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Blood Glucose Testing and Diabetes Management
Publication Date: 01-APR-09
Pages: 366
Study: TMRGLUC
Format/Price: PDF document / $3,400.00
   


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There has been a dramatic increase in the incidence of diabetes worldwide, which has been exacerbated by the growing obesity problem across the globe. Once thought of as primarily a childhood disease--sometimes referred to as juvenile diabetes, now mostly Type 1 diabetes--the obesity crisis linked to the adoption of a high-fat, high-carbohydrate, high-calorie American diet has resulted in skyrocketing rates of diabetes, particularly Type 2 diabetes, among adults across the world. As such, the global market for blood glucose testing products is undergoing a significant transition driven by the advent of new analytical technologies and developments in diabetes treatment. Although the blood glucose testing segment of the in vitro diagnostics (IVD) industry is mature, certain segments of the market, such as home testing devices for diabetes management, will exhibit strong growth. What's more, non-invasive testing now represents a major new area for the application of IVD testing. Additionally, direct access testing--or over-the-counter testing, which allows consumers to order tests themselves without visiting a doctor--has emerged as a strong force in the blood glucose testing segment. The purpose of this TriMark Publications report is to describe the specific market segments for blood glucose testing and diabetes management. This study reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum or plasma or whole-blood glucose concentrations. Moreover, it examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctor's offices and at-home care locations.





Table of Contents:

  1. 1. Overview 9
  2. 1.1 Statement of Report 9
  3. 1.2 About this Report 9
  4. 1.3 Scope of the Report 11
  5. 1.4 Methodology 11
  6. 1.5 Executive Summary 12
  7. 2. Diabetes 15
  8. 2.1 Demographics of Diabetes 17
  9. 2.1.1 Worldwide Diabetes Incidence 17
  10. 2.1.2 Diabetes in the U.S. 19
  11. 2.2 Economics of Diabetes 22
  12. 2.3 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 31
  13. 2.3.1 Pre-Diabetes Syndrome 33
  14. 2.3.2 Metabolic Syndrome 33
  15. 2.3.3 Diabetes and Inflammation 33
  16. 2.3.4 Progression of Diabetes 33
  17. 2.3.5 Complications and Co-Morbidities in Type 2 Diabetes 34
  18. 2.3.6 Hypoglycemia and Treatment 36
  19. 2.3.7 Risk Factors and Diabetes 36
  20. 2.3.8 Cardiovascular Disease Facts 37
  21. 2.4 Glucose Control in Diabetic Patients 43
  22. 2.5 Tight Glucose Control in Treating Diabetes 44
  23. 2.6 Glucose Monitoring Devices 45
  24. 2.6.1 Key Issues Identified for Glucose Monitoring 45
  25. 2.6.2 Device Description 45
  26. 2.6.3 Precision 47
  27. 2.6.4 Limitations of Existing Glucose Monitoring Products 48
  28. 3. Glucose Measurements 50
  29. 3.1 Glucose Monitoring Markets 50
  30. 3.1.1 Overview of Market Segments 50
  31. 3.1.1.1 Over-the-Counter (OTC) Self-Testing Glucose Market 52
  32. 3.1.1.2 Professional Glucose Testing Market 53
  33. 3.1.2 Market Analysis: Size, Growth, Share and Competitors 54
  34. 3.1.2.1 Worldwide Market 54
  35. 3.1.2.2 U.S. Market 56
  36. 3.1.2.3 European Market 59
  37. 3.1.2.4 Asian Market 60
  38. 3.2 Glucose Analytical Test Methods 74
  39. 3.2.1 Glucose Oxidase 74
  40. 3.2.2 Glucose Hexokinase 75
  41. 3.2.3 Glucose Dehydrogenase Pyrroloquinoline quinone (GDH-PQQ) 75
  42. 3.2.4 Amperometric Biosensors 76
  43. 3.2.5 Interfering Substances 76
  44. 3.2.6 Monitoring HbA1c Levels 77
  45. 3.2.7 Quality Control Criteria 77
  46. 3.3 Reagents and Equipment 77
  47. 3.3.1 Lancets 79
  48. 3.3.2 Blood Glucose Test Kit 87
  49. 3.3.3 Blood Glucose Monitor and Insulin Doser 89
  50. 3.3.4 Diabetes Tracking System 89
  51. 3.3.5 Blood Glucose Sensors 89
  52. 3.3.6 Blood Glucose Reagent Test Strips 92
  53. 3.3.7 Control Solutions and Calibrators 93
  54. 3.3.8 Sharps Devices 94
  55. 3.3.9 Needle Destruction Devices 94
  56. 3.3.10 Urine Strips 95
  57. 3.3.11 Blood Ketone Testing 96
  58. 3.3.12 Voice Operated Glucose Meters 97
  59. 3.4 Glucose Meters 100
  60. 3.4.1 LifeScan 100
  61. 3.4.2 Roche Accu-Chek 102
  62. 3.4.3 Bayer 104
  63. 3.4.4 Abbott 106
  64. 3.4.5 Acon Laboratories 109
  65. 3.4.6 Quest Diagnostics Company 109
  66. 3.4.7 Agamatrix 110
  67. 3.4.8 AiMedics 110
  68. 3.4.9 Apex Biotechnology 111
  69. 3.4.10 77 Elektronika 111
  70. 3.4.11 Arkray 111
  71. 3.4.12 Accurex 112
  72. 3.4.13 Axis-Shield 112
  73. 3.4.14 Home Diagnostics 112
  74. 3.4.15 Hypoguard 114
  75. 3.4.16 Metrika 115
  76. 3.4.17 Biopeak 115
  77. 3.4.18 BioTex 115
  78. 3.4.19 Integrity Applications 116
  79. 3.4.20 Calisto Medical 116
  80. 3.4.21 Allmedicus 117
  81. 3.4.22 Diabetech 117
  82. 3.4.23 Diagnostic Devices 118
  83. 3.4.24 DIRAmed 118
  84. 3.4.25 Entelos 118
  85. 3.4.26 Fifty50 Pharmacy 119
  86. 3.4.27 Fluent Biomedical 119
  87. 3.4.28 GenExel-Sein 119
  88. 3.4.29 GlucoLight 119
  89. 3.4.30 GluMetrics 119
  90. 3.4.31 Glucoplus 120
  91. 3.4.32 GlySens 120
  92. 3.4.33 HMD BioMedical 120
  93. 3.4.34 InLight Solutions 120
  94. 3.4.35 Insulet 121
  95. 3.4.36 IntelliDx 121
  96. 3.4.37 Kumetrix 122
  97. 3.4.38 Lein Applied Diagnostics 122
  98. 3.4.39 Cholestech 123
  99. 3.4.40 LighTouch Medical 123
  100. 3.4.41 LG Electronics 123
  101. 3.4.42 Luminous Medical 123
  102. 3.4.43 Menarini Diagnostics 124
  103. 3.4.44 OrSense 124
  104. 3.4.45 Pelikan Technologies 125
  105. 3.4.46 Polymer Technology Systems 126
  106. 3.4.47 PreciSense 126
  107. 3.4.48 Sensys Medical 126
  108. 3.4.49 Smiths Medical MD 127
  109. 3.4.50 TaiDoc Technology 127
  110. 3.4.51 U.S. Diagnostics 127
  111. 3.4.52 VeraLight 128
  112. 3.4.53 Zyvex 128
  113. 3.4.54 Health Hero Network 128
  114. 3.4.55 IN4 Technology 128
  115. 3.4.56 Nipro 129
  116. 3.4.57 Teco Diagnostics 129
  117. 3.4.58 Uchain Industrial 129
  118. 3.4.59 GlucoStats System 129
  119. 3.4.60 Sanko Junyaku 130
  120. 3.4.61 International Technidyne 130
  121. 3.4.62 Medtronic MiniMed 130
  122. 3.4.63 Diacare 130
  123. 3.4.64 Tyson Bioresearch 130
  124. 3.4.65 Bionime 130
  125. 3.4.66 Home Diagnostics 131
  126. 3.4.67 BTNX 132
  127. 3.5 Diagnosing Diabetes Using In Vitro Laboratory Tests 133
  128. 3.5.1 New Diagnostic Guidelines 133
  129. 3.5.2 Fasting Plasma Glucose (FPG) Test 133
  130. 3.5.3 Glucose Tolerance Test 134
  131. 3.5.4 Test for Glycosylated Hemoglobin 134
  132. 3.5.5 Fructosamine 135
  133. 3.5.6 Combined Self-Testing Glucose Monitor with Insulin Delivery 136
  134. 3.6 Continuous and Non-invasive Glucose Patient Monitoring 137
  135. 3.6.1 Medtronic MiniMed Continuous Glucose Monitoring System 146
  136. 3.6.2 Cygnus GlucoWatch Biographer 147
  137. 3.6.3 Abbott FreeStyle Continuous Glucose Monitor System 147
  138. 3.6.4 DexCom, Inc. STS Continuous Glucose Monitoring System 148
  139. 3.6.5 Echo Therapeutics 148
  140. 3.6.6 Sensors for Medicine and Science 148
  141. 3.6.7 New Developments in Glucose Monitors 149
  142. 3.6.8 Strategies for Developing Non-invasive Continuous Glucose Monitoring 150
  143. 3.7 Glycosylated Hemoglobin Glucose Monitoring 151
  144. 3.8 Clinical Laboratory Instruments 153
  145. 3.8.1 Ultra-Large Throughput Chemistry Analyzers Large-Throughput Analyzers 155
  146. 3.8.2 Large-Throughput Analyzers 157
  147. 3.8.3 Mid-Size Clinical Chemistry Analyzers 160
  148. 3.8.4 Chemistry Analyzers for the Small Volume Market 163
  149. 4. Business Trends in Glucose Testing 167
  150. 4.1 Expanding Opportunities in Blood Glucose Monitoring Market 167
  151. 4.2 Home Diabetes Test Kits an Evolving Market 167
  152. 4.3 Competitive Strategies 168
  153. 4.4 Analyses of the Current Market Conditions, Competition and Product Mix 170
  154. 4.5 The New Paradigm 171
  155. 4.6 Mergers of Diagnostic Companies 171
  156. 4.7 Healthcare Cost Controls 174
  157. 4.8 Competition for Services 174
  158. 4.9 Drivers of Clinical Glucose Testing 175
  159. 4.10 Confluence of New Technology 176
  160. 4.11 Trends in Reimbursement Practices 176
  161. 4.12 Managed Care 179
  162. 4.13 Changes in Patient Management 179
  163. 4.14 Satellite Facilities 180
  164. 4.15 Point-of-Care Testing 180
  165. 4.16 Regionalization of Laboratory Care 181
  166. 4.17 Drivers of the Point of Care Testing Sector 182
  167. 4.18 Diagnostic Testing Growth Trends 183
  168. 4.19 PIPE Financing 184
  169. 4.20 Brand Loyalty 184
  170. 4.21 Insurance Coverage a Key Factor 184
  171. 4.22 Medicare Coverage 184
  172. 4.23 Products at Competitive Price Points 184
  173. 4.24 Drugstores Critical to the Diabetic Care Category 184
  174. 4.25 Drugstore Chains Increasingly Running Diabetes Care Programs 185
  175. 4.26 Co-branding Strategies 185
  176. 5. Important Technology Trends 186
  177. 5.1 Biosensor Technology 186
  178. 5.2 Data Management 190
  179. 5.2.1 Information Management Advances 192
  180. 5.2.2 Patient Care Information System Strategy 195
  181. 5.2.3 Connectivity Platforms 196
  182. 5.2.3.1 DataLink Data Management System 197
  183. 5.2.3.2 RALS-Plus 198
  184. 5.2.3.3 LabPortal.com 200
  185. 5.2.3.4 LifeScan Electronic Data Interfaces 200
  186. 5.2.3.5 Computer Software for Home Glucose Meters 201
  187. 5.2.3.6 Health Buddy Systems Monitoring Technologies 201
  188. 5.2.3.7 Medtronic's MiniMed Paradigm Glucose Meter 201
  189. 5.2.4 POL Laboratory Data Management 202
  190. 5.2.4.1 Electronic Medical Record Systems and Physician Office Laboratory Data Linking Software 202
  191. 5.2.4.2 Physician Office Laboratory Data Linking Software and Interface to the Laboratory Information System 204
  192. 5.2.5 Technical Problems of Connectivity 204
  193. 5.2.6 Web-based Data Interface 205
  194. 5.2.7 HIT Competition 205
  195. 5.2.8 FDA Required Software Verification 205
  196. 5.3 Advantages of Connectivity 206
  197. 5.4 Home Care Analysis 206
  198. 5.4.1 Remote Patient Monitoring 206
  199. 5.5 Technology Platform Innovations in Glucose Testing 209
  200. 5.6 Move Away from Central Laboratory 210
  201. 5.7 Trends in Detection and Diagnosis 210
  202. 5.7.1 Minimally-Invasive Devices 210
  203. 5.7.2 Non-invasive Devices Future Developments and Market Strategy 213
  204. 5.7.3 Continuous Test Systems and the Future of Integrated Glucose/Insulin Delivery 215
  205. 6. Competitive Analysis of the Glucose Testing Markets 218
  206. 6.1 The Market Players 218
  207. 6.2 Device Categories 221
  208. 6.3 Range of Products 222
  209. 6.3.1 Cost of Testing 222
  210. 6.3.2 Sample Size Required 222
  211. 6.3.3 Sampling Other Areas 223
  212. 6.3.4 Time Until Patient Obtains Results 223
  213. 6.3.5 Enclosed Test Strips 223
  214. 6.3.6 Test Strip Calibration 223
  215. 6.3.7 Lancing Devices 224
  216. 6.4 Data Handling 224
  217. 6.5 New Developments 226
  218. 6.6 Marketing New Features 227
  219. 6.7 Test Strip Sales 227
  220. 6.8 Reimbursement 227
  221. 6.9 Market Demand and Composition 228
  222. 6.10 Product Mix 230
  223. 6.10.1 LifeScan 230
  224. 6.10.2 Roche Diagnostics 232
  225. 6.10.3 Bayer Diagnostics 234
  226. 6.10.4 Abbott (MediSense) 234
  227. 6.10.5 Other Players 236
  228. 6.10.5.1 Hemocue 237
  229. 6.10.5.2 Home Diagnostics, Inc. 237
  230. 6.10.5.3 ArkRay Hypoguard 238
  231. 6.10.5.4 Polymer Technology Systems, Inc. 239
  232. 6.10.5.5 QuestStar Medical, Inc. 239
  233. 6.11 Devices that Measure Glycohemoglobin 239
  234. 6.12 Market Drivers and Restraints 240
  235. 6.13 Market and Product Trends 241
  236. 6.14 Increased Market Penetration 241
  237. 6.15 Costs of Doing Business in Europe 241
  238. 6.16 Drivers of European Diagnostics Testing 242
  239. 6.17 European Reimbursement Practices 242
  240. 6.18 Cost Containment in Europe 242
  241. 6.19 Market Overview of Glucose Monitoring 242
  242. 6.19.1 U.S. Market Segment 244
  243. 6.19.2 European Market 245
  244. 6.19.3 Japanese Market 247
  245. 6.20 Competitive Strategies 248
  246. 6.21 Price Competition 249
  247. 6.22 Analyses of the Current Market Conditions, Competition and Product Mix 249
  248. 6.22.1 First-Generation Monitors 249
  249. 6.22.2 Second-Generation Monitors 250
  250. 6.22.3 Third-Generation SMBG Technologies 251
  251. 6.23 Design of Glucose Testing Devices 252
  252. 6.24 Insulin Delivery Devices 252
  253. 6.25 Key Glucose Testing Sector Developments 258
  254. 6.26 Important M&A Activity 259
  255. 6.27 Product Launches 262
  256. 7. Government Regulation of Medical Devices 264
  257. 7.1 U.S. Regulations 265
  258. 7.1.1 Importing Medical Devices into the U.S. 266
  259. 7.1.2 Exporting Medical Devices from the U.S. 267
  260. 7.2 U.K. Regulations 267
  261. 7.3 E.U. Regulations 268
  262. 7.4 French Regulations 274
  263. 7.5 Japanese Regulations 274
  264. 7.6 Korean Regulations 278
  265. 7.7 China Regulations 278
  266. 7.8 FDA Regulations and Recalls 282
  267. 7.9 Legal Liability for Glucose Meters 283
  268. 7.10 ISO 9000 Quality System 283
  269. 7.11 Recent Regulatory Approvals 284
  270. 7.12 FDA Labeling Requirements 284
  271. 8. Corporate Profiles 286
  272. 8.1 Abbott Laboratories 286
  273. 8.2 Accurex Biomedical 291
  274. 8.3 Acon Laboratories 291
  275. 8.4 AgaMatrix 291
  276. 8.5 AiMedics 291
  277. 8.6 Apex Biotechnology 292
  278. 8.7 Axis-Shield 292
  279. 8.8 Bayer 292
  280. 8.9 Biopeak Corporation 293
  281. 8.10 BioTex 293
  282. 8.11 Calisto Medical 293
  283. 8.12 Cybermedical 294
  284. 8.13 DexCom 294
  285. 8.14 Diabetech 295
  286. 8.15 DIRAmed 295
  287. 8.16 Echo Therapeutics 295
  288. 8.17 Entelos 296
  289. 8.18 Fora Care 296
  290. 8.19 Glucoplus 296
  291. 8.20 77 Elektronika 296
  292. 8.21 Flexsite Diagnostics 297
  293. 8.22 GenExel-Sein 297
  294. 8.23 GlucoLight 297
  295. 8.24 GluMetrics 298
  296. 8.25 GlySens 298
  297. 8.26 Hemocue 298
  298. 8.27 Home Diagnostics 299
  299. 8.28 HTL Strefa 300
  300. 8.29 Hypoguard 300
  301. 8.30 IN4 Technology 301
  302. 8.31 InLight Solutions 301
  303. 8.32 International Technidyne 301
  304. 8.33 Insulet 302
  305. 8.34 IntelliDx 302
  306. 8.35 Lein Applied Diagnostics 302
  307. 8.36 LifeScan 303
  308. 8.37 Luminous Medical 304
  309. 8.38 Medtronic 304
  310. 8.39 Menarini Diagnostics 305
  311. 8.40 Newton Photonics 306
  312. 8.41 Nipro Medical 306
  313. 8.42 OrSense 306
  314. 8.43 Panasonic Shikoku Electronics 306
  315. 8.44 Pelikan Technologies 307
  316. 8.45 Polymer Technology Systems 307
  317. 8.46 PreciSense 307
  318. 8.47 Roche Diagnostics 308
  319. 8.48 Sanko Junyaku 310
  320. 8.49 Sanwa Kagaku Kenkyusho 310
  321. 8.50 Sensys Medical 311
  322. 8.51 Solianis Holding 311
  323. 8.52 SurgiLance 312
  324. 8.53 Smiths Medical MD 312
  325. 8.54 SpectRx 312
  326. 8.55 Taidoc Technology 312
  327. 8.56 Teco Diagnostics 313
  328. 8.57 U.S. Diagnostics 313
  329. 8.58 VeraLight 313
  330. 8.59 Ypsomed Holding 314
  331. 8.60 Zyvex 314
  332. Appendix 1: Contact Information for Companies Profiled 315
  333. Appendix 2: List of Competitors for Glucose Test Meters and Equipment 322
  334. Appendix 3: FDA Proprietary Devices for Measuring Blood Glucose 331
  335. Appendix 4: Overview of FDA Device Regulations 340
  336. Appendix 5: Retail Prices of Glucose Meters 343
  337. Appendix 6: Glucose Meters: Components, Design, Sources 348
  338. Appendix 7: Pharmaceutical Sampling Practices 354
  339. INDEX OF FIGURES
  340. Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-2025 18
  341. Figure 2.2: Prevalence of Diabetes by Age in the U.S., 2007 20
  342. Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2007 21
  343. Figure 2.4: Rate of New Diabetes Cases among Children in the U.S., 2007 22
  344. Figure 2.5: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 25
  345. Figure 2.6: Annual Death Rate of U.S. Population from Heart Disease, 1950-2008 26
  346. Figure 2.7: How Diabetes Dollars Are Spent in the U.S., 2007 29
  347. Figure 2.8: Percentage Breakdown of U.S. Healthcare Spending, 2008 30
  348. Figure 2.9: Percentage of U.S. Population that is Overweight, 1976-2004 32
  349. Figure 2.10: Hypertension Drugs Newly Prescribed or Continued in the U.S., 1994-2007 40
  350. Figure 3.1: Glucose Self-Monitoring Market Share by Geographical Region, 2007 55
  351. Figure 3.2: Share of the U.S. Self-Testing Diagnostic Market, 2008 59
  352. Figure 3.3: Domestic Manufacturers' Share of Chinese Glucose Meter Market, 2007 65
  353. Figure 3.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2008 83
  354. Figure 3.5: Estimated U.S. Inpatient Volume, 2008 154
  355. INDEX OF TABLES
  356. Table 2.1: Normal Glucose Values-Fasting State 16
  357. Table 2.2: Countries with the Largest Numbers of Diabetics, 2007 and 2025 18
  358. Table 2.3: U.S. Population of Diabetics (Diagnosed and Undiagnosed) by Ethnic Group, 2007 20
  359. Table 2.4: Healthcare Utilization by Diabetic Patients, 2006 20
  360. Table 2.5: Cost of Diabetes in the U.S., 2007 23
  361. Table 2.6: Ten Leading Diagnoses for Co-morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006 24
  362. Table 2.7: U.S. Incidence of Diagnosed Diabetes by Age, 2006 24
  363. Table 2.8: Prevalence and Financial Burden of Major Diseases in the U.S., 2007 24
  364. Table 2.9: Top Twelve Causes of Death in the U.S., 2006 25
  365. Table 2.10: Death Rate from Cardiovascular Diseases by Country, 2008 26
  366. Table 2.11: Life Expectancy Rate by Country, 2008 27
  367. Table 2.12: Per-Event Costs of Diabetes Complications 28
  368. Table 2.13: Odds Ratio of Progression to Complications Associated With Type 2 Diabetes 34
  369. Table 2.14: Prevalence of Complications among Patients with Diabetes 34
  370. Table 2.15: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 35
  371. Table 2.16: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 35
  372. Table 2.17: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008 38
  373. Table 2.18: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 39
  374. Table 2.19: Top 20 Drugs for 2007 by U.S. Sales 41
  375. Table 2.20: Major Causes of End-Stage Renal Disease 43
  376. Table 2.21: Key Features Considered for Glucose Meter Devices 46
  377. Table 3.1: Laboratory Assessment of Diabetic Vascular Disease 51
  378. Table 3.2: Key Market Drivers for Glucose Testing 51
  379. Table 3.3: Key Aspects of Professional Glucose Testing 51
  380. Table 3.4: Demographic Characteristics Home Testing Kit Buyers 52
  381. Table 3.5: Top Brand Preferences for Home Glucose Testing Kits 52
  382. Table 3.6: Instances When Patients Prefer Professional Glucose Testing 52
  383. Table 3.7: Advantages of a Home Testing Kit 53
  384. Table 3.8: Disadvantages of Using a Home Testing Kit 53
  385. Table 3.9: Popular Shopping Destinations for Buying or Seeking Information on Home Testing Kits 53
  386. Table 3.10: Total Global Professional Glucose Testing Market, 2007-2012 53
  387. Table 3.11: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, Lancets), 2004-2012 55
  388. Table 3.12: Percentage of GDP Healthcare Spending by Country, 2008 56
  389. Table 3.13: Worldwide Glucose Market for Self-Testing Sales (Meters and Strips), 2004-2012 56
  390. Table 3.14: U.S. Blood Glucose Reagent Strip Market, 2004-2013 57
  391. Table 3.15: U.S. Sales for OTC Blood Glucose Meters and Strips, 2007 58
  392. Table 3.16: Top Four Players in the U.S. Blood Glucose Strips Market (Ranked by % Sales), 2008 59
  393. Table 3.17: European Glucose Self-Testing Market (Meters, Strips, Lancets), 2003-2012 60
  394. Table 3.18: Asian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 61
  395. Table 3.19: Japanese Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 62
  396. Table 3.20: Chinese Glucose Self-Testing (Meters, Strips, Lancets) Market and Professional POC Devices, 2000-2012 64
  397. Table 3.21: China Blood Glucose Reagent Strip Market, 2000-2012 64
  398. Table 3.22: Indian IVD Market, 2006-2012 67
  399. Table 3.23: Number of Clinical Labs in India, 2008 68
  400. Table 3.24: Indian IVD Market Sectors and Market Share, 2006 69
  401. Table 3.25: Indian Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 69
  402. Table 3.26: Indian Blood Glucose Reagent Strip Market, 2000-2012 70
  403. Table 3.27: Top Domestic IVD Companies in India 71
  404. Table 3.28: Leading Global IVD Companies in India, 2008 71
  405. Table 3.29: BRIC countries, Percentage of GDP Spent on Healthcare, 2008 72
  406. Table 3.30: ROW Glucose Self-Testing Market (Meters, Strips, Lancets), 2000-2012 74
  407. Table 3.31: Global Unit Sales of Home care Lancets, 2006-2012 81
  408. Table 3.32: Dollar Sales of Lancets in the U.S., 2000-2012 81
  409. Table 3.33: Dollar Sales of Lancets in the E.U., 2000-2012 81
  410. Table 3.34: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2000-2012 82
  411. Table 3.35: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2000-2012 82
  412. Table 3.36: Competition in the Lancet Market Segment 83
  413. Table 3.37: Currently Available Lancing Devices and Lancets 85
  414. Table 3.38: Customer Priorities-Glucose Meter Self-Testing Market, 2001-2012 88
  415. Table 3.39: Current Blood Glucose Meters: Pricing, Sample Size, Features 88
  416. Table 3.40: Technology of Glucose Testing Instruments 90
  417. Table 3.41: Key Features of Reagent Test Strips 93
  418. Table 3.42: Limitations of Urine Glucose Monitoring 96
  419. Table 3.43: Advantages of Urine Glucose Monitoring 96
  420. Table 3.44: Blood Ketone Reading Indications 97
  421. Table 3.45: Accu-Chek Blood Glucose Monitoring Systems 103
  422. Table 3.46: GlucoTrack Comparison and Results 116
  423. Table 3.47: Home Diagnostics' Current Product Portfolio 132
  424. Table 3.48: Detailed Features of Selected CGM Systems Currently Available 140
  425. Table 3.49: Relationship of A1C to Average Whole Blood and Plasma Glucose Levels 152
  426. Table 3.50: Distributors of Glucose Meters 153
  427. Table 3.51: Ultra-Large Clinical Chemistry Analyzers 157
  428. Table 3.52: JEOL Analyzer Comparison 158
  429. Table 3.53: Large Clinical Chemistry Analyzers 160
  430. Table 3.54: Mid-size Clinical Chemistry Analyzers 163
  431. Table 3.55: Small Clinical Chemistry Analyzers 166
  432. Table 4.1: Medicare Billing Guidelines for Multichannel Chemistry Tests 177
  433. Table 5.1: Customized Reports Must Support CAP and JCAHO Requirements 198
  434. Table 5.2: Applications of RALS Connectivity with POCT Devices 198
  435. Table 6.1: Comparisons of Blood Glucose Monitoring Systems 220
  436. Table 6.2: Major Lancing Devices on the Market 224
  437. Table 6.3: Glucose Meters Offering Data Management 225
  438. Table 6.4: Comparison of A1C Home Test Kits. 240
  439. Table 6.5: Unit Costs of Glucose-Monitoring Supplies in the U.K. 247
  440. Table 6.6: Annual Costs of SMBG in the U.K. 247
  441. Table 6.7: Syringes for Administering Insulin 253
  442. Table 6.8: Insulin Pens 253
  443. Table 6.9: Injection Aids 254
  444. Table 6.10: Jet Injectors 254
  445. Table 6.11: External Insulin Pumps 255
  446. Table 6.12: Status of Inhaled Insulin Products, 2009 257
  447. Table 6.13: Insulin Delivery Device Market, 2004-2014 258
  448. Table 7.1: Leading Global Medical Device Companies, 2007 264
  449. Table 7.2: Imports of U.S. Medical Devices to Japan, 2005-2007 275
  450. Table 8.1: Products Marketed by Abbott in the Diagnostic Market 289
  451. Table 8.2: Key Roche Diagnostic Products 310
  452. Table A1.1: Company Headquarters Contact Information 315
  453. Table A2.1: Glucose Meters and Equipment- List of Manufacturers and Suppliers 322
  454. Table A3.1: Detailed Information on Available Glucose Meters 331
  455. Table A5.1: Glucose Meters' Pricing 343
  456. Table A6.1: Contract Manufacturers for Glucose Meter Components 351
  457. Table A6.2: ASIC manufacturers 353

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