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Report Description

Over-the-Counter Diagnostic Products World Markets
Publication Date: 05-SEP-06
Pages: 358
Study: TMROTC
Format/Price: PDF document / $3,400.00
   


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The purpose of this TriMark Publications analysis is to describe the specific market segments of the over-the-counter (OTC) diagnostic products and home healthcare markets. It examines the diagnostic measurement devices and their reagents and supplies that are utilized in clinics and by patients directly in their homes to diagnose and monitor disease. This study also includes a review of home healthcare kits and devices that measure health-related conditions. Focus is on market dynamics and current market drivers of the OTC and home self-testing diagnostics market. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. The analysis covers healthcare-related devices that are designed for the home market in order to allow consumers to assess their health status through self-testing. In addition, this review examines some biowarfare detection systems. The emphasis in this report is on those companies and products that are actively developing and marketing diagnostic reagents and supplies in market segments that are targeted for direct sale to the public. It is believed that this market segment has the potential for growth rates above 15% per year over the next five years in some of the less well-explored and well-developed areas.





Table of Contents:

  1. 1 Overview 7
  2. 1.1 Statement of Report 7
  3. 1.2 About This Report 7
  4. 1.3 Scope of the Report 9
  5. 1.4 Objectives 10
  6. 1.5 Methodology 11
  7. 1.6 Executive Summary 11
  8. 2 Sector Overview 17
  9. 2.1 Global Diagnostic Products Industry 17
  10. 2.2 Global OTC Diagnostic Products Industry 18
  11. 2.2.1 General Global Market 18
  12. 2.2.2 German OTC and Home Self-Testing Diagnostic Markets 22
  13. 2.2.3 U.K. OTC and Home Self-Test Diagnostic Markets 22
  14. 2.2.3.1 U.K. Market Statistics 23
  15. 2.2.3.2 U.K. Competitive Analysis 24
  16. 2.2.3.3 U.K. Market Access 25
  17. 2.2.4 French OTC Diagnostic Market 25
  18. 2.2.5 Italian OTC Diagnostic Market 26
  19. 2.2.6 Spanish OTC Diagnostic Market 26
  20. 2.2.7 Japanese OTC Diagnostic Market 27
  21. 2.2.8 Chinese OTC Diagnostic Market 28
  22. 2.3 Description of the U.S. OTC Diagnostics Industry Segment 29
  23. 2.3.1 Market Overview 29
  24. 2.3.2 Diagnostic Test Categories 30
  25. 2.4 Market Drivers in the OTC Diagnostics Sector 31
  26. 2.4.1 Overview 31
  27. 2.4.2 Market Segments 31
  28. 2.5 Key Players in the OTC Diagnostics Segment 32
  29. 2.6 Sector Analysis 34
  30. 3 Market Analysis: Size, Growth, Share and Competitors 35
  31. 3.1 Glucose Monitoring 35
  32. 3.1.1 Glucose Control in Diabetic Patients 41
  33. 3.1.2 Tight Glucose Control in Treating Diabetes 41
  34. 3.1.3 Glucose-Monitoring Devices 42
  35. 3.1.4 Key Issues for Glucose Monitoring 43
  36. 3.1.5 Glucose Device Description 43
  37. 3.1.6 Precision in Glucose Meters 44
  38. 3.1.7 Limitations of Existing Glucose Monitoring Products 45
  39. 3.1.8 Over-the-Counter (OTC) Self-Testing Glucose Market 46
  40. 3.1.9 Worldwide Glucose Testing Market 48
  41. 3.1.9.1 U.S. Market 49
  42. 3.1.9.2 European Market 53
  43. 3.1.9.3 Asian Market 54
  44. 3.1.9.3.1 Japanese Market 55
  45. 3.1.9.3.2 China Market 56
  46. 3.1.9.3.3 Indian Market 58
  47. 3.1.9.4 ROW Markets 59
  48. 3.1.10 Reagents and Equipment 59
  49. 3.1.10.1 Blood Glucose Monitoring 59
  50. 3.1.10.2 Lancets 60
  51. 3.1.10.3 Blood Glucose Monitor and Insulin Doser 67
  52. 3.1.10.4 Blood Glucose Reagent Test Strips 67
  53. 3.1.10.5 Control Solutions and Calibrators 68
  54. 3.1.10.6 Sharps Devices 68
  55. 3.1.10.7 Needle Destruction Devices 69
  56. 3.1.10.8 Voice-Operated Glucose Meters 70
  57. 3.1.11 Glucose Meters 73
  58. 3.2 Pregnancy Testing 98
  59. 3.2.1 Major Players 99
  60. 3.2.1.1 U.S. Market 100
  61. 3.2.1.2 European Market 101
  62. 3.2.2 Diagnostic Kit Information 101
  63. 3.3 Hepatitis Testing 108
  64. 3.4 Drugs of Abuse Screening Testing 111
  65. 3.5 Infectious Disease Testing 126
  66. 3.5.1 HIV 128
  67. 3.5.2 Tuberculosis Testing 139
  68. 3.5.3 Infectious Disease Testing in Non-medical Settings 140
  69. 3.5.4 West Nile Virus 142
  70. 3.5.5 Urinary Tract Infections 143
  71. 3.6 Cholesterol Testing 144
  72. 3.7 Coagulation Testing 146
  73. 3.8 Urine Dipstick Testing 153
  74. 3.9 Fertility Testing 153
  75. 3.9.1 Players 155
  76. 3.9.2 Diagnostic Test Kits 156
  77. 3.10 At-Home DNA Analysis 159
  78. 3.11 Biowarfare Detection 164
  79. 3.12 Home Patient Monitoring Devices 166
  80. 3.13 Home Patient Alert Systems 167
  81. 3.14 Home Genetic Testing Kits 167
  82. 3.15 Home Paternity Testing 171
  83. 3.16 Health Hazards Detection 172
  84. 3.16.1 Lead 172
  85. 3.16.2 Radon 172
  86. 3.16.3 Asbestos 172
  87. 3.16.4 Pesticides 173
  88. 3.16.5 Mold 173
  89. 3.16.6 Carbon Monoxide 173
  90. 3.16.7 Water Quality 173
  91. 3.16.8 Bacteria in Water 173
  92. 3.17 Thyroid Disease 174
  93. 3.18 Carpal Tunnel 174
  94. 3.19 Allergies 174
  95. 3.20 Nutrition and Wellness 174
  96. 3.20.1 Testosterone and Male Hormones 174
  97. 3.20.2 Female Hormones 174
  98. 3.20.3 Antioxidants 174
  99. 3.20.4 Sleep Apnea 175
  100. 3.20.5 Mineral Check 175
  101. 3.20.6 Stress Check 175
  102. 3.21 Colorectal Cancer (Occult Blood) Testing 176
  103. 3.22 Alzheimer's Disease Home Screening Test 177
  104. 3.23 Tobacco Testing 177
  105. 4. Business Trends In The Industry 178
  106. 4.1 Wholesale Distribution Overview 178
  107. 4.2 Factors Affecting OTC Medical Product Distribution 180
  108. 4.3 Government Regulation of Medical Devices 181
  109. 4.3.1 U.S. Regulations 181
  110. 4.3.2 U.K. Regulations 184
  111. 4.4 Clinical Laboratory Improvement Act (CLIA) 185
  112. 4.5 Legal, M&A and Corporate Partnerships 189
  113. 4.6 New Product Launches 189
  114. 5. Patient Management Trends 190
  115. 5.1 Trends in OTC Testing and Reimbursement 190
  116. 5.1.1 American OTC Testing and Home Self-testing Reimbursement 190
  117. 5.1.2 European Reimbursement 191
  118. 5.2 Drivers of OTC and Home Self-Testing 191
  119. 5.3 Cost Elements of OTC Testing 192
  120. 5.4 Important Elements of OTC Testing 192
  121. 5.5 Growth of Home Care Testing 192
  122. 5.6 Non-Traditional Methods for Sample Collecting 193
  123. 6. Technology Trends 194
  124. 6.1 Sensor Systems for Diagnostic Applications 194
  125. 6.2 Glucose Measurements 195
  126. 6.3 Cholesterol Testing 200
  127. 6.4 Immunoassay Technology 201
  128. 6.5 Biosensor Technology 201
  129. 6.6 Fructosamine Test 203
  130. 6.7 Home Telemedicine Devices 203
  131. 7. OTC Testing: Critical Issues 206
  132. 7.1 Moderators of Growth for OTC Testing 206
  133. 7.2 Attitudes of Critical Care Nurses and Physicians 206
  134. 7.3 Personnel Impact for OTC Testing 207
  135. 7.4 Data Management Issues 207
  136. 7.5 POC Decentralization Issues 207
  137. 7.6 POC Testing and Clinical Outcomes 207
  138. 7.7 Focused Testing 208
  139. 7.8 Satellite Facilities 208
  140. 7.9 POC Testing Comparison and Cost Analysis 208
  141. 8. Competitive Assessments of the High-Growth Markets 211
  142. 8.1 Glucose Monitoring 211
  143. 8.1.1 Overview of Market Segment 211
  144. 8.1.2 Competitive Strategies 214
  145. 8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix 215
  146. 8.1.4 Product Mix 222
  147. 8.1.5 Adjacent Markets 229
  148. 8.1.6 Market Drivers and Restraints 230
  149. 8.1.7 Market and Product Trends 230
  150. 8.2 Coagulation Testing 230
  151. 8.2.1 Overview of Market Segment 230
  152. 8.2.2 Competitive Strategies 234
  153. 8.2.3 Analyses of Current Market Conditions 235
  154. 8.2.4 Product Mix in Coagulation Testing 235
  155. 8.2.5 Adjacent Markets 237
  156. 8.2.6 Market Drivers and Restraints 237
  157. 8.2.7 Market and Product Trends 239
  158. 8.3 Cholesterol Testing 239
  159. 8.3.1 Overview of Market Segment 239
  160. 8.3.2 Competitive Strategies 240
  161. 8.3.3 Adjacent Markets 242
  162. 8.4 Infectious Disease Testing 242
  163. 8.4.1 Overview of Market Segment 242
  164. 8.4.2 Competitive Strategies 247
  165. 8.5 Drugs of Abuse 247
  166. 8.5.1 Overview of Market Segment 247
  167. 8.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 248
  168. 8.5.3 Adjacent Markets 252
  169. 8.6 Home Pregnancy Testing 252
  170. 8.6.1 Overview of Market Segment 252
  171. 8.6.2 Competitive Strategies 252
  172. 8.6.3 Analysis of Current Market Conditions 253
  173. 8.6.4 Product Mix 254
  174. 8.6.5 Adjacent Markets 255
  175. 8.6.6 Market Drivers and Restraints 255
  176. 8.6.7 Market and Product Trends 255
  177. 9. Current Issues for OTC and Home Diagnostic Testing 256
  178. 9.1 New Markets for OTC and Home Diagnostic Testing 256
  179. 9.2 Utility of OTC and Home Self-Testing 258
  180. 9.3 Corporate Screening 259
  181. 9.4 Generational Drivers of Home Testing 260
  182. 9.5 Move Away from Central Laboratories 262
  183. 9.6 Healthcare Cost Controls 262
  184. 9.7 Mergers of Diagnostic Companies 262
  185. 9.8 Home Healthcare Trends 262
  186. 9.9 Home Healthcare Providers versus Mass Market Retailers 263
  187. 9.10 Demographic Merchandising 263
  188. 9.11 Marketing Strategies 264
  189. 9.12 Third-Party Pharmacy Networks 264
  190. 9.13 Which Customer Segments Are Purchasing Home Healthcare, and What Products Fit Their Needs? 265
  191. 9.14 Future of Patient Self-Testing 266
  192. 10. Corporate Profiles 268
  193. 10.1 Abbott Diagnostics (MediSense) 268
  194. 10.2 AmeriSourceBergen 269
  195. 10.3 Avitar Technologies, Inc. 271
  196. 10.4 Bayer Diagnostics 271
  197. 10.5 Beacon Diagnostics 273
  198. 10.6 Becton Dickinson 274
  199. 10.7 Bindley Western Industries, Inc. 275
  200. 10.8 Biosite, Inc. 275
  201. 10.9 Cardinal Health, Inc. 277
  202. 10.10 Cholestech 277
  203. 10.11 HemoCue 281
  204. 10.12 Home Access Health Corp. 281
  205. 10.13 Inverness Medical Innovations, Inc. 281
  206. 10.14 Johnson & Johnson 282
  207. 10.15 LifeScan 282
  208. 10.16 Princeton BioMeditech 283
  209. 10.17 Quidel Corp. 283
  210. 10.18 Roche Diagnostics 283
  211. 10.19 Saliva Diagnostics 285
  212. 10.20 Technical Chemicals & Products, Inc. 286
  213. 10.21 Worldwide Medical Corporation 287
  214. 11. Corporate Directory 288
  215. Appendix 1: Over-the-Counter In Vitro Diagnostic Devices 294
  216. Appendix 2: OTC Waived Tests for Drugs of Abuse 315
  217. Appendix 3: FDA Approved and Unapproved Tests for HIV Home Testing 317
  218. Appendix 4: Home Medical Equipment Reimbursement Contacts for Medicare 321
  219. Appendix 5: Tests Waived by the FDA from January 2000 to June 30, 2005 322
  220. Appendix 6: Frequently-Asked Questions About Drug Screening Kits 356
  221. INDEX OF FIGURES
  222. Figure 2.1: European OTC Diagnostic Products Market by Country 20
  223. Figure 3.1: Single-Day Continuous Blood Glucose Data 46
  224. Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 2006 52
  225. Figure 3.3: The Glucose Market U.S. Sales, 2000-2012 52
  226. INDEX OF TABLES
  227. Table 2.1: Worldwide Market Share of In Vitro Diagnostic Companies 17
  228. Table 2.2: Worldwide Clinical In Vitro Diagnostics Market Size, 2001-2007 18
  229. Table 2.3: Worldwide Clinical In Vitro Central Lab Diagnostic Testing, 2001-2007 18
  230. Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2001-2007 18
  231. Table 2.5: Worldwide OTC Diagnostic Products Market, 2001-2010 20
  232. Table 2.6: Worldwide OTC Diagnostic Products Market by Region, 2005 20
  233. Table 2.7: Major European OTC Diagnostics Markets, 2004 21
  234. Table 2.8: German OTC Diagnostic Products Market Sales, 1999-2007 22
  235. Table 2.9: U.K. OTC Diagnostic Products Market Sales, 1998-2009 23
  236. Table 2.10: Major U.K. IVD Manufacturers 24
  237. Table 2.11: U.S. IVD Manufacturers Doing Business in the U.K. 24
  238. Table 2.12: Other European Companies that Manufacture IVD Products in the U.K. 25
  239. Table 2.13: French OTC Diagnostic Products Market Sales, 1998-2007 25
  240. Table 2.14: Italian OTC Diagnostic Products Market Sales, 1998-2009 26
  241. Table 2.15: Spanish OTC Diagnostic Products Market Sales, 1998-2009 27
  242. Table 2.16: Japanese OTC Diagnostic Products Market Sales, 1998-2007 28
  243. Table 2.17: Chinese OTC Diagnostic Products Market Sales, 2000-2007 28
  244. Table 2.18: U.S. OTC Diagnostic Products Market Sales 1992-2010 30
  245. Table 2.19: U.S. Clinical Diagnostic Home Test Market Segments 30
  246. Table 2.20: Top Drugstore Retailers in the U.S. 32
  247. Table 2.21: Top Drugstore Wholesalers in the U.S. 32
  248. Table 3.1: The Glucose Market for OTC Testing in the U.S., 1996-2010 36
  249. Table 3.2: The Glucose Market for OTC Testing Worldwide, 2000-2010 36
  250. Table 3.3: The Global Population of Persons with Diabetes, 1995 and 2025 37
  251. Table 3.4: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 38
  252. Table 3.5: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 40
  253. Table 3.6: World Market Share of POC Glucose Monitoring Marketers 40
  254. Table 3.7: Key Features Considered for Glucose Meter Devices 44
  255. Table 3.8: Demographic Characteristics Home-Testing Kit Buyers 47
  256. Table 3.9: Top Brand Preferences for Home Glucose Testing Kits 47
  257. Table 3.10: Instances when Patients Prefer Professional's Glucose Testing 47
  258. Table 3.11: Advantages of a Home-Testing Kit 48
  259. Table 3.12: Disadvantages of Using a Home-Testing Kit 48
  260. Table 3.13: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 48
  261. Table 3.14: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2000-2012 49
  262. Table 3.15: The Glucose Market for Self-Testing and POC Devices in the U.S., 2000-2012 50
  263. Table 3.16: U.S. Blood Glucose Reagent Strip Market, 2000-2012 50
  264. Table 3.17: OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 51
  265. Table 3.18: U.S. Diabetes Glucose Monitoring Market Repeat Retail Replacement Sales Percentages 52
  266. Table 3.19: Top Four Players in the U.S. Blood Glucose Strips Market-Ranked by Percentage Sales, 2006 52
  267. Table 3.20: Leading Blood Glucose Meters and Strips Brands in the U.S., 2006 53
  268. Table 3.21: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2004-2012 53
  269. Table 3.22: European Glucose Self-Testing Market by Country Market 54
  270. Table 3.23: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 55
  271. Table 3.24: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 56
  272. Table 3.25: Chinese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 57
  273. Table 3.26: China Blood Glucose Reagent Strip Market, 2000-2012 57
  274. Table 3.27: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 58
  275. Table 3.28: Indian Blood Glucose Reagent Strip Market, 2000-2012 58
  276. Table 3.29: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 59
  277. Table 3.30: Unit Sales of Homecare Lancets in the U.S., 2000-2012 62
  278. Table 3.31: Unit Sales of Lancets in the E.U., 2000-2012 63
  279. Table 3.32: Dollar Sales of Lancets in the U.S., 2000-2012 63
  280. Table 3.33: Dollar Sales of Lancets in the E.U., 2000-2012 64
  281. Table 3.34: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2000-2012 64
  282. Table 3.35: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2000-2012 65
  283. Table 3.36: Competition in the Lancet Market Segment 65
  284. Table 3.37: Key Features of Reagent Test Strips 68
  285. Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001, 2006 and 2012 70
  286. Table 3.39: Accu-Chek Blood Glucose Monitoring Systems 80
  287. Table 3.40: The Pregnancy Test Market for OTC Testing in the U.S., 2000-2010 99
  288. Table 3.41: The Pregnancy Test Market for OTC Testing in Europe, 2000-2010 99
  289. Table 3.42: U.S. Market Share for Home Pregnancy Tests 100
  290. Table 3.43: European Market Share for OTC Pregnancy Tests 101
  291. Table 3.44: Home Pregnancy Tests Available in the U.S. Market 104
  292. Table 3.45: Hepatitis C Statistics 109
  293. Table 3.46: The Hepatitis Market for OTC Testing in the U.S., 2000-2007 110
  294. Table 3.47: The Drugs of Abuse Market for OTC Testing in the U.S., 2000-2006 111
  295. Table 3.48: Illicit Drugs that are Important for Detection 113
  296. Table 3.49: Analytical Detection Levels for Drugs of Abuse 114
  297. Table 3.50: Princeton BioMeditech's Drugs of Abuse Tests 125
  298. Table 3.51: Abbott Tests on the ADx System 125
  299. Table 3.52: The Infectious Disease Market for OTC Testing in the U.S., 2000-2010 128
  300. Table 3.53: The HIV Testing Market for OTC Testing in the U.S., 2000-2008 133
  301. Table 3.54: Home Testing for Urinary Tract Infections 143
  302. Table 3.55: The Cholesterol Market for OTC and Home Self-Testing in the U.S., 2000-2010 144
  303. Table 3.56: The Coagulation Market for OTC Testing in the U.S., 2000-2010 148
  304. Table 3.57: The Glucose Market for OTC Testing in the U.S., 2000-2010 153
  305. Table 3.58: The Fertility Testing Market for OTC Testing in the U.S., 2000-2010 155
  306. Table 3.59: The Fertility Testing Market for OTC Testing in Europe, 2000-2008 155
  307. Table 3.60: Rite Aid and Other OEM Ovulation Predictors 158
  308. Table 3.61: At-Home DNA Tests 159
  309. Table 3.62: The At-Home DNA Market for OTC Testing Worldwide, 2001-2007 160
  310. Table 3.63: The Home Genetic Testing Market in the U.S., 2003-2010 168
  311. Table 3.64: Genovations Profiles 169
  312. Table 3.65: Featured Tests by DNA Direct 170
  313. Table 3.66: Fee Schedule for Personal Home-Based Paternity Studies 171
  314. Table 4.1: Financial Comparison for Moderate and Waived CLIA Labs 188
  315. Table 5.1: U.S. Home Testing Market Size, 2004-2010 193
  316. Table 6.1: Normal Glucose Values, Fasting State 197
  317. Table 6.2: Leading Home Patient Monitoring Products in the U.S. Market 204
  318. Table 6.3: Home Telemonitoring and Patient Assessment Products 205
  319. Table 7.1: POCT Clinical Outcomes in Diabetic Ketoacidosis 207
  320. Table 7.2: POC Testing: Cost Analysis with Labor Included 209
  321. Table 7.3: POC Testing: Cost Analysis with Labor Included 210
  322. Table 8.1: U.S. Diabetes Glucose Monitoring Market, 2002 212
  323. Table 8.2: Total U.S. Market Size and CAGRs of Emerging At-Home Diagnostic Tests, 1997-2007 240
  324. Table A.1: Over-the-Counter In Vitro Diagnostic Devices 294
  325. Table A.2: Over-the-Counter In Vitro Diagnostic Devices Approved by the FDA 304

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