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 ($m), 2017-2021 94 Figure 19: T2DM Therapeutics Market, Asia-Pacific, ITCA-650 (exenatide) Products Forecast ($m), 2017-2021 96 Figure 20: T2DM Therapeutics Market, Asia-Pacific, Ertugliflozin Products Forecast ($m), 2018-2021 97 Figure 21: T2DM Market, Global, Heat Map for Pipeline Products, 2015 98 Figure 22: T2DM Therapeutics Market, Asia-Pacific, Treatment Usage Patterns, 2014-2021 100 Figure 23: T2DM Therapeutics Market, Asia-Pacific, Market Size ($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 ($), 2014-2021 103 Figure 26: T2DM Therapeutics Market, China, Market Size ($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 ($), 2014-2021 106 Figure 29: T2DM Therapeutics Market, India, Market Size ($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 ($), 2014-2021 108 Figure 32: T2DM Therapeutics Market, Australia, Market Size ($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) ($), 2014-2021 110 Figure 35: T2DM Therapeutics Market, Japan, Market Size ($bn), 2014-2021 110 Figure 36: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value ($m), 2006-2015 113 Figure 37: T2DM Therapeutics Market, Global, Licensing Deals by Region, 2006-2015 114 Figure 38: T2DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2014 115 Figure 39: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-2015 116 Figure 40: T2DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($bn), 2006-2015 117 Figure 41: T2DM Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2015 118 Figure 42: T2DM Therapeutics Market, Global, Co-development Deals by Value ($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 ($m) and Aggregate Upfront Payment Value ($m), 2006-2014 122 Figure 45: T2DM Therapeutics Market, Global, Co-development Deals by Deal Value ($m), Upfront Payment Value ($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 ($bn), 2006-2015 125 Figure 47: T2DM Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2015 126