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Report Description

Point of Care Diagnostic Testing World Markets
Publication Date: 01-NOV-09
Pages: 388
Study: TMRPOC
Format/Price: PDF document / $3,400.00
   


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This TriMark Publications report describes latest developments in the point of care diagnostic testing (POCT) market segment. It examines clinical instruments, devices and reagents and supplies as utilized in near-patient environments like hospital emergency rooms, critical care units, clinics and doctor's offices. The study defines the dollar volume of point of care sales and makes five year projections--both in the U.S. and worldwide--including Europe, Asia and Latin America. It also examines in detail the point of care sector for 25 individual country markets. The current market condition of all clinical segments involving point of care testing is examined. A detailed summary of all important instruments in each clinical market is provided with emphasis on newly introduced products. Also, parallel areas where rapid detection is important using hand held devices such as rapid detection of food pathogens and infectious pathogens (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed. Growth moderators and developing trends in point of care applications, as well as technology platform innovations and connectivity questions are discussed in detail.
The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S and worldwide, including China and India. Each company is discussed in depth, with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position.

The main objectives of this analysis are:

• Identifying viable technology drivers through a comprehensive look at platform technologies for POCT.

• Understanding the different sectors of POCT, looking at the
hospital market segment and, separately, at a description of the instruments, reagents and supplies marketed by major companies in each segment.

• Obtaining a complete understanding of the individual point of care tests from their basic principles to their clinical applications.

• Discovering exciting market opportunities by identifying high-growth applications in different analytical diagnostic areas, focusing on the biggest and expanding markets.

• Focusing on global industry development through an in-depth analysis of the major world markets for point of care technology, as well as important country markets, including growth forecasts.

• Presenting market figures regarding the current value of the POCT, five year market projections, market share, key players and sector growth rates. The source of this information is the most current data derived from the global diagnostic industry.

This study contains:

• A detailed analysis of recent trends in the point of care marketplace.

• In-depth profiles of the leading companies with point of care tools and technologies.

• A forecast for the point of care market in the biotechnology and diagnostic industries.

• Views and principles on the point of care industry from leading industry experts.

• An analysis of potential new point of care applications in the clinical sector.

• Market predictions and trends analysis concerning U.S. expenditures on point of care solutions.

• Projections of point of care market sizes for European and Asian markets.

• Projections for future applications of molecular diagnostic tests in point of care-related screening.

• Analysis of commercial point of care business strategies.

• The latest news and M&A developments in the point of care marketplace.

• A comprehensive overview and insight into point of care business strategies.

• An in-depth examination of the subsections of each market segment, including the physician office laboratories (POLs) and clinic testing.

Analysis includes over 100 charts and graphs measuring product growth and trends within the point of care marketplace. Company-specific information, including sales figures, product pipeline status and R&D trends, is provided. This review will also:

• Assess point of care market drivers and bottlenecks, from medical and scientific community perspectives.

• Discuss the potential benefits of point of care for various sectors of the medical and scientific community.

• Establish the current total market size and future growth of the point of care market and analyze the current size and growth of individual segments.

• Provide current and forecasted market shares by company.

• Discuss profit and business opportunities by segment.

• Provide strategic recommendations for near-term business opportunities.

• Assess current commercial uses of the point of care market.

The following questions will also be addressed in this analysis:

• What are the near-term business opportunities in the point of care market?

• What are the current and forecasted point of care market sizes in the U.S., European Union (E.U.) and Japan, as well as in other key country markets?

• What are the business models currently used by companies in the point of care market?

• How will manufacturers, researchers, physicians and patients influence this market?

• What are the drivers and bottlenecks influencing the point of care market?

• What are the technologies used in point of care?

• Who holds the proprietary rights to the point of care market technology platforms?

• In the U.S., Japan and the E.U., what regulatory processes apply to point of care technologies?

• How will new point of care technologies change diagnostic screening testing paradigms?

• How will new point of care technologies reduce healthcare expenditures and affect R&D spending?

The report contains:

• A comprehensive overview of the several categories of point of care technology platforms that are, or will be, revolutionizing the use of diagnostic tests in hospitals.

• A sector on each of the important point of care categories and applications.

• Full descriptions of the technologies involved and how these differ from existing and emerging technologies.

• Analysis of the technological approaches undertaken by various competitors, as well as industry and end-user responses to these products.

• Regulatory issues and legislation affecting use and marketing of point of care products.

• Market forecasts for each category of product, including profiles of selected competitors.





Table of Contents:

  1. 1. Overview 14
  2. 1.1 About this Report 14
  3. 1.2 Scope of the Report 15
  4. 1.3 Objectives 16
  5. 1.4 Methodology 16
  6. 1.5 Executive Summary 17
  7. 2. Overview of Diagnostic Testing Point of Care 21
  8. 2.1 Point of Care Testing Sites 21
  9. 2.2 Point of Care Market Structure 22
  10. 2.3 New Directions in Clinical IVD Testing 23
  11. 3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors 26
  12. 3.1 Global POCT Market 32
  13. 3.2 U.S. POCT Market 34
  14. 3.3 European POCT Market 37
  15. 3.3.1 German POCT Diagnostic Market 43
  16. 3.3.2 U.K. POCT Diagnostic Market 45
  17. 3.3.2.1 U.K. POCT Market Statistics 46
  18. 3.3.2.2 U.K. Competitive Analysis 47
  19. 3.3.2.3 U.K. Market Access 48
  20. 3.3.3 French POCT Diagnostic Market 48
  21. 3.3.4 Italian POCT Diagnostic Market 50
  22. 3.3.5 Spanish POCT Diagnostic Market 51
  23. 3.3.6 Scandinavian POCT Diagnostic Market 53
  24. 3.3.7 Swedish POCT Diagnostic Market 54
  25. 3.3.8 Finnish POCT Diagnostic Market 55
  26. 3.3.9 Norwegian POCT Diagnostic Market 56
  27. 3.3.10 Swiss POCT Diagnostic Market 57
  28. 3.3.11 Dutch POCT Diagnostic Market 58
  29. 3.3.12 Belgian POCT Diagnostic Market 59
  30. 3.3.13 Portuguese POCT Diagnostic Market 60
  31. 3.3.14 Austrian POCT Diagnostic Market 61
  32. 3.3.15 Greek POCT Diagnostic Market 62
  33. 3.3.16 Polish POCT Diagnostic Market 63
  34. 3.3.17 Czech Republic POCT Diagnostic Market 64
  35. 3.3.18 Turkish POCT Diagnostic Market 65
  36. 3.4 Asian POCT Markets 65
  37. 3.4.1 Japanese POCT Diagnostic Market 65
  38. 3.4.2 Indian POCT Diagnostic Market 67
  39. 3.4.3 Chinese POCT Diagnostic Market 72
  40. 3.5 Rest of the World POCT Market 82
  41. 3.5.1 Canadian POCT Diagnostic Market 82
  42. 3.5.2 Brazilian POCT Diagnostic Market 83
  43. 3.5.3 Australian POCT Diagnostic Market 83
  44. 3.6 Overview of Asian Healthcare Market 84
  45. 3.6.1 Singapore 85
  46. 3.6.2 Malaysia 86
  47. 3.6.3 Thailand 86
  48. 3.6.4 Indonesia 86
  49. 3.6.5 Philippines 87
  50. 3.6.6 South Korea 87
  51. 3.6.7 Taiwan 87
  52. 4. POCT Individual Markets 88
  53. 4.1 Glucose Testing 88
  54. 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 90
  55. 4.2.1 World Market 90
  56. 4.2.2 U.S. Market 90
  57. 4.2.3 European Market 92
  58. 4.2.4 Alternate Glucose Monitoring Products 93
  59. 4.2.5 HbA1c POCT 94
  60. 4.3 Blood Gas and Electrolytes 94
  61. 4.3.1 Whole Blood Lactate 97
  62. 4.4 Rapid Coagulation Tests 97
  63. 4.4.1 World POCT Coagulation Market 100
  64. 4.4.2 U.S. Coagulation Market 100
  65. 4.4.3 European Coagulation Market 103
  66. 4.4.4 Trends in POCT Coagulation Testing 103
  67. 4.5 Rapid Cardiac Markers 104
  68. 4.5.1 U.S. Market 104
  69. 4.5.2 European Market 106
  70. 4.6 Drugs of Abuse Screening Testing 107
  71. 4.6.1 Acetaminophen 114
  72. 4.6.2 Tricyclic Antidepressants (TCAs) 114
  73. 4.6.3 Other Toxic Drugs 115
  74. 4.6.4 Drug Testing Selectivity 115
  75. 4.6.5 Methaqualone and Phencyclidine (PCP) 115
  76. 4.6.6 Tetrahydrocannabinol 115
  77. 4.6.7 Drug Panels by Toxidromes 115
  78. 4.6.8 Alcohol Testing 116
  79. 4.7 Urine Strips 116
  80. 4.8 Pregnancy Tests 119
  81. 4.9 Fecal Occult Blood 121
  82. 4.10 Hemoglobin Testing 122
  83. 4.11 Miscellaneous Rapid Tests 122
  84. 4.11.1 Estriol 122
  85. 4.11.2 Fetal Fibronectin (fFN) 123
  86. 4.11.3 H. pylori 123
  87. 4.11.4 Vaginal pH and Vaginitis 124
  88. 4.11.5 Bladder Cancer 124
  89. 4.11.6 Fetal Status 125
  90. 4.11.7 Heparin-induced Thrombocytopenia 126
  91. 4.12 Human Immunodeficiency Virus (HIV) 126
  92. 4.13 Cholesterol 133
  93. 4.14 Infectious Disease 134
  94. 4.14.1 Clostridium difficile 134
  95. 4.14.2 Giardia 135
  96. 4.14.3 Salmonella and Campylobacter 136
  97. 4.14.4 Malaria Testing 136
  98. 4.14.5 Influenza Testing 138
  99. 4.14.6 Strep Testing 139
  100. 4.14.7 Chlamydia 141
  101. 4.14.8 Mononucleosis 142
  102. 4.14.9 Rubella 142
  103. 4.14.10 Methicillin-resistant Staphylococcus Aureus (MRSA) 142
  104. 4.14.11 Hepatitis 148
  105. 4.14.12 Gonorrhea 150
  106. 4.14.13 Tuberculosis (TB) 151
  107. 4.14.14 Herpes Simplex Virus Type-2 153
  108. 4.15 Infant Jaundice 153
  109. 4.16 Anthrax 153
  110. 4.17 Rupture of Fetal Membranes (ROM) 155
  111. 4.18 Food Pathogens 155
  112. 4.19 Typhoid 155
  113. 5. POCT: Reagents and Equipment 157
  114. 5.1 Blood Glucose Monitoring 157
  115. 5.1.1 LifeScan 158
  116. 5.1.2 Roche Accu-Chek 161
  117. 5.1.3 Siemens Healthcare Diagnostics 162
  118. 5.1.4 Cholestech (Acquired by Inverness Medical Innovations) 164
  119. 5.1.5 Abbott Diabetes Care 164
  120. 5.1.6 International Technidyne Corporation 165
  121. 5.1.7 HemoCue 166
  122. 5.1.8 Stanbio/GDS Technology 166
  123. 5.1.9 Disetronic Medical Systems 167
  124. 5.1.10 Medtronic MiniMed 167
  125. 5.1.11 Abaxis, Inc. 168
  126. 5.1.12 Arkray 170
  127. 5.1.13 Nova Bio 170
  128. 5.1.14 Accurex (India) 170
  129. 5.1.15 Axis-Shield 170
  130. 5.1.16 Home Diagnostics, Inc. 170
  131. 5.1.17 Medisys/Hypoguard 170
  132. 5.1.18 Diametrics Medical 171
  133. 5.1.19 Metrika 171
  134. 5.1.20 Nova Biomedical 171
  135. 5.1.21 DexCom, Inc. 171
  136. 5.1.22 Bayer 172
  137. 5.1.23 Biosite 172
  138. 5.2 Blood Gas and Electrolytes 172
  139. 5.2.1 Roche Corporation 172
  140. 5.2.2 TechnoMedica 173
  141. 5.2.3 Siemens Healthcare Diagnostics 173
  142. 5.2.4 Instrumentation Laboratory 173
  143. 5.2.5 Nova Biomedical 174
  144. 5.2.6 Radiometer 174
  145. 5.2.7 Abbott Laboratories 174
  146. 5.2.8 Span Diagnostics 175
  147. 5.2.9 Avox Systems 175
  148. 5.2.10 ITC 176
  149. 5.2.11 OPTImedical 177
  150. 5.3 Rapid Coagulation Tests 177
  151. 5.3.1 POC Coagulation Instrument Description 181
  152. 5.3.1.1 Roche Diagnostics Corp. 182
  153. 5.3.1.2 Abbott Laboratories 183
  154. 5.3.1.3 International Technidyne Corporation 184
  155. 5.3.1.4 Medtronic 186
  156. 5.3.1.5 HemoSense (Inverness) 186
  157. 5.3.1.6 Helena Laboratories Point of Care 187
  158. 5.3.1.7 Sienco, Inc. 188
  159. 5.3.1.8 Accumetrics 188
  160. 5.3.2 Connectivity Issues 189
  161. 5.3.3 Cost Benefits 189
  162. 5.3.4 Quality Control Issues 190
  163. 5.3.5 Certification for Point of Care Coagulation Devices 190
  164. 5.4 Rapid Cardiac Markers 190
  165. 5.4.1 Nanogen 190
  166. 5.4.2 Biosite Diagnostics (Inverness) 191
  167. 5.4.3 Roche Diagnostics 192
  168. 5.4.4 Ani Biotech 193
  169. 5.4.5 Response Biomedical Corporation 193
  170. 5.4.6 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation, and Dade Behring) 194
  171. 5.4.7 Lab21 Ltd. 194
  172. 5.4.8 Abbott Laboratories 195
  173. 5.4.9 LifeSign (Princeton BioMediTech Corp.) 195
  174. 5.4.10 Mitsubishi Kagaku Iatron 195
  175. 5.5 Rapid Drugs of Abuse 195
  176. 5.5.1 Biosite Diagnostics (now a brand of Inverness Medical Innovations) 197
  177. 5.5.2 Abbott Diagnostics 198
  178. 5.5.3 Roche Diagnostics 198
  179. 5.5.4 BioScan Screening Systems, Inc. 199
  180. 5.5.5 American Bio Medica Corp. 200
  181. 5.5.6 Phamatech, Inc. 203
  182. 5.5.7 Worldwide Medical 204
  183. 5.5.8 OraSure 204
  184. 5.5.9 LifePoint 204
  185. 5.5.10 Avitar, Inc. 205
  186. 5.5.11 Cozart Biosciences 205
  187. 5.5.12 Pathtech 206
  188. 5.5.13 Alfa Scientific Designs, Inc. 206
  189. 5.5.14 TCPI, Inc. 207
  190. 5.5.15 Roche 207
  191. 5.5.16 Siemens Corporation 207
  192. 5.5.17 Diagnostic Chemical Ltd. 208
  193. 5.5.18 Quidel 208
  194. 5.5.19 HemoCue (Quest) 208
  195. 5.5.20 Biophor Diagnostics 208
  196. 5.6 Rapid Pregnancy and Fertility Tests 209
  197. 5.7 Fecal Occult Blood 210
  198. 5.7.1 Helena Laboratories 211
  199. 5.7.2 Biomerica 211
  200. 5.7.3 Beckman Coulter 211
  201. 5.7.4 Worldwide Medical 212
  202. 5.7.5 Aerscher Diagnostics 212
  203. 5.7.6 Enterix 212
  204. 5.7.7 Medix Biochemica 212
  205. 5.7.8 Orion Diagnostica 213
  206. 5.8 Hemoglobin Testing 213
  207. 5.8.1 Wampole Laboratories 213
  208. 5.8.2 HemoCue, Inc. 213
  209. 5.8.3 Stanbio/GDS Technology 213
  210. 5.9 Miscellaneous Rapid Tests 213
  211. 5.9.1 Triage C. difficile Panel 213
  212. 5.9.2 Ketoacids 214
  213. 5.9.3 Acetaminophen 214
  214. 5.9.4 Estriol 214
  215. 5.9.5 H. pylori 215
  216. 5.9.6 Vaginal Fluid pH and Vaginitis 217
  217. 5.9.7 Prostate-specific Antigen (PSA) 217
  218. 5.9.8 Bladder Cancer 218
  219. 5.9.9 Other Rapid Cancer Tests 221
  220. 5.9.10 Fetal Status (PROM) 222
  221. 5.9.11 Osteoporosis 222
  222. 5.9.12 Hemodynamic Monitoring 222
  223. 5.9.13 Heparin-induced Thrombocytopenia 222
  224. 5.10 HIV 222
  225. 5.10.1 Whole Blood, Serum or Plasma-based HIV Tests 225
  226. 5.10.1.1 Bio-Rad Laboratories 225
  227. 5.10.1.2 Orgenics (wholly-owned by Inverness Medical Innovations) 225
  228. 5.10.1.3 StatSure Diagnostic Systems 226
  229. 5.10.1.4 Trinity Biotech 226
  230. 5.10.1.5 Savyon Diagnostics 226
  231. 5.10.1.6 MedPharm 226
  232. 5.10.1.7 American Bio Medica Corp. 226
  233. 5.10.1.8 Chembio Diagnostics 227
  234. 5.10.1.9 OraSure Technologies 227
  235. 5.10.1.10 Inverness 228
  236. 5.10.2 Saliva-based HIV Tests 228
  237. 5.10.2.1 OraSure Collection Device 229
  238. 5.10.2.2 SureStat 230
  239. 5.10.3 Urine-based HIV Tests 230
  240. 5.10.3.1 MedMira Laboratories, Inc. 230
  241. 5.10.3.2 Medical Services International, Inc. 231
  242. 5.10.3.3 Maxim Biomedical 231
  243. 5.10.3.4 Wampole Laboratories 231
  244. 5.11 Cholesterol 231
  245. 5.11.1 Cholestech (now a brand of Inverness Medical Innovations) 232
  246. 5.11.2 Actimed Laboratories 233
  247. 5.11.3 StatSite Meter 233
  248. 5.11.4 Polymer Technology Systems 234
  249. 5.11.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 234
  250. 5.11.6 Abaxis, Inc. 234
  251. 5.12 Infectious Disease 234
  252. 5.12.1 C. difficile 234
  253. 5.12.2 Giardia 235
  254. 5.12.3 Dengue Fever 236
  255. 5.12.4 Malaria Testing 236
  256. 5.12.5 Rapid Influenza Testing 238
  257. 5.12.6 Streptococcus Testing 239
  258. 5.12.7 Chlamydia 240
  259. 5.12.8 Mononucleosis 241
  260. 5.12.9 Rubella 242
  261. 5.12.10 Staphylococcus Aureus and MRSA 242
  262. 5.12.11 Hepatitis 243
  263. 5.12.12 E. Coli O157 245
  264. 5.12.13 Gonorrhea Testing 245
  265. 5.12.14 Smallpox 245
  266. 5.12.15 SARS 245
  267. 5.12.16 Rabies 246
  268. 5.12.17 Tuberculosis 246
  269. 5.12.18 Avian Flu 246
  270. 5.12.19 West Nile Virus 246
  271. 5.12.20 Herpes Simplex Virus Type-2 247
  272. 5.13 Infant Jaundice 247
  273. 5.14 Anthrax 247
  274. 5.15 Homeland Defense (Plague and Tularemia) 249
  275. 5.16 BSE (Mad Cow Disease) 249
  276. 5.17 Tuberculosis 249
  277. 5.18 Typhoid 250
  278. 5.19 Avian Flu 250
  279. 5.20 Food Pathogens (Salmonella, Listeria, Campylobacter) 250
  280. 5.21 Ruptured Fetal Membranes (ROM) 251
  281. 6. POCT: Growth Regulators 253
  282. 6.1 Moderators of Growth 253
  283. 6.2 Personnel Acceptance 253
  284. 6.3 Key People for POCT 254
  285. 6.4 Information Management Issues 254
  286. 6.4.1 Elements of Information Management for POCT: Information Processing Capabilities 255
  287. 6.4.2 Data Mining 255
  288. 6.4.3 Middleware 256
  289. 6.4.4 Web Portals 257
  290. 6.4.5 POCT-1A Standard 257
  291. 6.5 Key Elements for POCT 258
  292. 6.6 POCT and Reimbursement 258
  293. 6.7 Effectiveness of Clinical Outcomes 260
  294. 6.8 Rapid Near-Patient Testing in Hospitals 261
  295. 6.9 Satellite Facilities 261
  296. 6.10 Regionalization of Laboratory Care 262
  297. 6.11 Requirements for POCT 263
  298. 6.12 Locations of Point of Care for Patient Care 264
  299. 6.13 Benefits of POCT 264
  300. 6.14 Cost Elements of POCT 264
  301. 6.15 Necessary Functions in POCT 265
  302. 6.16 TAT for POCT 265
  303. 6.17 Clinical Laboratory Improvement Amendments (CLIA) 265
  304. 6.18 Sexually-Transmitted Diseases in Underdeveloped Countries 267
  305. 7. Business Trends in the Point of Care Sector 268
  306. 7.1 Sector Consolidation 268
  307. 7.2 Diagnostic Testing Growth Trends 268
  308. 7.3 Acquisition, License Agreements, Internal Development and Partnerships 269
  309. 7.4 Product Testing Depth in POCT 272
  310. 7.5 Government Regulation 273
  311. 7.5.1 U.S. Regulation 273
  312. 7.5.1.1 Importing Medical Devices into the U.S. 274
  313. 7.5.1.2 Exporting Medical Devices from the U.S. 275
  314. 7.5.2 U.K. Regulation 275
  315. 7.5.3 E.U. Regulation 277
  316. 7.5.3.1 French Regulation 278
  317. 7.5.4 Japanese Regulation 279
  318. 7.5.5 Korean Regulation 279
  319. 7.6 Increased Market Penetration 279
  320. 7.7 Costs of Doing Business in Europe 280
  321. 7.8 Drivers of European Diagnostics Testing 280
  322. 7.9 European Reimbursement Practices 281
  323. 7.10 Cost Containment in Europe 281
  324. 8. Technology Platform Innovations in POCT 282
  325. 8.1 Sensor Systems for Diagnostic Applications 282
  326. 8.2 Glucose Measurements 285
  327. 8.3 Glucose Test Methods 287
  328. 8.4 Cholesterol Testing 288
  329. 8.5 The New Paradigm 289
  330. 8.6 Consolidated Workstations and Modularity 289
  331. 8.7 Automation and Robotics in the Clinical Laboratory 289
  332. 8.8 Laboratory Information Systems (LIS) 290
  333. 8.8.1 NOVIUS Lab 290
  334. 8.9 Biosensor Technology 290
  335. 8.10 Nanogen Third Generation Point of Care Analyzer 292
  336. 8.11 Quidel MChip 293
  337. 9. Data Management and Connectivity 294
  338. 9.1 Wireless LANs 294
  339. 9.2 Connectivity Platforms 296
  340. 9.2.1 DataLink Data Management System 297
  341. 9.2.2 RALS-Plus 298
  342. 9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 299
  343. 9.2.2.2 Siemens Diagnostics Rapidpoint® Coag 300
  344. 9.2.2.3 Radiometer 300
  345. 9.2.2.4 HemoCue's DM Hemoglobin 300
  346. 9.2.2.5 Roche Diagnostics 300
  347. 9.2.3 BD.id 301
  348. 9.2.4 Medical Implant Communications Service (MICS) 301
  349. 9.3 Advantages of POCT Connectivity 301
  350. 9.3.1 Cost Benefit of POCT and IT Connectivity 301
  351. 9.3.2 Hospital Network Issues 302
  352. 10. Corporate Profiles 303
  353. 10.1 Abaxis, Inc. 303
  354. 10.2 Abbott Diagnostics 306
  355. 10.3 Accumetrics, Inc. 310
  356. 10.4 Accurex Biomedical, Pvt. Ltd. 310
  357. 10.5 Akers Biosciences, Inc. 310
  358. 10.6 Alfa Scientific Design, Inc. 311
  359. 10.7 Ambri Ltd. 311
  360. 10.8 American Bio Medica Corporation 311
  361. 10.9 Ani Biotech Oy Ltd. 313
  362. 10.10 Apogent Technologies 313
  363. 10.11 Ark Therapeutics 313
  364. 10.12 Arkray, Inc. 314
  365. 10.13 Atlas Genetics 314
  366. 10.14 Atonomics 314
  367. 10.15 Avitar, Inc. 314
  368. 10.16 Augurix Diagnostics Ltd. 315
  369. 10.17 Axis-Shield 315
  370. 10.18 Beckman Coulter, Inc. 315
  371. 10.19 Binax Corporation 320
  372. 10.20 Biomerica, Inc. 320
  373. 10.21 bioMérieux Vitek, Inc. 321
  374. 10.22 BioScan Screening Systems, Inc. 321
  375. 10.23 Biosite Diagnostics 321
  376. 10.24 BioStar, Inc. 321
  377. 10.25 British Biocell Holdings 321
  378. 10.26 Caliper Life Sciences 321
  379. 10.27 Calypte Biomedical Corporation 322
  380. 10.28 Chembio Diagnostics, Inc. 323
  381. 10.29 Cholestech 324
  382. 10.30 Chongqing Sungene Pharmaceutical Co., Ltd. 324
  383. 10.31 CompuCyte Corporation 324
  384. 10.32 Cortech Diagnostics Ltd. (now Kent International Holdings) 325
  385. 10.33 Cozart Biosciences Ltd. 325
  386. 10.34 Cygnus Therapeutic Systems 325
  387. 10.35 Cytogen Corporation 325
  388. 10.36 DexCom, Inc. 326
  389. 10.37 Daiichi Sankyo Group 326
  390. 10.38 Denka Seiken Co., Ltd. 327
  391. 10.39 Diagnostic Chemicals Ltd. 327
  392. 10.40 Enigma Diagnostics Ltd. 327
  393. 10.41 Focus Diagnostics, Inc. 327
  394. 10.42 GDS Technology 327
  395. 10.43 GenBio 328
  396. 10.44 Genzyme Diagnostics 328
  397. 10.45 Grant Life Sciences, Inc. 330
  398. 10.46 Gryphus Diagnostics, LLC 331
  399. 10.47 Helena Laboratories 331
  400. 10.48 Hema Diagnostic Systems, LLC 331
  401. 10.49 Hemocue, Inc. 332
  402. 10.50 Home Access Health Corp. 332
  403. 10.51 ImmunoScience, Inc. 332
  404. 10.52 Instrumentation Laboratory 333
  405. 10.53 International Medical Innovations 333
  406. 10.54 Inverness Medical Innovations, Inc. 333
  407. 10.55 Johnson & Johnson 338
  408. 10.56 Kyowa Medex Co., Ltd. 340
  409. 10.57 LifeAssays 341
  410. 10.58 LifePoint, Inc. 341
  411. 10.59 LifeScan Corporation 341
  412. 10.60 Lifestream Technologies 341
  413. 10.61 LXN Corp. (Inverness Medical Technologies) 341
  414. 10.62 Matritech 341
  415. 10.63 Medical Services International, Inc. 342
  416. 10.64 MediSense, Inc. 342
  417. 10.65 Medisys 342
  418. 10.66 Medix Biochemica 343
  419. 10.67 MedMira Laboratories 343
  420. 10.68 Meretek Corporation 344
  421. 10.69 Meridian Bioscience 344
  422. 10.70 MiniMed, Inc. 346
  423. 10.71 Mitsubishi Chemical USA, Inc. 347
  424. 10.72 Mitsubishi Kagaku Iatron 347
  425. 10.73 Nanogen 348
  426. 10.74 New Horizons Diagnostics 348
  427. 10.75 Nova Biomedical 348
  428. 10.76 OraSure Technologies, Inc. 350
  429. 10.77 Orgenics 354
  430. 10.78 Orion Diagnostica 354
  431. 10.79 PanBio Ltd. 354
  432. 10.80 Phamatech, Inc. 354
  433. 10.81 Polymedco, Inc. 354
  434. 10.82 Polymer Technology Systems, Inc. 355
  435. 10.83 Princeton BioMeditech Corporation 356
  436. 10.84 Quest Diagnostics, Inc. 356
  437. 10.85 Quidel Corporation 357
  438. 10.86 Radiometer 360
  439. 10.87 Response Biomedical Corp. 362
  440. 10.88 Roche Diagnostics 363
  441. 10.89 Royal Philips Electronics 365
  442. 10.90 Savyon Diagnostics 366
  443. 10.91 Selfcare, Inc. 367
  444. 10.92 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 367
  445. 10.93 Shionogi & Co., Ltd. 367
  446. 10.94 Siemens Corporation 367
  447. 10.95 SpectRx, Inc. 368
  448. 10.96 Spectral Diagnostics 369
  449. 10.97 StatSure Diagnostic Systems 369
  450. 10.98 Strategic Diagnostics, Inc. 369
  451. 10.99 Sun Biomedical Laboratories, Inc. 370
  452. 10.100 Thoratec/International Technidyne Corporation 370
  453. 10.101 Transmedica International, Inc. 371
  454. 10.102 Trinity Biotech 371
  455. 10.103 Väsamed, Inc. 374
  456. 10.104 Venkateshwara Hatcheries Pvt. Ltd. 374
  457. 11. POCT Sector Trends and Forecasts 375
  458. 11.1 Home Care Analysis as Part of Near-Patient Testing 375
  459. 11.2 Non-Traditional Collection for POCT 375
  460. 11.3 New Systems for Critical Care and Near-Patient Testing 375
  461. 11.4 Utility of Near-Patient Testing in Critical Care Settings 376
  462. 11.5 Physician's Office Market 376
  463. 11.6 Information Management Advances 377
  464. 11.7 Test-Ordering Patterns and Demand for POCT 377
  465. 11.8 Demand for Emergency Department Services 377
  466. 11.9 Move Away from Central Laboratory 378
  467. 11.10 Healthcare Cost Controls 379
  468. 11.11 M&A in POCT 379
  469. 11.12 Competition for Services 380
  470. 11.13 Drivers of POCT 380
  471. 11.14 Confluence of New Technology 380
  472. 11.15 Difficulties of Design for Point of Care Products 381
  473. 11.16 European Hospital Structure 381
  474. 11.17 The Biggest New Opportunities in POCT 381
  475. 12. Corporate Directory 382
  476. INDEX OF FIGURES
  477. Figure 3.1: Blood Tests Ordered in Emergency Department Visits 27
  478. Figure 3.2: Worldwide Distribution of IVD Testing, 2008 30
  479. Figure 3.3: Global POCT Share of Total IVD Testing Market, 2007 34
  480. Figure 4.1: U.S. POCT Share of Glucose Testing Market, 2008 88
  481. Figure 4.2: Number of HbA1c Tests Performed Globally as POCT, 1991-2006 94
  482. Figure 4.3: Total Spending on Healthcare in the U.S., 1960-2007 143
  483. Figure 4.4: International Per Capita Healthcare Spending Per Country, 2006 144
  484. Figure 5.1: Global POCT Share of HIV Testing Market, 2008 225
  485. Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 260
  486. INDEX OF TABLES
  487. Table 2.1: Percentage of POCT Performed in Selected Hospitals 22
  488. Table 2.2: POCT Procedural Advantages for Hospital Testing 24
  489. Table 2.3: POCT Trends 24
  490. Table 2.4: Professional POCT Compared to Home Testing 24
  491. Table 2.5: Drivers for Integrating POCT into Hospital Routines 25
  492. Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2008 26
  493. Table 3.2: Number of Point of Care Tests in the U.S., 2000-2012 27
  494. Table 3.3: Global Clinical Laboratory Market Sales, 1998-2011 29
  495. Table 3.4: Overall IVD Testing Market Worldwide, 2007 30
  496. Table 3.5: Worldwide Distribution of IVD Testing, 2008 30
  497. Table 3.6: Top 12 Country IVD Testing Markets, 2007 31
  498. Table 3.7: Top 13 Diagnostic Companies Worldwide, 2007 31
  499. Table 3.8: Global Point of Care Revenues, 2005-2012 32
  500. Table 3.9: Worldwide POCT Market Size by Geographic Location, 2005-2012 33
  501. Table 3.10: Worldwide Distribution of POCT, 2008 33
  502. Table 3.11: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 33
  503. Table 3.12: Worldwide POCT by Performance Location, 2008 34
  504. Table 3.13: Largest POCT Diagnostic Companies Worldwide, 2007 34
  505. Table 3.14: U.S. Clinical Laboratory Testing Market, 2003-2012 35
  506. Table 3.15: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2008 35
  507. Table 3.16: U.S. POCT Market, 2000-2012 36
  508. Table 3.17: U.S. POCT by Performance Location, 2008 36
  509. Table 3.18: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 36
  510. Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Dollars, 2000-2012 37
  511. Table 3.20: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Euros, 2000-2012 37
  512. Table 3.21: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 38
  513. Table 3.22: European Rapid POCT by Country Market Estimates, 2008 39
  514. Table 3.23: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 42
  515. Table 3.24: European POCT Market, 2005-2012 42
  516. Table 3.25: Top 12 Country IVD and POCT Markets, 2007 42
  517. Table 3.26: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 43
  518. Table 3.27: German POCT Diagnostics Products Market Sales, 2003-2012 43
  519. Table 3.28: German Clinical Diagnostic Rapid Test Market Segments, 2007 44
  520. Table 3.29: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 45
  521. Table 3.30: U.K. POCT Diagnostics Products Market Sales, 2006-2012 46
  522. Table 3.31: U.K. Clinical Diagnostic Rapid Test Market Segments, 2007 46
  523. Table 3.32: Major U.K. IVD Manufacturers 47
  524. Table 3.33: U.S. IVD Manufacturers Doing Business in the U.K. 47
  525. Table 3.34: Other European Companies that Manufacture IVD Products in the U.K. 48
  526. Table 3.35: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 48
  527. Table 3.36: French POCT Diagnostics Products Market Sales, 2005-2012 49
  528. Table 3.37: French Clinical Diagnostic Rapid Test Market Segments, 2007 50
  529. Table 3.38: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 50
  530. Table 3.39: Italian POCT Diagnostics Products Market Sales, 2005-2012 51
  531. Table 3.40: Italian Clinical Diagnostic Rapid Test Market Segments, 2007 51
  532. Table 3.41: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 52
  533. Table 3.42: Spanish Clinical Diagnostic Rapid Test Market Segments, 2007 52
  534. Table 3.43: Spanish POCT Diagnostics Products Market Sales, 2005-2012 53
  535. Table 3.44: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 53
  536. Table 3.45: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 54
  537. Table 3.46: Swedish POCT Diagnostics Products Market Sales, 2005-2012 54
  538. Table 3.47: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 55
  539. Table 3.48: Finnish POCT Diagnostics Products Market Sales, 2005-2012 55
  540. Table 3.49: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 56
  541. Table 3.50: Norwegian POCT Diagnostics Products Market Sales, 2005-2012 56
  542. Table 3.51: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 57
  543. Table 3.52: Swiss POCT Diagnostics Products Market Sales, 2005-2012 57
  544. Table 3.53: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 58
  545. Table 3.54: Dutch POCT Diagnostics Products Market Sales, 2005-2012 58
  546. Table 3.55: Belgian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 59
  547. Table 3.56: Belgian POCT Diagnostics Products Market Sales, 2005-2012 59
  548. Table 3.57: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 60
  549. Table 3.58: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 60
  550. Table 3.59: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 61
  551. Table 3.60: Austrian POCT Diagnostics Products Market Sales, 2005-2012 61
  552. Table 3.61: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 62
  553. Table 3.62: Greek POCT Diagnostics Products Market Sales, 2005-2012 62
  554. Table 3.63: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 63
  555. Table 3.64: Polish POCT Diagnostics Products Market Sales, 2005-2012 63
  556. Table 3.65: Czech Clinical Laboratory Diagnostics Products Market Sales, 2004-2012 64
  557. Table 3.66: Czech POCT Diagnostics Products Market Sales, 2005-2012 64
  558. Table 3.67: Turkish POCT Market, 2000-2012 65
  559. Table 3.68: Japanese POCT Market, 2000-2012 66
  560. Table 3.69: Japanese Population and Aging Demographics Forecast, 2000-2050 66
  561. Table 3.70: Indian IVD Market for Instruments and Reagents, 2004-2012 67
  562. Table 3.71: Number of Automated Clinical Labs in India, 2004-2012 68
  563. Table 3.72: Indian IVD Market, 2007 68
  564. Table 3.73: Indian POCT Diagnostics Products Market Sales, 2000-2012 72
  565. Table 3.74: Chinese IVD Market, 2006-2012 72
  566. Table 3.75: Number of Automated Clinical Labs in China, 2004-2012 74
  567. Table 3.76: Chinese IVD Market, 2007 74
  568. Table 3.77: Chinese POCT Diagnostics Products Market Sales, 2000-2012 79
  569. Table 3.78: Rest of the World POCT Market, 2000-2012 82
  570. Table 3.79: Canadian POCT Market, 2000-2012 82
  571. Table 3.80: Brazilian POCT Market, 2000-2012 83
  572. Table 3.81: Australian POCT Market, 2000-2012 83
  573. Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers 88
  574. Table 4.2: Global Population of Persons with Diabetes, 1995 and 2025 89
  575. Table 4.3: Professional Glucose Testing Market for POCT Worldwide, 2001-2012 90
  576. Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 91
  577. Table 4.5: Manufacturer Market Share U.S. POCT Market, 2008 91
  578. Table 4.6: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 92
  579. Table 4.7: HbA1c Testing Market for POCT Worldwide, 2006-2012 94
  580. Table 4.8: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012 95
  581. Table 4.9: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 95
  582. Table 4.10: Location Market Share of Critical Care Blood Gas Testing, 1990 and 2008 96
  583. Table 4.11: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2007 97
  584. Table 4.12: Hospital Locations of Point of Care Coagulation Testing 98
  585. Table 4.13: Drivers for Point of Care Coagulation Testing 99
  586. Table 4.14: Barriers for Point of Care Coagulation Testing 99
  587. Table 4.15: Coagulation Testing Market for POCT Worldwide, 2006-2012 100
  588. Table 4.16: Handheld Coagulation Testing Market for POCT Worldwide, 2006-2012 100
  589. Table 4.17: Coagulation Market for POCT in the U.S., 2001-2012 101
  590. Table 4.18: Point of Care Prothrombin Market for POCT in the U.S., 2000-2008 101
  591. Table 4.19: Cardiac Marker Market for POCT in the U.S., 2001-2012 105
  592. Table 4.20: Cardiac Marker Market for POCT Worldwide, 2001-2012 105
  593. Table 4.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2007 106
  594. Table 4.22: Cardiac Marker Market for POCT in Europe, 2001-2011 106
  595. Table 4.23: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2012 112
  596. Table 4.24: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2012 112
  597. Table 4.25: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 114
  598. Table 4.26: Stat Urine Testing Drug Recommendations 114
  599. Table 4.27: Device Specifications for POCT Breath Alcohol Analysis 116
  600. Table 4.28: Global Point of Care Urine Test Strip Testing Market, 2001-2008 117
  601. Table 4.29: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012 117
  602. Table 4.30: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 117
  603. Table 4.31: U.S. Point of Care Urine Test Strip Testing Market Share 118
  604. Table 4.32: Medicare Fee Schedule for Urine Chemistry Testing, 2003 119
  605. Table 4.33: Pregnancy Testing Market for POCT Worldwide, 2006-2012 120
  606. Table 4.34: U.S. Point of Care Pregnancy Testing Market, 2001-2012 120
  607. Table 4.35: International Point of Care Pregnancy Testing Markets, 2001-2007 121
  608. Table 4.36: U.S. Market Share for Rapid Point of Care Pregnancy Tests 121
  609. Table 4.37: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 122
  610. Table 4.38: Drivers of Demand for HIV Testing 127
  611. Table 4.39: Worldwide POCT Market for HIV, 2001-2012 128
  612. Table 4.40: U.S. POCT Market for HIV, 2001-2012 128
  613. Table 4.41: Countries with the Highest Prevalence of HIV/AIDS 130
  614. Table 4.42: FDA-approved Rapid HIV Antibody Screening Tests 131
  615. Table 4.43: OraSure OraQuick Rapid HIV Test Revenues, 2008 132
  616. Table 4.44: Cholesterol Testing Market for POCT Worldwide, 2006-2012 134
  617. Table 4.45: Infectious Disease Testing Market for POCT Worldwide, 2006-2012 134
  618. Table 4.46: Salmonella Testing Market, 2002-2007 136
  619. Table 4.47: Worldwide Point of Care Influenza Testing Market, 2002-2007 138
  620. Table 4.48: U.S. Point of Care Influenza Testing Market, 2002-2007 138
  621. Table 4.49: International Point of Care Influenza Testing Markets, 2002-2007 139
  622. Table 4.50: U.S. Market for Rapid Point of Care Influenza Tests, 2007 139
  623. Table 4.51: Worldwide Point of Care Strep A Testing Market, 2002-2007 140
  624. Table 4.52: U.S. Point of Care Strep A Testing Market, 2002-2007 140
  625. Table 4.53: International Point of Care Strep A Testing Markets, 2002-2007 140
  626. Table 4.54: U.S. Market for Rapid Point of Care for Group A Strep Tests 140
  627. Table 4.55: Global Market for Chlamydia Diagnostic Testing, 2000-2009 141
  628. Table 4.56: U.S. Market for Chlamydia Diagnostic Testing, 2000-2009 141
  629. Table 4.57: U.S. Market for MRSA Rapid Testing, 2006-2013 147
  630. Table 4.58: Global Market for Gonorrhea Diagnostic Testing, 2000-2009 151
  631. Table 4.59: Global Market for TB Diagnostic Testing, 2000-2008 153
  632. Table 4.60: U.S. Anthrax Test Market 154
  633. Table 5.1: Largest U.S. POCT Coagulation Diagnostic Testing Companies, 2008 182
  634. Table 5.2: Actalyke XL 187
  635. Table 5.3: Actalyke Mini 187
  636. Table 5.4: Drug Test Sensitivity Cut-Off Levels Set by NIDA, WHO and SAMHSA for Drugs of Abuse 196
  637. Table 5.5: Major Competitors in the Drugs of Abuse Testing Market Segment 196
  638. Table 5.6: Major Competitors in the Drugs of Abuse Oral Testing Market Segment 196
  639. Table 5.7: Major Competitors in the Drugs of Abuse Urine Testing Market Segment 197
  640. Table 5.8: Major Competitors in the Drugs of Abuse Saliva Testing Market Segment 197
  641. Table 5.9: Siemens Urinalysis Near-Patient Devices 208
  642. Table 5.10: ColoCARE Fecal Occult Blood Test 211
  643. Table 5.11: Competitive Factors Related to HIV Tests 224
  644. Table 5.12: Largest POCT Diagnostic Companies Worldwide, 2008 225
  645. Table 5.13: Type of Hepatitis Test: Lateral Flow 243
  646. Table 5.14: Flow-through 244
  647. Table 5.15: Agglutination 244
  648. Table 5.16: Immunoblot 245
  649. Table 5.17: AmniSure 252
  650. Table 6.1: Access Points 254
  651. Table 6.2: Desktop Adapters-Four Computers 254
  652. Table 6.3: Desktop Adapters-One Computer 255
  653. Table 6.4: PCMCIA Adapters 255
  654. Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments 257
  655. Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 260
  656. Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 260
  657. Table 6.8: POCT in Three Hospitals-Cost Analysis with Labor Included 263
  658. Table 6.9: POCT versus Central Lab-Cost Analysis for Glucose Testing 263
  659. Table 6.10: Financial Comparison for Moderate and Waived CLIA Labs 266
  660. Table 7.1: Key Changes in IVD Business Structure 272
  661. Table 7.2: Business Trends in POCT 281
  662. Table 7.3: Key Players Bring Business Developments to Point of Care Diagnostic Testing 281
  663. Table 8.1: Normal Glucose Values-Fasting State 286
  664. Table 9.1: Applications for Wireless LAN Technology 294
  665. Table 9.2: Customized Reports Must Support CAP and JCAHO Requirements 297
  666. Table 9.3: RALS-Plus Point of Care Market Share 298
  667. Table 9.4: Applications of RALS Connectivity with POCT Devices 299
  668. Table 10.1: Abaxis Blood Analysis Diagnostic Tests 304
  669. Table 10.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 304
  670. Table 10.3: Products Marketed by Abbott in the Diagnostic Market 308
  671. Table 10.4: Inverness Brands 338
  672. Table 10.5: Orasure's Products 353
  673. Table 10.6: Quidel Product Sales Distribution and Sales, 2008 358
  674. Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT 376
  675. Table 11.2: Test Menu and TAT for ED 377
  676. Table 11.3: Top Reasons Why Point of Care Cardiac Marker Testing is Implemented in the ED 377
  677. Table 11.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED 378
  678. Table 11.5: Estimates of Patient Costs by DRG 379

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