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Clinical Immunoanalyzer Markets
Publication Date: 15-DEC-07
Pages: 156
Study: TMRCIA
Format/Price: PDF document / $3,400.00
   


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Clinical immunoanalyzer analysis is one of the most important functions of clinical laboratory analysis. By all accounts, automated immunoassay testing is the most rapidly developing of the traditional clinical laboratory sectors. Clinical immunoanalyzer analysis usually refers to determining the concentration or activity of protein, carbohydrate, lipid, enzyme or small molecule in easily collected body fluids, such as blood, serum, plasma or urine. However, it is not necessarily limited to these purposes. The analysis of virtually any biologically active substance in any place in the body can generally be defined as clinical immunoassay testing. In fact, traditional specialization barriers, such as microbiology, hematology, blood banking, immunology and even anatomical pathology are fading rapidly, both operationally and instrumentally. This TriMark Publications report deals with the traditional scope of clinical immunoassay, while looking at the emerging technology trends in this sector. The purpose of this study is to describe the specific segments of the global clinical immunoanalyzer instrumentation market. Within this area, the highly-active segments in terms of innovation and growth are covered. Specifically, it examines the markets for small labs and highly-automated large lab platforms, as well as the market for accessory equipment, such as reagents and supplies. Emphasis is on those companies and products that are actively developing and marketing immunoanalyzer products for clinical setting, including hospitals, independent labs, physician's offices and clinics. Readers can gain the following insights from this report:

• Complete analysis of the major sectors of the clinical immunoanalyzer instrumentation market, their size, growth rates and major drivers.

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

• Analysis of the partnerships and alliances that various key sector players have forged, including the financing linkages of these market participants, apart from insights into potential market collaborations.

• Examination of new technology platforms in the U.S., Japan and Europe that seek to dominate this mature market.





Table of Contents:

  1. 1. Overview 6
  2. 1.1 Objectives 6
  3. 1.2 Methodology 6
  4. 1.3 TriMark Publications Report Research and Data Acquisition Structure 8
  5. 1.4 Scope 8
  6. 1.5 Executive Summary 9
  7. 2. IVD Clinical Immunoanalyzer Market 11
  8. 2.1 Introduction 11
  9. 3. IVD Clinical Immunoanalyzer Market Analysis 13
  10. 3.1 Markets 13
  11. 3.1.1 Global Markets 13
  12. 3.1.2 Global Drivers of Clinical Immunoanalyzer Testing 14
  13. 3.1.3 Global Outlook 15
  14. 3.1.4 U.S. Market 16
  15. 3.1.5 European IVD Market 18
  16. 3.1.5.1 German Clinical Immunoanalyzer Diagnostic Markets 22
  17. 3.1.5.2 U.K. Clinical Immunoanalyzer Testing Diagnostic Market 24
  18. 3.1.5.3 French Clinical Laboratory Diagnostic Testing Market 25
  19. 3.1.5.4 Italian Clinical Immunochemistry Diagnostic Market 25
  20. 3.1.5.5 Spanish Immunoanalyzer Market 26
  21. 3.1.5.6 Finnish Immunoanalyzer Market 27
  22. 3.1.5.7 Belgian Immunoanalyzer Market 27
  23. 3.1.5.8 Swiss Immunoanalyzer Market 27
  24. 3.1.5.9 Dutch Immunoanalyzer Market 28
  25. 3.1.5.10 Portugese Immunoanalyzer Market 28
  26. 3.1.5.11 Austrian Immunoanalyzer Market 29
  27. 3.1.5.12 Greek Immunoanalyzer Market 29
  28. 3.1.5.13 Polish Immunoanalyzer Market 29
  29. 3.1.5.14 Romanian Immunoanalyzer Market 30
  30. 3.1.6 Indian Clinical Analyzer Diagnostic Market 30
  31. 3.1.6.1 India's in vitro Diagnostic Testing Industry 30
  32. 3.1.7 Japanese Clinical Immunoanalyzer Testing Market 36
  33. 3.1.8 Country Clinical Analyzer Smaller Markets 37
  34. 3.1.8.1 China Clinical Analyzer Market 37
  35. 3.1.8.2 Canada Clinical Analyzer Market 40
  36. 3.1.8.3 Brazil Clinical Analyzer Market 41
  37. 3.1.8.4 Turkey Clinical Immunoanalyzer Market 41
  38. 3.1.8.5 Australia Clinical Analyzer Market 41
  39. 3.1.8.6 Rest of the World Clinical Analyzer Testing Market 42
  40. 3.1.9 Overview of Asian Healthcare Market 42
  41. 3.1.9.1 Singapore 42
  42. 3.1.9.2 Malaysia 43
  43. 3.1.9.3 Thailand 43
  44. 3.1.9.4 Indonesia 43
  45. 3.1.9.5 Philippines 43
  46. 3.1.9.6 South Korea 44
  47. 3.1.9.7 India 44
  48. 3.1.9.8 Hong Kong 44
  49. 3.1.9.9 Taiwan 45
  50. 3.2 Clinical Immunoanalyzer Sector 46
  51. 3.2.1 Industry-Served Markets 47
  52. 3.2.2 Industry Players 47
  53. 3.2.2.1 Manufacturing Companies 47
  54. 3.2.3 Market Specialization 49
  55. 3.2.4 Revenue and Reimbursement 51
  56. 3.2.5 Companies 51
  57. 3.3 Outlook for Clinical Immunoanalyzer Testing 52
  58. 3.3.1 Long-Term Changes 52
  59. 3.3.2 Market Drivers 53
  60. 3.3.3 Limits to Growth 54
  61. 3.3.4 Hot Sectors in IVD Market 54
  62. 3.3.5 Key Technologies 55
  63. 3.3.6 Analyzer Integration Chemistry/Immunoassay 55
  64. 3.3.7 Conclusion 57
  65. 4. Clinical Immunoanalyzer Instrument Market by Sector 58
  66. 4.1 Market Analysis: Size, Growth, Share and Competitors 58
  67. 4.1.1 Immunochemistry Analyzers 58
  68. 4.1.2 Large-Volume Immunochemistry Analyzers 58
  69. 4.1.2.1 Abbott Diagnostics 58
  70. 4.1.2.2 Siemens Medical Solutions Diagnostics 59
  71. 4.1.2.3 Beckman Coulter 62
  72. 4.1.2.4 Dade Behring (Siemens) 63
  73. 4.1.2.5 Diagnostics Products Corporation (Siemens) 64
  74. 4.1.2.6 Olympus 65
  75. 4.1.2.7 Ortho-Clinical Diagnostics 66
  76. 4.1.2.8 Roche Diagnostics 68
  77. 4.1.2.9 Tosoh Bioscience 70
  78. 4.1.3 Batch-Type Immunoassay Analyzers 72
  79. 4.1.3.1 Bio-Rad 72
  80. 4.1.3.2 Dade Behring 72
  81. 4.1.3.3 Diamedix 72
  82. 4.1.3.4 Tosoh 75
  83. 4.1.4 Small-Volume to Mid-Volume Immunoassay Analyzers 75
  84. 4.1.4.1 Awareness Technology 75
  85. 4.1.4.2 Siemens Diagnostics 75
  86. 4.1.4.3 Beckman Coulter 76
  87. 4.1.4.4 bioMérieux 77
  88. 4.1.4.5 Dade Behring (Siemens) 77
  89. 4.1.4.6 Randox 81
  90. 4.1.4.6.1 Randox Laboratories 81
  91. 4.1.4.7 Tosoh 82
  92. 4.1.5 Other Immunoassay Analyzers 83
  93. 4.1.5.1 Inverness Medical Professional Diagnostics 83
  94. 4.1.5.2 Hycor BioMedical 83
  95. 4.1.5.3 Phadia 83
  96. 4.1.5.4 Trinity Biotech 84
  97. 4.1.5.5 Diasorin 84
  98. 4.1.5.6 Grifols 84
  99. 4.1.5.7 Bio-Rad 85
  100. 4.1.5.8 SFRI Diagnostics 85
  101. 4.1.5.9 Qualigen 85
  102. 4.1.5.10 PerkinElmer Life and Analytical Sciences 85
  103. 4.1.5.11 Innotrac Diagnostics 85
  104. 4.1.5.12 Tecan 86
  105. 5. Important Technology Trends 88
  106. 5.1 Technology Innovations in Immunoassay Testing 88
  107. 5.2 Immunoassay Detection Technology Platforms 88
  108. 5.2.1 Fluorescence Detection 88
  109. 5.2.2 Chemiluminescence Detection 88
  110. 5.3 The New Paradigm 89
  111. 5.4 Consolidated Workstations 89
  112. 5.5 Automation in the Laboratory in Response to Labor Shortages 91
  113. 5.6 Laboratory Information System (LIS) 92
  114. 5.7 Biosensor Technology 92
  115. 5.8 Data Management Issues 94
  116. 5.8.1 Wireless LANs 95
  117. 5.8.2 Data and Workflow Management Systems 96
  118. 5.8.3 Beckman Central Command 96
  119. 5.8.4 Advances in Information Management 98
  120. 5.8.5 Connectivity Platforms 101
  121. 5.8.6 DataLink Data Management System 103
  122. 5.8.7 LabPortal.com 105
  123. 5.8.8 LifeScan Electronic Data Interfaces 105
  124. 5.8.9 Technical Problems of Connectivity 106
  125. 5.8.10 Web-Based Data Interface and Internet Connectivity 106
  126. 5.8.11 HIT Competition 107
  127. 5.8.12 FDA-Required Software Verification 108
  128. 5.8.13 Advantages of Connectivity 108
  129. 5.8.14 Technologies for Internet-based Remote Architecture 109
  130. 5.8.15 Abbott Multitiered Internet System 109
  131. 6. Business Trends in Clinical Immunoanalyzer Sector 110
  132. 6.1 Key Developments 110
  133. 6.2 Sector Consolidation 110
  134. 6.3 Diagnostic Testing Growth Trends 111
  135. 6.4 Reagents and Hardware Business in Japan 111
  136. 6.5 New Products 112
  137. 6.6 Acquisitions, License Agreements, Internal Developments and Partnerships 112
  138. 6.7 Product Testing Depth in Clinical Immunoanalyzer Testing 113
  139. 6.8 Government Regulations 113
  140. 6.8.1 U.S. Government Regulations 113
  141. 6.8.1.1 Importing Medical Devices into the U.S. 115
  142. 6.8.1.2 Exporting Medical Devices from the U.S. 115
  143. 6.8.2 U.K. Regulations 116
  144. 6.8.3 E.U. Regulations 117
  145. 6.8.4 Japanese Regulations 119
  146. 6.8.5 Korean Regulations 119
  147. 6.9 Increased Market Penetration 119
  148. 6.10 Costs of Doing Business in Europe 121
  149. 6.11 Drivers of European Diagnostics Testing 121
  150. 6.12 European Reimbursement Practices 121
  151. 6.13 Cost Containment in Europe 122
  152. 6.14 Medicare Spending Trends/Medicare Part B Spending Trends 122
  153. 7. Company Profiles 125
  154. 7.1 Abbott Diagnostics 125
  155. 7.2 Bayer Healthcare 127
  156. 7.3 Beckman Coulter 127
  157. 7.4 bioMérieux 129
  158. 7.5 Dade Behring 129
  159. 7.6 Bio-Rad Laboratories 131
  160. 7.7 Olympus 132
  161. 7.8 Ortho-Clinical Diagnostics 133
  162. 7.9 Phadia 134
  163. 7.10 Randox Laboratories 135
  164. 7.11 Roche Diagnostics 135
  165. 7.12 Tosoh 137
  166. 7.13 Siemens 137
  167. 8. Clinical Immunoanalyzer Testing Sector: Trends and Forecasts 139
  168. 8.1 Automated Intrument Platforms Evolution 139
  169. 8.2 Reagents and Supplies Market for Clinical Lab Instruments 139
  170. 8.3 Bar Code Reading 140
  171. 8.4 Measurement and Detection for Immunoassay Analyzers 140
  172. 8.5 Robotics 141
  173. 8.6 Move Away from Central Laboratory 142
  174. 8.7 Modular Automation 142
  175. 8.8 Components of Immunoassay Analyzers 142
  176. 8.9 Drivers of Clinical Immunoanalyzer Testing 146
  177. 8.10 Confluence of New Technology 147
  178. 8.11 New Trends in Clinical Laboratory Testing 147
  179. 8.11.1 Trends in Reimbursement Practices 147
  180. 8.11.2 Managed Care 150
  181. 8.11.3 Changes in Patient Management 150
  182. 8.11.4 Focused Testing 150
  183. 8.11.5 Spending for Clinical Laboratory Testing 150
  184. 8.11.6 Reimbursement Pressure 151
  185. 8.11.7 Multiplexing Technology 151
  186. 9. Product Launches 153
  187. 9.1 Immunoassay Analyzer Product Launches 153
  188. 9.2 Immunoassay Reagent Product Launches 154
  189. INDEX OF TABLES
  190. Table 2.1: Common Immunoassay Tests 11
  191. Table 3.1: The Overall IVD Diagnostic Testing Market Worldwide, 2006 13
  192. Table 3.2: Worldwide Distribution of IVD Testing, 2006 13
  193. Table 3.3: Global Clinical Immunoassay Revenues, 2000 to 2012 14
  194. Table 3.4: Worldwide Distribution of Clinical Immunoassay Testing, 2006 14
  195. Table 3.5: U.S. Clinical Laboratory Testing Market, 2003 to 2012 17
  196. Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2006 17
  197. Table 3.7: U.S. Clinical Laboratory Diagnostic Testing Reagents and Instruments Markets by Analyte, 2006 18
  198. Table 3.8: U.S. Clinical Immunoanalyzer Testing Market, 2000 to 2012 18
  199. Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Dollars), 2000 to 2012 19
  200. Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market (Euros), 2000 to 2012 19
  201. Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte, 2006 20
  202. Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2006 20
  203. Table 3.13: The European Immunochemistry Market, 2001 to 2012 21
  204. Table 3.14: European Immunochemical Reagents and Instruments Markets by Country, 2006 22
  205. Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003 to 2012 23
  206. Table 3.16: German Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012 23
  207. Table 3.17: UK Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012 24
  208. Table 3.18: French Clinical Immunochemistry Testing Diagnostics Products Market Sales, 2006 to 2012 25
  209. Table 3.19: Italian Immunochemistry Diagnostics Products Market Sales, 2006 to 2012 26
  210. Table 3.20: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2006 to 2012 26
  211. Table 3.21: Finnish Clinical Immunoassay Products Market Sales, 2006 to 2012 27
  212. Table 3.22: Belgium Clinical Immunoassay Products Market Sales, 2006 to 2012 27
  213. Table 3.23: Swiss Clinical Immunoassay Products Market Sales, 2006 to 2012 28
  214. Table 3.24: Dutch Clinical Immunoassay Products Market Sales, 2006 to 2012 28
  215. Table 3.25: Portugese Clinical Immunoassay Products Market Sales, 2006 to 2012 28
  216. Table 3.26: Austrian Clinical Immunoassay Products Market Sales, 2006 to 2012 29
  217. Table 3.27: Greek Clinical Immunoassay Products Market Sales, 2006 to 2012 29
  218. Table 3.28: Polish Clinical Immunoassay Products Market Sales, 2006 to 2012 30
  219. Table 3.29: Romanian Clinical Immunoassay Products Market Sales, 2006 to 2012 30
  220. Table 3.30: Indian IVD Market, 2006 to 2012 31
  221. Table 3.31: Number of Automated Clinical Labs in India, 2004 to 2012 31
  222. Table 3.32: Indian IVD Market (by Sector), 2006 31
  223. Table 3.33: IVD Equipment and Reagents Market (by Company) in India, 2004 and 2005 32
  224. Table 3.34: Japanese Clinical Immunoanalyzer Testing Market, 2000 to 2008 36
  225. Table 3.35: Chinese Clinical Diagnostic Products Market, 2000 to 2008 37
  226. Table 3.36: Canadian Clinical Analyzer Testing Market, 2000 to 2008 40
  227. Table 3.37: Brazilian Clinical Immunoanalyzer Testing Market, 2000 to 2008 41
  228. Table 3.38: Turkish Clinical Analyzer Testing Market, 2000 to 2008 41
  229. Table 3.39: Australian Clinical Immunoanalyzer Testing Market, 2000 to 2008 42
  230. Table 3.40: ROW Clinical Immunoanalyzer Testing Market, 2000 to 2008 42
  231. Table 3.41: Estimated Number of Clinical Laboratories in Latin America 45
  232. Table 3.42: Principal Marketers of Automated Clinical Immunoanalyzer Instruments 47
  233. Table 4.1: Samples and Sample Handling Features of Centaur CP 61
  234. Table 4.2: Large Immunochemistry Analyzers 71
  235. Table 4.3: Small- to Mid-Volume Immunoassay Analyzers 87
  236. Table 5.1: Wireless LAN Technology Companies 95
  237. Table 5.2: Applications for Wireless LAN Technology 96
  238. Table 5.3: CAP and JCAHO Requirements for Customized Reporting 104
  239. Table 6.1: Hospital Laboratory Share of Part B Medicare Spending, 1996 to 2005 123
  240. Table 6.2: Medicare Part B Spending Per Medicare Enrollee, 1998 to 2005 123
  241. Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005 124
  242. Table 8.1: Technology Platforms for Analyzer Detection Systems 140
  243. Table 8.2: Medicare Billing Guidelines for Multi-Channel Immunoanalyzer Tests 148
  244. LIST OF FIGURES
  245. Figure 3.1: U.S. Revenue for Six Largest IVD Vendors, 2005 48
  246. Figure 3.2: U.S. Revenue Change for Six Largest IVD Vendors, 2005 48
  247. Figure 6.1: Part B Spending on Clinical Lab Services, 1991 to 2005 122
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