Cardiovascular Biomarkers: Players, products and prospects
Volume III
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| Overview: | |
| 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. |
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By Dr Cheryl L Barton / Publication Date: 28th August 2008
Contents:
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 & TREATMENT244
Epidemiology.. 244
Figure 4: Breakdown of deaths from cardiovascular diseases in the US (2004)..245
Diagnosis 245
Screening .. 246
Table 1: Screening for cardiovascular disease246
Current treatments. 246
Table 2: Cardiovascular therapeutic drug categories and their indications247
Future treatments 247
Figure 5: Drugs in clinical development for heart disease248
CARDIOVASCULAR BIOMARKERS .249
Cardiovascular biomarker R&D 249
Figure 6: Impact of biomarkers on the drug R&D process250
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 – global261
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 2015263
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 biomarkers264
Pharma and specialty pharma deals 265
Collaborations with service providers 265
Collaborations with academics and consortia 265
BIOMARKER ANALYSIS266
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
Affymetrix273
Biomarker novelty & technology platform 273
Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility applications273
Association studies/clinical data. 273
Management strategy274
Application & market potential274
Biomarker analysis275
Beckman Coulter276
Biomarker novelty & technology platform.276
Association studies/clinical data..276
Management strategy276
Application & market potential.. 277
Biomarker analysis.. 277
Berkeley HeartLab.278
Biomarker novelty & technology platform 278
Figure 14: Markers of cardiovascular disease measured at Berkeley HeartLab278
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 Programme281
Application & market potential.. 281
Biomarker analysis.. 282
CardioDx283
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 Data289
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 Diagnostics293
Biomarker novelty & technology platform 293
Association studies/clinical data. 293
Management strategy.. 293
Application & market potential.. 293
Biomarker analysis.. 294
deCODE Genetics295
Biomarker novelty & technology platform 295
Association studies/clinical data. 295
Management strategy.. 295
Figure 16: deCODE’s approach to target discovery and development296
Application & market potential.. 296
Biomarker analysis.. 296
diaDexus297
Biomarker novelty & technology platform 297
Association studies/clinical data. 297
Management strategy.. 297
Application & market potential.. 297
Biomarker analysis.. 298
Entelos299
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 Healthcare303
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 strategy311
Application & market potential311
Biomarker analysis311
Competitor Ratio Analysis Score = 12/40311
Laboratory Corporation of America. 312
Biomarker novelty & technology platform.312
Association studies/clinical data..312
Management strategy312
Application & market potential312
Biomarker analysis313
Lipomics Technologies.. 314
Biomarker novelty & technology platform.314
Association studies/clinical data..314
Management strategy314
Application & market potential314
Biomarker analysis315
LipoScience.316
Biomarker novelty & technology platform.316
Association studies/clinical data..316
Management strategy316
Application & market potential316
Biomarker analysis317
Competitor Ratio Analysis Score = 15/40317
Nanosphere Inc318
Biomarker novelty & technology platform.318
Association studies/clinical data..318
Management strategy318
Application & market potential318
Biomarker analysis319
Osmetech Molecular Diagnostics..320
Biomarker novelty & technology platform 320
Association studies/clinical data. 320
Management strategy.. 320
Application & market potential.. 320
Biomarker analysis321
Competitor Ratio Analysis Score = 12/40321
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 = 27/40324
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-proBNP326
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 strategy331
Application & market potential331
Biomarker analysis331
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 platform336
Association studies/clinical data. 336
Management strategy.. 336
Application & market potential.. 336
biomarker APPENDIX 1 338
Table 9: Global biomarker sales 2007-20015E..338
Cardiovascular biomarker APPENDIX 2 339
Table 10: Global cardiovascular biomarker sales 2007-20015E339
Cardiovascular biomarker APPENDIX 3340
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 Developers343
GLOSSARY.344
ACRONYMS346
BIBLIOGRAPHY & end NOTES.. 350
List of Tables:
Table 1: Screening for cardiovascular disease246
Table 2: Cardiovascular therapeutic drug categories and their indications247
Table 3: Types of biomarker.251
Table 4: Commercially available cardiovascular diagnostics.251
Table 5: Probable cardiovascular biomarkers ..254
Table 6: Possible cardiovascular biomarkers .255
Table 7: Recent deals in cardiovascular biomarkers264
Table 8: Zora metabolite profiling platform336
Table 9: Global biomarker sales 2007-20015E..338
Table 10: Global cardiovascular biomarker sales 2007-20015E339
Table 11: Key cardiovascular biomarker companies.341
Table 8: Zora metabolite profiling platform336
Table 9: Global biomarker sales 2007-20015E..338
Table 10: Global cardiovascular biomarker sales 2007-20015E339
Table 9: Key cardiovascular biomarker companies.341
Figure 1: Global cardiovascular disease drug sales 2007 241
Figure 2: Leading Cardiovascular brands (2007).242
Figure 3: Top 10 cardiovascular players (2007 revenues)243
Figure 4: Breakdown of deaths from cardiovascular diseases in the US (2004)..245
Figure 5: Drugs in clinical development for heart disease248
Figure 6: Impact of biomarkers on the drug R&D process250
Figure 7: Cardiovascular biomarker opportunities .258
Figure 8: Cardiovascular biomarker challenges ..259
Figure 9: Global biomarker sales in 2007.261
Figure 10: Global cardiovascular biomarker sales in 2007.262
Figure 11: Global biomarker sales in 2015263
Figure 12: Global cardiovascular biomarker sales in 2015..263
Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility
Figure 14: Markers of cardiovascular disease measured at Berkeley HeartLab278
Figure 15: BG Medicine’s Biomarker Programme281
Figure 16: deCODE’s approach to target discovery and development296
Figure 17: Cardiology focus at GE Healthcare 303
Figure 18: PhysioGenomics Technology from Genomas..305
Figure 19: Jurilab’s Genetic Discovery Method..310
Figure 20: Roche’s technologies for biomarker discovery and development.325
Figure 21: Roche’s clinical trial programme for cardiac biomarker NT-proBNP326
Figure 22: Siemens Integrated in vivo & in vitro diagnostic suites..328
Figure 23: Sensitivity of Singulex’s Erenna system compared to ELISA and bead-based
Figure 26: Leading Cardiovascular Biomarker Companies – Service providers, Technology