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Table of Contents for Clinical Laboratory Testing Volume 1: Reagents and Instruments



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Table of Contents:

  1. 1. Overview 9
  2. 1.1 Objectives of the Report 9
  3. 1.2 Methodology 10
  4. 1.3 Scope of the Report 11
  5. 1.4 Executive Summary 12
  6. 2. IVD Clinical Laboratory Market 17
  7. 2.1 Introduction 17
  8. 2.2 Independent Clinical Labs 19
  9. 2.2.1 Key Players for Independent Clinical Labs 20
  10. 2.2.2 Quest and LabCorp 20
  11. 2.2.3 Competitive Advantages at Quest and LabCorp 23
  12. 2.2.4 Competitive Disadvantages of Quest and LabCorp 24
  13. 2.2.5 Revenue Growth of Quest and LabCorp 25
  14. 2.2.6 Sector Consolidation 27
  15. 2.2.7 Additional Independent Clinical Laboratories 27
  16. 2.3 Hospital Market 28
  17. 2.3.1 Hospital Market Overview 28
  18. 2.3.2 Hospital Lab Testing Drivers 29
  19. 2.3.3 Evaluation Models of Laboratory Testing 29
  20. 2.3.4 GPOs and IDNs 30
  21. 2.3.5 Distributors 30
  22. 2.3.6 Clinical Lab Testing Suppliers 31
  23. 2.3.7 European Hospital Purchasing Practices 31
  24. 2.3.8 Changes in Hospital Funding 32
  25. 2.3.9 European Group Purchasing 33
  26. 2.4 POL Market 33
  27. 2.5 IVD Industry 35
  28. 2.5.1 Industry Overview 35
  29. 2.5.2 IVD Industry Leading Players Comparison and Review 35
  30. 2.5.3 Biotechnology Reagents and Supplies 56
  31. 2.5.3.1 Vendor Quality Assurance 57
  32. 2.5.3.2 Partnership Support 58
  33. 2.5.3.3 Protecting Supply of Raw Materials 59
  34. 2.5.3.4 Selecting a Second Source for Chemicals 60
  35. 2.5.3.5 Cost Analysis for Reagent Manufacture 60
  36. 2.5.3.6 Outsourcing Production of Reagents 61
  37. 2.5.4 The Fastest Growing IVD Reagent Markets 61
  38. 2.5.5 Automated Instrumentation 61
  39. 2.5.6 High Growth Applications Spur Industry Growth 62
  40. 2.6 Automated Instrument Platforms Evolution 62
  41. 2.7 Reagents and Supplies Market for Clinical Lab Instruments 62
  42. 2.8 Spending for Clinical Laboratory Testing 62
  43. 2.8.1 Reimbursement Pressure 63
  44. 2.8.2 Medicare Part B Spending Trends 63
  45. 2.8.3 Strategies for Revenue Growth 66
  46. 3. IVD Clinical Laboratory Market 67
  47. 3.1 Markets 67
  48. 3.1.1 Global Markets 67
  49. 3.1.2 Global Drivers of Clinical Laboratory Testing 69
  50. 3.1.3 Global Outlook 70
  51. 3.1.4 U.S. Market 71
  52. 3.1.5 European IVD Market 73
  53. 3.1.5.1 German Clinical Laboratory Diagnostic Markets 81
  54. 3.1.5.2 U.K. Clinical Laboratory Testing Diagnostic Market 83
  55. 3.1.5.2.1 U.K. Competitive Analysis 85
  56. 3.1.5.2.2 U.K. Market Access 86
  57. 3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 86
  58. 3.1.5.4 Italian Clinical Laboratory Diagnostic Market 88
  59. 3.1.5.5 Spanish Clinical Laboratory Diagnostic Market 89
  60. 3.1.5.6 Finnish Clinical Laboratory Market 90
  61. 3.1.5.7 Turkish Clinical Laboratory Market 91
  62. 3.1.5.8 Belgium Clinical Laboratory Diagnostic Market 91
  63. 3.1.5.9 Swiss Clinical Laboratory Diagnostic Market 92
  64. 3.1.5.10 Dutch Clinical Laboratory Diagnostic Market 93
  65. 3.1.5.11 Portuguese Clinical Laboratory Diagnostic Market 94
  66. 3.1.5.12 Austrian Clinical Laboratory Diagnostic Market 95
  67. 3.1.5.13 Greek Clinical Laboratory Diagnostic Market 96
  68. 3.1.5.14 Polish Clinical Laboratory Diagnostic Market 97
  69. 3.1.5.15 Romanian Clinical Laboratory Diagnostic Market 98
  70. 3.1.5.16 Czech Republic Clinical Laboratory Diagnostic Market 99
  71. 3.1.5.17 Swedish Clinical Laboratory Diagnostic Market 99
  72. 3.1.5.18 Norwegian Clinical Laboratory Diagnostic Market 100
  73. 3.1.5.19 Irish Clinical Laboratory Diagnostic Market 100
  74. 3.1.5.20 Hungarian Clinical Laboratory Diagnostic Market 101
  75. 3.1.5.21 Bulgarian Clinical Laboratory Diagnostic Market 101
  76. 3.1.5.22 Slovakian Clinical Laboratory Diagnostic Market 102
  77. 3.1.5.23 Lithuanian Clinical Laboratory Diagnostic Market 102
  78. 3.1.5.24 Latvian Clinical Laboratory Diagnostic Market 103
  79. 3.1.5.25 Estonian Clinical Laboratory Diagnostic Market 103
  80. 3.1.5.26 Slovenian Clinical Laboratory Diagnostic Market 104
  81. 3.1.6 Asian Markets 104
  82. 3.1.6.1 Indian Clinical Laboratory Diagnostic Market 104
  83. 3.1.6.1.1 Indian IVD Testing Industry 104
  84. 3.1.6.2 Japanese Clinical Laboratory Testing Market 111
  85. 3.1.6.3 Chinese Clinical Laboratory Market 111
  86. 3.1.7 Clinical Laboratory Smaller Country Markets 119
  87. 3.1.7.1 Canadian Clinical Laboratory Market 119
  88. 3.1.7.2 Brazilian Clinical Laboratory Market 120
  89. 3.1.7.3 Australian Clinical Laboratory Market 120
  90. 3.1.8 ROW Clinical Laboratory Testing Market 121
  91. 3.1.9 Overview of Asian Healthcare Market 121
  92. 3.1.9.1 Singapore 121
  93. 3.1.9.2 Malaysia 122
  94. 3.1.9.3 Thailand 122
  95. 3.1.9.4 Indonesia 122
  96. 3.1.9.5 Philippines 123
  97. 3.1.9.6 South Korea 123
  98. 3.1.9.7 India 124
  99. 3.1.9.8 Hong Kong 124
  100. 3.1.9.9 Taiwan 124
  101. 3.1.10 Overview of the Latin American Diagnostics Market 125
  102. 3.2 Clinical Laboratory Sector 125
  103. 3.2.1 Worldwide IVD Sales 125
  104. 3.2.1.1 POLs 127
  105. 3.2.2 Industry Players 132
  106. 3.2.2.1 Manufacturing Companies 132
  107. 3.2.3 Market Specialization 134
  108. 3.2.4 Revenue and Reimbursement 136
  109. 3.2.5 Companies 136
  110. 3.3 Outlook for Clinical Laboratory Testing 137
  111. 3.3.1 Long-Term Changes 137
  112. 3.3.2 Market Drivers 139
  113. 3.3.3 The Limits to Growth 139
  114. 3.3.4 Hot Sectors in the IVD Market 139
  115. 3.3.5 Key Technologies 141
  116. 3.3.6 Conclusion 141
  117. 4. Clinical Laboratory Instrument Market by Sector 142
  118. 4.1 Chemistry Analyzers 142
  119. 4.1.1 Ultra-Large Throughput Laboratory Analyzers 142
  120. 4.1.2 Large-Throughput Analyzers 149
  121. 4.1.3 Mid-Size Clinical Laboratory Analyzers 160
  122. 4.1.4 Laboratory Analyzers for the Small Volume Market 164
  123. 4.2 Immunochemistry Analyzers 169
  124. 4.2.1 Large Immunochemistry Analyzers 169
  125. 4.2.2 Small Immunoassay Analyzers 178
  126. 4.3 Hematology Analyzers 180
  127. 4.4 POCT 194
  128. 4.4.1 U.S. POC Markets 199
  129. 4.4.2 European POCT Market 201
  130. 4.4.2.1 German POC Diagnostic Markets 204
  131. 4.4.2.2 U.K. POCT Diagnostic Market 207
  132. 4.4.2.2.1 U.K. Market Statistics 207
  133. 4.4.2.2.2 U.K. Competitive Analysis 208
  134. 4.4.2.2.3 U.K. Market Access 209
  135. 4.4.2.3 French POC Diagnostic Market 209
  136. 4.4.2.4 Italian POC Diagnostic Market 210
  137. 4.4.2.5 Spanish POC Diagnostic Market 211
  138. 4.4.2.6 Scandinavian POC Market 211
  139. 4.4.3 Japanese POCT Market 211
  140. 4.4.4 Chinese POC Market 212
  141. 4.4.5 Canadian POC Market 214
  142. 4.4.6 Brazilian POC Market 215
  143. 4.4.7 Turkish POC Market 215
  144. 4.4.8 Australian POC Market 216
  145. 4.5 ROW POCT Market 216
  146. 4.6 Cytology Testing 217
  147. 4.7 Microbiology Testing 219
  148. 4.8 Serology Testing 219
  149. 4.9 Esoteric Testing 219
  150. 4.10 Anatomic Pathology 220
  151. 4.11 Drug Testing 220
  152. 5. Important Technology Trends in IVD Instrumentation and Reagents 221
  153. 5.1 Technology Innovations in Instrument and Reagent Development 221
  154. 5.2 Sensor Systems for Diagnostic Applications 221
  155. 5.3 Glucose Measurements 223
  156. 5.4 Glucose Test Methods 226
  157. 5.5 Cholesterol Measurements 227
  158. 5.6 The New Paradigm 227
  159. 5.7 Consolidated Workstations 227
  160. 5.8 Automation in the Laboratory 229
  161. 5.9 Laboratory Information Systems 230
  162. 5.10 New User-friendly Interfaces 231
  163. 5.11 Biosensor Technology 232
  164. 5.12 Data-Management Issues 233
  165. 5.12.1 Wireless LANs 234
  166. 5.12.2 Cepheid's POC GBS and BCR/ABL Tests 234
  167. 5.12.3 Data and Workflow Management Systems 235
  168. 5.12.4 Beckman Central Command 235
  169. 6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market 236
  170. 6.1 Key Market Developments 236
  171. 6.1.1 Decreasing Revenue from Traditional IVD Markets 236
  172. 6.1.2 High Growth in POCT and Molecular Diagnostics Arena 236
  173. 6.1.3 Move Away from Traditional Kit Testing Methods 237
  174. 6.1.4 Integrated Analytical Systems 237
  175. 6.1.5 Regulatory Changes 237
  176. 6.1.6 Development of a Two-Tier Industry Structure 238
  177. 6.1.7 Labor Costs 238
  178. 6.1.8 Increasing Value of Companies with High-Margin Technology Platforms 238
  179. 6.1.9 The Joining of IVD Testing and Computer Technology 239
  180. 6.1.10 User-Friendly User Interfaces 239
  181. 6.2 Sector Consolidation 240
  182. 6.2.1 IVD Company Consolidation 240
  183. 6.2.2 Lab Company Consolidation 243
  184. 6.2.2.1 Acquisition Pricing 244
  185. 6.2.2.2 A Closer Look at Six Big Lab Deals 244
  186. 6.3 Diagnostic Testing Growth Trends 246
  187. 6.4 Reagent and Hardware Business in Japan 246
  188. 6.5 New Products 247
  189. 6.6 Acquisition, License Agreements, Internal Development and Partnerships 247
  190. 6.7 Product Testing Depth in Clinical Laboratory Testing 251
  191. 6.8 Government Regulation of IVD Devices 251
  192. 6.8.1 U.S. Regulation 251
  193. 6.8.1.1 Importing Medical Devices into the U.S. 252
  194. 6.8.1.2 Exporting Medical Devices from the U.S. 253
  195. 6.8.2 U.K. Regulation 253
  196. 6.8.3 E.U. Regulation 255
  197. 6.8.3.1 France 256
  198. 6.8.4 Japanese Regulation 257
  199. 6.8.5 Korean Regulation 257
  200. 6.8.6 Chinese Regulation 257
  201. 6.9 Increased Market Penetration 258
  202. 6.10 Costs of Doing Business in Europe 260
  203. 6.11 Drivers of European Diagnostics Testing 260
  204. 6.12 European Reimbursement Practices 260
  205. 6.13 Cost Containment in Europe 260
  206. 6.14 Hospital Outreach Programs 260
  207. 6.15 Electronic Procurement: New Challenges 261
  208. 6.16 Competition for Supply Chain Management Solutions 263
  209. 6.17 E-Commerce in the Hospital Supply Chain 264
  210. 6.17.1 Drivers of E-Commerce Solutions 265
  211. 6.17.2 Barriers to E-Commerce Solutions 265
  212. 6.18 Top Trends in Laboratory Business Practices 268
  213. 6.19 The Value of the New Diagnostics 268
  214. 6.20 Converging Technologies-Drugs and Diagnostic Tests Combine for Improved Healthcare 269
  215. 6.21 Emerging Technologies in the Downstream Manufacture of Bio-Materials 269
  216. 6.22 GMP Readiness 269
  217. 6.23 Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future 269
  218. 6.24 Partnering with Patient-Based Organizations to Achieve Patient Health Goals 269
  219. 6.25 Rumors of the Platform Company's Demise are Greatly Exaggerated 270
  220. 6.26 Who's Going to Pay for It? 270
  221. 7. Company Profiles 273
  222. 7.1 Abaxis 273
  223. 7.2 Abbott Diagnostics 274
  224. 7.3 Adaltis, Inc. 278
  225. 7.4 Alfa Wasserman, Inc. (formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 279
  226. 7.5 Awareness Technology 280
  227. 7.6 Bayer Diagnostics 280
  228. 7.7 Beckman Coulter, Inc. 281
  229. 7.8 Bio-Reference Laboratories, Inc. 286
  230. 7.9 Clarient, Inc. 286
  231. 7.10 Dade Behring, Inc. 287
  232. 7.11 Enzo Biochem, Inc. 295
  233. 7.12 Genomic Health, Inc. 295
  234. 7.13 Hitachi 296
  235. 7.14 Horiba Ltd. 296
  236. 7.15 JEOL Ltd. 297
  237. 7.16 LabCorp 297
  238. 7.17 Medtox Scientific, Inc. 298
  239. 7.18 Monogram Biosciences, Inc. 298
  240. 7.19 Myriad Genetics, Inc. 299
  241. 7.20 Nova Biomedical 299
  242. 7.21 Olympus America, Inc. Diagnostic Systems Division 299
  243. 7.22 Ortho-Clinical Diagnostics, a J&J Company 301
  244. 7.23 Psychemedics Corporation 303
  245. 7.24 Quest Diagnostics, Inc. 304
  246. 7.25 Roche Diagnostics Corp. 304
  247. 7.26 Shimadzu 307
  248. 7.27 Sysmex Corporation 307
  249. 7.28 Thermo Fisher Scientific, Inc. 308
  250. 7.29 Vital Scientific, NV 308
  251. LIST OF FIGURES
  252. Figure 2.1: Clinical Laboratory Testing Sector Providers 18
  253. Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-2005 63
  254. Figure 3.1: European IVD Market by Clinical Specialty 76
  255. Figure 3.2: Chinese IVD Market, 1995-2004 112
  256. Figure 3.3: Annual Worldwide IVD Market Growth, 2003-2005 126
  257. Figure 3.4: POL Revenue, 2000-2006 128
  258. Figure 3.5: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006 128
  259. Figure 3.6: Total Number of Non-Waived POLs, 2000-2006 129
  260. Figure 3.7: Number of New Tests Granted CLIA-Waived Status, 2000-2006 129
  261. Figure 3.8: High-Volume Waived Tests 130
  262. Figure 3.9: U.S. Revenue for Six Largest IVD Vendors, 2005 132
  263. Figure 3.10: U.S. Revenue Change for Six Largest IVD Vendors, 2005 133
  264. Figure 6.1: Average Revenue-Multiple Paid to Acquire Labs, 2000-2006 244
  265. Figure 6.2: Hospital Market Share for Outreach Programs 261
  266. LIST OF TABLES
  267. Table 2.1: Total U.S. Clinical Laboratory Revenue from Third Party and Direct Payment, 2005-2012 18
  268. Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2005 19
  269. Table 2.3: Independent Commercial Laboratory Testing Market Value, 2005-2012 19
  270. Table 2.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012 19
  271. Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization, 2006 20
  272. Table 2.6: Revenue Growth at Quest Diagnostics, 2000-2006 25
  273. Table 2.7: Revenue Growth at LabCorp, 2000-2006 25
  274. Table 2.8: Quest Diagnostics Revenue from Managed Care Contracts, 2004-2006 26
  275. Table 2.9: LabCorp Revenue from Managed Care Contracts, 2004-2006 26
  276. Table 2.10: Quest's Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing, 2005 26
  277. Table 2.11: Number of Hospital Based Clinical Laboratory Tests in the U.S., 2002-2008 28
  278. Table 2.12: European Cardiovascular Disease Management Expenditures, 2003-2010 32
  279. Table 2.13: U.S. Doctor's Office Lab Test Dollar Volume and Growth Rates, 2006 34
  280. Table 2.14: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012 34
  281. Table 2.15: Top IVD Manufacturers, 2005 36
  282. Table 2.16: Products Marketed by Abbott in the Diagnostic Market 41
  283. Table 2.17: Prodesse's ASRs 57
  284. Table 2.18: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005 64
  285. Table 2.19: Medicare Spending on Clinical Lab Services, 1991-2005 64
  286. Table 2.20: Medicare Part B Spending Per Medicare Enrollee, 1998-2005 65
  287. Table 2.21: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005 65
  288. Table 3.1: Worldwide IVD Testing Market, 2006 67
  289. Table 3.2: Worldwide Distribution of IVD Testing, 2006 67
  290. Table 3.3: Global Clinical Laboratory Market Sales, 1998-2010 68
  291. Table 3.4: Top 15 IVD Manufacturers' Worldwide Revenue 69
  292. Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012 71
  293. Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2006 72
  294. Table 3.7: U.S. Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 72
  295. Table 3.8: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2006 72
  296. Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 73
  297. Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 73
  298. Table 3.11: European Clinical Chemistry Testing Reagents and Instruments Market, 2006 74
  299. Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 2006 74
  300. Table 3.13: European Rapid POCT by Country Market, 2006 75
  301. Table 3.14: European Patient Self Testing OTC Diagnostics by Country Market, 2006 75
  302. Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 82
  303. Table 3.16: German Clinical Reagents and Instruments Market, 2003 82
  304. Table 3.17: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 84
  305. Table 3.18: U.K. Clinical Reagents and Instruments Market, 2006 84
  306. Table 3.19: Major U.K. IVD Manufacturers 85
  307. Table 3.20: U.S. IVD Manufacturers Doing Business in the U.K. 85
  308. Table 3.21: Other European Companies that Manufacture IVD Products in the U.K. 86
  309. Table 3.22: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 87
  310. Table 3.23: French Clinical Reagents and Instruments Market, 2006 87
  311. Table 3.24: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 88
  312. Table 3.25: Italian Clinical Reagents and Instruments Market, 2006 88
  313. Table 3.26: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 89
  314. Table 3.27: Spanish Clinical Reagents and Instruments Market, 2006 89
  315. Table 3.28: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 90
  316. Table 3.29: Finnish Clinical Reagents and Instruments Market, 2006 90
  317. Table 3.30: Turkish Clinical Laboratory Testing Market, 2003-2012 91
  318. Table 3.31: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 91
  319. Table 3.32: Belgium Clinical Reagents and Instruments Market, 2006 92
  320. Table 3.33: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 92
  321. Table 3.34: Swiss Clinical Reagents and Instruments Market, 2006 93
  322. Table 3.35: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 93
  323. Table 3.36: Dutch Clinical Reagents and Instruments Market, 2006 93
  324. Table 3.37: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 94
  325. Table 3.38: Portuguese Clinical Reagents and Instruments Market, 2006 94
  326. Table 3.39: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 95
  327. Table 3.40: Austrian Clinical Reagents and Instruments Market, 2006 95
  328. Table 3.41: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 96
  329. Table 3.42: Greek Clinical Reagents and Instruments Market, 2006 96
  330. Table 3.43: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 97
  331. Table 3.44: Polish Clinical Reagents and Instruments Market, 2006 97
  332. Table 3.45: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 98
  333. Table 3.46: Romanian Clinical Reagents and Instruments Market, 2006 98
  334. Table 3.47: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 99
  335. Table 3.48: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 99
  336. Table 3.49: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 100
  337. Table 3.50: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 100
  338. Table 3.51: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 101
  339. Table 3.52: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 101
  340. Table 3.53: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 102
  341. Table 3.54: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 102
  342. Table 3.55: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 103
  343. Table 3.56: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 103
  344. Table 3.57: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 104
  345. Table 3.58: Indian IVD Market for Instruments and Reagents, 2004-2012 104
  346. Table 3.59: Number of Automated Clinical Labs in India, 2004-2012 105
  347. Table 3.60: Indian IVD Market, 2006 105
  348. Table 3.61: Market Sales of IVD Equipment and Reagents by Company in India, 2004 and 2005 108
  349. Table 3.62: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012 111
  350. Table 3.63: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 112
  351. Table 3.64: Chinese IVD Market 112
  352. Table 3.65: Proportion of Medical Expenses Paid Privately 114
  353. Table 3.66: Chinese International IVD Manufacturers 115
  354. Table 3.67: Chinese Domestic IVD Manufacturers 116
  355. Table 3.68: Chinese IVD Distributors 118
  356. Table 3.69: Canadian Clinical Laboratory Testing Market, 2000-2008 119
  357. Table 3.70: Brazilian Clinical Laboratory Testing Market, 2000-2008 120
  358. Table 3.71: Australian Clinical Laboratory Testing Market, 2000-2008 120
  359. Table 3.72: ROW Clinical Laboratory Testing Market, 2000-2008 121
  360. Table 3.73: Number of Clinical Laboratories in Latin America 125
  361. Table 3.74: Twenty Most Common Laboratory Tests Offered at Family Physician Offices 131
  362. Table 3.75: Important New Waived Tests 132
  363. Table 3.76: Principal Marketers of Automated Clinical Laboratory Instruments 133
  364. Table 4.1: Ultra-Large Clinical Laboratory Analyzers 149
  365. Table 4.2: JEOL Analyzer Comparison 157
  366. Table 4.3: Large Clinical Laboratory Analyzers 160
  367. Table 4.4: Mid-size Clinical Laboratory Analyzers 163
  368. Table 4.5: Small Clinical Laboratory Analyzers 168
  369. Table 4.6: Large Immunochemistry Analyzers 177
  370. Table 4.7: Small Immunoassay Analyzers 180
  371. Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 182
  372. Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 183
  373. Table 4.10: Linearity and Precision of Bayer Hematology Analyzers 184
  374. Table 4.11: Accuracy of the Automated Differential of Bayer Hematology Analyzers 184
  375. Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments 186
  376. Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 186
  377. Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers 188
  378. Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers 189
  379. Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers 191
  380. Table 4.17: Accuracy of the Sysmex Hematology Analyzers 192
  381. Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 192
  382. Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 193
  383. Table 4.20: Hematology Analyzers with a Five-Part WBC Differential 193
  384. Table 4.21: Hematology Analyzers with a Three-Part WBC Differential 194
  385. Table 4.22: POCT 195
  386. Table 4.23: Number of ER Visits in U.S. Hospitals, 1996-2005 197
  387. Table 4.24: Number of POCT in U.S., 2000-2011 198
  388. Table 4.25: Global POC Revenues, 1998-2008 199
  389. Table 4.26: Worldwide Distribution of POCT, 2005 199
  390. Table 4.27: U.S. POCT Market, 2000-2011 200
  391. Table 4.28: U.S. Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 2005 200
  392. Table 4.29: U.S. POCT by Distribution Location, 2005 200
  393. Table 4.30: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2005 201
  394. Table 4.31: Drivers of European Diagnostics Testing 202
  395. Table 4.32: Regional Comparison of Healthcare and IVD for Eastern Europe 203
  396. Table 4.33: European IVD Reagent Testing Market, 2000-2012 203
  397. Table 4.34: European Testing Diagnostics Market, 2004 203
  398. Table 4.35: Top Dozen Country IVD Testing Markets and POC Share, 2004 204
  399. Table 4.36: German POCT Diagnostics Products Market Sales, 2002-2007 204
  400. Table 4.37: German Patient Care Central Lab Test Market, 2000-2008 205
  401. Table 4.38: German Alternate Site Testing Market (POL), 2000-2008 205
  402. Table 4.39: German Hospital POC Market, 2000-2008 205
  403. Table 4.40: German Clinical Diagnostic Test Market Segments; Sales from Clinical Laboratory Testing, 2004 206
  404. Table 4.41: German Clinical Diagnostic Rapid Test Market Segments 206
  405. Table 4.42: U.K. POC Diagnostics Products Market Sales, 1998-2007 207
  406. Table 4.43: Major U.K. IVD Manufacturers 208
  407. Table 4.44: U.S. IVD Manufacturers Doing Business in the U.K. 208
  408. Table 4.45: Other European Companies that Manufacture IVD Products in the U.K. 209
  409. Table 4.46: French POC Diagnostics Products Market Sales, 1998-2007 210
  410. Table 4.47: Italian POC Diagnostics Products Market Sales, 1998-2007 210
  411. Table 4.48: Spanish POC Diagnostics Products Market Sales, 1998-2007 211
  412. Table 4.49: Scandinavian POC Diagnostics Products Market Sales, 2000-2008 211
  413. Table 4.50: Japanese POCT Market, 2000-2008 212
  414. Table 4.51: Chinese POC Diagnostics Products Market Sales, 2000-2008 212
  415. Table 4.52: Canadian POCT Market, 2000-2008 214
  416. Table 4.53: Brazilian POCT Market, 2000-2008 215
  417. Table 4.54: Turkish POCT Market, 2000-2008 215
  418. Table 4.55: Australian POCT Market, 2000-2008 216
  419. Table 4.56: ROW POCT Market, 2000-2007 216
  420. Table 4.57: PAP Tests in Top European Markets 218
  421. Table 4.58: PAP Tests in Top Asian Markets 218
  422. Table 5.1: Normal Glucose Values-Fasting State 225
  423. Table 5.2: Applications for Wireless LAN Technology 234
  424. Table 7.1: Products Marketed by Abbott in the Diagnostics Market 277
  425. Table 7.2: Products Marketed by Dade Behring in the Diagnostics Market 288
  426. Table 7.3: Clinically Significant Tests Available From Dade 292
  427. Table 7.4: Comparison of JEOL Analyzers 297
  428. Table 7.5: The VITROS ECiQ Immunodiagnostic System 302
  429. Table 7.6: Sysmex Marketing Summary for China 308



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