Global Diabetes and Obesity Drugs Market to 2022 - Insulins and GPCRs Retain Commercial Prominence, While High Unmet Need Remains in Weight Loss Treatment

GBI Research
100 Pages - GBI10554
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Summary

Diabetes is a chronic metabolic disease characterized by hyperglycemia (high blood glucose levels) that results from defects in insulin secretion, insulin action, or both. Chronic hyperglycemia in diabetic patients 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). Obesity, meanwhile, is defined as abnormal or excessive body fat accumulation that presents a risk to health.

A current global rise in T2DM prevalence is intrinsically linked with the current global rise in obesity. The rapidly increasing global obesity prevalence has resulted in it being considered a global epidemic, and there is a vast and growing global patient population potentially requiring pharmacotherapeutic treatment.

Historically anti-obesity therapeutics have been out of favor due to safety concerns. Both diabetes and obesity products are commonly associated with cardiovascular adverse events, and this is further compounded by concerns relating to cancer development through long-term usage of anti-obesity products. This has resulted in an unmet need for products with favorable safety and efficacy profiles, particularly in the case of obesity.

The market size for the diabetes and obesity disease cluster is set to increase considerably, driven by the success of a number of T2DM pipeline products, and a rapidly expanding global patient population. However, obesity pipeline activity is set to remain markedly low, despite a patient population of epidemic proportions.

Scope

- What are the current treatment options for diabetes and obesity?
- What are the common molecular targets of pipeline therapies, and how strongly do they overlap with the current market?
- Will the pipeline address unmet needs such as a lack of safe treatment options for diabetes and obesity patients?
- Which late-stage pipeline products are likely to impact the current market?
- How are revenues of key companies, targets and molecule types anticipated to change over the forecast period?
- Which companies are anticipated to be the most prominent players over the next seven years?
- How do licensing and co-development deals compare between diabetes and obesity?

Reasons to buy

- Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
- Visualize the composition of the diabetes and obesity market in terms of the clinical and commercial standing of current dominant therapies. Unmet needs are highlighted to allow a competitive understanding of gaps in the current market.
- Analyze the diabetes and obesity pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There is a strong contrast in the amount of pipeline activity for diabetes and obesity.
- Analyze how individual company, molecule type and molecular target revenues are anticipated to change over the forecast period, highlighting prominent companies and the most promising molecule types and targets.
- Identify which companies are the current key players for the disease cluster, and how this pattern is anticipated to change over the forecast period.
- Identify commercial opportunities in the diabetes and obesity deals landscape by analyzing trends in licensing and co-development deals by stage of development, molecule type and molecular target.

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1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 6
2 Introduction 9
2.1 Therapy Area Introduction 9
2.1.1 Diabetes 9
2.1.2 Obesity 10
2.2 Symptoms 11
2.2.1 Diabetes 11
2.2.2 Obesity 11
2.3 Etiology and Pathophysiology 11
2.3.1 Type 1 Diabetes Mellitus 11
2.3.2 Type 2 Diabetes Mellitus 12
2.3.3 Obesity 12
2.3.4 The Association between Obesity and T2DM 13
2.4 Comorbidities and Complications 13
2.5 Epidemiology Patterns and Forecasts across the 7MM 14
2.5.1 Diabetes 15
2.5.2 Obesity 17
2.6 Treatment 17
2.6.1 Diabetic Pharmacotherapeutics 17
2.6.2 Insulin Therapy 18
2.6.3 Amylin Analogs 19
2.6.4 Obesity Pharmacotherapeutics 20
3 Key Marketed Products 22
3.1 Overview 22
3.2 Diabetes - Top Eight Key Marketed Products 23
3.2.1 Lantus (insulin glargine) - Sanofi 23
3.2.2 Novolog (insulin aspart) - Novo Nordisk 24
3.2.3 Januvia (sitagliptin phosphate) - Merck & Co 25
3.2.4 Levemir (insulin detemir) - Novo Nordisk 26
3.2.5 Victoza (liraglutide) - Novo Nordisk 27
3.2.6 Humalog (insulin lispro) - Eli Lilly 28
3.2.7 Janumet (metformin hydrochloride plus sitagliptin phosphate) - Merck & Co 29
3.2.8 New Market Entrants 30
3.3 Obesity Overview 31
3.3.1 Saxenda (liraglutide) 32
3.3.2 Belviq (lorcaserin hydrochloride) 33
3.3.3 Xenical (orlistat) 34
3.3.4 Contrave (bupropion hydrochloride plus naltrexone) 34
3.4 Conclusion 35
4 Pipeline Landscape Assessment 36
4.1 Overview 36
4.2 Pipeline Development Landscape 37
4.3 Molecular Targets in the Pipeline 40
4.4 Clinical Trials 43
4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 43
4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 47
4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 50
4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 53
4.5 Late-Stage Drugs of the Developmental Pipeline 56
4.5.1 Saxagliptin plus dapagliflozin (dapagliflozin propanediol plus saxagliptin) - AstraZeneca 56
4.5.2 Semaglutide (OG-217SC and NN-9535 - Oral and Subcutaneous) - Novo Nordisk 57
4.5.3 LixiLan (insulin glargine plus lixisenatide) - Sanofi 58
4.5.4 NN-1218 (insulin aspart) - Novo Nordisk 59
4.5.5 Ertugliflozin (PF-04971729) - Merck & Co/Pfizer 60
4.5.6 Sotagliflozin - Lexicon Pharmaceuticals 61
4.6 Conclusion 62
5 Multi Scenario Market Forecast to 2022 63
5.1 Overall Market Size 63
5.2 Generic Penetration 64
5.3 Revenue Forecast by Molecular Target 65
5.3.1 Insulin Receptor 65
5.3.2 GLP1R 66
5.3.3 DPP4 67
5.3.4 SGLT2 68
5.3.5 AMPK 69
5.3.6 ABCC8 70
5.4 Conclusion 71
6 Company Analysis and Positioning 72
6.1 Revenue and Market Share Analysis by Company 73
6.1.1 Novo Nordisk 77
6.1.2 Eli Lilly 78
6.1.3 Sanofi 79
6.1.4 Merck & Co 80
6.1.5 AstraZeneca 81
6.1.6 Takeda 82
6.2 Company Landscape 83
6.3 Marketed and Pipeline Portfolio Analysis 84
7 Strategic Consolidations 87
7.1 Licensing Deals 87
7.1.1 Deals by Region, Year and Value 87
7.1.2 Deals by Stage of Development and Value 88
7.1.3 Deals by Molecule Type, Mechanism of Action and Value 89
7.2 Co-development Deals 90
7.2.1 Deals by Region, Year and Value 90
7.2.2 Deals by Stage of Development and Value 91
7.2.3 Deals by Molecule Type, Mechanism of Action and Value 92
8 Appendix 94
8.1 References 94
8.2 Abbreviations 97
8.3 Methodology 98
8.3.1 Coverage 98
8.3.2 Secondary Research 99
8.3.3 Market Size and Revenue Forecasts 99
8.3.4 Pipeline Analysis 99
8.3.5 Competitive Landscape 100
8.4 Contact Us 100
8.5 Disclaimer 100

1.1 List of Tables
Table 1: Body Mass Index Classifications 10
Table 2: Epidemiology of T1DM, T2DM and Obesity, Global, 2016 15
Table 3: Obesity Therapeutics Market, Seven Major Markets, Summary of the Action, Efficacy and Pathway of the Six Top-Selling FDA-Approved Pharmacotherapeutics, 2015 21
Table 4: Diabetes and Obesity Therapeutics Market, Global, Number of Pipeline Products, 2015 36

1.2 List of Figures
Figure 1: Diabetes and Obesity Therapeutics Market, Seven Major Markets, Prevalence (%) and Number of Patients (‘000) with T1DM, 2015-2022 16
Figure 2: Diabetes and Obesity Therapeutics Market, Seven Major Markets, Prevalence (%) and Number of Patients (‘000) with T2DM, 2015-2022 16
Figure 3: Diabetes and Obesity Therapeutics Market, Seven Major Markets, Prevalence (%) and Number of Patients (‘000) with Obesity, 2015-2022 17
Figure 4: Diabetes and Obesity Therapeutics Market, Seven Major Markets, Key Marketed Products and Indications, 2015 23
Figure 5  : Diabetes Therapeutics Market, Global, Annual Revenue for Lantus ($bn), 2006-2022 24
Figure 6 : Diabetes Therapeutics Market, Global, Annual Revenue for Novolog ($bn), 2006-2022 25
Figure 7 : Diabetes Therapeutics Market, Global, Annual Revenue for Januvia ($bn), 2006-2022 26
Figure 8: Diabetes Therapeutics Market, Global, Annual Revenue for Levemir ($bn), 2006-2022 27
Figure 9: Diabetes Therapeutics Market, Global, Annual Revenue for Victoza ($bn), 2006-2022 28
Figure 10: Diabetes Therapeutics Market, Global, Annual Revenue for Humalog ($bn), 2006-2022 29
Figure 11: Diabetes Therapeutics Market, Global, Annual Revenue for Janumet ($bn), 2006-2022 30
Figure 12: Diabetes Therapeutics Market, Global,  Current and Pipeline indications of Additional  Therapeutics for which Annual Revenue is Expected to Exceed $2 billion by 2022 31
Figure 13: Diabetes Therapeutics Market, Global, Expected Revenues for Additional Therapeutics for which Annual Revenue is Expected to Exceed $2 billion by 2022 31
Figure 14: Obesity Therapeutics Market, Global, Annual Revenue for Saxenda ($m), 2015-2022 32
Figure 15: Obesity Therapeutics Market, Global, Annual Revenue for Belviq ($m), 2013-2022 33
Figure 16: Obesity Therapeutics Market, Global, Annual Revenue for Xenical ($m), 2006-2012 34
Figure 17: Overall Pharmaceutical Industry Pipeline by Therapy Area, Global, 2015 36
Figure 18: Diabetes and Obesity Therapeutics Market, Global, Pipeline by Stage of Development, Molecule Type and Program Type, 2016 38
Figure 19: Diabetes and Obesity Therapeutics Market, Global, Pipeline by Indication and Stage of Development, 2016 39
Figure 20: Diabetes and Obesity Therapeutics Market, Global, Pipeline by Indication and Molecule Type, 2016 40
Figure 21: Diabetes and Obesity Therapeutics Market, Global, Pipeline for by Molecular Target, 2016 41
Figure 22: Diabetes and Obesity Therapeutics Market, Global, Pipeline by Indication and Molecular Target, 2016 42
Figure 23: Diabetes and Obesity Therapeutics Market, Global, Pipeline by Indication and ‘Multiple’ Subcategory of Molecular Target, 2016 43
Figure 24: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development, 2006-2016 44
Figure 25: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Attrition Rates by Indication and Stage of Development, 2006-2015 45
Figure 26: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type, 2006-2016 46
Figure 27: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target, 2006-2016 47
Figure 28: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Duration (months) by Stage of Development and Indication, 2006-2016 48
Figure 29: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Duration (months) by Stage of Development and Molecule Type, 2006-2015 49
Figure 30: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Duration (months) by Stage of Development and Molecular Target, 2006-2016 50
Figure 31: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Size (participants) by Stage of Development and Indication, 2006-2015 51
Figure 32: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Size (participants) by Stage of Development and Molecule Type, 2006-2015 52
Figure 33: Diabetes and Obesity Therapeutics Market, Global, Clinical Trial Size (participants) by Stage of Development and Molecular Target, 2006-2015 53
Figure 34: Diabetes and Obesity Therapeutics Market, Global, Clinical Program Size (participants) by Stage of Development and Indication, 2006-2015 54
Figure 35: Diabetes and Obesity Therapeutics Market, Global, Clinical Program Size (participants) by Stage of Development and Molecule Type, 2006-2015 55
Figure 36: Diabetes and Obesity Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecular Target, 2006-2015 56
Figure 37: Diabetes and Obesity Therapeutics Market, Global, Revenue Forecast for Saxagliptin plus Dapagliflozin ($m), 2015-2022 57
Figure 38: Diabetes and Obesity Therapeutics Market, Global, Revenue Forecast for NN-9535 ($m), 2015-2022 58
Figure 39: Diabetes and Obesity Therapeutics Market, Global, Revenue Forecast for LixiLan ($m), 2015-2022 59
Figure 40: Diabetes and Obesity Therapeutics Market, Global, Revenue Forecast for NN-1218 ($m), 2015-2022 60
Figure 41: Diabetes and Obesity Therapeutics Market, Global, Revenue Forecast for Ertugliflozin ($m), 2015-2022 61
Figure 42: Diabetes and Obesity Therapeutics Market, Global, Revenue Forecast for Sotagliflozin ($m), 2015-2022 62
Figure 43: Diabetes and Obesity Therapeutics Market, Global, Market Size ($bn), 2015-2022 64
Figure 44: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for Key Products ($bn), 2015-2022 65
Figure 45: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for Insulin Mimetics ($bn), 2015-2022 66
Figure 46: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for GLP1R Agonists ($bn), 2015-2022 67
Figure 47: Diabetes and Obesity Therapeutics Market , Global, Annual Revenue Forecast for DPP4 Inhibitors ($bn), 2015-2022 68
Figure 48: Diabetes and Obesity Therapeutics Market , Global, Annual Revenue Forecast for SGLT2 Inhibitors ($bn), 2015-2022 69
Figure 49: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for AMPK Activators ($bn), 2015-2022 70
Figure 50: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for ABCC8 Inhibitors ($m), 2015-2022 71
Figure 51: Diabetes and Obesity Therapeutics Market, Global, Cluster by Growth and Market Share, 2015-2022 72
Figure 52: Diabetes and Obesity Therapeutics Market, Global, Forecast Revenues by Company ($m), 2015-2022 73
Figure 53: Diabetes and Obesity Therapeutics Market, Global, Forecast Market Share by Company (%), 2015-2022 75
Figure 54: Diabetes and Obesity Therapeutics Market, Global, Companies by Compound Annual Growth Rate (%), 2015-2022 76
Figure 55: Diabetes and Obesity Therapeutics Market , Global, Revenues by Product Type ($bn), 2015-2022 77
Figure 56: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for Novo Nordisk ($bn), 2015-2022 78
Figure 57: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for Eli Lilly ($bn), 2015-2022 79
Figure 58: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for Sanofi ($bn), 2015-2022 80
Figure 59: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for Merck & Co ($bn), 2015-2022 81
Figure 60: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for AstraZeneca ($bn), 2015-2022 82
Figure 61: Diabetes and Obesity Therapeutics Market, Global, Annual Revenue Forecast for Takeda Pharmaceutical Company Limited ($bn), 2015-2022 83
Figure 62: Diabetes and Obesity Therapeutics Market , Global, High-activity and Late-stage Companies by Type, 2015 84
Figure 63: Diabetes and Obesity Therapeutics Market, Global, Companies by Specialization and Type, 2015 85
Figure 64: Diabetes and Obesity Therapeutics Market, Global, Proportion of Total Company Revenue Attributable to Disease Cluster, 2015-2022 86
Figure 65: Diabetes and Obesity Therapeutics Market , Global, Licensing Deals by Region, Value And Year, 2006-2015 88
Figure 66: Diabetes and Obesity Therapeutics Market, Global, Number of Licensing Deals by Value and Stage of Development, 2006-2015 89
Figure 67: Diabetes and Obesity Therapeutics Market , Global, Number of Licensing Deals by Molecule Type and Molecular Target, 2006-2015 90
Figure 68: Diabetes and Obesity Therapeutics Market , Global, Co-development Deals by Region, Value and Year, 2006-2015 91
Figure 69: Diabetes and Obesity Therapeutics Market, Global, Co-development Deals by Value and Stage of Development, 2006-2015 92
Figure 70: Diabetes and Obesity Therapeutics Market , Global, Number of Co-development Deals by Molecule Type and Molecular Target, 2006-2015 93

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