Obesity - Lack of Reimbursement Limits Market Potential
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the cardiovascular pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the Analysis - page 3
- Datamonitor insight into the Obesity market - page 4
- The obesity "epidemic" is taking place to a certain extent in all the major markets, and the rate of obesity prevalence growth is not showing any signs of slowing down in the near future - page 4
- The anti-obesity market growth does not follow the growth of obesity prevalence. The major cause for the lack of growth in most of the major markets is lack of reimbursement for pharmacological management of obesity - page 5
- The drugs currently available in the major markets for treatment of obesity have significant unmet needs and do not meet the expectations of obese patients - page 6
- The pipeline drugs will be able to satisfy some of the unmet needs and will be able to expand the market. However, the growth of the market will still be marginal in comparison to the growth of obesity prevalence - page 7
- Key metrics - page 8
- CHAPTER 2 PATIENT POTENTIAL - page 26
- Definition of obesity - page 26
- Segmentation of obesity - page 26
- Causes of obesity - page 29
- Genetic factors - page 29
- Environmental factors - page 29
- Psychological factors - page 30
- Other causes - page 30
- Obesity as a Risk Factor - page 30
- Obesity and overweight prevalence - page 31
- Obesity and overweight prevalence methodology - page 35
- US - page 35
- Japan - page 36
- France - page 36
- Germany - page 36
- Italy - page 37
- Spain - page 37
- UK - page 37
- Obesity and overweight prevalence methodology - page 35
- Overview of guidelines - page 38
- NHLBI Guidelines - page 38
- American College of Physicians guidelines - page 40
- PRODIGY - page 41
- Unmet needs in obesity - page 45
- More cost-effective care - page 46
- Increased patient knowledge and physician awareness - page 46
- Safe and tolerable drugs - page 47
- Drugs with greater efficacy - page 47
- Improved patient compliance - page 48
- CHAPTER 3 MARKET ANALYSIS - page 50
- Overview of the global anti-obesity drug market - page 50
- Lack of reimbursement is the key market resistor - page 52
- Overview of the US anti-obesity drug market - page 52
- Reimbursement - page 55
- DTC advertising - page 56
- National organizations and Awareness campaigns - page 57
- FDA's Obesity Working Group - page 57
- The United States Department of Health and Human Services - page 57
- Trust for America's Health - page 58
- 2001-2006 - The VERB Youth Media - page 59
- 2003 - Steps to a HealthierUS - page 59
- 2004 - Preventing Childhood Obesity: Health in the Balance - page 59
- 2004 - The Calories Count initiative - page 59
- 2004 - The Obesity and the Built Environment: Improving Public Health Through Community Design conference - page 59
- 2005 - Dietary Guidelines for Americans, 2005 - page 60
- 2005 - "We Can!" - page 60
- 2006 - Perspectives on Marketing, Self- Regulation, and Childhood Obesity - page 60
- 2006 - Food Marketing to Children and Youth: Threat or Opportunity? - page 60
- 2006 - Shape of the Nation - page 60
- Overview of the anti-obesity drug market in Japan - page 62
- Overview of the anti-obesity drug market in Europe - page 64
- France - page 65
- Germany - page 67
- Italy - page 69
- Spain - page 71
- UK - page 73
- UK-specific awareness campaigns - page 75
- TOAST - page 75
- The British Dietetic Association's Food First Program - page 75
- National Obesity Forum - page 75
- The International Obesity Taskforce - page 76
- Other European initiatives - page 77
- Food & Nutrition Action Plan - page 78
- The European Childhood Obesity Group - page 78
- EU platform for action "diet, physical activity and health" - page 79
- Green Paper: "Promoting healthy diets and physical activity" - page 80
- Anti-Obesity Charter - page 80
- Global market forecast - page 82
- Overview of the global anti-obesity drug market - page 50
- CHAPTER 4 OBESITY PIPELINE ANALYSIS - page 84
- The anti-obesity pipeline is mechanistically diversified - page 88
- The anti-obesity pipeline is rich in Phase I and Phase II candidates - page 90
- Numerous companies have their stake in the R&D landscape - page 91
- CHAPTER 5 R&D APPROACH - page 94
- Classification of pipeline products - page 94
- Cannabinoid (CB1) antagonists - page 94
- 5-HT (Serotonin) Receptors - page 95
- SNRIs - page 96
- Lipase inhibitors - page 96
- Alpha MSH (alpha-melanocyte-stimulating hormone) modulator - page 96
- Clinical trial design - page 98
- Clinical endpoints - page 101
- Insulin sensitivity and prevention of type 2 diabetes - page 103
- HDL and LDL cholesterol levels - page 104
- Critique of clinical trial design in obesity - page 104
- Strategies for achieving reimbursement - page 105
- Sanofi-Aventis raises the bar - page 106
- Classification of pipeline products - page 94
- CHAPTER 6 DRUG ANALYSIS - DRUGS ON THE MARKET - page 109
- Xenical analysis - page 109
- Drug overview - page 109
- Marketing support - page 111
- The XENDOS study shows orlistat reduces risk of type 2 diabetes - page 112
- The FDA approves the use of orlistat in adolescents - page 113
- The European Commission approves label extension - page 115
- Xenical may slow cancer growth - page 115
- Chugai discontinues clinical development of orlistat in Japan - page 115
- The European Commission approves the use of orlistat in obese adolescents - page 115
- FDA gives conditional approval for OTC use of orlistat - page 115
- Public Citizen petitions FDA to remove orlistat from the market - page 117
- Trials with Orlistat (60 mg) prove efficacy and improved tolerability in weight loss and reduction in LDL cholesterol. - page 117
- Marketing strategies - page 118
- Promotion of long-term efficacy and safety - page 118
- Promotion of Xenical use in obese adolescents and the reduced risk of developing type 2 diabetes - page 119
- Provide more patient support to increase patient compliance - page 120
- Xenical forecasts to 2015 - page 121
- Launch of Acomplia - page 122
- Orlistat goes OTC - page 122
- Loss of Patent Protection - page 122
- Launch of Contrave - page 122
- Launch of Qnexa - page 123
- Launch of Lorcaserin - page 123
- Launch of Cetilistat - page 123
- Drug overview - page 109
- Meridia analysis - page 124
- Drug overview - page 124
- Behavior therapy and sibutramine for the treatment of adolescent obesity - page 126
- STORM trial shows weight-maintenance success after weight loss is positively influenced by sibutramine and leisure-time activity. - page 128
- Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome (PCOS) - page 129
- Sibutramine effective in the treatment of binge-eating disorder - page 129
- No benefits shown in health-related quality of life study in sibutramine-treated obese patients with type 2 diabetes - page 130
- Eisai announces the start of phase III trials in Japan - page 131
- SCOUT study - page 131
- Marketing strategies - page 132
- Increase patient support strategies to improve patient compliance - page 132
- Invest in more clinical trials for new indications - page 133
- Conduct more trials focusing on the safety of Meridia - page 133
- Meridia forecasts to 2015 - page 134
- Launch of Acomplia - page 135
- Launch of Sibutramine in Japan - page 135
- Disclosure of SCOUT results - page 135
- Patent expiry - page 136
- Launch of Contrave - page 136
- Launch of Qnexa - page 136
- Launch of Lorcaserin - page 136
- Launch of Cetilistat - page 137
- Drug overview - page 124
- Acomplia analysis - page 138
- Drug overview - page 138
- Results of RIO-Lipids presented - page 139
- Results of RIO-Diabetes presented - page 141
- FDA issues approvable letter for obesity - page 143
- EU CHMP recommends approval of rimonabant for obesity - page 143
- Germany classifies rimonabant as lifestyle drug - page 144
- Results of SERENADE presented - page 144
- Marketing strategies - page 146
- Conduct more safety studies focusing on depression - page 146
- Promote the improvement of multiple risk factors for CV disease - page 147
- Conduct an outcome study with prevention of diabetes as primary end point - page 147
- Acomplia forecasts to 2015 - page 148
- Launch of Acomplia - page 148
- Potential for a black box warning - page 149
- Launch of Contrave - page 149
- Launch of Qnexa - page 149
- Launch of Lorcaserin - page 150
- Launch of Cetilistat - page 150
- Drug overview - page 138
- Xenical analysis - page 109
- CHAPTER 7 DRUG ANALYSIS - LATE STAGE AGENTS - page 151
- Phase III - page 151
- Pipeline summary - page 151
- Contrave (bupropion+ naltrexone) - page 152
- Drug Overview - page 152
- Clinical Trial Data - page 152
- Datamonitor Comments - page 153
- Forecasts to 2015 - page 153
- Lorcaserin (APD356) - page 155
- Drug overview - page 155
- Clinical Trial Data - page 156
- Datamonitor Comments - page 157
- Forecasts to 2015 - page 162
- MK0557 (L-000753721) - page 163
- Drug Overview - page 163
- Clinical Trial Data - page 163
- Datamonitor Comments - page 164
- MK0364 (c5093) - page 164
- Drug Overview - page 164
- Clinical Trial Data - page 164
- CP945598 - page 164
- Phase II - Pipeline summary - page 166
- Phase II - most promising compounds - page 168
- Cetilistat (ATL962) - page 168
- Drug Overview - page 168
- Datamonitor Comments - page 169
- Forecasts to 2015 - page 170
- Qnexa (phentermine + topiramate; VI0521) - page 172
- Drug Overview - page 172
- Clinical Trial Data - page 172
- Datamonitor Comments - page 173
- Forecasts to 2015 - page 173
- Cetilistat (ATL962) - page 168
- Phase II - other compounds - page 175
- Excalia (zonisamide +bupropion) - page 175
- Drug Overview - page 175
- Clinical Trial Data - page 175
- Datamonitor Comments - page 176
- AOD9604 - page 177
- Drug Overview - page 177
- Clinical Trial Data - page 177
- Datamonitor Comments - page 178
- Surinabant (SR 147778) - page 178
- Drug Overview - page 178
- Clinical Trial Data - page 179
- Datamonitor Comments - page 179
- Recombinant Methionyl human leptin - page 180
- Drug Overview - page 180
- Clinical Trial Data - page 180
- Datamonitor Comments - page 181
- Pramlintide (AC137) - page 181
- Drug Overview - page 181
- Clinical Trial Data - page 181
- Datamonitor Comments - page 183
- S2367 - page 183
- Drug Overview - page 183
- Clinical Trial Data - page 183
- Datamonitor Comments - page 184
- Oleoyl-estrone - page 184
- Drug Overview - page 184
- Clinical Trial Data - page 185
- Teglicar (ST1326) - page 187
- N5984 (KRP204) - page 187
- CP741952 - page 188
- MK0916 - page 188
- AVE1625 - page 189
- C2735 - page 189
- MK0493 (c2624) - page 189
- Sergliflozin (KGT1251, 869682) - page 189
- Tesofensine (NS2330) - page 190
- Excalia (zonisamide +bupropion) - page 175
- Phase III - page 151
- CHAPTER 8 DRUG ANALYSIS - EARLY STAGE AGENTS - page 191
- KB2115 - page 193
- SLV319 - page 193
- PROTEIN TYROSINE PHOSPHATASE 1B INHIBITORS, SERONO - page 193
- 856464 - page 193
- AC162352 - page 193
- ANDROGEN RECEPTOR AGONISTS, GTX - page 194
- AMG076 - page 194
- QRX431 - page 194
- BDC03 - page 194
- RESVERATROL (SRT501) - page 195
- PRX07034 - page 195
- TM30338 - page 195
- GT389255 - page 195
- PEPTIDE YY [3-36] (OBESITY, INTRANASAL), NASTECH - page 196
- ID1101 - page 198
- RADAFAXINE - page 198
- FLUASTERONE - page 198
- NGD4715 - page 198
- BVT74316 - page 199
- APPENDIX A - page 200
- Contributing experts - page 200
- Interviewed in 2004 - page 200
- Interviewed in 2006 - page 200
- Bibliography - page 202
- Epidemiology sources - page 202
- US - page 202
- Japan - page 202
- France - page 202
- Germany - page 202
- Italy - page 202
- Spain - page 203
- UK - page 203
- General Sources - page 204
- Epidemiology sources - page 202
- Report methodology - page 213
- Japanese market data - page 213
- Contributing experts - page 200
- APPENDIX B - page 214
- About Datamonitor - page 214
- About Datamonitor Healthcare - page 214
- Datamonitor Healthcare's research and analysis methodologies - page 215
- Datamonitor Healthcare's therapy area capabilities - page 215
- About the Cardiovascular analysis team - page 216
- Disclaimer - page 217
- About Datamonitor - page 214
- List of Tables
- Table 1: Prevalence of obesity in the seven major markets (000s), 2006-2015 - page 9
- Table 2: Prevalence of obesity / overweight in the seven major markets (000s), 2006-2015 - page 10
- Table 3: Global anti-obesity drug forecast, 2006-15, $m - page 12
- Table 4: Classification of overweight, obesity by BMI, waist circumference and associated disease risk - page 28
- Table 5: Prevalence of obesity in the seven major markets (000s), 2006-2015 - page 33
- Table 6: Prevalence of obesity / overweight in the seven major markets (000s), 2006-2015 - page 34
- Table 7: A guide to treatment selection according to the NHLBI guidelines - page 40
- Table 8: Global anti-obesity drug forecast, 2006-15, $m - page 83
- Table 9: Pipeline of anti-obesity compounds, 2006 - page 85
- Table 10: The pipeline for anti-obesity agents is mechanistically diversified: full listing, 2006 - page 88
- Table 11: Pipeline of anti-obesity agents by company, 2006 - page 91
- Table 12: Clinical trial design - page 99
- Table 13: Clinical trial endpoints - page 102
- Table 14: Phase III(b) rimonabant clinical development program - page 108
- Table 15: Xenical: key characteristics - page 109
- Table 16: Xenical events, 2003-06 - page 112
- Table 17: Meridia: key characteristics - page 124
- Table 18: Meridia events, 2003-06 - page 126
- Table 19: Acomplia: key characteristics - page 138
- Table 20: Acomplia events, 2003-6 - page 139
- Table 21: Results of the Phase III RIO-Lipids study - page 140
- Table 22: Results of the Phase III RIO-Diabetes study - page 141
- Table 23: Results of the SERENADE trial - page 145
- Table 24: Key products in Phase III R&D pipeline for obesity, Oct 2006 - page 151
- Table 25: Key products in Phase II R&D pipeline for obesity, December 2006 - page 167
- Table 26: Results of phase Ib trial with Oleoyl-Estrone (kilograms) - page 186
- Table 27: Percentage Changes after the treatment with N5984 - page 188
- Table 28: Key products in early-stage R&D pipeline for obesity, Dec 2006 - page 192
- List of Figures
- Figure 1: Pipeline of anti-obesity compounds, 2006 - page 11
- Figure 2: Classification of overweight and obesity - page 27
- Figure 3: Overview of obesity treatment guidelines from the NHLBI - page 39
- Figure 4: Global anti-obesity drug sales, 2002-2005, $m - page 50
- Figure 5: US anti-obesity drug sales, 2002-2005, $m - page 53
- Figure 6: US anti-obesity drug sales, 2002-2005, SU (000,000) - page 55
- Figure 7: Japan anti-obesity drug sales, 2002-2005, $m - page 62
- Figure 8: France - anti-obesity drug sales, 2002-2005, $m - page 65
- Figure 9: France anti-obesity drug sales, 2002-2005, SU (000,000) - page 66
- Figure 10: Germany - anti-obesity drug sales, 2002-2005, $m - page 67
- Figure 11: Germany - anti-obesity drug sales, 2002-2005, SU (000,000) - page 68
- Figure 12: Italy - anti-obesity drug sales, 2002-2005, $m - page 69
- Figure 13: Italy - anti-obesity drug sales, 2002-2005, SU (000,000) - page 70
- Figure 14: Spain - anti-obesity drug sales, 2002-2005, $m - page 71
- Figure 15: Spain - anti-obesity drug sales, 2002-2005, SU (000,000) - page 72
- Figure 16: UK - anti-obesity drug sales, 2002-2005, $m - page 73
- Figure 17: UK - anti-obesity drug sales, 2002-2005, SU (000,000) - page 74
- Figure 18: Pipeline of anti-obesity compounds, 2006 - page 84
- Figure 19: The pipeline of anti-obesity agents is mechanistically diverse, 2006 - page 89
- Figure 20: Pipeline maturity: percentage of R&D products in each phase of development, 2006 - page 90
- Figure 21: Xenical SWOT analysis - page 118
- Figure 22: Global sales forecasts for Xenical, 2006-15, $m - page 121
- Figure 23: Meridia SWOT analysis - page 132
- Figure 24: Global sales forecasts for Meridia, 2006-15 - page 134
- Figure 25: Acomplia SWOT analysis - page 146
- Figure 26: Global sales forecasts for Acomplia, 2006-15 - page 148
- Figure 27: Global sales forecasts for Contrave, 2006-15, $m - page 154
- Figure 28: Global sales forecasts for Lorcaserin, 2006-15, $m - page 162
- Figure 29: Global sales forecasts for Cetilistat, 2006-15, $m - page 170
- Figure 30: Global sales forecasts for Qnexa, 2006-15, $m - page 174
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