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Key Diagnostic Testing Markets
Publication Date: 04-DEC-04
Pages: 222
Study: TMRKEY
Format/Price: PDF document / $999.00
   


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This TriMark Publications report reviews the high-growth market segments for clinical laboratory testing equipment and supplies in the clinical hospital market, using screening reagents and instruments for analysis of individual components in blood, serum or plasma. Further, it examines the subsections of each market segment, including the clinical laboratory and research areas. Activity and trends in the clinical diagnostic market are discussed, including the numbers of institutions using this type of testing, and the factors that influence purchasing activity. Discussion details the trends that have developed that stimulate this market, and offers detailed comments on the patterns of information processing in point-of-care (POC) testing instruments. The study surveys most of the important companies known to be marketing, manufacturing or developing instruments and reagents in the areas selected as high-growth diagnostic markets in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product line, business and marketing analysis, and a subjective commentary on the company's position in its market and its strategic direction.





Table of Contents:

  1. 1. Overview 10
  2. 1.1 Objectives 10
  3. 1.2 Content and Scope 10
  4. 1.3 Methodology 11
  5. 1.4 Executive Summary 12
  6. 1.4.1 Glucose Monitoring 13
  7. 1.4.2 Coagulation 13
  8. 1.4.3 Rapid Cardiac Markers 14
  9. 1.4.4 Drugs of Abuse Screening 14
  10. 1.4.5 Infectious Disease Testing 15
  11. 1.4.5.1 Campylobacter 15
  12. 1.4.5.2 Chlamydia 15
  13. 1.4.5.3 Clostridium difficile 15
  14. 1.4.5.4 Cryptosporidium 15
  15. 1.4.5.5 Dengue Fever 15
  16. 1.4.5.6 Entamoeba histolytica 15
  17. 1.4.5.7 Giardia Species 15
  18. 1.4.5.8 Helicobacter pylori 15
  19. 1.4.5.9 Hepatitis Testing 16
  20. 1.4.5.10 HIV 16
  21. 1.4.5.11 Rapid Influenza Testing 16
  22. 1.4.5.12 Mononucleosis 16
  23. 1.4.5.13 Streptococcus Testing 16
  24. 1.4.6 Cholesterol Testing 16
  25. 1.4.7 Tumor Markers 16
  26. 1.4.7.1 Prostate Specific Antigen (PSA) Testing 17
  27. 2. Introduction 18
  28. 2.1 Basic Structure and Perspectives 18
  29. 2.2 Global Diagnostic Products Industry Status and Prognosis 18
  30. 2.3 Size, Structure and Growth of the Industry 19
  31. 2.3.1 Current Market Size 19
  32. 2.3.2 Market Segments 20
  33. 2.3.2.1 Clinical Chemistry 20
  34. 2.3.2.2 Immunoassays 21
  35. 2.3.2.3 Nucleic Acid Arrays 22
  36. 2.3.2.4 Coagulation Tests 23
  37. 2.3.2.5 Critical Care Testing 24
  38. 2.4 Trends and Forces Driving the Industry 24
  39. 2.4.1 Global Demographics 24
  40. 2.4.2 Healthcare Delivery and Disease Management 25
  41. 2.4.3 Technological Innovation 26
  42. 2.5 Alternate Site Diagnostic Testing 26
  43. 3. Market Analysis 30
  44. 3.1 Glucose Monitoring 30
  45. 3.1.1 Market Size 30
  46. 3.1.2 Competitive Landscape 31
  47. 3.1.2.1 LifeScan, Inc. 31
  48. 3.1.2.2 Roche Diagnostics 33
  49. 3.1.2.3 Bayer 33
  50. 3.1.2.4 Abbott Diagnostics 35
  51. 3.1.2.5 HemoCue 35
  52. 3.1.2.6 Technical Chemicals & Products 35
  53. 3.1.2.7 GDS Technology 35
  54. 3.1.2.8 LXN Corp. 35
  55. 3.1.2.9 Cholestech 35
  56. 3.1.2.10 Alternate Glucose Monitoring Products 35
  57. 3.2 Rapid Coagulation Tests 37
  58. 3.2.1 Roche Diagnostics 39
  59. 3.2.2 Avocet Medical 40
  60. 3.2.3 International Technidyne Corporation 40
  61. 3.2.4 Cardiovascular Diagnostics 41
  62. 3.2.5 Other Companies 42
  63. 3.3 Rapid Cardiac Markers 43
  64. 3.3.1 The Companies 44
  65. 3.3.1.1 Spectral Diagnostics 44
  66. 3.3.1.2 Biosite Diagnostics 44
  67. 3.3.1.3 Roche Diagnostics 45
  68. 3.3.1.4 Beckman Coulter, Inc. 46
  69. 3.3.1.5 First Medical 46
  70. 3.3.1.6 ANI Biotech 46
  71. 3.3.1.7 Chembio Diagnostics 46
  72. 3.3.1.8 Abbott Diagnostics 46
  73. 3.3.1.9 TOSOH Medics, Inc. 47
  74. 3.3.1.10 Roche Diagnostics 47
  75. 3.3.1.11 Bayer Diagnostics 47
  76. 3.3.1.12 Diagnostic Products 47
  77. 3.3.1.13 Dade Behring 48
  78. 3.3.2 BNP Testing and Congestive Heart Failure 48
  79. 3.3.2.1 Differential Diagnosis 48
  80. 3.3.2.2 Staging of Heart Failure 48
  81. 3.3.2.3 Circulating Marker of CHF 49
  82. 3.3.2.4 Commercial Assays for BNP and NT-proBNP 49
  83. 3.3.2.5 Clinical Applications of BNP 50
  84. 3.3.2.6 Correlation with NYHA Classifications 50
  85. 3.3.2.7 Correlation with LVSD 50
  86. 3.3.2.8 Prediction of Adverse Outcomes in Acute and Chronic Heart Disease 51
  87. 3.3.2.9 Selection and Monitoring of Therapy 51
  88. 3.3.2.10 Summary 52
  89. 3.4 Drugs of Abuse Screening 52
  90. 3.4.1 Major Players 57
  91. 3.4.1.1 Bayer Diagnostics 57
  92. 3.4.1.2 Biosite Diagnostics 57
  93. 3.4.1.3 Dade Behring Syva (POC Technologies) 58
  94. 3.4.1.4 Roche Diagnostics 59
  95. 3.4.1.5 BioScan Screening Systems, Inc. 60
  96. 3.4.1.6 American Bio Medica Corp. 60
  97. 3.4.1.7 Instant Diagnostics, Inc. 61
  98. 3.4.1.8 Worldwide Medical 62
  99. 3.4.1.9 STC Diagnostics 62
  100. 3.4.1.10 DynaGen, Inc. 63
  101. 3.4.1.11 Avitar Technologies 63
  102. 3.4.1.12 Princeton BioMeditech 63
  103. 3.4.1.13 Abbott Diagnostics 64
  104. 3.4.1.14 Diagnostic Products 64
  105. 3.5 Infectious Disease Testing 65
  106. 3.5.1 Campylobacter 65
  107. 3.5.2 Chlamydia 66
  108. 3.5.3 Clostridium difficile 66
  109. 3.5.4 Cryptosporidium 67
  110. 3.5.5 Dengue Fever 67
  111. 3.5.6 Entamoeba histolytica 68
  112. 3.5.7 Giardia Species 68
  113. 3.5.8 Helicobacter pylori 69
  114. 3.5.9 Hepatitis Testing 71
  115. 3.5.9.1 Overview 71
  116. 3.5.9.2 Hepatitis Serologic Markers and Nucleic Acid Testing 72
  117. 3.5.9.2.1 Hepatitis A Virus 72
  118. 3.5.9.2.2 Hepatitis B Virus 72
  119. 3.5.9.2.3 Hepatitis C Virus 75
  120. 3.5.9.2.4 Hepatitis D Virus 77
  121. 3.5.9.2.5 Hepatitis E virus 77
  122. 3.5.9.2.6 Hepatitis B Virus/Hepatitis C Virus Viral Load and Drug Resistance 78
  123. 3.5.9.3 Companies and Hepatitis Tests 78
  124. 3.5.9.3.1 Home Access Health 78
  125. 3.5.9.3.2 Orgenics 78
  126. 3.5.9.3.3 Princeton BioMeditech Corp. 78
  127. 3.5.9.3.4 Chembio Diagnostics 78
  128. 3.5.9.3.5 Abbott Diagnostics 79
  129. 3.5.9.3.6 Beckman Coulter 79
  130. 3.5.9.2.7 Roche Diagnostics 79
  131. 3.5.9.3.8 Bayer Diagnostics 80
  132. 3.5.9.3.9 Diagnostic Products Corp. 80
  133. 3.5.9.3.10 LabCorp 80
  134. 3.5.10 HIV 82
  135. 3.5.10.1 Blood Versus Oral Fluid/Urine Testing 84
  136. 3.5.10.2 Life Insurance Companies and Urine Testing 86
  137. 3.5.10.3 HIV Outside the U.S. 86
  138. 3.5.10.4 Markets Analysis 87
  139. 3.5.10.5 Calypte Biomedical Corp. 89
  140. 3.5.10.6 Orgenics 90
  141. 3.5.10.7 Princeton BioMeditech Corp. 90
  142. 3.5.10.8 Chembio Diagnostics 90
  143. 3.5.10.9 OraSure Technologies 90
  144. 3.5.10.10 Ely Labs 91
  145. 3.5.10.11 Abbott Diagnostics 91
  146. 3.5.10.12 Beckman Coulter 91
  147. 3.5.10.13 Bayer Diagnostics 92
  148. 3.5.10.14 Celera Diagnostics 92
  149. 3.5.10.15 Roche Diagnostics 92
  150. 3.5.10.16 MedMira, Inc. 93
  151. 3.5.10.17 Summary and Recent Developments 93
  152. 3.5.11 Rapid Influenza Testing 94
  153. 3.5.12 Mononucleosis 94
  154. 3.5.12.1 Quidel 95
  155. 3.5.12.2 Worldwide Medical 95
  156. 3.5.12.3 Genzyme Diagnostics 95
  157. 3.5.12.4 Wyntek Diagnostics 95
  158. 3.5.12.5 Wampole Laboratories 95
  159. 3.5.12.6 GenBio 95
  160. 3.5.12.7 Other Companies in the Market 95
  161. 3.5.13 Rubella 96
  162. 3.5.14 Salmonella 96
  163. 3.5.15 Shiga-Toxin E. coli 96
  164. 3.5.16 Staphylococcus 96
  165. 3.5.17 Streptococcus Testing 97
  166. 3.5.17.1 Quidel 97
  167. 3.5.17.2 Other Companies 98
  168. 3.5.18 TB and Lyme Disease 98
  169. 3.6 Cholesterol Testing 98
  170. 3.6.1 Consumer Market Disposable Testing (Single-Use) 99
  171. 3.6.2 Instrument/Disposable Strip (Multiple-Use Instruments) 100
  172. 3.6.3 Homocysteine 100
  173. 3.6.4 Companies in the Market 100
  174. 3.6.4.1 Cholestech 100
  175. 3.6.4.2 Lifestream Technologies 100
  176. 3.6.4.3 Actimed Laboratories 101
  177. 3.6.4.4 Drew Scientific 101
  178. 3.6.4.5 International Medical Innovations 101
  179. 3.7 Tumor Markers 102
  180. 3.7.1 Market Description 102
  181. 3.7.2 Clinical Diagnostic Serum-Based Cancer Markers 103
  182. 3.7.2.1 Beckman Coulter 104
  183. 3.7.2.2 Fujirebio, Inc. 104
  184. 3.7.2.3 Abbott Diagnostics 104
  185. 3.7.2.4 Beckman Coulter 104
  186. 3.7.2.5 Roche Diagnostics 105
  187. 3.7.3 PSA Testing 105
  188. 3.7.3.1 TOSOH Medics, Inc. 105
  189. 3.7.3.2 Bayer Diagnostics 106
  190. 3.7.3.3 Diagnostic Products 106
  191. 3.7.4 Other Markers 106
  192. 4. Business Trends 108
  193. 4.1 Industry Consolidation 108
  194. 4.2 Breadth of Product Offering 109
  195. 4.3 Government Regulation of Medical Devices 109
  196. 4.3.1 Importing/Exporting Medical Devices Into and Out of the U.S. 111
  197. 4.3.2 U.K. Regulations 112
  198. 4.3.3 EU Regulations 113
  199. 4.3.4 Japanese Regulations 115
  200. 4.4 Clinical Laboratory Improvement Act (CLIA) 115
  201. 5. Patient Management Trends 117
  202. 5.1 Trends in Patient Care and Reimbursement 117
  203. 5.1.1 A Curious System 118
  204. 5.1.2 The Case of Tumor Markers 119
  205. 5.1.3 Other Federal Policy Considerations 120
  206. 5.2 Alternate Site Testing 120
  207. 5.3 Moderators of Growth 120
  208. 5.3.1 Quality Assurance Issues 120
  209. 5.3.2 Political Control 121
  210. 5.3.3 Regulatory Requirements 121
  211. 5.3.4 Record Keeping and Data Management 121
  212. 5.3.5 Finance 121
  213. 5.3.6 Emergency Room Admissions and Trends 122
  214. 5.3.7 Attitudes of Critical Care Nurses and Physicians 122
  215. 5.4 Personnel for POC Testing 122
  216. 5.5 Locations of POC for Patient Care 123
  217. 5.6 Focused Testing 124
  218. 5.7 Satellite Facilities 124
  219. 5.8 POC Testing 124
  220. 5.9 Hospital Labs 125
  221. 5.10 Doctor's Office Testing 126
  222. 5.11 Home Care 127
  223. 5.12 Non-traditional Collection for Sample Testing 127
  224. 6. Technology Trends 128
  225. 6.1 Sensor Systems for Diagnostic Applications 128
  226. 6.2 Glucose Measurements 129
  227. 6.2.1 Different Types of Diabetes 130
  228. 6.2.2 Public Health Impact of Diabetes 130
  229. 6.2.3 Diagnosis of Diabetes 130
  230. 6.2.4 Hypoglycemia 131
  231. 6.2.5 Glucose Test Methods 131
  232. 6.3 Cholesterol Testing 132
  233. 6.4 The New Paradigm 132
  234. 6.5 Consolidated Workstations and Modularity 133
  235. 6.6 Automation and Robotics 133
  236. 6.7 Laboratory Information Systems (LIS) 134
  237. 6.8 Biosensor Technology 134
  238. 6.8.1 Microfluidic and Biosensor Chip Technology 135
  239. 6.9 Protein Sequencing 136
  240. 6.10 DNA Sequencing 136
  241. 6.11 The Human Genome Project 137
  242. 6.12 Liquid Phase Chromatography 138
  243. 6.13 Polymerase Chain Reaction 138
  244. 6.14 Capillary Electrophoresis 139
  245. 6.15 Proteomics 139
  246. 7. Data Management Issues 141
  247. 7.1 Wireless Local Area Networks 141
  248. 7.2 Wireless Technology 141
  249. 7.3 Wireless Devices 142
  250. 7.4 Considerations 142
  251. 7.5 Hospital Costs of Information Management 143
  252. 7.6 Other Information Processing Capabilities 143
  253. 8. Competitive Assessment of High-Growth Markets 144
  254. 8.1 Glucose Monitoring 144
  255. 8.1.1 Overview of Market Segment 144
  256. 8.1.2 Competitive Strategies 145
  257. 8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix 146
  258. 8.1.4 New Approaches to the Glucose Data Management Marketplace 147
  259. 8.1.5 How Each Company is Losing/Gaining Market Share 147
  260. 8.1.6 Partnering Opportunities with Complementary Third-Party Products 147
  261. 8.1.7 Adjacent Markets 148
  262. 8.2 Tumor Markers 148
  263. 8.2.1 Overview of Market Segment 148
  264. 8.2.2 Competitive Strategies 148
  265. 8.2.3 Analyses of the Current Market Conditions, Competition and Product Mix 149
  266. 8.2.4 Adjacent Markets 152
  267. 8.3 Cardiac Care 152
  268. 8.4 Infectious Disease 153
  269. 8.4.1 Overview of Market Segment 153
  270. 8.4.2 Competitive Strategies 153
  271. 8.4.3 Analyses of the Current Market Conditions, Competition and Product Mix 154
  272. 8.4.4 New Approaches to the Infectious Disease Marketplace 154
  273. 8.4.5 The Impact of Molecular Diagnostic Methods on the Diagnosis of Infectious Disease 154
  274. 8.4.6 Partnering Opportunities with Complementary Third-Party Products 155
  275. 8.4.7 Emerging Viral Infections 156
  276. 8.5 Coagulation 156
  277. 8.6 Drugs of Abuse Testing/Therapeutic Drug Monitoring 156
  278. 9. Market Trends and Forecasts 158
  279. 9.1 Home Care Analysis 158
  280. 9.2 Non-traditional Collection for POC Testing 158
  281. 9.3 New Systems for Critical Care and Near-Patient Testing 158
  282. 9.4 Utility of Near-Patient Testing in Critical Care Settings 158
  283. 9.5 Mergers of Diagnostic Companies 158
  284. 9.6 Information Management Advances 158
  285. 9.7 Test Ordering Patterns 158
  286. 9.8 Patient Satisfaction 158
  287. 9.9 Move Away from Central Laboratory 159
  288. 9.10 Healthcare Cost Controls 159
  289. 9.11 Future of POC Testing 159
  290. 9.12 Biotechnology Industry Trends 159
  291. 9.13 Pharmaceutical Industry Trends 160
  292. 9.14 Acquisition, License Agreement, Partnerships 160
  293. 10. Corporate Profiles 161
  294. 10.1 LabCorp 161
  295. 10.2 Lifescan, Inc. 162
  296. 10.3 OraSure Technologies, Inc. 162
  297. 10.3.1 OraSure Collection Device 162
  298. 10.3.2 OraQuick Rapid Test 162
  299. 10.3.3 UPT 162
  300. 10.3.4 Histofreezer 163
  301. 10.3.5 Immunoassay Tests and Reagents 163
  302. 10.4 Bayer Corp. 163
  303. 10.4.1 Background 163
  304. 10.4.2 Business Analysis 164
  305. 10.5 MediSense 166
  306. 10.6 i-STAT Corp. 166
  307. 10.7 Nova Biomedical 167
  308. 10.7.1 Introduction 167
  309. 10.7.2 Electrolyte and Blood Gas Analyzers 167
  310. 10.7.3 Business Analysis 168
  311. 10.8 Wyntek Diagnostics 169
  312. 10.9 Savyon Diagnostics 169
  313. 10.10 Spectral Diagnostics 170
  314. 10.11 Biosite Diagnostics 170
  315. 10.12 Abbott Laboratories 173
  316. 10.12.1 Background 173
  317. 10.12.2 Key Opportunities in Rapid Tests 173
  318. 10.12.3 Business Analysis 174
  319. 10.13 Wampole Laboratories 175
  320. 10.14 Beckman Coulter Diagnostics Corp. 175
  321. 10.15 Instrumentation Laboratory 176
  322. 10.16 MedMira Laboratories 176
  323. 10.17 Radiometer 177
  324. 10.17.1 Background 177
  325. 10.17.2 Instrumentation 177
  326. 10.17.3 Business Analysis 178
  327. 10.18 GenBio 178
  328. 10.19 Ely labs 178
  329. 10.20 Orgenics 179
  330. 10.21 bioMérieux Vitek, Inc. 179
  331. 10.22 ANI Biotech 179
  332. 10.23 Sybron International Corp. 180
  333. 10.24 Optical Sensors, Inc. 180
  334. 10.25 Worldwide Medical Corp. 181
  335. 10.26 International Medical Innovations (IMI) 181
  336. 10.27 Cardiovascular Diagnostics 181
  337. 10.28 Abaxis, Inc. 181
  338. 10.29 Inverness Medical Innovations 183
  339. 10.29.1 Consumer Products 183
  340. 10.29.2 Clinical Diagnostic Products 184
  341. 10.30 ChemTrak, Inc. 184
  342. 10.30.1 The AccuMeter Cassette System 184
  343. 10.30.2 The Home Test Service 185
  344. 10.30.3 Parent's Alert Home Drug Test Service 185
  345. 10.30.4 CholesTrak Home Cholesterol Test 185
  346. 10.30.5 Sales and Marketing 185
  347. 10.30.6 Competition 186
  348. 10.31 Cholestech 187
  349. 10.31.1 Diagnostic Products 187
  350. 10.31.2 WellCheck 187
  351. 10.32 HemoCue, Inc. 188
  352. 10.33 Binax Corp. 188
  353. 10.34 Selfcare 188
  354. 10.35 Johnson & Johnson 189
  355. 10.36 Accumetrics 189
  356. 10.37 First Medical, Inc. 189
  357. 10.38 Response Biomedical Corp. 189
  358. 10.39 Compucyte Corp. 190
  359. 10.40 Caliper Technologies 190
  360. 10.41 Princeton BioMeditech 190
  361. 10.42 American Biogenics Sciences 190
  362. 10.43 New Horizons Diagnostics 191
  363. 10.44 Beacon Diagnostics 191
  364. 10.45 Saliva Diagnostics 191
  365. 10.46 Calypte Biomedical Corp. 192
  366. 10.46.1 The Calypte Urine-Based HIV-1 Screening and Supplemental Tests 192
  367. 10.46.2 The Cambridge Biotech Serum-Based HIV-1 Supplemental Test 192
  368. 10.46.3 The Sentinel Testing Service 192
  369. 10.46.4 HIV Viral Lysate Stock 193
  370. 10.47 Meridian Diagnostic 193
  371. 10.48 Quidel 195
  372. 10.49 Biomerica 195
  373. 10.50 Diagnology, Inc. 196
  374. 10.51 BioStar (Thermo Electron Corp.) 196
  375. 10.52 ActiMed Diagnostics 196
  376. 10.53 Empyrean Diagnostics 197
  377. 10.54 STC Technologies 197
  378. 10.55 Trinity Diagnostics 197
  379. 10.56 Genzyme Diagnostics 198
  380. 10.57 ImmunoScience, Inc. 198
  381. 10.58 Cygnus Therapeutic Systems 199
  382. 10.58.1 The GlucoWatch System 199
  383. 10.58.2 GlucoWatch G2 Biographer 199
  384. 10.58.3 Partnerships 200
  385. 10.59 Seradyn Clinical Diagnostics/Apogent Technologies 201
  386. 10.60 Adeza Biomedical Corp. 201
  387. 10.61 Array Medical 202
  388. 10.62 Transmedica 202
  389. 10.63 BioScan Screening Systems, Inc. 202
  390. 10.64 American Bio Medica Corp. 202
  391. 10.65 GDS Technology 203
  392. 10.66 Home Access Health Corp. 203
  393. 10.67 Pharmatech Corp. 204
  394. 10.68 Thoratec/International Technidyne Corp. 204
  395. 10.69 SpectRx, Inc. 204
  396. 10.70 Helena Laboratories 205
  397. 10.71 Technical Chemicals & Products 205
  398. 10.72 Roche Diagnostics 206
  399. 10.73 Simplex Medical Systems 208
  400. 10.74 Biex, Inc. 208
  401. 10.75 POC Technologies 208
  402. 10.76 LXN Corp. (Inverness Medical Technologies) 209
  403. 10.77 American Biogenetic Sciences, Inc. 209
  404. 10.78 Lifestream Technologies 209
  405. 10.79 PanBio Corp. 210
  406. 10.80 Phillips Medical Systems 210
  407. 10.81 Jiangnan Biotech 211
  408. 10.82 MiniMed 211
  409. 10.83 Meretek Corp. 212
  410. 10.84 Avox Systems 212
  411. 10.85 Dade Behring 212
  412. 10.86 Chongqing Sungene Pharmaceutical Co., Ltd. 213
  413. 10.87 Medical Services International, Inc. 213
  414. 10.88 Therasense, Inc. 213
  415. 10.89 PharmaNetics, Inc. 213
  416. 10.90 Shanghai SIIC Kehua Biotech Co., Ltd. (Kehua Biotech) 214
  417. 10.91 LifePoint, Inc. 214
  418. 10.92 Avitar, Inc. 214
  419. 10.93 Cozart Biosciences 215
  420. 10.94 Enterix, Inc. 215
  421. 10.95 Kyowa Medex Co., Ltd. 215
  422. 10.96 Iatron 215
  423. 10.97 Denka Seiken Co., Ltd. 215
  424. 10.98 Accurex Biomedical, Pvt., Ltd. 215
  425. 11. Corporate Directory 216
  426. INDEX OF FIGURES
  427. Figure 1: Serological and Clinical Course of Acute HBV Infection 73
  428. Figure 2: Time Course of Serologic Markers in Acute Hepatitis C Infection 76
  429. INDEX OF TABLES
  430. Table 1: Ten Largest Diagnostic Companies Worldwide Revenues and Market Share 2000 19
  431. Table 2: Total Clinical Diagnostics Dollar Volume by Market Segment 2000 20
  432. Table 3: U.S. Market for Clinical Chemistry Dollar Volume by Analyte 2000 21
  433. Table 4: Worldwide Market for Clinical Chemistry Dollar Volume by Analyte 2000 22
  434. Table 5: Worldwide Market for Other Immunoassays Dollar Volume by Analyte 2000 22
  435. Table 6: Worldwide Market for Nucleic Acid Assays for Infectious Disease Dollar Volume by Analyte 2000 23
  436. Table 7: Worldwide Market for Other Nucleic Acid Arrays Dollar Volume by Analyte 2000 23
  437. Table 8: Market for Coagulation Tests Dollar Volume by Region 2000 24
  438. Table 9: Market for Critical Care Tests Dollar Volume by Region 2000 24
  439. Table 10: U.S. Alternate Site Diagnostic Test Dollar Volume by Sector 26
  440. Table 11: U.S. Clinical Diagnostic POC Testing and Rapid Test Market Segments Dollar Volume 27
  441. Table 12: Number of Sites by Type Doing In Vitro Diagnostic Testing in the U.S. 27
  442. Table 13: U.S. Clinical Laboratory Testing Services Revenue and Growth Rates by Segment 28
  443. Table 14: U.S. Doctor's Office Test Market Revenue and Growth Rate by Segment 28
  444. Table 15: U.S. Clinical Diagnostic Home Test Market Revenue and Growth Rates by Segments 1999 28
  445. Table 16: U.S. In Vitro Diagnostic Testing Including Reagents, Instruments, Consumables and Controls Total Sales by Segments 1999 29
  446. Table 17: Global Diabetic Population 1995 and 2025 30
  447. Table 18: Worldwide POC Glucose Testing Market Dollar Volume and Growth Rate 31
  448. Table 19: U.S. Market for POC and Near-Patient Blood Glucose Testing Market Share by Company 31
  449. Table 20: World Market Share of POC Glucose Monitoring Marketers 31
  450. Table 21a: Worldwide Market for Rapid Coagulation Testing Dollar Volume 2000-2008 38
  451. Table 21b: U.S. Market for Rapid Coagulation Testing Dollar Volume 2000-2008 38
  452. Table 21c: U.S. Market for Rapid Coagulation POC Testing Dollar Volume 1996-2007 38
  453. Table 22: U.S. Market for POC Cardiac Marker Testing Dollar Volume and Growth Rate 1999-2007 44
  454. Table 23: Drugs of Abuse Screening U.S. Market Size 1998-2007 53
  455. Table 24: National Institute on Drug Abuse Screening Standards Cutoff Levels by Drug and Test Method 55
  456. Table 25: U.S. POC Drugs of Abuse Testing Market 2001-2007 56
  457. Table 26: Serological Diagnosis of Hepatitis B Virus Infections 74
  458. Table 27: Lower Detection Limits of HBV DNA Assays 75
  459. Table 28: U.S. and Global Market for HAV Diagnostic Testing 81
  460. Table 29: U.S. and Global Market for HBV Diagnostic Testing 81
  461. Table 30: U.S. and Global Market for HCV Diagnostic Testing 82
  462. Table 31: Current Assays for HIV Viral Load Testing 93
  463. Table 32: U.S. and World Markets for HIV Diagnostic Testing 94
  464. Table 33: U.S. Cholesterol Testing Volume 2000-2007 99
  465. Table 34: Worldwide Market for In Vitro Cancer Marker Products Dollar Volume in 1999 and 2007 102
  466. Table 35: U.S. Market for Tumor Marker Assays Dollar Volume by Marker 1998-2002 103
  467. Table 36: Comparison of Costs at "Moderately Complex" and "Waived" CLIA Labs 115
  468. Table 37: CPT Codes and Reimbursement Amount for Selected Tumor Markers New York and California 119
  469. Table 38a: POC Testing Versus Laboratory Testing Clinical Outcomes in Diabetic Ketoacidosis 121
  470. Table 38b: POC Testing Versus Laboratory Testing Clinical Outcomes in ABG Measurements 121
  471. Table 39: Emergency Room Admissions in the U.S. 122
  472. Table 40: POC Testing Cost Analysis with Labor Included 123
  473. Table 41: Cost Analysis for Glucose Testing: POCT versus Central Lab 123
  474. Table 42: Normal Blood Glucose Values in Fasting State and Two Hours Postprandially 131
  475. Table 43: Applications for Wireless LAN Technology Present and Future 141
  476. Table 44: Wireless Hospital Network Access Points Technology Prices Access Points 143
  477. Table 45: Wireless Hospital Network Access Points Technology Prices Desktop Adapters (One Computer) 143
  478. Table 46: Wireless Hospital Network Access Points Technology Prices PCMCIA Adapters 143

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