Overview
Introduction
The prevalence of obesity has increased by 61% in the US during the period 1991-2001. According to Datamonitor estimates 127m people suffered from the disease in the seven major markets in 2003. Even though there is an increasing awareness of obesity in response to various advertising campaigns and educational programs, the prevalence of obesity is expected to reach 94m by 2012 in the US alone.
Scope
- Commercial overview of current anti-obesity drug market
- Clinical opinion leader intelligence and best-in-class case studies, leading to actionable recommendations
- RD pipeline and unmet needs analysis
- Seven major market scenario-based revenue and epidemiology forecasting to 2012
Report Highlights
Datamonitor estimates that there are 127 million obese people in the seven major markets and numbers are expected to increase. The two leading drugs Xenical and Meridia are both associated with unpleasant side effects, poor efficacy and high costs. Therefore, there is a huge demand in this market for drugs that can address the current unmet needs.
An estimated 15% of children and adolescents between the ages of six and 19 years old in the US are overweight. The prevalence of childhood obesity is expected to increase further, but Xenical is the only drug officially indicated for use in adolescents. This is a key patient population that needs to be targeted by pharmaceutical companies.
Obesity is an active area of research and development. Datamonitor has identified 22 key compounds in Phase I development or above. For future therapies to achieve market success, however, they must be able to produce greater weight loss, have a better side-effect profile and cost less than currently approved therapies.
Reasons to Purchase
- Identify optimal RD development strategies based on market characteristics
- Discover licensing opportunities based on company portfolio and market needs
- Validate internal forecasts for pipeline products and confirm market potential
TABLE OF CONTENTS
ABOUT DATAMONITOR HEALTHCARE
- About the Cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the anti-obesity drug market
- Summary
- Key metrics
CHAPTER 2 PATIENT POTENTIAL
- Definition of obesity
- Causes of obesity
- Obesity prevalence
- Obesity prevalence
- Obesity forecasts
- Obesity prevalence methodology
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Forecast methodology
- Prevalence of obesity in juveniles
- Segmentation of obesity
- Overview of guidelines
- Unmet needs in obesity
- More cost-effective care
- Increased patient knowledge and physician awareness
- Safe and tolerable drugs
- Drugs with greater efficacy
- Improved patient compliance
CHAPTER 3 GLOBAL MARKET OVERVIEW
- Overview of the global anti-obesity drug market
- US
- REIMBURSEMENT
- DTC ADVERTISING
- National organizations
- FDA'S OBESITY WORKING GROUP
- Awareness campaigns
- THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
- Japan
- Takeda
- Europe
- European initiatives
- FOOD NUTRITION ACTION PLAN
- THE EUROPEAN CHILDHOOD OBESITY GROUP
- FRANCE
- GERMANY
- ITALY
- SPAIN
- UK
- Awareness campaigns
- TOAST
- THE BRITISH DIETETIC ASSOCIATION'S FOOD FIRST PROGRAMME, 2002-04
- NATIONAL OBESITY FORUM
- GOVERNMENT INITIATIVES
- THE INTERNATIONAL OBESITY TASKFORCE
- Global market forecast
CHAPTER 4 DRUG ANALYSIS
- Xenical analysis
- Drug overview
- MARKETING SUPPORT
- THE XENDOS STUDY SHOWS ORLISTAT REDUCES RISK OF TYPE 2 DIABETES
- THE FDA APPROVES THE USE OF ORLISTAT IN ADOLESCENTS
- THE EUROPEAN COMMISSION APPROVES LABEL EXTENSION
- XENICAL MAY SLOW CANCER GROWTH
- Marketing strategies
- PROMOTION OF LONG-TERM EFFICACY AND SAFETY
- PROMOTION OF XENICAL USE IN OBESE ADOLESCENTS AND THE REDUCED RISK OF DEVELOPING TYPE 2 DIABETES
- PROVIDE MORE PATIENT SUPPORT TO INCREASE PATIENT COMPLIANCE
- XENICAL MAY BECOME PRESCRIPTION-FREE
- Xenical forecasts to 2012
- FDA APPROVAL OF USE OF XENICAL IN ADOLESCENTS
- LONG-TERM SAFETY DATA FROM THE XENDOS STUDY
- OTHER POSITIVE FACTORS
- LAUNCH OF ACOMPLIA
- FURTHER PRODUCT LAUNCHES AND PATENT EXPIRIES
- Meridia analysis
- Drug overview
- NO BENEFITS SHOWN IN HEALTH-RELATED QUALITY OF LIFE STUDY IN SIBUTRAMINE-TREATED OBESE PATIENTS WITH TYPE 2 DIABETES
- Marketing strategies
- INCREASE PATIENT SUPPORT STRATEGIES TO IMPROVE PATIENT COMPLIANCE
- INVEST IN MORE CLINICAL TRIALS FOR NEW INDICATIONS
- CONDUCT MORE TRIALS FOCUSING ON THE SAFETY OF MERIDIA (ESPECIALLY ON HEART)
- Meridia forecasts to 2012
- LAUNCH OF ACOMPLIA
- PATENT EXPIRY
CHAPTER 5 RD APPROACH
- Classification of pipeline products
- Cannabinoid (CB1) antagonists
- SNRIs
- Beta-3 adrenergic agonists
- Cholecystokinin agonists
- Carboxypeptidase inhibitors
- Ciliary neurotrophic factor (CNTF) agonists
- Lipase inhibitors
- Leptin agonists
- Lipid metabolism modulators
- Clinical trial design
- Clinical endpoints
- Insulin sensitivity and prevention of type 2 diabetes
- HDL and LDL cholesterol levels
- Critique of clinical trial design in obesity
CHAPTER 6 OBESITY PIPELINE ANALYSIS
- Pipeline overview
- Key companies involved in the anti-obesity drug market
- Sanofi-Aventis
- Breakdown by type of therapy
- Key marketing opportunities
- Axokine
- AOD9604
CHAPTER 7 DRUGS IN DEVELOPMENT
- Phase III
- Pipeline summary
- Definition of current comparator therapy
- Acomplia (rimonabant)
- Drug overview
- Clinical trial data
- PHASE IIA
- PHASE IIB
- RESULTS
- PHASE III RIO-LIPIDS TRIAL
- BACKGROUND
- STUDY DESIGN
- RESULTS
- AUTHOR CONCLUSION
- DATAMONITOR COMMENTS
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- WEIGHT LOSS
- SIDE EFFECTS
- PATIENT POTENTIAL
- MARKETING STRENGTH
- OVERALL PERFORMANCE
- Forecasts to 2012
- Axokine
- Drug overview
- Clinical trial data
- BACKGROUND
- STUDY DESIGN
- RESULTS
- AUTHOR CONCLUSIONS
- DATAMONITOR COMMENTS
- PHASE II
- BACKGROUND
- STUDY DESIGN
- RESULTS
- AUTHOR CONCLUSION
- DATAMONITOR COMMENTS
- PATIENT POTENTIAL
- MARKETING FACTORS
- Satisfaction of unmet needs
- WEIGHT LOSS
- SIDE EFFECTS
- PATIENT POTENTIAL
- MARKETING STRENGTH
- OVERALL PERFORMANCE
- Forecasts to 2012
- Phase II drugs
- ATL-962
- Drug overview
- Clinical trial data
- BACKGROUND
- STUDY DESIGN
- RESULTS
- AUTHOR CONCLUSIONS
- DATAMONITOR COMMENTS
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- WEIGHT LOSS
- SIDE EFFECTS
- PATIENT POTENTIAL
- MARKETING STRENGTH
- OVERALL PERFORMANCE
- Forecasts to 2012
- 1426
- Drug overview
- Clinical trial background
- STUDY DESIGN
- RESULTS
- DATAMONITOR COMMENTS
- MARKETING FACTORS
- Satisfaction of unmet needs
- WEIGHT LOSS
- SIDE EFFECTS
- PATIENT POTENTIAL
- MARKETING STRENGTH
- OVERALL PERFORMANCE
- Forecasts to 2012
- AOD9604
- Drug overview
- Clinical trial data
- BACKGROUND
- STUDY DESIGN
- RESULTS
- AUTHOR CONCLUSIONS
- DATAMONITOR COMMENTS
- Satisfaction of unmet needs
- WEIGHT LOSS
- SIDE EFFECTS
- PATIENT POTENTIAL
- MARKETING STRENGTH
- OVERALL PERFORMANCE
- Forecast to 2012
- GI181771
- A137
- Comparison of key compounds
- 10% and 5% weight loss
- Side effects
- Patient potential
- Marketing strength
- Overall performance
- Comparative forecasts
- Innovative early-stage projects
- 1954
- C2624
- C5093
- LY377604
- Peptide YY [3-36]
- SLV319
- T71
- APD356
- S2367
- Peg Axokine
- CP 331684
- Discontinued anti-obesity agents
APPENDIX A
- Contributing experts
- Bibliography
- Epidemiology sources
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Report methodology
- Japanese market data
APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's research and analysis methodologies
- Datamonitor Healthcare's therapy area capabilities
- About the Cardiovascular analysis team
- Key therapy team members
- Dr Allison Fleetwood
- Disclaimer
- List of Tables
- Table 1: Prevalence of obesity in the seven major markets by age (000s), 2003
- Table 2: Forecast of key pipeline products in the anti-obesity drug market in 2012
- Table 3: Prevalence of obesity in the seven major markets by age (000s), 2003
- Table 4: Prevalence of overweight in the seven major markets by age (000s), 2003
- Table 5: Forecast prevalence of obesity in the US (000s), 2003-12
- Table 6: Forecast prevalence of overweight in the US (000s), 2003-12
- Table 7: Forecast prevalence of obesity in the UK (000s), 2003-12
- Table 8: Forecast prevalence of overweight in the UK (000s), 2003-12
- Table 9: Classification of overweight, obesity by BMI, waist circumference and associated disease risk
- Table 10: A guide to treatment selection
- Table 11: Global anti-obesity drug sales 1999-2003, across the seven major markets
- Table 12: US anti-obesity drug sales from 1999-2003
- Table 13: Anti-obesity drug sales in Japan, 1999-03
- Table 14: French anti-obesity drug sales, 1999-2003
- Table 15: German anti-obesity drug sales, 1999-2003
- Table 16: Italian anti-obesity drug sales, 1999-2003
- Table 17: Spanish anti-obesity drug sales, 1999-2003
- Table 18: UK anti-obesity drug sales, 1999-2003
- Table 19: Global anti-obesity drug forecast, 2003-12
- Table 20: Xenical: key characteristics
- Table 21: Xenical events, 2003-04
- Table 22: Impacting factors on the sales of Xenical, 2003-12
- Table 23: Meridia: key characteristics
- Table 24: Meridia events, 2003-04
- Table 25: Impacting factors on the revenues of Meridia, 2003-12
- Table 26: Clinical trial designs
- Table 27: Clinical trial endpoints
- Table 28: Anti-obesity RD pipeline, June 2004
- Table 29: Companies with anti-obesity drugs in Phase I or above
- Table 30: Breakdown of the anti-obesity pipeline by type of therapy, 2004
- Table 31: Marketing position of companies with anti-obesity RD products
- Table 32: Key products in late-stage RD pipeline for obesity, June 2004
- Table 33: Results of the Phase III RIO-Lipids study
- Table 34: Impacting factors on the revenues of Acomplia, 2003-12
- Table 35: Phase III Axokine trial results
- Table 36: Comparison of Axokine trial results according to patients developing antibodies and those who did not
- Table 37: Average weight loss in pounds in Phase II of Axokine trial from baseline weight
- Table 38: Percentage of patients losing at least 5% of body weight
- Table 39: Impacting factors on the revenues of Axokine, 2006-12
- Table 40: Impacting factors on the revenues of ATL-962, 2008-12
- Table 41: Impacting factors on the revenues of 1426, 2009-12
- Table 42: Impacting factors on the revenues of AOD9604, 2009-12
- Table 43: Global sales forecasts for anti-obesity drugs, 2003-12
- Table 44: Anti-obesity agents in Phase I of development, June 2004
- Table 45: Discontinued RD anti-obesity agents
- List of Figures
- Figure 1: Impacts on the global anti-obesity market to 2012
- Figure 2: Classification of overweight and obesity
- Figure 3: Overview of obesity treatment guidelines from the NHLBI
- Figure 4: Growth and market share of anti-obesity drugs, 2002-03
- Figure 5: Xenical SWOT analysis
- Figure 6: Global sales forecasts for Xenical, 2003-12
- Figure 7: Meridia SWOT analysis
- Figure 8: Global sales forecasts for Meridia, 2003-12
- Figure 9: Rimonabant's satisfaction of unmet needs
- Figure 10: Global sales forecasts for Acomplia, 2003-12
- Figure 11: Phase III Axokine trial design
- Figure 12: Axokine Phase II trial design
- Figure 13: Axokine's satisfaction of unmet needs
- Figure 14: Global sales forecasts for Axokine, 2006-12
- Figure 15: ATL-962 Phase II trial designs
- Figure 16: ATL-962's satisfaction of unmet needs
- Figure 17: Global sales forecasts for ATL-962, 2008-12
- Figure 18: 1426's satisfaction of unmet needs
- Figure 19: Global sales forecasts for 1426, 2003-12
- Figure 20: AOD9604's satisfaction of unmet needs
- Figure 21: Global sales forecasts for AOD9604, 2003-12
- Figure 22: Comparison of key RD products in anti-obesity pipeline
- Figure 23: Comparative sales forecasts for the key therapies in the anti-obesity drug market, 2003-12
