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Clinical Laboratory Testing Volume 1: Reagents and Instruments
Publication Date: 01-APR-09
Pages: 283
Study: TMRCLTV1
Format/Price: PDF document / $3,400.00
   


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Clinical laboratory analysis for in vitro diagnostic (IVD) testing is one of the most important sectors of medical care. By all accounts, it is very mature, large and diverse--crossing the $39 billion mark in 2008--and employing over 100,000 laboratory workers, and spawning an industry for reagents and instruments comprised of thousands of companies worldwide. The term clinical laboratory analysis usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily collected body fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations. The purpose of this TriMark Publications report is to describe the specific segments of the global clinical laboratory instrumentation and reagent market. Within this area, the report covers those segments that are highly active in terms of innovation and growth. Specifically, this global clinical laboratory markets report examines the markets for small lab equipment all the way up to highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers' original equipment manufacturer (OEM) additional equipment. The emphasis in this analysis is on those companies and products that are actively developing and marketing laboratory analyzer products for the clinical setting, including hospitals, independent labs, physician's offices and miscellaneous clinics. This study concentrates on the clinical laboratory instrumentation industry market segment and the companion reagents sector in the U.S. and around the world. The regional markets and their differences are examined, including Europe, Asia (Japan, China and India) and the rest of the world (ROW). Particular attention is paid to those areas of the clinical laboratory instrumentation and reagents sector that are showing the greatest growth or the most innovation.

This report attempts to answer the following questions:

• Which companies are the key players?
• What are the opportunities in clinical laboratory instrumentation and reagent markets?
• What is happening with the information revolution in lab instruments?
• What are the developing trends?
• Where are the new market growth areas?
• What are the most favored lab analysis technology platforms?
• Where is the laboratory analyzer instrument technology taking us?
• How is immunological technology blending with more established laboratory procedures?
• What are the business trends in the IVD industry?

This analysis reviews the market for clinical laboratory instrumentation used in clinical practice. It defines the dollar volume of sales in each major regional market, as well as 25 individual European country markets, and it analyzes the factors that influence the size and the growth of the individual market segments. The report details market sizes and growth rates for the U.S. and world markets. The study surveys some of the leading companies known to be marketing, manufacturing or developing products for the clinical laboratory instrumentation and reagent market for those sectors covered here. Each company is discussed in depth with a section on the history of the company, product lines, business and marketing analysis, and a subjective commentary of the position of the company in its market. The unique benefits of this report are:

• In-depth analysis of the major sectors of the clinical laboratory instrumentation and reagent sectors, their size, growth rates and major drivers.

• Presentation of some of the emerging technology platforms, elucidating the potential areas that could gain traction in this market.

• Analysis of the partnerships and alliances the various key sector players have forged, as well as describing financings of these market participants, giving insight into potential market collaborations.

• Examination of new technology platforms in the U.S., Japan and Europe that seek to dominate this mature market, and to identify lead positions and potential future growth areas.





Table of Contents:

  1. 1. Overview 8
  2. 1.1 Objectives of the Report 8
  3. 1.2 Methodology 9
  4. 1.3 Scope of the Report 10
  5. 1.4 Executive Summary 11
  6. 2. IVD Clinical Laboratory Market 16
  7. 2.1 Introduction 16
  8. 2.2 Independent Clinical Labs 18
  9. 2.2.1 Key Players for Independent Clinical Labs 19
  10. 2.2.2 Quest Diagnostics and LabCorp 19
  11. 2.2.3 Competitive Advantages at Quest and LabCorp 22
  12. 2.2.4 Competitive Disadvantages of Quest and LabCorp 24
  13. 2.2.5 Revenue Growth of Quest and LabCorp 24
  14. 2.2.6 Sector Consolidation 25
  15. 2.2.7 Additional Independent Clinical Laboratories 26
  16. 2.3 Hospital Market 27
  17. 2.3.1 Hospital Market Overview 27
  18. 2.3.2 Hospital Lab Testing Drivers 27
  19. 2.3.3 Evaluation Models of Laboratory Testing 28
  20. 2.3.4 GPOs and IDNs 29
  21. 2.3.5 Distributors 29
  22. 2.3.6 Clinical Lab Testing Suppliers 30
  23. 2.3.7 European Hospital Purchasing Practices 30
  24. 2.3.8 Changes in Hospital Funding 31
  25. 2.3.9 European Group Purchasing 31
  26. 2.4 POL Market 32
  27. 2.5 IVD Industry 33
  28. 2.5.1 Industry Overview 33
  29. 2.5.2 IVD Industry Leading Players Comparison and Review 34
  30. 2.5.3 Biotechnology Reagents and Supplies 48
  31. 2.5.3.1 Vendor Quality Assurance 49
  32. 2.5.3.2 Partnership Support 50
  33. 2.5.3.3 Protecting Supply of Raw Materials 51
  34. 2.5.3.4 Selecting a Second Source for Chemicals 52
  35. 2.5.3.5 Cost Analysis for Reagent Manufacture 52
  36. 2.5.3.6 Outsourcing Production of Reagents 53
  37. 2.5.4 The Fastest Growing IVD Reagent Markets 53
  38. 2.5.5 Automated Instrumentation 53
  39. 2.5.6 High Growth Applications Spur Industry Growth 54
  40. 2.6 Automated Instrument Platforms Evolution 54
  41. 2.7 Reagents and Supplies Market for Clinical Lab Instruments 54
  42. 2.8 Spending for Clinical Laboratory Testing 54
  43. 2.8.1 Reimbursement Pressure 55
  44. 2.8.2 Medicare Part B Spending Trends 57
  45. 2.8.3 Strategies for Revenue Growth 58
  46. 3. IVD Clinical Laboratory Market 59
  47. 3.1 Markets 59
  48. 3.1.1 Global Markets 59
  49. 3.1.2 Global Drivers of Clinical Laboratory Testing 61
  50. 3.1.3 Global Outlook 62
  51. 3.1.4 U.S. Market 63
  52. 3.1.5 European IVD Market 66
  53. 3.1.5.1 German Clinical Laboratory Diagnostic Markets 76
  54. 3.1.5.2 U.K. Clinical Laboratory Testing Diagnostic Market 77
  55. 3.1.5.2.1 U.K. Competitive Analysis 78
  56. 3.1.5.2.2 U.K. Market Access 79
  57. 3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 80
  58. 3.1.5.4 Italian Clinical Laboratory Diagnostic Market 81
  59. 3.1.5.5 Spanish Clinical Laboratory Diagnostic Market 82
  60. 3.1.5.6 Finnish Clinical Laboratory Market 83
  61. 3.1.5.7 Turkish Clinical Laboratory Market 84
  62. 3.1.5.8 Belgium Clinical Laboratory Diagnostic Market 84
  63. 3.1.5.9 Swiss Clinical Laboratory Diagnostic Market 85
  64. 3.1.5.10 Dutch Clinical Laboratory Diagnostic Market 86
  65. 3.1.5.11 Portuguese Clinical Laboratory Diagnostic Market 87
  66. 3.1.5.12 Austrian Clinical Laboratory Diagnostic Market 88
  67. 3.1.5.13 Greek Clinical Laboratory Diagnostic Market 89
  68. 3.1.5.14 Polish Clinical Laboratory Diagnostic Market 90
  69. 3.1.5.15 Romanian Clinical Laboratory Diagnostic Market 91
  70. 3.1.5.16 Czech Republic Clinical Laboratory Diagnostic Market 92
  71. 3.1.5.17 Swedish Clinical Laboratory Diagnostic Market 93
  72. 3.1.5.18 Norwegian Clinical Laboratory Diagnostic Market 93
  73. 3.1.5.19 Irish Clinical Laboratory Diagnostic Market 94
  74. 3.1.5.20 Hungarian Clinical Laboratory Diagnostic Market 94
  75. 3.1.5.21 Bulgarian Clinical Laboratory Diagnostic Market 95
  76. 3.1.5.22 Slovakian Clinical Laboratory Diagnostic Market 95
  77. 3.1.5.23 Lithuanian Clinical Laboratory Diagnostic Market 96
  78. 3.1.5.24 Latvian Clinical Laboratory Diagnostic Market 96
  79. 3.1.5.25 Estonian Clinical Laboratory Diagnostic Market 97
  80. 3.1.5.26 Slovenian Clinical Laboratory Diagnostic Market 97
  81. 3.1.6 Asian Markets 98
  82. 3.1.6.1 Indian Clinical Laboratory Diagnostic Market 98
  83. 3.1.6.1.1 Indian IVD Testing Industry 98
  84. 3.1.6.2 Japanese Clinical Laboratory Testing Market 103
  85. 3.1.6.3 Chinese Clinical Laboratory Market 103
  86. 3.1.7 Clinical Laboratory Smaller Country Markets 111
  87. 3.1.7.1 Canadian Clinical Laboratory Market 111
  88. 3.1.7.2 Brazilian Clinical Laboratory Market 112
  89. 3.1.7.3 Australian Clinical Laboratory Market 112
  90. 3.1.8 ROW Clinical Laboratory Testing Market 113
  91. 3.1.9 Overview of Asian Healthcare Market 113
  92. 3.1.9.1 Singapore 114
  93. 3.1.9.2 Malaysia 115
  94. 3.1.9.3 Thailand 116
  95. 3.1.9.4 Indonesia 116
  96. 3.1.9.5 Philippines 116
  97. 3.1.9.6 South Korea 116
  98. 3.1.9.7 India 117
  99. 3.1.9.8 Hong Kong 117
  100. 3.1.9.9 Taiwan 117
  101. 3.1.10 Overview of the Latin American Diagnostics Market 118
  102. 3.2 Clinical Laboratory Sector 118
  103. 3.2.1 Worldwide IVD Sales 118
  104. 3.2.1.1 POLs 120
  105. 3.2.2 Industry Players 125
  106. 3.2.2.1 Manufacturing Companies 125
  107. 3.2.3 Market Specialization 126
  108. 3.2.4 Revenue and Reimbursement 128
  109. 3.2.5 Companies 129
  110. 3.3 Outlook for Clinical Laboratory Testing 130
  111. 3.3.1 Long-Term Changes 130
  112. 3.3.2 Market Drivers 131
  113. 3.3.3 The Limits to Growth 132
  114. 3.3.4 Hot Sectors in the IVD Market 133
  115. 3.3.5 Key Technologies 135
  116. 3.3.6 Conclusion 135
  117. 4. Clinical Laboratory Instrument Market by Sector 136
  118. 4.1 Chemistry Analyzers 136
  119. 4.1.1 Ultra-Large Throughput Laboratory Analyzers 136
  120. 4.1.2 Large-Throughput Analyzers 143
  121. 4.1.3 Mid-Size Clinical Laboratory Analyzers 154
  122. 4.1.4 Laboratory Analyzers for the Small Volume Market 158
  123. 4.2 Immunochemistry Analyzers 165
  124. 4.2.1 Large Immunochemistry Analyzers 165
  125. 4.2.2 Small Immunoassay Analyzers 174
  126. 4.3 Hematology Analyzers 176
  127. 4.4 Point of Care Testing 192
  128. 4.6 Cytology Testing 196
  129. 4.7 Microbiology Testing 198
  130. 4.8 Serology Testing 198
  131. 4.9 Esoteric Testing 198
  132. 4.10 Anatomic Pathology 199
  133. 4.11 Drug Testing 199
  134. 5. Important Technology Trends in IVD Instrumentation and Reagents 200
  135. 5.1 Technology Innovations in Instrument and Reagent Development 200
  136. 5.2 Sensor Systems for Diagnostic Applications 200
  137. 5.3 Glucose Measurements 205
  138. 5.4 Glucose Test Methods 207
  139. 5.5 Cholesterol Measurements 208
  140. 5.6 The New Paradigm 209
  141. 5.7 Consolidated Workstations 209
  142. 5.8 Automation in the Laboratory 211
  143. 5.9 Laboratory Information Systems 212
  144. 5.10 New User-friendly Interfaces 213
  145. 5.11 Biosensor Technology 214
  146. 5.12 Data-Management Issues 216
  147. 5.12.1 Wireless LANs 216
  148. 5.12.2 Cepheid's POC GBS and BCR/ABL Tests 216
  149. 5.12.3 Data and Workflow Management Systems 217
  150. 5.12.4 Beckman Central Command 217
  151. 6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market 218
  152. 6.1 Key Market Developments 218
  153. 6.1.1 Decreasing Revenue from Traditional IVD Markets 218
  154. 6.1.2 High Growth in POCT and Molecular Diagnostics Arena 218
  155. 6.1.3 Move Away from Traditional Kit Testing Methods 219
  156. 6.1.4 Integrated Analytical Systems 219
  157. 6.1.5 Regulatory Changes 220
  158. 6.1.6 Development of a Two-Tier Industry Structure 220
  159. 6.1.7 Labor Costs 220
  160. 6.1.8 Increasing Value of Companies with High-Margin Technology Platforms 220
  161. 6.1.9 The Joining of IVD Testing and Computer Technology 221
  162. 6.1.10 User-Friendly User Interfaces 221
  163. 6.2 Sector Consolidation 222
  164. 6.2.1 IVD Company Consolidation 222
  165. 6.2.2 Lab Company Consolidation 225
  166. 6.2.2.1 Acquisition Pricing 226
  167. 6.2.2.2 A Closer Look at Six Big Lab Deals 226
  168. 6.3 Diagnostic Testing Growth Trends 228
  169. 6.4 Reagent and Hardware Business in Japan 228
  170. 6.5 New Products 228
  171. 6.6 Acquisition, License Agreements, Internal Development and Partnerships 229
  172. 6.7 Product Testing Depth in Clinical Laboratory Testing 230
  173. 6.8 Government Regulation of IVD Devices 230
  174. 6.8.1 U.S. Regulation 230
  175. 6.8.1.1 Importing Medical Devices into the U.S. 232
  176. 6.8.1.2 Exporting Medical Devices from the U.S. 233
  177. 6.8.2 U.K. Regulation 233
  178. 6.8.3 E.U. Regulation 234
  179. 6.8.3.1 France 236
  180. 6.8.4 Japanese Regulation 237
  181. 6.8.5 Korean Regulation 237
  182. 6.8.6 Chinese Regulation 237
  183. 6.9 Increased Market Penetration 238
  184. 6.10 Costs of Doing Business in Europe 239
  185. 6.11 Drivers of European Diagnostics Testing 239
  186. 6.12 European Reimbursement Practices 239
  187. 6.13 Cost Containment in Europe 240
  188. 6.14 Hospital Outreach Programs 240
  189. 6.15 Electronic Procurement: New Challenges 240
  190. 6.16 Competition for Supply Chain Management Solutions 243
  191. 6.17 E-Commerce in the Hospital Supply Chain 244
  192. 6.17.1 Drivers of E-Commerce Solutions 244
  193. 6.17.2 Barriers to E-Commerce Solutions 245
  194. 6.18 Top Trends in Laboratory Business Practices 247
  195. 6.19 The Value of the New Diagnostics 247
  196. 6.20 Converging Technologies-Drugs and Diagnostic Tests Combine for Improved Healthcare 248
  197. 6.21 Emerging Technologies in the Downstream Manufacture of Bio-Materials 248
  198. 6.22 GMP Readiness 248
  199. 6.23 Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future 248
  200. 6.24 Partnering with Patient-Based Organizations to Achieve Patient Health Goals 249
  201. 6.25 Rumors of the Platform Company's Demise are Greatly Exaggerated 249
  202. 6.26 Who's Going to Pay for It? 249
  203. 7. Company Profiles 252
  204. 7.1 Abaxis 252
  205. 7.2 Abbott 252
  206. 7.3 Adaltis, Inc. 255
  207. 7.4 Alfa Wasserman, Inc. (formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 255
  208. 7.5 Awareness Technology 256
  209. 7.6 Beckman Coulter, Inc. 256
  210. 7.7 Bio-Reference Laboratories, Inc. 264
  211. 7.8 Dade Behring, Inc. 264
  212. 7.9 Enzo Biochem, Inc. 265
  213. 7.10 Genomic Health, Inc. 265
  214. 7.11 Hitachi 265
  215. 7.12 Horiba Ltd. 266
  216. 7.13 JEOL Ltd. 267
  217. 7.14 LabCorp 268
  218. 7.15 MEDTOX Scientific, Inc. 268
  219. 7.16 Monogram Biosciences, Inc. 269
  220. 7.17 Myriad Genetics, Inc. 269
  221. 7.18 Nova Biomedical 269
  222. 7.19 Olympus America, Inc. Diagnostic Systems Division 270
  223. 7.20 Ortho-Clinical Diagnostics, a J&J Company 271
  224. 7.21 Psychemedics Corporation 274
  225. 7.22 Quest Diagnostics, Inc. 274
  226. 7.23 Roche Diagnostics Corp. 275
  227. 7.24 Shimadzu 278
  228. 7.25 Sysmex Corporation 278
  229. 7.26 Thermo Fisher Scientific, Inc. 279
  230. 7.27 Vital Scientific, NV 281
  231. LIST OF FIGURES
  232. Figure 2.1: Clinical Laboratory Testing Sector Providers 17
  233. Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-2007 57
  234. Figure 3.1: IVD Product Demand 63
  235. Figure 3.2: European IVD Market by Clinical Specialty 70
  236. Figure 3.3: Chinese IVD Market, 2006-2012 104
  237. Figure 3.4: Annual Worldwide IVD Market Growth, 2003-2012 119
  238. Figure 3.5: POL Revenue, 2000-2006 121
  239. Figure 3.6: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006 121
  240. Figure 3.7: Total Number of Non-Waived POLs, 2000-2006 122
  241. Figure 3.8: Number of New Tests Granted CLIA-Waived Status, 2000-2006 123
  242. Figure 3.9: High-Volume Waived Tests 124
  243. Figure 6.1: Average Revenue-Multiple Paid to Acquire Labs, 2000-2006 226
  244. Figure 6.2: Hospital Market Share for Outreach Programs 240
  245. LIST OF TABLES
  246. Table 2.1: Total U.S. Clinical Laboratory Revenue from Third Party and Direct Payment, 2005-2012 17
  247. Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007 18
  248. Table 2.3: Independent Commercial Laboratory Testing Market Value, 2005-2012 18
  249. Table 2.4: Independent Commercial Laboratory Testing Test Volume, 2005-2012 18
  250. Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization, 2008 19
  251. Table 2.6: Revenue Growth at Quest Diagnostics, 2000-2008 24
  252. Table 2.7: Revenue Growth at LabCorp, 2000-2008 25
  253. Table 2.8: Quest's Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing, 2007 25
  254. Table 2.9: Number of Hospital Based Clinical Laboratory Tests in the U.S., 2002-2008 27
  255. Table 2.10: European Cardiovascular Disease Management Expenditures, 2003-2010 31
  256. Table 2.11: U.S. Doctor's Office Lab Test Dollar Volume and Growth Rates, 2006 32
  257. Table 2.12: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-2012 33
  258. Table 2.13: Thirteen Largest Diagnostic Companies Worldwide, 2007 34
  259. Table 2.14: Products Marketed by Abbott in the Diagnostic Market 39
  260. Table 2.15: Prodesse's ASRs 49
  261. Table 2.16: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009 58
  262. Table 3.1: Worldwide IVD Testing Market, 2008 59
  263. Table 3.2: Worldwide Distribution of IVD Testing, 2008 59
  264. Table 3.3: Global Clinical Laboratory Market Sales, 1998-2012 60
  265. Table 3.4: Thirteen Largest Diagnostic Companies Worldwide, 2007 61
  266. Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-2012 64
  267. Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007 64
  268. Table 3.7: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 65
  269. Table 3.8: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2007 65
  270. Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 66
  271. Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2006 66
  272. Table 3.11: European Clinical Chemistry Testing IVD Reagents and Instruments Market, 2000-2012 67
  273. Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 2008 68
  274. Table 3.13: European Rapid POCT by Country Market, 2008 69
  275. Table 3.14: European Patient Self Testing OTC Diagnostics by Country Market, 2006 69
  276. Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 76
  277. Table 3.16: German Clinical Diagnostic Rapid Test Market Segments, 2008 76
  278. Table 3.17: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 77
  279. Table 3.18: U.K. Clinical Diagnostic Rapid Test Market Segments, 2008 78
  280. Table 3.19: Major U.K. IVD Manufacturers 79
  281. Table 3.20: U.S. IVD Manufacturers Doing Business in the U.K. 79
  282. Table 3.21: Other European Companies that Manufacture IVD Products in the U.K. 79
  283. Table 3.22: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 80
  284. Table 3.23: French Clinical Diagnostic Rapid Test Market Segments, 2008 80
  285. Table 3.24: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 81
  286. Table 3.25: Italian Clinical Diagnostic Rapid Test Market Segments, 2008 82
  287. Table 3.26: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 82
  288. Table 3.27: Spanish Clinical Diagnostic Rapid Test Market Segments, 2008 83
  289. Table 3.28: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 83
  290. Table 3.29: Turkish Clinical Laboratory Testing Market, 2000-2012 84
  291. Table 3.30: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 84
  292. Table 3.31: Belgium Clinical Reagents and Instruments Market, 2006 85
  293. Table 3.32: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 85
  294. Table 3.33: Swiss Clinical Reagents and Instruments Market, 2006 86
  295. Table 3.34: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 86
  296. Table 3.35: Dutch Clinical Reagents and Instruments Market, 2006 87
  297. Table 3.36: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 87
  298. Table 3.37: Portuguese Clinical Reagents and Instruments Market, 2006 88
  299. Table 3.38: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 88
  300. Table 3.39: Austrian Clinical Reagents and Instruments Market, 2006 89
  301. Table 3.40: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 89
  302. Table 3.41: Greek Clinical Reagents and Instruments Market, 2006 90
  303. Table 3.42: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 90
  304. Table 3.43: Polish Clinical Reagents and Instruments Market, 2006 91
  305. Table 3.44: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 91
  306. Table 3.45: Romanian Clinical Reagents and Instruments Market, 2006 92
  307. Table 3.46: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 92
  308. Table 3.47: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 93
  309. Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 93
  310. Table 3.49: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 94
  311. Table 3.50: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 94
  312. Table 3.51: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 95
  313. Table 3.52: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 95
  314. Table 3.53: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 96
  315. Table 3.54: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 96
  316. Table 3.55: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 97
  317. Table 3.56: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 97
  318. Table 3.57: Indian IVD Market for Instruments and Reagents, 2004-2012 98
  319. Table 3.58: Number of Automated Clinical Labs in India, 2004-2012 98
  320. Table 3.59: Indian IVD Market, 2008 99
  321. Table 3.60: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012 103
  322. Table 3.61: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 104
  323. Table 3.62: Chinese IVD Market, 2008 104
  324. Table 3.63: Proportion of Medical Expenses Paid Privately 106
  325. Table 3.64: Chinese International IVD Manufacturers 107
  326. Table 3.65: Chinese Domestic IVD Manufacturers 108
  327. Table 3.66: Chinese IVD Distributors 110
  328. Table 3.67: Canadian Clinical Laboratory Testing Market, 2000-2008 111
  329. Table 3.68: Brazilian Clinical Laboratory Testing Market, 2000-2008 112
  330. Table 3.69: Australian Clinical Laboratory Testing Market, 2000-2008 112
  331. Table 3.70: ROW Clinical Laboratory Testing Market, 2000-2008 113
  332. Table 3.71: Number of Clinical Laboratories in Latin America 118
  333. Table 3.72: Twenty Most Common Laboratory Tests Offered at Family Physician Offices 125
  334. Table 3.73: Important New Waived Tests 125
  335. Table 3.74: Principal Marketers of Automated Clinical Laboratory Instruments 126
  336. Table 3.75: Key Market Drivers of Automated Clinical Laboratory Instruments 131
  337. Table 3.76: Key Market Limits of Automated Clinical Laboratory Instruments 133
  338. Table 4.1: Ultra-Large Clinical Laboratory Analyzers 143
  339. Table 4.2: JEOL Analyzer Comparison 151
  340. Table 4.3: Large Clinical Laboratory Analyzers 154
  341. Table 4.4: Mid-size Clinical Laboratory Analyzers 158
  342. Table 4.5: Small Clinical Laboratory Analyzers 164
  343. Table 4.6: Large Immunochemistry Analyzers 173
  344. Table 4.7: Small Immunoassay Analyzers 176
  345. Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 178
  346. Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 179
  347. Table 4.10: Linearity and Precision of Siemens Hematology Analyzers 180
  348. Table 4.11: Accuracy of the Automated Differential of Siemens Hematology Analyzers 181
  349. Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments 183
  350. Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 183
  351. Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers 185
  352. Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers 186
  353. Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers 189
  354. Table 4.17: Accuracy of the Sysmex Hematology Analyzers 189
  355. Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 190
  356. Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 190
  357. Table 4.20: Hematology Analyzers with a Five-Part WBC Differential 191
  358. Table 4.21: Hematology Analyzers with a Three-Part WBC Differential 191
  359. Table 4.22: Point of Care Testing 193
  360. Table 4.23: Number of ER Visits in U.S. Hospitals, 1997-2007 195
  361. Table 4.24: Number of POCT in U.S., 2000-2012 195
  362. Table 4.25: PAP Tests in Top European Markets 197
  363. Table 4.26: PAP Tests in Top Asian Markets 197
  364. Table 5.1: Normal Glucose Values-Fasting State 207
  365. Table 5.2: Applications for Wireless LAN Technology 216
  366. Table 7.1: Products Marketed by Abbott in the Diagnostics Market 253
  367. Table 7.2: Comparison of JEOL Analyzers 267
  368. Table 7.3: The VITROS ECiQ Immunodiagnostic System 273
  369. Table 7.4: Sysmex Marketing Summary for China 279

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