Cancer, CNS & Cardiovascular Biomarkers: Players, Products and Prospects - Market Research Reports

Contents:

EXECUTIVE SUMMARY 1
Figure1: Growth in biomarker market 2007-2015 1
What are biomarkers? 2
Why are they important? 2
Figure 2: Potential impact of biomarkers on disease pathways 2
What technologies are involved? 3
What impact will biomarkers have on R&D? 3
Figure 3: Potential impact of biomarkers on R&D 3
Who are the major biomarker players and in what research area? 4
Cancer biomarker companies 5
Cardiovascular biomarker companies 6
CNS biomarkers companies 7
Company Analysis Criteria 7
Biomarker technology & platforms 7
Association/clinical studies 8
Management strategy 8
Application & potential 8

CANCER MARKET & REVENUES 9
Market revenues - global 9
Figure 1: Global cancer drugs sales (2007) 9
Market revenues – leading brands 10
Figure 2: Leading cancer brands (2007) 10
Market revenues – leading players 11
Figure 3: Top 10 oncology players (2007 revenues) 11

CANCER EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT 12
Epidemiology 12
Table 1: Cancer Statistics for four most common cancers, 2008 12
Diagnosis 12
Screening 13
Table 2: Cancer screening 13
Current & future treatment 14
Future treatment 14
Figure 4: Anticancer drugs in clinical development 15

CANCER BIOMARKERS 16
Cancer biomarker R&D 16
Table 3: Types of biomarker 17
Known cancer biomarkers 17
Table 4: Commercially available known cancer biomarker diagnostics 17
Probable and possible valid cancer biomarkers 18
Table 5: Probable cancer biomarkers diagnostics 19
Table 6: Possible cancer biomarkers diagnostics 19

CANCER BIOMARKER OPPORTUNITIES & CHALLENGES 21
Opportunities 21
Challenges 21

BIOMARKER MARKET 23
Biomarker market revenues - global 23
Figure 8: Global biomarker sales in 2007 23
Cancer biomarker market revenues - global 24
Figure 9: Global cancer biomarker sales in 2007 24
Future biomarker market revenues – global 24
Figure 10: Global biomarker sales in 2015 25
Future cancer biomarker market revenues - global 25
Figure 11: Global cancer biomarker sales in 2015 26

CANCER BIOMARKER TRENDS 27
Table 7: Recent deals in oncology biomarkers 27
Pharma and specialty pharma deals 29
Collaborations with service providers 29
Collaborations with academics and consortia 29
BIOMARKER ANALYSIS 30
DNA biomarkers 30
RNA and microRNA biomarkers 30
Proteomic biomarkers 30

KEY BIOMARKER COMPANIES ANALYSED 31
KEY BIOMARKER EVALUATION CRITERIA 32
CANCER BIOMARKER- COMPANY ANALYSIS 33
Abbott Diagnostics 33
Biomarker novelty & technology platform .33
Figure 12: Abbott’s UroVysion bladder cancer test 33
Association studies/clinical data 34
Pivotal Trial 34
Table 7: Comparison of UroVysion vs Cystoscopy/Histology for Detection of Bladder Cancer Recurrence by Stage and Grade* 34
Management strategy 34
Application & market potential 34
Biomarker analysis 35
Affymetrix 36
Biomarker novelty & technology platform 36
Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility applications 36
Association studies/clinical data 37
Management strategy 37
Application & market potential 37
Biomarker analysis 37
Agendia BV 39
Biomarker novelty & technology platform 39
Association studies/clinical data 39
Figure 14: MammaPrint Profile vs NIH Consensus Criteria 39
Management strategy 40
Application & market potential 40
Biomarker analysis 40
AltheaDx 41
Biomarker novelty & technology platform .41
Association studies/clinical data 41
Management strategy 41
Application & market potential 41
Biomarker analysis 41
AVEO Pharmaceuticals 43
Biomarker novelty & technology platform 43
Association studies/clinical data 43
Management strategy 43
Application & market potential 43
Biomarker analysis 44
AviaraDx 45
Biomarker novelty & technology platform 45
Association studies/clinical data 45
Management strategy 45
Application & market potential 46
Biomarker analysis 46
BG Medicine 47
Biomarker novelty & technology platform .47
Association studies/clinical data 47
Management strategy 47
Figure 15: BG Medicines Biomarker Programme 48
Application & market potential 48
Biomarker analysis 48
Beckman Coulter 50
Biomarker novelty & technology platform 50
Association studies/clinical data 50
Management strategy 50
Application & market potential 51
Biomarker analysis 51
BioCurex 52
Biomarker novelty & technology platform .52
Association studies/clinical data 52
Management strategy 52
Application & market potential 53
Biomarker analysis 53
Biomedical Diagnostics 54
Biomarker novelty & technology platform 54
Association studies/clinical data 54
Management strategy 54
Application & market potential 54
Biomarker analysis 55
Biomerica 56
Biomarker novelty & technology platform 56
Association studies/clinical data 56
Management strategy 56
Application & market potential 56
Biomarker analysis 57
Bruker Daltonics 58
Biomarker novelty & technology platform 58
Association studies/clinical data 58
Management strategy 58
Application & market potential 58
Biomarker analysis 58
Caprion Proteomics 60
Biomarker novelty & technology platform 60
Association studies/clinical data 60
Management strategy 60
Application & market potential 60
Biomarker analysis 60
Clinical Data 62
Biomarker novelty & technology platform 62
Association studies/clinical data 62
Management strategy 62
Application & market potential 62
Biomarker analysis 63
Celera 64
Biomarker novelty & technology platform 64
Association studies/clinical data 64
Management strategy 64
Application & market potential 65
Biomarker analysis 65
Dako Denmark A/S 66
Biomarker novelty & technology platform 66
Association studies/clinical data 66
Management strategy 66
Application & market potential 66
Biomarker analysis 67
DxS Ltd 68
Biomarker novelty & technology platform 68
Association studies/clinical data 68
Management strategy 68
Application & market potential 68
Biomarker analysis 69
Epigenomics AG 70
Biomarker novelty & technology platform .70
Association studies/clinical data 70
Management strategy 70
Application & market potential 71
Biomarker analysis 71
Epistem Plc 72
Biomarker novelty & technology platform 72
Figure 16: Epistem’s Biomarker Drug Development Programme 72
Association studies/clinical data 73
Management strategy 73
Application & market potential 73
Biomarker analysis 73
GeneNews 75
Biomarker novelty & technology platform .75
Figure 17: GeneNews’ Sentinel Principle 75
Association studies/clinical data 76
Management strategy 76
Application & market potential 76
Biomarker analysis 76
Fujirebio Diagnostics, Inc 78
Biomarker novelty & technology platform 78
Association studies/clinical data 78
Management strategy 78
Application & market potential 79
Biomarker analysis 79
Genomic Health 80
Biomarker novelty & technology platform 80
Figure 18: Oncotype Dx test for invasive breast cancer 80
Association studies/clinical data 80
Management strategy 81
Application & market potential 81
Biomarker analysis 81
Gen-Probe 83
Biomarker novelty & technology platform 83
Association studies/clinical data 83
Management strategy 83
Application & market potential 84
Biomarker analysis 84
Genzyme Genetics 85
Biomarker novelty & technology platform 85
Association studies/clinical data 85
Management strategy 85
Application & market potential 85
Biomarker analysis 86
InterGenetics 87
Biomarker novelty & technology platform 87
Association studies/clinical data 87
Management strategy 87
Application & market potential 87
Biomarker analysis 88
Ipsogen Therapeutics 89
Biomarker novelty & technology platform 89
Association studies/clinical data 89
Management strategy 89
Figure 19: Oncotype Dx test for invasive breast cancer 90
Application & market potential 90
Biomarker analysis 90
Laboratory Corporation of America 91
Biomarker novelty & technology platform .91
Association studies/clinical data 91
Management strategy 91
Application & market potential 91
Biomarker analysis 91
Matritech 93
Biomarker novelty & technology platform 93
Association studies/clinical data 93
Management strategy 93
Application & market potential 93
Biomarker analysis 94
Monogram Biosciences 95
Biomarker novelty & technology platform 95
Figure 20: VeraTag Assay 95
Association studies/clinical data 95
Figure 21: VeraTag Clinical Data: Bordet Cohort 96
Management strategy 96
Application & market potential 96
Biomarker analysis 97
Orion Genomics 98
Biomarker novelty & technology platform 98
Figure 22: Orion’s MethylScope 98
Association studies/clinical data 98
Management strategy 99
Application & market potential 99
Biomarker analysis 99
Oxford Genome Biosciences (UK) Ltd 100
Biomarker novelty & technology platform 100
Association studies/clinical data 100
Management strategy 100
Application & market potential 100
Biomarker analysis 101
Power3 Medical Products 102
Biomarker novelty & technology platform 102
Association studies/clinical data 102
Management strategy 102
Figure 23: Powder3’s business strategy 103
Application & market potential 103
Biomarker analysis 103
Predictive Biosciences 105
Biomarker novelty & technology platform 105
Association studies/clinical data 105
Management strategy 105
Application & market potential 105
Biomarker analysis 106
Provista Life Sciences 107
Biomarker novelty & technology platform 107
Association studies/clinical data 107
Management strategy 107
Application & market potential 108
Biomarker analysis 108
Quest Diagnostics 109
Biomarker novelty & technology platform 109
Association studies/clinical data 109
Management strategy 109
Application & market potential 109
Biomarker analysis 110
Roche Diagnostics 111
Biomarker novelty & technology platform 111
Figure 24: Diagnostic marker candidate to a product 111
Association studies/clinical data 112
Figure 25: Biomarkers distinguish Leukaemia subclasses 112
Management strategy 112
Application & market potential 113
Biomarker analysis 113
SuperArray Bioscience Corporation 114
Biomarker novelty & technology platform 114
Association studies/clinical data 114
Management strategy 114
Application & market potential 114
Biomarker analysis 114
Third Wave Technologies 116
Biomarker novelty & technology platform 116
Association studies/clinical data 116
Management strategy 116
Application & market potential 116
Biomarker analysis 117
Upstream Biosciences 118
Biomarker novelty & technology platform 118
Association studies/clinical data 118
Management strategy 118
Application & market potential 118
Biomarker analysis 119
Veridex, LLC 120
Biomarker novelty & technology platform 120
Association studies/clinical data 120
Management strategy 120
Application & market potential 121
Biomarker analysis 121
Vermillion 122
Biomarker novelty & technology platform 122
Association studies/clinical data 122
Management strategy 122
Application & market potential 123
Biomarker analysis 123

Cancer biomarker APPENDIX 1 124
Table 8: Global biomarker sales 2007-20015E 124
Cancer biomarker APPENDIX 2 125
Table 8: Global cancer biomarker sales 2007-20015E 125
Cancer biomarker APPENDIX 3 126
Company Analysis Criteria 126
Biomarker technology & platforms 126
Association studies 126
Management strategy 126
Application & potential 126
Table 9: Key cancer biomarker companies 128
Figure 26: Leading Cancer Biomarker Companies – Service providers, Technology Providers, Biomarker Discovery & Diagnostic Developers .130

GLOSSARY 131
ACRONYMS 133
BIBLIOGRAPHY & end NOTES 138

CNS MARKET & REVENUES 139
Market revenues - global 139
Figure 1: Global CNS drugs sales (2007) 139
Market revenues – leading brands 140
Figure 2: Leading CNS brands (2007) 140
Market revenues – leading players 141
Figure 3: Top 10 CNS players (2007 revenues) 141

CNS EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT 142
Epidemiology 142
Table 1: CNS statistics for the most common CNS disorders, 2008 142
Diagnosis 142
Table 2: Indication for CT and MRI in the CNS 143
Screening 143
Current & future treatment 143
Table 3: Classes of CNS drugs approved for acute and chronic conditions 144
Future treatment 144
Figure 4: CNS drugs in clinical development 144

CNS BIOMARKERS 145
CNS biomarker R&D 145
Figure 5: Imaging biomarkers as surrogate endpoints 146
Table 4: Types of biomarker 146
Known CNS biomarkers 147
Table 5: Commercially available known CNS biomarker diagnostics 147
Probable and possible valid CNS biomarkers 147
Table 6: Probable CNS biomarkers diagnostics 148
Table 7: Possible CNS biomarkers diagnostics 148

CNS BIOMARKER OPPORTUNITIES & CHALLENGES 152
Opportunities 152
Figure 7: CNS biomarker opportunities 152
Challenges 153
Figure 8: CNS biomarker challenges 153

BIOMARKER MARKET 155
Biomarker market revenues - global 155
Figure 9: Global biomarker sales in 2007 155
CNS biomarker market revenues - global 156
Figure 10: Global CNS biomarker sales in 2007 156
Future biomarker market revenues – global 156
Figure 11: Global biomarker sales in 2015 157
Future CNS biomarker market revenues - global 157
Figure 12: Global CNS biomarker sales in 2015 158

CNS BIOMARKER TRENDS 159
Table 8: Recent deals in the oncology biomarkers 159
Pharma deals 160
Collaborations with CNS discovery companies 160
Collaborations with academics and consortia 160
BIOMARKER ANALYSIS 162
DNA biomarkers 162
Proteomic biomarkers 162
Metabolomic biomarkers 162
Electrophysiology biomarkers 162
Imaging biomarkers 162

KEY BIOMARKER COMPANIES ANALYSED 163
KEY BIOMARKER EVALUATION CRITERIA .164
CNS BIOMARKER- COMPANY ANALYSIS 165
Affymetrix 165
Biomarker novelty & technology platform 165
Association studies/clinical data 165
Management strategy 165
Application & market potential 166
Biomarker analysis 166
Applied NeuroSolutions 167
Biomarker novelty & technology platform 167
Association studies/clinical data 167
Management strategy 167
Application & market potential 167
Biomarker analysis 168
Banyan Biomarkers 169
Biomarker novelty & technology platform 169
Figure 14: Source Of Banyans TNI biomarkers 169
Association studies/clinical data 169
Management strategy 169
Application & market potential 169
Biomarker analysis 170
BG Medicine 171
Biomarker novelty & technology platform 171
Association studies/clinical data 171
Management strategy 171
Application & market potential 172
Biomarker analysis 172
Biosite, Inc 173
Biomarker novelty & technology platform 173
Association studies/clinical data 173
Management strategy 173
Application & market potential 174
Biomarker analysis 174
Biospective 175
Biomarker novelty & technology platform 175
Association studies/clinical data 175
Management strategy 175
Application & market potential 175
Biomarker analysis 176
Celera, Inc 177
Biomarker novelty & technology platform 177
Association studies/clinical data 177
Management strategy 177
Application & market potential 177
Biomarker analysis 178
Clinical Data Inc 179
Biomarker novelty & technology platform 179
Association studies/clinical data 179
Management strategy 180
Application & market potential 180
Biomarker analysis 180
Curidium Medica 181
Biomarker novelty & technology platform 181
Association studies/clinical data 181
Figure 17: Curidium’s PsychINDx test for schizophrenia/bipolar disorder 181
Management strategy 182
Application & market potential 182
Digilab Peptidomics 183
Biomarker novelty & technology platform 183
Association studies/clinical data 183
Management strategy 183
Application & market potential 183
Biomarker analysis 184
EnVivo Pharmaceuticals 185
Biomarker novelty & technology platform 185
Association studies/clinical data 185
Management strategy 185
Application & market potential 185
Biomarker analysis 186
Innogenetics NV 187
Biomarker novelty & technology platform 187
Figure 18: Innogenetic multiparameter analysis 187
Association studies/clinical data 187
Management strategy 187
Application & market potential 188
Biomarker analysis 188
KineMed, Inc 189
Biomarker novelty & technology platform 189
Figure 19: KineMarker technology platform 189
Association studies/clinical data 190
Management strategy 190
Application & market potential 190
Biomarker analysis 190
Lipomics Technologies 191
Biomarker novelty & technology platform 191
Association studies/clinical data 191
Management strategy 191
Application & market potential 191
Biomarker analysis 192
Luminex Corporation 193
Biomarker novelty & technology platform 193
Association studies/clinical data 193
Management strategy 193
Figure 20: Luminex is capturing end-user market share 194
Application & market potential 194
Biomarker analysis 194
Memory Pharmaceuticals Corporation 195
Biomarker novelty & technology platform 195
Association studies/clinical data 195
Management strategy 195
Application & market potential 195
Biomarker analysis 196
Metabolon, Inc 197
Biomarker novelty & technology platform 197
Figure 21: Metabolon integrated analytic platform 197
Association studies/clinical data 197
Management strategy 198
Application & market potential 198
Biomarker analysis 198
Nanogen, Inc 199
Biomarker novelty & technology platform 199
Association studies/clinical data 199
Management strategy 199
Application & market potential 199
Biomarker analysis 200
Nanosphere, Inc 201
Biomarker novelty & technology platform 201
Figure 22. Nanosphere’s gold nanoparticle technology 201
Association studies/clinical data 202
Management strategy 202
Application & market potential 202
Biomarker analysis 202
Nymox Pharmaceutical 203
Biomarker novelty & technology platform 203
Association studies/clinical data 203
Management strategy 203
Application & market potential 203
Biomarker analysis 204
Competitor Ratio Analysis Score = 12/40 204
Osta Biotechnologies 205
Biomarker novelty & technology platform 205
Association studies/clinical data 205
Management strategy 205
Application & market potential 205
Biomarker analysis 206
Phenomenome Discoveries, Inc 207
Biomarker novelty & technology platform 207
Association studies/clinical data 207
Management strategy 207
Application & market potential 207
Biomarker analysis 208
PPD, Inc 209
Biomarker novelty & technology platform 209
Association studies/clinical data 209
Management strategy 209
Application & market potential 209
Biomarker analysis 210
Competitor Ratio Analysis Score = 16/40 210
Power3 Medical Products 211
Biomarker novelty & technology platform 211
Association studies/clinical data 211
Management strategy 211
Application & market potential 211
Biomarker analysis 212
Provista Life Sciences 213
Biomarker novelty & technology platform 213
Association studies/clinical data 213
Management strategy 213
Application & market potential 213
Biomarker analysis 214
Psynova Neurotech Ltd 215
Biomarker novelty & technology platform 215
Association studies/clinical data 215
Figure 23: Two proteins identified in CSF are also biomarkers in serum 215
Management strategy 216
Application & market potential 216
Biomarker analysis 216
Satoris, Inc 217
Biomarker novelty & technology platform 217
Association studies/clinical data 217
Figure 24: Early identification of Alzheimer's disease in at-risk MCI patients 217
Management strategy 218
Application & market potential 218
Biomarker analysis 218
Siemens Medical Solutions 219
Biomarker novelty & technology platform 219
Figure 25: Siemens Integrated in vivo & in vitro diagnostic suites 219
Association studies/clinical data 219
Management strategy 220
Application & market potential 220
Biomarker analysis 220
Competitor Ratio Analysis Score = 20/40 220
SuperArray Bioscience Corporation 222
Biomarker novelty & technology platform 222
Association studies/clinical data 222
Management strategy 222
Application & market potential 222
Biomarker analysis 223

CNS biomarker APPENDIX 1 224
Table 9: Global biomarker sales 2007-20015E 224
CNS biomarker APPENDIX 2 225
Table 10: Global CNS biomarker sales 2007-20015E 225
CNS biomarker APPENDIX 3 226
Company Analysis Criteria 226
Biomarker technology & platforms 226
Association studies 226
Management strategy 226
Application & potential 226
Table 9: Key CNS Biomarker Companies 227
Figure 26: Leading CNS Biomarker Companies – Service Providers, Technology Providers, Biomarker Discovery & Diagnostic Developers 228

GLOSSARY 229
ACRONYMS 234
BIBLIOGRAPHY 239
CARDIOVASCULAR MARKET & REVENUES 241
Market revenues - global 241
Figure 1: Global cardiovascular disease drug sales 2007 241
Market revenues – leading brands 242
Figure 2: Leading Cardiovascular brands (2007) 242
Market revenues – leading players 243
Figure 3: Top 10 cardiovascular players (2007 revenues) 243

CARDIOVASCULAR EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT .244
Epidemiology 244
Figure 4: Breakdown of deaths from cardiovascular diseases in the US (2004) 245
Diagnosis 245
Screening 246
Table 1: Screening for cardiovascular disease 246
Current treatments 246
Table 2: Cardiovascular therapeutic drug categories and their indications 247
Future treatments 247
Figure 5: Drugs in clinical development for heart disease 248

CARDIOVASCULAR BIOMARKERS 249
Cardiovascular biomarker R&D 249
Figure 6: Impact of biomarkers on the drug R&D process 250
Table 3: Types of biomarker 251
Known cardiovascular biomarkers 251
Table 4: Commercially available cardiovascular diagnostics 251
Probable and possible valid cardiovascular biomarkers 253
Table 5: Probable cardiovascular biomarkers 254
Table 6: Possible cardiovascular biomarkers 255

CARDIOVASCULAR BIOMARKER OPPORTUNITIES & CHALLENGES 258
Opportunities 258
Figure 7: Cardiovascular biomarker opportunities 258
Challenges 259
Figure 8: Cardiovascular biomarker challenges 259

BIOMARKER MARKET 261
Biomarker market revenues – global 261
Figure 9: Global biomarker sales in 2007 261
Cardiovascular biomarker market revenues – global 262
Figure 10: Global cardiovascular biomarker sales in 2007 262
Future biomarker market revenues – global 262
Figure 11: Global biomarker sales in 2015 263
Future cardiovascular biomarker market revenues – global 263
Figure 12: Global cardiovascular biomarker sales in 2015 263

CARDIOVASCULAR BIOMARKER TRENDS 264
Table 7: Recent deals in cardiovascular biomarkers 264
Pharma and specialty pharma deals 265
Collaborations with service providers 265
Collaborations with academics and consortia 265

BIOMARKER ANALYSIS 266
Assays for circulating biomarkers 266
DNA and RNA biomarkers 266
Proteomic, metabolomic biomarkers 266
Systems biology for biomarker discovery 266
Imaging biomarkers 267

KEY BIOMARKER COMPANIES ANALYSED 268
KEY BIOMARKER EVALUATION CRITERIA .269
CARDIOVASCULAR BIOMARKERS - COMPANY ANALYSIS 270
Abbott Diagnostics 270
Biomarker novelty & technology platform 270
Association studies/clinical data 270
Management strategy 270
Application & market potential 270
Biomarker analysis 271
Atherotech 272
Biomarker novelty & technology platform 272
Association studies/clinical data 272
Management strategy 272
Application & market potential 272
Biomarker analysis 272
Affymetrix 273
Biomarker novelty & technology platform 273
Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility applications .273
Association studies/clinical data 273
Management strategy 274
Application & market potential 274
Biomarker analysis 275
Beckman Coulter 276
Biomarker novelty & technology platform 276
Association studies/clinical data 276
Management strategy 276
Application & market potential 277
Biomarker analysis 277
Berkeley HeartLab 278
Biomarker novelty & technology platform 278
Figure 14: Markers of cardiovascular disease measured at Berkeley HeartLab 278
Association studies/clinical data 278
Management strategy 279
Application & market potential 279
Biomarker analysis 279
BG Medicine 280
Biomarker novelty & technology platform 280
Association studies/clinical data 280
Management strategy 280
Figure 15: BG Medicine’s Biomarker Programme 281
Application & market potential 281
Biomarker analysis 282
CardioDx 283
Biomarker novelty & technology platform 283
Association studies/clinical data 283
Management strategy 283
Application & market potential 283
Biomarker analysis 284
Competitor Ratio Analysis Score = 9/40 284
Celera 285
Biomarker novelty & technology platform 285
Association studies/clinical data 285
Management strategy 286
Application & market potential 286
Biomarker analysis 286
CIS Biotech 287
Biomarker novelty & technology platform 287
Association studies/clinical data 287
Management strategy 287
Application & market potential 287
Biomarker analysis 288
Clinical Data 289
Biomarker novelty & technology platform 289
Association studies/clinical data 289
Management strategy 290
Application & market potential 290
Biomarker analysis 290
Compugen 291
Biomarker novelty & technology platform 291
Association studies/clinical data 291
Management strategy 291
Application & market potential 292
Biomarker analysis 292
Critical Diagnostics 293
Biomarker novelty & technology platform 293
Association studies/clinical data 293
Management strategy 293
Application & market potential 293
Biomarker analysis 294
deCODE Genetics 295
Biomarker novelty & technology platform 295
Association studies/clinical data 295
Management strategy 295
Figure 16: deCODE’s approach to target discovery and development 296
Application & market potential 296
Biomarker analysis 296
diaDexus 297
Biomarker novelty & technology platform 297
Association studies/clinical data 297
Management strategy 297
Application & market potential 297
Biomarker analysis 298
Entelos 299
Biomarker novelty & technology platform 299
Association studies/clinical data 299
Management strategy 299
Application & market potential 299
Biomarker analysis 300
FoxHollow Technologies 301
Biomarker novelty & technology platform 301
Association studies/clinical data 301
Management strategy 301
Application & market potential 301
Biomarker analysis 302
GE Healthcare 303
Biomarker novelty & technology platform 303
Figure 17: Cardiology focus at GE Healthcare 303
Association studies/clinical data 304
Management strategy 304
Application & market potential 304
Biomarker analysis 304
Genomas 305
Biomarker novelty & technology platform 305
Figure 18: PhysioGenomics Technology from Genomas 305
Association studies/clinical data 305
Management strategy 306
Application & market potential 306
Biomarker analysis 306
Inverness Medical Innovations 307
Biomarker novelty & technology platform 307
Association studies/clinical data 307
Management strategy 307
Application & market potential 308
Biomarker analysis 308
Jurilab 309
Biomarker novelty & technology platform 309
Figure 19: Jurilab’s Genetic Discovery Method 310
Association studies/clinical data 310
Management strategy 311
Application & market potential 311
Biomarker analysis 311
Competitor Ratio Analysis Score = 12/40 311
Laboratory Corporation of America 312
Biomarker novelty & technology platform 312
Association studies/clinical data 312
Management strategy 312
Application & market potential 312
Biomarker analysis 313
Lipomics Technologies 314
Biomarker novelty & technology platform 314
Association studies/clinical data 314
Management strategy 314
Application & market potential 314
Biomarker analysis 315
LipoScience 316
Biomarker novelty & technology platform 316
Association studies/clinical data 316
Management strategy 316
Application & market potential 316
Biomarker analysis 317
Competitor Ratio Analysis Score = 15/40 317
Nanosphere Inc 318
Biomarker novelty & technology platform 318
Association studies/clinical data 318
Management strategy 318
Application & market potential 318
Biomarker analysis 319
Osmetech Molecular Diagnostics 320
Biomarker novelty & technology platform 320
Association studies/clinical data 320
Management strategy 320
Application & market potential 320
Biomarker analysis 321
Competitor Ratio Analysis Score = 12/40 321
PrognostiX 322
Biomarker novelty & technology platform 322
Association studies/clinical data 322
Management strategy 322
Application & market potential 322
Biomarker analysis 322
Quest Diagnostics 323
Biomarker novelty & technology platform 323
Association studies/clinical data 323
Management strategy 323
Application & market potential 323
Biomarker analysis 324
Competitor Ratio Analysis Score = 27/40 324
Roche Diagnostics 325
Biomarker novelty & technology platform 325
Figure 20: Roche’s technologies for biomarker discovery and development 325
Association studies/clinical data 325
Figure 21: Roche’s clinical trial programme for cardiac biomarker NT-proBNP 326
Management strategy 326
Application & market potential 326
Biomarker analysis 327
Siemens Medical Solutions 328
Biomarker novelty & technology platform 328
Figure 22: Siemens Integrated in vivo & in vitro diagnostic suites 328
Association studies/clinical data 328
Management strategy 329
Application & market potential 329
Biomarker analysis 329
Singulex 330
Biomarker novelty & technology platform 330
Figure 23: Sensitivity of Singulex’s Erenna system compared to ELISA and bead-based fluorescence readout systems 330
Association studies/clinical data 330
Management strategy 331
Application & market potential 331
Biomarker analysis 331
SuperArray Bioscience Corporation 332
Biomarker novelty & technology platform 332
Association studies/clinical data 332
Management strategy 332
Application & market potential 332
Biomarker analysis 333
Vermillion 334
Biomarker novelty & technology platform 334
Association studies/clinical data 334
Management strategy 334
Application & market potential 335
Biomarker analysis 335
Zora Biosciences OY 336
Biomarker novelty & technology platform 336
Table 8: Zora metabolite profiling platform 336
Association studies/clinical data 336
Management strategy 336
Application & market potential 336
Biomarker analysis 337

Cardiovascular biomarker APPENDIX 1 338
Table 9: Global biomarker sales 2007-20015E 338
Cardiovascular biomarker APPENDIX 2 339
Table 10: Global cardiovascular biomarker sales 2007-20015E 339
Cardiovascular biomarker APPENDIX 3 340
Company Analysis Criteria 340
Biomarker technology & platforms 340
Association studies 340
Management strategy 340
Application & potential 340
Table 9: Key cardiovascular biomarker companies 341
Figure 26: Leading Cardiovascular Biomarker Companies – Service providers, Technology Providers, Biomarker Discovery & Diagnostic Developers 343

GLOSSARY 344
ACRONYMS 346
BIBLIOGRAPHY & end NOTES 350

Summary:

This new 3-volume report provides a comprehensive analysis of the major therapy areas which are driving growth, along with a critical assessment of the companies involved.

Cancer Biomarkers

The cancer biomarker market represents one of the largest segments of biomarkers in terms of revenue. In 2007, the estimated cancer biomarker market accounted for around 55% of biomarker revenues at over US$3 billion, with the majority of revenues derived from biomarker discovery and molecular diagnostics.

This market is relatively mature due to researchers’ comprehensive understanding of the underlying genetic and proteomic components of the disease. It has been the focus for the majority of the early biomarker research which was aimed at the discovery and identification of biomarkers that guided the development of targeted therapies (companion diagnostics) and has been stimulated by advances in technology platforms for the analysis of biological samples (blood, serum and tissue).

Collaborative working is essential

During the last two years, the leading pharma companies such as Abbott, AstraZeneca, Eisai, Merck & Co, sanofi-aventis, Solvay, Pfizer, Roche and Wyeth have been forming strategic alliances with a variety of companies, including Caprion Proteomics, Celera, Epigenomics, EpiStem, Monogram BioSciences (formerly ViroLogic) and Vermillion which are all actively involved in biomarker discovery and validation.

Many of these agreements have been established in the last 12 months and pursue the identification of multiple oncology biomarkers that complement pharma product pipelines. For example, in March 2008 Abbott established a collaboration with Genentech, Roche and OSI to develop an EGFR FISH based test for NSCLC testing. Similarly, specialty pharma companies such as Amgen, Myriad and OSI Pharmaceuticals have formed collaborations to utilise biomarkers in drug discovery and development programmes.

Increasingly, the industry is establishing relationships with leading academic institutes to clinically validate biomarkers prior to their use in clinical drug development programmes. For example, in the US, the Eastern Virginia Medical School, the Johns Hopkins University, The University of Kentucky, the Mayo Clinic, and the MD Anderson Cancer Center and, in Europe, the Institut Curie in France and the University of Oxford in the UK are all assessing new cancer biomarkers and technology platforms for biomarker discovery and validation.

Questions, Questions
- What will the global cancer biomarker market be worth in 2015?
- What developments in proteomic biomarkers are proving fruitful in the cancer sector and which companies are developing them?
- Why might drug discovery companies be interested in Dutch diagnostic company Agendia BV?
- How is Beckman Coulter strengthening its presence in the cancer biomarker arena?

Focus on...opportunities
The cancer biomarker sector will be driven by...
Increases in the number of new cases of a range of cancers due to an aging population, e.g. prostate, breast and ovarian cancers. These will continue to drive growth and research interest in cancer therapies and investigation into the underlying mechanisms of the disease.

Improvements in diagnostic tests and technology platforms to direct treatment and surgery which instil confidence and renewed interest in developing PoC diagnostics, e.g. EPCA/PSA tests for prostate cancer and HER-2 for breast cancer.
The development of easy-to-use and rapid PoC diagnostics that may help to increase the number of cancer patients treated with first line therapy.

CNS Biomarkers

By 2015, we estimate the global CNS biomarker market will account for around 15% of global biomarker sales to be worth over US$3.4 billion as the market matures; driven by growth in clinical biomarkers for neurodegenerative diseases, the development of biomarkers for neuropsychiatric diseases (e.g. schizophrenia and depression) for clinical trial guidance and the commercialisation of the first molecular tests to predict AD and MCI and to differentiate MS patients. 57% of the market will be taken by the biomarker discovery sector.

The majority of the CNS biomarker research at the present time is aimed at the discovery and identification of biomarker signatures through the application of gene expression profiling, protein profiling and/or metabolomics, as well as the use of imaging and electrophysiological surrogate biomarkers. Many “probable” biomarker signatures are now under evaluation, particularly in AD, MS and schizophrenia.

This market is immature as CNS disorders are often ill-defined and their underlying aetiology poorly understood. However, in certain areas such as neurodegenerative diseases, a clear genetic component has been established and significant strides have been made in discovering and identifying novel biomarkers to guide drug development
programmes and/or as diagnostic aids.

The CNS biomarker market represents one of the smallest segments of biomarkers in terms of revenue as relatively few CNS biomarkers are commercially available. In 2007, we estimate the CNS biomarker market accounted for less than 5% of biomarker revenues, with the majority coming from biomarker discovery in schizophrenia and neurodegenerative disorders.

Collaboration between the industry and academia is critical if the potential of CNS biomarkers is to be realised. During the last ten years several public-private partnerships have been established to discover biomarkers and their uses in the
diagnosis of CNS disorders. According to PhRMA, around US$44 .5 billion was spent on R&D. However, there is still only an 8% chance that a drug entering clinical trials will reach the market. Reliable read-outs are essential if the industry is to improve its track record on drug attrition and continue to attract investment.

Focus on...research approaches
DNA biomarkers
Companies have utilised gene expression profiling using microarray based technologies to discover and identify novel genetic biomarkers for development. One approach is to identify single genes associated with a disease state (e.g. schizophrenia susceptibility genes) or treatment response (pharmacometabolomic biomarkers). Conversely, companies are increasingly applying panels of biomarkers or biosignatures to develop prognostic diagnostics.

Proteomic biomarkers
In addition, companies may evaluate single proteins or quantitative proteomic profiling of blood plasma, serum, urine or CSF using chromatography and mass spectrometry based technologies (BG Medicine) to discover and identify novel biomarkers. This approach has been widely adopted by Applied NeuroSolutions, BioSite, Nymox Pharmaceuticals, PPD, Power3 Medical Products, Provista Life Sciences and Satoris.

Electrophysiology biomarkers
Some companies have adopted alternative surrogate biomarkers that measure electrophysiological changes in neural pathways. For example, EnVivo Pharmaceuticals and Memory Pharmaceuticals monitor P50 auditory evoked response and mismatch negativity as a read-out where abnormalities in sensory gating are associated with schizophrenia.

“Biomarkers have the potential to revolutionise the diagnosis of disease and the drug discovery process”

Cardiovascular Biomarkers

In 2007, the cardiovascular biomarker market accounted for an estimated 23% of biomarker revenues to generate over US$1.3 billion with the majority of revenues derived from biomarker discovery and molecular diagnostics. The market has yet to reach the maturity of the oncology biomarker market, but over the coming years the importance of genetic markers and companion diagnostics will grow. By 2015, the estimated market value will be US$6.6 billion, with biomarker discovery being the largest component.

One of the largest markets for cardiovascular biomarkers lies in the diagnosis of acute coronary syndromes in patients presenting with acute signs and symptoms, such as shortness of breath or chest pain.

For example, Troponin is well established as a diagnostic marker of myocardial infarction and has been described as the cornerstone of diagnosis for the condition. However, the marker has a major limitation: troponin levels only rise six to eight hours after a myocardial ischaemia. The search for new diagnostic biomarkers for use in the acute setting has focused on the identification of earlier markers of infarction. These include ischaemia modified albumin (IMA) as well as potential markers, heart fatty acid binding protein and glycogen phosphorylase isoenzyme BB (GPBB). In addition, some of the leading providers are suggesting that panels of cardiac markers are most useful for diagnosis in acute settings. Examples include Biosite’s (now part of Inverness Medical Innovations) CardioProfiler Triage panel. This is a PoC diagnostic that measures a number of markers including Troponin I, CK-MB, myoglobin and BNP. New multi-marker panels are also under development. These include an index score panel for the diagnosis of peripheral artery disease (VASCLIR, Vermillion). The panel evaluates ß-2-microglobulin, cystatin C, hsCRP and glucose to create an index score and is currently in clinical trials.

Screening patients for prediction of future cardiovascular disease is currently the second major market for cardiovascular biomarkers. These markers include lipid biomarkers (e.g. LDL, HDL, triglycerides, LDL particle number and lipoprotein concentrations) or inflammatory biomarkers (e.g. CRP or Lp-PLA2). Lipid profiles are well-established as indicators of future cardiovascular risk that can be reduced through the use of lipid-lowering therapies such as statins.

Questions, Questions
- What clinical studies are CardioDx currently engaged in?
- What approach is deCODE Genetics taking in its research?
- Which pharmaceutical companies are utilising Entelos predictive biostimulation technology?

Focus on...market potential
In 2007, the cardiovascular biomarker market accounted for and estimated 23% of biomarker revenues generating over US$1.3 billion, with the majority of revenues derived from biomarker discovery and molecular diagnostics. The market has yet to reach the maturity of the oncology biomarker market, but will grow in the short term with the introduction of new, proprietary markers for acute coronary syndromes. Over the coming years, the importance of genetic markers and companion diagnostics will grow.

By 2015, we estimate the global cardiovascular biomarker market will account for around one third of global biomarker sales and will be worth up to US$6.6 billion as it becomes more mature; driven by growth in clinical biomarkers, the development of targeted therapies and associated companion diagnostics, discovery and validation of genetic markers of cardiovascular risk and reimbursement of pharmacogenomic and prognostic tests.