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Innovations in Protein Kinase Therapies: Company pipelines, therapeutic applications and market forecasts
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Innovations in Protein Kinase Therapies
Company pipelines, therapeutic applications and market forecasts
Report Overview
During the last decade, approvals for several first-in-class kinase inhibito.....
Innovations in Protein Kinase Therapies Company pipelines, therapeutic applications and market forecasts Report Overview During the last decade, approvals for several first-in-class kinase inhibitors have resulted in a wider recognition of kinases as an important class of drug targets. In the cancer market, there are now seven launched agents targeting EGFR family kinases, three launched agents targeting ABL family kinases and two launched agents targeting VGFR family kinases. Although the kinase market is still relatively young, 173 kinase-related genes are now being targeted in drug developments. ‘Innovations in Protein Kinase Therapies’ is a report published by Business Insights that provides analysis of 608 kinase-targeting drugs in commercial development by 232 originating companies. This report identifies areas of innovation and opportunity for kinase targeting drugs in cancer and examines the non-cancer applications of kinase drugs across inflammatory/autoimmune diseases, restenosis, diabetes, and other disorders. Leading kinase drug originating companies are profiled to reveal their drugs in development and co-development strategies. Global sales forecasts to 2013 for kinase-targeted drugs are also provided. Key Findings This report has identified 608 drugs under development from 232 originating companies. These include 455 anticancer drugs directed at a total of 122 molecular targets, and 153 drugs for indications other than cancer, which are directed at 79 molecular targets. 21 (3.5%) of the developmental kinase drugs identified by this report have been launched, and 28 (7.8%) are in Phase 3 clinical trials or beyond. The vast majority of kinase drugs in development are small molecule drugs (78.8%). Cancer is the most popular indication for kinase drugs (74.8%), followed by arthritis, diabetes and inflammation. A number of marketed drugs are also targeting restenosis. The global market for kinase-targeted drugs is forecast to grow by 18% per annum, from $13bn in 2008 to $35bn in 2013, based on this report’s analysis of kinase-targeting drug segments. Novartis has a commanding lead of the kinase drug market, with a 29% share in 2008. In 2013, Novartis' leadership is set to continue, but the most improved company is expected to be Bristol-Myers Squibb, as a result of strong growth from Sprycel. Use this report to... • Examine the novel approaches to small molecule kinase inhibitor discovery with this report’s analysis of the strategies currently under development for the efficient discovery and optimization of new inhibitors. • Identify the most promising approaches to kinase modulation in cancer and other diseases by examining drug targets including ABL1, EGFR, ERBB2, FLT3, KIT, PDGFRA, PDGFRB, FLT1, FLT4, KDR, JAK2, MET, AKT1, CDC2, CDK2, AURKA, AURKB, PLK1, FRAP1, and PIK3CA. • Compare the activities of the top 20 kinase drug originating companies and identify potential development partners with this report’s analysis of each player’s kinase-related collaborations and drug pipelines. • Understand future developments in the global kinase drug market, review global pharma trends by region/indication and forecast sales to 2013 for drugs directed at specific kinase-related targets. Explore issues including... The potential of ATP competitive inhibitor libraries. With the binding of ATP being essential for kinase activity, most R&D efforts in the past have been directed at the discovery of small molecule reversible ATP competitive inhibitors. Vast libraries of ATP competitive inhibitors offer the promise of easy success in the search for new kinase inhibitors. The importance of profiling drug candidate activity against a wide variety of kinases. Understanding the behaviour of a compound provides an early indication of whether or not it can have potentially toxic side-effects. Assays developed to allow the selectivity of a new kinase inhibitor to be evaluated at the protein and cellular level are described in this report. Selectivity criteria for kinases as targets in inflammation. The key issue in the inflammation area is mainly the selectivity of both the target and the inhibitor, in addition to the associated side effect profile of corresponding drugs. In contrast to oncology applications where efficacy is by far the most important criteria, a high safety profile is key for the treatment of chronic inflammatory and autoimmune diseases. Discover... • What types of kinase-targeting drugs are currently available? • Which are the most important therapeutic indications for kinase drugs? • Which kinase targets are being pursued by drug developers? • Which companies are the most prolific developers of kinase drugs and what drugs are in their portfolios? • What is the nature of commercial activity surrounding the major kinase targets? • How is the kinase-targeting drug market segmented and how are these sectors expected to perform over the period 2009-13? • Which areas of unmet need are new kinase drugs likely to address? • What are the trends in kinase-related patenting in the US? Report Highlights [Studien Infos ausblenden] |
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Table of Contents Kinases: Highways to Drug Discovery Executive Summary 16 Chapter 1 Kinases as drug targets 16 Chapter 2 Small molecule kinase inhibitor discovery 17 Chapter 3 Targeting kinases in cancer 18 Chapter 4 Non-cancer applications of kinase drugs 20 Chapter 5 Leading kinase drug originating companies 21 Chapter 6 Market Analysis: Trends and Forecasts 22 Chapter 1 Kinases as drug targets 26 Summary 26 Introduction 27 Overview of human protein kinases 30 Classification schemes 32 Kinases in signal transduction pathways 36 MAPK pathways 38 MAPK (ERK) pathway 39 JNK/SAPK pathway 40 MAPK14 pathway 40 PI3K/AKT signaling 41 JAK/STAT signaling 41 NFKB pathway 42 Insulin receptor signaling 43 Immune cell signaling 43 T cell receptor signaling 43 B-cell receptor complexes 44 Signaling in vascular morphogenesis 44 VEGF receptor signaling 44 EGF receptor signaling 45 Cyclic nucleotide metabolism 45 Cell cycle checkpoint controls 45 Categories of kinase-targeted drugs 46 Small molecules 47 Monoclonal antibodies 49 Emerging biopharmaceuticals 50 Kinase drug audit 51 Chapter 2 Small molecule kinase inhibitor discovery 58 Summary 58 Introduction 59 Mechanisms of kinase inhibition 60 ATP competitive inhibitors 60 Irreversible inhibitors 61 Allosteric inhibitors 62 Approaches to kinase inhibitor discovery 63 Traditional kinase inhibitor discovery 63 High-throughput screening of compound libraries 63 Lead optimization 65 Synthesis of inhibitor analogs 65 Structure-informed drug design 66 Structure-informed drug re-design 67 Fragment-based drug discovery 68 Kinase inhibitor selectivity assays 69 Protein selectivity assays 70 Kinase activity assays 70 Kinase binding assays 71 Cellular selectivity assays 73 Identifying substrates of kinases 74 Chapter 3 Targeting kinases in cancer 78 Summary 78 Overview of cancer 79 Established and emerging therapies 84 Therapeutic potential of kinase inhibition 86 Types of kinase targets 89 Mutationally-activated kinases 89 Kinases which sustain tumor growth 90 Kinases with roles in tumorigenesis 91 Top 20 kinase targets 92 Group: TK 92 ABL1 (Abl family) 92 Target characteristics 92 Inhibitors on the market 93 Inhibitors in development 96 EGFR and ERBB2 (EGFR family) 101 Target characteristics 101 Approaches to EGFR inhibition 102 Inhibitors on the market 104 Inhibitors in development 107 FLT3, KIT, PDGFRA, and PDGFRB (PDGFR family) 117 Target characteristics 117 Inhibitors on the market 118 Inhibitors in development 119 FLT1, FLT4, and KDR (VEGFR family) 136 Target characteristics 136 Inhibitors on the market 137 Inhibitors in development 138 JAK2 (JakA family) 152 Target characteristics 152 Drugs in development 152 MET (Met family) 155 Target characteristics 155 Agents in development 155 Group: AGC 158 AKT1 (AKT family) 158 Target characteristics 158 Drugs in development 158 Group: CMGC 161 CDC2 and CDK2 (CDK family; CDC2 subfamily) 161 Target characteristics 161 Drugs in development 161 Group: Other 165 AURKA and AURKB (AUR family) 165 Target characteristics 165 Drugs in development 165 PLK1 (PLK family) 169 Target characteristics 169 Drugs in development 169 Group: Atypical 171 Target characteristics 171 Inhibitors on the market 171 Inhibitors in development 172 Dual specificity lipid/protein kinases 176 PIK3CA (PI3K) 176 Target characteristics 176 Inhibitors in development 177 Future trends 181 Chapter 4 Non-cancer applications of kinase drugs 184 Summary 184 Introduction 185 Chronic inflammation and kinases 185 Leading indications 187 Arthritis 187 Diabetes 195 Inflammation 201 Immunosuppression 205 Ophthalmology 208 Psoriasis 211 Pulmonary diseases 214 Cardiovascular 218 Myelodysplastic disorders 222 GI disorders 227 Pain 229 Leading kinase targets 231 MAPK14 231 Target characteristics 231 Inhibitors in development 232 FRAP1 233 Target characteristics 233 Inhibitors on the market 233 Inhibitors in development 234 JAK3 234 Target characteristics 234 Inhibitors in development 234 NTRK1 234 Target characteristics 234 Inhibitors in development 235 ROCK1 235 Target characteristics 235 Inhibitors on the market 235 Inhibitors in development 236 Chapter 5 Leading kinase drug originating companies 238 Summary/Introduction 238 5.1 Abbott Laboratories 239 Company overview 239 Kinase-related collaborations (2005 onwards) 239 Kinase drug pipeline 239 Ambit Biosciences Corp 241 Company overview 241 Kinase-related collaborations (2005 onwards) 241 Kinase drug pipeline 242 Amgen Inc 244 Company overview 244 Kinase-related collaborations (2005 onwards) 244 Kinase drug pipeline 244 Array BioPharma Inc 246 Company overview 246 Kinase-related collaborations (2005 onwards) 246 Kinase drug pipeline 246 AstraZeneca plc 248 Company overview 248 Kinase-related collaborations (2005 onwards) 248 Kinase drug pipeline 249 Avila Therapeutics Inc 251 Company overview 251 Kinase drug pipeline 252 Boehringer Ingelheim GmbH 253 Company overview 253 Kinase-related collaborations (2005 onwards) 253 Kinase drug pipeline 254 Bristol-Myers Squibb Co 256 Company overview 256 Kinase-related collaborations (2005 onwards) 256 Kinase drug pipeline 257 Cephalon Inc 259 Company overview 259 Kinase-related collaborations (2005 onwards) 259 Kinase drug pipeline 259 Deciphera Pharmaceuticals LLC 261 Company overview 261 Kinase-related collaborations (2005 onwards) 261 Kinase drug pipeline 261 Eli Lilly Co 263 Company overview 263 Kinase-related collaborations (2005 onwards) 263 Kinase drug pipeline 264 Exelixis Inc 268 Company overview 268 Kinase-related collaborations (2005 onwards) 268 Kinase drug pipeline 269 GlaxoSmithKline plc 271 Company overview 271 Kinase-related collaborations (2005 onwards) 271 Kinase drug pipeline 272 Hoffmann-La Roche Ltd 274 Company overview 274 Kinase-related collaborations (2005 onwards) 274 Kinase drug pipeline 275 Johnson & Johnson 277 Company overview 277 Kinase-related collaborations (2005 onwards) 277 Kinase drug pipeline 278 Kyowa Hakko Kirin Co Ltd 280 Company overview 280 Kinase-related collaborations (2005 onwards) 280 Kinase drug pipeline 280 Novartis International AG 282 Company overview 282 Kinase-related collaborations (2005 onwards) 282 Kinase drug pipeline 283 Pfizer Inc 286 Company overview 286 Kinase-related collaborations (2005 onwards) 287 Kinase drug pipeline 287 Sanofi-Aventis Group 289 Company overview 289 Kinase drug pipeline 289 Wyeth 291 Company overview 291 Kinase-related collaborations (2005 onwards) 291 Kinase drug pipeline 292 Chapter 6 Market Analysis: Trends and Forecasts 296 Summary 296 Prevalence of targeted diseases 297 Analyses and Forecasts by Type of Agent 299 Limus agents/mTOR inhibitors 303 Overview 303 Standalone mTOR inhibitors 304 Drug-eluting stents 305 Drug-eluting stent market 306 Sirolimus-eluting stents 307 Everolimus- and zotarolimus-eluting stents 307 Sales trends in mTOR inhibitors 308 Forthcoming mTOR inhibitors 308 EGFR Family inhibitors 309 Overview 309 Trastuzumab 309 Erlotinib 310 Cetuximab 310 Gefitinib 311 Panitumumab 311 Lapatinib 311 Nimotuzumab 312 Sales trends in EGFR Family inhibitors 312 Forthcoming EGFR Family Inhibitors 313 ABL/FLT3 Group Inhibitors 313 Overview 313 Imatinib 314 Dasatinib 314 Nilotinib 315 Sales trends in ABL1/FLT3 Family Inhibitors 315 Forthcoming ABL1/FLT3 Family Inhibitors 315 VEGFR Family 316 Overview 316 Sunitinib 317 Sorafenib 317 Sales trends in VEGFR Family inhibitors 317 Forthcoming VEGFR Family Inhibitors 318 Other launched agents 318 Overview 318 Fasudil 319 Pirfenidone 319 Sales trends of other agents 319 Other forthcoming agents 320 Company sales and trends 321 Patenting trends 323 Appendix 1 Kinase-related targets and their abbreviations 326 Appendix 2 Other abbreviations and acronyms 329 Appendix 3 Research Methodology 331 Index 332 [Inhaltsverzeichnis ausblenden] |
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List of Tables Table 1.1: Human Kinase Gene Audit 29 Table 1.2: Hanks Classification of Protein Kinases (1995) 34 Table 1.3: Hanks Classification of Protein Kinases (1995) (continued) 35 Table 1.4: Kinase Agents by Development Stage 52 Table 1.5: Kinase Drugs by Product Type 52 Table 1.6: Leading developers of therapeutic kinase-targeted drugs 53 Table 1.7: Kinase Agonists and Stimulants 55 Table 3.8: Kinases implicated in human cancer 82 Table 3.9: Kinases implicated in human cancer (continued) 83 Table 3.10: Top 20 Kinase Targets in Cancer 90 Table 3.11: Overview of ABL1-targeted agents in cancer 98 Table 3.12: Overview of ABL1-targeted agents in cancer (continued 1) 99 Table 3.13: Overview of ABL1-targeted agents in cancer (continued 2) 100 Table 3.14: Overview of EGFR-targeted agents in cancer 109 Table 3.15: Overview of EGFR-targeted agents in cancer (Phase III and above) 110 Table 3.16: Overview of EGFR-targeted agents in cancer (Phase II) 111 Table 3.17: Overview of EGFR-targeted agents in cancer (Phase I) 112 Table 3.18: Overview of EGFR-targeted agents in cancer (Preclinical) 113 Table 3.19: Overview of ERBB2-targeted agents in cancer (Phase III and above) 114 Table 3.20: Overview of ERBB2-targeted agents in cancer (Phase II) 115 Table 3.21: Overview of ERBB2-targeted agents in cancer (Phase I and Preclinical) 116 Table 3.22: Overview of FLT3-targeted agents in cancer (Launched) 120 Table 3.23: Overview of FLT3-targeted agents in cancer (Phase II and III) 121 Table 3.24: Overview of FLT3-targeted agents in cancer (Phase I and II) 122 Table 3.25: Overview of FLT3-targeted agents in cancer (Preclinical and Phase I) 123 Table 3.26: Overview of KIT-targeted agents in cancer 124 Table 3.27: Overview of KIT-targeted agents in cancer (Continued 1) 125 Table 3.28: Overview of KIT-targeted agents in cancer (Continued 2) 126 Table 3.29: Overview of KIT-targeted agents in cancer (Continued 3) 127 Table 3.30: Overview of KIT-targeted agents in cancer (Continued 4) 128 Table 3.31: Overview of KIT-targeted agents in cancer (Continued 4) 129 Table 3.32: Overview of PDGFRA-targeted agents in cancer 130 Table 3.33: Overview of PDGFRA-targeted agents in cancer (Continued 1) 131 Table 3.34: Overview of PDGFRA-targeted agents in cancer (Continued 2) 132 Table 3.35: Overview of PDGFRA-targeted agents in cancer (Continued 3) 133 Table 3.36: Overview of PDGFRB-targeted agents in cancer (Phase II and Phase III) 134 Table 3.37: Overview of PDGFRB-targeted agents in cancer (Preclinical and Phase I) 135 Table 3.38: Overview of FLT1-targeted agents in cancer 139 Table 3.39: Overview of FLT1-targeted agents in cancer (Continued 1) 140 Table 3.40: Overview of FLT1-targeted agents in cancer (Continued 2) 141 Table 3.41: Overview of FLT1-targeted agents in cancer (Continued 3) 142 Table 3.42: Overview of FLT4-targeted agents in cancer 143 Table 3.43: Overview of FLT4-targeted agents in cancer (Continued 1) 144 Table 3.44: Overview of FLT4-targeted agents in cancer (Continued 2) 145 Table 3.45: Overview of KDR-targeted agents in cancer 146 Table 3.46: Overview of KDR-targeted agents in cancer (Continued 1) 147 Table 3.47: Overview of KDR-targeted agents in cancer (Continued 2) 148 Table 3.48: Overview of KDR-targeted agents in cancer (Continued 3) 149 Table 3.49: Overview of KDR-targeted agents in cancer (Continued 4) 150 Table 3.50: Overview of KDR-targeted agents in cancer (Continued 5) 151 Table 3.51: Overview of JAK2-Targeted Agents in Cancer 153 Table 3.52: Overview of JAK2-Targeted Agents in Cancer (continued) 154 Table 3.53: Overview of MET-Targeted Agents in Cancer (continued) 156 Table 3.54: Overview of MET-Targeted Agents in Cancer (continued) 157 Table 3.55: Overview of AKT1-Targeted Agents in Cancer (continued) 159 Table 3.56: Overview of AKT1-Targeted Agents in Cancer (continued) 160 Table 3.57: Overview of CDC2-Targeted Agents in Cancer 162 Table 3.58: Overview of CDK2-Targeted Agents in Cancer 163 Table 3.59: Overview of CDK2-Targeted Agents in Cancer (continued) 164 Table 3.60: Overview of AURKA-Targeted Agents in Cancer 166 Table 3.61: Overview of AURKA -Targeted Agents in Cancer (continued) 167 Table 3.62: Overview of AURKB -Targeted Agents in Cancer 168 Table 3.63: Overview of PLK1 -Targeted Agents in Cancer 170 Table 3.64: Overview of FRAP1 -Targeted Agents in Cancer 173 Table 3.65: Overview of FRAP1 -Targeted Agents in Cancer (Continued 1) 174 Table 3.66: Overview of FRAP1 -Targeted Agents in Cancer (Continued 2) 175 Table 3.67: Overview of PIK3CA -Targeted Agents in Cancer 179 Table 3.68: Overview of PIK3CA -Targeted Agents in Cancer (Continued) 180 Table 4.69: Kinase-Targeted Agents With Anti-Arthritic Applications 188 Table 4.70: Kinase-Targeted Agents With Anti-Arthritic Applications (continued 1) 189 Table 4.71: Kinase-Targeted Agents With Anti-Arthritic Applications (continued 2) 190 Table 4.72: Kinase-Targeted Agents With Anti-Arthritic Applications (continued 3) 191 Table 4.73: Kinase-Targeted Agents With Anti-Arthritic Applications (continued 4) 192 Table 4.74: Kinase-Targeted Agents With Anti-Arthritic Applications (continued 5) 193 Table 4.75: Kinase-Targeted Agents With Diabetes Applications 198 Table 4.76: Kinase-Targeted Agents With Diabetes Applications (continued 1) 199 Table 4.77: Kinase-Targeted Agents With Diabetes Applications (continued 2) 200 Table 4.78: Kinase-Targeted Agents With Inflammatory Applications 202 Table 4.79: Kinase-Targeted Agents With Inflammatory Applications (Continued 1) 203 Table 4.80: Kinase-Targeted Agents With Inflammatory Applications (Continued 2) 204 Table 4.81: Kinase-Targeted Agents With Immunosuppresive Applications 206 Table 4.82: Kinase-Targeted Agents With Immunosuppresive Applications (continued) 207 Table 4.83: Kinase-Targeted Agents With Ophthalmological Applications 209 Table 4.84: Kinase-Targeted Agents With Ophthalmological Applications (continued) 210 Table 4.85: Kinase-Targeted Agents With Psoriasis Applications (continued) 212 Table 4.86: Kinase-Targeted Agents With Psoriasis Applications (continued) 213 Table 4.87: Kinase-Targeted Agents With PulmonaryApplications (Launched) 215 Table 4.88: Kinase-Targeted Agents With PulmonaryApplications (Phase I-III) 216 Table 4.89: Kinase-Targeted Agents With PulmonaryApplications (Preclinical) 217 Table 4.90: Kinase-targeted agents with cardiovascular applications 220 Table 4.91: Kinase-targeted agents with cardiovascular applications (continued) 221 Table 4.92: Kinase-targeted agents with myelodysplastic disorder applications 223 Table 4.93: Kinase-targeted agents with myelodysplastic disorder applications (continued) 224 Table 4.94: Kinase-targeted agents with myelodysplastic disorder applications (continued 2) 225 Table 4.95: Kinase-targeted agents with myelodysplastic disorder applications (continued 3) 226 Table 4.96: Kinase-targeted agents with GI disorder applications 228 Table 4.97: Kinase-targeted agents with GI disorder applications 230 Table 5.98: Overview of Abbott's kinase pipeline by status 240 Table 5.99: Overview of Ambit Biosciences' Kinase Pipeline by Status 243 Table 5.100: Overview of Amgen's kinase pipeline by status 245 Table 5.101: Overview of Array BioPharma's kinase pipeline by status 247 Table 5.102: Overview of AstraZeneca’s kinase pipeline by status 250 Table 5.103: Overview of Avila Therapeutics' kinase pipeline by status 252 Table 5.104: Overview of Boehringer Ingelheim's kinase pipeline by status 255 Table 5.105: Overview of Bristol-Myers Squibb's (BMS) kinase pipeline by status 258 Table 5.106: Overview of Cephalon's kinase pipeline by status 260 Table 5.107: Overview of Deciphera Pharmaceuticals' kinase pipeline by status 262 Table 5.108: Overview of Eli Lilly’s kinase pipeline by status 266 Table 5.109: Overview of Eli Lilly’s kinase pipeline by status (continued) 267 Table 5.110: Overview of Exelixis’ kinase pipeline by status 270 Table 5.111: Overview of Exelixis’ kinase pipeline by status 273 Table 5.112: Overview of Hoffmann-La Roche's kinase pipeline by status 276 Table 5.113: Overview of Johnson & Johnson's kinase pipeline by status 279 Table 5.114: Overview of Kyowa Hakko Kirin's kinase pipeline by status 281 Table 5.115: Overview of Novartis’ kinase pipeline by status 284 Table 5.116: Overview of Novartis’ kinase pipeline by status (continued) 285 Table 5.117: Overview of Pfizer’s kinase pipeline by status 288 Table 5.118: Overview of Sanofi-Aventis' kinase pipeline by status 290 Table 5.119: Overview of Wyeth’s kinase pipeline by status 293 Table 6.120: World Prevalence Of Diseases 297 Table 6.121: World Pharma Market by Indication (US$m), 2008-2013 300 Table 6.122: World Pharma Market by Region (US$m), 2008-2013 301 Table 6.123: Kinase Drug Analysis (in 2007-2008) and Forecasts, 2009-2013 ($USm) 302 Table 6.124: Kinase Inhibitors by Geography ($USm), 2008 and 2013 303 Table 6.125: Manufacturer Analysis (2008) and Forecasts (US$m), 2009-2013 322 Table 6.126: Major Kinase Patent Indications 324 Table 6.127: Leading Kinase Patent Assignees 325 List of Figures Figure 1.1: Leading kinase-targeted drug applications 53 Figure 1.2: Kinase target landscape 54 Figure 6.3: Kinase originator market shares 323 [Tabellenverzeichnis ausblenden] |
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