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Point of Care Testing: Evaluating the return to evidence based medicine, novel technologies and the competitive landscape
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Zahlen und Fakten zur Studie: | 283 Pages | |||||||||
| Inhalt der Studie: |
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-.....
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? Report Highlights Companies mentioned in the report: Abaxis Inc, Abbott Laboratories, Accumetrics, AccuTech LLC, Akers Biosciences Inc, American Bio Medica Corporation, AmniSure International LLC, Arkray USA Inc, Banyan Biomarkers Inc, BioHelix Corporation, Bio-Rad Laboratories Inc, BiOracle Ltd, Calypte Biomedical Corporation, Cepheid, Diazyme Laboratories, ELITech Group, Enigma Diagnostics Ltd, GeneEx Inc, Health-Chem Diagnostics LLC, Helena Laboratories Corporation, Home Diagnostics Inc, International Technidyne Corporation, Inverness Medical Innovations Inc, Meso Scale Diagnostics LLC, Micronics, Molecular Vision Ltd, NOVX Systems Inc, OraSure Technologies Inc, Phadia AB, PointCare Technologies Inc, Polymer Technology Systems Inc, Princeton BioMeditech Corporation, Qualigen Inc, Quidel Corporation, Rapid Pathogen Screening Inc, Response Biomedical Corporation, Roche Diagnostics Corporation, Siemens Healthcare Diagnostics Inc, Trinity Biotech Plc, Verax Biomedical Inc [Studien Infos ausblenden] |
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Table of Contents 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 26 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 50 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 76 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 94 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 118 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 142 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 176 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 198 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 218 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 270 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 [Inhaltsverzeichnis ausblenden] |
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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 n/a [Tabellenverzeichnis ausblenden] |
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