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Report Description

Hematology Analyzer Instrumentation and Reagent Markets
Publication Date: 24-JAN-07
Pages: 156
Study: TMRHEMA
Format/Price: PDF document / $3,400.00
   


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Clinical hematology analyzer analysis is one of the oldest and most important sectors of clinical laboratory analysis. The hematology instrument and reagent market is centered around a group of instruments called hematology analyzers. The term clinical hematology analyzer usually refers to an automated instrument for determining the presence, number and type of cellular elements in easily collected body fluids, such as blood. However, it is not necessarily limited to these determinations. The hematology analysis always includes determination of non-cellular parameters in blood, such as hemoglobin and hematocrit. Other closely related areas of clinical interest are coagulation and flow cytometry. In fact, traditional specialization barriers, such as microbiology, hematology, blood banking, immunology and even anatomical pathology are rapidly fading both operationally and instrumentally. But for the sake of defining the subject to a reasonable size, the more traditional scope of clinical hematology analyzer will be the focus of this examination. The purpose of this TriMark Publications report is to describe the specific segments of the global clinical hematology analyzer instrumentation and reagent marketplace. The review covers those segments that are highly active in terms of innovation and growth. Specifically, this study examines the markets for small-lab, as well as highly-automated large-lab, platforms and accessory equipment, such as reagents, supplies and add-on equipment from original equipment manufacturers. This review attempts to answer the following questions:

• Which companies are the key players?
• What are the opportunities in clinical hematology analyzer instrumentation?
• What are the development trends in hematology?
• Where are the new market growth areas in hematology instruments?
• What are the most favored technology platforms for hematology instruments?
• Where is the hematology analyzer instrument technology taking us?
• How is immunological technology blending with hematology analyzer?





Table of Contents:

  1. 1. Overview 7
  2. 1.1 Objectives of the Report 7
  3. 1.2 Methodology 8
  4. 1.3 Scope of the Report 8
  5. 1.4 Executive Summary 9
  6. 2 IVD Clinical Hematology Analyzer Market 11
  7. 2.1 Introduction 11
  8. 2.2 Key Product Segments 17
  9. 2.2.1 Hematology and Associates Instruments 17
  10. 2.2.1.1 Hematology Analyzers 17
  11. 2.2.1.2 Hematology Instruments Offerings by Major Players 17
  12. 2.2.1.2.1 Hematology Reagents and Controls 18
  13. 2.2.1.2.2 Hematology Point of Care Instruments 19
  14. 2.2.1.3 Flow Cytometers 20
  15. 2.2.1.3.1 Flow Cytometry Technology Platforms 20
  16. 2.2.1.3.2 Clinical Applications of Flow Cytometry 20
  17. 2.2.1.3.2.1 Leukocyte Analysis 20
  18. 2.2.1.3.2.2 Immunophenotyping of Leukemias and Lymphomas 21
  19. 2.2.1.3.2.3 Neutropenia 21
  20. 2.2.1.3.2.4 Platelet Analysis 21
  21. 2.2.1.3.2.5 T Cell Subsets 22
  22. 2.2.1.3.2.6 Reticulocyte Count 22
  23. 2.2.1.3.3 Flow Cytometry Market Growth 22
  24. 2.2.1.3.3.1 Applications 23
  25. 2.2.1.3.3.2 Market Size 23
  26. 2.2.1.3.3.3 Instrumentation Preferences 24
  27. 2.2.1.3.3.4 Reagent Selection and Use 24
  28. 2.2.1.3.3.5 Instrument Manufacturers 25
  29. 2.2.1.3.3.6 Future Directions of Flow Cytometry 26
  30. 2.2.1.4 Coagulation Analyzers 26
  31. 2.2.1.4.1 Coagulation Market Size 27
  32. 2.2.1.4.2 Prothrombin Time Test 28
  33. 2.2.1.4.3 Activated Partial Thromboplastin Time (APTT) 28
  34. 2.2.1.4.4 Clinical Advantages of Coagulation Testing 29
  35. 2.2.1.4.5 Coagulation Instruments 30
  36. 2.2.1.4.5.1 Roche Diagnostics 30
  37. 2.2.1.4.5.2 Avocet Medical 31
  38. 2.2.1.4.5.3 International Technidyne Corporation 31
  39. 2.2.1.4.5.4 Cardiovascular Diagnostics 32
  40. 2.2.1.4.5.5 Diagnostica Stago's STA-R Evolution 32
  41. 2.2.1.4.5.6 Other Companies 33
  42. 2.2.1.4.5.7 Coagulation Reagents 34
  43. 2.2.1.5 Hemoglobinometers 34
  44. 2.2.1.6 Slide Stainers 34
  45. 2.2.1.7 Differential Counters 36
  46. 2.2.1.8 Hematology Stains 37
  47. 2.3 Blood Components 37
  48. 2.3.1 Complete Blood Count (CBC) 37
  49. 2.3.2 Red Blood Cells (RBCs) 38
  50. 2.3.3 White Blood Cells (WBCs) 38
  51. 2.3.4 Platelets 39
  52. 2.3.5 Hematocrit (HCT) 39
  53. 2.4 Hematology Tests 39
  54. 2.5 The Coulter Principle 40
  55. 2.6 Blood Collection 40
  56. 3. IVD Clinical Hematology Analyzer Market 41
  57. 3.1 Markets 41
  58. 3.1.1 Global Markets 41
  59. 3.1.2 Global Drivers of Clinical Hematology Analyzer Testing 45
  60. 3.1.3 Global Outlook 45
  61. 3.1.4 U.S. Market 46
  62. 3.1.5 European Market 48
  63. 3.1.5.1 German Clinical Hematology Analyzer and Reagent Diagnostic Markets 51
  64. 3.1.5.2 U.K. Clinical Hematology Market 53
  65. 3.1.5.3 French Clinical Hematology Market 55
  66. 3.1.5.4 Italian Clinical Hematology Market 55
  67. 3.1.5.5 Spanish Clinical Hematology Market 56
  68. 3.1.5.6 Belgian Clinical Hematology Market 56
  69. 3.1.5.7 Swiss Clinical Hematology Market 56
  70. 3.1.5.8 Dutch Clinical Hematology Market 57
  71. 3.1.5.9 Portuguese Clinical Hematology Market 57
  72. 3.1.5.10 Austrian Clinical Hematology Market 58
  73. 3.1.5.11 Greek Clinical Hematology Market 58
  74. 3.1.5.12 Polish Clinical Hematology Market 59
  75. 3.1.5.13 Czech Clinical Hematology Market 59
  76. 3.1.5.14 Finnish Clinical Hematology Market 60
  77. 3.1.5.15 Scandinavian Clinical Hematology Market 60
  78. 3.1.6 Asian Market 61
  79. 3.1.6.1 Indian Clinical Hematology Market 61
  80. 3.1.6.1.1 India's in vitro Diagnostic Testing Industry 61
  81. 3.1.6.1.2 Major Indian IVD Companies 62
  82. 3.1.6.2 Japanese Clinical Hematology Market 64
  83. 3.1.6.3 Chinese Clinical Hematology Market 64
  84. 3.1.7 Country Clinical Hematology Smaller Markets 68
  85. 3.1.7.1 Canada Clinical Hematology Market 68
  86. 3.1.7.2 Brazil Clinical Hematology Market 68
  87. 3.1.7.3 Turkey Clinical Hematology Market 68
  88. 3.1.7.4 Australia Clinical Hematology Market 69
  89. 3.1.8 Remaining World Clinical Hematology Market 69
  90. 3.1.9 Overview of Asian Healthcare Market 70
  91. 3.1.9.1 Singapore 70
  92. 3.1.9.2 Malaysia 70
  93. 3.1.9.3 Thailand 70
  94. 3.1.9.4 Indonesia 71
  95. 3.1.9.5 Philippines 71
  96. 3.1.9.6 South Korea 72
  97. 3.1.9.7 Hong Kong 72
  98. 3.1.9.8 Taiwan 72
  99. 3.1.10 Overview of the Latin American Diagnostics Market 73
  100. 3.2 Clinical Hematology Analyzer and Reagents Sector 73
  101. 3.2.1 Industry-Served Markets 73
  102. 3.2.2 Industry Players 75
  103. 3.2.2.1 Manufacturing Companies 75
  104. 3.2.3 Market Specialization 75
  105. 3.2.4 Hematology Sector Companies 76
  106. 3.3 Outlook for Clinical Hematology Analyzer Testing 77
  107. 3.3.1 Long-Term Changes 77
  108. 3.3.2 Market Drivers 78
  109. 3.3.3 The Limits to Growth 79
  110. 3.3.4 Hot Sectors in the IVD Market 79
  111. 3.3.5 Key Technologies 79
  112. 3.3.6 Conclusion 80
  113. 4. Clinical Hematology Instrument Market by Type and Competitor 81
  114. 4.1 Abbott Diagnostics 81
  115. 4.2 Bayer Diagnostics 84
  116. 4.3 Beckman Coulter 85
  117. 4.4 Drew Scientific 87
  118. 4.5 Horiba ABX Inc. 88
  119. 4.6 Sysmex 89
  120. 4.7 Boule Medical 94
  121. 4.8 Beijing Shining Sun 95
  122. 4.9 Hematology Analyzers for Point of Care 95
  123. 5. Important Technology Trends 97
  124. 5.1 Technology Platform Innovations in Hematology Testing 97
  125. 5.2 The New Paradigm 97
  126. 5.3 Consolidated Workstations 97
  127. 5.4 Automation in the Laboratory 99
  128. 5.5 Laboratory Information Systems 100
  129. 5.6 New User-friendly Interfaces 101
  130. 5.7 Data-Management Issues 102
  131. 5.7.1 Wireless LANs 102
  132. 5.7.2 Data and Workflow Management Systems 103
  133. 5.7.3 Beckman Central Command 103
  134. 5.7.4 Middleware 104
  135. 5.8 Robotics - Total Laboratory Automation Robotic Sample Handling 104
  136. 5.9 Image Analysis 105
  137. 5.10 Flow Cytometry 106
  138. 5.11 Laser Technology 106
  139. 5.12 Automating Preanalytics 106
  140. 5.13 Telepathology 107
  141. 6. Business Trends in the Clinical Hematology Analyzer Sector 108
  142. 6.1 Key Developments 108
  143. 6.2 Industrial Sector Consolidation 108
  144. 6.3 Hospital and Commercial Laboratory Consolidation 110
  145. 6.4 Changing Ordering Patterns 111
  146. 6.5 New Products 111
  147. 6.6 Acquisition, License Agreements, Internal Development and Partnerships 114
  148. 6.7 Breadth of Product Offerings 117
  149. 6.8 Government Regulation 117
  150. 6.8.1 U.S. Regulation 117
  151. 6.8.1.1 Importing Medical Devices into the U.S. 118
  152. 6.8.1.2 Exporting Medical Devices from the U.S. 119
  153. 6.8.2 U.K. Regulation 120
  154. 6.8.3 E.U. Regulation 121
  155. 6.8.4 Japanese Regulation 123
  156. 6.8.5 Korean Regulation 123
  157. 6.9 Costs of Doing Business in Europe 124
  158. 6.10 Drivers of European Diagnostics Testing 124
  159. 6.11 European Reimbursement Practices 124
  160. 6.12 Cost Containment in Europe 124
  161. 6.13 Revenue and Reimbursement 124
  162. 7. Product Launches 126
  163. 7.1 Horiba ABX Unveils Pentra DF 120 126
  164. 7.2 Sysmex America Launches Software for Sysmex XE-2100 Hematology Analyzers 126
  165. 7.3 SurroScan™ Develops Laser Scan Cytometry System 127
  166. 7.4 Abbott Receives Clearance for Hematology Instrument 127
  167. 7.5 Clinical Data Receives FDA Clearance for Excyte 128
  168. 7.6 Becton Introduces FACSCanto™ 128
  169. 7.7 Abbott's International Launch of CELL-DYN Sapphire™ Hematology Instrument 128
  170. 7.8 Beckman Coulter Launches LH 1500 Series 128
  171. 7.9 Beckman Launches High-Performance Hematology Analyzer Ac•T 128
  172. 7.10 Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer. 129
  173. 7.11 Becton Dickinson Biosciences' Imagn System 129
  174. 7.12 Sysmex Network Communications System 129
  175. 7.13 Sysmex XS-1000i Automated Hematology Analyzer 129
  176. 7.14 The Melet Schloesing MS4-5 129
  177. 7.15 Roche CoaguChek XS Plus System 130
  178. 7.16 Sysmex Corp Launches KX-21 130
  179. 7.17 Streck nRBC-Chex 130
  180. 7.18 HORIBA ABX Introduces Micros CRP 200 130
  181. 7.19 Heska Corporation Introduces Advanced Hematology Analyzer 130
  182. 7.20 Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers 130
  183. 7.21 HORIBA ABX e-Sat module 130
  184. 7.22 Medonic M series Hematology Analyzer 131
  185. 7.23 Streck's ESR-AutoPlus 131
  186. 7.24 Streck Quality Control Reagents 131
  187. 8. Clinical Hematology Testing Sector Trends and Forecasts 132
  188. 8.1 Home Care Analysis 132
  189. 8.2 Non-Traditional Collection for Hematology Analyzer Testing 132
  190. 8.3 New Systems for Critical-Care and Near-Patient Testing 132
  191. 8.4 Utility of Near-Patient Testing in Critical-Care Settings 132
  192. 8.5 Mergers of Diagnostic Companies 132
  193. 8.6 Information Management Advances 132
  194. 8.7 Test Ordering Patterns 132
  195. 8.8 Patient Satisfaction 132
  196. 8.9 Move Away From Central Laboratory 133
  197. 8.10 Healthcare Cost Controls 133
  198. 8.11 Competition for Services 133
  199. 8.12 Drivers of Clinical Hematology analyzer Testing 133
  200. 8.13 Confluence of New Technology 133
  201. 8.14 New Trends in Clinical Laboratory Testing 134
  202. 8.14.1 Trends in Reimbursement Practices 134
  203. 8.14.2 Managed Care 136
  204. 8.14.3 Changes in Patient Management 137
  205. 8.14.4 Focused Testing 137
  206. 8.14.5 Satellite Facilities 137
  207. 8.15 Demographic Trends 137
  208. 9. Corporate Profiles 138
  209. 9.1 Abbott Diagnostics 138
  210. 9.2 A.Menarini Diagnostics 140
  211. 9.3 Bayer Diagnostics 140
  212. 9.4 Beckman Coulter 142
  213. 9.5 Becton Dickenson Biosciences 146
  214. 9.6 Bio-Rad Laboratories Inc. 146
  215. 9.7 Boule Medical AB 147
  216. 9.8 Careside Inc. 147
  217. 9.9 Cholestech 147
  218. 9.10 Dade Behring 148
  219. 9.11 HemoCue 149
  220. 9.12 Heska Corporation 150
  221. 9.13 Horiba Group 150
  222. 9.14 Melet Schloesing 151
  223. 9.15 Micronics 151
  224. 9.16 Nihon Kohden 152
  225. 9.17 PPD 152
  226. 9.18 Roche Diagnostics 152
  227. 9.19 Shenzhen Mindray Bio-Medical Electronics Co. Ltd. 154
  228. 9.20 Streck 154
  229. 9.21 Sysmex 154
  230. LIST OF TABLES
  231. Table 2.1: Clinical Hematology Tests Submitted to Medicare, 2005-2012 12
  232. Table 2.2: Clinical Hematology Tests Performed in the U.S., 2005-2012 12
  233. Table 2.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005 13
  234. Table 2.4: Competitive Landscape: Companies Participating in the Hematology IVD Sector 14
  235. Table 2.5: Key Product Segments 16
  236. Table 2.6: Worldwide Market for Flow Cytometry Instruments and Reagents, 2000-2010 23
  237. Table 2.7: Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 27
  238. Table 2.8: U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 27
  239. Table 2.9: U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 1996-2007 28
  240. Table 2.10: Slide Stainer Instruments and Manufacturers 35
  241. Table 2.11: Hematology Stains 37
  242. Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide in 2005 41
  243. Table 3.2: Worldwide Distribution of IVD Testing in 2005 41
  244. Table 3.3: Global Clinical Hematology Analyzer and Reagent Revenues, 2005-2012 42
  245. Table 3.4: Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, 2005 42
  246. Table 3.5: Top 15 IVD Manufacturers' Worldwide Revenue ($ Millions) 43
  247. Table 3.6 Key Players in Worldwide Hematology Analyzers and Reagent Market 44
  248. Table 3.7: Leading Players in Worldwide Coagulation Analyzer and Reagent Market 44
  249. Table 3.8: U.S. Clinical Hematology Analyzer Testing Market, 2000-2011 47
  250. Table 3.9: U.S. Clinical Hematology Diagnostic Test Market Segments, 2005 47
  251. Table 3.10: Leading Players in the U.S. Hematology Analyzers Market 47
  252. Table 3.11: Leading Players in the U.S. Coagulation Analyzers Market 48
  253. Table 3.12: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 49
  254. Table 3.13: European Clinical Laboratory Diagnostic Testing Markets by Analyte, 2003 50
  255. Table 3.14: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2004 50
  256. Table 3.15: European Clinical Hematology Instrument and Reagent Testing Market, 2000-2008 51
  257. Table 3.16: German Hematology Reagent Market Sales, 2003-2012 52
  258. Table 3.17: UK Hematology Reagent Market Sales, 2003-2012 54
  259. Table 3.18: French Hematology Reagent Market Sales, 2003-2012 55
  260. Table 3.19: Italian Hematology Reagent Market Sales, 2003-2012 55
  261. Table 3.20: Spanish Hematology Reagent Market Sales, 2003-2012 56
  262. Table 3.21: Belgian Hematology Reagent Market Sales, 2003-2012 56
  263. Table 3.22: Swiss Hematology Reagent Market Sales, 2003-2012 57
  264. Table 3.23: Dutch Hematology Reagent Market Sales, 2003-2012 57
  265. Table 3.24: Portuguese Hematology Reagent Market Sales, 2003-2012 57
  266. Table 3.25: Austrian Hematology Reagent Market Sales, 2003-2012 58
  267. Table 3.26: Greek Hematology Reagent Market Sales, 2003-2012 58
  268. Table 3.27: Polish Hematology Reagent Market Sales, 2003-2012 59
  269. Table 3.28: Czech Hematology Reagent Market Sales, 2003-2012 59
  270. Table 3.29: Finnish Hematology Reagent Market Sales, 2003-2012 60
  271. Table 3.30: Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-2008 60
  272. Table 3.31: Indian IVD Market, 2006-2012 61
  273. Table 3.32: Indian Hematology Reagent Market Sales, 2006-2012 61
  274. Table 3.33: Number of Automated Clinical Labs in India, 2004-2012 62
  275. Table 3.34: Indian IVD Market, 2006 62
  276. Table 3.35: Market Sales of IVD Equipment and Reagents by Company in India 63
  277. Table 3.36: Japanese Clinical Hematology Testing Market, 2000-2008 64
  278. Table 3.37: Chinese Clinical Hematology Reagent Market Sales, 2000-2008 65
  279. Table 3.38: Canadian Clinical Hematology Testing Market, 2000-2008 68
  280. Table 3.39: Brazilian Clinical Hematology Analyzer Testing Market, 2000-2008 68
  281. Table 3.40: Turkish Clinical Hematology Reagents Testing Market, 2000-2008 69
  282. Table 3.41: Australian Clinical Hematology Reagents Testing Market, 2000-2008 69
  283. Table 3.42: The ROW Clinical Hematology Reagents Testing Market, 2000-2008 69
  284. Table 3.43: Estimated Number of Clinical Laboratories in Latin America 73
  285. Table 3.44: Principal Marketers of Automated Clinical Hematology Analyzer Instruments 75
  286. Table 4.1: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 83
  287. Table 4.2: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 84
  288. Table 4.3: Linearity and Precision of Bayer Hematology Analyzers 85
  289. Table 4.4: Accuracy of the Automated Differential of Bayer Hematology Analyzers 85
  290. Table 4.5: Linearity and Precision of Beckman Coulter Hematology Instruments 87
  291. Table 4.6: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 87
  292. Table 4.7: Linearity and Precision of Horiba ABX Hematology Analyzers 89
  293. Table 4.8: Accuracy of the Horiba ABX Hematology Analyzers 89
  294. Table 4.9: Linearity and Precision of Sysmex Hematology Analyzers 92
  295. Table 4.10: Accuracy of the Sysmex Hematology Analyzers 92
  296. Table 4.11: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 93
  297. Table 4.12: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 93
  298. Table 4.13: Hematology Analyzers with a 5-Part WBC Differential 94
  299. Table 4.14: Hematology Analyzers with a Three-Part WBC Differential 94
  300. Table 5.1: Applications for Wireless LAN Technology 102
  301. Table 8.1: Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests 135

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