Published : Jul-2017
No. of Pages : 377
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 10
2 Type 2 Diabetes (T2D): Executive Summary 11
2.1 T2D Sales to Double Across 7MM 12
2.2 Multiple Opportunities Exist to Address Existing T2D Market Unmet Needs 14
2.3 The Arrival of Insulin Biosimilars and Abundance of "Me-Too" Drugs Illustrates Corporate Shift in Focus from Therapeutic Value Towards Competitive Pricing and Non-novel Agents that Confer Incremental Benefits 18
2.4 Glucagon-Like Peptide -1 Receptor Agonist Class Faces Intense Internal Competition, Largely Revolving Around Drugs' Ability to Improve Patient Compliance/Ease of Administration and Cardiovascular Effects 19
2.5 Newest T2D Drug Class, Sodium-Glucose Cotransporter Inhibitors, Will Continue To Gain Significant Market Share Despite Concerns 19
2.6 What Do Physicians Think? 20
3 Introduction 23
3.1 Catalyst 23
3.2 Related Reports 24
4 Disease Overview 25
4.1 Etiology 25
4.2 Pathophysiology 27
4.3 Symptoms 29
4.4 Prognosis 31
4.5 Quality of Life 31
5 Epidemiology 31
5.1 Disease Background 32
5.2 Risk Factors and Comorbidities 32
5.3 Global and Historical Trends 34
5.4 Forecast Methodology 35
5.4.1 Sources Used 36
5.4.2 Forecast Assumptions and Methods 39
5.5 Epidemiological Forecast for T2D in the 8MM (2016-2026) 48
5.5.1 Diagnosed Prevalent Cases of T2D 48
5.5.2 Age-Specific Diagnosed Prevalent Cases of T2D 49
5.5.3 Sex-Specific Diagnosed Prevalent Cases of T2D 49
5.5.4 Comorbidities Among the Diagnosed Prevalent Cases of T2D 50
5.6 Discussion 54
5.6.1 Epidemiological Forecast Insight 54
5.6.2 Limitations of Analysis 55
5.6.3 Strengths of Analysis 55
6 Disease Management 57
6.1 Diagnosis and Treatment Overview 57
6.1.1 Diagnosis and Referrals 57
6.1.2 Treatment Guidelines and Leading Prescribed Drugs 58
6.1.3 Clinical Practice 63
6.2 US 64
6.3 France 66
6.4 Germany 68
6.5 Italy 71
6.6 Spain 75
6.7 UK 78
6.8 Japan 82
7 Competitive Assessment 86
7.1 Overview 86
7.2 Strategic Competitor Assessment 86
7.3 Product Profiles - Major Brands 89
7.3.1 Metformin 89
7.3.2 Sulfonylureas and Other Insulin Secretagogues 93
7.3.3 a-glucosidase Inhibitors 97
7.3.4 Thiazolidinediones 100
7.3.5 Glucagon-Like Peptide-1 Receptor Agonists 104
7.3.6 Dipeptidyl-Peptidase 4 Inhibitors 131
7.3.7 Sodium-Glucose Cotransporter 2 Inhibitors 165
7.3.8 Insulin Formulations 184
8 Unmet Needs and Opportunities 221
8.1 Overview 221
8.2 Disease-Modifying Treatments Providing Sustained Glycemic Control 222
8.2.1 Unmet Need 222
8.2.2 Gap Analysis 223
8.2.3 Opportunity 224
8.3 Drugs with Non-Glycemic Benefits 224
8.3.1 Unmet Need 224
8.3.2 Gap Analysis 224
8.3.3 Opportunity 225
8.4 Drugs with Improved Side-Effect Profiles 225
8.4.1 Unmet Need 225
8.4.2 Gap Analysis 226
8.4.3 Opportunity 226
8.5 Increased Patient Compliance 226
8.5.1 Unmet Need 226
8.5.2 Gap Analysis 227
8.5.3 Opportunity 228
9 Pipeline Assessment 229
9.1 Overview 229
9.2 Clinical Trial Mapping 230
9.2.1 Clinical Trials by Country 230
9.2.2 Clinical Trials by Phase and Trial Status 231
9.3 Promising Drugs in Clinical Development 232
9.3.1 Semaglutide 235
9.3.2 OG217SC/Semaglutide (oral) 239
9.3.3 ITCA 650 241
9.3.4 Ertugliflozin 245
9.3.5 Sotagliflozin 249
9.3.6 Bexagliflozin 252
10 Current and Future Players 256
10.1 Overview 256
10.2 Trends in Corporate Strategy 260
10.3 Company Profiles 262
10.3.1 Eli Lilly 262
10.3.2 Novo Nordisk 265
10.3.3 Sanofi 268
10.3.4 AstraZeneca 271
10.3.5 Merck & Co. 273
10.3.6 Boehringer Ingelheim 274
10.3.7 GlaxoSmithKline 276
10.3.8 Takeda 278
10.3.9 Roche 279
10.3.10 Pfizer 280
10.3.11 Johnson & Johnson 282
10.3.12 Novartis 283
10.3.13 Intarcia Therapeutics 284
10.3.14 Theracos 285
11 Market Outlook 287
11.1 Global Markets 287
11.1.1 Forecast 287
11.1.2 Drivers and Barriers - Global Issues 290
11.2 US 291
11.2.1 Forecast 291
11.2.2 Key Events 293
11.2.3 Drivers and Barriers 294
11.3 France 295
11.3.1 Forecast 295
11.3.2 Key Events 297
11.3.3 Drivers and Barriers 297
11.4 Germany 299
11.4.1 Forecast 299
11.4.2 Key Events 301
11.4.3 Drivers and Barriers 301
11.5 Italy 303
11.5.1 Forecast 303
11.5.2 Key Events 305
11.5.3 Drivers and Barriers 305
11.6 Spain 307
11.6.1 Forecast 307
11.6.2 Key Events 309
11.6.3 Drivers and Barriers 309
11.7 UK 311
11.7.1 Forecast 311
11.7.2 Key Events 313
11.7.3 Drivers and Barriers 313
11.8 Japan 315
11.8.1 Forecast 315
11.8.2 Key Events 317
11.8.3 Drivers and Barriers 318
12 Appendix 320
12.1 Bibliography 320
12.2 Abbreviations 351
12.3 Methodology 358
12.4 Forecasting Methodology 358
12.4.1 Diagnosed T2D Patients 358
12.4.2 Percent Drug-Treated Patients 358
12.4.3 Drugs Included in Each Therapeutic Class 358
12.4.4 Launch and Patent Expiry Dates 359
12.4.5 General Pricing Assumptions 359
12.4.6 Individual Drug Assumptions 360
12.4.7 Generic Erosion 371
12.4.8 Pricing of Pipeline Agents 371
12.5 Physicians and Specialists Included in this Study 371
12.6 About the Authors 374
12.6.1 Managing Analyst 374
12.6.2 Therapy Area Director 374
12.6.3 Epidemiologists 374
12.6.4 Global Director of Therapy Analysis and Epidemiology 376
12.6.5 Global Head and EVP of Healthcare Operations and Strategy 376
12.7 About GlobalData 377
12.8 Contact Us 377
12.9 Disclaimer 377
1.1 List of Tables
Table 1: T2D: Key Metrics in the Seven Major Pharmaceutical Markets 11
Table 2: Overall Unmet Needs - Current Level of Attainment 15
Table 3: Primary pathophysiologic conditions associated with T2D 28
Table 4: Symptoms of T2D 30
Table 5: Risk Factors and Comorbidities for T2D. 33
Table 6: 7MM, Diagnosed Prevalent Cases of T2D, Ages =20 Years, Both Sexes, N, Selected Years 2016-2026 48
Table 7: Diagnostic Tests and Typical Criteria for Diagnosing T2D 57
Table 8: T2D Treatments 60
Table 9: Country Profile, T2D Management, US 65
Table 10: Country Profile, T2D Management, France 67
Table 11: Country Profile, T2D Management, Germany 70
Table 12: Country Profile, T2D Management, Italy 74
Table 13: Country Profile, T2D Management, Spain 77
Table 14: Country Profile, T2D Management, UK 81
Table 15: Country Profile, T2D Management, Japan 84
Table 16: Leading Branded Treatments for T2D, 2016 88
Table 17: Product Profile - Metformin 90
Table 18: Metformin SWOT Analysis, 2016 92
Table 19: First-Generation SUs 94
Table 20: Second-Generation SUs 94
Table 21: : Product Profile - SUsTable 26 95
Table 22: SUs SWOT Analysis, 2016 96
Table 23: Product Profile - Acarbose 98
Table 24: AGIs SWOT Analysis, 2016 100
Table 25: Product Profile - Actos 102
Table 26: TZDs SWOT Analysis, 2016 104
Table 27: GLP-1RAs 106
Table 28: Product Profile - Byetta 108
Table 29: Byetta SWOT Analysis, 2016 110
Table 30: Product Profile - Victoza 112
Table 31: Victoza SWOT Analysis, 2016 114
Table 32: Product Profile - Bydureon 116
Table 33: Bydureon SWOT Analysis, 2016 118
Table 34: Product Profile - Lyxumia 120
Table 35: Lyxumia SWOT Analysis, 2016 122
Table 36: Product Profile - Tanzeum 124
Table 37: Tanzeum SWOT Analysis, 2016 127
Table 38: Product Profile - Trulicity 128
Table 39: Trulicity SWOT Analysis, 2016 131
Table 40: Marketed DPP-4Is 134
Table 41: Marketed DPP-4Is in Combination with Other OADs 134
Table 42: Product Profile - Januvia 136
Table 43: Januvia SWOT Analysis, 2016 138
Table 44: Product Profile - Onglyza 140
Table 45: Onglyza SWOT Analysis, 2016 142
Table 46: Product Profile - Tradjenta 144
Table 47: Tradjenta SWOT Analysis, 2016 146
Table 48: Product Profile - Galvus 148
Table 49: Galvus SWOT Analysis, 2016 150
Table 50: Product Profile - Nesina 152
Table 51: Nesina SWOT Analysis, 2016 153
Table 52: Product Profile - Tenelia 155
Table 53: Tenelia SWOT Analysis, 2016 157
Table 54: Product Profile - Suiny 158
Table 55: Suiny SWOT Analysis, 2016 159
Table 56: Product Profile - Zafatek 160
Table 57: Zafatek SWOT Analysis, 2016 162
Table 58: Product Profile - Marizev 164
Table 59: Marizev SWOT Analysis, 2016 165
Table 60: SGLT-2Is 167
Table 61: Marketed SGLT-2Is in Combination with Other T2D Drugs 167
Table 62: Product Profile - Forxiga 168
Table 63: Forxiga SWOT Analysis, 2016 170
Table 64: Product Profile - Invokana 171
Table 65: Invokana SWOT Analysis, 2016 173
Table 66: Product Profile - Jardiance 174
Table 67: Jardiance SWOT Analysis, 2016 177
Table 68: Product Profile - Apleway 178
Table 69: Apleway SWOT Analysis, 2016 179
Table 70: Product Profile - Suglat 181
Table 71: Suglat SWOT Analysis, 2016 182
Table 72: Product Profile - Lusefi 183
Table 73: Lusefi SWOT Analysis, 2016 184
Table 74: Insulins - Overview and Comparison 186
Table 75: Marketed Combination Insulins 186
Table 76: Insulin Formulations 186
Table 77: Product Profile - Humalog 187
Table 78: Humalog SWOT Analysis, 2016 189
Table 79: Product Profile - Lantus 191
Table 80: Lantus SWOT Analysis, 2016 193
Table 81: Toujeo SWOT Analysis, 2016 197
Table 82: Product Profile - Levemir 198
Table 83: Levemir SWOT Analysis, 2016 200
Table 84: Product Profile - NovoLog 201
Table 85: NovoLog SWOT Analysis, 2016 202
Table 86: Fiasp SWOT Analysis, 2016 203
Table 87: Product Profile - Apidra 204
Table 88: Apidra SWOT Analysis, 2016 205
Table 89: Product Profile - Tresiba 207
Table 90: Tresiba SWOT Analysis, 2016 209
Table 91: Product Profile - Afrezza 211
Table 92: Afrezza SWOT Analysis, 2016 212
Table 93: Product Profile - Insulin glargine biosimilars 218
Table 94: Insulin Glargine Biosimilars SWOT Analysis, 2016 219
Table 95: Unmet Needs and Opportunities in T2D 222
Table 96: T2D - Clinical Trials by Phase and Status, 2016 232
Table 97: T2D - Phase Pipeline, 2016 234
Table 98: Comparison of Therapeutic Classes in Development for T2D, 2016 234
Table 99: Product Profile - Semaglutide 236
Table 100: Semaglutide SWOT Analysis, 2016 238
Table 101: Product Profile - OG217SC 239
Table 102: OG217SC SWOT Analysis, 2016 241
Table 103: Product Profile - ITCA 650 242
Table 104: ITCA 650 SWOT Analysis, 2016 245
Table 105: Product Profile - Ertugliflozin 246
Table 106: Ertugliflozin SWOT Analysis, 2016 248
Table 107: Product Profile - Sotagliflozin 250
Table 108: Sotagliflozin SWOT Analysis, 2016 252
Table 109: Product Profile - Bexagliflozin 253
Table 110: Bexagliflozin SWOT Analysis, 2016 255
Table 111: Key Companies in the T2D Market, 2016 258
Table 112: Other Companies in the T2D Market, 2016 259
Table 113: Eli Lilly's T2D Portfolio Assessment, 2016 264
Table 114: Eli Lilly SWOT Analysis, 2016 265
Table 115: Novo Nordisk's T2D Portfolio Assessment, 2016 267
Table 116: Novo Nordisk SWOT Analysis, 2016 268
Table 117: Sanofi's T2D Portfolio Assessment, 2016 270
Table 118: Sanofi SWOT Analysis, 2016 271
Table 119: AstraZeneca's T2D Portfolio Assessment, 2016 272
Table 120: AstraZeneca SWOT Analysis, 2016 273
Table 121: Merck's T2D Portfolio Assessment, 2016 274
Table 122: Merck SWOT Analysis, 2016 274
Table 123: BI's T2D Portfolio Assessment, 2016 275
Table 124: BI SWOT Analysis, 2016 276
Table 125: GSK's T2D Portfolio Assessment, 2016 277
Table 126: GSK SWOT Analysis, 2016 277
Table 127: Takeda's T2D Portfolio Assessment, 2016 279
Table 128: Takeda SWOT Analysis, 2016 279
Table 129: Roche's T2D Portfolio Assessment, 2016 280
Table 130: Roche SWOT Analysis, 2016 280
Table 131: Pfizer's T2D Portfolio Assessment, 2016 281
Table 132: Pfizer SWOT Analysis, 2016 282
Table 133: J&J's T2D Portfolio Assessment, 2016 283
Table 134: J&J SWOT Analysis, 2016 283
Table 135: Novartis' T2D Portfolio Assessment, 2016 284
Table 136: Novartis SWOT Analysis, 2016 284
Table 137: Intarcia Therapeutics' T2D Portfolio Assessment, 2016 285
Table 138: Intarcia Therapeutics SWOT Analysis, 2016 285
Table 139: Theracos' T2D Portfolio Assessment, 2016 285
Table 140: Theracos, SWOT Analysis, 2016 286
Table 141: T2D Market - Drivers and Barriers, 2016 290
Table 142: Key Events Impacting Sales for T2D in US, 2016-2026 293
Table 143: T2D Market - Drivers and Barriers in the US, 2016 294
Table 144: Key Events Impacting Sales for T2D in Germany, 2016-2026 297
Table 145: T2D Market - Drivers and Barriers in France, 2016 297
Table 146: Key Events Impacting Sales for T2D in Germany, 2016-2026 301
Table 147: T2D Market - Drivers and Barriers in Germany, 2016 301
Table 148: Key Events Impacting Sales for T2D in Italy, 2016-2026 305
Table 149: T2D Market - Drivers and Barriers in Italy, 2016 305
Table 150: Key Events Impacting Sales for T2D in Spain, 2016-2026 309
Table 151: T2D Market - Drivers and Barriers in Spain, 2016 309
Table 152: Key Events Impacting Sales for T2D in the UK, 2016-2026 313
Table 153: T2D Market - Drivers and Barriers in the UK, 2016 313
Table 154: Key Events Impacting Sales for T2D in Japan, 2016-2026 317
Table 155: T2D Market - Drivers and Barriers in Japan, 2016 318
Table 156: Key Launch Dates 359
Table 157: Key Patent Expiries 359
Table 158: Number of High-Prescribing Physicians Surveyed 373
1.2 List of Figures
Figure 1: Global Sales for T2D by Country/Region, 2016 and 2026 13
Figure 2: Company Portfolio Gap Analysis in T2D, 2016-2026 16
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in T2D, 2016-2026 17
Figure 4: T2D Pathophysiology 27
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence (%) of T2D , Men, Ages =20 Years, 2006-2026 34
Figure 6: 7MM, Age-Standardized Diagnosed Prevalence (%) of T2D , Women, Ages =20 Years, 2006-2026 35
Figure 7: 7MM, Sources Used and Not Used, Diagnosed Prevalent Cases of T2D 36
Figure 8: 7MM, Sources Used, Prevalent Cases of CKD Among the Diagnosed Prevalent Cases of T2D 37
Figure 9: 7MM, Sources Used, Prevalent Cases of CVD Among the Diagnosed Prevalent Cases of T2D 37
Figure 10: 7MM, Sources Used, Prevalent Cases of Obesity Among the Diagnosed Prevalent Cases of T2D 38
Figure 11: 7MM, Sources Used, Prevalent Cases of Hypertension Among the Diagnosed Prevalent Cases of T2D 38
Figure 12: 7MM, Sources Used, Prevalent Cases of Dyslipidemia Among the Diagnosed Prevalent Cases of T2D 39
Figure 13: 7MM, Age-Specific Diagnosed Prevalent Cases of T2D, Ages =20 Years, Both Sexes, N, 2016 49
Figure 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of T2D, Ages =20 Years, N, 2016 50
Figure 15: 7MM, Prevalent Cases of CKD Among the Diagnosed Prevalent Cases of T2D, Ages =20 Years, Both Sexes, N, 2016 51
Figure 16: 7MM, Prevalent Cases of CVD Among the Diagnosed Prevalent Cases of T2D, Ages =20 Years, Both Sexes, N, 2016 51
Figure 17: 7MM, Prevalent Cases of Obesity Among the Diagnosed Prevalent Cases of T2D, Ages =20 Years, Both Sexes, N, 2016 52
Figure 18: 7MM, Prevalent Cases of Hypertension Among the Diagnosed Prevalent Cases of T2D, Ages =20 Years, Both Sexes, N, 2016 53
Figure 19: 7MM, Prevalent Cases of Dyslipidemia Among the Diagnosed Prevalent Cases of T2D, Ages =20 Years, Both Sexes, N, 2016 54
Figure 20: Incretin and SGLT-2I Mechanisms of Action 62
Figure 21: ADA/EASD General Recommendations for Antihyperglycemic Therapy 63
Figure 22: Pipeline Agents in Develpoment for T2D 230
Figure 23: Competitive Assessment of Late-Stage Pipeline Agents in T2D, 2016-2026 235
Figure 24: Company Portfolio Gap Analysis in T2D, 2016-2026 260
Figure 25: Global Sales for T2D by Country/Region, 2016 and 2026 289
Figure 26: Sales for T2D in the US by Drug Class, 2016 and 2026 292
Figure 27: Sales for T2D in the France by Drug Class, 2016 and 2026 296
Figure 28: Sales for T2D in the Germany by Drug Class, 2016 and 2026 300
Figure 29: Sales for T2D in the Italy by Drug Class, 2016 and 2026 304
Figure 30: Sales for T2D in the Spain by Drug Class, 2016 and 2026 308
Figure 31: Sales for T2D in the UK by Drug Class, 2016 and 2026 312
Figure 32: Sales for T2D in the Japan by Drug Class, 2016 and 2026 316
