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Type 2 Diabetes Mellitus Therapeutics in Asia-Pacific Markets to 2021

Type 2 Diabetes Mellitus Therapeutics in Asia-Pacific Markets to 2021


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Executive Summary

Type 2 Diabetes Mellitus Therapeutics in Asia-Pacific Markets to 2021-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. 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 85-95% 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 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 in the Asia-Pacific (APAC) market contains novel products, including Jardiance-a SGLT-2 inhibitor; Victoza-a GLP-1 receptor agonist; and Galvus-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 II, at 54%, with the overall attrition rate for T2DM at 82.6%.

-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 2014-2021 forecast period, the T2DM therapeutics in the APAC markets is expected to increase in value at a CAGR of 7.7%, from USD 6.07 billion to over USD 10.2 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 four assessed Asia-Pacific 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?

-Which patent expirations will have the most significant impact on the market?

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 China, India, Australia, and Japan.

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 6

1.2 List of Figures 7

2 Introduction 9

2.1 Disease Overview 9

2.2 Classification 9

2.3 Symptoms 10

2.4 Etiology 10

2.5 Pathophysiology 11

2.6 Epidemiology 13

2.7 Prognosis 13

2.8 Co-morbidities and Complications 14

2.9 Diagnosis 15

2.10 Assessing Treatment Effectiveness 17

2.11 Treatment 17

2.11.1 Non-insulin T2DM Therapies 19

2.11.2 Insulin T2DM Therapies 22

2.12 Treatment Segments 24

2.12.1 Non-insulin therapies 24

2.12.2 Insulin Therapies 39

3 Marketed Products 43

3.1 Overview 43

3.2 Biguanides 44

3.2.1 Metformin 44

3.3 Sulfonylureas 45

3.4 Thiazolidinediones 47

3.4.1 Pioglitazone 47

3.5 GLP-1 receptor agonists 48

3.5.1 Byetta (exenatide) 48

3.5.2 Bydureon (exenatide) 49

3.5.3 Victoza (liraglutide) 50

3.5.4 Lyxumia (lixisenatide) 51

3.5.5 Tanzeum (albiglutide) 53

3.5.6 Trulicity (dulaglutide) 54

3.6 DPP-4 Inhibitors 55

3.6.1 Januvia/Glactiv (sitagliptin) 55

3.6.2 Galvus (vildagliptin) 56

3.6.3 Onglyza (saxagliptin) 57

3.6.4 Trazenta (linagliptin) 58

3.6.5 Zafatek (trelagliptin succinate) 59

3.6.6 Marizev (omarigliptin) 60

3.7 SGLT-2 Inhibitors 61

3.7.1 Forxiga (dapagliflozin) 61

3.7.2 Invokana (canagliflozin) 62

3.7.3 Jardiance (empagliflozin) 63

3.8 Insulin Therapies 63

3.8.1 Lantus (insulin glargine) 63

3.8.2 Levemir (insulin detemir) 64

3.8.3 Tresiba (insulin degludec) 65

3.8.4 Toujeo/ Lantus XR (insulin glargine) 66

3.9 Marketed Products Heat Maps 67

4 Pipeline 70

4.1 Overview 70

4.2 Pipeline Distribution by Stage of Development, Molecule Type and Program Type 71

4.3 Pipeline Distribution by Molecular Target 72

4.4 Clinical Trial Landscape 79

4.4.1 Clinical Trial Failure Rates 79

4.4.2 Clinical Trial Duration 84

4.4.3 Clinical Trial Size 87

4.4.4 Clinical Trial Metrics Analysis 90

4.5 Promising Pipeline Molecules 92

4.5.1 NN-9535 (subcutaneous semaglutide) and OG-217SC (oral semaglutide)-Novo Nordisk 92

4.5.2 ITCA 650-Intarcia Therapeutics 94

4.5.3 Ertugliflozin-Pfizer 96

4.6 Pipeline Products Heat Map 98

5 Market Forecast to 2021 99

5.1 Geographical Markets 99

5.2 Asia-Pacific Markets 99

5.3 China 102

5.3.1 Treatment Usage Patterns 102

5.3.2 Annual Cost of Therapy 103

5.3.3 Market Size 103

5.4 India 104

5.4.1 Treatment Usage Patterns 104

5.4.2 Annual Cost of Therapy 105

5.4.3 Market Size 106

5.5 Australia 107

5.5.1 Treatment Usage Patterns 107

5.5.2 Annual Cost of Therapy 107

5.5.3 Market Size 108

5.6 Japan 109

5.6.1 Treatment Usage Patterns 109

5.6.2 Annual Cost of Therapy 109

5.6.3 Market Size 110

5.7 Drivers and Barriers for the T2DM Therapeutics Market 111

5.7.1 Drivers 111

5.7.2 Barriers 112

6 Strategic Consolidations 113

6.1 Licensing Deals 113

6.1.1 AbbVie Collaborates with Halozyme Therapeutics to Bank on its ENHANZE Technology 119

6.1.2 Janssen Collaborates with Halozyme Therapeutics to Bank on its ENHANZE Technology 119

6.1.3 Emisphere Signs Licensing Agreement with Novo Nordisk to Develop Oral Formulations Targeting Metabolic Indications 119

6.1.4 Amunix Announces Exclusive Agreements with Naia to Develop GLP-1 and GLP-2 XTEN Products 120

6.2 Co-development Deals 120

6.2.1 Intarcia Therapeutics Enters into Co-Development Agreement with Servier for ITCA 650 (DUROS delivery exenatide) 126

6.2.2 Merck Enters into Co-Development Agreement with Pfizer for ertugliflozin 127

6.2.3 AstraZeneca Enters into Research Agreement with Inserm 127

6.2.4 Intarcia Therapeutics Enters into Co-Development Agreement with Numab 127

6.2.5 AstraZeneca Enters into Co-development Agreement with Bristol-Myers Squibb 128

7 Appendix 129

7.1 All Pipeline Drugs by Phase of Development 129

7.1.1 Discovery 129

7.1.2 Preclinical 132

7.1.3 IND/CTA-filed 140

7.1.4 Phase I 141

7.1.5 Phase II 143

7.1.6 Phase III 145

7.1.7 Pre-registration 145

7.2 Market Forecasts to 2021 146

7.2.1 Asia-Pacific 146

7.2.2 China 146

7.2.3 India 146

7.2.4 Australia 147

7.2.5 Japan 147

7.3 References 148

7.4 Abbreviations 160

7.5 Research Methodology 162

7.5.1 Secondary Research 162

7.5.2 Marketed Product Profiles 163

7.5.3 Late-Stage Pipeline Candidates 163

7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 163

7.5.5 Forecasting Model 164

7.5.6 Deals Data Analysis 165

7.6 Contact Us 165

7.7 Disclaimer 166

1.1 List of Tables

Table 1: Dose Levels for Groups Initially Receiving Metformin in Combination with Glyburide, Metformin Monotherapy and Glyburide Monotherapy 27

Table 2: T2DM Therapeutics Market, Global, Breakdown of Multiple Molecular Targets, 2015 77

Table 3: T2DM Therapeutics Market, Global, Breakdown of ''Other'' Molecular Targets, 2015 78

Table 4: T2DM Therapeutics, Global, All Pipeline Products, Discovery Phase, 2015 129

Table 5: T2DM Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2015 132

Table 6: T2DM Therapeutics, Global, All Pipeline Products, IND/CTA-filed Phase, 2015 140

Table 7: T2DM Therapeutics, Global, All Pipeline Products, Phase I, 2015 141

Table 8: T2DM Therapeutics, Global, All Pipeline Products, Phase II, 2015 143

Table 9: T2DM Therapeutics, Global, All Pipeline Products, Phase III, 2015 145

Table 10: T2DM Therapeutics, Global, All Pipeline Products, Pre-registration Phase, 2015 145

Table 11: T2DM Therapeutics Market, Asia-Pacific, Market Forecast, 2014-2021 146

Table 12: T2DM Therapeutics Market, China, Market Forecast, 2014-2021 146

Table 13: T2DM Therapeutics Market, India, Market Forecast, 2014-2021 146

Table 14: T2DM Therapeutics Market, Australia, Market Forecast, 2014-2021 147

Table 15: T2DM Therapeutics Market, Japan, Market Forecast, 2014-2021 147

1.2 List of Figures

Figure 1: T2DM Therapeutics Market, Global, Heat Map for Marketed Products, 2015 68

Figure 2: T2DM Therapeutics Market, Global, Heat Map for Marketed Products, 2015 (continued) 69

Figure 3: T2DM Therapeutics Market, Global, Pipeline, 2015 71

Figure 4: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, 2015 73

Figure 5: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of GPCR Molecular Targets, 2015 74

Figure 6: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Protein Kinase Molecular Targets, 2015 75

Figure 7: T2DM Therapeutics Market, Global, Clinical Trial Failure Rates and Reasons for Failure, 2006-2015 80

Figure 8: T2DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2015 81

Figure 9: T2DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2015 83

Figure 10: T2DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, (months), 2006-2015 85

Figure 11: T2DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target, (months), 2006-2015 86

Figure 12: T2DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type, (participants), 2006-2015 87

Figure 13: T2DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecular Target, (participants), 2006-2015 88

Figure 14: T2DM Mellitus Therapeutics Market, Global, Cumulative Clinical Trial Recruitment Size by Stage of Development and Molecule Type, (participants), 2006-2015 89

Figure 15: T2DM Therapeutics Market, Global, Cumulative Clinical Trial Recruitment Size by Stage of Development and Molecular Target, (participants), 2006-2015 90

Figure 16: T2DM Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 91

Figure 17: T2DM Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 91

Figure 18: T2DM Therapeutics Market, Asia-Pacific, Semaglutide Products Forecast (USD m), 2017-2021 94

Figure 19: T2DM Therapeutics Market, Asia-Pacific, ITCA-650 (exenatide) Products Forecast (USD m), 2017-2021 96

Figure 20: T2DM Therapeutics Market, Asia-Pacific, Ertugliflozin Products Forecast (USD m), 2018-2021 97

Figure 21: T2DM Market, Global, Heat Map for Pipeline Products, 2015 98

Figure 22: T2DM Therapeutics Market, Asia-Pacific, Treatment Usage Patterns, 2014-2021 100

Figure 23: T2DM Therapeutics Market, Asia-Pacific, Market Size (USD bn), 2014-2021 101

Figure 24: T2DM Therapeutics Market, China, Treatment Usage Patterns, 2014-2021 102

Figure 25: T2DM Therapeutics Market, China, Annual Cost of Therapy (USD ), 2014-2021 103

Figure 26: T2DM Therapeutics Market, China, Market Size (USD bn), 2014-2021 104

Figure 27: T2DM Therapeutics Market, India, Treatment Usage Patterns, 2014-2021 105

Figure 28: T2DM Therapeutics Market, India, Annual Cost of Therapy (USD ), 2014-2021 106

Figure 29: T2DM Therapeutics Market, India, Market Size (USD bn), 2014-2021 106

Figure 30: T2DM Therapeutics Market, Australia, Treatment Usage Patterns, 2014-2021 107

Figure 31: T2DM Therapeutics Market, Australia, Annual Cost of Therapy (USD ), 2014-2021 108

Figure 32: T2DM Therapeutics Market, Australia, Market Size (USD bn), 2014-2021 108

Figure 33: T2DM Therapeutics Market, Japan, Treatment Usage Patterns, 2014-2021 109

Figure 34: T2DM Therapeutics Market, Japan, Annual Cost of Therapy (ACoT) (USD ), 2014-2021 110

Figure 35: T2DM Therapeutics Market, Japan, Market Size (USD bn), 2014-2021 110

Figure 36: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value (USD m), 2006-2015 113

Figure 37: T2DM Therapeutics Market, Global, Licensing Deals by Region, 2006-2015 114

Figure 38: T2DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Value (USD m), 2006-2014 115

Figure 39: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value (USD m), Upfront Payment Value (USD m) and Stage of Development, 2006-2015 116

Figure 40: T2DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Molecule Type and Aggregate Deal Value (USD bn), 2006-2015 117

Figure 41: T2DM Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value (USD m), 2006-2015 118

Figure 42: T2DM Therapeutics Market, Global, Co-development Deals by Value (USD m), 2006-2015 120

Figure 43: T2DM Therapeutics Market, Global, Co-Development Deals by Region, 2006-2015 121

Figure 44: T2DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-Development Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Payment Value (USD m), 2006-2014 122

Figure 45: T2DM Therapeutics Market, Global, Co-development Deals by Deal Value (USD m), Upfront Payment Value (USD m) and Stage of Development, 2006-2015 123

Figure 46: T2DM Therapeutics Market, Global, Co-development Deals by Stage of Development, Molecule Type and Aggregate Deal Value (USD bn), 2006-2015 125

Figure 47: T2DM Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value (USD m), 2006-2015 126

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