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The U.S. Market For Portable Diagnostics TestPublished by: PJB Publications USA Inc. Published: Jan. 1, 2001 - 360 Pages Table of Contents1. Overview 1
1.2 Scope of the Report 2 1.3 Methodology 5 1.4 Executive Summary 6 1.4.1 Glucose Monitoring 8 1.4.2 Pregnancy Testing 8 1.4.3 Hepatitis Testing 9 1.4.4 Drugs-of-abuse Screening Testing 9 1.4.5 HIV Testing 9 1.4.6 Cholesterol Testing 10 1.4.7 Coagulation Testing 11 1.4.8 Occult Blood Testing 11 1.4.9 Urine Dipstick Testing 12 1.4.10 Fertility Testing 12
2.2 Emerging Need for Over-the-Counter Diagnostics 14 2.3 The Structure and Size of the Industry 15 2.4 Industry Trends 20 2.5 Competitive Outlook 21 2.6 Market Strategies 23
3.1.1 Diabetes Statistics 26 3.1.2 Market Size 29 3.1.3 Glucose Detection Kits 32 3.1.4 Hemoglobin A1c and Long-Term Glucose Monitoring 40 3.2 Pregnancy Testing 42 3.2.1 Market Size 42 3.2.2 The Tests 45 3.2.3 Competition 46 3.3 Hepatitis Testing 50 3.4 Drugs-of-abuse Screening Testing 55 3.4.1 Market Size and Demographics 57 3.4.2 Types of Tests 63 3.4.3 Urine Tests 66 3.4.3 Saliva 77 3.4.4 Hair 79 3.4.5 Gas Chromatography/Mass Spectrometry (GC/MS) 80 3.4.6 Alcohol 82 3.5 HIV Testing 83 3.5.1 Antibody Tests 87 3.5.2 Non-Blood-Based Testing 88 3.5.3 Insurance Industry Use 91 3.5.4 Pharmacy and Public Health Clinical Market 93 3.5.5 International Markets 94 3.5.6 OTC Market 94 3.6 Cholesterol Testing 100 3.7 Coagulation Testing 104 3.7.1 Clinical and Cost Benefits 105 3.7.2 Competitive Landscape 106 3.8 Occult Blood Testing 110 3.9 Urine Dipstick Testing 113 3.10 Fertility Testing 114 3.10.1 Urine-based Fertility Tests 115 3.10.2 Saliva-Based Tests 121 3.11 Urinary Tract Infections 122 3.12 Male Hormone Tests 123 3.13 Antioxidant Tests 125 3.14 Mineral Tests 126 3.15 Osteoporosis Tests 127 3.16 Performance Hormone Tests 128 3.17 Prostate Cancer Tests 129 3.18 Melatonin Tests 130 3.19 Stress Hormone Tests 131
4.2 Growth Strategies 136 4.3 Distribution 140 4.4 Reimbursement Issues 140 4.4 Regulatory Issues 144 4.4.1 FDA Pre-Market Approval and 510(k) 145 4.4.2 International Regulation 148 4.4.3 Clinical Laboratory Improvement Act (CLIA) 149 4.5 Important Cost and Efficacy Elements to Consider 150
5.2 Management Benefits of OTC Testing 154 5.3 Home Care Analysis 155 5.4 Non-traditional Methods for Sample Collecting 155
6.2 Glucose Measurements 161 6.3 Cholesterol Testing 162 6.4 Biosensor Technology 162 6.5 Microfluidic and Biosensor Chip Technology 164 6.6 Fructosamine Tests 166 6.7 Technology Formats 167
7.2 Political Control 170 7.3 Regulatory Requirements 170 7.4 Finance 170 7.5 Attitudes of Critical Care Nurses and Physicians 170 7.6 Record Keeping and Data Management 171 7.6.1 Wireless LANS 172 7.7 Point-of-Care Decentralization Issues 175 7.8 Requirements for Point-of-Care Testing 179
8.1.1 Competitive Strategies 182 8.1.2 Analyses of the Current Market Conditions, Competition, and Product Mix 183 8.1.3 Adjacent Markets 187 8.2 Rapid Coagulation Testing 187 8.2.1 Competitive Strategies 188 8.2.2 Analyses of the Current Market Conditions, Competition, and Product Mix 189 8.2.3 Adjacent Markets 198 8.3 Cholesterol Testing 198 8.3.1 Competitive Strategies 199 8.3.2 Analyses of the Current Market Conditions, Competition, and Product Mix 201 8.3.3 Adjacent Markets 202 8.4 Infectious Disease Testing 202 8.4.1 Competitive Strategies 203 8.4.2 Analyses of the Current Market Conditions, Competition, and Product Mix 206 8.5 Drugs-of-abuse Screening Testing 213 8.5.1 Competitive Strategies 215 8.5.2 Analyses of the Current Market Conditions, Competition, and Product Mix 217 8.5.3 Adjacent Markets 225
9.2 Utility of OTC Testing 228 9.3 Information Management Advances 228 9.4 Wellness Testing 228 9.5 Patient Satisfaction 228 9.6 Move Away from Central Laboratory Testing 229 9.7 Healthcare Cost Controls 229 9.8 Mergers of Diagnostic Companies 229 9.9 Bio-Microfabrication 230 9.10 Rx-Directed OTC Testing 231
10.2 Amerisource Health Corp. 235 10.3 Avitar Technologies 241 10.4 Avocet Medical 243 10.5 Bayer Diagnostics 245 10.7 Bergen Brunswig Corp. 247 10.8 Biosite Diagnostics 251 10.9 Cardinal Health Inc. 253 10.11 Carter-Wallace 255 10.12 Chembio Diagnostic Systems Inc. 257 10.13 Cholestech Corp. 259 10.14 DynaGen Inc. 271 10.15 GDS Technology Inc. 273 10.16 Home Access Health Corp. 275 10.17 Johnson & Johnson 279 10.18 Pharmanetics Inc./Cardiovascular Diagnostics Inc. 281 10.19 Quidel Corp. 285 10.20 Roche Diagnostics 289 10.21 Saliva Diagnostics 291 10.22 Selfcare Inc./Inverness Medical Technology 293 10.23 Syntron Bioresearch Inc. 297 10.24 Technical Chemicals and Products 301
11.2 Bindley Western Industries Inc. 307 11.4 Chematics Inc. 309 11.5 Epitope (OraSure) 309 11.6 HemoCue AB 309 11.7 LXN Corporation 311 11.8 McKessonHBOC 311 11.9 Metrika 313 11.10 Orasure Technologies Inc. (Epitope & STC Technologies) 313 11.12 Princeton Biomeditech 315 11.13 STC Technologies Corp. (OraSure) 315 11.14 Unipath Diagnostics Co. 317 11.16 Worldwide Medical Corp. 317
AbstractOver-the-counter diagnostic tests (such as cholesterol, blood glucose, and others) are a $1 billion market in the United States-and growing at an annual rate of 10-12%. Advancing in vitro technology is making more types of tests portable, thereby creating even more opportunities for an over-the-counter sales channel.Learn about key opportunities and challenges for the U.S. market for over-the-counter tests. Find out:
Types of tests covered in this report:
The U.S. Market for Over-the-Counter Diagnostics analyzes the data, and predicts the future shape of these segments. Don't miss out on these opportunities. Learn about the prospects in this sector.
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