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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.

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