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Hematology Analyzer Instrumentation and Reagent Markets
Publication Date: 01-JUL-09
Pages: 147
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. TABLE OF CONTENTS
  2. 1. Overview 7
  3. 1.1 Objectives of the Report 7
  4. 1.2 Methodology 8
  5. 1.3 Scope of the Report 9
  6. 1.4 Executive Summary 10
  7. 2. IVD Clinical Hematology Analyzer Market 11
  8. 2.1 Introduction 11
  9. 2.2 Key Product Segments 16
  10. 2.2.1 Hematology and Associates Instruments 16
  11. 2.2.1.1 Hematology Analyzers 16
  12. 2.2.1.2 Hematology Instruments Offerings by Major Players 17
  13. 2.2.1.2.1 Hematology Reagents and Controls 18
  14. 2.2.1.2.2 Hematology Point of Care Instruments 19
  15. 2.2.1.3 Flow Cytometers 20
  16. 2.2.1.3.1 Flow Cytometry Technology Platforms 20
  17. 2.2.1.3.2 Clinical Applications of Flow Cytometry 21
  18. 2.2.1.3.2.1 Leukocyte Analysis 21
  19. 2.2.1.3.2.2 Immunophenotyping of Leukemias and Lymphomas 21
  20. 2.2.1.3.2.3 Neutropenia 21
  21. 2.2.1.3.2.4 Platelet Analysis 21
  22. 2.2.1.3.2.5 T Cell Subsets 22
  23. 2.2.1.3.2.6 Reticulocyte Count 22
  24. 2.2.1.3.3 Flow Cytometry Market Growth 22
  25. 2.2.1.3.3.1 Applications 23
  26. 2.2.1.3.3.2 Market Size 23
  27. 2.2.1.3.3.3 Instrumentation Preferences 24
  28. 2.2.1.3.3.4 Reagent Selection and Use 25
  29. 2.2.1.3.3.5 Instrument Manufacturers 25
  30. 2.2.1.3.3.6 Future Directions of Flow Cytometry 26
  31. 2.2.1.4 Coagulation Analyzers 27
  32. 2.2.1.4.1 Coagulation Market Size 27
  33. 2.2.1.4.2 Prothrombin Time Test 28
  34. 2.2.1.4.3 Activated Partial Thromboplastin Time (APTT) 29
  35. 2.2.1.4.4 Clinical Advantages of Coagulation Testing 29
  36. 2.2.1.4.5 Coagulation Instruments 30
  37. 2.2.1.4.5.1 Roche Diagnostics 30
  38. 2.2.1.4.5.2 Avocet Medical (Acquired by Beckman Coulter, Inc.) 31
  39. 2.2.1.4.5.3 International Technidyne Corporation (ITC) 31
  40. 2.2.1.4.5.4 Diagnostica Stago's STA-RE Evolution 32
  41. 2.2.1.4.5.5 Other Companies 32
  42. 2.2.1.4.5.6 Coagulation Reagents 33
  43. 2.2.1.5 Hemoglobinometers 33
  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 38
  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. Global Analyzer Market 41
  57. 3.1 Global Markets 41
  58. 3.1.1 Global Drivers of Clinical Hematology Analyzer Testing 44
  59. 3.1.2 Global Outlook 45
  60. 3.1.3 U.S. Market 46
  61. 3.1.4 European Market 48
  62. 3.1.5.1 German Clinical Hematology Analyzer and Reagent Diagnostic Markets 50
  63. 3.1.5.2 U.K. Clinical Hematology Market 52
  64. 3.1.5.3 French Clinical Hematology Market 53
  65. 3.1.5.4 Italian Clinical Hematology Market 54
  66. 3.1.5.5 Spanish Clinical Hematology Market 54
  67. 3.1.5.6 Belgian Clinical Hematology Market 54
  68. 3.1.5.7 Swiss Clinical Hematology Market 55
  69. 3.1.5.8 Dutch Clinical Hematology Market 55
  70. 3.1.5.9 Portuguese Clinical Hematology Market 56
  71. 3.1.5.10 Austrian Clinical Hematology Market 56
  72. 3.1.5.11 Greek Clinical Hematology Market 56
  73. 3.1.5.12 Polish Clinical Hematology Market 57
  74. 3.1.5.13 Czech Clinical Hematology Market 57
  75. 3.1.5.14 Finnish Clinical Hematology Market 58
  76. 3.1.5.15 Scandinavian Clinical Hematology Market 58
  77. 3.1.6 Asian Market 58
  78. 3.1.6.1 Indian Clinical Hematology Market 58
  79. 3.1.6.1.1 India's in vitro Diagnostic Testing Industry 58
  80. 3.1.6.1.2 Major Indian IVD Companies 60
  81. 3.1.6.2 Japanese Clinical Hematology Market 61
  82. 3.1.6.3 Chinese Clinical Hematology Market 61
  83. 3.1.7 Country Clinical Hematology Smaller Markets 65
  84. 3.1.7.1 Canada Clinical Hematology Market 65
  85. 3.1.7.2 Brazil Clinical Hematology Market 65
  86. 3.1.7.3 Turkey Clinical Hematology Market 66
  87. 3.1.7.4 Australia Clinical Hematology Market 66
  88. 3.1.8 Remaining World Clinical Hematology Market 66
  89. 3.1.9 Overview of Asian Healthcare Market 67
  90. 3.1.9.1 Singapore 67
  91. 3.1.9.2 Malaysia 67
  92. 3.1.9.3 Thailand 67
  93. 3.1.9.4 Indonesia 68
  94. 3.1.9.5 Philippines 68
  95. 3.1.9.6 South Korea 68
  96. 3.1.9.7 Hong Kong 69
  97. 3.1.10 Overview of the Latin American Diagnostics Market 69
  98. 3.2 Clinical Hematology Analyzer and Reagents Sector 70
  99. 3.2.1 Industry-Served Markets 70
  100. 3.2.2 Industry Players 71
  101. 3.2.2.1 Manufacturing Companies 71
  102. 3.2.3 Market Specialization 72
  103. 3.2.4 Hematology Sector Companies 72
  104. 3.3 Outlook for Clinical Hematology Analyzer Testing 73
  105. 3.3.1 Long-Term Changes 73
  106. 3.3.2 Market Drivers 75
  107. 3.3.3 The Limits to Growth 75
  108. 3.3.4 Hot Sectors in the IVD Market 75
  109. 3.3.5 Key Technologies 76
  110. 3.3.6 Conclusion 76
  111. 4. Clinical Hematology Instrument Market by Type and Competitor 77
  112. 4.1 Abbott Diagnostics 77
  113. 4.2 Siemens Healthcare Diagnostics 80
  114. 4.3 Beckman Coulter, Inc. 81
  115. 4.4 Drew Scientific Group 83
  116. 4.5 Horiba ABX Inc. 84
  117. 4.6 Sysmex Corporation 85
  118. 4.7 Boule Medical AB 90
  119. 4.8 Beijing ShiningSun Technology Co., Ltd. 91
  120. 4.9 Hematology Analyzers for Point of Care 91
  121. 5. Important Technology Trends 92
  122. 5.1 Technology Platform Innovations in Hematology Testing 92
  123. 5.2 The New Paradigm 92
  124. 5.3 Consolidated Workstations 92
  125. 5.4 Automation in the Laboratory 94
  126. 5.5 Laboratory Information Systems 95
  127. 5.6 New User-friendly Interfaces 96
  128. 5.7 Data-Management Issues 97
  129. 5.7.1 Wireless LANs 97
  130. 5.7.2 Data and Workflow Management Systems 98
  131. 5.7.3 Beckman Central Command Central Version 2.0 98
  132. 5.7.4 Middleware 98
  133. 5.8 Robotics - Total Laboratory Automation Robotic Sample Handling 99
  134. 5.9 Image Analysis 100
  135. 5.10 Flow Cytometry 100
  136. 5.11 Laser Technology 101
  137. 5.12 Automating Preanalytics 101
  138. 5.13 Telepathology 101
  139. 6. Business Trends in the Clinical Hematology Analyzer Sector 103
  140. 6.1 Key Developments 103
  141. 6.2 Industrial Sector Consolidation 103
  142. 6.3 Hospital and Commercial Laboratory Consolidation 105
  143. 6.4 Changing Ordering Patterns 106
  144. 6.5 New Products 106
  145. 6.6 Acquisition, License Agreements, Internal Development and Partnerships 108
  146. 6.7 Breadth of Product Offerings 111
  147. 6.8 Government Regulation 111
  148. 6.8.1 U.S. Regulation 111
  149. 6.8.1.1 Importing Medical Devices into the U.S. 112
  150. 6.8.1.2 Exporting Medical Devices from the U.S. 113
  151. 6.8.2 U.K. Regulation 113
  152. 6.8.3 E.U. Regulation 114
  153. 6.8.4 Japanese Regulation 117
  154. 6.8.5 Korean Regulation 117
  155. 6.9 Costs of Doing Business in Europe 118
  156. 6.10 Drivers of European Diagnostics Testing 118
  157. 6.11 European Reimbursement Practices 118
  158. 6.12 Cost Containment in Europe 118
  159. 6.13 Revenue and Reimbursement 118
  160. 7. Product Launches 120
  161. 7.1 Horiba ABX Unveils Pentra DX 120 120
  162. 7.2 Sysmex to Launch Sales of the XT-4000i Hematology Analyzers 120
  163. 7.3 Laser Scan Cytometry System 121
  164. 7.4 Abbott Receives Clearance for Hematology Instrument 121
  165. 7.5 Vital Diagnostics announced the Addition of the Excyte Mini Automated ESR Analyzer 121
  166. 7.6 Becton Introduces FACSCanto II 121
  167. 7.7 Abbott's International Launch of CELL-DYN Emerald™ Hematology Instrument 122
  168. 7.8 Beckman Coulter Launches UniCel DxH 800 122
  169. 7.9 Beckman Launches High-Performance Hematology Analyzer Ac•T 123
  170. 7.10 Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer. 123
  171. 7.11 BD (Becton Dickinson Biosciences) Imagn System 123
  172. 7.12 Sysmex Network Communications System 123
  173. 7.13 Sysmex XT-V Multi-Species Hematology Analyzer 123
  174. 7.14 The Melet Schloesing MS4-5 124
  175. 7.15 Roche CoaguChek XS Plus System 124
  176. 7.16 Sysmex Corp Launches KX-4500 124
  177. 7.17 Streck nRBC-Chex 124
  178. 7.18 HORIBA ABX Introduces Micros CRP 200 124
  179. 7.19 Heska Corporation Introduces Veterinary Hematology Analyzer 124
  180. 7.20 Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers 125
  181. 7.21 HORIBA ABX e-Sat module 125
  182. 7.22 Medonic M series Hematology Analyzer 125
  183. 7.23 Streck's ESR-AutoPlus 125
  184. 7.24 Streck Quality Control Reagents 125
  185. 8. Clinical Hematology Testing Sector Trends and Forecasts 126
  186. 8.1 Home Care Analysis 126
  187. 8.2 Non-Traditional Collection for Hematology Analyzer Testing 126
  188. 8.3 New Systems for Critical-Care and Near-Patient Testing 126
  189. 8.4 Utility of Near-Patient Testing in Critical-Care Settings 126
  190. 8.5 Mergers of Diagnostic Companies 126
  191. 8.6 Information Management Advances 126
  192. 8.7 Test Ordering Patterns 126
  193. 8.8 Patient Satisfaction 126
  194. 8.9 Move Away From Central Laboratory 127
  195. 8.10 Healthcare Cost Controls 127
  196. 8.11 Competition for Services 127
  197. 8.12 Drivers of Clinical Hematology analyzer Testing 127
  198. 8.13 Confluence of New Technology 127
  199. 8.14 New Trends in Clinical Laboratory Testing 128
  200. 8.14.1 Trends in Reimbursement Practices 128
  201. 8.14.2 Managed Care 130
  202. 8.14.3 Changes in Patient Management 131
  203. 8.14.4 Focused Testing 131
  204. 8.14.5 Satellite Facilities 131
  205. 8.15 Demographic Trends 131
  206. 9. Company Profiles 132
  207. 9.1 Abbott Diagnostics 132
  208. 9.2 A.Menarini Diagnostics 133
  209. 9.3 Bayer HealthCare, AG 134
  210. 9.4 Beckman Coulter, Inc. 135
  211. 9.5 Becton Dickenson Biosciences 139
  212. 9.6 Boule Diagnostics International AB 140
  213. 9.7 Cholestech Corporation 140
  214. 9.8 Dade Behring (Acquired by Siemens) 141
  215. 9.9 HemoCue, Inc. 141
  216. 9.10 Heska Corporation 141
  217. 9.11 Horiba Group 142
  218. 9.12 MELET SCHLOESING Laboratories 142
  219. 9.13 Micronics, Inc. 143
  220. 9.14 Nihon Kohden Corporation 143
  221. 9.15 PPD (Pharmaceutical Product Development, Inc.) 144
  222. 9.16 Roche Diagnostics (F. Hoffmann-La Roche, Ltd.) 144
  223. 9.17 Shenzhen Mindray Bio-Medical Electronics Co. Ltd. 145
  224. 9.18 Streck, Inc. 145
  225. 9.19 Sysmex Corporation 146
  226. LIST OF TABLES
  227. Table 2.1: Clinical Hematology Tests Submitted to Medicare, 2005-2012 12
  228. Table 2.2: Clinical Hematology Tests Performed in the U.S., 2005-2012 12
  229. Table 2.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009 13
  230. Table 2.4: Competitive Landscape: Companies Participating in the Hematology IVD Sector 14
  231. Table 2.5: Key Product Segments 16
  232. Table 2.6: Worldwide Market for Flow Cytometry Instruments and Reagents, 2000-2010 24
  233. Table 2.7: Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 28
  234. Table 2.8: U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-2008 28
  235. Table 2.9: U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 2001-2012 28
  236. Table 2.10: Slide Stainer Instruments and Manufacturers 35
  237. Table 2.11: Hematology Stains 37
  238. Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide, 2008 41
  239. Table 3.2: Worldwide Distribution of IVD Testing, 2008 41
  240. Table 3.3: Global Clinical Hematology Analyzer and Reagent Revenues, 2005-2012 42
  241. Table 3.4: Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, 2006 42
  242. Table 3.5: Ten Largest Diagnostic Companies Worldwide, 2007 43
  243. Table 3.6 Key Players in Worldwide Hematology Analyzers and Reagent Market 43
  244. Table 3.7: Leading Players in Worldwide Coagulation Analyzer and Reagent Market 44
  245. Table 3.8: U.S. Clinical Hematology Analyzer Testing Market, 2000-2011 46
  246. Table 3.9: U.S. Clinical Laboratory Diagnostic Test Market Segments, 2007 46
  247. Table 3.10: Leading Players in the U.S. Hematology Analyzers Market 47
  248. Table 3.11: Leading Players in the U.S. Coagulation Analyzers Market 47
  249. Table 3.12: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 49
  250. Table 3.14: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 49
  251. Table 3.15: European Clinical Hematology Instrument and Reagent Testing Market, 2000-2008 50
  252. Table 3.16: German Hematology Reagent Market Sales, 2003-2012 51
  253. Table 3.17: UK Hematology Reagent Market Sales, 2003-2012 53
  254. Table 3.18: French Hematology Reagent Market Sales, 2003-2012 53
  255. Table 3.19: Italian Hematology Reagent Market Sales, 2003-2012 54
  256. Table 3.20: Spanish Hematology Reagent Market Sales, 2003-2012 54
  257. Table 3.21: Belgian Hematology Reagent Market Sales, 2003-2012 55
  258. Table 3.22: Swiss Hematology Reagent Market Sales, 2003-2012 55
  259. Table 3.23: Dutch Hematology Reagent Market Sales, 2003-2012 55
  260. Table 3.24: Portuguese Hematology Reagent Market Sales, 2003-2012 56
  261. Table 3.25: Austrian Hematology Reagent Market Sales, 2003-2012 56
  262. Table 3.26: Greek Hematology Reagent Market Sales, 2003-2012 57
  263. Table 3.27: Polish Hematology Reagent Market Sales, 2003-2012 57
  264. Table 3.28: Czech Hematology Reagent Market Sales, 2003-2012 57
  265. Table 3.29: Finnish Hematology Reagent Market Sales, 2003-2012 58
  266. Table 3.30: Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-2008 58
  267. Table 3.31: Indian IVD Market, 2006-2012 59
  268. Table 3.32: Indian Hematology Reagent Market Sales, 2006-2012 59
  269. Table 3.33: Number of Automated Clinical Labs in India, 2004-2012 59
  270. Table 3.34: Indian IVD Market, 2008 60
  271. Table 3.36: Japanese Clinical Hematology Testing Market, 2000-2008 61
  272. Table 3.37: Chinese Clinical Hematology Reagent Market Sales, 2000-2008 62
  273. Table 3.38: Canadian Clinical Hematology Testing Market, 2000-2008 65
  274. Table 3.39: Brazilian Clinical Hematology Analyzer Testing Market, 2000-2008 65
  275. Table 3.40: Turkish Clinical Hematology Reagents Testing Market, 2000-2008 66
  276. Table 3.41: Australian Clinical Hematology Reagents Testing Market, 2000-2008 66
  277. Table 3.42: The ROW Clinical Hematology Reagents Testing Market, 2000-2008 66
  278. Table 3.43: Estimated Number of Clinical Laboratories in Latin America 69
  279. Table 3.44: Principal Marketers of Automated Clinical Hematology Analyzer Instruments 71
  280. Table 4.1: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers 79
  281. Table 4.2: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers 80
  282. Table 4.3: Linearity and Precision of Siemens Hematology Analyzers 81
  283. Table 4.4: Accuracy of the Automated Differential of Siemens Hematology Analyzers 81
  284. Table 4.5: Linearity and Precision of Beckman Coulter Hematology Instruments 83
  285. Table 4.6: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers 83
  286. Table 4.7: Linearity and Precision of Horiba ABX Hematology Analyzers 85
  287. Table 4.8: Accuracy of the Horiba ABX Hematology Analyzers 85
  288. Table 4.9: Linearity and Precision of Sysmex Hematology Analyzers 88
  289. Table 4.10: Accuracy of the Sysmex Hematology Analyzers 88
  290. Table 4.11: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers 89
  291. Table 4.12: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers 89
  292. Table 4.13: Hematology Analyzers with a 5-Part WBC Differential 90
  293. Table 4.14: Hematology Analyzers with a Three-Part WBC Differential 90
  294. Table 5.1: Applications for Wireless LAN Technology 97
  295. Table 8.1: Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests 129

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