View Sample PDF

The technologies that constitute molecular diagnostics--like 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?

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
9. 2. Introduction to Molecular Diagnostics and PCR Technology 15
10. 2.1 Science Overview: Introduction to Genomics and Its Opportunity 15
11. 2.2 Impact of the Human Genome Project on Molecular Diagnostics 17
12. 2.3 Considerations for Molecular and Clinical Diagnosis 18
13. 2.4 Molecular Diagnosis in the Post-Genomic Era 19
14. 2.5 Advances in Molecular Diagnostics Technologies 20
15. 2.6 Genetic Variability and Disease 22
16. 2.7 Major Technology Platforms 22
17. 2.7.1 Gene-based Amplification Technologies 23
18. 2.7.2 Detection of Amplified Gene Products 23
19. 2.7.3 Target-Based Gene Amplification 24
20. 2.7.3.1 Polymerase Chain Reaction 24
21. 2.7.3.2 Real-time PCR 25
22. 2.7.3.3 Nucleic Acid Sequence-Based Amplification 26
23. 2.7.4 Probe-Based Amplification 26
24. 2.7.4.1 Ligase Chain Reaction 26
25. 2.7.4.2 Strand Displacement Amplification 26
26. 2.7.4.3 Q¦Â-replicase Amplified Probe Assay 26
27. 2.7.5 Signal-Based Amplification 27
28. 2.7.5.1 Branched DNA (bDNA) 27
29. 2.7.6 Other Gene Amplification Technologies 27
30. 2.7.6.1 Immuno-PCR 27
31. 2.7.6.2 Bio-Barcode Assay 27
33. 3. Nucleic Acid Test Applications 29
34. 3.1 Blood Testing and Infectious Diseases 30
35. 3.1.1 Molecular Diagnostics Market 30
36. 3.1.1.1 Methods for DNA Detection and Gene Sequencing 42
37. 3.1.1.2 Products and Applications 43
38. 3.1.1.3 Oncology 44
39. 3.1.2 SNPs and Genes: Medical Utility (Clinical Applications) 44
40. 3.1.2.1 Clinical Application Initiatives 46
41. 3.1.2.2 A Sampling of Clinical Application Collaborations 47
42. 3.1.2.3 Collaborative Relationships 49
43. 3.2 Diagnostic Testing Using DNA 50
44. 3.2.1 HIV 52
45. 3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing 54
46. 3.2.2.1 Hepatitis A Virus (HAV) 54
47. 3.2.2.2 Hepatitis B Virus (HBV) 55
48. 3.2.2.3 Hepatitis C Virus (HCV) 58
49. 3.2.2.4 Hepatitis D Virus (HDV) 63
50. 3.2.2.5 Hepatitis E Virus (HEV) 63
51. 3.2.2.6 HBV/HCV Viral Load and Drug Resistance 63
52. 3.2.3 Severe Acute Respiratory Syndrome (SARS) 65
53. 3.2.3.1 New Approach to Diagnosing Avian Influenza 66
54. 3.2.3.2 Microarray or DNA Chip-Based Tests 68
55. 3.2.4 Cancer Detection Using PCR 69
56. 3.2.4.1 Lung Cancer 69
57. 3.2.4.2 Oral Cancer 70
58. 3.2.4.3 Prostate Cancer 70
59. 3.2.4.4 Chronic Myelogenous Leukemia 70
60. 3.2.4.5 Malignant Gliomas 71
61. 3.2.4.6 Colorectal Cancer 71
62. 3.2.4.7 Breast Cancer 71
63. 3.2.4.8 Bladder Cancer 71
64. 3.2.5 Microbiology Testing 71
65. 3.2.5.1 Chlamydia 72
66. 3.2.5.2 Gonorrhea 72
67. 3.2.5.3 Tuberculosis 72
68. 3.2.5.4 Group B Streptococcus 75
69. 3.2.5.5 Pathogenic Enteric Bacteria 77
70. 3.2.5.6 Bordetella pertussis 78
71. 3.2.5.7 Legionella Pneumophila 78
72. 3.2.5.8 Peridontal Bacteria 78
73. 3.2.5.9 Pneumocystis Carinii 78
74. 3.2.5.10 Methicillin-resistant Staphylococcus Aureus 79
75. 3.2.6 Blood Screening 79
76. 3.3 SNPs in Clinical Diagnostics 84
77. 3.3.1 Functional Genomics 88
78. 3.3.2 Paternity Testing 88
79. 3.4 Industrial Testing and Food Diagnostics 89
80. 3.4.1 The Market 89
81. 3.4.2 Detection of H. pylori by PCR 92
82. 3.4.3 Detection of E. coli 0157 92
83. 3.4.4 Detection of Enteric Viruses 92
84. 3.5 Forensics Market 93
85. 3.5.1 Isolation of DNA for PCR Profiling 94
86. 3.5.2 Analysis by PCR-Based DNA Typing 95
87. 3.5.3 Rapid Isolation of DNA for RFLP and PCR 95
88. 3.5.4 DNA for PCR-STR Typing 95
89. 3.6 Bioterrorism and Molecular Diagnostics 95
90. 3.6.1 Introduction 95
91. 3.6.1.1 Current Biological Threat Detection Systems 98
92. 3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWA 99
93. 3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection System 100
94. 3.6.2 Biological Warfare Agents 101
95. 3.6.2.1 Anthrax 101
96. 3.6.2.2 Botulinum Toxin 102
97. 3.6.2.3 Ricin 102
98. 3.6.2.4 IVD Industry and Bioterrorism Preparedness 102
99. 3.6.2.4.1 Brucellosis 102
100. 3.6.2.4.2 Cholera 103
101. 3.6.2.5 Rapid Lateral Flow Immunoassays 104
102. 3.6.2.6 Biosensors 105
103. 3.6.2.6.1 Antibody and Synthetic Receptor-Based Sensors 105
104. 3.6.2.6.2 DNA Sensors 106
105. 3.6.2.6.3 Reagentless Sensors 107
106. 3.6.3 Anthrax in Clinical Samples 108
107. 3.6.3.1 Overview of Anthrax and Its Infectivity 108
108. 3.6.3.2 Rapid Tests 110
109. 3.6.3.2.1 PCR Tests 110
110. 3.7 Cystic Fibrosis Testing 111
111. 3.8 HLA Sequencing-Based Typing Kits 113
112. 3.9 Cytogenetic Testing 115
113. 3.9.1 Hereditary Hemochromatosis 117
114. 3.9.2 Apolipoprotein E (ApoE) Genotyping 117
115. 3.9.3 Fragile X Syndrome 118
116. 3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing 119
117. 3.10 Developments in Biochips for Clinical Applications 120
118. 3.10.1 Roche AmpliChip Microarray 120
119. 3.10.2 Breast Cancer DNA Chips 120
120. 3.10.3 eSensor DNA Detection System 121
121. 3.11 Pharmacogenomics 122
122. 3.11.1 Coumadin 123
123. 3.12 Thrombic Disorders 125
125. 4. Trends in Molecular Diagnostics 126
126. 4.1 Pharmacogenomics 126
127. 4.1.1 The Market 126
128. 4.1.1.1 Oncology 126
129. 4.1.1.2 Toxicogenomics 126
130. 4.1.2 Market Influences and Forecast 127
131. 4.2 DNA Microarrays 127
132. 4.2.1 Techniques 132
133. 4.2.2 The Market 132
134. 4.2.3 Identification of Sequence SNPs 132
135. 4.2.4 Determining Gene Expression Levels 133
136. 4.2.4.1 Hybridization Tests 133
137. 4.2.4.2 Oligonucleotide Probes 134
138. 4.2.5 Molecular Diagnostics Entry into Point-of-Care Testing 134
139. 4.3 Emerging Markets of DNA Arrays 134
140. 4.3.1 Pharmacogenomics 136
141. 4.3.2 Adoption of Amplified Screening Technology 136
142. 4.3.3 Advances in Automated Testing 136
143. 4.3.4 Increased Focus on Safety of Blood Supply 137
144. 4.3.5 Development of Emerging Markets for NAT Technology 137
145. 4.3.6 Cancer 137
146. 4.3.7 Human Leukocyte Antigen Typing 137
147. 4.3.8 Neonatal Screening 138
148. 4.4 Drivers and Restraints 139
149. 4.5 Market Forecast 140
150. 4.6 Business Trends in the Industry 140
151. 4.6.1 Molecular Diagnostics Industry Trends 140
152. 4.6.1.1 Adoption of Amplified Screening Technology 140
153. 4.6.1.2 Advances in Automated Testing 140
154. 4.6.1.3 Responsiveness to Newly Emerging Threats 141
155. 4.6.1.4 Increased Focus on Safety of Blood Supply 141
156. 4.6.1.5 Growth in Viral Load Testing 141
157. 4.6.1.6 Development of Emerging Markets for NAT Technology 141
158. 4.6.1.7 Improvements in Detection Technologies 142
159. 4.6.2 Pharmaceutical Industry Trends 142
160. 4.6.3 Acquisitions, License Agreements and Partnerships 144
161. 4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information 147
162. 4.6.5 Regulatory Issues 147
163. 4.6.6 Reimbursement Issues 148
164. 4.6.6.1 Cystic Fibrosis 148
165. 4.6.6.2 Viral Load Testing 148
166. 4.6.6.3 NMP22 148
168. 5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA 149
169. 5.1 Gene Expression Profiling 150
170. 5.2 Proteomic Multiplex Assays 150
171. 5.3 Solution-Phase Multiplexing 150
172. 5.4 RNA Interference (RNAi) 151
173. 5.4.1 Role of RNAi in Drug Target Validation 152
174. 5.4.2 Other Companies Involved in the RNAi Market 152
175. 5.5 DNA Tags 153
177. 6. Market Trends and Forecasts 154
178. 6.1 Market Dynamics 154
179. 6.1.1 Technological Perspective on Molecular Diagnostics 154
180. 6.1.2 Molecular Diagnostics Market Opportunities 154
181. 6.1.3 Market Forces 155
182. 6.1.3.1 Adoption of Amplified Screening Technology 156
183. 6.1.3.2 Advances in Automated Testing 156
184. 6.1.3.3 Responsiveness to Newly Emerging Threats 156
185. 6.1.3.4 Increased Focus on Safety of Blood Supply 157
186. 6.1.3.5 Growth in Viral Load Testing 157
187. 6.1.3.6 Development of Emerging Markets for NAT Technology 157
188. 6.1.3.7 Improvements in Detection Technologies 158
189. 6.2 Future Considerations for Molecular Diagnosis 158
190. 6.3 Role of Genomics in Transforming Pharmaceutical R&D 159
191. 6.4 Cancer Markers 159
192. 6.5 Cytology Markers 160
193. 6.6 RNA Detection 160
194. 6.7 Diagnosis of Inherited Disease 160
195. 6.8 Ethical Considerations 160
196. 6.9 NAT and Personalized Medicine 162
197. 6.10 Five Molecular Diagnostics Growth Areas 162
198. 6.11 Specific Commercial Nucleic Acid Probes 162
199. 6.12 Novel Amplification Techniques in the Market 163
200. 6.13 Ramification Amplification Method (RAM) 164
201. 6.14 Invader Assays/Third Wave Technologies 164
202. 6.15 Molecular Beacons 166
203. 6.16 HLA Sequencing-Based Typing Kits 167
204. 6.17 Prenatal Diagnosis 167
205. 6.18 Newborn Screening 168
206. 6.19 NAT and Preventive Medicine: NAT-Based Assays 168
207. 6.20 Prenatal and Pre-implantation Diagnosis 169
208. 6.21 FISH-Based Tests on Fetal Cells 169
209. 6.22 Companion Therapeutic/Diagnostic Approach 169
210. 6.23 Sample Preparation Market 170
212. 7. Corporate Directory 171
213. 7.1 Abbott Laboratories 171
214. 7.2 Affymetrix 175
215. 7.3 Agendia 183
216. 7.4 Agilent Technologies 183
217. 7.5 Ambion 184
218. 7.6 Applied Biosystems Group 184
219. 7.7 Beckman Coulter 188
220. 7.8 BioGenex 191
221. 7.9 bioM¨¦rieux 191
222. 7.10 Bio-Rad Laboratories 191
223. 7.11 Biotage 192
224. 7.12 Biotest 192
225. 7.13 Caliper Life Sciences 193
226. 7.14 Celera Group 195
227. 7.15 Cellomics 196
228. 7.16 Cepheid 196
229. 7.17 Chiron (Novartis) 197
230. 7.18 Ciphergen Biosystems 198
231. 7.19 CuraGen 199
232. 7.20 Cytocell Technologies 204
233. 7.21 Dako A/S (formerly DakoCytomation A/S) 204
234. 7.22 DiaDexus 205
235. 7.23 Digene 207
236. 7.24 Enzo Biochem 207
237. 7.25 Epigenomics 207
238. 7.26 EraGen Biosciences 208
239. 7.27 Eurogentec 208
240. 7.28 Exiqon 208
241. 7.29 Gene Link 209
242. 7.30 Gene Logic 209
243. 7.31 GeneOhm Sciences 211
244. 7.32 Genisphere 211
245. 7.33 Gen-Probe 212
246. 7.34 Genzyme 214
247. 7.35 Hamilton Thorne Biosciences 215
248. 7.36 ID Biomedical 215
249. 7.37 Illumina 216
250. 7.38 Incyte 219
251. 7.39 Innogenetics 221
252. 7.40 Interleukin Genetics 222
253. 7.41 Invitrogen 223
254. 7.42 Kreatech Biotechnology 224
255. 7.43 LabCorp 225
256. 7.44 LI-COR Biosciences 225
257. 7.45 Matritech 226
258. 7.46 Meridian Bioscience 228
259. 7.47 Monogram Biosciences 229
260. 7.48 Motorola 231
261. 7.49 MWG Biotech 231
262. 7.50 Myriad Genetics 232
263. 7.51 Nanogen 233
264. 7.52 Nanosys 236
265. 7.53 NimbleGen Systems 237
266. 7.54 Nuvelo 237
267. 7.55 Nymox Pharmaceutical 238
268. 7.56 Orchid BioSciences 239
269. 7.57 Orchid Cellmark 239
270. 7.58 Organon International 242
271. 7.59 Ortho-Clinical Diagnostics 242
272. 7.60 Ostex International 244
273. 7.61 PerSeptive Biosystems 244
274. 7.62 PharMingen 244
275. 7.63 PPD 244
276. 7.64 PPGx (DNA Sciences Laboratories) 244
277. 7.65 Prodesse 245
278. 7.66 Professional Genetics Laboratory 245
279. 7.67 Promega 246
280. 7.68 QIAGEN 246
281. 7.69 Quantum Biotechnologies 249
282. 7.70 Response Biomedical 249
283. 7.71 Roche Diagnostics 249
284. 7.72 Siemens 253
285. 7.73 Sequenom 253
286. 7.74 SurModics 256
287. 7.75 Tepnel Life Sciences 257
288. 7.76 Third Wave Technologies 257
289. 7.77 Tm Bioscience 258
290. 7.78 Visible Genetics 259
291. 7.79 VisiGen Biotechnologies 259
292. 7.80 Vysis 259
293. 7.81 Alternative Sequencing Companies 259
294. 7.81.1 Callida Genomics, Inc. 259
295. 7.81.2 Mobious Genomics, Ltd. 259
296. 7.81.3 Perlegen Sciences, Inc. 259
297. 7.81.4 Solexa, Ltd. 260
298. 7.81.5 U.S. Genomics, Inc. 260
300. 8. Market Overview 261
301. 8.1 Snapshot of Molecular Diagnostics Industry Structure 262
302. 8.2 Global Molecular Diagnostics Testing Market 263
303. 8.3 U.S. Molecular Diagnostics Testing Market 265
304. 8.4 European Molecular Diagnostics Market 266
305. 8.5 Japanese Molecular Diagnostics Testing Market 267
306. 8.6 Overview of the European Molecular Diagnostics Country Markets 267
307. 8.6.1 France 267
308. 8.6.2 Germany 267
309. 8.6.3 The United Kingdom 267
310. 8.6.4 Italy 268
311. 8.6.5 Spain 268
313. Appendix 1: Biowarfare Agents 269
316. LIST OF FIGURES
318. Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship 16
319. Figure 3.1: Applications of Molecular Diagnostics Technology Platforms 30
320. Figure 3.2: Overall Structure of Nucleic Acid Testing Market 32
321. Figure 3.3: Applications of Key Players and Market Share in Molecular Diagnostics Testing Markets 35
322. Figure 3.4: Serologic and Clinical Course of Acute HBV Infection 56
323. Figure 3.5: Primary Causes of Chronic Liver Disease 58
324. Figure 3.6: Combination Therapy in Typical HCV Infection 59
325. Figure 3.7: Time Course of Markers in Typical HCV Infection 60
326. Figure 3.8: Bacillus anthracis 109
327. Figure 8.1: Molecular Diagnostics Market Segmentation 261
328. Figure 8.2: Molecular Diagnostics Market Segmentation by Technology 262
329. Figure 8.3: Breakout of the Molecular Diagnostics Marketplace 264
330. Figure 8.4: U.S. Molecular Diagnostics Market Segments 2007 265
333. LIST OF TABLES
335. Table 3.1: Global Market for Molecular Diagnostics Testing, 2000 to 2012 33
336. Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2004 to 2012 33
337. Table 3.3: Global Market for Nucleic Acid Testing, 2000 to 2012 34
338. Table 3.4: Summary of Molecular Diagnostics Testing 34
339. Table 3.5: Share of Molecular Diagnostics Testing by Testing Type 35
340. Table 3.6: Key Players and Market Share in Molecular Diagnostics Testing Market 35
341. Table 3.7: Annual U.S. Market for DNA Probe Diagnostics, 1998 to 2012 36
342. Table 3.8: Annual Global Market for DNA Probe Diagnostics, 1998 to 2009 36
343. Table 3.9: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Research Market 38
344. Table 3.10: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Diagnostics Market 38
345. Table 3.11: Roche PCR Licenses 38
346. Table 3.12: DNA Probe Market Segments in the U.S. 39
347. Table 3.13: Companies Marketing Products Using DNA Probes 41
348. Table 3.14: Companies Marketing Multiple Products in Molecular Diagnostics Sector 41
349. Table 3.15: Global Sales of DNA Probe Kits, 1998 to 2005 42
350. Table 3.16: Companies Marketing DNA Detection Platforms 42
351. Table 3.17: Companies Marketing Genotyping Technologies 45
352. Table 3.18: Companies Marketing Clinical Genotyping Technologies 46
353. Table 3.19: Summary of Assays for HIV Viral Load Testing 52
354. Table 3.20: Global Market for HIV Diagnostic Testing, 2000 to 2012 54
355. Table 3.21: U.S. Market for HIV Diagnostic Testing, 2000 to 2012 54
356. Table 3.22: Serologic Diagnosis of HBV Infections* 56
357. Table 3.23: Unusual HBV Serologic Profiles Requiring Further Evaluation 57
358. Table 3.24: Recommendations for HBV Diagnostic Testing 57
359. Table 3.25: Lower Detection Limits of HBV DNA Assays 57
360. Table 3.26: Recommendations for HCV Diagnostic Testing 61
361. Table 3.27: Important HCV Statistics 61
362. Table 3.28: Global Market for HAV Diagnostic Testing, 2000 to 2008 63
363. Table 3.29: U.S. Market for HAV Diagnostic Testing, 2000 to 2008 64
364. Table 3.30: Global Market for HBV Diagnostic Testing, 2000 to 2008 64
365. Table 3.31: U.S. Market for HBV Diagnostic Testing, 2000 to 2008 64
366. Table 3.32: Global Market for HCV Diagnostic Testing, 2000 to 2008 64
367. Table 3.33: U.S. Market for HCV Diagnostic Testing, 2000 to 2008 65
368. Table 3.34: Global Market for SARS Diagnostics Testing, 2002 to 2008 66
369. Table 3.35: U.S. Market for SARS Diagnostics Testing, 2002 to 2008 66
370. Table 3.36: Global Market for Molecular Diagnostics Cancer Testing, 2000 to 2008 69
371. Table 3.37: Annual Volume of NAT Infectious Disease Testing, 2000 to 2008 73
372. Table 3.39: Global Market Dollar Volume of NAT STD Testing, 2000 to 2008 73
373. Table 3.39: U.S. Market Dollar Volume of NAT STD Testing, 2000 to 2009 73
374. Table 3.40: U.S. Market Share of NAT STD Testing 74
375. Table 3.41: Global Market for Chlamydia Diagnostic Testing, 2000 to 2009 74
376. Table 3.42: U.S. Market for Chlamydia Diagnostic Testing, 2000 to 2009 74
377. Table 3.43: Global Market for Gonorrhea Diagnostic Testing, 2000 to 2008 74
378. Table 3.44: Global Market for TB Diagnostic Testing, 2000 to 2008 75
379. Table 3.45: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000 to 2009 75
380. Table 3.46: U.S. Market for Group B Streptococcus Diagnostic Testing, 2000 to 2009 75
381. Table 3.47: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-organisms 77
382. Table 3.48: Global Market for Blood-Screening Diagnostic Testing, 2000 to 2008 81
383. Table 3.49: U.S. Market for Blood-Screening Diagnostic Testing, 2000 to 2008 81
384. Table 3.50: Leading Players in SNP Genotyping 85
385. Table 3.51: Global Market for SNP Genotyping, 2000 to 2011 85
386. Table 3.52: DNA-Analysis Market Competitors 88
387. Table 3.53: Leading Companies in Medical Utility of SNPs 88
388. Table 3.54: Competitors in the Field of Identity Genomics Testing 89
389. Table 3.55: U.S. Market for Food-Screening Diagnostic Testing Using Molecular Diagnostics Techniques, 2000 to 2008 91
390. Table 3.56: Methods for Detection of Salmonella in Food Using Molecular Diagnostics Methods 92
391. Table 3.57: U.S. Market for Forensic Diagnostics Testing, 2000 to 2010 94
392. Table 3.58: U.S. Market for Biological Threat Detection Testing, 2000 to 2010 98
393. Table 3.59: Biotest Reagents 101
394. Table 3.60: Variation of CF Carrier Risks by Ethnic Group 112
395. Table 3.61: Reasons for CF Testing 112
396. Table 3.62: Variation of CF Detection Rates by Ethnic Background 112
397. Table 3.63: Global Market for CF Diagnostic Testing, 2000 to 2008 112
398. Table 3.64: U.S. Market for CF Diagnostic Testing, 2000 to 2008 112
399. Table 3.65: Commercial CF-Screening Products 113
400. Table 3.66: Emerging CF-Screening Products 113
401. Table 3.67: CF Screening Technology Summary 113
402. Table 3.68: U.S. Market for HLA Type Testing, 2000 to 2008 114
403. Table 3.69: Competitors in HLA Testing 115
404. Table 3.70: U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008 116
405. Table 3.71: Non-U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008 116
406. Table 3.72: U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008 116
407. Table 3.73: Non-U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008 116
408. Table 3.74: Carrier Rates of Common HFE Mutations in Caucasians 117
409. Table 3.75: Results and Diagnosis for Fragile X Syndrome 118
410. Table 3.76: Principal Competitors in Pharmacogenetics R&D for Personalized Medicine 122
411. Table 3.77: Principal Competitors in Pharmacogenetics Patient Testing 122
412. Table 4.1: DNA-Sequencing Market Players 129
413. Table 4.2: Global Market for DNA Chips, 2000 to 2007 129
414. Table 4.3: Top Ten Companies for Molecular Diagnostics Patents 147
415. Table 6.1: Companies Licensed to Sell Custom Molecular Beacon Probes 167
416. Table 6.2: U.S. Sample Preparation Market, 2005 to 2012 170
417. Table 7.1: Products Marketed by Abbott in the Diagnostics Market 174
418. Table 7.2: Summary of Selected Affymetrix Expression-Profiling Customers 178
419. Table 7.3: PACE Product Sales as a Percentage of Total Company Revenue, 2000 to 2005 213
420. Table 7.4: Innogenetics HLA Products for Genetic Testing and Transplantation 222
421. Table 7.5: Nanogen Product Sales, 2000 to 2006 234
422. Table 7.6: Rarely-Expressed Genes as Therapeutic Product Candidates 238
423. Table 7.7: Roche Diagnostics Key Products 251
424. Table 7.8: Sales by Region 251
425. Table 7.9: Sales by Business Area 252
426. Table 7.10: Product Line Sales 2005 252
427. Table 7.11: Growth Drivers 252
428. Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2000 to 2008 261
429. Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000 to 2012 264
430. Table 8.3: Global Distribution of Molecular Diagnostics Testing 264
431. Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004 to 2012 266
432. Table 8.5: European Molecular Diagnostics Testing Market, 2005 to 2012 266
433. Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005 to 2012 267