PharmaPoint: Type 2 Diabetes - US Drug Forecast and Market Analysis to 2022

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London (PRWEB) December 10, 2013

PharmaPoint: Type 2 Diabetes - US Drug Forecast and Market Analysis to 2022

Summary

GlobalData has released its new Country report, “PharmaPoint: Type 2 Diabetes - US Drug Forecast and Market Analysis to 2022”. The type 2 diabetes market is mature and crowded with inexpensive generics. Despite being marked by a late-stage pipeline filled with me-too drugs, this market will undergo substantial growth between 2012 and 2022, more than doubling over this period. The main drivers of growth will be the dramatic increase in disease prevalence and physicians’ efforts to delay disease progression and reduce the costly burden of diabetic complications through the use of combination therapies and novel branded drugs. In the emerging markets in particular, uptake of branded drugs will increase due to rapid economic growth. We anticipate that the type 2 diabetes market will not experience a fundamental shift in the classes of drugs that are preferred by physicians. Rapid uptake of drugs from the novel class of SGLT-2 inhibitors will occur; however, DPP-4 inhibitors and GLP-1 receptor agonists will continue dominating the noninsulin type 2 diabetes space. GLP-1 receptor agonists will experience the fastest growth of all classes (CAGR of 17%), due to their weight-loss effects and their novel once-weekly administration, which is preferable to the standard once- or twice-daily therapies.

A dip in sales caused by Actos patent expiry in 2012 and three insulin products’ patent expiry by 2015 will be offset by 16 pipeline product launches over the forecast period. Byetta’s patent expiration in 2016 will not have a major impact on the market as its sales have been constantly declining with Victoza and Bydureon overtaking its shares.

Scope

-Overview of type 2 diabetes including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
-Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
-Sales forecast for the top drugs in the US from 2012-2022.
-Analysis of the impact of key events as well the drivers and restraints affecting the US type 2 diabetes market.

Reasons to buy

-Understand and capitalize by identifying products that are most likely to ensure a robust return
-Stay ahead of the competition by understanding the changing competitive landscape for type 2 diabetes
-Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
-Make more informed business decisions from insightful and in-depth analysis of drug performance
-Obtain sales forecast for drugs from 2012-2022 in the US

Table of Contents

1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 11
2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 17
3.1.3 Prognosis 18
3.1.4 Quality of Life 19
3.2 Symptoms 19
4 Disease Management 21
4.1 Treatment Overview 21
4.1.1 Diagnosis and Referrals 21
4.1.2 Treatment Guidelines 22
4.2 US 28
4.2.1 Diagnosis 28
4.2.2 Clinical Practice 28
5 Competitive Assessment 29
5.1 Overview 29
5.2 Strategic Competitor Assessment 30
5.3 Product Profiles - Major Brands 32
5.3.1 Metformin 32
5.3.2 Sulfonylureas (SUs) and Other Insulin Secretagogues 37
5.3.3 α-glucosidase Inhibitors (AGIs) 41
5.3.4 Thiazolidinediones (TZDs) 44
5.3.5 GLP-1 Receptor Agonists 48
5.3.6 DPP-4 Inhibitors 67
5.3.7 SGLT-2 Inhibitors 85
5.3.8 Insulin Formulations 93
6 Opportunity and Unmet Need 113
6.1 Overview 113
6.2 Unmet Needs 114
6.2.1 Drugs Providing Sustained Glycemic Control 114
6.2.2 Drugs with Non-Glycemic Benefits 115
6.2.3 Increased Patient Compliance 116
6.2.4 Drugs with Improved Side-Effect Profiles 117
6.2.5 Earlier Diagnosis 118
6.3 Unmet Needs Gap Analysis 119
6.4 Oral Therapy with Sustainable Efficacy 120
6.5 Oral Therapy Offering Weight Loss 120
6.6 Cardio-metabolic Therapy 121
6.7 Promotion of Type 2 Diabetes Drugs in Emerging Markets 121
7 Pipeline Assessment 122
7.1 Overview 122
7.2 Promising Drugs in Clinical Development 123
7.2.1 Albiglutide 128
7.2.2 Dulaglutide (LY2189265) 133
7.2.3 Semaglutide 139
7.2.4 MK-3102 143
7.2.5 Empagliflozin 147
7.2.6 Tofogliflozin 152
7.2.7 Fasiglifam (TAK-875) 155
7.2.8 LY2409021 160
7.2.9 LY2605541 (insulin peglispro) 164
8 Market Outlook 168
8.1 US 168
8.1.1 Forecast 168
8.1.2 Key Events 172
8.1.3 Drivers and Barriers 173
9 Appendix 175
9.1 Bibliography 175
9.2 Abbreviations 199
9.3 Methodology 202
9.4 Forecasting Methodology 202
9.4.1 Diagnosed Type 2 Patients 202
9.4.2 Percent Drug-Treated Patients 203
9.4.3 Drugs Included in Each Therapeutic Class 203
9.4.4 Launch and Patent Expiry Dates 204
9.4.5 General Pricing Assumptions 205
9.4.6 Individual Drug Assumptions 205
9.4.7 Pricing of Pipeline Agents 214
9.5 Physicians and Specialists Included in this Study 215
9.6 About the Authors 217
9.6.1 Analyst II - CVMD 217
9.6.2 Therapy Director - CVMD and Infectious Disease 217
9.6.3 Global Head of Healthcare 218
9.7 About GlobalData 219
9.8 Disclaimer 219

List of Tables

Table 1: Symptoms of Type 2 Diabetes 20
Table 2: Diagnostic Tests and Typical Criteria for Type 2 Diabetes 21
Table 3: Treatment Guidelines for Type 2 Diabetes 23
Table 4: Most-Prescribed Drugs (Following Metformin and Sulfonylureas) for Type 2 Diabetes by Class in the Global Markets, 2012 26
Table 5: Leading Branded Treatments for Type 2 Diabetes, 2012 31
Table 6: Product Profile - Metformin 34
Table 7: Metformin SWOT Analysis, 2012 36
Table 8: First-Generation Sulfonylureas 38
Table 9: Second-Generation Sulfonylureas 38
Table 10: Product Profile - Sulfonylureas 39
Table 11: Sulfonylureas SWOT Analysis, 2012 40
Table 12: Product Profile - Acarbose 42
Table 13: AGIs SWOT Analysis, 2012 44
Table 14: Product Profile - Actos 46
Table 15: Actos SWOT Analysis, 2012 48
Table 16: GLP-1 Receptor Agonists 50
Table 17: Product Profile - Byetta 52
Table 18: Byetta SWOT Analysis, 2012 54
Table 19: Product Profile - Victoza 56
Table 20: Victoza SWOT Analysis, 2012 58
Table 21: Product Profile - Bydureon 60
Table 22: Bydureon SWOT Analysis, 2012 62
Table 23: Product Profile - Lyxumia 64
Table 24: Lyxumia SWOT Analysis, 2012 67
Table 25: Marketed DPP-4 Inhibitors 69
Table 26: Marketed DPP-4 Inhibitors in Combination with Other OADs 69
Table 27: Product Profile - Januvia 71
Table 28: Januvia SWOT Analysis, 2012 73
Table 29: Product Profile - Onglyza 75
Table 30: Onglyza SWOT Analysis, 2012 77
Table 31: Product Profile - Tradjenta 79
Table 32: Tradjenta SWOT Analysis, 2012 81
Table 33: Product Profile - Nesina 83
Table 34: Nesina SWOT Analysis, 2012 85
Table 35: Product Profile - Forxiga 87
Table 36: Forxiga SWOT Analysis, 2012 89
Table 37: Product Profile - Invokana 90
Table 38: Invokana SWOT Analysis, 2012 92
Table 39: Insulins - Overview and Comparison 94
Table 40: Insulin Formulations 94
Table 41: Product Profile - Humalog 95
Table 42: Humalog SWOT Analysis, 2012 97
Table 43: Product Profile - Lantus 98
Table 44: Lantus SWOT Analysis, 2012 101
Table 45: Product Profile - Levemir 102
Table 46: Levemir SWOT Analysis, 2012 104
Table 47: Product Profile - Novolog 105
Table 48: Novolog SWOT Analysis, 2012 106
Table 49: Product Profile - Apidra 107
Table 50: Apidra SWOT Analysis, 2012 109
Table 51: Product Profile - Tresiba 110
Table 52: Tresiba SWOT Analysis, 2012 112
Table 53: Overall Unmet Needs - Current Level of Attainment 113
Table 54: Clinical Unmet Needs - Gap Analysis, 2013 119
Table 55: Type 2 Diabetes - Phase Pipeline, 2012 125
Table 56: Comparison of Therapeutic Classes in Development for Type 2 Diabetes, 2012 126
Table 57: Product Profile - Albiglutide 129
Table 58: Albiglutide SWOT Analysis, 2013 133
Table 59: Product Profile - Dulaglutide 135
Table 60: Dulaglutide SWOT Analysis, 2012 139
Table 61: Product Profile - Semaglutide 140
Table 62: Semaglutide SWOT Analysis, 2012 143
Table 63: Product Profile - MK-3102 144
Table 64: MK-3102 SWOT Analysis, 2013 146
Table 65: Product Profile - Empagliflozin 148
Table 66: Empagliflozin SWOT Analysis, 2013 151
Table 67: Product Profile - Tofogliflozin 153
Table 68: Tofogliflozin SWOT Analysis, 2013 155
Table 69: Product Profile - Fasiglifam 156
Table 70: Fasiglifam SWOT Analysis, 2013 159
Table 71: Product Profile - LY2409021 161
Table 72: LY2409021 SWOT Analysis, 2013 163
Table 73: Product Profile - LY2605541 165
Table 74: LY2605541 SWOT Analysis, 2013 167
Table 75: US Sales Forecasts ($m) for Type 2 Diabetes, 2012-2022 169
Table 76: Key Events Impacting Sales for Type 2 Diabetes in the US, 2012-2022 172
Table 77: Type 2 Diabetes Market - Drivers and Barriers in the US, 2012 173
Table 78: Key Launch Dates 204
Table 79: Key Patent Expiries 204
Table 80: Number of High-Prescribing Physicians Surveyed 21

List of Figures

Figure 1: ADA/EASD General Recommendations for Antihyperglycemic Therapy 25
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Type 2 Diabetes, 2012-2022 127
Figure 3: Sales for Type 2 Diabetes in the US by Drug Class, 2012-2022 171

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PharmaPoint: Type 2 Diabetes - US Drug Forecast and Market Analysis to 2022

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