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Type 2 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021

Type 2 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021


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Executive Summary

Type 2 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021-Strong Pipeline and Expanding Treatment Population to Encourage Robust Growth

Type 2 Diabetes Mellitus (T2DM) is a metabolic disease characterized by chronic hyperglycemia (high blood glucose levels). Global prevalence has risen rapidly in the past several decades, particularly in line with obesity. This has been attributed to a range of factors, including economic development, increasing urbanization, aging populations, and changes in lifestyle patterns such as reduced levels of physical activity and consumption of higher-calorie diets.

This has led to strong commercial interest in the development of T2DM therapeutics. The current market is large and diverse, comprising several drug classes, including generic and branded drugs. Owing to the range of therapeutic options available, the treatment algorithm is complex. However, current treatment regimens are often associated with limited long-term efficacy, complex and inconvenient dosing regimens, and undesirable side effects such as weight gain and hypoglycemia (low blood glucose levels).

Scope

Metformin monotherapy will remain the first-line pharmacotherapy for T2DM.

The emergence of several new drug classes over the past decade, namely the Glucagon-Like Peptide-1 (GLP-1) receptor agonists, Dipeptidyl Peptidase 4 (DPP-4) inhibitors, and Sodium-Glucose Cotransporter 2 (SGLT-2) inhibitors, has led to considerable market growth.

Which products lead these drug classes and what threats do they face from the pipeline?

How will the continued uptake of newer drug classes impact established drug classes such as the sulfonylureas and thiazolidinediones?

Leading insulin therapy Lantus (insulin glargine) recently lost patent protection in most major markets.

Will recently approved insulin therapies such as Tresiba (insulin degludec) and Toujeo (insulin glargine) be able to capture a significant portion of Lantus' market share?

The pipeline is large and highly innovative, comprising a range of molecule types and molecular targets.

How do different molecule types and molecular targets compare in terms of average failure rate, clinical trial duration, and clinical trial size?

Which late-stage pipeline molecules show the most promise and how will they impact the treatment algorithm over the forecast period?

Which late-stage pipeline molecules are expected to generate the highest revenues?

Over the 2014-2021 forecast period, the global T2DM market is expected to increase in value at a CAGR of 7.5% from USD 23.5 billion to USD 39.0 billion.

How do prevalence, diagnosis, and treatment patterns vary in the eight major markets?

Which factors will drive market growth most significantly?

Strategic consolidation activity in T2DM is considerable, with US-based companies being key players.

Do T2DM products tend to attract high levels of investment?

Reasons To Buy

Understand the clinical context of the T2DM indication and the global burden of the disease by considering epidemiology, symptoms, etiology, pathophysiology, co-morbidities and complications, disease classification, disease prognosis, and treatment options

Appreciate the current T2DM marketed products landscape, including the dominant therapeutic strategies, products, and companies, and recognize gaps within the market and areas of unmet need

Identify key pipeline trends in molecule type and molecular target

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

Consider market opportunities and potential risks by examining trends in T2DM clinical trial size, duration, and failure rate by phase of development, molecule type, and molecular target

Discern variances in treatment usage patterns, annual therapy costs, and market growth projections for the US, Canada, the UK, France, Germany, Italy, Spain, and Japan

Discover how strategic consolidations have shaped the current T2DM pipeline and marketed products landscapes

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 9

2.1 Disease Overview 9

2.2 Epidemiology 9

2.3 Symptoms 10

2.4 Etiology 10

2.5 Pathophysiology 11

2.6 Co-morbidities and Complications 13

2.7 Classification 15

2.8 Prognosis 15

2.9 Diagnosis 16

2.10 Assessing Treatment Effectiveness 17

2.11 Treatment Algorithm 17

2.12 Non-insulin T2DM Therapies 19

2.12.1 Biguanides 19

2.12.2 Sulfonylureas and Meglitinides 19

2.12.3 Thiazolidinediones 20

2.12.4 Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists and Dipeptidyl Peptidase 4 (DPP-4) Inhibitors 20

2.12.5 Sodium-Glucose Linked Transporter-2 (SGLT-2) Inhibitors 21

2.12.6 Other Non-insulin Therapies 21

2.13 Insulin T2DM Therapies 22

2.14 Treatment Segments 24

2.14.1 Non-insulin therapies 24

2.14.2 Insulin Therapies 39

3 Marketed Products 43

3.1 Overview 43

3.2 Biguanides 44

3.2.1 Metformin-Various Companies 44

3.3 Sulfonylureas 45

3.4 Thiazolidinediones 46

3.4.1 Actos (pioglitazone)-Takeda 46

3.5 GLP-1 receptor agonists 47

3.5.1 Byetta (exenatide)-AstraZeneca 47

3.5.2 Bydureon (exenatide)-AstraZeneca 48

3.5.3 Victoza (liraglutide)-Novo Nordisk 49

3.5.4 Tanzeum (albiglutide)-GlaxoSmithKline 50

3.5.5 Trulicity (dulaglutide)-Eli Lilly 51

3.6 DPP-4 Inhibitors 53

3.6.1 Januvia (sitagliptin)-Merck 53

3.6.2 Galvus (vildagliptin)-Novartis 54

3.6.3 Onglyza (saxagliptin)-AstraZeneca 55

3.6.4 Tradjenta (linagliptin)-Boehringer Ingelheim 56

3.6.5 Zafatek (trelagliptin succinate)-Takeda 57

3.7 SGLT-2 Inhibitors 58

3.7.1 Farxiga (dapagliflozin)-AstraZeneca 58

3.7.2 Invokana (canagliflozin)-Janssen 59

3.7.3 Jardiance (empagliflozin)-Boehringer Ingelheim 60

3.8 Insulin Therapies 61

3.8.1 Lantus (insulin glargine)-Sanofi 61

3.8.2 Levemir (insulin detemir)-Novo Nordisk 62

3.8.3 Tresiba (insulin degludec)-Novo Nordisk 63

3.8.4 Toujeo (insulin glargine)-Sanofi 63

3.9 Marketed Products Heat Maps 64

4 Pipeline 67

4.1 Overview 67

4.2 Pipeline Distribution by Stage of Development, Molecule Type and Program Type 68

4.3 Pipeline Distribution by Molecular Target 71

4.4 Clinical Trial Landscape 78

4.4.1 Clinical Trial Failure Rates 78

4.4.2 Clinical Trial Duration 83

4.4.3 Clinical Trial Size 86

4.5 Promising Pipeline Molecules 91

4.5.1 Omarigliptin-Merck 91

4.5.2 NN-9535 (semaglutide) and OG-217SC (semaglutide)-Novo Nordisk 92

4.5.3 ITCA 650-Intarcia Therapeutics 94

4.5.4 LX-4211 (sotagliflozin)-Lexicon Pharmaceuticals 96

4.5.5 Insulin peglispro-Eli Lilly and Company 98

4.5.6 ISIS-GCGRRx-Isis Pharmaceuticals 100

4.5.7 BSN-175 (D-Tagatose)-Biospherics.net Incorporated 102

4.6 Pipeline Products Heat Map and Competitive Product Framework 103

5 Market Forecast to 2021 106

5.1 Geographical Markets 106

5.2 Global Markets 106

5.3 North America 109

5.3.1 Treatment Usage Patterns 109

5.3.2 Annual Cost of Therapy 111

5.3.3 Market Size 112

5.4 Top Five European Markets 114

5.4.1 Treatment Usage Patterns 114

5.4.2 Annual Cost of Therapy 116

5.4.3 Market Size 117

5.5 Japan 118

5.5.1 Treatment Usage Patterns 118

5.5.2 Annual Cost of Therapy 118

5.5.3 Market Size 119

5.6 Drivers and Barriers for the T2DM Therapeutics Market 120

5.6.1 Drivers 120

5.6.2 Barriers 121

6 Strategic Consolidations 122

6.1 Licensing Deals 122

6.1.1 Sanofi Enters into Licensing Agreement with MannKind for Afrezza 127

6.1.2 Array BioPharma Enters into a Licensing Agreement with Amgen-Now Terminated 128

6.1.3 Emisphere Technologies Enters into a Licensing Agreement with Novo Nordisk 128

6.1.4 Eli Lilly Enters into Licensing Agreement with Adocia 128

6.1.5 Depomed Enters into a Licensing Agreement with Merck 129

6.2 Co-development Deals 129

6.2.1 Intarcia Therapeutics Enters into Co-Development Agreement with Les Laboratoires Servier for ITCA 650 (exenatide) 136

6.2.2 Merck Enters into Co-Development Agreement with Pfizer for PF-04971729 (ertugliflozin) 137

6.2.3 Eli Lilly Enters into a Co-development Agreement with Boehringer Ingelheim 137

6.2.4 Amylin Pharma Terminates Co-development Agreement with Eli Lilly for Exenatide 137

6.2.5 AstraZeneca Enters into Co-development Agreement with Bristol-Myers Squibb 138

6.2.6 Neurocrine Biosciences Enters into a Collaboration Agreement with Boehringer Ingelheim 138

7 Appendix 139

7.1 All Pipeline Drugs by Phase of Development 139

7.1.1 Discovery 139

7.1.2 Preclinical 142

7.1.3 IND/CTA-filed 150

7.1.4 Phase I 151

7.1.5 Phase II 153

7.1.6 Phase III 156

7.1.7 Pre-registration 157

7.2 Market Forecasts to 2021 158

7.2.1 Global 158

7.2.2 US 158

7.2.3 Canada 158

7.2.4 UK 159

7.2.5 France 159

7.2.6 Germany 159

7.2.7 Italy 160

7.2.8 Spain 160

7.2.9 Japan 160

7.3 References 161

7.4 References for Heat Maps 171

7.4.1 Marketed Products Heat Map 171

7.4.2 Pipeline Heat Map 172

7.5 Abbreviations 173

7.6 Research Methodology 175

7.7 Secondary Research 175

7.8 Marketed Product Profiles 176

7.9 Late-Stage Pipeline Candidates 176

7.10 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 176

7.11 Product Competitiveness Framework 176

7.12 Pipeline Analysis 177

7.12.1 Overall Pipeline 177

7.12.2 Clinical Trials 177

7.12.3 Failure Rate 177

7.12.4 Clinical Trial Size 177

7.12.5 Clinical Trial Duration 177

7.12.6 Clinical Trial Endpoint Analysis 177

7.13 Forecasting Model 178

7.14 Deals Data Analysis 179

7.15 Expert Panel Validation 179

7.16 Contact Us 179

7.17 Disclaimer 179

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 76

Table 3: T2DM Therapeutics Market, Global, Breakdown of 'Other' Molecular Targets, 2015 77

Table 4: T2DM Therapeutics, Global, All Pipeline Products, Discovery Phase, 2015 139

Table 5: T2DM Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2015 142

Table 6: T2DM Therapeutics, Global, All Pipeline Products, IND/CTA-filed Phase, 2015 150

Table 7: T2DM Therapeutics, Global, All Pipeline Products, Phase I, 2015 151

Table 8: T2DM Therapeutics, Global, All Pipeline Products, Phase II, 2015 153

Table 9: T2DM Therapeutics, Global, All Pipeline Products, Phase III, 2015 156

Table 10: T2DM Therapeutics, Global, All Pipeline Products, Pre-registration Phase, 2015 157

Table 11: T2DM Therapeutics Market, Global, Market Forecast, 2014-2021 158

Table 12: T2DM Therapeutics Market, US, Market Forecast, 2014-2021 158

Table 13: T2DM Therapeutics Market, Canada, Market Forecast, 2014-2021 158

Table 14: T2DM Therapeutics Market, UK, Market Forecast, 2014-2021 159

Table 15: T2DM Therapeutics Market, France, Market Forecast, 2014-2021 159

Table 16: T2DM Therapeutics Market, Germany, Market Forecast, 2014-2021 159

Table 17: T2DM Therapeutics Market, Italy, Market Forecast, 2014-2021 160

Table 18: T2DM Therapeutics Market, Spain, Market Forecast, 2014-2021 160

Table 19: T2DM Therapeutics Market, Japan, Market Forecast, 2014-2021 160

1.2 List of Figures

Figure 1: T2DM Therapeutics Market, Global, Heat Map for Marketed Products, 2015 65

Figure 2: T2DM Therapeutics Market, Global, Heat Map for Marketed Products, 2015 (continued) 66

Figure 3: T2DM Therapeutics Market, Global, Pipeline, 2015 69

Figure 4: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, 2015 72

Figure 5: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of GPCR Molecular Targets, 2015 73

Figure 6: T2DM Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Protein Kinase Molecular Targets, 2015 74

Figure 7: T2DM Therapeutics Market, Global, Clinical Trial Failure Rates and Reasons for Failure, 2006-2015 79

Figure 8: T2DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2015 80

Figure 9: T2DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2015 82

Figure 10: T2DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, (months), 2006-2015 84

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, Omarigliptin Forecast (USD m), 2015-2021 92

Figure 17: T2DM Therapeutics Market, Global, Semaglutide Products Forecast (USD bn), 2017-2021 94

Figure 18: T2DM Therapeutics Market, Global, ITCA-650 Forecast (USD m), 2017-2021 96

Figure 19: T2DM Therapeutics Market, Global, LX-4211 Forecast (USD m), 2018-2021 98

Figure 20: T2DM Therapeutics Market, Global, insulin peglispro Forecast (USD m), 2018-2021 100

Figure 21: T2DM Therapeutics Market, Global, ISIS-GCGRRx Forecast (USD m), 2020-2021 102

Figure 22: T2DM Therapeutics Market, Global, BSN-175 Forecast (USD m), 2018-2021 103

Figure 23: T2DM Market, Global, Heat Map for Pipeline Products, 2015 104

Figure 24: T2DM Therapeutics Market, Global, Competitiveness Framework for Marketed and Pipeline Products, 2015 105

Figure 25: T2DM Therapeutics Market, Global, Treatment Usage Patterns, 2014-2021 107

Figure 26: T2DM Therapeutics Market, Global, Market Size (USD bn), 2014-2021 108

Figure 27: T2DM Therapeutics Market, North America, Treatment Patterns, 2014-2021 110

Figure 28: T2DM Therapeutics Market, North America, Annual Cost of Therapy (USD ), 2014-2021 112

Figure 29: T2DM Therapeutics Market, North America, Market Size (USD bn), 2014-2021 113

Figure 30: T2DM Therapeutics Market, Top Five EU Countries, Treatment Usage Patterns, 2014-2021 115

Figure 31: T2DM Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy (USD ), 2014-2021 116

Figure 32: T2DM Therapeutics Market, Top Five Countries of Europe, Market Size (USD bn), 2014-2021 117

Figure 33: T2DM Therapeutics Market, Japan, Treatment Usage Patterns, 2014-2021 118

Figure 34: T2DM Therapeutics Market, Japan, Annual Cost of Therapy (ACoT) (USD ), 2014-2021 119

Figure 35: T2DM Therapeutics Market, Japan, Market Size (USD bn), 2014-2021 120

Figure 36: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value (USD m), 2006-2015 122

Figure 37: T2DM Mellitus Therapeutics Market, Global, Licensing Deals by Region, 2006-2015 123

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 124

Figure 39: T2DM Therapeutics Market, Global, Licensing Deals by Deal Value (USD m), Upfront Payment Value (USD m) and Stage of Development, 2006-2015 125

Figure 40: T2DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Molecule Type and Aggregate Deal Value (USD bn), 2006-2015 126

Figure 41: T2DM Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value (USD m), 2006-2015 127

Figure 42: T2DM Therapeutics Market, Global, Co-development Deals by Value (USD m), 2006-2015 129

Figure 43: T2DM Therapeutics Market, Global, Co-Development Deals by Region, 2006-2015 130

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 131

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 132

Figure 46: T2DM Therapeutics Market, Global, Co-development Deals by Stage of Development, Molecule Type and Aggregate Deal Value (USD bn), 2006-2015 134

Figure 47: T2DM Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value (USD m), 2006-2015 136

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