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

Published By :

GlobalData

Published Date : Jul 2013

Category :

Metabolic Disorders

No. of Pages : 227 Pages


GlobalData has released its new Country report, PharmaPoint: Type 2 Diabetes Italy 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.

As in the global market, this growth will be fueled by the dramatic increase in the prevalence and diagnosis of the disease as well as by the uptake of new branded drugs. A dip in sales caused by Actos patent expiry in 2012 and three insulin products patent expiries by 2015 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 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 Italy including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Italy from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting Italy 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 Italy
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 Italy 28
4.2.1 Diagnosis 28
4.2.2 Clinical Practice 29

5 Competitive Assessment 31
5.1 Overview 31
5.2 Strategic Competitor Assessment 32
5.3 Product Profiles - Major Brands 34
5.3.1 Metformin 34
5.3.2 Sulfonylureas (SUs) and Other Insulin Secretagogues 39
5.3.3 a-glucosidase Inhibitors (AGIs) 43
5.3.4 Thiazolidinediones (TZDs) 46
5.3.5 GLP-1 Receptor Agonists 50
5.3.6 DPP-4 Inhibitors 69
5.3.7 SGLT-2 Inhibitors 92
5.3.8 Insulin Formulations 100

6 Opportunity and Unmet Need 120
6.1 Overview 120
6.2 Unmet Needs 121
6.2.1 Drugs Providing Sustained Glycemic Control 121
6.2.2 Drugs with Non-Glycemic Benefits 122
6.2.3 Increased Patient Compliance 123
6.2.4 Drugs with Improved Side-Effect Profiles 124
6.2.5 Earlier Diagnosis 125
6.3 Unmet Needs Gap Analysis 126
6.4 Oral Therapy with Sustainable Efficacy 127
6.5 Oral Therapy Offering Weight Loss 127
6.6 Cardio-metabolic Therapy 128
6.7 Promotion of Type 2 Diabetes Drugs in Emerging Markets 128

7 Pipeline Assessment 129
7.1 Overview 129
7.2 Promising Drugs in Clinical Development 130
7.2.1 Albiglutide 135
7.2.2 Dulaglutide (LY2189265) 140
7.2.3 Semaglutide 146
7.2.4 MK-3102 150
7.2.5 Empagliflozin 154
7.2.6 Tofogliflozin 159
7.2.7 Fasiglifam (TAK-875) 162
7.2.8 LY2409021 167
7.2.9 LY2605541 (insulin peglispro) 171

8 Market Outlook 175
8.1 Italy 175
8.1.1 Forecast 175
8.1.2 Key Events 179
8.1.3 Drivers and Barriers 180

9 Appendix 182
9.1 Bibliography 182
9.2 Abbreviations 206
9.3 Methodology 209
9.4 Forecasting Methodology 209
9.4.1 Diagnosed Type 2 Patients 209
9.4.2 Percent Drug-Treated Patients 210
9.4.3 Drugs Included in Each Therapeutic Class 210
9.4.4 Launch and Patent Expiry Dates 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 33
Table 6: Product Profile - Metformin 36
Table 7: Metformin SWOT Analysis, 2012 38
Table 8: First-Generation Sulfonylureas 40
Table 9: Second-Generation Sulfonylureas 40
Table 10: Product Profile - Sulfonylureas 41
Table 11: Sulfonylureas SWOT Analysis, 2012 42
Table 12: Product Profile - Acarbose 44
Table 13: AGIs SWOT Analysis, 2012 46
Table 14: Product Profile - Actos 48
Table 15: Actos SWOT Analysis, 2012 50
Table 16: GLP-1 Receptor Agonists 52
Table 17: Product Profile - Byetta 54
Table 18: Byetta SWOT Analysis, 2012 56
Table 19: Product Profile - Victoza 58
Table 20: Victoza SWOT Analysis, 2012 60
Table 21: Product Profile - Bydureon 62
Table 22: Bydureon SWOT Analysis, 2012 64
Table 23: Product Profile - Lyxumia 66
Table 24: Lyxumia SWOT Analysis, 2012 69
Table 25: Marketed DPP-4 Inhibitors 71
Table 26: Marketed DPP-4 Inhibitors in Combination with Other OADs 71
Table 27: Product Profile - Januvia 73
Table 28: Januvia SWOT Analysis, 2012 75
Table 29: Product Profile - Onglyza 77
Table 30: Onglyza SWOT Analysis, 2012 79
Table 31: Product Profile - Tradjenta 81
Table 32: Tradjenta SWOT Analysis, 2012 83
Table 33: Product Profile - Galvus 85
Table 34: Galvus SWOT Analysis, 2012 88
Table 35: Product Profile - Nesina 89
Table 36: Nesina SWOT Analysis, 2012 91
Table 37: Product Profile - Forxiga 94
Table 38: Forxiga SWOT Analysis, 2012 96
Table 39: Product Profile - Invokana 97
Table 40: Invokana SWOT Analysis, 2012 99
Table 41: Insulins - Overview and Comparison 101
Table 42: Insulin Formulations 101
Table 43: Product Profile - Humalog 102
Table 44: Humalog SWOT Analysis, 2012 104
Table 45: Product Profile - Lantus 105
Table 46: Lantus SWOT Analysis, 2012 108
Table 47: Product Profile - Levemir 109
Table 48: Levemir SWOT Analysis, 2012 111
Table 49: Product Profile - Novolog 112
Table 50: Novolog SWOT Analysis, 2012 113
Table 51: Product Profile - Apidra 114
Table 52: Apidra SWOT Analysis, 2012 116
Table 53: Product Profile - Tresiba 117
Table 54: Tresiba SWOT Analysis, 2012 119
Table 55: Overall Unmet Needs - Current Level of Attainment 120
Table 56: Clinical Unmet Needs - Gap Analysis, 2013 126
Table 57: Type 2 Diabetes - Phase Pipeline, 2012 132
Table 58: Comparison of Therapeutic Classes in Development for Type 2 Diabetes, 2012 133
Table 59: Product Profile - Albiglutide 136
Table 60: Albiglutide SWOT Analysis, 2013 140
Table 61: Product Profile - Dulaglutide 142
Table 62: Dulaglutide SWOT Analysis, 2012 146
Table 63: Product Profile - Semaglutide 147
Table 64: Semaglutide SWOT Analysis, 2012 150
Table 65: Product Profile - MK-3102 151
Table 66: MK-3102 SWOT Analysis, 2013 153
Table 67: Product Profile - Empagliflozin 155
Table 68: Empagliflozin SWOT Analysis, 2013 158
Table 69: Product Profile - Tofogliflozin 160
Table 70: Tofogliflozin SWOT Analysis, 2013 162
Table 71: Product Profile - Fasiglifam 163
Table 72: Fasiglifam SWOT Analysis, 2013 166
Table 73: Product Profile - LY2409021 168
Table 74: LY2409021 SWOT Analysis, 2013 170
Table 75: Product Profile - LY2605541 172
Table 76: LY2605541 SWOT Analysis, 2013 174
Table 77: Italy Sales Forecasts ($m) for Type 2 Diabetes, 2012-2022 176
Table 78: Key Events Impacting Sales for Type 2 Diabetes in Italy, 2012-2022 179
Table 79: Type 2 Diabetes Market - Drivers and Barriers in Italy, 2012 180
Table 80: Key Launch Dates 211
Table 81: Key Patent Expiries 211
Table 82: Number of High-Prescribing Physicians Surveyed 223

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 134
Figure 3: Sales for Type 2 Diabetes in Italy by Drug Class, 2012-2022 178

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