trichomonas Rapid Test .165OSOM BVBLUE Test 165OSOM C. difficile Toxin A/B Test 165Thermo Fisher Scientific .166Sure-Vue Tests .166Remel's Xpect Tests 167Trinity Biotech 168POC HIV Tests 168Uni-Gold Recombigen HIV 168Other POC Tests 169Uni-Gold Giardia Test 169Uni-Gold HSV-2 Rapid .169Uni-Gold Legionella Urinary Antigen PLUS .169Fiomi Diagnostics 169Alere Licence 170Financial Performance .170Trinity Biotech Operating Results, 2007-2011 (US$ million) 170Trinity Biotech - Sales by Product Line, 2006-2011 (US$ million) 171Fig.34: Trinity Biotech - Sales by Product Type, 2011 171Latest Results and Outlook .171APPENDICES .172APPENDIX 1 - LIST OF ABBREVIATIONS .172APPENDIX 2 - REPORT METHODOLOGY 173

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