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Type 2 Diabetes Therapeutics Market to 2019 - A Shifting Treatment Algorithm and Intensified Competition Expected to Drive Growth by 2019

GBI Research
Published Date » 2013-10-18
No. Of Pages » 123

GBI Research has released its latest report for the pharmaceuticals industry, “Type 2 Diabetes Therapeutics Market to 2019 A Shifting Treatment Algorithm and Intensified Competition Expected to Drive Growth by 2019”. There is currently a large number of blood glucose-lowering drugs in the crowded type 2 diabetes market indicated for the treatment of chronically high blood glucose. The market is led by Lantus, which achieved global sales amounting to $6.4 billion in 2012. Over the forecast period from 2012 to 2019, the safer, more efficacious newer classes of drug (GLP-1 agonists, DPP-4 Inhibitors and SGLT-2 inhibitors) are expected to capture substantial market shares, largely replacing older classes such as sulfonylureas and thiazolidinediones. Additionally, a variety of novel drugs belonging to these newer classes are due to enter the market, and are expected to offer a moderate improvement in terms of efficacy and safety. The price of these new therapies is expected to be high, but this is unlikely to hinder their uptake. As a result, as well as an overall increase in the prevalent population, GBI Research believes that the value of the global market has the potential to grow to reach $38.8 billion by 2019.

Scope

  • A brief introduction to type 2 diabetes, including the symptoms, pathogenesis, risk factors and diagnosis
  • In-depth analysis of major glucose-lowering drugs for type 2 diabetes, including analyses of their safety, efficacy, treatment patterns, strengths/weaknesses and overall commercial prospects. Includes a heat map comparing major drugs in terms of safety, efficacy and dosing parameters.
  • Comprehensive review of the pipeline for type 2 diabetes therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule types and molecular targets.
  • Additional in-depth analysis of pipeline drug clinical trials by phase, molecule type, trial size, trial duration and program failure rate analyses for each molecule type and mechanism of action
  • Multi-scenario forecast data for the market up to 2019, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs, and changes in disease epidemiology across key developed markets including the US, Japan, Germany, the UK, France, Italy and Spain
  • Discussion of the drivers and barriers for market growth

Reasons to buy

  • Understand the many different types of type 2 diabetes therapies on the market, from the older, established classes of treatment to newer, moderately superior types of drug, and their positions in the treatment algorithm
  • Understand the strengths and weaknesses of each product
  • Understand the scope of the pipeline, including which molecule types and mechanisms of action are prominent
  • Observe trends in clinical trial duration and size amongst clinical phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for type 2 diabetes therapeutics
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the type 2 diabetes therapeutics market.
Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 9

2 Introduction 10
2.1 Epidemiology 10
2.2 Symptoms 10
2.3 Etiology 11
2.4 Pathophysiology 11
2.5 Co-morbidities and Complications 12
2.6 Classification 13
2.7 Prognosis 14
2.8 Diagnosis 14
2.9 Assessing Treatment Effectiveness 16
2.10 Treatment Algorithm 16
2.10.1 The Role of Insulin in Type 2 Diabetes 18
2.10.2 Non-insulin Diabetic Drugs 19
2.10.3 Other Drugs 21

3 Key Marketed Products 22
3.1 Metformin 22
3.2 DPP-4 Inhibitors 23
3.2.1 Januvia (sitagliptin) – Merck & Co 23
3.2.2 Tradjenta (linagliptin) – Boehringer Ingelheim 24
3.2.3 Onglyza (saxagliptin) – Bristol-Myers Squibb and AstraZeneca 25
3.2.4 Nesina (alogliptin) – Takeda 25
3.2.5 Galvus (vildagliptin) – Novartis 26
3.2.6 Tenelia (teneligliptin) – Daiichi Sankyo and Mitsubishi Tanabe 27
3.3 GLP-1 Agonists 28
3.3.1 Byetta and Bydureon (exenatide) – Bristol-Myers Squibb 28
3.3.2 Lyxumia (lixisenatide) – Sanofi 29
3.3.3 Victoza (liraglutide) – Novo Nordisk 30
3.4 Sulfonylureas 31
3.4.1 Glimepiride 31
3.4.2 Gliclazide 31
3.5 Thiazolidinediones 32
3.5.1 Actos (pioglitazone) – Takeda Pharmaceuticals Limited 32
3.5.2 Avandia (rosiglitazone) – GlaxoSmithKline 33
3.6 Long-Acting Insulins 34
3.6.1 Lantus (insulin glargine) – Sanofi 34
3.6.2 Levemir (insulin detemir) – Novo Nordisk 35
3.6.3 Tresiba and Ryzodeg (Insulin degludec) – Novo Nordisk 36
3.7 SGLT-2 Inhibitors 37
3.7.1 Forxiga (dapagliflozin) – Bristol-Myers Squibb 37
3.7.2 Invokana (canagliflozin) – Janssen 37
3.8 Heat Map for Marketed Products 38

4 Pipeline for Type 2 Diabetes 41
4.1 Overall Pipeline 41
4.2 Therapeutic Classes 42
4.3 Rate of Attrition 44
4.3.1 Failure Rate by Molecule Type 44
4.3.2 Failure Rate by Therapeutic Class 45
4.4 Reasons for Failure of Developmental Programs 48
4.5 Clinical Trial Duration 48
4.5.1 Duration by Molecule Type 48
4.5.2 Duration by Therapeutic Class 49
4.6 Clinical Trial Size 51
4.6.1 Clinical Trial Size by Molecule Type 52
4.6.2 Clinical Trial Size by Therapeutic Class 53
4.7 Promising Drugs in the Pipeline 55
4.7.1 LY-2189265 (dulaglutide) – Eli Lilly 55
4.7.2 Albiglutide – GlaxoSmithKline 55
4.7.3 LC15-044 (gemigliptin) – LG Life Sciences 56
4.7.4 TAK-875 – Takeda 56
4.7.5 Ipragliflozin – Astellas Pharma 57
4.7.6 LX-4211 – Lexicon Pharmaceuticals 57
4.7.7 Imeglimin – Poxel SA 58
4.7.8 CCX-140-B – ChemoCentryx 58
4.7.9 Semaglutide – Novo Nordisk A/S 59
4.7.10 PC-DAC Exendin-4 – ConjuChem Biotechnologies 59
4.8 Heat Map for Pipeline Products 59
4.9 Conclusion 62

5 Market Forecast to 2019 64
5.1 Global Market 64
5.1.1 Treatment Usage Patterns 64
5.1.2 Market Size 65
5.2 US 66
5.2.1 Treatment Usage Patterns 66
5.2.2 Annual Cost of Therapy 67
5.2.3 Market Size 67
5.3 Top Five Countries of Europe 68
5.3.1 Treatment Usage Patterns 68
5.3.2 Annual Cost of Therapy 69
5.3.3 Market Size 70
5.4 Japan 72
5.4.1 Treatment Usage Patterns 72
5.4.2 Annual Cost of Therapy 72
5.4.3 Market Size 73
5.5 Drivers and Barriers 73
5.5.1 Drivers 73
5.5.2 Barriers 74

6 Deals and Strategic Consolidations 75
6.1 Licensing Deals 75
6.1.1 TransTech Pharma Enters into Licensing Agreement with Forest Laboratories 78
6.1.2 Xoma Enters into Licensing Agreement with Les Laboratoires Servier for Xoma 052 78
6.1.3 Zealand Pharma Enters into a Licensing and Collaboration Agreement with Boehringer Ingelheim 78
6.1.4 Exelixis Enters into Licensing Agreement with Bristol-Myers Squibb for XL475 79
6.1.5 Prosidion Limited Enters into a Licensing Agreement with Eli Lilly and Company 79
6.1.6 Metabolex Enters into Licensing Agreement with Sanofi 79
6.1.7 Wellstat Enters into a License Agreement with Sanofi 79
6.1.8 CureDM and Lankenau Institute Enter into a Licensing Agreement with Sanofi 79
6.1.9 Metabolex Enters into a Development and Licensing Agreement with Janssen Pharmaceuticals 80
6.1.10 Dainippon Sumitomo Pharma Enters into Licensing Agreement with Intercept Pharma for INT-747 80
6.1.11 Ipsen Enters into Licensing Agreement with F. Hoffmann-La Roche for BIM 51077 80
6.1.12 Glenmark Pharma Enters into Licensing Agreement with Merck KGaA 80
6.1.13 Euroscreen Enters into Licensing Agreement with Janssen Pharmaceuticals 81
6.1.14 Phenomix Enters into Licensing Agreement with Chiesi Farmaceutici 81
6.1.15 Otsuka Pharma Enters into Licensing Agreement with Kyowa Hakko Kirin for Saxagliptin 81
6.1.16 Nastech Pharma Enters into Licensing Agreement with Amylin Pharma 81
6.1.17 Emisphere Technologies Enters into a Licensing Agreement with Novo Nordisk 81
6.1.18 Array BioPharma Enters into a Licensing Agreement with Amgen 82
6.1.19 Theratechnologies Enters into a Licensing Agreement with OctoPlus 82
6.1.20 Diabetica Enters into a Licensing Agreement with Amylin 82
6.1.21 Celtic Therapeutics Enters into a Licensing Agreement with Bellus Health 82
6.1.22 Aradigm Enters into a Licensing Agreement with Novo Nordisk 83
6.1.23 Santarus Enters into a License Agreement with Shore Therapeutics 83
6.1.24 Depomed Enters into a Licensing Agreement with Boehringer Ingelheim 83
6.1.25 Depomed Enters into a Licensing Agreement with Merck 83
6.1.26 Depomed Enters into a Licensing Agreement with Teva 84
6.2 Co-development Deals 84
6.2.1 Eli Lilly Enters into a Co-development Agreement with Boehringer Ingelheim 85
6.2.2 AstraZeneca Enters into Co-development Agreement with Bristol-Myers Squibb 86
6.2.3 Metabolex Enters into a Co-development Agreement with Janssen Pharmaceuticals 86
6.2.4 Amylin Pharma Terminates Co-development Agreement with Eli Lilly for Exenatide 86
6.2.5 Isis Enters into a Collaboration Agreement with Janssen Pharmaceuticals 86
6.2.6 Neurocrine Biosciences Enters into a Collaboration Agreement with Boehringer Ingelheim 87
6.2.7 Intercept Pharma Enters into Co-development Agreement with Servier 87
6.2.8 Transition Therapeutics Enters into an Agreement with Eli Lilly 87
6.2.9 Ambrx Enters into a Co-Development Agreement with Bristol-Myers Squibb 87
6.2.10 Biocompatibles Enters into a Co-Development Agreement with AstraZeneca 88

7 Appendix 89
7.1 All Pipeline Drugs by Stage of Development 89
7.1.1 Discovery 89
7.1.2 Preclinical and IND-filed 91
7.1.3 Phase I 95
7.1.4 Phase II 98
7.1.5 Phase III and Pre-registration 102
7.1.6 Undisclosed 104
7.2 Market Forecasts to 2019 105
7.2.1 Global 105
7.2.2 US 105
7.2.3 UK 106
7.2.4 France 106
7.2.5 Germany 107
7.2.6 Italy 107
7.2.7 Spain 108
7.2.8 Japan 108
7.3 Market Definitions 109
7.4 Abbreviations 109
7.5 References for Heat Maps 112
7.6 References 114
7.7 Research Methodology 119
7.7.1 Coverage 119
7.7.2 Secondary Research 120
7.7.3 Primary Research 120
7.8 Therapeutic Landscape 121
7.9 Epidemiology-based Forecasting 121
7.10 Market Size by Geography 122
7.11 Geographical Landscape 123
7.12 Pipeline Analysis 123
7.13 Expert Panel Validation 123
7.14 Contact Us 123
7.15 Disclaimer 123

List of Tables


Table 1: The Relationship between HbA1c and Mean Blood Glucose 15
Table 2: Pipeline Drugs (Discovery) 89
Table 3: Pipeline Drugs (Preclinical and IND-filed) 91
Table 4: Pipeline Drugs (Phase I) 95
Table 5: Pipeline Drugs (Phase II) 98
Table 6: Pipeline Drugs (Phase III) 102
Table 7: Pipeline Drugs (Undisclosed stage of development) 104
Table 8: Type 2 Diabetes Therapeutics Market, Global, Market Forecast, 2012–2019 105
Table 9: Type 2 Diabetes Therapeutics Market, US, Market Forecast, 2012–2019 105
Table 10: Type 2 Diabetes Therapeutics Market, UK, Market Forecast, 2012–2019 106
Table 11: Type 2 Diabetes Therapeutics Market, France, Market Forecast, 2012–2019 106
Table 12: Type 2 Diabetes Therapeutics Market, Germany, Market Forecast, 2012–2019 107
Table 13: Type 2 Diabetes Therapeutics Market, Italy, Market Forecast, 2012–2019 107
Table 14: Type 2 Diabetes Therapeutics Market, Spain, Market Forecast, 2012–2019 108
Table 15: Type 2 Diabetes Therapeutics Market, Japan, Market Forecast, 2012–2019 108
Table 16: Type 2 Diabetes Therapeutics Market, Global, References for Heat Maps, 2013 112

List of Figures


Figure 1: Type 2 Diabetes Therapeutics Market, Global, Composite Treatment Algorithm, 2013 17
Figure 2: Type 2 Diabetes Therapeutics Market, Global, Sales of Januvia and Janumet ($m), 2006-2012 23
Figure 3: Type 2 Diabetes Therapeutics Market, Global, Sales of Onglyza ($m), 2009-2012 25
Figure 4: Type 2 Diabetes Therapeutics Market, Global, Sales of Galvus ($m), 2007–2012 26
Figure 5: Type 2 Diabetes Therapeutics Market, Global, Sales of Byetta ($m), 2005–2010 28
Figure 6: Type 2 Diabetes Therapeutics Market, Global, Sales of Victoza ($m), 2009–2012 30
Figure 7: Type 2 Diabetes Therapeutics Market, Global, Sales of Actos ($m), 2003-2011 32
Figure 8: Type 2 Diabetes Therapeutics Market, Global, Sales of Avandia ($m), 1999–2012 33
Figure 9: Type 2 Diabetes Therapeutics Market, Global, Sales of Lantus ($m), 2003-2012 34
Figure 10: Type 2 Diabetes Therapeutics Market, Global, Sales of Levemir (As reported by Novo Nordisk), 2008-2012 35
Figure 11: Type 2 Diabetes Therapeutics Market, Global, Heat Map of Marketed Products, 2013 39
Figure 12: Type 2 Diabetes Therapeutics Market, Global, Sales of Novel Products ($m, Years after Approval), 1998–2012 40
Figure 13: Type 2 Diabetes Therapeutics Pipeline Overview 41
Figure 14: Type 2 Diabetes Therapeutics Market, Global, Therapeutic Classes 42
Figure 15: Type 2 Diabetes Therapeutics Market, Global, Clinical Trial Failure Rate (%), 2006–2013 44
Figure 16: Type 2 Diabetes Therapeutics Market, Global, Failure Rate by Molecule Type, 2006–2013 45
Figure 17: Type 2 Diabetes Therapeutics Market, Global, Failure Rate by Therapeutic Class, 2006–2013 46
Figure 18: Type 2 Diabetes Therapeutics Market, Global, Reasons for Clinical Trial Failure (%), 2006–2013 48
Figure 19: Type 2 Diabetes Therapeutics Market, Global, Clinical Trial Duration, 2006–2013 49
Figure 20: Type 2 Diabetes Therapeutics Market, Mean Clinical Trial Duration by Therapeutic Class, Global, 2006–2013 50
Figure 21: Type 2 Diabetes Therapeutics Market, Mean and Median Clinical Trial Size, Global, 2006–2013 51
Figure 22: Type 2 Diabetes Therapeutics Market, Clinical Trial Size by Molecule Type, Global, 2006–2013 52
Figure 23: Type 2 Diabetes Therapeutics Market, Clinical Trial Size by Therapeutic Class, Global, 2006–2013 53
Figure 24: Type 2 Diabetes Therapeutics Market, Heat Map of Pipeline Products 60
Figure 25: Type 2 Diabetes Therapeutics Market, Global, Heat Map of Marketed Products, 2013 61
Figure 26: Type 2 Diabetes Therapeutics Market, Global, Treatment Usage Patterns (‘000), 2012–2019 64
Figure 27: Type 2 Diabetes Therapeutics Market, Global, Market Size ($m), 2012–2019 65
Figure 28: Type 2 Diabetes Therapeutics Market, US, Treatment Usage Patterns, 2012–2019 66
Figure 29: Type 2 Diabetes Therapeutics Market, Global, Market Size ($m), 2012–2019 67
Figure 30: Type 2 Diabetes Therapeutics Market, Top Five Countries of Europe, Treatment Usage Patterns, 2012–2019 68
Figure 31: Type 2 Diabetes Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2012–2019 69
Figure 32: Type 2 Diabetes Therapeutics Market, Top Five Countries of Europe, Market Size ($m), 2012–2019 71
Figure 33: Type 2 Diabetes Therapeutics Market, Japan, Treatment Usage Patterns, 2012–2019 72
Figure 34: Type 2 Diabetes Therapeutics Market, Japan, Market Size ($m), 2012–2019 73
Figure 35: Type 2 Diabetes Therapeutics Market, Global, Licensing Deals by Country, 2006–2013 75
Figure 36: Type 2 Diabetes Therapeutics Market, Global, Licensing Deals, 2006–2013 76
Figure 37: Type 2 Diabetes Therapeutics Market, Global, Licensing Deals, 2006–2013 77
Figure 38: Type 2 Diabetes Therapeutics Market, Global, Licensing Deals by Country, 2006–2013 84
Figure 39: Type 2 Diabetes Therapeutics Market, Global, Co-development Deals, 2006–2012 85
Figure 40: GBI Research Market Forecasting Model 122

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