Summary
Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia - high blood glucose levels - that results from defects in insulin secretion, insulin action, or a combination of these. This chronic hyperglycemia is associated with long-term damage, dysfunction and failure of multiple organs, including the eyes, kidneys, nerves, heart and blood vessels. The vast majority of diabetes mellitus patients can be classified as having either Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM). Approximately 90-95% of all diabetics have T2DM.
T2DM treatment has been revolutionized in the past decade, especially with the increased use of new therapies. The marketed products landscape comprises a wide range of treatment options, including biguanide (metformin), sulfonylureas, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, and insulin therapies. Nevertheless, significant unmet need remains for products that can offer better glycemic control, as well as the prevention and cure of diabetic complications, such as diabetic nephropathy, retinopathy, and cardiovascular disease.
Scope
The current South-East Asia T2DM market contains novel products, including Jardiance, a SGLT-2 inhibitor; Victoza, a GLP-1 receptor agonist; and Januvia, a DPP-4 inhibitor.
- What are the competitive advantages of the existing novel drugs?
With over 500 active pipeline molecules, most of the late-stage investigational drug candidates are being evaluated, featuring improved dosing regimens and administration routes in comparison to currently marketed products and combination therapies.
- Which classes of novel drugs are most prominent within the pipeline?
- Is there strong potential for the pipeline to address unmet needs within the T2DM market?
Analysis of clinical trials since 2006 identified that the failure rates of T2DM molecules were highest in Phase III, at 49%, with the overall attrition rate for T2DM standing at 75%.
- How do failure rates vary by product stage of development, molecule type, and mechanism of action?
- How do other factors, such as average trial duration and trial size, influence the costs and risks associated with product development?
Over the 2015-2022 forecast period, the South-East Asia T2DM therapeutics market is expected to increase in value at a CAGR of 7.1%, from $1.7 billion to over $2.7 billion.
- Which markets make the most significant contribution to the current market size?
- What are the epidemiology trends in these markets?
- Will new market entrants lead to substantial changes in annual therapy costs?
- How will different treatment usage patterns impact growth in the eight assessed South-East Asia markets?
Rising T2DM prevalence and the uptake of newer therapies will lead to significant market growth over the forecast period, despite generic sales erosion resulting from patent expirations.
- Will patent expirations or emerging pipeline molecules threaten the commercial success of existing drugs?
Reasons to buy
This report will enable you to -
- Understand the clinical context of T2DM by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options.
- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
- Identify key pipeline trends in molecule type, administration route, mechanism of action, and novelty.
- Consider market opportunities and potential risks by examining trends in T2DM clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action.
- Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in T2DM by examining clinical trial data and multi-scenario product forecast projections.
- Compare treatment usage patterns, annual therapy costs, and market growth projections for South Korea, Singapore, Taiwan, Malaysia, the Philippines, Thailand, Vietnam, and Indonesia.
- Discover trends in licensing and co-development deals concerning T2DM products and identify the major strategic consolidations that have shaped the commercial landscape.
'
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 11
2.4 Etiology and Pathophysiology 11
2.5 Diagnosis 14
2.6 Classification 15
2.7 Prognosis 15
2.8 Treatment Options 16
2.8.1 Treatment Algorithm 16
2.8.2 Non-insulin T2DM Therapies 18
2.8.3 Insulin T2DM Therapies 21
2.9 Treatment Segments 22
2.9.1 Non-insulin therapies 23
2.9.2 Insulin Therapies 38
2.10 Co-morbidities and Complications 41
3 Marketed Products 43
3.1 Overview 43
3.2 Biguanides 44
3.2.1 Metformin 44
3.3 Sulfonylureas 45
3.4 Thiazolidinediones 46
3.4.1 Pioglitazone 46
3.4.2 Duvie (lobeglitazone) - Chong Kun Dang 48
3.5 GLP-1 Receptor Agonists 48
3.5.1 Byetta (exenatide) - Eli Lilly 48
3.5.2 Bydureon (exenatide) - AstraZeneca 49
3.5.3 Victoza (liraglutide) - Novo Nordisk 50
3.5.4 Lyxumia (lixisenatide) - Sanofi 52
3.5.5 Tanzeum (albiglutide) - GlaxoSmithKline 53
3.6 DPP-4 Inhibitors 54
3.6.1 Januvia (sitagliptin) - Merck 54
3.6.2 Galvus (vildagliptin) - Novartis 55
3.6.3 Onglyza (saxagliptin) - Bristol-Myers Squibb/AstraZeneca 57
3.6.4 Trajenta (linagliptin) - Bristol-Myers Squibb/AstraZeneca 58
3.6.5 Zemiglo (gemigliptin) - LG Life Sciences 59
3.6.6 Suganon (evogliptin) - Dong-A ST 59
3.6.7 Gadret (anagliptin) - JW Pharmaceutical 60
3.6.8 Nesina (alogliptin) - Takeda 61
3.6.9 Tenelia (teneligliptin) - Mitsubishi Tanabe Pharma 61
3.7 SGLT-2 Inhibitors 62
3.7.1 Forxiga (dapagliflozin) - AstraZeneca 62
3.7.2 Invokana (canagliflozin) - Janssen 63
3.7.3 Jardiance (empagliflozin) - Boehringer Ingelheim 64
3.7.4 Suglat (ipragliflozin) - Astellas 65
3.8 Insulin Therapies 66
3.8.1 Lantus (insulin glargine) - Sanofi 66
3.8.2 Levemir (insulin detemir) - Novo Nordisk 67
3.8.3 Tresiba (insulin degludec) - Novo Nordisk 67
3.8.4 Toujeo (insulin glargine) - Sanofi 68
3.9 Comparative Efficacy and Safety of Marketed Products 69
4 Pipeline 72
4.1 Overview 72
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 73
4.3 Pipeline by Molecular Target 74
4.4 Promising Pipeline Candidates 78
4.4.1 NN-9535 (subcutaneous semaglutide) and OG-217SC (oral semaglutide) - Novo Nordisk 78
4.4.2 Trulicity (dulaglutide) 81
4.4.3 Ertugliflozin - Pfizer 83
4.4.4 Bexagliflozin - Theracos 84
4.4.5 Omarigliptin - Merck 86
4.5 Comparative Efficacy and Safety of Pipeline Products 88
4.6 Product Competitive Framework 88
5 Clinical Trial Analysis 92
5.1 Failure Rate 92
5.1.1 Overall Failure Rate 92
5.1.2 Failure Rate by Phase and Molecule Type 92
5.1.3 Failure Rate by Phase and Molecular Target 93
5.2 Clinical Trial Size 94
5.3 Clinical Trial Duration 98
5.3.1 Trial Duration by Stage of Development and Molecule Type 98
5.3.2 Trial Duration by Stage of Development and Molecular Target 100
5.4 Summary of Clinical Trial Metrics 100
6 Multi-Scenario Forecast 102
6.1 Geographical Markets 102
6.2 South-East Asia Markets 102
6.3 South Korea 105
6.3.1 Treatment Usage Patterns 105
6.3.2 Annual Cost of Therapy 105
6.3.3 Market Size 106
6.4 Singapore 107
6.4.1 Treatment Usage Patterns 107
6.4.2 Annual Cost of Therapy 107
6.4.3 Market Size 108
6.5 Taiwan 109
6.5.1 Treatment Usage Patterns 109
6.5.2 Annual Cost of Therapy 109
6.5.3 Market Size 110
6.6 Malaysia 111
6.6.1 Treatment Usage Patterns 111
6.6.2 Annual Cost of Therapy 112
6.6.3 Market Size 113
6.7 Philippines 113
6.7.1 Treatment Usage Patterns 113
6.7.2 Annual Cost of Therapy 114
6.7.3 Market Size 115
6.8 Thailand 115
6.8.1 Treatment Usage Patterns 115
6.8.2 Annual Cost of Therapy 116
6.8.3 Market Size 117
6.9 Vietnam 118
6.9.1 Treatment Usage Patterns 118
6.9.2 Annual Cost of Therapy 118
6.9.3 Market Size 119
6.10 Indonesia 120
6.10.1 Treatment Usage Patterns 120
6.10.2 Annual Cost of Therapy 121
6.10.3 Market Size 122
7 Market Dynamics, (Drivers and Barriers) 123
7.1 Drivers 123
7.1.1 Aging Population, Increasing Obesity and Growing Economy 123
7.1.2 Increasing Awareness of T2DM 123
7.1.3 Continued Uptake of Recently Approved Drug Classes 123
7.1.4 Promising Late-Stage Pipeline Products can Change the Treatment Paradigm 123
7.1.5 Enhanced Usage of Combination Therapies 123
7.2 Barriers 124
7.2.1 Non-pharmacological First-line Treatment 124
7.2.2 Widespread Usage of Generic Drugs 124
7.2.3 Poor Adherence to Treatment Regimens 124
7.2.4 Generic Erosion Resulting from Patent Expirations 124
8 Deals and Strategic Consolidations 125
8.1 Licensing Deals 125
8.1.1 Deals by Region and Value 125
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 126
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 127
8.1.4 Key Licensing Deals 129
8.2 Co-development Deals 130
8.2.1 Deals by Region and Value 130
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 132
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 134
8.2.4 Key Co-Development Deals 136
9 Appendix 138
9.1 All Pipeline Drugs by Phase of Development 138
9.1.1 Discovery 138
9.1.2 Preclinical 141
9.1.3 IND/CTA-filed 149
9.1.4 Phase I 149
9.1.5 Phase II 151
9.1.6 Phase III 153
9.1.7 Pre-registration 154
9.2 Market Forecasts to 2022 155
9.2.1 South-East Asia 155
9.2.2 South Korea 155
9.2.3 Singapore 156
9.2.4 Taiwan 156
9.2.5 Malaysia 157
9.2.6 Philippines 157
9.2.7 Thailand 158
9.2.8 Vietnam 158
9.2.9 Indonesia 159
9.3 References 159
9.4 Abbreviations 170
9.5 Research Methodology 172
9.5.1 Secondary Research 172
9.5.2 Marketed Product Profiles 173
9.5.3 Late-Stage Pipeline Candidates 173
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 173
9.5.5 Pipeline Analysis 173
9.5.6 Forecasting Model 174
9.5.7 Deals Data Analysis 175
9.6 Contact Us 176
9.7 Disclaimer 176
1.1 List of Tables
Table 1: Dose Levels for Groups Initially Receiving Metformin in Combination with Glyburide, Metformin Monotherapy and Glyburide Monotherapy 26
Table 2: T2DM Therapeutics, Global, All Pipeline Products, Discovery Stage, March 2016 138
Table 3: T2DM Therapeutics, Global, All Pipeline Products, Preclinical Stage, March 2016 141
Table 4: T2DM Therapeutics, Global, All Pipeline Products, IND/CTA-filed Stage, March 2016 149
Table 5: T2DM Therapeutics, Global, All Pipeline Products, Phase I, March 2016 149
Table 6: T2DM Therapeutics, Global, All Pipeline Products, Phase II, March 2016 151
Table 7: T2DM Therapeutics, Global, All Pipeline Products, Phase III, March 2016 153
Table 8: T2DM Therapeutics, Global, All Pipeline Products, Pre-registration Stage, March 2016 154
Table 9: T2DM Therapeutics Market, South-East Asia, Market Forecast, 2015-2022 155
Table 10: T2DM Therapeutics Market, South Korea, Market Forecast, 2015-2022 155
Table 11: T2DM Therapeutics Market, Singapore, Market Forecast, 2015-2022 156
Table 12: T2DM Therapeutics Market, Taiwan, Market Forecast, 2015-2022 156
Table 13: T2DM Therapeutics Market, Malaysia, Market Forecast, 2015-2022 157
Table 14: T2DM Therapeutics Market, Philippines, Market Forecast, 2015-2022 157
Table 15: T2DM Therapeutics Market, Thailand, Market Forecast, 2015-2022 158
Table 16: T2DM Therapeutics Market, Vietnam, Market Forecast, 2015-2022 158
Table 17: T2DM Therapeutics Market, Indonesia, Market Forecast, 2015-2022 159
1.2 List of Figures
Figure 1: T2DM Therapeutics Market, South-East Asia, Heat Map for Marketed Products, 2016 70
Figure 2: T2DM Therapeutics Market, South-East Asia, Heat Map for Marketed Products, 2016 (continued) 71
Figure 3: T2DM Therapeutics Market, Global, Pipeline, 2016 73
Figure 4: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, 2016 75
Figure 5: T2DM Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2016 76
Figure 6: T2DM Therapeutics Market, South-East Asia, NN-9535 Forecast ($m), 2018-2022 80
Figure 7: T2DM Therapeutics Market, South-East Asia, OG-217SC Forecast ($m), 2020-2022 81
Figure 8: T2DM Therapeutics Market, South-East Asia, Trulicity Products Forecast ($m), 2016-2022 83
Figure 9: T2DM Therapeutics Market, South-East Asia, Ertugliflozin Products Forecast ($m), 2018-2022 84
Figure 10: T2DM Therapeutics Market, South-East Asia, Bexagliflozin Products Forecast ($m), 2020-2022 85
Figure 11: T2DM Therapeutics Market, South-East Asia, Omarigliptin Products Forecast ($m), 2017-2022 87
Figure 12: T2DM Market, South-East Asia, Heat Map for Pipeline Products, March 2016 88
Figure 13: T2DM Therapeutics Market, South-East Asia, Competitor Matrix for Marketed and Pipeline Products, March 2016 91
Figure 14: T2DM Therapeutics, Global, Clinical Trial Attrition Rates (%), 2006-March 2016 92
Figure 15: T2DM Therapeutics, Global, Clinical Trial Attrition Rates by Molecule Type (%), 2006-March 2016 93
Figure 16: T2DM Therapeutics, Global, Clinical Trial Attrition Rates by Molecular Target (%), 2006-March 2016 94
Figure 17: T2DM Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-March 2016 95
Figure 18: T2DM Therapeutics, Global, Clinical Trial Size per Product Molecular Target (participants), 2006-March 2016 96
Figure 19: T2DM Therapeutics, Global, Clinical Trial Size per Individual Trial by Molecule Type (participants), 2006-March 2016 97
Figure 20: T2DM Therapeutics, Global, Clinical Trial Size per Individual Trial by Molecular Target (participants), 2006-March 2016 98
Figure 21: T2DM Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-March 2016 99
Figure 22: T2DM Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-March 2016 100
Figure 23: T2DM Therapeutics, Global, Comparison of Average Trial Metrics by Phase and Molecule Type, 2006-March 2016 101
Figure 24: T2DM Therapeutics, Global, Comparison of Average Trial Metrics by Phase and Molecular Target, 2006-March 2016 101
Figure 25: T2DM Therapeutics Market, South-East Asia, Treatment Usage Patterns (million), 2015-2022 103
Figure 26: T2DM Therapeutics Market, South-East Asia, Market Size ($bn), 2015-2022 104
Figure 27: T2DM Therapeutics Market, South Korea, Treatment Usage Patterns (million), 2015-2022 105
Figure 28: T2DM Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2015-2022 106
Figure 29: T2DM Therapeutics Market, South Korea, Market Size ($m), 2015-2022 106
Figure 30: T2DM Therapeutics Market, Singapore, Treatment Usage Patterns (million), 2015-2022 107
Figure 31: T2DM Therapeutics Market, Singapore, Annual Cost of Therapy ($), 2015-2022 108
Figure 32: T2DM Therapeutics Market, Singapore, Market Size ($m), 2015-2022 108
Figure 33: T2DM Therapeutics Market, Taiwan, Treatment Usage Patterns (million), 2015-2022 109
Figure 34: T2DM Therapeutics Market, Taiwan, Annual Cost of Therapy ($), 2015-2022 110
Figure 35: T2DM Therapeutics Market, Taiwan, Market Size ($m), 2015-2022 111
Figure 36: T2DM Therapeutics Market, Malaysia, Treatment Usage Patterns (million), 2015-2022 112
Figure 37: T2DM Therapeutics Market, Malaysia, Annual Cost of Therapy ($), 2015-2022 112
Figure 38: T2DM Therapeutics Market, Malaysia, Market Size ($m), 2015-2022 113
Figure 39: T2DM Therapeutics Market, Philippines, Treatment Usage Patterns (million), 2015-2022 114
Figure 40: T2DM Therapeutics Market, Philippines, Annual Cost of Therapy ($), 2015-2022 114
Figure 41: T2DM Therapeutics Market, Philippines, Market Size ($m), 2015-2022 115
Figure 42: T2DM Therapeutics Market, Thailand, Treatment Usage Patterns (million), 2015-2022 116
Figure 43: T2DM Therapeutics Market, Thailand, Annual Cost of Therapy ($), 2015-2022 117
Figure 44: T2DM Therapeutics Market, Thailand, Market Size ($m), 2015-2022 117
Figure 45: T2DM Therapeutics Market, Vietnam, Treatment Usage Patterns (million), 2015-2022 118
Figure 46: T2DM Therapeutics Market, Vietnam, Annual Cost of Therapy ($), 2015-2022 119
Figure 47: T2DM Therapeutics Market, Vietnam, Market Size ($m), 2015-2022 120
Figure 48: T2DM Therapeutics Market, Indonesia, Treatment Usage Patterns (million), 2015-2022 121
Figure 49: T2DM Therapeutics Market, Indonesia, Annual Cost of Therapy ($), 2015-2022 121
Figure 50: T2DM Therapeutics Market, Indonesia, Market Size ($m), 2015-2022 122
Figure 51: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value, 2006-March 2016 125
Figure 52: T2DM Therapeutics Market, Global, Licensing Deals by Region, 2006-March 2016 126
Figure 53: T2DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-March 2016 126
Figure 54: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-March 2016 127
Figure 55: T2DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($bn), 2006-March 2016 128
Figure 56: T2DM Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006-March 2016 129
Figure 57: T2DM Therapeutics Market, Global, Co-development Deals by Value ($m), 2006-March 2016 131
Figure 58: T2DM Therapeutics Market, Global, Co-Development Deals by Region, 2006-March 2016 131
Figure 59: T2DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-Development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Payment Value ($m), 2006-March 2016 132
Figure 60: T2DM Therapeutics Market, Global, Co-development Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-March 2016 133
Figure 61: T2DM Therapeutics Market, Global, Co-development Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($bn), 2006-March 2016 135
Figure 62: T2DM Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value ($m), 2006-March 2016 136
