Global Diabetes Drugs Market to 2023 – A Diversifying Treatment Landscape as GLP-1 Receptor Agonists and SGLT-2 Inhibitors Gain Ground Following Landmark Cardiac Outcomes

This report provides insight into the diversifying and highly lucrative diabetes mellitus (DM) market. Analysis has identified a high level of diversification in the market, which is of vital importance for investors and key market players. Furthermore, the report provides insight into groundbreaking drugs, and the threats that they are likely to encounter over the forecast period. Also identified are opportunities for investment and co-marketing in key BRIC economies, where the yearly incidence of T1DM is set to exceed the total number of T1DM patients in the US.

This report also comprehensively reviews the strategies of key players in the DM market, and provides market share forecasts. Pipeline and marketed products are analyzed in detail, along with the impact that products expected to come to market between 2016 and 2023 will have on existing established products. Licensing and co-marketing deals in DM are analyzed by region and value.

There is a high unmet clinical need to develop favorable routes of administration for insulin products. Likewise, there is high unmet need for a curative or prophylactic treatment for both T1DM and T2DM.

There are currently over 800 products in the DM pipeline, with developmental molecules generally being aimed at improving on existing products. Most pipeline molecules are insulin or GLP-1 agonists. There are several combination therapy trials for the use of insulin receptor/GLP-1 agonists with other compounds – particularly SGLT-2 inhibitors. Among these products, an entirely novel SGLT1/2 inhibitor is expected to enter the market, and is expected to become a blockbuster drug, achieving licensed status for both T1DM and T2DM.

Scope

– Global revenue from the DM market between 2016 and 2023

– Novel compounds and new drugs achieving blockbuster status by 2023

– Analysis of market share changes for leading compounds by 2023

– Analysis of leading companies by market share

– Analysis of deals conducted during the 2006-2017 period

Reasons to buy

- Understand the current treatment landscape, with profile assessments of key marketed products and a focus on historical and forecast sales patterns.

- Gain insight into a highly diversifying market for DM products, and the factors behind the significant changes projected in market share between key compounds.

- Analyze the DM pipeline through a comprehensive review of products, segmented by stage of development, molecule type and molecular target - as well as detailed profile assessments and multi-scenario revenue projections for the most promising late-stage pipeline candidates.

- Consider market opportunities and potential risks associated with attempting to bring pipeline products to market by examining trends in clinical trial size, duration and failure rate by stage of development, key indication, molecule type and molecular target.

- Predict growth in market size, with multi-scenario forecasting from 2016 to 2023. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value.

- Identify the leading companies in the DM market and understand the factors that will influence growth and market share with profile assessments of key companies, including multi-scenario revenue projections.

- Identify commercial opportunities in the DM deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 7

2 Introduction 10

2.1 Overview 10

2.2 Classification of Diabetes 10

2.3 Symptoms 11

2.4 Diagnostic Criteria 11

2.5 Etiology 12

2.5.1 T1DM 12

2.5.2 T2DM 13

2.6 Pathophysiology 14

2.6.1 Physiology of Glucose Metabolism 14

2.6.2 T1DM Pathophysiology 15

2.6.3 T2DM Pathophysiology 16

2.7 Epidemiology 17

2.7.1 T1DM 18

2.7.2 T2DM 19

2.8 Comorbidities and Complications 20

2.9 Treatments 21

2.9.1 Insulin Therapy 21

2.9.2 Insulin Secretagogues 22

2.9.3 Thiazolidinediones 23

2.9.4 Biguanides 23

2.9.5 Dipeptidyl Peptidase 4 Inhibitors 23

2.9.6 Glucagon-Like Peptide-1 Receptor Agonists 24

2.9.7 Sodium-Glucose Co-Transporter-2 Inhibitors 24

2.9.8 Amylin Analogs 24

2.9.9 Combination Therapies 25

2.9.10 Non-pharmacological Therapy 25

3 Key Marketed Products 27

3.1 Overview 27

3.1.1 Market Share of the Top Five Grossing Drugs in 2016 27

3.1.2 Market Share of the Five Strongest Growing Blockbuster Drugs 28

3.2 Long-Acting Insulin Therapies (Basal Insulins) 29

3.2.1 Lantus (insulin glargine) - Sanofi 29

3.2.2 Levemir (insulin detemir) - Novo Nordisk 31

3.2.3 Tresiba (insulin degludec) - Novo Nordisk 32

3.2.4 Toujeo (insulin glargine) - Sanofi 33

3.3 Short-Acting Insulin Therapies (Bolus Insulins) 35

3.3.1 Humalog (insulin lispro) - Eli Lilly 35

3.3.2 Novolog (Insulin aspart) - Novo Nordisk 36

3.3.3 Apidra (insulin glulisine) - Sanofi 38

3.4 GLP-1 Receptor Agonists 39

3.4.1 Victoza (liraglutide) - Novo Nordisk 39

3.4.2 Trulicity (dulaglutide) - Eli Lilly 41

3.5 DPP-4 Inhibitors 42

3.5.1 Januvia (sitagliptin) - Merck and Co 42

3.5.2 Galvus (vildagliptin) - Novartis 44

3.5.3 Tradjenta (linagliptin) - Boehringer Ingelheim 45

3.6 SGLT-2 Inhibitors 46

3.6.1 Invokana (canagliflozin) - Johnson and Johnson 46

3.6.2 Jardiance (empagliflozin) - Boehringer Ingelheim 47

3.6.3 Farxiga (dapagliflozin) - AstraZeneca 49

3.7 Combination Therapies 50

3.7.1 Soliqua 100/33 (insulin glargine and lixisenatide) - Sanofi 50

3.7.2 Xultophy (insulin degludec and liraglutide) - Novo Nordisk 51

3.7.3 Janumet - Merck 52

3.7.4 Qtern (saxagliptin and dapagliflozin) - AstraZeneca 53

3.8 Unmet Needs 54

3.9 Conclusion 55

4 Pipeline Landscape Assessment 56

4.1 Overview 56

4.2 Pipeline Development Landscape 57

4.3 Molecular Targets in the Pipeline 59

4.4 Clinical Trials Landscape 61

4.4.1 Clinical Trial Failure Rates 62

4.4.2 Clinical Trial Duration 66

4.4.3 Clinical Trial Size 69

4.4.4 Aggregate Clinical Program Size 73

4.5 Assessment of Key Pipeline Products 76

4.5.1 Semaglutide (NN-9535) - Novo Nordisk 76

4.5.2 Oral Semaglutide (OG-217SC) - Novo Nordisk 77

4.5.3 ITCA 650 - Intarcia 78

4.5.4 Sotagliflozin - Lexicon Pharmaceuticals and Sanofi 79

4.5.5 Ertugliflozin - Merck and Co and Pfizer 81

5 Multi-scenario Market Forecast to 2023 82

5.1 Overall Market Size 82

5.2 Generic Penetration 86

5.3 Revenue Forecast by Molecular Target 88

5.3.1 Insulin Receptors 89

5.3.2 GLP-1 Receptors 90

5.3.3 SGLT-2 Inhibitors 90

5.3.4 DPP-4 Inhibitors 91

6 Company Analysis and Positioning 93

6.1 Revenue and Market Share Analysis by Company 93

6.1.1 Novo Nordisk - Sales from Recently Approved and Upcoming Products to Increase Already Substantial Market Share 97

6.1.2 Eli Lilly - Strong Growth to Result in Elevation to Second Place in Market 99

6.1.3 Sanofi - Large Market Share Loss Due to Declining Sales of Lantus 100

6.1.4 AstraZeneca - Growth in Revenue Largely Attributable to Farxiga Sales 101

6.1.5 Johnson and Johnson - Continued Uptake of Invokana to Drive Market Growth 102

6.1.6 Merck & Co - Patent Expiry of Januvia to Limit Growth 103

6.2 Company Landscape 104

6.3 Marketed and Pipeline Portfolio Analysis 104

7 Strategic Consolidations 107

7.1 Licensing deals 107

7.1.1 Deals by Region, Value and Year 107

7.1.2 Deals by Stage of Development and Value 109

7.1.3 Deals by Molecule Type and Molecular Target 109

7.1.4 Licensing Deals Valued at $100m or above 111

7.2 Co-Development Deals 111

7.2.1 Deals by Region, Value and Year 111

7.2.2 Deals by Stage of Development and Value 112

7.2.3 Deals by Molecule Type and Molecular Target 113

7.2.4 Co-development Deals Valued at $100m and above 115

8 Appendix 116

8.1 References 116

8.2 Abbreviations 123

8.3 List of All Pipeline Products 125

8.4 Disease List 135

8.5 Methodology 135

8.5.1 Coverage 135

8.5.2 Secondary Research 135

8.5.3 Market Size and Revenue Forecasts 136

8.5.4 Pipeline Analysis 136

8.5.5 Competitive Landscape 136

8.6 Contact Us 137

8.7 Disclaimer 137

List of Tables

1.1 List of Tables

Table 1: Diabetes Drugs Market, Global, Approved Indications for Lantus, 2017 30

Table 2: Diabetes Drugs Market, Global, Approved Indications for Levemir, 2017 31

Table 3: Diabetes Drugs Market, Global, Approved Indications for Tresiba, 2017 33

Table 4: Diabetes Drugs Market, Global, Approved Indications for Toujeo, 2017 34

Table 5: Diabetes Drugs Market, Global, Approved Indications for Humalog, 2017 35

Table 6: Diabetes Drugs Market, Global, Approved Indications for Novolog, 2017 37

Table 7: Diabetes Drugs Market, Global, Approved Indications for Apidra, 2017 38

Table 8: Diabetes Drugs Market, Global, Approved Indications for Victoza, 2017 40

Table 9: Diabetes Drugs Market, Global, Approved Indications for Trulicity, 2017 41

Table 10: Diabetes Drugs Market, Global, Approved Indications for Januvia, 2017 43

Table 11: Diabetes Drugs Market, Global, Approved Indications for Galvus, 2017 44

Table 12: Diabetes Drugs Market, Global, Approved Indications for Tradjenta, 2017 45

Table 13: Diabetes Drugs Market, Global, Approved Indications for Invokana, 2017 46

Table 14: Diabetes Drugs Market, Global, Approved Indications for Jardiance, 2017 48

Table 15: Diabetes Drugs Market, Global, Approved Indications for Farxiga, 2017 49

Table 16: Diabetes Drugs Market, Global, Approved Indications for Soliqua, 2017 50

Table 17: Diabetes Drugs Market, Global, Approved Indications for Xultophy, 2017 51

Table 18: Diabetes Drugs Market, Global, Approved Indications for Janumet, 2017 52

Table 19: Market, Global, Approved Indications for Qtern, 2017 53

Table 20: Diabetes Drugs Market, Global, Annual Revenue Forecast for Key Products ($m), 2016-2023 (Part 1) 84

Table 21: Diabetes Drugs Market, Global, Annual Revenue Forecast for Key Products ($m), 2016-2023 (Part 2) 85

Table 22: Diabetes Drugs Market, Global, Generic Usage Across Key Indications, 2017 88

Table 23: Diabetes Drugs Market, Global, Annual Revenue within Diabetes by Company, 2016-2023 94

Table 24: Abbreviations 123

List of Figures

1.2 List of Figures

Figure 1: Diabetes Drugs Market, Global, Epidemiology Patterns for T1DM, 2016-2023 18

Figure 2: Diabetes Drugs Market, Global, Epidemiology Patterns for T2DM, 2016-2023 19

Figure 3: Diabetes Drugs Market, Global, Market Share Projections for Key Established Products, 2016-2023 27

Figure 4: Diabetes Drugs Market, Global, Market Share Projections for Key Upcoming Products, 2016-2023 28

Figure 5: Diabetes Drugs Market, Global, Percentage Change in Market Share for Key Products 2016-2023 28

Figure 6: Diabetes Drugs Market, Global, Key Marketed Products and Approved Indications, 2017 29

Figure 7: Diabetes Drugs Market, Global, Annual Revenue for Lantus ($bn), 2006-2023 31

Figure 8: Diabetes Drugs Market, Global, Annual Revenue for Levemir ($bn), 2006-2023 32

Figure 9: Diabetes Drugs Market, Global, Annual Revenue for Tresiba ($bn), 2016-2023 33

Figure 10: Diabetes Drugs Market, Global, Annual Revenue for Toujeo ($bn), 2015-2023 35

Figure 11: Diabetes Drugs Market, Global, Annual Revenue for Humalog ($bn), 2006-2023 36

Figure 12: Diabetes Drugs Market, Global, Annual Revenue for Novolog ($bn), 2006-2023 38

Figure 13: Diabetes Drugs Market, Global, Annual Revenues for Apidra ($m), 2009-2023 39

Figure 14: Diabetes Drugs Market, Global, Annual Revenues for Victoza ($bn), 2009-2023 41

Figure 15: Diabetes Drugs Market, Global, Annual Revenue for Trulicity ($bn), 2014-2023 42

Figure 16: Diabetes Drugs Market, Global, Annual Revenue for Januvia ($bn), 2006-2023 43

Figure 17: Diabetes Drugs Market, Global, Annual Revenue for Galvus ($bn), 2007-2023 45

Figure 18:

Figure 17: Diabetes Drugs Market, Global, Annual Revenues for Tradjenta ($m), 2011-2023 46

Figure 19: Diabetes Drugs Market, Global, Annual Revenues for Invokana ($bn), 2013-2023 47

Figure 20: Diabetes Drugs Market, Global, Annual Revenue for Jardiance ($bn), 2014-2023 48

Figure 21: Diabetes Drugs Market, Global, Annual Revenue for Farxiga ($bn), 2013-2023 50

Figure 22: Diabetes Drugs Market, Global, Annual Revenues for Soliqua 100/33 ($m), 2017-2023 51

Figure 23: Diabetes Drugs Market, Global, Annual Revenue for Xultophy ($bn), 2017-2023 52

Figure 24: Diabetes Drugs Market, Global, Annual Revenue for Janumet ($bn), 2007-2023 53

Figure 25: Diabetes Drugs Market, Global, Annual Revenue for Qtern ($m), 2017-2023 54

Figure 26: Diabetes Drugs Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 56

Figure 27: Diabetes Drugs Market, Global, Pipeline by Stage of Development, Molecule Type and Program Type, 2017 57

Figure 28: Diabetes Drugs Market, Global, T1DM and T2DM Pipeline by Stage of Development, 2017 58

Figure 29: Diabetes Drugs Market, Global, T1DM and T2DM Pipeline by Molecule Type, 2017 59

Figure 30: Diabetes Drugs Market, Global, Pipeline by Molecular Target, 2017 60

Figure 31: Diabetes Drugs Market, Global, T1DM and T2DM Pipeline by Molecular Target, 2017 61

Figure 32: Diabetes Drugs Market, Clinical Trial Failure Rates by Stage of Development and Overall Clinical Trial Attrition Rate (%), 2006-2017 62

Figure 33: Diabetes Drugs Market, Global, Clinical Trial Failure Rates and Overall Clinical Trial Attrition Rates by Indication (%), 2006-2017 63

Figure 34: Diabetes Drugs Market, Global, Clinical Trial Failure Rates and Overall Clinical Trial Attrition Rate by Molecule Type (%), 2006-2017 64

Figure 35: Diabetes Drugs Market, Global, Clinical Trial Failure Rates and Overall Clinical Trial Attrition Rate by Molecular Target (%), 2006-2017 65

Figure 36: Diabetes Drugs Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2017 66

Figure 37: Diabetes Drugs Market, Global, Clinical Trial Duration by Indication and Stage of Development (months), 2006-2017 67

Figure 38: Diabetes Drugs Market, Global, Clinical Trial Duration by Molecule Type and Stage of Development (months), 2006-2017 68

Figure 39: Diabetes Drugs Market, Global, Clinical Trial Duration by Molecular Target and Stage of Development (months), 2006-2017 69

Figure 40: Diabetes Drugs Market, Global, Clinical Trial Size by Stage of Development, 2006-2017 69

Figure 41: Diabetes Drugs Market, Global, Clinical Trial Size by Indication and Stage of Development (participants), 2006-2017 70

Figure 42: Diabetes Drugs Market, Global, Clinical Trial Size by Molecule Type and Stage of Development (participants), 2006-2017 71

Figure 43: Diabetes Drugs Market, Global, Clinical Trial Size by Molecular Target and Stage of Development (Participants), 2006-2017 72

Figure 44: Diabetes Drugs Market, Global, Aggregate Clinical Program Size by Stage of Development, 2006-2017 73

Figure 45: Diabetes Drugs Market, Global, Aggregate Clinical Program Size by Indication and Stage of Development (participants), 2006-2017 74

Figure 46: Diabetes Drugs Market, Global, Aggregate Clinical Program Size by Molecule Type and Stage of Development (participants), 2006-2017 75

Figure 47: Diabetes Drugs Market, Global, Aggregate Clinical Program Size by Molecular Target and Stage of Development (participants), 2006-2017 76

Figure 48: Diabetes Drugs Market, Global, Revenue Forecast for Semaglutide (NN-9535) ($bn), 2017-2023 77

Figure 49: Diabetes Drugs Market, Global, Revenue Forecast for Oral Semaglutide (OG-217SC) ($bn), 2020-2023 78

Figure 50: Diabetes Drugs Market, Global, Revenue Forecast for ITCA 650 ($bn), 2018-2023 79

Figure 51: Diabetes Drugs Market, Global, Revenue Forecast for Sotagliflozin ($bn), 2018-2023 80

Figure 52: Diabetes Drugs Market, Global, Revenue Forecast for Ertugliflozin ($m), 2017-2023 81

Figure 53: Diabetes Drugs Market, Global, Annual Revenue Forecast, 2016-2023 83

Figure 54: Diabetes Drugs Market, Global, Annual Revenue Forecast for Premium and Generic Products ($bn), 2016-2023 87

Figure 55: Diabetes Drugs Market, Global, Annual Revenue Forecast for Insulin Receptors ($bn), 2016-2023 89

Figure 56: Diabetes Drugs Market, Global, Annual Revenue Forecast for GLP-1 Receptors, 2016-2023 90

Figure 57: Diabetes Drugs Market, Global, Annual Revenue Forecast for SGLT-2 Inhibitors, 2016-2023 91

Figure 58: Diabetes Drugs Market, Global, Annual Revenue Forecast for DPP-4 Inhibitors, 2016-2023 92

Figure 59: Diabetes Drugs Market, Global, Cluster by Growth and Market Share, 2016-2023 93

Figure 60: Diabetes Drugs Market, Global, Forecast Market Share by Company (%), 2016-2023 95

Figure 61: Diabetes Drugs Market Global, Companies by Compound Annual Growth Rate (%), 2016-2023 96

Figure 62: Diabetes Drugs Market, Global, Revenue by Route of Acquisition, 2016-2023 97

Figure 63: Diabetes Drugs Market, Global, Novo Nordisk Annual Revenue Forecast, ($bn), 2016-2023 98

Figure 64: Diabetes Drugs Market, Global, Eli Lilly Annual Revenue Forecast ($bn), 2016-2023 99

Figure 65: Diabetes Drugs Market, Global, Sanofi Annual Revenue Forecast ($bn), 2016-2023 100

Figure 66: Diabetes Drugs Market, Global, AstraZeneca Annual Revenue Forecast ($bn), 2016-2023 101

Figure 67: Diabetes Drugs Market, Global, Johnson & Johnson Annual Revenue Forecast ($bn), 2016-2023 102

Figure 68: Diabetes Drugs Market, Global, Merck and Co Annual Revenue Forecast ($bn), 2016-2023 103

Figure 69: Diabetes Drugs Market, Global, High-activity and Late-stage Pipeline Developers by Company Type, 2016-2023 104

Figure 70: Diabetes Drugs Market, Global, Pipeline Developers by Level of Diabetes Specialization, 2016-2023 105

Figure 71: Diabetes Drugs Market, Global, Proportion of Total Company Revenue Attributable to Diabetes, 2016-2023 106

Figure 72: Diabetes Drugs Market, Licensing Deals by Region, Value and Year, 2006-2017 108

Figure 73: Diabetes Drugs Market, Global, Number of Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 109

Figure 74: Diabetes Drugs Market, Global, Licensing Deals by Molecule Type and Molecular Target, 2006-2017 110

Figure 75: Diabetes Drugs Market, Global, Licensing Deals Valued at $100m and above, 2006-2017 111

Figure 76: Diabetes Drugs Market, Global, Co-development Deals by Region, Value and Year, 2006-2017 112

Figure 77: Diabetes Drugs Market, Global, Number of Co-development Deals by Value and Stage of Development, 2006-2017 113

Figure 78: Diabetes Drugs Market, Global, Co-development Deals by Molecule Type and Molecular Target, 2006-2017 114

Figure 79: Diabetes Drugs Market, Global, Co-development Deals Valued at $100m and above, 2006-2017 115

Figure 80: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 1) 125

Figure 81: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 2) 126

Figure 82: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 3) 127

Figure 83: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 4) 128

Figure 84: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 5) 129

Figure 85: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 6) 130

Figure 86: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 7) 131

Figure 87: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 8) 132

Figure 88: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 9) 133

Figure 89: Diabetes Drugs Market, Global, All Pipeline Products, 2017 (Part 10) 134

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