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

Published By :

GlobalData

Published Date : Jul 2013

Category :

Metabolic Disorders

No. of Pages : 212 Pages


GlobalData has released its new Country report, PharmaPoint: Type 2 Diabetes Germany 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 onceor twice-daily therapies.

Actos patent expiry in 2012 will not affect the German market, as the drug was taken off the market in 2011. Three insulin products face patent expiry by 2015, but this will be offset by 16 pipeline product launches over the forecast period. Byettas 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 Germany including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Germany from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting Germany 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 Germany
Table of Contents

1 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 Germany 28
4.2.1 Diagnosis 28
4.2.2 Clinical Practice 28

5 Competitive Assessment 30
5.1 Overview 30
5.2 Strategic Competitor Assessment 31
5.3 Product Profiles - Major Brands 33
5.3.1 Metformin 33
5.3.2 Sulfonylureas (SUs) and Other Insulin Secretagogues 38
5.3.3 a-glucosidase Inhibitors (AGIs) 42
5.3.4 Thiazolidinediones (TZDs) 45
5.3.5 GLP-1 Receptor Agonists 46
5.3.6 DPP-4 Inhibitors 61
5.3.7 SGLT-2 Inhibitors 80
5.3.8 Insulin Formulations 88

6 Opportunity and Unmet Need 108
6.1 Overview 108
6.2 Unmet Needs 109
6.2.1 Drugs Providing Sustained Glycemic Control 109
6.2.2 Drugs with Non-Glycemic Benefits 110
6.2.3 Increased Patient Compliance 111
6.2.4 Drugs with Improved Side-Effect Profiles 112
6.2.5 Earlier Diagnosis 113
6.3 Unmet Needs Gap Analysis 114
6.4 Oral Therapy with Sustainable Efficacy 115
6.5 Oral Therapy Offering Weight Loss 115
6.6 Cardio-metabolic Therapy 116
6.7 Promotion of Type 2 Diabetes Drugs in Emerging Markets 116

7 Pipeline Assessment 117
7.1 Overview 117
7.2 Promising Drugs in Clinical Development 118
7.2.1 Albiglutide 123
7.2.2 Dulaglutide (LY2189265) 128
7.2.3 MK-3102 134
7.2.4 Empagliflozin 138
7.2.5 Tofogliflozin 144
7.2.6 Fasiglifam (TAK-875) 147
7.2.7 LY2409021 153
7.2.8 LY2605541 (insulin peglispro) 157

8 Market Outlook 161
8.1 Germany 161
8.1.1 Forecast 161
8.1.2 Key Events 165
8.1.3 Drivers and Barriers 166

9 Appendix 168
9.1 Bibliography 168
9.2 Abbreviations 192
9.3 Methodology 195
9.4 Forecasting Methodology 195
9.4.1 Diagnosed Type 2 Patients 195
9.4.2 Percent Drug-Treated Patients 196
9.4.3 Drugs Included in Each Therapeutic Class 196
9.4.4 Launch and Patent Expiry Dates 197
9.4.5 General Pricing Assumptions 198
9.4.6 Individual Drug Assumptions 198
9.4.7 Pricing of Pipeline Agents 206
9.5 Physicians and Specialists Included in this Study 207
9.6 About the Authors 209
9.6.1 Analyst II - CVMD 209
9.6.2 Therapy Director - CVMD and Infectious Disease 209
9.6.3 Global Head of Healthcare 210
9.7 About GlobalData 211
9.8 Disclaimer 211

List of Table


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 32
Table 6: Product Profile - Metformin 35
Table 7: Metformin SWOT Analysis, 2012 37
Table 8: First-Generation Sulfonylureas 39
Table 9: Second-Generation Sulfonylureas 39
Table 10: Product Profile - Sulfonylureas 40
Table 11: Sulfonylureas SWOT Analysis, 2012 41
Table 12: Product Profile - Acarbose 43
Table 13: AGIs SWOT Analysis, 2012 45
Table 14: GLP-1 Receptor Agonists 48
Table 15: Product Profile - Byetta 50
Table 16: Byetta SWOT Analysis, 2012 52
Table 17: Product Profile - Victoza 54
Table 18: Victoza SWOT Analysis, 2012 56
Table 19: Product Profile - Bydureon 58
Table 20: Bydureon SWOT Analysis, 2012 60
Table 21: Marketed DPP-4 Inhibitors 63
Table 22: Marketed DPP-4 Inhibitors in Combination with Other OADs 63
Table 23: Product Profile - Januvia 64
Table 24: Januvia SWOT Analysis, 2012 67
Table 25: Product Profile - Onglyza 68
Table 26: Onglyza SWOT Analysis, 2012 71
Table 27: Product Profile - Galvus 73
Table 28: Galvus SWOT Analysis, 2012 76
Table 29: Product Profile - Nesina 77
Table 30: Nesina SWOT Analysis, 2012 79
Table 31: Product Profile - Forxiga 82
Table 32: Forxiga SWOT Analysis, 2012 84
Table 33: Product Profile - Invokana 85
Table 34: Invokana SWOT Analysis, 2012 87
Table 35: Insulins - Overview and Comparison 89
Table 36: Insulin Formulations 89
Table 37: Product Profile - Humalog 90
Table 38: Humalog SWOT Analysis, 2012 92
Table 39: Product Profile - Lantus 93
Table 40: Lantus SWOT Analysis, 2012 96
Table 41: Product Profile - Levemir 97
Table 42: Levemir SWOT Analysis, 2012 99
Table 43: Product Profile - Novolog 100
Table 44: Novolog SWOT Analysis, 2012 101
Table 45: Product Profile - Apidra 102
Table 46: Apidra SWOT Analysis, 2012 104
Table 47: Product Profile - Tresiba 105
Table 48: Tresiba SWOT Analysis, 2012 107
Table 49: Overall Unmet Needs - Current Level of Attainment 108
Table 50: Clinical Unmet Needs - Gap Analysis, 2013 114
Table 51: Type 2 Diabetes - Phase Pipeline, 2012 120
Table 52: Comparison of Therapeutic Classes in Development for Type 2 Diabetes, 2012 121
Table 53: Product Profile - Albiglutide 124
Table 54: Albiglutide SWOT Analysis, 2013 128
Table 55: Product Profile - Dulaglutide 130
Table 56: Dulaglutide SWOT Analysis, 2012 134
Table 57: Product Profile - MK-3102 135
Table 58: MK-3102 SWOT Analysis, 2013 137
Table 59: Product Profile - Empagliflozin 139
Table 60: Empagliflozin SWOT Analysis, 2013 142
Table 61: Global Sales Forecasts ($m) for Empagliflozin, 2012-2022 143
Table 62: Product Profile - Tofogliflozin 145
Table 63: Tofogliflozin SWOT Analysis, 2013 147
Table 64: Product Profile - Fasiglifam 148
Table 65: Fasiglifam SWOT Analysis, 2013 151
Table 66: Global Sales Forecasts ($m) for Fasiglifam, 2012--2022 152
Table 67: Product Profile - LY2409021 154
Table 68: LY2409021 SWOT Analysis, 2013 156
Table 69: Product Profile - LY2605541 158
Table 70: LY2605541 SWOT Analysis, 2013 160
Table 71: Germany Sales Forecasts ($m) for Type 2 Diabetes, 2012-2022 162
Table 72: Key Events Impacting Sales for Type 2 Diabetes in Germany, 2012-2022 165
Table 73: Type 2 Diabetes Market - Drivers and Barriers in Germany, 2012 166
Table 74: Key Launch Dates 197
Table 75: Key Patent Expiries 197
Table 76: Number of High-Prescribing Physicians Surveyed 208

List of Chart


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 122
Figure 3: Sales for Type 2 Diabetes in Germany by Drug Class, 2012-2022 164

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