Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity



Summary



GBI Research, the leading business intelligence provider, has released its latest research, “Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity”. Obesity is often described as a global endemic, with incidence dramatically increasing over the past decades, particularly in developed countries. Being overweight or obese is a major risk factor in the development of many chronic diseases, including cardiovascular diseases, cancer, and diabetes, of which treatment incurs extensive economic and healthcare costs. Numerous anti-obesity drugs have been approved in the past decade, including Knoll Pharmaceutical’s Meridia (sibutramine) and Acomplia (rimonabant), only for them to be removed from the market due to evidence of suicidal thoughts, depression and cardiovascular problems with their long-term use. As such, healthcare professionals have a negative perception of such drugs and do not widely prescribe them, a major barrier to the growth of the anti-obesity therapeutics market.

Only orlistat is currently deemed safe for the long-term treatment of obesity; being proven to produce a placebo-adjusted weight-loss average of a limited 3kg. Two anti-obesity drugs were approved in June and July 2012, and GBI Research believes that only one, Vivus’ Qsymia, has a strong enough safety and efficacy (average placebo-adjusted weight loss of 5kg at the medium dose) profile to make a significant impact on the market, providing it is proven safe in long-term-use studies. If proven safe, GBI Research expects the sales of Qsymia and other drugs expected to be approved over the forecast period to increase the market size to $2.7 billion. Although moderate, this is significantly below the market potential given the size of the prevalence population. Optimally safe and effective anti-obesity drugs which overcome healthcare professionals’ negative opinions will have to be developed if the size of the market is ever to reflect the prevalence of obesity.



Scope


- The report analyzes the incidence of obesity, current treatment options, pipeline and market forecasts, and deals surrounding anti-obesity drugs.
- A brief introduction to obesity; detailed analysis of recent, current and projected incidence trends; co-morbidities; economic implications of their treatment; and the current treatment options
- Analysis of the currently marketed anti-obesity drugs, including recent sales figures, safety and efficacy data, and a discussion of each drug’s expected performance within the forecast period
- Comprehensive reviews of the pipeline for anti-obesity drugs, including analysis by molecule type and mechanism of action
- Statistical analysis of clinical trial duration, size, and failure rate by Phase and molecule type
- An in-depth forecast model for the anti-obesity drugs market in the US, UK, France, Germany, Italy, Spain and Japan. Each model is based on the anticipated market performance of marketed drugs and those expected to be approved within the forecast period, and takes into account drug cost, efficacy, safety, and likely prescription volumes.
- A detailed discussion of the drivers and barriers for this immature market.



Reasons to buy


The report will enhance your decision-making capability by allowing you to -
- Understand the large number of potential molecular targets for the development of an anti-obesity drug, as well as the strengths, weaknesses, and risks of each drug type
- Gain an in-depth view of the current status of the anti-obesity drug pipeline, including the most common molecular targets and molecule types in development
- Observe the trends in clinical trial duration and size by Phase, molecule type and mechanism of action, and use the clinical trial failure rate analysis to assess the risk profiles of current and future developmental programs
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the anti-obesity drugs market
- Analyze current and past deals surrounding anti-obesity drugs, including their value, year of deal and in depth details of the highest value deals.

Table Of Contents

1 Table of Contents

1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 9
2.1 Etiology and Pathophysiology 9
2.2 Classification 9
2.3 Epidemiology 10
2.3.1 The US 10
2.3.2 Obesity in the Top Five European Markets 10
2.3.3 Japan 10
2.4 Comorbidities 11
2.4.1 Type 2 Diabetes 11
2.4.2 Hypertension 11
2.4.3 Dyslipidemia 11
2.4.4 Respiratory Problems 12
2.4.5 Osteoarthritis 12
2.4.6 Cancer Risk 12
2.5 Economic Burden 12
2.6 Current Therapy Options 12
2.6.1 Lifestyle and Behavioral Modifications 12
2.6.2 Bariatric Surgery 13
2.6.3 Pharmacotherapy 13
2.6.4 Treatment Algorithms and Prescription Habits 15
2.6.5 Method of Determining Treatment Effectiveness 16
2.7 Why Develop Therapeutic Anti-obesity Drugs? 16
3 Marketed Products 18
3.1 Amphetamine-like Drugs 18
3.1.1 Overview 18
3.1.2 Efficacy Profile 19
3.1.3 Safety Profile 19
3.2 Qsymia, Vivus, Inc. 19
3.2.1 Overview 19
3.2.2 Efficacy Profile 20
3.2.3 Safety Profile 21
3.2.4 Discussion 22
3.3 Orlistat 22
3.3.1 Overview 22
3.3.2 Efficacy Profile 23
3.3.3 Safety Profile 25
3.3.4 Discussion 25
3.4 Belviq, Arena Pharmaceuticals 26
3.4.1 Introduction 26
3.4.2 Efficacy Profile 26
3.4.3 Safety Profile 27
3.4.4 Discussion 27
3.5 Low Long-term Success Rate of Marketed Anti-Obesity Drugs 28
3.6 Discussion 29
4 Pipeline 33
4.1 Overview of Pipeline by Phase, Molecule Type and Molecular Target 33
4.2 Clinical Trial Duration and Size 36
4.2.1 Clinical Trial Duration 36
4.2.2 Clinical Trial Size 38
4.3 Clinical Trial Failure, Attrition Rate and Reasons for Clinical Trial Failure 39
4.4 Primary and Secondary Endpoints 41
4.5 Late-stage Drugs of the Developmental Pipeline 43
4.5.1 Contrave, Orexigen Therapeutics 43
4.5.2 Cametor, Norgine BV 45
4.5.3 Victoza, Novo Nordisk 47
4.5.4 Tesofensine (NeuroSearch) 50
4.6 Discussion 51
5 Market Forecasts 54
5.1 Global Market 54
5.2 The US 56
5.2.1 Epidemiology and Treatment Usage Patterns 56
5.2.2 Annual Cost of Therapy 56
5.2.3 Market Size 56
5.3 Europe 58
5.3.1 Treatment Usage Patterns 58
5.3.2 Annual Cost of Therapy 60
5.3.3 Market Size 61
5.4 Japan 63
5.4.1 Treatment Usage Patterns 63
5.4.2 Annual Cost of Therapy 63
5.4.3 Market Forecast 63
5.5 Discussion 64
5.6 Drivers and Barriers of the Anti-obesity Market 65
5.7 Obesity Market Drivers 65
5.7.1 Obesity is a Very Prevalent Disease with Large Potential Target Populations Globally 65
5.7.2 Recent Approval of Qsymia to Drive Market Growth Providing its Long-term Safety is Proved 65
5.7.3 Diversification of Molecular Targets 65
5.8 Obesity Market Barriers 66
5.8.1 Low Treatment Rate 66
5.8.2 Reimbursement Issues 66
6 Licensing and Co-Development Deals 67
6.1 Licensing Deals 67
6.1.1 EMD Serono Enters into Collaboration and Licensing Agreement with Theratechnologies 68
6.1.2 Amylin Pharma Enters into Licensing Agreement with Takeda Pharma 68
6.1.3 Palatin Technologies Extends License Agreement with AstraZeneca 69
6.1.4 Zealand Pharma Enters into Licensing and Collaboration Agreement with Boehringer Ingelheim 69
6.2 Co-development Deals 70
6.2.1 Isis Enters into Collaboration Agreement with Ortho-McNeil 71
6.2.2 Orexigen Therapeutics Enters into Co-development Agreement with Takeda Pharma for Contrave 71
7 Appendix 72
7.1 References 72
7.2 Abbreviations 76
7.3 All Pipeline Drugs by Phase 79
7.3.1 Discovery 79
7.3.2 Preclinical 80
7.3.3 Phase I 84
7.3.4 Phase II 85
7.3.5 Phase III 86
7.3.6 Pre-Registration 86
7.4 Market Forecasts to 2019 87
7.4.1 Global 87
7.4.2 The US 87
7.4.3 UK 88
7.4.4 France 88
7.4.5 Germany 88
7.4.6 Italy 89
7.4.7 Spain 89
7.4.8 Japan 89
7.5 Methodology 90
7.6 Secondary Research 90
7.7 Therapeutic Landscape 90
7.8 Epidemiology-Based Forecasting 91
7.9 Market Size by Geography 92
7.10 Pipeline Analysis 93
7.11 Contact Us 93
7.12 Disclaimer 93

1.1 List of Tables

Table 1: BMI Classifications 10
Table 2: Key Components of Pathways Thought to be Related to Obesity 14
Table 3: Treatment Options Dependent on BMI 16
Table 4: Obesity Therapeutics, Leading Brand Names of Phentermine 18
Table 5: Efficacy Results* for Qsymia at 52 Weeks 21
Table 6: Changes in Key Safety Parameters in Patients Treated with Qsymia 21
Table 7: Sales Data for Xenical ($m), 2008-2011 23
Table 8: Efficacy Results for Orlistat as an Initial and Maintenance Therapy 24
Table 9: Safety Results of Orlistat 25
Table 10: Efficacy Results for Belviq 27
Table 11: Placebo-adjusted Safety Results for Belviq 27
Table 12: Obesity Therapeutics Market, Global, Common Molecular Targets in the Obesity Pipeline 35
Table 13: Obesity Therapeutics Market, Global, Average Clinical Trial Size for the Most Common Modes of Action Amongst Pipeline Drugs, 2006-2013 38
Table 14: Obesity Therapeutics Market, Global, Average Clinical Trial Duration for the Main Modes of Action Amongst Pipeline Drugs, 2013 38
Table 15: Contrave, Phase III Clinical Trial Results 43
Table 16: Contrave, Efficacy Results, Phase III Clinical Trial 44
Table 17: Cametor, Efficacy Results of a Phase II Clinical Trial 45
Table 18: Cametor, Safety and Efficacy Results, Phase III Clinical Trial 46
Table 19: Victoza, Clinical Trial Results, Phase III Clinical Trial, 2009 48
Table 20: Victoza, Clinical Trial Results, Phase III Clinical Trial, 2009 49
Table 21: Victoza ,Safety and Efficacy Results, Phase III Clinical Trial, 2009 49
Table 22: Obesity Therapeutics Market, Europe, Current Prevalence Rate of the Population Which is Obese or Overweight, 2012-2019 58
Table 23: Obesity Therapeutics Market: Global, Developmental Pipeline, Discovery Phase 79
Table 24: Obesity Therapeutics Market: Global, Developmental Pipeline, Preclinical Phase 80
Table 25: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase I 84
Table 26: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase II 85
Table 27: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase III 86
Table 28: Obesity Pharmacotherapy Market: Global, Developmental Pipeline, Pre-Registration 86
Table 29: Obesity Therapeutics Market, Global, Market Forecasts, 2012-2019 87
Table 30: Obesity Therapeutics Market, US, Market Forecasts, 2012-2019 87
Table 31: Obesity Therapeutics Market, UK, Market Forecasts, 2012-2019 88
Table 32: Obesity Therapeutics Market, France, Market Forecasts, 2012-2019 88
Table 33: Obesity Therapeutics Market, Germany, Market Forecasts, 2012-2019 88
Table 34: Obesity Therapeutics Market, Italy, Market Forecasts, 2012-2019 89
Table 35: Obesity Therapeutics Market, Spain, Market Forecasts, 2012-2019 89
Table 36: Obesity Therapeutics Market, Japan, Market Forecasts, 2012-2019 89

1.2 List of Figures


Figure 1: Obesity, Global, Prevalence (%), 1990-2010 11
Figure 2: Effects of Topiramate on Food Intake 20
Figure 3: Obesity Therapeutics Market, Obesity Drug Approvals and Market Removals 29
Figure 4: Obesity Therapeutics Market, Heat Map Comparing the Safety and Efficacy of Marketed Drugs 31
Figure 5: Obesity Therapeutics Market, Heat Map Comparing the Performance of Marketed Drugs in Major Safety Parameters 32
Figure 6: Obesity Therapeutics Market, Global, Pipeline by Phase and Molecule Type and Molecular Target 34
Figure 7: Obesity Therapeutics Market, Global, Clinical Trial Duration by Phase and Molecule Type, 2006-2013 37
Figure 8: Obesity Therapeutics Market: Global, Clinical Trial Size by Phase and Molecule Type, 2006-2013 39
Figure 9: Obesity Therapeutics Market, Global, Clinical Trial Failure and Attrition Rates by Phase and Molecule Type, 2006-2013 40
Figure 10: Obesity Therapeutics Market, Global, Clinical Trial Primary and Secondary Endpoints, 2006-2013 42
Figure 11: Heat Map Comparing the Safety and Efficacy of Marketed and Key Pipeline Drugs 52
Figure 12: Heat Map Comparing the Performance of Marketed and Key Pipeline Drugs in Major Safety Parameters 53
Figure 13: Obesity Therapeutics Market, Global, Epidata and Market Forecasts, 2012-2019 55
Figure 14: Obesity Therapeutics Market, US, Epidata and Market Forecasts, 2012-2019 57
Figure 15: Obesity Therapeutics Market, Europe, Treatment Patterns, 2012-2019 59
Figure 16: Obesity Therapeutics Market, Europe, Annual Cost of Therapy, 2012-2019 60
Figure 17: Obesity Therapeutics Market, Europe, Market Forecasts, 2012-2019 62
Figure 18: Obesity Therapeutics Market, Japan, Epidata and Market Forecast, 2012-2019 64
Figure 19: Obesity Therapeutics Market, Global, Status, Value and Number of Licensing Deals, 2006-2013 67
Figure 20: Obesity Therapeutics Market, Global, Licensing Deals by Phase, Molecule Type and Value, 2006-2013 68
Figure 21: Obesity Therapeutics Market, Global, Status, Value and Number of Co-development Deals, 2006-2011 70
Figure 22: Obesity Market, Global, GBI Research Market Sizing Model 92

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