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

• Publication date: February 2013
• Report size: 174 pages

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 diagno...

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.

In Vitro Diagnostic Industry in the United States

Contents

EXECUTIVE SUMMARY .1
INTRODUCTION 2
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
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
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
COMPETITIVE LANDSCAPE .11
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
GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES .15
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
MARKET OUTLOOK 19
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
PRODUCTS AND TECHNOLOGIES 21
POC RESPIRATORY DISEASE DIAGNOSTICS .21
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
OTHER PRIMARY CARE POC TESTS 36
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
POC HIV TESTING 42
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
Chembio’s SURE CHECK HIV OTC 58
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
POC HEPATITIS TESTS .61
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
COMBINATION POC TESTS .70
TB and HIV 70
MedMira’s Multiplo Rapid Tests .70

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