Type 2 Diabetes Mellitus Therapeutics in South-East Asia Markets to 2023 – Increasing Usage of Newer Therapies and Expanding Treatment Population to Encourage Robust Growth

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. Chronic hyperglycemia is associated with the long-term damage, dysfunction and failure of multiple organs including the eyes, kidneys, nerves, heart and blood vessels. Prevalence of the disease has risen rapidly in recent decades in the assessed South-East Asia countries, primarily as a result of rising obesity, a major risk factor for type 2 diabetes mellitus (T2DM). This has resulted in a large and competitive market landscape, with a number of drugs vying for various market segments across multiple lines of therapy.

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 agonist, DPP-4 inhibitor, SGLT-2 inhibitor, 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 T2DM market in South-East Asia 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?

There are over 609 active pipeline molecules, with most of the late-stage investigational drug candidates featuring improved dosing regimens and administration routes compared with currently marketed products and combination therapies.

– Which classes of novel drugs are most prominent in the pipeline?

– Is there potential for pipeline molecules 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 62.1%, with the overall attrition rate for T2DM standing at 88.3%.

– 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 2016-2023 forecast period, the T2DM therapeutics market in South-East Asia is expected to increase in value at a CAGR of 6.3%, from $1.92 billion to over $2.96 billion.

– Which markets make the most significant contribution to the regional 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

- 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 product 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.

Table of Contents

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 11

2.3 Symptoms 11

2.4 Etiology and Pathophysiology 12

2.5 Diagnosis 14

2.6 Classification 16

2.7 Prognosis 17

2.8 Treatment Options 17

2.8.1 Treatment Algorithm 18

2.8.2 Non-insulin T2DM Therapies 20

2.8.3 Insulin T2DM Therapies 23

2.9 Treatment Segments 25

2.9.1 Non-Insulin Therapies 25

2.9.2 Insulin Therapies 41

2.10 Co-morbidities and Complications 44

2.11 Non-pharmacological Treatments 46

2.11.1 Dietary Interventions 46

2.11.2 Exercise 46

3 Marketed Products 47

3.1 Overview 47

3.2 Biguanides 48

3.2.1 Metformin 48

3.3 Sulfonylureas 49

3.4 Thiazolidinediones 51

3.4.1 Pioglitazone 51

3.4.2 Duvie (lobeglitazone) - Chong Kun Dang 52

3.5 GLP-1 Receptor Agonists 52

3.5.1 Byetta (exenatide) - AstraZeneca 52

3.5.2 Bydureon (exenatide) - AstraZeneca 53

3.5.3 Victoza (liraglutide) - Novo Nordisk 55

3.5.4 Lyxumia (lixisenatide) - Sanofi 56

3.5.5 Tanzeum (albiglutide) - GlaxoSmithKline 58

3.5.6 Trulicity (dulaglutide) - Eli Lilly 59

3.6 DPP-4 Inhibitors 60

3.6.1 Januvia (sitagliptin) - Merck & Co. 60

3.6.2 Galvus (vildagliptin) - Novartis 62

3.6.3 Onglyza (saxagliptin) - Bristol-Myers Squibb/AstraZeneca 63

3.6.4 Tradjenta (linagliptin) - Bristol-Myers Squibb/AstraZeneca 64

3.6.5 Zemiglo (gemigliptin) - LG Life Sciences 65

3.6.6 Suganon (evogliptin) - Dong-A ST 66

3.6.7 Gadret (anagliptin) - JW Pharmaceutical 67

3.6.8 Nesina (alogliptin) - Takeda 67

3.6.9 Tenelia (teneligliptin) - Mitsubishi Tanabe Pharma 68

3.7 SGLT-2 Inhibitors 69

3.7.1 Forxiga (dapagliflozin) - AstraZeneca 69

3.7.2 Invokana (canagliflozin) - Janssen 71

3.7.3 Jardiance (empagliflozin) - Boehringer Ingelheim 72

3.7.4 Suglat (ipragliflozin) - Astellas 73

3.8 Insulin Therapies 74

3.8.1 Lantus (insulin glargine) - Sanofi 74

3.8.2 Levemir (insulin detemir) - Novo Nordisk 75

3.8.3 Tresiba (insulin degludec) - Novo Nordisk 76

3.8.4 Toujeo (insulin glargine) - Sanofi 77

3.9 Comparative Efficacy and Safety of Marketed Products 78

4 Pipeline Analysis 84

4.1 Overview 84

4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 85

4.3 Pipeline by Molecular Target 87

4.4 Promising Pipeline Molecules 91

4.4.1 NN-9535 (subcutaneous semaglutide) and OG-217SC (oral semaglutide) - Novo Nordisk 91

4.4.2 Ertugliflozin - Pfizer 95

4.4.3 Bexagliflozin - Theracos 96

4.4.4 Omarigliptin - Merck & Co. 97

4.4.5 Sotagliflozin- Sanofi 99

4.5 Comparative Efficacy and Safety of Pipeline Products 101

4.6 Product Competitive Framework 102

5 Clinical Trial Analysis 105

5.1 Failure Rate 105

5.1.1 Overall Failure Rate 105

5.1.2 Failure Rate by Phase and Molecule Type 107

5.1.3 Failure Rate by Phase and Molecular Target 107

5.2 Clinical Trial Duration 108

5.2.1 Trial Duration by Molecule Type and Stage of Development 108

5.2.2 Trial Duration by Molecular Target and Stage of Development 109

5.3 Clinical Trial Size 110

5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 110

5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 113

5.4 Summary of Clinical Trial Metrics 114

6 Multi-Scenario Forecast 116

6.1 Geographical Markets 116

6.2 South-East Asia Markets 116

6.3 South Korea 119

6.3.1 Treatment Usage Patterns 119

6.3.2 Annual Cost of Therapy 120

6.3.3 Market Size 120

6.4 Singapore 121

6.4.1 Treatment Usage Patterns 121

6.4.2 Annual Cost of Therapy 122

6.4.3 Market Size 123

6.5 Taiwan 123

6.5.1 Treatment Usage Patterns 123

6.5.2 Annual Cost of Therapy 124

6.5.3 Market Size 125

6.6 Malaysia 125

6.6.1 Treatment Usage Patterns 125

6.6.2 Annual Cost of Therapy 126

6.6.3 Market Size 127

6.7 Philippines 127

6.7.1 Treatment Usage Patterns 127

6.7.2 Annual Cost of Therapy 128

6.7.3 Market Size 129

6.8 Thailand 130

6.8.1 Treatment Usage Patterns 130

6.8.2 Annual Cost of Therapy 131

6.8.3 Market Size 132

6.9 Vietnam 132

6.9.1 Treatment Usage Patterns 132

6.9.2 Annual Cost of Therapy 133

6.9.3 Market Size 134

6.10 Indonesia 135

6.10.1 Treatment Usage Patterns 135

6.10.2 Annual Cost of Therapy 136

6.10.3 Market Size 137

7 Drivers and Barriers 138

7.1 Drivers 138

7.1.1 Aging Population, Increasing Obesity and Growing Economy 138

7.1.2 Increasing Awareness of T2DM 138

7.1.3 Continued Uptake of Recently Approved Drug Classes 138

7.1.4 Promising Late-Stage Pipeline Products Can Change the Treatment Paradigm 138

7.1.5 Enhanced Usage of Combination Therapies 139

7.2 Barriers 139

7.2.1 Non-pharmacological First-line Treatment 139

7.2.2 Widespread Usage of Generic Drugs 139

7.2.3 Poor Adherence to Treatment Regimens 139

7.2.4 Generic Erosion Resulting from Patent Expirations 139

8 Deals and Strategic Consolidations 140

8.1 Licensing Deals 140

8.1.1 Deals by Region and Value 140

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 141

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 142

8.1.4 Key Licensing Deals 145

8.2 Co-development Deals 148

8.2.1 Deals by Region and Value 148

8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 149

8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 151

8.2.4 Key Co-development Deals 153

9 Appendix 157

9.1 All Pipeline Drugs by Stage of Development 157

9.1.1 Discovery 157

9.1.2 Preclinical 161

9.1.3 IND/CTA-filed 172

9.1.4 Phase I 173

9.1.5 Phase II 175

9.1.6 Phase III 178

9.1.7 Pre-registration 179

9.2 Summary of Multi-Scenario Market Forecasts to 2023 179

9.2.1 South-East Asia 179

9.2.2 South Korea 180

9.2.3 Singapore 180

9.2.4 Taiwan 181

9.2.5 Malaysia 181

9.2.6 Philippines 182

9.2.7 Thailand 182

9.2.8 Vietnam 183

9.2.9 Indonesia 183

9.3 Bibliography 184

9.4 Abbreviations 196

9.5 Research Methodology 198

9.5.1 Secondary Research 198

9.5.2 Marketed Product Profiles 199

9.5.3 Late-Stage Pipeline Candidates 199

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 199

9.5.5 Product Competitiveness Framework 199

9.5.6 Pipeline Analysis 200

9.5.7 Forecasting Model 201

9.5.8 Deals Data Analysis 201

9.6 Contact Us 202

9.7 Disclaimer 202

List of Tables

1.1 List of Tables

Table 1: Dose Levels for Groups Initially Receiving Metformin in Combination with Glyburide, Metformin Monotherapy and Glyburide Monotherapy 29

Table 2: T2DM Therapeutics Market, Global, Licensing Deals Valued over $50m, 2006-April 2017 147

Table 3: T2DM Therapeutics Market, Global, Licensing Deals Valued over $100m, 2006-April 2017 155

Table 4: T2DM Therapeutics, Global, All Pipeline Products, Discovery, April 2017 157

Table 5: T2DM Therapeutics, Global, All Pipeline Products, Preclinical, April 2017 161

Table 6: T2DM Therapeutics, Global, All Pipeline Products, IND/CTA-filed, April 2017 172

Table 7: T2DM Therapeutics, Global, All Pipeline Products, Phase I, April 2017 173

Table 8: T2DM Therapeutics, Global, All Pipeline Products, Phase II, April 2017 175

Table 9: T2DM Therapeutics, Global, All Pipeline Products, Phase III, April 2017 178

Table 10: T2DM Therapeutics, Global, All Pipeline Products, Pre-registration, April 2017 179

Table 11: T2DM Therapeutics Market, South-East Asia, Market Forecast, 2016-2023 179

Table 12: T2DM Therapeutics Market, South Korea, Market Forecast, 2016-2023 180

Table 13: T2DM Therapeutics Market, Singapore, Market Forecast, 2016-2023 180

Table 14: T2DM Therapeutics Market, Taiwan, Market Forecast, 2016-2023 181

Table 15: T2DM Therapeutics Market, Malaysia, Market Forecast, 2016-2023 181

Table 16: T2DM Therapeutics Market, Philippines, Market Forecast, 2016-2023 182

Table 17: T2DM Therapeutics Market, Thailand, Market Forecast, 2016-2023 182

Table 18: T2DM Therapeutics Market, Vietnam, Market Forecast, 2016-2023 183

Table 19: T2DM Therapeutics Market, Indonesia, Market Forecast, 2016-2023 183

Table 20: Abbreviations 196

List of Figures

1.2 List of Figures

Figure 1: T2DM Therapeutics Market, Comparative Efficacy and Safety Heatmap for Conventional Anti-diabetic Marketed Products 79

Figure 2: T2DM Therapeutics Market, Comparative Efficacy and Safety Heatmap for GLP-1 Receptor 80

Figure 3: T2DM Therapeutics Market, Comparative Efficacy and Safety Heatmap for DPP-4 inhibitors 81

Figure 4: T2DM Therapeutics Market, Comparative Efficacy and Safety Heatmap for SGLT-2 Inhibitors 82

Figure 5: T2DM Therapeutics Market, Comparative Efficacy and Safety Heatmap for Insulin Therapy 83

Figure 6: T2DM Therapeutics Market, Global, Pipeline, 2017 86

Figure 7: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, 2017 90

Figure 8: T2DM Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2017 91

Figure 9: T2DM Therapeutics Market, South-East Asia, NN-9535 Forecast ($m), 2018-2023 94

Figure 10: T2DM Therapeutics Market, South-East Asia, OG-217SC Forecast ($m), 2020-2023 94

Figure 11: T2DM Therapeutics Market, South-East Asia, Ertugliflozin Forecast ($m), 2018-2023 96

Figure 12: T2DM Therapeutics Market, South-East Asia, Bexagliflozin Forecast ($m), 2020-2023 97

Figure 13: T2DM Therapeutics Market, South-East Asia, Omarigliptin Forecast ($m), 2017-2023 99

Figure 14: T2DM Therapeutics Market, South-East Asia, Sotagliflozin Forecast ($m), 2021-2023 100

Figure 15: T2DM Therapeutics Market, South-East Asia, Heatmap for Pipeline Products, April 2017 102

Figure 16: T2DM Therapeutics Market, South-East Asia, Competitor Matrix for Marketed and Pipeline Products, April 2017 104

Figure 17: T2DM Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2017 106

Figure 18: T2DM Therapeutics, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2017 107

Figure 19: T2DM Therapeutics, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2017 108

Figure 20: T2DM Therapeutics, Global, Clinical Trial Duration by Phase and Molecule Type, 2006-2017 109

Figure 21: T2DM Therapeutics, Global, Clinical Trial Duration by Phase and Molecular Target, 2006-2017 110

Figure 22: T2DM Therapeutics, Global, Clinical Trial Size per Product by Stage of Development and Molecule Type, 2006-2017 111

Figure 23: T2DM Therapeutics, Global, Clinical Trial Size per Product by Stage of Development and Molecular Target, 2006-2017 112

Figure 24: T2DM Therapeutics, Global, Clinical Trial Size per Individual Trial by Molecule Type (participants), 2006-2017 113

Figure 25: T2DM Therapeutics, Global, Clinical Trial Size per Individual Trial by Molecular Target (participants), 2006-2017 114

Figure 26: T2DM Therapeutics, Global, Comparison of Average Trial Metrics by Phase and Molecular Type 115

Figure 27: T2DM Therapeutics, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 115

Figure 28: T2DM Therapeutics Market, South-East Asia, Treatment Usage Patterns (million), 2016-2023 117

Figure 29: T2DM Therapeutics Market, South-East Asia, Market Size ($bn), 2016-2023 118

Figure 30: T2DM Therapeutics Market, South Korea, Treatment Usage Patterns (million), 2016-2023 119

Figure 31: T2DM Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023 120

Figure 32: T2DM Therapeutics Market, South Korea, Market Size ($m), 2016-2023 121

Figure 33: T2DM Therapeutics Market, Singapore, Treatment Usage Patterns (million), 2016-2023 122

Figure 34: T2DM Therapeutics Market, Singapore, Annual Cost of Therapy ($), 2016-2023 122

Figure 35: T2DM Therapeutics Market, Singapore, Market Size ($m), 2016-2023 123

Figure 36: T2DM Therapeutics Market, Taiwan, Treatment Usage Patterns (million), 2016-2023 124

Figure 37: T2DM Therapeutics Market, Taiwan, Annual Cost of Therapy ($), 2016-2023 124

Figure 38: T2DM Therapeutics Market, Taiwan, Market Size ($m), 2016-2023 125

Figure 39: T2DM Therapeutics Market, Malaysia, Treatment Usage Patterns (million), 2016-2023 126

Figure 40: T2DM Therapeutics Market, Malaysia, Annual Cost of Therapy ($), 2016-2023 126

Figure 41: T2DM Therapeutics Market, Malaysia, Market Size ($m), 2016-2023 127

Figure 42: T2DM Therapeutics Market, Philippines, Treatment Usage Patterns (million), 2016-2023 128

Figure 43: T2DM Therapeutics Market, Philippines, Annual Cost of Therapy ($), 2016-2023 129

Figure 44: T2DM Therapeutics Market, Philippines, Market Size ($m), 2016-2023 130

Figure 45: T2DM Therapeutics Market, Thailand, Treatment Usage Patterns (million), 2016-2023 131

Figure 46: T2DM Therapeutics Market, Thailand, Annual Cost of Therapy ($), 2016-2023 131

Figure 47: T2DM Therapeutics Market, Thailand, Market Size ($m), 2016-2023 132

Figure 48: T2DM Therapeutics Market, Vietnam, Treatment Usage Patterns (million), 2016-2023 133

Figure 49: T2DM Therapeutics Market, Vietnam, Annual Cost of Therapy ($), 2016-2023 134

Figure 50: T2DM Therapeutics Market, Vietnam, Market Size ($m), 2016-2023 135

Figure 51: T2DM Therapeutics Market, Indonesia, Treatment Usage Patterns (million), 2016-2023 136

Figure 52: T2DM Therapeutics Market, Indonesia, Annual Cost of Therapy ($), 2016-2023 136

Figure 53: T2DM Therapeutics Market, Indonesia, Market Size ($m), 2016-2023 137

Figure 54: T2DM Therapeutics, Global, Licensing Deals by Region and Value, 2006- April 2017 141

Figure 55: T2DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006- April 2017 142

Figure 56: T2DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-April 2017 143

Figure 57: T2DM Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006- April 2017 144

Figure 58: T2DM Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006-April 2017 145

Figure 59: T2DM Therapeutics Market, Global, Co-development Deals by Value ($m), 2006-April 2017 149

Figure 60: 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- April 2017 150

Figure 61: T2DM Therapeutics Market, Global, Co-development Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-April 2017 151

Figure 62: T2DM Therapeutics Market, Global, Co-development Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($bn), 2006-April 2017 152

Figure 63: T2DM Therapeutics Market, Global, Co-development Deals by Molecular Target and Aggregate Deal Value ($m), 2006-April 2017 153

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