CNS Biomarkers: Players, products and prospects
Volume II
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| Overview: | |
| 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. |
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By Dr Cheryl L Barton / Publication Date: 28th August 2008
Contents:
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 & TREATMENT142
Epidemiology142
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 development144
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 diagnostics147
Probable and possible valid CNS biomarkers147
Table 6: Probable CNS biomarkers diagnostics 148
Table 7: Possible CNS biomarkers diagnostics ..148
CNS BIOMARKER OPPORTUNITIES & CHALLENGES152
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 - global156
Figure 10: Global CNS biomarker sales in 2007.156
Future biomarker market revenues – global.156
Figure 11: Global biomarker sales in 2015157
Future CNS biomarker market revenues - global157
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 ANALYSIS162
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
Affymetrix165
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 strategy167
Application & market potential167
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 analysis170
BG Medicine171
Biomarker novelty & technology platform.171
Association studies/clinical data..171
Management strategy171
Application & market potential172
Biomarker analysis172
Biosite, Inc173
Biomarker novelty & technology platform.173
Association studies/clinical data..173
Management strategy173
Application & market potential174
Biomarker analysis174
Biospective.. 175
Biomarker novelty & technology platform.175
Association studies/clinical data..175
Management strategy175
Application & market potential175
Biomarker analysis176
Celera, Inc.177
Biomarker novelty & technology platform.177
Association studies/clinical data..177
Management strategy177
Application & market potential177
Biomarker analysis178
Clinical Data Inc179
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 disorder181
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 Pharmaceuticals185
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 strategy191
Application & market potential191
Biomarker analysis192
Luminex Corporation..193
Biomarker novelty & technology platform.193
Association studies/clinical data..193
Management strategy193
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 = 12/40204
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 analysis210
Competitor Ratio Analysis Score = 16/40210
Power3 Medical Products. 211
Biomarker novelty & technology platform.211
Association studies/clinical data..211
Management strategy211
Application & market potential211
Biomarker analysis212
Provista Life Sciences.. 213
Biomarker novelty & technology platform.213
Association studies/clinical data..213
Management strategy213
Application & market potential213
Biomarker analysis214
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 strategy216
Application & market potential216
Biomarker analysis216
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 patients217
Management strategy218
Application & market potential218
Biomarker analysis218
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 = 20/40220
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 Companies227
Figure 26: Leading CNS Biomarker Companies – Service Providers, Technology Providers, Biomarker Discovery & Diagnostic Developers228
GLOSSARY. 229
ACRONYMS234
BIBLIOGRAPHY .. 239
List of Tables:
Table 1: CNS statistics for the most common CNS disorders, 2008..142
Table 2: Indication for CT and MRI in the CNS.143
Table 3: Classes of CNS drugs approved for acute and chronic conditions..144
Table 4: Types of biomarker.146
Table 5: Commercially available known CNS biomarker diagnostics147
Table 6: Probable CNS biomarkers diagnostics 148
Table 7: Possible CNS biomarkers diagnostics ..148
Table 8: Recent deals in the oncology biomarkers..159
Table 9: Global biomarker sales 2007-20015E..224
Table 10: Global CNS biomarker sales 2007-20015E..225
Table 9: Key CNS Biomarker Companies227
Figure 1: Global CNS drugs sales (2007)139
Figure 2: Leading CNS brands (2007).140
Figure 3: Top 10 CNS players (2007 revenues)141
Figure 4: CNS drugs in clinical development144
Figure 5: Imaging biomarkers as surrogate endpoints.146
Figure 7: CNS biomarker opportunities 152
Figure 8: CNS biomarker challenges ..153
Figure 9: Global biomarker sales in 2007.155
Figure 10: Global CNS biomarker sales in 2007.156
Figure 11: Global biomarker sales in 2015157
Figure 12: Global CNS biomarker sales in 2015.158
Figure 14: Source Of Banyans TNI biomarkers..169
Figure 17: Curidium’s PsychINDx test for schizophrenia/bipolar disorder181
Figure 18: Innogenetic multiparameter analysis.187
Figure 19: KineMarker technology platform..189
Figure 20: Luminex is capturing end-user market share.194
Figure 21: Metabolon integrated analytic platform..197
Figure 22. Nanosphere’s gold nanoparticle technology..201
Figure 23: Two proteins identified in CSF are also biomarkers in serum..215
Figure 24: Early identification of Alzheimer's disease in at-risk MCI patients217
Figure 25: Siemens Integrated in vivo & in vitro diagnostic suites..219
Figure 26: Leading CNS Biomarker Companies – Service Providers, Technology Providers,