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Molecular Diagnostics Markets
Publication Date: 01-MAR-08
Pages: 282
Study: TMRMDM
Format/Price: PDF document / $3,400.00
   


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The technologies that constitute molecular diagnostics-first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels-are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments. This TriMark Publications report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor's offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap. The main objectives of this analysis are: 1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a complete understanding of the chief molecular diagnostics tests-i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic-from their basic principles to their applications; 3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and 4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

By Purchasing This Report You Will Have:

· An improved understanding of the current state and future of the molecular diagnostics market.
· The latest information on the leading companies engaged in research and development and products in the pipeline.
· The leading perspective of recent imaging developments and revelations.
· Knowledge of the molecular diagnostics market as an area of growth, research and investment.

This Report Will Cover the Following Molecular Diagnostics Technologies:

· Nucleic acid test applications.
· Blood testing and infectious diseases.
· Diagnostic testing using DNA.
· Cancer detection using PCR.
· Microbiology testing.
· Blood screening.
· SNPs in clinical diagnostics.
· Industrial testing and food diagnostics.
· Forensics market.
· Bioterrorism and molecular diagnostics.
· Cystic fibrosis testing.
· HLA sequencing-based typing kits
· Cytogenetic testing.
· Developments in biochips for clinical applications.
· Pharmacogenomics.

Analysis includes the use of charts and graphs measuring product growth and trends within the marketplace. In addition, a discussion of research into the molecular diagnostics arena provides the reader with a deeper understanding of the possibilities for future treatment and avenues for possible research and development budgets. Company-specific information, including sales figures, product pipeline status and research and development trends is provided throughout the report. The report will:

· Assess the molecular diagnostics market drivers and bottlenecks, from the perspective of the medical and scientific communities.
· Discuss the potential benefits of the molecular diagnostics market for various sectors of the medical and scientific community.
· Establish the current total market size and future growth of the molecular diagnostics market and analyze the current size and growth of various segments.
· Provide current and forecasted market shares by company.
· Discuss profit/business opportunities by imaging segment.
· Provide strategic recommendations for near-term business opportunities.
· Assess current commercial uses of the molecular diagnostics market.
· Assess the molecular diagnostics business models.

This report answers the following questions:

· What are the near-term business opportunities in the molecular diagnostics market?
· What are the current and forecasted sizes of the molecular diagnostics market?
· What are the business models currently used by companies in molecular diagnostics?
· How will manufacturers, researchers, physicians, patients and payers influence the molecular diagnostics market?
· What are the drivers and bottlenecks influencing the molecular diagnostics market?
· What are the technologies used in the molecular diagnostics sector?
· Who holds the proprietary rights to molecular diagnostics market technology?
· What are current applications of this technology?
· What regulatory processes must molecular diagnostics undergo in the United States (U.S.), Japan and Europe?
· How will new molecular diagnostics change treatment and payment paradigms?
· How will molecular diagnostics reduce healthcare expenditures?





Table of Contents:

  1. 1. Overview 9
  2. 1.1 Statement of Report 9
  3. 1.2 About This Report 9
  4. 1.3 Scope of the Report 9
  5. 1.4 Objectives 9
  6. 1.5 Methodology 10
  7. 1.6 Executive Summary 12
  8. 2. Introduction to Molecular Diagnostics and PCR Technology 15
  9. 2.1 Science Overview: Introduction to Genomics and Its Opportunity 15
  10. 2.2 Impact of the Human Genome Project on Molecular Diagnostics 17
  11. 2.3 Considerations for Molecular and Clinical Diagnosis 18
  12. 2.4 Molecular Diagnosis in the Post-Genomic Era 19
  13. 2.5 Advances in Molecular Diagnostics Technologies 20
  14. 2.6 Genetic Variability and Disease 22
  15. 2.7 Major Technology Platforms 22
  16. 2.7.1 Gene-based Amplification Technologies 23
  17. 2.7.2 Detection of Amplified Gene Products 23
  18. 2.7.3 Target-Based Gene Amplification 24
  19. 2.7.3.1 Polymerase Chain Reaction 24
  20. 2.7.3.2 Real-time PCR 25
  21. 2.7.3.3 Nucleic Acid Sequence-Based Amplification 26
  22. 2.7.4 Probe-Based Amplification 26
  23. 2.7.4.1 Ligase Chain Reaction 26
  24. 2.7.4.2 Strand Displacement Amplification 26
  25. 2.7.4.3 Qß-replicase Amplified Probe Assay 26
  26. 2.7.5 Signal-Based Amplification 27
  27. 2.7.5.1 Branched DNA (bDNA) 27
  28. 2.7.6 Other Gene Amplification Technologies 27
  29. 2.7.6.1 Immuno-PCR 27
  30. 2.7.6.2 Bio-Barcode Assay 27
  31. 3. Nucleic Acid Test Applications 29
  32. 3.1 Blood Testing and Infectious Diseases 30
  33. 3.1.1 Molecular Diagnostics Market 30
  34. 3.1.1.1 Methods for DNA Detection and Gene Sequencing 41
  35. 3.1.1.2 Products and Applications 42
  36. 3.1.1.3 Oncology 43
  37. 3.1.2 SNPs and Genes: Medical Utility (Clinical Applications) 43
  38. 3.1.2.1 Clinical Application Initiatives 45
  39. 3.1.2.2 A Sampling of Clinical Application Collaborations 46
  40. 3.1.2.3 Collaborative Relationships 48
  41. 3.2 Diagnostic Testing Using DNA 49
  42. 3.2.1 HIV 51
  43. 3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing 53
  44. 3.2.2.1 Hepatitis A Virus (HAV) 53
  45. 3.2.2.2 Hepatitis B Virus (HBV) 54
  46. 3.2.2.3 Hepatitis C Virus (HCV) 57
  47. 3.2.2.4 Hepatitis D Virus (HDV) 62
  48. 3.2.2.5 Hepatitis E Virus (HEV) 62
  49. 3.2.2.6 HBV/HCV Viral Load and Drug Resistance 62
  50. 3.2.3 Severe Acute Respiratory Syndrome (SARS) 64
  51. 3.2.3.1 New Approach to Diagnosing Avian Influenza 65
  52. 3.2.3.2 Microarray or DNA Chip-Based Tests 67
  53. 3.2.4 Cancer Detection Using PCR 68
  54. 3.2.4.1 Lung Cancer 68
  55. 3.2.4.2 Oral Cancer 69
  56. 3.2.4.3 Prostate Cancer 69
  57. 3.2.4.4 Chronic Myelogenous Leukemia 69
  58. 3.2.4.5 Malignant Gliomas 70
  59. 3.2.4.6 Colorectal Cancer 70
  60. 3.2.4.7 Breast Cancer 70
  61. 3.2.4.8 Bladder Cancer 70
  62. 3.2.5 Microbiology Testing 70
  63. 3.2.5.1 Chlamydia 71
  64. 3.2.5.2 Gonorrhea 71
  65. 3.2.5.3 Tuberculosis 71
  66. 3.2.5.4 Group B Streptococcus 74
  67. 3.2.5.5 Pathogenic Enteric Bacteria 76
  68. 3.2.5.6 Bordetella pertussis 77
  69. 3.2.5.7 Legionella Pneumophila 77
  70. 3.2.5.8 Peridontal Bacteria 77
  71. 3.2.5.9 Pneumocystis Carinii 77
  72. 3.2.5.10 Methicillin-resistant Staphylococcus Aureus 78
  73. 3.2.6 Blood Screening 78
  74. 3.3 SNPs in Clinical Diagnostics 83
  75. 3.3.1 Functional Genomics 87
  76. 3.3.2 Paternity Testing 87
  77. 3.4 Industrial Testing and Food Diagnostics 88
  78. 3.4.1 The Market 88
  79. 3.4.2 Detection of H. pylori by PCR 91
  80. 3.4.3 Detection of E. coli 0157 91
  81. 3.4.4 Detection of Enteric Viruses 91
  82. 3.5 Forensics Market 92
  83. 3.5.1 Isolation of DNA for PCR Profiling 93
  84. 3.5.2 Analysis by PCR-Based DNA Typing 94
  85. 3.5.3 Rapid Isolation of DNA for RFLP and PCR 94
  86. 3.5.4 DNA for PCR-STR Typing 94
  87. 3.6 Bioterrorism and Molecular Diagnostics 94
  88. 3.6.1 Introduction 94
  89. 3.6.1.1 Current Biological Threat Detection Systems 97
  90. 3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWA 98
  91. 3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection System 99
  92. 3.6.2 Biological Warfare Agents 100
  93. 3.6.2.1 Anthrax 100
  94. 3.6.2.2 Botulinum Toxin 101
  95. 3.6.2.3 Ricin 101
  96. 3.6.2.4 IVD Industry and Bioterrorism Preparedness 101
  97. 3.6.2.4.1 Brucellosis 101
  98. 3.6.2.4.2 Cholera 102
  99. 3.6.2.5 Rapid Lateral Flow Immunoassays 103
  100. 3.6.2.6 Biosensors 104
  101. 3.6.2.6.1 Antibody and Synthetic Receptor-Based Sensors 104
  102. 3.6.2.6.2 DNA Sensors 105
  103. 3.6.2.6.3 Reagentless Sensors 106
  104. 3.6.3 Anthrax in Clinical Samples 107
  105. 3.6.3.1 Overview of Anthrax and Its Infectivity 107
  106. 3.6.3.2 Rapid Tests 109
  107. 3.6.3.2.1 PCR Tests 109
  108. 3.7 Cystic Fibrosis Testing 110
  109. 3.8 HLA Sequencing-Based Typing Kits 112
  110. 3.9 Cytogenetic Testing 114
  111. 3.9.1 Hereditary Hemochromatosis 116
  112. 3.9.2 Apolipoprotein E (ApoE) Genotyping 116
  113. 3.9.3 Fragile X Syndrome 117
  114. 3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing 118
  115. 3.10 Developments in Biochips for Clinical Applications 119
  116. 3.10.1 Roche AmpliChip Microarray 119
  117. 3.10.2 Breast Cancer DNA Chips 119
  118. 3.10.3 eSensor DNA Detection System 120
  119. 3.11 Pharmacogenomics 121
  120. 3.11.1 Coumadin 122
  121. 3.12 Thrombic Disorders 124
  122. 4. Trends in Molecular Diagnostics 125
  123. 4.1 Pharmacogenomics 125
  124. 4.1.1 The Market 125
  125. 4.1.1.1 Oncology 125
  126. 4.1.1.2 Toxicogenomics 125
  127. 4.1.2 Market Influences and Forecast 126
  128. 4.2 DNA Microarrays 126
  129. 4.2.1 Techniques 131
  130. 4.2.2 The Market 131
  131. 4.2.3 Identification of Sequence SNPs 131
  132. 4.2.4 Determining Gene Expression Levels 132
  133. 4.2.4.1 Hybridization Tests 132
  134. 4.2.4.2 Oligonucleotide Probes 133
  135. 4.2.5 Molecular Diagnostics Entry into Point-of-Care Testing 133
  136. 4.3 Emerging Markets of DNA Arrays 133
  137. 4.3.1 Pharmacogenomics 135
  138. 4.3.2 Adoption of Amplified Screening Technology 135
  139. 4.3.3 Advances in Automated Testing 135
  140. 4.3.4 Increased Focus on Safety of Blood Supply 136
  141. 4.3.5 Development of Emerging Markets for NAT Technology 136
  142. 4.3.6 Cancer 136
  143. 4.3.7 Human Leukocyte Antigen Typing 136
  144. 4.3.8 Neonatal Screening 137
  145. 4.4 Drivers and Restraints 138
  146. 4.5 Market Forecast 139
  147. 4.6 Business Trends in the Industry 139
  148. 4.6.1 Molecular Diagnostics Industry Trends 139
  149. 4.6.1.1 Adoption of Amplified Screening Technology 139
  150. 4.6.1.2 Advances in Automated Testing 139
  151. 4.6.1.3 Responsiveness to Newly Emerging Threats 140
  152. 4.6.1.4 Increased Focus on Safety of Blood Supply 140
  153. 4.6.1.5 Growth in Viral Load Testing 140
  154. 4.6.1.6 Development of Emerging Markets for NAT Technology 140
  155. 4.6.1.7 Improvements in Detection Technologies 141
  156. 4.6.2 Pharmaceutical Industry Trends 141
  157. 4.6.3 Acquisitions, License Agreements and Partnerships 143
  158. 4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information 146
  159. 4.6.5 Regulatory Issues 146
  160. 4.6.6 Reimbursement Issues 147
  161. 4.6.6.1 Cystic Fibrosis 147
  162. 4.6.6.2 Viral Load Testing 147
  163. 4.6.6.3 NMP22 147
  164. 4.6.6.4 iFOB Reimbursement 147
  165. 5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA 148
  166. 5.1 Gene Expression Profiling 149
  167. 5.2 Proteomic Multiplex Assays 149
  168. 5.3 Solution-Phase Multiplexing 149
  169. 5.4 RNA Interference (RNAi) 150
  170. 5.4.1 Role of RNAi in Drug Target Validation 151
  171. 5.4.2 Other Companies Involved in the RNAi Market 151
  172. 5.5 DNA Tags 152
  173. 6. Market Trends and Forecasts 153
  174. 6.1 Market Dynamics 153
  175. 6.1.1 Technological Perspective on Molecular Diagnostics 153
  176. 6.1.2 Molecular Diagnostics Market Opportunities 153
  177. 6.1.3 Market Forces 154
  178. 6.1.3.1 Adoption of Amplified Screening Technology 155
  179. 6.1.3.2 Advances in Automated Testing 155
  180. 6.1.3.3 Responsiveness to Newly Emerging Threats 155
  181. 6.1.3.4 Increased Focus on Safety of Blood Supply 156
  182. 6.1.3.5 Growth in Viral Load Testing 156
  183. 6.1.3.6 Development of Emerging Markets for NAT Technology 156
  184. 6.1.3.7 Improvements in Detection Technologies 157
  185. 6.2 Future Considerations for Molecular Diagnosis 157
  186. 6.3 Role of Genomics in Transforming Pharmaceutical R&D 158
  187. 6.4 Cancer Markers 158
  188. 6.5 Cytology Markers 159
  189. 6.6 RNA Detection 159
  190. 6.7 Diagnosis of Inherited Disease 159
  191. 6.8 Ethical Considerations 159
  192. 6.9 NAT and Personalized Medicine 161
  193. 6.10 Five Molecular Diagnostics Growth Areas 161
  194. 6.11 Specific Commercial Nucleic Acid Probes 161
  195. 6.12 Novel Amplification Techniques in the Market 162
  196. 6.13 Ramification Amplification Method (RAM) 163
  197. 6.14 Invader Assays/Third Wave Technologies 163
  198. 6.15 Molecular Beacons 165
  199. 6.16 HLA Sequencing-Based Typing Kits 166
  200. 6.17 Prenatal Diagnosis 166
  201. 6.18 Newborn Screening 167
  202. 6.19 NAT and Preventive Medicine: NAT-Based Assays 167
  203. 6.20 Prenatal and Pre-implantation Diagnosis 168
  204. 6.21 FISH-Based Tests on Fetal Cells 168
  205. 6.22 Companion Therapeutic/Diagnostic Approach 168
  206. 6.23 Sample Preparation Market 169
  207. 7. Corporate Directory 170
  208. 7.1 Abbott Laboratories 170
  209. 7.2 Affymetrix 174
  210. 7.3 Agendia 182
  211. 7.4 Agilent Technologies 182
  212. 7.5 Ambion 183
  213. 7.6 Applied Biosystems Group 183
  214. 7.7 Beckman Coulter 187
  215. 7.8 BioGenex 190
  216. 7.9 bioMérieux 190
  217. 7.10 Bio-Rad Laboratories 190
  218. 7.11 Biotage 191
  219. 7.12 Biotest 191
  220. 7.13 Caliper Life Sciences 192
  221. 7.14 Celera Group 194
  222. 7.15 Cellomics 195
  223. 7.16 Cepheid 195
  224. 7.17 Chiron (Novartis) 196
  225. 7.18 Ciphergen Biosystems 197
  226. 7.19 CuraGen 198
  227. 7.20 Cytocell Technologies 203
  228. 7.21 Dako A/S (formerly DakoCytomation A/S) 203
  229. 7.22 DiaDexus 204
  230. 7.23 Digene 206
  231. 7.24 Enzo Biochem 206
  232. 7.25 Epigenomics 206
  233. 7.26 Epoch Biosciences 207
  234. 7.27 EraGen Biosciences 207
  235. 7.28 Eurogentec 207
  236. 7.29 Exiqon 208
  237. 7.30 Gene Link 208
  238. 7.31 Gene Logic 208
  239. 7.32 GeneOhm Sciences 210
  240. 7.33 Genisphere 211
  241. 7.34 Gen-Probe 211
  242. 7.35 Genzyme 213
  243. 7.36 Hamilton Thorne Biosciences 214
  244. 7.37 ID Biomedical 214
  245. 7.38 Illumina 215
  246. 7.39 Incyte 218
  247. 7.40 Innogenetics 220
  248. 7.41 Interleukin Genetics 221
  249. 7.42 Invitrogen 222
  250. 7.43 Kreatech Biotechnology 224
  251. 7.44 LabCorp 224
  252. 7.45 LI-COR Biosciences 224
  253. 7.46 Matritech 225
  254. 7.47 Meridian Bioscience 227
  255. 7.48 Monogram Biosciences 228
  256. 7.49 Motorola 230
  257. 7.50 MWG Biotech 231
  258. 7.51 Myriad Genetics 231
  259. 7.52 Nanogen 233
  260. 7.53 Nanosys 235
  261. 7.54 NimbleGen Systems 236
  262. 7.55 Nuvelo 236
  263. 7.56 Nymox Pharmaceutical 237
  264. 7.57 Orchid BioSciences 238
  265. 7.58 Orchid Cellmark 238
  266. 7.59 Organon International 241
  267. 7.60 Ortho-Clinical Diagnostics 241
  268. 7.61 Ostex International 243
  269. 7.62 PerSeptive Biosystems 243
  270. 7.63 PharMingen 243
  271. 7.64 PPD 243
  272. 7.65 PPGx (DNA Sciences Laboratories) 244
  273. 7.66 Prodesse 244
  274. 7.67 Professional Genetics Laboratory 244
  275. 7.68 Promega 245
  276. 7.69 QIAGEN 245
  277. 7.70 Quantum Biotechnologies 248
  278. 7.71 Quidel 248
  279. 7.72 Response Biomedical 250
  280. 7.73 Roche Diagnostics 250
  281. 7.74 Siemens 253
  282. 7.75 Sequenom 254
  283. 7.76 SurModics 256
  284. 7.77 Tepnel Life Sciences 257
  285. 7.78 Thermo Fisher Scientific 257
  286. 7.79 Third Wave Technologies 258
  287. 7.80 Tm Bioscience 259
  288. 7.81 Visible Genetics 259
  289. 7.82 VisiGen Biotechnologies 260
  290. 7.83 Vysis 260
  291. 7.84 Alternative Sequencing Companies 260
  292. 7.84.1 Callida Genomics, Inc. 260
  293. 7.84.2 Mobious Genomics, Ltd. 260
  294. 7.84.3 Perlegen Sciences, Inc. 260
  295. 7.84.4 Solexa, Ltd. 261
  296. 7.84.5 U.S. Genomics, Inc. 261
  297. 8. Market Overview 262
  298. 8.1 Snapshot of Molecular Diagnostics Industry Structure 263
  299. 8.2 Global Molecular Diagnostics Testing Market 264
  300. 8.3 U.S. Molecular Diagnostics Testing Market 266
  301. 8.4 European Molecular Diagnostics Market 267
  302. 8.5 Japanese Molecular Diagnostics Testing Market 268
  303. 8.6 Overview of the European Molecular Diagnostics Country Markets 268
  304. 8.6.1 France 268
  305. 8.6.2 Germany 268
  306. 8.6.3 The United Kingdom 268
  307. 8.6.4 Italy 269
  308. 8.6.5 Spain 269
  309. Appendix 1: Biowarfare Agents 270
  310. LIST OF FIGURES
  311. Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship 16
  312. Figure 3.1: Applications of Molecular Diagnostics Technology Platforms 30
  313. Figure 3.2: Overall Structure of Nucleic Acid Testing Market 32
  314. Figure 3.3: Serologic and Clinical Course of Acute HBV Infection 55
  315. Figure 3.4: Primary Causes of Chronic Liver Disease 57
  316. Figure 3.5: Combination Therapy in Typical HCV Infection 58
  317. Figure 3.6: Time Course of Markers in Typical HCV Infection 59
  318. Figure 3.7: Bacillus anthracis 108
  319. Figure 8.1: Molecular Diagnostics Market Segmentation 262
  320. Figure 8.2: Molecular Diagnostics Market Segmentation by Technology 263
  321. Figure 8.3: Breakout of the Molecular Diagnostics Marketplace 265
  322. Figure 8.4: U.S. Molecular Diagnostics Market Segments 2007 266
  323. LIST OF TABLES
  324. Table 3.1: Global Market for Molecular Diagnostics Testing, 2000 to 2012 33
  325. Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2004 to 2012 33
  326. Table 3.3: Global Market for Nucleic Acid Testing, 2000 to 2012 34
  327. Table 3.4: Summary of Molecular Diagnostics Testing 34
  328. Table 3.5: Annual U.S. Market for DNA Probe Diagnostics, 1998 to 2012 35
  329. Table 3.6: Annual Global Market for DNA Probe Diagnostics, 1998 to 2009 35
  330. Table 3.7: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Research Market 37
  331. Table 3.8: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Diagnostics Market 37
  332. Table 3.9: Roche PCR Licenses 37
  333. Table 3.10: DNA Probe Market Segments in the U.S. 38
  334. Table 3.11: Companies Marketing Products Using DNA Probes 40
  335. Table 3.12: Companies Marketing Multiple Products in Molecular Diagnostics Sector 40
  336. Table 3.13: Global Sales of DNA Probe Kits, 1998 to 2005 41
  337. Table 3.14: Companies Marketing DNA Detection Platforms 41
  338. Table 3.15: Companies Marketing Genotyping Technologies 44
  339. Table 3.16: Companies Marketing Clinical Genotyping Technologies 45
  340. Table 3.17: Summary of Assays for HIV Viral Load Testing 51
  341. Table 3.18: Global Market for HIV Diagnostic Testing, 2000 to 2012 53
  342. Table 3.19: U.S. Market for HIV Diagnostic Testing, 2000 to 2012 53
  343. Table 3.20: Serologic Diagnosis of HBV Infections* 55
  344. Table 3.21: Unusual HBV Serologic Profiles Requiring Further Evaluation 56
  345. Table 3.22: Recommendations for HBV Diagnostic Testing 56
  346. Table 3.23: Lower Detection Limits of HBV DNA Assays 56
  347. Table 3.24: Recommendations for HCV Diagnostic Testing 60
  348. Table 3.25: Important HCV Statistics 60
  349. Table 3.26: Global Market for HAV Diagnostic Testing, 2000 to 2008 62
  350. Table 3.27: U.S. Market for HAV Diagnostic Testing, 2000 to 2008 63
  351. Table 3.28: Global Market for HBV Diagnostic Testing, 2000 to 2008 63
  352. Table 3.29: U.S. Market for HBV Diagnostic Testing, 2000 to 2008 63
  353. Table 3.30: Global Market for HCV Diagnostic Testing, 2000 to 2008 63
  354. Table 3.31: U.S. Market for HCV Diagnostic Testing, 2000 to 2008 64
  355. Table 3.32: Global Market for SARS Diagnostics Testing, 2002 to 2008 65
  356. Table 3.33: U.S. Market for SARS Diagnostics Testing, 2002 to 2008 65
  357. Table 3.34: Global Market for Molecular Diagnostics Cancer Testing, 2000 to 2008 68
  358. Table 3.35: Annual Volume of NAT Infectious Disease Testing, 2000 to 2008 72
  359. Table 3.36: Global Market Dollar Volume of NAT STD Testing, 2000 to 2008 72
  360. Table 3.37: U.S. Market Dollar Volume of NAT STD Testing, 2000 to 2009 72
  361. Table 3.38: U.S. Market Share of NAT STD Testing 73
  362. Table 3.39: Global Market for Chlamydia Diagnostic Testing, 2000 to 2009 73
  363. Table 3.40: U.S. Market for Chlamydia Diagnostic Testing, 2000 to 2009 73
  364. Table 3.41: Global Market for Gonorrhea Diagnostic Testing, 2000 to 2008 73
  365. Table 3.42: Global Market for TB Diagnostic Testing, 2000 to 2008 74
  366. Table 3.43: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000 to 2009 74
  367. Table 3.44: U.S. Market for Group B Streptococcus Diagnostic Testing, 2000 to 2009 74
  368. Table 3.45: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-organisms 76
  369. Table 3.46: Global Market for Blood-Screening Diagnostic Testing, 2000 to 2008 80
  370. Table 3.47: U.S. Market for Blood-Screening Diagnostic Testing, 2000 to 2008 80
  371. Table 3.48: Leading Players in SNP Genotyping 84
  372. Table 3.49: Global Market for SNP Genotyping, 2000 to 2011 84
  373. Table 3.50: DNA-Analysis Market Competitors 87
  374. Table 3.51: Leading Companies in Medical Utility of SNPs 87
  375. Table 3.52: Competitors in the Field of Identity Genomics Testing 88
  376. Table 3.53: U.S. Market for Food-Screening Diagnostic Testing Using Molecular Diagnostics Techniques, 2000 to 2008 90
  377. Table 3.54: Methods for Detection of Salmonella in Food Using Molecular Diagnostics Methods 91
  378. Table 3.55: U.S. Market for Forensic Diagnostics Testing, 2000 to 2010 93
  379. Table 3.56: U.S. Market for Biological Threat Detection Testing, 2000 to 2010 97
  380. Table 3.57: Biotest Reagents 100
  381. Table 3.58: Variation of CF Carrier Risks by Ethnic Group 111
  382. Table 3.59: Reasons for CF Testing 111
  383. Table 3.60: Variation of CF Detection Rates by Ethnic Background 111
  384. Table 3.61: Global Market for CF Diagnostic Testing, 2000 to 2008 111
  385. Table 3.62: U.S. Market for CF Diagnostic Testing, 2000 to 2008 111
  386. Table 3.63: Commercial CF-Screening Products 112
  387. Table 3.64: Emerging CF-Screening Products 112
  388. Table 3.65: CF Screening Technology Summary 112
  389. Table 3.66: U.S. Market for HLA Type Testing, 2000 to 2008 113
  390. Table 3.67: Competitors in HLA Testing 114
  391. Table 3.68: U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008 115
  392. Table 3.69: Non-U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008 115
  393. Table 3.70: U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008 115
  394. Table 3.71: Non-U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008 115
  395. Table 3.72: Carrier Rates of Common HFE Mutations in Caucasians 116
  396. Table 3.73: Results and Diagnosis for Fragile X Syndrome 117
  397. Table 3.74: Principal Competitors in Pharmacogenetics R&D for Personalized Medicine 121
  398. Table 3.75: Principal Competitors in Pharmacogenetics Patient Testing 121
  399. Table 4.1: DNA-Sequencing Market Players 128
  400. Table 4.2: Global Market for DNA Chips, 2000 to 2007 128
  401. Table 4.3: Top Ten Companies for Molecular Diagnostics Patents 146
  402. Table 6.1: Companies Licensed to Sell Custom Molecular Beacon Probes 166
  403. Table 6.2: U.S. Sample Preparation Market, 2005 to 2012 169
  404. Table 7.1: Products Marketed by Abbott in the Diagnostics Market 173
  405. Table 7.2: Summary of Selected Affymetrix Expression-Profiling Customers 177
  406. Table 7.3: PACE Product Sales as a Percentage of Total Company Revenue, 2000 to 2005 213
  407. Table 7.4: Innogenetics HLA Products for Genetic Testing and Transplantation 221
  408. Table 7.5: Nanogen Product Sales, 2000 to 2006 233
  409. Table 7.6: Rarely-Expressed Genes as Therapeutic Product Candidates 237
  410. Table 7.7: Roche Diagnostics Key Products 251
  411. Table 7.8: Sales by Region 252
  412. Table 7.9: Sales by Business Area 252
  413. Table 7.10: Product Line Sales 2005 252
  414. Table 7.11: Growth Drivers 252
  415. Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2000 to 2008 262
  416. Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000 to 2012 265
  417. Table 8.3: Global Distribution of Molecular Diagnostics Testing 265
  418. Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004 to 2012 267
  419. Table 8.5: European Molecular Diagnostics Testing Market, 2005 to 2012 267
  420. Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005 to 2012 268

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