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Pipeline Insight: Non-insulin Antidiabetics - Rise of the weight-reducers: Once-weekly GLP-1 agonists and novel SGLT-2 inhibitors bring added benefits to diabetes therapy.
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Introduction
Datamonitor forecasts the non-insulins antidiabetics market to grow to $18.8 billion in 2019 for the seven major markets, with pipeline products contributing 39% of sales. GLP-1 agonists.....
Introduction Datamonitor forecasts the non-insulins antidiabetics market to grow to $18.8 billion in 2019 for the seven major markets, with pipeline products contributing 39% of sales. GLP-1 agonists are driving pipeline growth, and the first launch of the novel SGLT-2 inhibitor class is also forecast. Scope *Comprehensive analysis of the current non-insulin antidiabetic pipeline detailing the broad range of developmental classes. *A detailed clinical and commercial assessment of all key emerging therapies. *Sales based sales forecasts for key late-stage developmental non-insulin antidiabetics agents in the seven major markets to 2019. *Analysis of unmet needs in non-insulin diabetes therapies and key development R&D strategies in light of regulatory changes. Highlights A huge number of molecules are in development as non-insulin antidiabetics to meet the increase in patient population and disease unmet needs. 179 candidates are in clinical trials, and 16 Big Pharma companies are engaged in diabetes drug development. GLP-1 agonists are likely to be the most successful pipeline candidates, and the class pipeline is forecast to generate sales of $3.7 billion in the seven major markets in 2019. Once-weekly Bydureon is forecast to be the class leader, despite FDA requirements for a new trial. DPP-4 inhibitors will continue to grow driven by new combinations of marketed molecules. The launch of SGLT-2 inhibitors will provide another option in a crowded treatment algorithm for type 2 diabetes. Reasons to Purchase *Quantify the sales of pipeline drugs in the non-insulin antidiabetic market. *Identify licensing opportunities based on company portfolio and market needs. *Assess the remaining market opportunities and barriers to uptake for novel antidiabetic therapies. [Studien Infos ausblenden] |
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Overview 1 Catalyst 1 Summary 1 About Datamonitor Healthcare 2 About the Cardiovascular and diabetes pharmaceutical analysis team 2 Executive Summary 3 Strategic scoping and focus 3 Datamonitor insight into the disease market 3 Related reports 4 Upcoming related reports 5 Table of Contents 6 Table of Figures 6 Table of tables 7 1. Pipeline Overview and Dynamics 8 Key findings 8 Pipeline overview 9 Increase in development candidates as western world focuses on diabetes 17 Non-insulin antidiabetics: a diverse pipeline 19 Incretin mimetic classes dominate pipeline 25 Forecast pipeline 2010-19 26 Comparative forecast 29 Market dominated by Big Pharma and single candidate companies 33 Key companies involved in the non-insulins pipeline 37 AstraZeneca 37 Roche 38 Eli Lilly 38 GlaxoSmithKline 39 Takeda 40 2. Epidemiology of Diabetes 41 Key findings 41 Introduction 42 Disease definition, classification and diagnosis criteria 42 Strengths and weaknesses of Datamonitor's epidemiologic projections 44 Risk factors of type 1 diabetes 45 Genetics 45 Environment 45 Ethnicity 45 Gender 45 Age 46 Global variation and temporal trends of incidence and prevalence of diabetes mellitus 46 Global variation of incidence and prevalence of type 1 diabetes 46 Global variation of type 2 diabetes prevalence 46 Temporal trends of type 1 diabetes mellitus 46 Temporal trends of type 2 diabetes mellitus 47 Prevalence 47 Incidence 47 Epidemiologic forecasting of type 1 diabetes mellitus 47 Sources of epidemiologic data 48 Description of methods 49 US 49 Japan 49 France 50 Germany 50 Italy 50 Spain 51 UK 51 Results for type 1 diabetes 52 Incidence 52 Prevalence 53 Risk factors of type 2 diabetes 54 Age 54 Genetic history 54 Race 55 Gender 55 Diet and exercise 55 Co-morbidities of type 2 diabetes 55 Overweight and obesity 55 Smoking 55 Hypertension and high cholesterol 56 Epidemiologic forecasting of type 2 diabetes mellitus 56 Sources of epidemiologic data 56 Description of methods 57 US 58 Japan 58 France 58 Germany 59 Italy 59 Spain 59 UK 60 Diagnosis rates 60 Results for type 2 diabetes prevalence 60 Current diagnosed prevalent cases and future trends 61 Diagnosis rates of type 2 diabetes in 2010 64 Prevalence of impaired glucose tolerance 65 Discussion 66 Conclusions 67 3. Disease Overview - Market Potential 68 Key findings 68 Definition 69 Current treatment options 69 Type 1 diabetes 69 Type 2 diabetes 71 Current gold standard and comparator therapies 72 Metformin - first-line treatment 75 Januvia - the gold-standard second-line oral antidiabetic 75 Byetta - injectable non-insulin therapy 76 Current market overview 77 Unmet needs in non-insulin antidiabetic therapies 82 Unmet market needs 82 Unmet market need 1: routine screening for the detection of type 2 diabetes mellitus 83 Unmet market need 2: greater patient awareness and education 86 Unmet market need 3: better treatment guidelines and physician education 87 Unmet clinical needs 90 Unmet clinical need 1: improved efficacy-safety balance for non-insulin antidiabetics 91 Unmet clinical need 2: improving cardiovascular mortality 92 Unmet clinical need 3: durability of therapy 93 Unmet clinical need 4: stability of glucose control and avoiding hypoglycemia 94 Unmet clinical need 5: better tolerability of non-insulin antidiabetics 95 Target product profile versus current level of attainment 96 4. R&D Approach 98 Key findings 98 Clinical trial design in non-insulin antidiabetics 99 Efficacy 99 Control of average blood glucose levels 99 Insulin 99 Blood markers 100 Weight loss 100 Safety and side effects 100 Weight gain 100 Cardiovascular endpoints 101 The Bydureon tQT requirement: what does it mean? 103 Comparators: add-on versus replacement therapy 104 Future trends 104 Safety 104 Positive macrovascular effects 105 Combinations 105 5. Pipeline Analysis & Forecasts: GLP-1 Agonists 107 Key findings 107 Overview for GLP-1 agonists 108 Biological effects of GLP-1 108 Marketed GLP-1 agonists 112 Byetta (exenatide, Amylin/Eli Lilly) 112 Victoza (liraglutide, Novo Nordisk) 114 Class attributes and concerns 116 General long-term safety concerns 116 Pancreatitis 116 Thyroid cancer and C-cell hyperplasia 117 Gastrointestinal side effects 117 Antibody formation and immunogenic reactions 117 Pipeline summary and comparative forecasts 118 Pipeline summary 118 Pipeline prospects 119 Comparative forecasts 121 Bydureon (exenatide long-acting release, Amylin/Eli Lilly) 126 Drug profile 128 Clinical trial data 128 Trial results 128 Ongoing trials for Bydureon 131 SWOT analysis 134 Datamonitor drug assessment summary for Bydureon 136 Clinical and commercial attractiveness 137 Commercial attractiveness 137 Clinical attractiveness 137 Bydureon's delivery mode attractiveness: needle size and premixing 138 Satisfaction of unmet needs 139 Forecasts to 2019 140 Lixisenatide (AVE-0010, Sanofi-Aventis/Zealand Pharma) 143 Drug profile 144 Clinical trial data 144 SWOT analysis 149 Datamonitor drug assessment summary for lixisenatide 150 Clinical and commercial attractiveness 151 Commercial attractiveness 151 Clinical attractiveness 152 Satisfaction of unmet needs 152 Forecasts to 2019 153 Syncria (albiglutide/GlaxoSmithKline) 156 Drug profile 157 Clinical trial data 157 SWOT analysis 160 Datamonitor drug assessment summary for Syncria 161 Clinical and commercial attractiveness 161 Satisfaction of unmet needs 162 Forecasts to 2019 163 LY2189265 (Eli Lilly) 166 Drug profile 167 Clinical trial data 167 SWOT analysis 171 Datamonitor drug assessment summary for LY2189265 172 Clinical and commercial attractiveness 172 Satisfaction of unmet needs 173 Forecasts to 2019 174 Taspoglutide (Roche/Ipsen/Teijin/Chugai) 177 Drug profile 179 Clinical trial data 179 Trial results 179 Ongoing trials 181 SWOT analysis 183 Datamonitor drug assessment summary for taspoglutide 184 Clinical and commercial attractiveness 185 Satisfaction of unmet needs 186 Forecasts to 2019 187 Other GLP-1 agonist drugs 190 Exenatide formulations 190 ITCA 650 (Intarcia Therapeutics) 190 Exenatide once-monthly (Amylin/Eli Lilly) 191 Exenatide transdermal (Amylin/Eli Lilly/Altea) 191 Exenatide intranasal (Amylin/Marina Biotech) 191 PT-302 (Peptron/NeoPharma) 191 ORMD 0901 (Oramed) 191 Other GLP-1 agonists 191 CJC-1134-PC (ConjuChem) 191 NN-9535 (semaglutide; Novo Nordisk), NN-9924, NN-9925 191 CMC3.1-AC100 (CellMed/AstraZeneca) 192 MKC253 (Mannkind) 192 TTP-054 (TransTech) 192 Uni-rE-4 (Uni-Bio Sciences) 192 MAR701 (Marcadia Biotech) 192 CVX-096 (Pfizer) 192 HM11260C (Hanmi) 192 6. Pipeline Analysis & Forecasts: DPP-4 inhibitors 193 Key findings 193 Overview for dipeptidyl peptidase-IV (DPP-4) inhibitors 194 Biological effects of DPP-4 inhibitors 194 Currently marketed DPP-4 inhibitors 195 Januvia franchise 195 Januvia franchise pipeline 197 Onglyza franchise 199 Onglyza franchise pipeline 201 Galvus franchise 202 Pipeline summary and comparative forecasts 203 Pipeline summary 203 Comparative forecasts 204 Nesina (alogliptin; Takeda) 209 Drug overview 209 Drug profile 210 Clinical trial data 210 SWOT analysis 211 Datamonitor drug assessment summary for Nesina 212 Clinical and commercial attractiveness 213 Commercial attractiveness 213 Clinical potential 214 Satisfaction of unmet needs 214 Forecasts to 2019 216 Linagliptin (Boehringer Ingelheim) 219 Drug overview 219 Drug profile 220 Clinical trial data 220 Trial results 221 Ongoing trials 221 SWOT analysis 226 Datamonitor drug assessment summary for linagliptin 227 Clinical and commercial attractiveness 228 Commercial considerations 228 Patient potential 228 Satisfaction of unmet needs 229 Forecasts to 2019 231 Other DPP-4 inhibitors 234 PHX1149T (dutogliptin; Phenomix) 234 MP-513 (teneligliptin/Mitsubishi Tanabe Pharma) 235 LC15-0444 (LG Life Sciences Korea) 235 SK-0403 (Kowa/Sanwa Kagaku Kenkyusho) 235 Early Phase DPP-4 inhibitors 235 TAK-472 (Takeda) 235 AMG-222 (Amgen/Servier) 236 KRP-104 (Kyorin) 236 ARI-2243 (Arisaph) 236 DSP-7238 (Dainippon Sumitomo) 236 DA-1229 (Dong-A) 236 GRC-8200 (Glenmark) 236 7. Pipeline Analysis & Forecasts: SGLT-2 Inhibitors 237 Key findings 237 Overview for SGLT-2 Inhibitors 238 Biological effects of SGLT-2 inhibitors 238 Clinical use and place in the treatment algorithm 238 Clinical and commercial significance of genital and urinary tract infections 240 General safety concerns 241 Pipeline summary and comparative forecasts 242 Pipeline summary 242 Comparative forecasts 243 Dapagliflozin (dapagliflozin/Bristol-Myers Squibb and AstraZeneca) 248 Drug overview 248 Drug profile 249 Clinical trial data 250 Trial results 251 Ongoing clinical trials 254 SWOT analysis 256 Datamonitor drug assessment summary for dapagliflozin 257 Clinical and commercial attractiveness 258 Patient potential 259 Satisfaction of unmet needs 259 Forecasts to 2019 260 Canagliflozin (Mitsubishi Tanabe Pharma and Johnson & Johnson) 264 Drug overview 264 Drug profile 265 Clinical trial data 265 Trial results 265 Ongoing clinical trials 266 SWOT analysis 269 Datamonitor drug assessment summary for canagliflozin 270 Clinical and commercial attractiveness 270 Satisfaction of unmet needs 271 Forecasts to 2019 272 ASP1941 (Astellas Pharma/Kotobuki Pharmaceutical Co. Ltd) 275 Drug overview 275 Drug profile 276 Clinical trial data 276 Trial results 276 Ongoing clinical trials 278 SWOT analysis 280 Datamonitor drug assessment summary for ASP1941 281 Clinical and commercial attractiveness 281 Satisfaction of unmet needs 282 Forecasts to 2019 283 BI 10773 (Boehringer Ingelheim) 286 Drug overview 286 Drug profile 287 Clinical trial data 287 Trial results 287 Ongoing clinical trials 288 SWOT analysis 291 Datamonitor drug assessment summary for BI 10773 292 Clinical and commercial attractiveness 292 Satisfaction of unmet needs 293 Forecasts to 2019 294 Other SGLT-2 inhibitors in development 297 RG7201 (Roche, Chugai) 297 LX4211 (Lexicon) 297 TS-071 (Taisho) 297 ISIS-SGLT2Rx (Isis) 298 DSP-3235 (GlaxoSmithKline/Dainippon Sumitomo) 298 SGLT-2 inhibitor drugs recently discontinued 298 Remogliflozin (GlaxoSmithKline/Kissei) 298 Sergliflozin (GlaxoSmithKline/Kissei) 298 AVE-2268 298 YM543 (Astellas/Kotobuki) 299 8. Pipeline Analysis & Forecasts: Autoimmune Therapies 300 Key findings 300 Overview for autoimmune therapies 300 The need for beta-cell preservation and autoimmune treatment 301 Pipeline summary and comparative forecasts 303 Pipeline summary 303 Comparative forecasts 304 Diamyd (rhGAD65, Diamyd Therapeutics AB/Johnson & Johnson) 308 Drug profile 309 Clinical trial data 309 Trial results 309 Ongoing trials 310 SWOT analysis 313 Datamonitor drug assessment summary for Diamyd 314 Clinical and commercial attractiveness 314 Satisfaction of unmet needs 315 Forecasts to 2019 316 Otelixizumab (GlaxoSmithKline) 319 Drug profile 320 Clinical trial data 320 SWOT analysis 323 Datamonitor drug assessment summary for otelixizumab 324 Clinical and commercial attractiveness 325 Satisfaction of unmet needs 325 Forecasts to 2019 327 Other autoimmune therapies in development 329 Teplizumab (Eli Lilly/MacroGenics) 329 DiaPep277 (Andromeda Biosciences/Teva) 329 NI-0401 (NovImmune) 330 BGP-15 (N-Gene) 331 Thymoglobulin (Genzyme) 331 BHT-3021 (Bayhill/Roche) 331 IL-7 stimulated immunoregulatory dendritic cells (University of Pittsburgh) 331 IBC-VS01 (Joslin Diabetes Center) 332 9. Other Non-insulin Antidiabetics 333 Key findings 333 PPAR modulators 334 Overview of PPAR modulators 334 Marketed PPAR-gammas 335 Actos (pioglitazone, Takeda) 337 Avandia (rosiglitazone, GlaxoSmithKline) 338 Pipeline PPAR-gamma modulators 338 Balaglitazone (Dr Reddy's/Rheoscience) 338 INT-131 (InteKrin) 339 THR-0921 (Theracos/Egret) 340 Mitoglitazone (Metabolic Solutions Development) 340 Pipeline pan-PPAR agonists 340 Lobeglitazone (Chong Kun Dang) 340 Indeglitazar (Plexxikon) 340 Chiglitazar (Shenzhen Chipscreen Biosciences) 340 Pipeline dual PPAR-alpha/PPAR-delta agonists 340 GFT505 (Genfit) 340 Pipeline dual PPAR-alpha/PPAR-gamma agonists 341 AVE-0897 (Genfit/Sanofi-Aventis) 341 DSP-8658 (Dainippon Sumitomo) 341 ZYH-2 (Zydus-Cadila) 341 Pipeline dual PPAR-delta/PPAR-gamma agonist 341 DB-959 (DARA) 341 Pipeline PPAR-alpha agonists and combinations 341 CRx-401 (CombinatoRx) 341 KRP-101 (Kyorin) 341 Unknown mechanisms 341 PN-2034 (WellStat/Sanofi-Aventis) 341 VVP-808 (Verva) 342 Late-stage PPAR agonist development compounds recently discontinued in type 2 diabetes 342 Aleglitazar (R-1439/Hoffmann-La Roche) 342 MBX-102 (Metabolex/Johnson and Johnson) 343 Rivoglitazone (Daiichi-Sankyo) 343 Anti-inflammatory therapies 344 IL-1 beta antagonists 344 ACZ885 (canakinumab; Novartis) 344 XOMA-052 (Xoma) 344 LY2189102 (Eli Lilly) 344 BLX-1002 (Orchid/BEXEL) 344 CYT-013-IL1bQb (Cytos Biotechnology) 345 NF-kappa B pathway inhibitors 345 Triolex (HE3286, Harbor BioSciences) 345 VGX-1027 (VGX Pharmaceuticals) 345 Other anti-inflammatory therapies 345 BMS-741672 (Bristol-Myers Squibb) 345 CCX-140 (ChemoCentryx) 346 Lisofylline (DiaKine) 346 Salsalate 346 Autonomic and central nervous system therapies 346 Cycloset (VeroScience/Santarus) 346 Cannabinoid (CB) -1 antagonist 347 Inhibitors of glycogenolysis and gluconeogenesis 347 Glucokinase activators 349 LY2599506 (Eli Lilly) 349 ARRY-403 (Array/Amgen) 349 TTP-399 (TransTech Pharma/ Forest Labs) 350 AZD1656 (AstraZeneca) 350 MK-0599 (Banyu/Merck) 350 TAK-329 (Takeda) 350 Glucagon receptor antagonists 350 AMG-477 (Amgen) 350 ISIS GCGRRx (Isis) 351 PTP-1B inhibitors 351 ISIS 113715 (Isis) 351 TTP814 (TransTech) 351 Glycogen phosphorylase inhibitor 351 GSK1362885 (GlaxoSmithKline) 351 GPR119 agonists 351 MBX-2982 (Metabolex/Sanofi-Aventis) 352 APD-597 (Ortho-McNeil, Arena) 352 PSN821 (Astellas) 352 GSK1292263 (GlaxoSmithKline) 352 11-beta-HSD inhibitors 352 INCB-13739 (Incyte) 353 JTT-654 (Japan Tobacco/Akros Pharma) 353 RG-7234 (Roche) and RG-4929 (Roche) 353 HSD-016 (Pfizer) 354 BMS-816336 (Bristol-Myers Squibb) 354 AZD4017 and AZD8329 (AstraZeneca) 354 AMG-221 (Amgen) 354 DGAT-1 inhibitors 354 LCQ-908 (Novartis) 354 PF-04620110 (Pfizer/Bristol-Myers Squibb) 354 AZD7687 (AstraZeneca) 355 Appetite regulators 355 Unacylated ghrelin (Alizé/Eli Lilly) 355 RG7089 (Roche) 355 AP1030 (Action Pharma) 355 Fatty acid digestion and metabolism 355 Bile acid sequestrants 355 Welchol (Colesevelam, Daiichi Sankyo) 355 Colestilan (Mitsubishi Tanabe) 356 Other 356 JNJ-16269110 (Johnson & Johnson) 356 JTT-130 (Japan Tobacco) 356 Islet transplantation and neogenesis 356 DiabeCell (Living Cell Technologies) 357 Human islet allografts (ViaCyte) 357 Exsulin (Kinexum Metabolics) 357 Combinations 357 Metgluna (mitiglinide+metformin, Kissei/Elixir) 357 DM-71, DM-83 (DiaMedica) 358 Qnexa (Vivus) 358 Other modes of action 358 Ramipril (King Pharmaceuticals) 358 D-tagatose (Spherix) 358 DM-99 (DiaMedica) 359 Sirtuins 359 Resveratrol (GlaxoSmithKline) 359 SRT-2104 (GlaxoSmithKline) 359 GSK184072 (GlaxoSmithKline) 359 Eprodisate (BELLUS/Celtic Therapeutic) 359 AR-9281 (Arête Therapeutics) 360 Ranolazine (Gilead Sciences) 360 Bibliography 361 References for Chapter 1. Pipeline overview 361 Articles 361 Other Sources 361 References for Chapter 2. Epidemiology of diabetes 361 Type 1 diabetes epidemiology references 361 Type 2 diabetes epidemiology references 363 References for Chapter 3. Disease overview 365 Articles 365 Other Sources 367 Datamonitor reports 367 References for Chapter 4. R&D approach 367 Articles 367 Other sources 368 References for Chapter 5. Pipeline analysis & forecasts: GLP-1 agonists 368 Articles 368 Other sources 370 References for Chapter 6. Pipeline analysis & forecasts: DPP-4 inhibitors 372 Articles 372 Other sources 373 References for Chapter 7. Pipeline analysis & forecasts: SGLT-2 inhibitors 374 Articles 374 Other Sources 376 References for Chapter 9. Pipeline analysis & forecasts: Autoimmune therapies 377 Articles 377 Other sources 377 References for Chapter 10. Other non-insulin antidiabetics 378 Articles 378 Other Sources 379 Appendix A - Market Assumptions 381 New product launches 381 Patent expiries 383 Methodology and data definitions, limitations and assumptions 384 Standard units 384 Datamonitor forecast methodology 384 Japan methodology 384 Exchange rates 384 Datamonitor drug assessment scorecard 385 Appendix B 388 Contributing experts 388 Conferences attended 388 Report methodology 388 About Datamonitor 389 About Datamonitor Healthcare 389 About the Cardiovascular and Diabetes analysis team 390 Datamonitor consulting 390 Disclaimer 392 List of Tables Table 1: Non-insulin pipeline products in clinical development for diabetes, 2010 10 Table 2: Non-insulin antidiabetic pipeline by broad mechanism of action, 2010 21 Table 3: Non-insulin antidiabetic pipeline by narrow mechanism of action, 2010 22 Table 4: Forecast non-insulin antidiabetics pipeline drugs in the seven major markets, 2010-19 27 Table 5: Sales forecast for pipeline products in non-insulin antidiabetics in the seven major markets ($m), 2010-19 30 Table 6: Big Pharma non-insulin antidiabetic pipeline, 2010 37 Table 7: 1999 World Health Organization definitions of diabetes mellitus and prediabetes 43 Table 8: Summary of sources used to forecast incidence of type 1 diabetes mellitus in those aged 0-14 years, published between 1993 and 2008 48 Table 9: Incident cases of type 1 diabetes mellitus in those aged 0-14 in the seven major markets, 2010-2020 52 Table 10: Incidence rates per 100,000 of type 1 diabetes mellitus in those aged 0-14 in the seven major markets, 2010-2020 53 Table 11: Number of prevalent cases and percent of population that has type 1 diabetes in those aged 0-79 in the seven major markets, 2010 54 Table 12: Summary of sources used in analyses of type 2 diabetes mellitus, published between 1999 and 2009 57 Table 13: Diagnosed prevalent cases (000s) of type 2 diabetes mellitus in those aged 20-79 years, in the seven major markets, 2010-2020 61 Table 14: Percent of population aged 20-79 years with type 2 diabetes mellitus in the seven major markets (%), 2010-2020 62 Table 15: Prevalent cases of type 2 diabetes in the seven major markets by age group, 2010 64 Table 16: Percentage of type 2 diabetes cases in each age group by country in the seven major markets (%), 2010 64 Table 17: Percentage of undiagnosed diabetes in those aged 20-79 in the seven major markets , 2010 (%) 65 Table 18: Prevalence of impaired glucose tolerance in those aged 20-79 years (000s) in the seven major markets, 2010-2020 65 Table 19: Prevalence rates of impaired glucose tolerance in those aged 20-79 years in the seven major markets (%), 2010-2020 66 Table 20: EASD/ADA Summary of glucose-lowering interventions, 2009 72 Table 21: Comparator non-insulin treatments for type 2 diabetes, 2009 74 Table 22: Metformin - drug profile, 2010 75 Table 23: Januvia - drug profile, 2010 76 Table 24: Byetta - drug profile, 2010 77 Table 25: Leading non-insulin antidiabetic brands in the seven major markets, 2009 80 Table 26: Ability of current class comparators to meet unmet needs in diabetes, 2010 97 Table 27: Byetta - drug profile, 2010 113 Table 28: Victoza franchise (Novo Nordisk) - drug profile, 2010 114 Table 29: Key products in late-stage R&D glucagon-like peptide-1 (GLP-1) agonists pipeline for diabetes, 2010 121 Table 30: Forecast assumptions for glucagon-like peptide-1 (GLP-1) agonist class pipeline antidiabetics across the seven major markets, 2009 123 Table 31: Sales forecasts for pipeline glucagon-like peptide-1 (GLP-1) agonists in the seven major markets ($m), 2009-2019 124 Table 32: Bydureon franchise (Amylin/Eli Lilly) - drug profile, 2010 128 Table 33: Bydureon (exenatide long-acting, Amylin/Eli Lilly): DURATION trials results summary, 2010 129 Table 34: DURATION-2 clinical trial data for Bydureon (exenatide long-acting, Amylin/Eli Lilly) with comparator prescription data 130 Table 35: DURATION-4 Bydureon (exenatide long-acting, Amylin/Eli Lilly) trial top line results 130 Table 36: Bydureon (exenatide long-acting, Amylin/Eli Lilly): ongoing Phase III trials in type 2 diabetes, 2010 132 Table 37: Ability of Bydureon (exenatide long-acting, Amylin/Eli Lilly) vs GLP-1 agonist class comparator Byetta (exenatide, Amylin/Eli Lilly) to address unmet needs in type 2 diabetes 140 Table 38: Sales forecasts ($m) for Bydureon (exenatide long-acting, Amylin/Eli Lilly) in the seven major markets, 2010-19 141 Table 39: Factors affecting revenues of Bydureon (exenatide long-acting, Amylin/Eli Lilly), 2010-19 143 Table 40: Lixisenatide franchise (Sanofi-Aventis/ Zealand Pharma) - drug profile, 2010 144 Table 41: Lixisenatide (Sanofi-Aventis/Zealand Pharma): ongoing Phase III trials in type 2 diabetes, 2010 146 Table 42: Ability of lixisenatide (Sanofi-Aventis/Zealand Pharma) vs GLP-1 agonist class comparator Byetta (exenatide, Amylin/Eli Lilly) to address unmet needs in type 2 diabetes 153 Table 43: Sales forecasts ($m) for lixisenatide (Sanofi-Aventis/Zealand Pharma) in the seven major markets, 2010-19 154 Table 44: Factors affecting revenues of lixisenatide (Sanofi-Aventis/Zealand Pharma), 2010-19 156 Table 45: Syncria (albiglutide, GlaxoSmithKline) - drug profile, 2010 157 Table 46: Ongoing Phase III trials of Syncria (albiglutide, GlaxoSmithKline), 2010 159 Table 47: Ability of Syncria (albiglutide, GlaxoSmithKline) vs GLP-1 agonist class comparator Byetta (exenatide, Amylin/Eli Lilly) to address unmet needs in type 2 diabetes 163 Table 48: Sales forecasts ($m) for Syncria (albiglutide, GlaxoSmithKline) in the seven major markets, 2010-19 164 Table 49: Factors affecting revenues of Syncria (albiglutide, GlaxoSmithKline), 2010-19 166 Table 50: LY2189265 (Eli Lilly) - drug profile, 2010 167 Table 51: LY2189265 (Eli Lilly): ongoing Phase III trials, 2010 169 Table 52: Ability of LY2189265 (Eli Lilly) vs GLP-1 agonist class comparator Byetta (exenatide, Amylin/Eli Lilly) to address unmet needs in type 2 diabetes 174 Table 53: Sales forecasts ($m) for LY2189265 (Eli Lilly) in the seven major markets, 2010-19 175 Table 54: Factors affecting revenues of LY2189265 (Eli Lilly), 2010-19 177 Table 55: Taspoglutide (Roche/Ipsen) - drug profile, 2010 179 Table 56: Taspoglutide (Roche/Ipsen/Teijin/Chugai): ongoing* Phase III trials in type 2 diabetes, 2010 181 Table 57: Ability of Taspoglutide (Roche/Ipsen/Teijin/Chugai) vs GLP-1 agonist class comparator Byetta (exenatide, Amylin/Eli Lilly) to address unmet needs in type 2 diabetes 187 Table 58: Sales forecasts ($m) for taspoglutide (Roche/Ipsen/Teijin/Chugai) in the seven major markets, 2010-19 188 Table 59: Factors affecting revenues of taspoglutide (Roche/Ipsen/Teijin/Chugai), 2010-19 190 Table 60: Januvia - drug profile, 2010 195 Table 61: Janumet - drug profile, 2010 196 Table 62: Sales forecasts ($m) for Januvia + pioglitazone (Merck & Co) in the seven major markets, 2010-19 198 Table 63: Sales forecasts ($m) for Januvia + simvastatin (Merck & Co) in the seven major markets, 2010-19 198 Table 64: Onglyza - drug profile, 2010 200 Table 65: Sales forecasts ($m) for Onglyza + metformin XR (Bristol-Myers Squibb/AstraZeneca) in the seven major markets, 2010-19 201 Table 66: Key products in late-stage R&D dipeptidyl peptidase-IV (DPP-4) pipeline for diabetes, 2010 204 Table 67: Forecast assumptions for dipeptidyl peptidase-IV (DPP-4)inhibitor class pipeline antidiabetics across the seven major markets, 2010 206 Table 68: Sales forecasts for pipeline dipeptidyl peptidase-IV (DPP-4) inhibitors in the seven major markets ($m), 2010-19 207 Table 69: Nesina (alogliptin, Takeda) - drug profile, 2010 210 Table 70: Ability of Nesina vs DPP-4 inhibitor class comparator Januvia (sitagliptin, Merck & Co) to address unmet needs in type 2 diabetes 215 Table 71: Sales forecasts ($m) for Nesina franchise (Takeda) by region in the seven major markets, 2010-19 216 Table 72: Factors affecting revenues of Nesina franchise (Takeda), 2010-19 219 Table 73: Linagliptin (Boehringer Ingelheim) - drug profile, 2010 220 Table 74: Linagliptin (Boehringer Ingelheim): summary of Phase III efficacy trial results, 2010 221 Table 75: Linagliptin (Boehringer Ingelheim): ongoing Phase III trials in type 2 diabetes, 2010 223 Table 76: Ability of linagliptin vs DPP-4 inhibitor class comparator Januvia (sitagliptin, Merck & Co) to address unmet needs in type 2 diabetes 231 Table 77: Sales forecasts ($m) for linagliptin (Boehringer Ingelheim) by region in the seven major markets, 2010-19 232 Table 78: Factors affecting revenues of linagliptin (Boehringer Ingelheim), 2010-19 234 Table 79: Key products in late-stage sodium-dependent glucose co-transporter 2 (SGLT-2) R&D pipeline for diabetes, 2010 243 Table 80: Forecast assumptions for sodium-dependent glucose co-transporter 2 (SGLT-2) inhibitor class pipeline antidiabetics across the seven major markets, 2010 245 Table 81: Sales forecasts for pipeline sodium-dependent glucose co-transporter 2 (SGLT-2) inhibitors in the seven major markets ($m), 2010-19 246 Table 82: Dapagliflozin (Bristol-Myers Squibb/AstraZeneca) - drug profile, 2010 249 Table 83: Dapagliflozin+metformin (Bristol-Myers Squibb/AstraZeneca) - drug profile, 2010 250 Table 84: Dapagliflozin (Bristol-Myers Squibb/AstraZeneca): Phase III efficacy trial results, 2010 252 Table 85: Dapagliflozin (Bristol-Myers Squibb/AstraZeneca): ongoing Phase III trials, 2010 254 Table 86: Ability of dapagliflozin (Bristol-Myers Squibb/AstraZeneca) vs oral antidiabetic gold standard Januvia (sitagliptin, Merck & Co) to address unmet needs in type 2 diabetes 260 Table 87: Sales forecasts ($m) for dapagliflozin franchise (Bristol-Myers Squibb/AstraZeneca) by region in the seven major markets, 2010-19 261 Table 88: Factors affecting revenues of dapagliflozin franchise (Bristol-Myers Squibb/AstraZeneca), 2010-19 264 Table 89: Canagliflozin (Johnson & Johnson /Mitsubishi Tanabe) - drug profile, 2010 265 Table 90: Canagliflozin (Johnson & Johnson /Mitsubishi Tanabe): ongoing Phase III clinical trials, 2010 267 Table 91: Ability of canagliflozin (Johnson & Johnson /Mitsubishi Tanabe) vs oral antidiabetic gold standard Januvia (sitagliptin, Merck & Co) to address unmet needs in type 2 diabetes 272 Table 92: Sales forecasts ($m) for canagliflozin (Johnson & Johnson /Mitsubishi Tanabe) by region in the seven major markets, 2010-19 273 Table 93: Factors affecting revenues of canagliflozin franchise (Johnson & Johnson /Mitsubishi Tanabe), 2010-19 275 Table 94: ASP1941 (Astellas Pharma/Kotobuki Pharmaceutical) - drug profile, 2010 276 Table 95: ASP1941 (Astellas Pharma/Kotobuki Pharmaceutical) - ongoing Phase III trials, 2010 278 Table 96: Ability of ASP1941 (Astellas Pharma/Kotobuki Pharmaceutical) vs oral antidiabetic gold standard Januvia (sitagliptin, Merck & Co) to address unmet needs in type 2 diabetes 283 Table 97: Sales forecasts ($m) for ASP1941 (Astellas Pharma/Kotobuki Pharmaceutical) by region in the seven major markets, 2010-19 284 Table 98: Factors affecting revenues of ASP1941 (Astellas Pharma/Kotobuki Pharmaceutical), 2010-19 286 Table 99: BI 10773 (Boehringer Ingelheim) - drug profile, 2010 287 Table 100: BI 10773 (Boehringer Ingelheim) - ongoing Phase III trials, 2010 289 Table 101: Ability of BI 10773 (Boehringer Ingelheim), vs oral antidiabetic gold standard Januvia (sitagliptin, Merck & Co) to address unmet needs in type 2 diabetes 294 Table 102: Sales forecasts ($m) for BI 10773 (Boehringer Ingelheim) by region in the seven major markets, 2010-19 295 Table 103: Factors affecting revenues of BI 10773 (Boehringer Ingelheim), 2010-19 297 Table 104: Key products in late-stage R&D autoimmune therapies pipeline for diabetes, 2010 304 Table 105: Forecast assumptions for autoimmune therapy class pipeline antidiabetics across the seven major markets, 2010 306 Table 106: Sales forecasts for pipeline autoimmune therapies in the seven major markets ($m), 2010-19 307 Table 107: Diamyd (Diamyd/Johnson & Johnson) - drug profile, 2010 309 Table 108: Diamyd (rhGAD65, Diamyd/Johnson&Johnson): ongoing Phase III clinical trials, 2010 311 Table 109: Ability of Diamyd (rhGAD65, Diamyd/Johnson&Johnson) vs insulins to address unmet needs in type 1 diabetes 316 Table 110: Sales forecasts ($m) for Diamyd (rhGAD65, Diamyd/Johnson & Johnson) by region in the seven major markets, 2010-19 317 Table 111: Factors affecting revenues of Diamyd (rhGAD65, Diamyd/Johnson&Johnson), 2010-19 318 Table 112: Otelixizumab (GlaxoSmithKline/Tolerx) - drug profile, 2010 320 Table 113: Otelixizumab (Tolerx/GlaxoSmithKline): ongoing Phase III trials, 2010 321 Table 114: Ability of otelixizumab (Tolerx/GlaxoSmithKline) vs insulins to address unmet needs in type 1 diabetes 326 Table 115: Sales forecasts ($m) for otelixizumab (Tolerx/GlaxoSmithKline) by region in the seven major markets, 2010-19 327 Table 116: Factors affecting revenues of otelixizumab (Tolerx/GlaxoSmithKline), 2010-19 328 Table 117: Actos - drug profile, 2010 337 Table 118: Actos + Blopress (pioglitazone + candesartan) sales ($m) in the seven major markets, 2010-19 338 Table 119: Datamonitor's estimated launch dates for diabetes products in the seven major markets, 2010-19 381 Table 120: Patent expiry or loss of market exclusivity dates for approved diabetes drugs in the seven major markets, 2010-19 383 Table 121: Datamonitor drug assessment parameters 386 List of Figures Figure 75: Methodology for forecasting price to remove impact of currency fluctuations on future trends 385 [Inhaltsverzeichnis ausblenden] |
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| Hinweis: | * Der Rechnungsbetrag für diese Studie wird in $ (Dollar) ausgewiesen. Kunden aus dem Inland bekommen von uns eine Rechnung in Euro, umgerechnet zum letztwöchigen Schlusskurs | |||||||||||
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