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

Published By :

GBI Research

Published Date : Oct 2013

Category :

Diabetes

No. of Pages : 120 Pages

GBI Research has released its latest report for the pharmaceuticals industry, “Type 2 Diabetes 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
1.1 List of Tables 5
1.2 List of Figures 6

2 Executive Summary 7
2.1 A Highly Competitive and Growing Market 7
2.2 Strong Pipeline Containing a Diverse Set of Products 8

3 Introduction 9
3.1 Epidemiology 9
3.2 Symptoms 9
3.3 Etiology 10
3.4 Pathophysiology 10
3.5 Co-morbidities and Complications 11
3.6 Classification 12
3.7 Prognosis 13
3.8 Diagnosis 13
3.9 Assessing Treatment Effectiveness 15
3.10 Treatment Algorithm 15
3.10.1 The Role of Insulin in Type 2 Diabetes 17
3.10.2 Non-insulin Diabetic Drugs 18
3.10.3 Other Drugs 20
3.11 GBI Research Report Guidance 20

4 Key Marketed Products 21
4.1 DPP-4 Inhibitors 21
4.1.1 Januvia (sitagliptin) – Merck & Co 21
4.1.2 Tradjenta (linagliptin) – Boehringer Ingelheim 23
4.1.3 Onglyza (saxagliptin) – Bristol-Myers Squibb and AstraZeneca 24
4.1.4 Nesina (alogliptin) – Takeda 24
4.1.5 Galvus (vildagliptin) – Novartis 25
4.2 GLP-1 Agonists 26
4.2.1 Byetta and Bydureon (exenatide) – Bristol-Myers Squibb 26
4.2.2 Lyxumia (lixisenatide) – Sanofi 27
4.2.3 Victoza (liraglutide) – Novo Nordisk 28
4.3 Sulfonylureas 28
4.3.1 Glimepiride 28
4.3.2 Gliclazide 29
4.4 Thiazolidinediones 30
4.4.1 Actos (pioglitazone) – Takeda Pharmaceuticals Limited 30
4.4.2 Avandia (rosiglitazone) – GlaxoSmithKline 31
4.5 Other 32
4.5.1 Metformin 32
4.5.2 Lantus (insulin glargine) – Sanofi 33
4.5.3 Levemir (insulin detemir) – Novo Nordisk 34
4.5.4 Forxiga (dapagliflozin) – Bristol-Myers Squibb 35
4.6 Heat Map for Marketed Products 35

5 Pipeline for Type 2 Diabetes 39
5.1 Overall Pipeline 39
5.2 Therapeutic Classes 40
5.3 Rate of Attrition 42
5.3.1 Failure Rate by Molecule Type 42
5.3.2 Failure Rate by Therapeutic Class 44
5.4 Reasons for Failure of Developmental Programs 46
5.5 Clinical Trial Duration 46
5.5.1 Duration by Molecule Type 46
5.5.2 Duration by Therapeutic Class 47
5.6 Clinical Trial Size 48
5.6.1 Clinical Trial Size by Molecule Type 49
5.6.2 Clinical Trial Size by Therapeutic Class 51
5.7 Promising Drugs in the Pipeline 53
5.7.1 LY-2189265 (dulaglutide) – Eli Lilly 53
5.7.2 Albiglutide – GlaxoSmithKline 53
5.7.3 LC15-044 (gemigliptin) – LG Life Sciences 54
5.7.4 TAK-875 – Takeda 54
5.7.5 Ipragliflozin – Astellas Pharma 55
5.7.6 LX-4211 – Lexicon Pharmaceuticals 55
5.7.7 Imeglimin – Poxel SA 56
5.7.8 CCX-140-B – ChemoCentryx 56
5.7.9 Semaglutide – Novo Nordisk A/S 57
5.7.10 PC-DAC Exendin-4 – ConjuChem Biotechnologies 57
5.8 Heat Map for Pipeline Products 57
5.9 Conclusion 60

6 Market Forecast to 2019 62
6.1 Global Market 62
6.1.1 Treatment Usage Patterns 62
6.1.2 Market Size 63
6.2 US 64
6.2.1 Treatment Usage Patterns 64
6.2.2 Annual Cost of Therapy 65
6.2.3 Market Size 65
6.3 Top Five Countries of Europe 66
6.3.1 Treatment Usage Patterns 66
6.3.2 Annual Cost of Therapy 67
6.3.3 Market Size 68
6.4 Japan 69
6.4.1 Treatment Usage Patterns 69
6.4.2 Annual Cost of Therapy 70
6.4.3 Market Size 70
6.5 Drivers and Barriers 71
6.5.1 Drivers 71
6.5.2 Barriers 71

7 Deals and Strategic Consolidations 72
7.1 Licensing Deals 72
7.1.1 TransTech Pharma Enters into Licensing Agreement with Forest Laboratories 74
7.1.2 Xoma Enters into Licensing Agreement with Les Laboratoires Servier for Xoma 052 75
7.1.3 Zealand Pharma Enters into a Licensing and Collaboration Agreement with Boehringer Ingelheim 75
7.1.4 Exelixis Enters into Licensing Agreement with Bristol-Myers Squibb for XL475 75
7.1.5 Prosidion Limited Enters into a Licensing Agreement with Eli Lilly and Company 76
7.1.6 Metabolex Enters into Licensing Agreement with Sanofi 76
7.1.7 Wellstat Enters into a License Agreement with Sanofi 76
7.1.8 CureDM and Lankenau Institute Enter into a Licensing Agreement with Sanofi 76
7.1.9 Metabolex Enters into a Development and Licensing Agreement with Janssen Pharmaceuticals 76
7.1.10 Dainippon Sumitomo Pharma Enters into Licensing Agreement with Intercept Pharma for INT-747 77
7.1.11 Ipsen Enters into Licensing Agreement with F. Hoffmann-La Roche for BIM 51077 77
7.1.12 Glenmark Pharma Enters into Licensing Agreement with Merck KGaA 77
7.1.13 Euroscreen Enters into Licensing Agreement with Janssen Pharmaceuticals 77
7.1.14 Phenomix Enters into Licensing Agreement with Chiesi Farmaceutici 78
7.1.15 Otsuka Pharma Enters into Licensing Agreement with Kyowa Hakko Kirin for Saxagliptin 78
7.1.16 Nastech Pharma Enters into Licensing Agreement with Amylin Pharma 78
7.1.17 Emisphere Technologies Enters into a Licensing Agreement with Novo Nordisk 78
7.1.18 Array BioPharma Enters into a Licensing Agreement with Amgen 78
7.1.19 Theratechnologies Enters into a Licensing Agreement with OctoPlus 79
7.1.20 Diabetica Enters into a Licensing Agreement with Amylin 79
7.1.21 Celtic Therapeutics Enters into a Licensing Agreement with Bellus Health 79
7.1.22 Aradigm Enters into a Licensing Agreement with Novo Nordisk 79
7.1.23 Santarus Enters into a License Agreement with Shore Therapeutics 80
7.1.24 Depomed Enters into a Licensing Agreement with Boehringer Ingelheim 80
7.1.25 Depomed Enters into a Licensing Agreement with Merck 80
7.1.26 Depomed Enters into a Licensing Agreement with Teva 80
7.2 Co-development Deals 81
7.2.1 Eli Lilly Enters into a Co-development Agreement with Boehringer Ingelheim 82
7.2.2 AstraZeneca Enters into Co-development Agreement with Bristol-Myers Squibb 82
7.2.3 Metabolex Enters into a Co-development Agreement with Janssen Pharmaceuticals 83
7.2.4 Amylin Pharma Terminates Co-development Agreement with Eli Lilly for Exenatide 83
7.2.5 Isis Enters into a Collaboration Agreement with Janssen Pharmaceuticals 83
7.2.6 Neurocrine Biosciences Enters into a Collaboration Agreement with Boehringer Ingelheim 84
7.2.7 Intercept Pharma Enters into Co-development Agreement with Servier 84
7.2.8 Transition Therapeutics Enters into an Agreement with Eli Lilly 84
7.2.9 Ambrx Enters into a Co-Development Agreement with Bristol-Myers Squibb 84
7.2.10 Biocompatibles Enters into a Co-Development Agreement with AstraZeneca 85

8 Appendix 86
8.1 All Pipeline Drugs by Stage of Development 86
8.1.1 Discovery 86
8.1.2 Preclinical and IND-filed 88
8.1.3 Phase I 92
8.1.4 Phase II 95
8.1.5 Phase III and Pre-registration 98
8.1.6 Undisclosed 101
8.2 Market Forecasts to 2019 102
8.2.1 Global 102
8.2.2 US 102
8.2.3 UK 103
8.2.4 France 103
8.2.5 Germany 104
8.2.6 Italy 104
8.2.7 Spain 105
8.2.8 Japan 105
8.3 Market Definitions 106
8.4 Abbreviations 106
8.5 References for Heat Maps 108
8.6 References 111
8.7 Research Methodology 116
8.7.1 Coverage 116
8.7.2 Secondary Research 117
8.7.3 Primary Research 117
8.7.4 Therapeutic Landscape 117
8.7.5 Epidemiology-based Forecasting 118
8.7.6 Pipeline Analysis 120
8.7.7 Expert Panel Validation 120
8.7.8 Contact Us 120
9 Disclaimer 120

List of Table

Table 1: The Relationship between HbA1c and Mean Blood Glucose 14
Table 2: Pipeline Drugs (Discovery) 86
Table 3: Pipeline Drugs (Preclinical and IND-filed) 88
Table 4: Pipeline Drugs (Phase I) 92
Table 5: Pipeline Drugs (Phase II) 95
Table 6: Pipeline Drugs (Phase III) 98
Table 7: Pipeline Drugs (Undisclosed stage of development) 101
Table 8: Type 2 Diabetes Market, Global, Market Forecast, 2012–2019 102
Table 9: Type 2 Diabetes Market, US, Market Forecast, 2012–2019 102
Table 10: Type 2 Diabetes Market, UK, Market Forecast, 2012–2019 103
Table 11: Type 2 Diabetes Market, France, Market Forecast, 2012–2019 103
Table 12: Type 2 Diabetes Market, Germany, Market Forecast, 2012–2019 104
Table 13: Type 2 Diabetes Market, Italy, Market Forecast, 2012–2019 104
Table 14: Type 2 Diabetes Market, Spain, Market Forecast, 2012–2019 105
Table 15: Type 2 Diabetes Market, Japan, Market Forecast, 2012–2019 105
Table 16: Type 2 Diabetes Market, Global, References for Heat Maps, 2013 108

List of Chart

Figure 1: Type 2 Diabetes Market , Market Size ($m), 2012–2019 7
Figure 2: Type 2 Diabetes Market , Global, Pipeline by Stage of Development, 2013 8
Figure 3: Type 2 Diabetes Market, Global, Composite Treatment Algorithm, 2013 16
Figure 4: Type 2 Diabetes Market, Global, Sales of Januvia and Janumet ($m), 2006-2012 21
Figure 5: Type 2 Diabetes Market, Global, Sales of Onglyza ($m), 2009-2012 24
Figure 6: Type 2 Diabetes Market, Global, Sales of Galvus ($m), 2007–2012 25
Figure 7: Type 2 Diabetes Market, Global, Sales of Byetta ($m), 2005–2010 26
Figure 8: Type 2 Diabetes Market, Global, Sales of Victoza ($m), 2009–2012 28
Figure 9: Type 2 Diabetes Market, Global, Sales of Actos ($m), 2003-2011 30
Figure 10: Type 2 Diabetes Market, Global, Sales of Avandia ($m), 1999–2012 31
Figure 11: Type 2 Diabetes Market, Global, Sales of Lantus ($m), 2003-2012 33
Figure 12: Type 2 Diabetes Market, Global, Sales of Levemir (As reported by Novo Nordisk), 2008-2012 34
Figure 13: Type 2 Diabetes Market, Global, Heat Map of Marketed Products, 2013 37
Figure 14: Type 2 Diabetes Market, Global, Sales of Novel Products ($m, Years after Approval), 1998–2012 38
Figure 15: Type 2 Diabetes Pipeline Overview 39
Figure 16: Type 2 Diabetes Market, Global, Therapeutic Classes 40
Figure 17: Type 2 Diabetes Market, Global, Clinical Trial Failure Rate (%), 2006–2013 42
Figure 18: Type 2 Diabetes Market, Global, Failure Rate by Molecule Type, 2006–2013 43
Figure 19: Type 2 Diabetes Market, Global, Failure Rate by Therapeutic Class, 2006–2013 44
Figure 20: Type 2 Diabetes Market, Global, Reasons for Clinical Trial Failure (%), 2006–2013 46
Figure 21: Type 2 Diabetes Market, Global, Clinical Trial Duration, 2006–2013 47
Figure 22: Type 2 Diabetes Market, Mean Clinical Trial Duration by Therapeutic Class, Global, 2006–2013 48
Figure 23: Type 2 Diabetes Market, Mean and Median Clinical Trial Size, Global, 2006–2013 49
Figure 24: Type 2 Diabetes Market, Clinical Trial Size by Molecule Type, Global, 2006–2013 50
Figure 25: Type 2 Diabetes Market, Clinical Trial Size by Therapeutic Class, Global, 2006–2013 51
Figure 26: Type 2 Diabetes Market, Heat Map of Pipeline Products 58
Figure 27: Type 2 Diabetes Market, Global, Heat Map of Marketed Products, 2013 59
Figure 28: Type 2 Diabetes Market, Global, Treatment Usage Patterns (‘000), 2012–2019 62
Figure 29: Type 2 Diabetes Market, Global, Market Size ($m), 2012–2019 63
Figure 30: Type 2 Diabetes Market, US, Treatment Usage Patterns, 2012–2019 64
Figure 31: Type 2 Diabetes Market, Global, Market Size ($m), 2012–2019 65
Figure 32: Type 2 Diabetes Market, Top Five Countries of Europe, Treatment Usage Patterns, 2012–2019 66
Figure 33: Type 2 Diabetes Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2012–2019 67
Figure 34: Type 2 Diabetes Market, Top Five Countries of Europe, Market Size ($m), 2012–2019 68
Figure 35: Type 2 Diabetes Market, Japan, Treatment Usage Patterns, 2012–2019 69
Figure 36: Type 2 Diabetes Market, Japan, Market Size ($m), 2012–2019 70
Figure 37: Type 2 Diabetes Market, Global, Licensing Deals by Country, 2006–2013 72
Figure 38: Type 2 Diabetes Market, Global, Licensing Deals, 2006–2013 73
Figure 39: Type 2 Diabetes Market, Global, Licensing Deals, 2006–2013 74
Figure 40: Type 2 Diabetes Market, Global, Licensing Deals by Country, 2006–2013 81
Figure 41: Type 2 Diabetes Market, Global, Co-development Deals, 2006–2012 82
Figure 42: GBI Research Market Forecasting Model 119

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