Obesity Drug Markets in the US and EU: Analysis of product pipelines and the competitive environment

Obesity Drug Markets in the US and EU: Analysis of product pipelines and the competitive environment

Obesity Drug Markets in the US and EU
Analysis of product pipelines and competitive environment

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Some key findings from this report
• An estimated 17% (85m people) of the EU population are obese and a further 32% (160m people) are overweight. The average rate of obesity in the US is forecast to reach 40% by 2010.

• US sales of obesity drugs more than tripled in 2007 to reach $421m following the introduction of Alli, which accounted for 71% of total revenue. Strong support from GlaxoSmithKline will stimulate further expansion for Alli in both the US and EU.

• The majority of weight loss products currently marketed have proven to be ineffective, with only a small proportion of consumers having been able to achieve and maintain weight loss.

• The US and European obesity drug markets will expand at a combined CAGR of 23.3% between 2008-2012. This growth will be driven by the launch of several products currently in late stage development, and increase revenues to an estimated $3.1b by 2012.

• A large number of novel obesity medications are currently under development, many of which represent novel approaches to the treatment of obesity and new drug classes such as CB1 antagonists and serotonin receptor agonists.

Obesity Drug Markets in the US and EU
The rising prevalence of obesity is a growing problem in developed countries, with 32% of Americans and 17% of EU residents considered obese in 2008. The condition is associated with a range of severe co-morbidities, the most significant of which include asthma, cardiovascular disease, cancer, diabetes, hypertension and kidney disease. Obesity-related treatments cost healthcare payors billions of dollars each year, and the market for medications is steadily expanding as incidence of obesity continues to increase. Stringent regulations have restricted the amount of medications currently available, however many currently marketed products are failing to meet consumer needs.

‘Obesity Drug Markets in the US and EU: Analysis of product pipelines and competitive environment’ is a new report published by Business Insights that explores the dynamics and drivers of the market for current and emerging obesity treatments. This report evaluates the performances and attributes of currently marketed products and highlights the most effective strategies for securing future success in this therapeutic area. The potential of leading obesity drug candidates is assessed and over 100 compounds are identified across pre-clinical, Phase I, Phase II and Phase III development. Forecasts of future sales are also provided, based upon trends in obesity drug usage, projected prevalence rates and the approval potential of emerging products.

Explore the latest trends and innovations in obesity treatments, assess the performances of currently marketed medications and evaluate the potential of leading pipeline candidates with this report...

Top five reasons to order your copy today
• Examine the major issues surrounding obesity in the US and EU with this report’s detailed analysis of co-morbidities, prevalence rates by sub-population, socioeconomic impacts, regulatory trends and the latest medical intelligence from this rapidly evolving treatment area.

• Evaluate the relative safety, efficacy and cost of currently marketed obesity drugs with this report’s comparative analysis of Rx and OTC medications including Alli, Meridia, Xenical and Accomplia.

• Explore emerging obesity treatments with details and descriptions of 146 drugs at various stages of pipeline development and assess the safety, efficacy and cross-indication potential of leading obesity drug candidates such as Lorcaserin hydrochloride, Lepislim, Taranabant, Contrave, CP-945,598 and Qnexa.

• Forecast sales for obesity medications in the US and EU through to 2013, measure the performances of currently marketed drugs in each region and discover how competitive dynamics will change in the future.

• Identify the strategies that offer the greatest success potential within the expanding market for obesity treatments and understand the challenges currently facing companies within this therapeutic area.

Key issues examined in this report...
• Full pipelines reflect demand. Increasing proportions of both US andEU populations are becoming overweight, obese, morbidly obese orsuper obese, creating a growing need for treatments in this field. Alarge number of pharma companies are currently developing suchtreatments, most of which are in the early stages of development.

• Consumer dissatisfaction. Consumers are largely dissatisfied withcurrent obesity products, as most require significant lifestyle changes(ie. diet and exercise) that can often prove difficult to accomodate.

• Rising regulatory scrutiny. Heightened scrutiny, particularly at theFDA, is causing approval delays and denials for all drug candidates.Sanofi-Aventis’s new obesity drug, Acomplia, is widely availableoutside the US but was rejected by the FDA on safety concerns.

• Non-prescription availability. Alli’s switch from Rx to OTC usage in2007 reinvigorated the US market for obesity treatments.GlaxoSmithKline is currently pursuing a similar switch in Europe withapproval expected during 2009 at the latest.

Your questions answered
• How can the rising trend of obesity in the US and EU be countered effectively?
• Which approaches to obesity management will experience the most growth through to 2012?
• Why was Alli able to achieve significantly more OTC sales than Xenical?
• Why are there relatively few advanced-stage drug candidates for obesity?
• How will the competitive dynamics of leading obesity medications change in the US and EU over the 2008-2012 period?
• Why is the approval late-stage obesity drugs under threat?
• Which newly identified condition is obesity related to?

Table of Contents
Obesity Drug Markets in the US and EU
Executive Summary 10
The large and growing obesity problem 10
Current approaches to obesity management 11
Pharmaceutical options for the treatment of obesity 12
The obesity drug pipeline 13
Market forecasts 14
Chapter 1 The large and growing obesity problem 18
Summary 18
A potentially life threatening medical condition 19
Levels of obesity 19
Overweight 20
Obesity 20
Morbid obesity 20
Super obesity 21
Co-morbidities and mortality 22
Arthritis 23
Asthma 23
Cancer 24
Cardiovascular disease and hypertension 25
Dementia 26
Depression 27
Diabetes 27
Kidney disease 27
Rising prevalence of obesity 28
Trends by sub-population 31
United States 31
Europe 31
Obesity in children and adolescents 33
Heavy social and economic impact 35
Cost burden 35
Social effects 36
Societal and other effects 38
Medical overview of obesity 39
Pathogenesis of obesity 39
Physiological factors 40
Genetic factors 41
Environmental factors 42
Lifestyle factors 43
Psychological factors 44
Societal trends 46
Obesity as a component of metabolic syndrome 47
Conclusion 48
Chapter 2 Current approaches to obesity management 50
Summary 50
Background 51
Diet and exercise programs 52
Dieting 52
Types of programs 53
Patient volumes 54
Exercise 54
Types of programs 54
Patient volumes 55
OTC weight loss supplements 56
Types of products 56
Patient volumes 57
Pharmaceutical options 58
Types of medications 58
Patient volumes 59
Surgical intervention 60
Types of procedures 61
Patient volumes 63
Comparison of options 64
Safety 65
Efficacy 66
Cost 67
Insurance reimbursement 67
Unmet needs 69
Conclusion 70
Chapter 3 Pharmaceutical options for treatment of obesity 72
Summary 72
Leading prescription medications 73
Meridia 74
Xenical 77
Acomplia 80
Others 83
OTC medicines 85
Alli 86
Comparison of pharmaceutical options 89
Safety 89
Efficacy 91
Cost 92
Insurance reimbursement 93
Conclusion 95
Chapter 4 The obesity drug pipeline 98
Summary 98
Introduction 99
Pre-clinical testing 99
Phase I testing 116
Phase II testing 116
Phase III testing 117
Leading obesity drug candidates 118
Lorcaserin hydrochloride 118
Lepislim 120
Taranabant 120
Contrave 121
CP-945,598 123
Qnexa 123
Discontinued obesity drug candidates 125
Conclusion 132
Chapter 5 Market forecasts 134
Summary 134
Introduction 135
Current sales levels 135
United States 137
Europe 138
Five year forecasts 139
United States 141
Europe 143
Conclusion 145
Index 146
List of Figures
Figure 1.1: Rates of obesity and overweight in the US, 1980–2006 29
Figure 1.2: Rates of obesity and overweight in Europe, 1980–2006 30
Figure 2.3: Comparison of safety, efficacy and cost of obesity management approaches 64
Figure 3.4: Comparison of safety, efficacy and cost of pharmaceutical options for obesity management 89
Figure 4.5: Comparison of leading obesity drug candidates, 2008 119
Figure 5.6: Obesity medication sales in the US and EU, 2006 and 2007 136
Figure 5.7: Obesity medication sales by region, 2007 137
Figure 5.8: Obesity medication sales in the US and EU, 2008–2013 140
Figure 5.9: Total obesity medication sales by region, 2008–2013 141
List of Tables
Table 1.1: Proportion of cancers related to obesity 24
Table 1.2: Prevalence of adult overweight and obesity by country, 2003 32
Table 2.3: US and EU patient caseloads for leading obesity management approaches, 2007–12 (millions of persons) 52
Table 2.4: Safety risks associated with obesity management approaches 65
Table 2.5: Comparative efficacy of obesity management approaches 66
Table 3.6: Safety risks associated with leading obesity medications 90
Table 3.7: Safety risks associated with leading obesity management approaches 92
Table 3.8: US cost comparison for leading obesity medications, 2008 93
Table 4.9: Pharmaceutical pipeline for obesity medications 101
Table 4.10: Discontinuations of obesity drug programs 126
Table 5.11: US sales of obesity medications, 2006 and 2007 138
Table 5.12: European sales of obesity medications, 2006 and 2007 139
Table 5.13: US sales of obesity medications in $m, 2008–2012 142
Table 5.14: European sales of obesity medications in $m, 2008–2012 143