Point of Care Testing: Evaluating the return to evidence based medicine, novel technologies and the competitive landscape

Date: January 22, 2010
Pages: 283
Price:
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF), Hard Copy Mail Delivery, CD-ROM Mail Delivery
ID: P25BAFFBCAEEN
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Point of Care Testing: Evaluating the return to evidence based medicine, novel technologies and the competitive landscape
Diagnostic practice is undergoing a quiet revolution, with IVD tests moving out of the centralized hospital laboratory to point of care testing (POCT) locations. POC tests are more expensive than lab-based tests, but promise to reduce the overall cost of healthcare while improving the quality of outcomes. They are thus attractive to manufacturers and increasingly in demand by physicians, patients, and healthcare providers.

This report explores the opportunities for POC testing provided by recent technology improvements, disease trends, and new marketing channels. It examines established and emerging health-related applications of POC diagnostics based on immunoassays, clinical chemistry, and nucleic acid testing. Within each POCT market sector, leading companies and their strategies and products are examined.

Key features of this report

  • Examines different types of POC testing technologies and information they provide in clinical situations.
  • Assesses current market satisfaction, areas of need and competition for POC testing in the areas of: diabetes; fertility; hemostasis; cardiology; infectious disease; drugs of abuse; automated urine/blood analysis; and cancer screening.
  • Surveys analytes/biomarkers incorporated in commercial POCT products on the market and in commercial development in all the major application areas.


  • Scope of this report

  • Understand the role of POC tests in diagnosis and monitoring in different clinical situations.
  • Gain an insight into how the market for POC tests is shaping up in each of the major application areas.
  • Identify competitors or potential collaborators developing improved or novel POC technologies and products.
  • Assess established and emerging marketing channels for POC tests.


  • Key Market Issues

  • In most countries, the average spending on IVDs is a very low percentage of the healthcare budget, but spending on POC IVDs which offer speed, convenience, and improved outcomes is set to grow at an increased rate.
  • Since 2006, wider adoption of POC testing in the US has been driven by the issuance of testing guidelines by the National Academy of Clinical Biochemistry; the US market now represents more than half of the global POC testing market.
  • Expanding medical and non-medical POC testing locations, which include fast-growing retail health clinics in the US, provide new marketing opportunities for manufacturers of POC tests.


  • Key findings from this report

  • The POC testing market is forecast to grow from $13.4 billion in 2008 to $22.5 billion in 2013. The POCT market currently represents 25% of the total IVD market.
  • There are many players in the POCT market and many diverse products. Examples of leading companies include Abbott Laboratories (glucose monitoring and blood analysis products), Inverness Medical Innovations (various consumer and professional products), Quidel (pregnancy and infectious disease products), and Cepheid (first POC molecular tests on the market).
  • 130 companies have had their POC products CLIA waived by the FDA in the 3 year period prior to November 2009. Amongst these companies were 53 companies with glucose monitoring products and 39 companies with pregnancy testing products.
  • Sales of glucose monitoring products accounted for 76% of the POCT market in 2008 and this sector is expected to remain the leading sector in 2013. However, POC testing for HbA1c is assuming increasing importance in diabetes.


  • Key questions answered

  • What are the applications for POCT technologies in healthcare?
  • Which are the prominent companies and products within each POCT market sector?
  • How are the key players making an impact on the POCT market?
  • Which POC tests have been CLIA waived in the last 3 years?


  • Point of Care Testing
    Executive summary 14
    Market overview 14
    POC testing in diabetes 15
    Fertility-related tests 16
    Hemostasis testing 17
    Cardiology tests 18
    Infectious disease tests 19
    Drugs of abuse testing 20
    Clinical chemistry and other rapid tests 21
    Company profiles 22
    Market analysis and forecasts 23

    CHAPTER 1 MARKET OVERVIEW

    Summary 26
    The shift to POC diagnostic testing 27
    Locations for POC testing 28
    Background on IVD technologies 28
    Clinical chemistry 28
    Immunoassays 29
    Nucleic acid testing 31
    Technologies for POC testing 33
    Lateral-flow tests 34
    Next-generation lateral-flow devices 37
    Electrochemical enzymatic tests 38
    Advances in microfluidics 39
    Data management and connectivity 40
    Market drivers 42
    Market restraints 44
    Regulation of in vitro diagnostic tests (US) 44
    CLIA 46

    CHAPTER 2 POC TESTING IN DIABETES

    Summary 50
    Diabetes diagnostics and monitoring 51
    Meter systems for blood glucose monitoring 54
    Increasing performance requirements 63
    Examples of POC device manufacturers 64
    Roche Diagnostics 64
    Arkray 65
    Home Diagnostics 65
    Abbott Diabetes Care 66
    Nova Biomedical 66
    Epocal 67
    Diagnostic Devices 67
    HemoCue 67
    Luminous Medical 68
    Health-Chem Diagnostics 68
    Continuous glucose monitoring systems 68
    Examples of POC device manufacturers 69
    DexCom 69
    Medtronic MiniMed 69
    Abbott Diabetes Care 70
    HbA1c testing 70
    Examples of POC device manufacturers 72
    Diazyme Laboratories 72
    HemoCue 72
    Bio-Rad Laboratories 73
    Siemens 73
    Trinity Biotech 74

    CHAPTER 3 FERTILITY-RELATED TESTS

    Summary 76
    Introduction 77
    Pregnancy (hCG) tests 77
    Detection of hCG variants 83
    Ovulation tests 84
    OTC pregnancy test kits 84
    Examples of manufacturers of pregnancy tests 85
    Inverness Medical Innovations 85
    Swiss Precision Diagnostics 87
    Church & Dwight 88
    Siemens Healthcare Diagnostics 88
    Applied DNA Technologies 89
    Quidel 89
    BTNX 89
    Germaine Laboratories 90
    Other fertility-related tests 90

    CHAPTER 4 HEMOSTASIS TESTING

    Summary 94
    Introduction 95
    Hemostasis modulation 96
    Use of anticoagulants 96
    Use of antiplatelets 97
    Hemostasis testing 98
    Coagulation testing 98
    Prothrombin time 98
    Activated partial thromboplastin time 100
    Activated coagulation time 101
    Guidelines on POC coagulation testing (US) 102
    Examples of manufacturers of POC tests 103
    Abbott Laboratories 103
    Axis-Shield 104
    Siemens 104
    Instrumentation Laboratory 105
    Haemoscope 105
    Helena Point of Care 106
    Inverness Medical Innovations 107
    International Technidyne 108
    Roche Diagnostics 108
    Akers Biosciences 109
    Platelet function tests 110
    POC testing 112
    Examples of manufacturers of POC tests 112
    Helena Point of Care 112
    Siemens Healthcare Diagnostics 112
    Accumetrics 113

    CHAPTER 5 CARDIOLOGY TESTS

    Summary 118
    Overview of cardiovascular disease 119
    Lipids associated with atherosclerosis 120
    Lipid management guidelines (US) 121
    Laboratory lipid profiling 122
    Mail-in fingerstick tests 123
    Point-of-care lipid tests 124
    Routine assay methods 126
    Examples of manufacturers of CLIA waived tests 127
    AccuTech 127
    Inverness Medical Innovations 128
    Polymer Technology Systems 129
    Abaxis 130
    Cardiac protein biomarker diagnostics 130
    Biomarkers of necrosis 131
    Biomarkers of hemodynamic stress 132
    Biomarker panels for risk stratification 133
    The need for POC testing 134
    Examples of manufacturers of POC tests 135
    Siemens 135
    Inverness Medical Innovations 136
    ELITech Group 137
    Roche Diagnostics 138
    Response Biomedical 139
    Abbott Point of Care 139

    CHAPTER 6 INFECTIOUS DISEASE TESTS

    Summary 142
    Introduction 143
    POC testing 143
    Rapid immunoassays 144
    Nucleic acid testing 148
    Sexually-transmitted diseases 150
    HIV 150
    Chlamydia 153
    HPV 154
    HSV-2 155
    Trichomonas vaginalis 155
    Gonorrhea 156
    Respiratory infections 156
    Influenza A and B 157
    Influenza A swine flu 161
    RSV 163
    Strep A 163
    Legionella 164
    M. tuberculosis 164
    Gastrointestinal infections 165
    H. pylori 165
    C. difficile 166
    Parasites 166
    Other infections/conditions 167
    Enteroviral meningitis 167
    Infectious mononucleosis 168
    Hepatitis C 168
    Strep B 169
    MRSA 170
    Sepsis 170
    Malaria 171
    Acute conjunctivitis 172
    Platelet-associated bacteria 172
    Periodontal disease 173
    Urine infection 173

    CHAPTER 7 DRUGS OF ABUSE TESTING

    Summary 176
    Introduction 177
    Point-of-care urine-based testing 177
    Commonly abused prescription drugs 178
    Opioids 178
    Central nervous system depressants 179
    Stimulants 180
    Psychoactive drugs 180
    Methadone 181
    Illicit drugs 181
    Methamphetamine 181
    Cocaine 182
    Heroin 183
    Phencyclidine 184
    Cannabinoids 184
    POC testing sites 185
    CLIA waived DOA rapid tests 186
    Examples of POC DOA test manufacturers 191
    Inverness Medical Innovations 191
    Nanogen 192
    Bio-Rad Laboratories 193
    Siemens Healthcare Diagnostics 193
    Instant Technologies 193
    NOVX Systems 194
    Detection of DOA in oral fluids 194

    CHAPTER 8 CLINICAL CHEMISTRY AND OTHER RAPID TESTS

    Summary 198
    Introduction 199
    Urinalysis reagent strips 199
    Automated urinalysis 202
    POC clinical chemistry analyzers 205
    Examples of manufacturers 208
    Abaxis 208
    Abbott Laboratories 209
    Arkray 210
    Cancer POC testing 210
    Colon cancer screening 211
    Bladder cancer screening 214
    Other products 214

    CHAPTER 9 COMPANY PROFILES

    Summary 218
    Abaxis Inc 219
    Company description 219
    POC technology/products 219
    Abbott Laboratories 220
    Company description 220
    POC technology/products 220
    Accumetrics 221
    Company description 222
    POC technology/products 222
    AccuTech LLC 222
    Company description 223
    POC technology/products 223
    Akers Biosciences Inc 223
    Company description 224
    POC technology/products 224
    American Bio Medica Corporation 224
    Company description 225
    POC technology/products 225
    AmniSure International LLC 225
    Company description 226
    POC technology/products 226
    Arkray USA Inc 226
    Company description 227
    POC technology/products 227
    Banyan Biomarkers Inc 228
    Company description 228
    POC technology/products 228
    BioHelix Corporation 228
    Company description 229
    POC technology/products 229
    Bio-Rad Laboratories Inc 230
    Company description 230
    POC technology/products 230
    BiOracle Ltd 231
    Company description 231
    POC technology/products 232
    Calypte Biomedical Corporation 232
    Company description 233
    POC technology/products 233
    Cepheid 233
    Company description 233
    POC technology/products 234
    Diazyme Laboratories 235
    Company description 235
    POC technology/products 235
    ELITech Group 236
    Company description 236
    POC technology/products 237
    Enigma Diagnostics Ltd 238
    Company description 238
    POC technology/products 238
    GeneEx Inc 239
    Company description 239
    POC technology/products 239
    Health-Chem Diagnostics LLC 239
    Company description 240
    POC technology/products 240
    Helena Laboratories Corporation 240
    Company description 241
    POC technology/products 241
    Home Diagnostics Inc. 242
    Company description 242
    POC technology/products 242
    International Technidyne Corporation 243
    Company description 243
    POC technology/products 243
    Inverness Medical Innovations Inc 244
    Company description 244
    POC technology/products 245
    Meso Scale Diagnostics LLC 246
    Company description 247
    POC technology/products 247
    Micronics 247
    Company description 248
    POC technology/products 248
    Molecular Vision Ltd 248
    Company description 249
    POC technology/products 249
    NOVX Systems Inc 249
    Company description 250
    POC technology/products 250
    OraSure Technologies Inc 251
    Company description 251
    POC technology/products 251
    Phadia AB 252
    Company description 252
    POC technology/products 252
    PointCare Technologies Inc 253
    Company description 253
    POC technology/products 254
    Polymer Technology Systems Inc 254
    Company description 254
    POC technology/products 255
    Princeton BioMeditech Corporation 255
    Company description 255
    POC technology/products 256
    Qualigen Inc 257
    Company description 257
    POC technology/products 257
    Quidel Corporation 257
    Company description 258
    POC technology/products 258
    Rapid Pathogen Screening Inc 259
    Company description 259
    POC technology/products 260
    Response Biomedical Corporation 260
    Company description 260
    POC technology/products 261
    Roche Diagnostics Corporation 261
    Company description 262
    POC technology/products 262
    Siemens Healthcare Diagnostics Inc 264
    Company description 264
    POC technology/products 264
    Trinity Biotech Plc 266
    Company description 266
    POC technology/products 266
    Verax Biomedical Inc 267
    Company description 267
    POC technology/products 267

    CHAPTER 10 MARKET ANALYSIS AND FORECASTS

    Summary 270
    Outlook for the POCT market 271
    Forecasts for individual POCT market sectors 273
    Glucose monitoring 273
    HbA1c testing 274
    Pregnancy/fertility testing 274
    Infectious disease testing 274
    Lipid profiling 275
    Cardiac marker testing 275
    Coagulation testing 276
    Drugs of abuse testing 276
    Automated urine/blood analysis 277
    Cancer screening 277
    Penetrating the healthcare system 277
    POCT in retail health clinics 278
    POCT in physicians office labs 279
    Future POCT technologies 279
    Appendix 281
    Research methodology 281
    Glossary 281

    LIST OF FIGURES

    Figure 1.1: Approaches to overcoming limitations of traditional PCR-based assays 33
    Figure 1.2: A representative basic lateral flow immunoassay (LFI) device 35
    Figure 1.3: Schematic of an electrochemical glucose biosensor with meter display 38
    Figure 1.4: Schematic of a lab-on-a-chip device 40
    Figure 1.5: Drivers & restraints for the POCT market 43
    Figure 2.6: Patient potential for type 2 diabetes 51
    Figure 2.7: Causes of inaccurate glucose test results 54
    Figure 6.8: Infectious disease tests CLIA waived (%), Nov 2006 - Oct 2009 144
    Figure 6.9: GeneXpert system for PCR-based DNA testing 149

    LIST OF TABLES

    Table 2.1: Glucose monitoring products 2006-09 56
    Table 2.2: Glucose monitoring products 2006-09 (ctd 1) 57
    Table 2.3: Glucose monitoring products 2006-09 (ctd 2) 58
    Table 2.4: Glucose monitoring products 2006-09 (ctd 3) 59
    Table 2.5: Glucose monitoring products 2006-09 (ctd 4) 60
    Table 2.6: Glucose monitoring products 2006-09 (ctd 5) 61
    Table 2.7: HbA1c testing products 72
    Table 3.8: Pregnancy and ovulation tests 78
    Table 3.9: Pregnancy and ovulation tests (ctd 1) 79
    Table 3.10: Pregnancy and ovulation tests (ctd 2) 80
    Table 3.11: Pregnancy and ovulation tests (ctd 3) 81
    Table 5.12: Lipid profiling tests 126
    Table 6.13: Infectious disease tests – Strep A infection 145
    Table 6.14: Infectious disease tests – H. pylori infection 146
    Table 6.15: Infectious disease tests – Infectious mononucleosis 147
    Table 6.16: Infectious disease tests – HIV infection 147
    Table 6.17: Infectious disease tests – influenza A/B infection 148
    Table 6.18: Infectious disease tests – urinary infection 148
    Table 7.19: Drugs of abuse (DOA) test systems and analytes 188
    Table 7.20: Drugs of abuse (DOA) test systems and analytes (ctd 1) 189
    Table 7.21: Drugs of abuse (DOA) test systems and analytes (ctd 1) 190
    Table 8.22: Automated urine analyzers/reagents 203
    Table 8.23: Automated urine analyzers/reagents (ctd 1) 204
    Table 8.24: Automated urine analyzers/reagents (ctd 2) 205
    Table 8.25: Blood chemistry analyzers/reagents 207
    Table 8.26: Blood chemistry analyzers/reagents (ctd 1) 208
    Table 8.27: Immunological Fecal Occult Blood (FOB) tests 213
    Table 9.28: Abbott Laboratories sales to external customers ($m), 2006-08 221
    Table 9.29: Cepheid product sales by market ($ thousands), 2007-08 234
    Table 9.30: Inverness Medical Innovations sales ($ thousands), 2007-08 245
    Table 9.31: Quidel POC diagnostic revenues ($ thousands), 2007-08 258
    Table 10.32: POCT market forecast by application, 2008-13 271
    Table 10.33: POCT market forecast by region, 2008-13 272
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