Anti-Obesity Treatments 2007-2012 - A blockbuster target market

1. Executive Summary: Anti-Obesity Treatments 2007-2012

2. An Introduction to Obesity and Its Treatment

• 2.1 What is Obesity?
  • 2.1.1 How Serious is the Problem?
  • 2.1.2 Fat is Necessary to Store Energy in the Body
  • 2.1.3 Drugs Have a Role in Treating Obesity
  • 2.1.4 Obesity is a Chronic Disease
  • 2.1.5 Obesity Greatly Increases Risk Factors for a Range of Other Diseases
  • 2.1.6 Obesity is Very Prevalent Worldwide
  • 2.1.7 Body Weight is Dependent Upon Several Factors
• 2.2 How is Obesity Measured?
  • 2.2.1 Weight-for-Height Tables
  • 2.2.2 Body Mass Index
  • 2.2.3 Waist Circumference
• 2.3 Urbanisation, Modernisation and Economic Development Have Contributed to Obesity
  • 2.3.1 Urban Areas Show Higher Levels of Obesity
  • 2.3.2 Technological Developments Have Contributed to the Problem of Obesity
  • 2.3.3 Modernisation Has Effected Obesity Levels in Native Populations
• 2.4 Those Most At Risk Are Poor in Developed Countries and Wealthy in Developing Nations
  • 2.4.1 Importing Poor Eating Habits
  • 2.4.2 The Costs of Poor Diets to Individuals and Society
• 2.5 Obesity Overtakes Smoking for Medical Costs in the US
• 2.6 Obesity in the US
  • 2.6.1 Prevalence of Obesity Has Increased Steadily in Recent Years
  • 2.6.2 There is a High Prevalence of Obesity Among Children in the US
• 2.7 Obesity in the UK
  • 2.7.1 High Incidence and Social Costs
  • 2.7.2 Increasing Juvenile Obesity
  • 2.7.3 National and Local Efforts Required
• 2.8 Effects of Obesity on Health: Linked Conditions Have High Social and Economic Cost
• 2.9 Childhood Obesity
• 2.10 Factors Causing Obesity
  • 2.10.1 Genetics
  • 2.10.2 Specific Genetic Factors
  • 2.10.3 Environment
  • 2.10.4 Diet
  • 2.10.5 Behaviour
  • 2.10.6 Regular Physical Exercise
• 2.11 Treatment of Obesity
• 2.12 Treatment of Obesity With Drugs
  • 2.12.1 Drugs May be Used Under Strict Clinical Guidance
  • 2.12.2 Types of Drugs for Treating Obesity
• 2.13 Lipase inhibitors
  • 2.13.1 Orlistat the First of the Lipase Inhibitors Currently Leads the Anti-Obesity Market
• 2.14 Anorectic Drugs
  • 2.14.1 Sibutramine Has Achieved Modest Success
  • 2.14.2 Phentermine Hydrochloride - An Older Drug
  • 2.14.3 Rimonabant - a Promising Cannabinoid Receptor Blocker
• 2.15 There is Much Scope for Future Development of Treatments for Obesity

3. The World Market for Anti-Obesity Drugs, 2006-2012

• 3.1 The Anti Obesity Market Generated Sales in Excess of $1bn in 2006
  • 3.1.1 Xenical and Meridia Overcame Difficulties in the Anti-Obesity Market in the Late 1990s
  • 3.1.2 New Drugs Such as Acomplia Have High Expectations to Live Up To
  • 3.1.3 Reductil/Ectiva/Meridia and Xenical Have More Limited Scope for Expanded Indications than Acomplia
• 3.2 Xenical and Reductil/Ectiva/Meridia are More Limited in their Scope for Gaining Further Indications than Acomplia
• 3.3 The Anti-Obesity Market Has Proved Very Difficult to Crack So Far
  • 3.3.1 Only Two Drugs are Currently Approved for Long-Term Treatment of Obesity
  • 3.3.2 Visiongain Believes That Significant Advances Will Occur in this Market With Potentially High Revenues for Next-Generation Products
• 3.4 Roche Currently Leads the Global Prescription Anti-Obesity Market
• 3.5 The Global Anti-Obesity Market Will Expand Strongly from 2006 to 2012
  • 3.5.1 Xenical and Reductil will be Overtaken by Acomplia
  • 3.5.2 Life-Long Therapy with Drugs May Constitute the Future of Obesity Management
• 3.6 Xenical Will Continue to Show Growth to 2009 Then Decline Gradually
  • 3.6.1 Xenical Versus Meridia - Efficacy and Side Effects
  • 3.6.2 Completion of Key Studies on Orlistat in 2002
  • 3.6.3 Indication for Use in Adolescents in both US and EU - a Significant Advantage for Xenical
  • 3.6.4 US Label Change to Include Delay of Diabetes Type 2 Onset Information
  • 3.6.5 Lifecycle Management Potential Includes Possible Anti-Cancer Role for Xenical
  • 3.6.6 OTC Version of Orlistat Approved in the US - Licensing Deal With GSK
  • 3.6.7 Discontinuation of Development of Orlistat by Chugai in Japan
• 3.7 Reductil/Ectiva/Meridia Will Also Lose Out to Acomplia from 2006-2012
  • 3.7.1 Sibutramine is a Dual Serotonin (5HT)/Noradrenaline Re-uptake Inhibitor Launched in the US in 1998
  • 3.7.2 Problems for Reductil/Meridia
  • 3.7.3 Abbott has Entered into Various Licensing Deals for Sibutramine
• 3.8 Sales of Clobenzorex Will Continue to Expand Throughout the Forecast Period
• 3.9 Acomplia Will Be the First Blockbuster in the Anti-Obesity Market Segment Comment
  • 3.9.1 Acomplia Launched in Europe in Mid 2006 with US Approval Pending
  • 3.9.2 Acomplia Has Therapeutic Promise that Should Ensure High Sales
  • 3.9.3 Acomplia Was Rejected by FDA Panel in June 2007 - Sanofi-Aventis Responded by Withdrawing its Application Temporarily
  • 3.9.4 Success of Acomplia Will be Driven by Expansion of Indications
  • 3.9.5 Phase III Results for Acomplia were Promising
  • 3.9.6 Further Trials are in Progress for Acomplia
  • 3.9.7 The RIO Studies on Diabetes and Lipids Were Promising for Acomplia
  • 3.9.8 The SERENADE Trial Reinforced Earlier Studies - Amelioration of Other Aspects of Metabolic Syndrome
  • 3.9.9 In Wake of FDA Panel Rejecting Acomplia, Sanofi-Aventis Announced Plans to Submit Additional Safety Data to European Authorities 3.9.10 Reimbursement for Acomplia is a Serious Concern for Sanofi-Aventis
  • 3.9.11 Rights for Japan Reverting to Sanofi-Aventis 3.10 Sales of Phentermine Will Continue to Decline Slowly from 2006-2012
  • 3.10.1 Phentermine is a Sympathomimetic Appetite Suppressant
  • 3.10.2 Phentermine is a Long-Established Treatment that Still Achieves High Prescription Volumes - Generics Make it a Lower Cost Therapy
  • 3.10.3 Phentermine Is Subject to the Controlled Substances Act in the US
• 3.11 Other Anti-Obesity Drugs Will Seize an Increasingly Significant Proportion of Total Sales in the Sector
  • 3.11.1 There are Promising Developments Currently in Mid to Late Stage Clinical Testing
  • 3.11.2 Compounds For Developed for Type 2 Diabetes Have Potential in Treating Obesity As Well
• 3.12 While the Past Has Been Difficult for Anti-Obesity Treatments, There is Optimism for the Future
• 3.13 The Anti-Obesity Market is Fragmented but Future Growth Is Assured by Rising Awareness of Obesity as a Major Health Problem in the Developed and Developing World
• 3.14 Safety Issues Affect Leading Anti-Obesity Drugs
• 3.15 The Anti-Obesity Market Will Expand Rapidly as Prescribers and Healthcare Providers Recognise the Pressing Need to Avert This Most Serious Threat to Health

4. Forces Affecting the Anti-Obesity Market

• 4.1 SWOT Analysis of the Anti-Obesity Market
• 4.2 An Expanding Patient Population Constitutes the Principal Driver in the Anti-Obesity Market
• 4.3 The Principal Restraints in the Anti-Obesity Market
• 4.4 Major Success in the Anti-Obesity Drugs Market Has Proved to Be Elusive to Date
• 4.4.1 Many Doctors and Healthcare Bodies Believe that Drugs Play an Important Role in Treating Obesity
• 4.5 Safety Concerns Over Anti-Obesity Treatments
  • 4.5.1 Market for Anti-Obesity Drugs Has Encountered Mixed Fortunes in Recent Years
  • 4.5.2 Two Drugs Approved for Long-Term Treatment of Obesity
  • 4.5.3 The Anti-Obesity Market Suffered After the Withdrawal of Fenfluramine and Dexfenfluramine
  • 4.5.4 Public Citizen Filed a Petition With The FDA Claiming that Xenical Should be Withdrawn
  • 4.5.5 Obstacles facing US Approval for Rimonabant Casts Shadow Over Other Obesity Drugs
• 4.6 The World Health Organisation Considers Obesity to be an Epidemic
• 4.7 Convincing Stakeholders of the Efficacy and Safety of Anti-Obesity Drugs Remains a Great Challenge for the Industry
  • 4.7.1 There is a Persisting Belief That Drugs Have a Limited Role in Treating Obesity
  • 4.7.2 Lack of Adequate Reimbursement Limits Potential of Anti-Obesity Drugs
• 4.8 US Health Gains Weakened by High Incidence of Excessive Weight and Obesity
  • 4.8.1 Overweight and Obesity Are Among The Most Pressing New Health Challenges
  • 4.8.2 Risks Caused by Obesity Compared with Those of Tobacco Use
  • 4.8.3 Over Half of US Residents are Overweight
  • 4.8.4 Community-Based Recommendations for Tacking Obesity in the US
• 4.9 EU Health Commissioner Reports That More Than Half Of Adults in the EU are Currently Overweight 4.10 Non Medicinal Treatments that Accompany Drug-Based Therapy - When Successful These Approaches Lessen the Requirement for Pharmaceuticals
  • 4.10.1 Reducing Energy Intake Through Changes to Diet and Eating Patterns
  • 4.10.2 Increasing Physical Activity
  • 4.10.3 Behavioural Therapy
• 4.11 Weight Loss Surgery For Severe Obesity - A Last Resort When Drug-Based Treatments Fail
• 4.12 Potential Risks of Anti-Obesity Medication Other Than Side-Effects
  • 4.12.1 Potential for Abuse or Dependence
  • 4.12.2 Development of Tolerance
  • 4.12.3 Reluctance to View Obesity as a Chronic Disease
• 4.13 Over-the-Counter Drugs and Herbal Remedies
  • 4.13.1 OTC Version of Orlistat Approved in Early 2007
• 4.14 Obesity Will Constitute a Devastating Burden on Healthcare and on Society in General Unless it is Effectively Prevented and Treated
• 4.15 Critics Warn of Over-Reliance on Anti-Obesity Drugs
  • 4.15.1 Use of Obesity Drug Increases in Britain
  • 4.15.2 Critics Accuse Doctors of Overlooking Side Effects of Drugs and Healthcare Authorities of Not Doing Enough to Encourage Lifestyle Changes
  • 4.15.3 Claims for Anti-Obesity Drug Disputed
• 4.16 Surgery And Drugs for Children To Tackle Obesity "Epidemic" in UK
• 4.17 There is Good Scope for New Drugs to Treat Obesity, Leading UK Expert Acknowledges
• 4.18 Controversy Over Vested Interests and Misinformation in Obesity

5. Obesity in the Leading Pharmaceutical Markets

• 5.1 The US Will Still Have The Highest Prevalence of Obesity in 2012
  • 5.1.1 WHO Considers Obesity to be a Global Epidemic
  • 5.1.2 Both Germany and the UK Will Have High Prevalence of Obesity
  • 5.1.3 Lifestyle Issues Raising the Obesity Levels
• 5.2 Sales of Anti-Obesity Drugs Will Rise Steadily in the US from 2006 to 2012
  • 5.2.1 The UK Will Have The Second-Highest Sales of Anti-Obesity Drugs
  • 5.2.2 Although Japan Will Retain a Low Prevalence of Obesity, the Relative Increase in Numbers of Obese People Will Be High
• 5.3 High Cost of Obesity in the UK Will Drive Sales of Anti-Obesity Medication
• 5.4 Health Survey for England Shows Marked Increase in Childhood Obesity
• 5.5 Drive to Reduce UK' s High Obesity Levels Given Boost by Online Resource
• 5.6 The National Institutes of Health Recognise that Obesity Now Constitutes an Epidemic in the US
  • 5.6.1 The NIH Obesity Research Task Force
  • 5.6.2 Efforts in the US and Europe Will Benefit the Development of New Pharmaceutical Treatments for Obesity

6. Experts' Views on Main Issues in the Treatment of Obesity

• 6.1 The Most Important Unmet Medical Needs in The Treatment of Obesity
• 6.2 The Most Favoured Type of Anti-Obesity Treatment by the Start of Next Decade
• 6.3 Future Prospects for Efficacy and Safety
• 6.4 Funding of Anti-Obesity Treatments
• 6.5 The Anti-Obesity Market in Developing Nations
• 6.6 Concluding Thoughts

7. Pipeline Developments in Anti-Obesity Treatments

• 7.1 Agents in Phase 2 of Clinical Development for Obesity
  • 7.1.1 Novo Nordisk' s Liraglutide
  • 7.1.2 Sanofi-Aventis' Surinabant (SR 147778)
  • 7.1.3 Pfizer' s CP 741952 and CP 866087
  • 7.1.4 Alizyme' s Cetilistat (ATL 962)
  • 7.1.5 Solvay' s SLV 319 (BMS 646256)
  • 7.1.6 Amylin' s Pramlintide (Symlin, Normylin)
  • 7.1.7 Kissei' s 869682
  • 7.1.8 Metabolic' s AOD 9604
  • 7.1.9 Sanofi-Aventis' AVE 1625
  • 7.1.10 Orexigen' s Bupropion/Zonisamide (Empatic/Excalia)
  • 7.1.11 Genzyme' s GT 389255
  • 7.1.12 Amgen' s Metreleptin
  • 7.1.13 VIVUS' Phentermine/topiramate (MK 0493)
  • 7.1.14 7TM Pharma' s TM 30338
  • 7.1.15 Shionogi' s S 2367
• 7.2 Agents in Phase 3 of Clinical Development for Obesity
  • 7.2.1 Merck & Co' s Taranabant
  • 7.2.2 Pfizer' s CP 945598
  • 7.2.3 Orexigen' s Bupropion and Naltrexone (Contrave)
  • 7.2.4 Arena' s Lorcaserin
• 7.3 Discussion of Current Pipeline Developments

8. Conclusions

• 8.1 Obesity is a Serious Condition With High Prevalence
• 8.2 Drugs Have a Role in Treating Obesity
• 8.3 The Anti-Obesity Market Has Proved Very Difficult to Crack So Far
• 8.4 The Global Anti-Obesity Market Will Expand Strongly from 2006 to 2012
• 8.4.1 Xenical and Reductil will be Overtaken by Acomplia
• 8.5 An Expanding Patient Population Constitutes the Principal Driver in the Anti-Obesity Market
• 8.6 The Principal Restraints in the Anti-Obesity Market
• 8.7 Geographical Breakdown of Revenues in the Anti-Obesity Market
  • 8.7.1 The US Will Still Have The Highest Prevalence of Obesity in 2012
  • 8.7.2 Both Germany and the UK Will Have High Prevalence of Obesity
  • 8.7.3 Sales of Anti-Obesity Drugs Will Rise Steadily in the US from 2006 to 2012
  • 8.7.4 The UK Will Have The Second-Highest Sales of Anti-Obesity Drugs
• 8.8 There are Promising Developments Currently in Mid to Late Stage Clinical Testing
• 8.9 Outlook for the Future

Appendices

• Appendix 1: Conditions Associated with Obesity Appendix 2: About visiongain
• Appendix 3: Visiongain Report Evaluation Form

• Table 2.1 BMI Classification Bands
• Table 2.2 Prevalence of Obesity (%) Amongst US Adults by Characteristics, 1991-2001
• Table 3.1 Leading Anti-Obesity Prescription Drugs ($m), 2006
• Table 3.2 Leading Companies for Anti-Obesity Prescription Drugs, 2006
• Table 3.3 Sales of Anti-Obesity Prescription Drugs ($m), 2006-2012
• Table 3.4 CAGR Values (%) for Leading Anti-Obesity Prescription Drugs, 2006-2012
• Table 3.5 Market Shares (%) for Leading Anti-Obesity Prescription Drugs, 2006 & 2012
• Table 3.6 US Patents on Orlistat
• Table 3.7 US Patents on Sibutramine
• Table 3.8 US Patents on Rimonabant
• Table 4.1 Table A SWOT Chart for Anti-Obesity Treatments, 2007-2012
• Table 5.1 Prevalence of Obesity in the Leading Pharmaceutical Markets, 2006 and 2012
• Table 5.2 Share (%) of the Obesity Market and Sales ($m) in the Leading Pharmaceutical Markets, 2006 and 2012

• Figure 2.1 Prevalence of Obesity in US Total and by Gender, 1991-2004
• Figure 2.2 Prevalence of Obesity in US by Age Group, 1991-2004
• Figure 3.1 Leading Anti-Obesity Prescription Drugs ($m), 2006
• Figure 3.2 Leading Anti-Obesity Prescription Drugs, Market Share (%), 2006
• Figure 3.3 Leading Anti-Obesity Prescription Drugs, Sales Growth (%), 2012
• Figure 3.4 Leading Companies for Anti-Obesity Prescription Drugs, 2006
• Figure 3.5 Leading Companies for Anti-Obesity Prescription Drugs, Market Share (%), 2006
• Figure 3.6 Sales of Leading Anti-Obesity Prescription Drugs ($m), 2006-2012
• Figure 3.7 Total Sales ($m) of Anti-Obesity Prescription Drugs, 2006-2012
• Figure 3.8 Market Shares (%) for Leading Anti-Obesity Prescription Drugs, 2006
• Figure 3.9 Market Shares (%) for Leading Anti-Obesity Prescription Drugs, 2006 & 2012
• Figure 3.10 Sales ($m) of Xenical, 2006-2012
• Figure 3.11 Sales ($m) of Reductil/Meridia, 2006-2012
• Figure 3.12 Sales ($m) of Clobenzorex, 2006-2012
• Figure 3.13 Sales ($m) of Acomplia, 2006-2012
• Figure 3.14 Sales ($m) of Phentermine, 2006-2012
• Figure 3.15 Sales ($m) of Other Anti-Obesity Drugs, 2006-2012
• Figure 5.1 Prevalence (%) of Obesity in the Leading Pharmaceutical Markets, 2006 and 2012
• Figure 5.2 Prevalence (Millions) of Obesity in the Leading Pharmaceutical Markets, 2006 and 2012
• Figure 5.3 Increase in Numbers (%) of Obesity Sufferers in the Leading Pharmaceutical Markets, 2006 and 2012
• Figure 5.4 Share (%) of the Obesity Market in the Leading Pharmaceutical Markets, 2006 and 2012
• Figure 5.5 Sales ($m) in the Leading Pharmaceutical Markets, 2006 and 2012
• Figure 5.6 Growth Rates (CAGR %) for The Anti-Obesity Segments of The Leading Pharmaceutical Markets
• Figure 8.1 Total Sales ($m) of Anti-Obesity Prescription Drugs, 2006-2012
• Figure 8.2 Sales of Leading Anti-Obesity Prescription Drugs ($m), 2006-2012

• 3M
• 7TM Pharma
• Abbott Laboratories
• Ache
• Activx Biosciences
• Alizyme
• ALTANA
• American Home Products
• Amgen
• Amylin
• Arena Pharmaceuticals
• Astellas
• Bayer
• Bracco
• Bristol-Myers Squibb
• Chugai
• Eli Lilly
• Gate Pharmaceuticals
• Genzyme
• GlaxoSmithKline
• Han Wha
• IMS Health
• King Pharmaceuticals
• Kissei
• Knoll
• Medeva Pharmaceuticals
• Medix
• Medley Brazil
• Merck & Co
• Metabolic
• Millennium
• Novartis
• Novo Nordisk
• Orexigen
• OSI Pharmaceuticals
• Peptimmune
• Pfizer
• Roche
• Roemmers
• Sanofi-Aventis
• Servier
• Shionogi
• SmithKline Beecham
• Solvay
• Teva
• VIVUS
• Watson Pharmaceuticals