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

Published By :

GlobalData

Published Date : Jul 2013

Category :

Metabolic Disorders

No. of Pages : 236 Pages


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

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. 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. Since the Japanese regulatory system requires safety trials to be conducted in Japanese patients, pipeline products will launch later in this country than in the other six major markets.

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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in Japan from 2012-2022.
  • Analysis of the impact of key events as well the drivers and restraints affecting Japan 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 Japan
Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 12

2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 14

3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 18
3.1.3 Prognosis 19
3.1.4 Quality of Life 20
3.2 Symptoms 20

4 Disease Management 22
4.1 Treatment Overview 22
4.1.1 Diagnosis and Referrals 22
4.1.2 Treatment Guidelines 23
4.2 Japan 28
4.2.1 Diagnosis 28
4.2.2 Clinical Practice 29

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 49
5.3.6 DPP-4 Inhibitors 68
5.3.7 SGLT-2 Inhibitors 91
5.3.8 Insulin Formulations 99

6 Opportunity and Unmet Need 119
6.1 Overview 119
6.2 Unmet Needs 120
6.2.1 Drugs Providing Sustained Glycemic Control 120
6.2.2 Drugs with Non-Glycemic Benefits 121
6.2.3 Increased Patient Compliance 122
6.2.4 Drugs with Improved Side-Effect Profiles 123
6.2.5 Earlier Diagnosis 124
6.3 Unmet Needs Gap Analysis 125
6.4 Oral Therapy with Sustainable Efficacy 126
6.5 Oral Therapy Offering Weight Loss 126
6.6 Cardio-metabolic Therapy 127
6.7 Promotion of Type 2 Diabetes Drugs in Emerging Markets 127

7 Pipeline Assessment 128
7.1 Overview 128
7.2 Promising Drugs in Clinical Development 129
7.2.1 Albiglutide 134
7.2.2 Dulaglutide (LY2189265) 139
7.2.3 Semaglutide 145
7.2.4 Trelagliptin (SYR-472) 149
7.2.5 MK-3102 153
7.2.6 Empagliflozin 157
7.2.7 Tofogliflozin 162
7.2.8 Ipragliflozin 165
7.2.9 Fasiglifam (TAK-875) 169
7.2.10 LY2409021 174
7.2.11 LY2605541 (insulin peglispro) 177

8 Market Outlook 182
8.1 Japan 182
8.1.1 Forecast 182
8.1.2 Key Events 186
8.1.3 Drivers and Barriers 187

9 Appendix 189
9.1 Bibliography 189
9.2 Abbreviations 214
9.3 Methodology 217
9.4 Forecasting Methodology 217
9.4.1 Diagnosed Type 2 Patients 217
9.4.2 Percent Drug-Treated Patients 218
9.4.3 Drugs Included in Each Therapeutic Class 218
9.4.4 Launch and Patent Expiry Dates 219
9.4.5 General Pricing Assumptions 220
9.4.6 Individual Drug Assumptions 220
9.4.7 Pricing of Pipeline Agents 229
9.5 Physicians and Specialists Included in this Study 231
9.6 About the Authors 233
9.6.1 Analyst II - CVMD 233
9.6.2 Therapy Director - CVMD and Infectious Disease 233
9.6.3 Global Head of Healthcare 234
9.7 About GlobalData 235
9.8 Disclaimer 235

List of Table


Table 1: Symptoms of Type 2 Diabetes 21
Table 2: Diagnostic Tests and Typical Criteria for Type 2 Diabetes 22
Table 3: Treatment Guidelines for Type 2 Diabetes 24
Table 4: Most-Prescribed Drugs (Following Metformin and Sulfonylureas) for Type 2 Diabetes by Class in the Global Markets, 2012 27
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: Product Profile - Actos 47
Table 15: Actos SWOT Analysis, 2012 49
Table 16: GLP-1 Receptor Agonists 51
Table 17: Product Profile - Byetta 53
Table 18: Byetta SWOT Analysis, 2012 55
Table 19: Product Profile - Victoza 57
Table 20: Victoza SWOT Analysis, 2012 59
Table 21: Product Profile - Bydureon 61
Table 22: Bydureon SWOT Analysis, 2012 63
Table 23: Product Profile - Lyxumia 65
Table 24: Lyxumia SWOT Analysis, 2012 68
Table 25: Marketed DPP-4 Inhibitors 70
Table 26: Marketed DPP-4 Inhibitors in Combination with Other OADs 70
Table 27: Product Profile - Januvia 72
Table 28: Januvia SWOT Analysis, 2012 74
Table 29: Product Profile - Onglyza 76
Table 30: Onglyza SWOT Analysis, 2012 78
Table 31: Product Profile - Tradjenta 80
Table 32: Tradjenta SWOT Analysis, 2012 82
Table 33: Product Profile - Galvus 84
Table 34: Galvus SWOT Analysis, 2012 87
Table 35: Product Profile - Nesina 88
Table 36: Nesina SWOT Analysis, 2012 90
Table 37: Product Profile - Forxiga 93
Table 38: Forxiga SWOT Analysis, 2012 95
Table 39: Product Profile - Invokana 96
Table 40: Invokana SWOT Analysis, 2012 98
Table 41: Insulins - Overview and Comparison 100
Table 42: Insulin Formulations 100
Table 43: Product Profile - Humalog 101
Table 44: Humalog SWOT Analysis, 2012 103
Table 45: Product Profile - Lantus 104
Table 46: Lantus SWOT Analysis, 2012 107
Table 47: Product Profile - Levemir 108
Table 48: Levemir SWOT Analysis, 2012 110
Table 49: Product Profile - Novolog 111
Table 50: Novolog SWOT Analysis, 2012 112
Table 51: Product Profile - Apidra 113
Table 52: Apidra SWOT Analysis, 2012 115
Table 53: Product Profile - Tresiba 116
Table 54: Tresiba SWOT Analysis, 2012 118
Table 55: Overall Unmet Needs - Current Level of Attainment 119
Table 56: Clinical Unmet Needs - Gap Analysis, 2013 125
Table 57: Type 2 Diabetes - Phase Pipeline, 2012 131
Table 58: Comparison of Therapeutic Classes in Development for Type 2 Diabetes, 2012 132
Table 59: Product Profile - Albiglutide 135
Table 60: Albiglutide SWOT Analysis, 2013 139
Table 61: Product Profile - Dulaglutide 141
Table 62: Dulaglutide SWOT Analysis, 2012 145
Table 63: Product Profile - Semaglutide 146
Table 64: Semaglutide SWOT Analysis, 2012 149
Table 65: Product Profile - Trelagliptin 150
Table 66: Trelagliptin SWOT Analysis, 2013 153
Table 67: Product Profile - MK-3102 154
Table 68: MK-3102 SWOT Analysis, 2013 156
Table 69: Product Profile - Empagliflozin 158
Table 70: Empagliflozin SWOT Analysis, 2013 161
Table 71: Product Profile - Tofogliflozin 163
Table 72: Tofogliflozin SWOT Analysis, 2013 165
Table 73: Product Profile - Ipragliflozin 166
Table 74: Ipragliflozin SWOT Analysis, 2013 169
Table 75: Product Profile - Fasiglifam 170
Table 76: Fasiglifam SWOT Analysis, 2013 173
Table 77: Product Profile - LY2409021 175
Table 78: LY2409021 SWOT Analysis, 2013 177
Table 79: Product Profile - LY2605541 178
Table 80: LY2605541 SWOT Analysis, 2013 181
Table 81: Japan Sales Forecasts ($m) for Type 2 Diabetes, 2012-2022 183
Table 82: Key Events Impacting Sales for Type 2 Diabetes in Japan, 2012-2022 186
Table 83: Type 2 Diabetes Market - Drivers and Barriers in Japan, 2012 187
Table 84: Key Launch Dates 219
Table 85: Key Patent Expiries 219
Table 86: Number of High-Prescribing Physicians Surveyed 232

List of Chart


Figure 1: ADA/EASD General Recommendations for Antihyperglycemic Therapy 26
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Type 2 Diabetes, 2012-2022 133
Figure 3: Sales for Type 2 Diabetes in Japan by Drug Class, 2012-2022 185

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