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Pipeline and Commercial Insight: Obesity - the $11 billion market that never was

Published by: Datamonitor

Published: Jul. 22, 2009 - 245 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About the cardiovascular analysis team
CHAPTER 1 EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor insight into the obesity market
Related current reports
Related future reports
CHAPTER 2 OBESITY MARKET POTENTIAL
Key findings
Definition
Patient segmentation
Epidemiology
Current treatment options
Collective obesity management
Pharmacological interventions as components of personalized programs
Unmet need in obesity
Safety
Efficacy
Compliance
CHAPTER 3 CURRENT MARKET OVERVIEW
Seven major market current and future market overview
Impact of recent launches has been short-lived
Imminent slowdown cannot be blamed on generics
US remains core market, Europe sees greatest fluctuations, and Japan revenues are negligible
Environmental factors in the obesity market
Obesity products go over-the-counter
Is late-stage and post-marketing trial design due for an overhaul?
Defining acceptable risk means demonstrating acceptable gain
Increasing patient potential works against expensive interventions
US current and future market assessment
Japan current and future market assessment
Five major European markets current and future market assessment
France
Germany
Italy
Spain
UK
CHAPTER 4 BRAND DYNAMICS
Overview of competitive landscape
Drivers of brand choice
Trends in marketing strategy: Xenical and Alli
Product
Pricing
Placement
Promotion
Xenical (orlistat, Roche)
Drug profile
Product positioning
SWOT analysis
Brand forecast to 2018
Alli (orlistat, GlaxoSmithKline)
Drug profile
Product positioning
SWOT analysis
Brand forecast to 2018
Reductil/Meridia (sibutramine, Abbott)
Drug profile
Product positioning
SWOT analysis
Brand forecast to 2018
Sanorex/Teronac (mazindol, Sandoz)
Drug profile
Product positioning
SWOT analysis
Brand forecast to 2018
Acomplia/Zimulti (rimonabant, Sanofi-Aventis)
Drug profile
Product positioning
Brand forecast to 2018
CHAPTER 5 R&D APPROACH
Key findings
Clinical trial design in obesity
Safety
Efficacy, endpoints and outcomes
Comparators
Future direction
CHAPTER 6 PIPELINE ANALYSIS & FORECASTS
Key findings
Overview
Pipeline summary
Comparative forecasts
Comparator tool comparisons
Clinical factors
Commercial factors
Contrave (bupropion and naltrexone, Orexigen)
Drug profile
Drug overview
SWOT analysis
Clinical trial data
Phase III trials
Phase II trials
Forecasts to 2018
Qnexa (phentermine and topiramate, Vivus Inc.)
Drug profile
Drug overview
SWOT analysis
Clinical trial data
Phase III trials
Phase II trials
Forecasts to 2018
Lorcaserin (Arena Pharmaceuticals)
Drug profile
Drug overview
SWOT analysis
Clinical trial data
Forecasts to 2018
Cetilistat, Alizyme Plc
Drug profile
Drug overview
SWOT analysis
Clinical trial data
Phase III trial data
Phase II trial data
Forecasts to 2018
Other drugs
BIBLIOGRAPHY
Journal papers
Presentations
Website information
Reports
Books
Datamonitor reports
APPENDIX A - MARKET ASSUMPTIONS
APPENDIX B
Contributing experts
Report methodology
About Datamonitor
About Datamonitor Healthcare
About the Cardiovascular Disease analysis team
Disclaimer
Disclaimer
List of Tables
Table 1: World Health Organization classification of obesity
Table 2: Projected and forecast adult obesity prevalence (million) in the seven major markets, 2008-2018
Table 3: Projected and forecast adult obesity prevalence rate in the seven major markets, 2008-2018
Table 4: Predicted UK prevalence of childhood obesity by gender, 2004-2050
Table 5: Summary of selected guidelines for obesity interventions, 2009
Table 6: Examples of obesity-associated co-morbidities
Table 7: Historical and forecast obesity market performance in the seven major markets by volume and value, 2008-2018
Table 8: Historical and forecast obesity market performance by region in the seven major markets, 2008-2018
Table 9: Sales and growth of drug classes and/or brands for obesity in the seven major markets, 2008-2018
Table 10: Sales forecasts for obesity in the seven major markets ($m), 2008-2018
Table 11: Summary of opportunities and threats for the obesity market, 2009
Table 12: Expected remaining lifetime healthcare costs - obese, healthy living and smoking adults, 2009
Table 13: Sales forecasts for obesity in the US ($m), 2008-2018
Table 14: Sales forecasts for obesity in Japan ($m), 2008-2018
Table 15: Historical and forecast obesity market performance in the five major European markets by country and value, , 2008-2018
Table 16: Historical and forecast obesity market share (%) in the five major European markets by value, 2004, 2008 and 2018
Table 17: Obesity prevalence versus volume and value sales across the five major European markets, 2008
Table 18: Sales forecasts ($m) for obesity in the five major European markets, 2008-2018
Table 19: Sales forecasts for obesity in France ($m), 2008-2018
Table 20: Sales forecasts for obesity in Germany ($m), 2008-2018
Table 21: Sales forecasts for obesity in Italy ($m), 2008-2018
Table 22: Sales forecasts for obesity in Spain($m), 2008-2018
Table 23: Specific advice on obesity drug use, National Institute for Health & Clinical Evidence Quick Reference Guide for the National Health Service
Table 24: Sales forecasts for obesity in the UK ($m), 2008-2018
Table 25: Key branded drugs indicated for obesity, 2009
Table 26: Brand dynamics of key marketed drugs for the treatment of obesity in the seven major markets, 2008-2018
Table 27: US formulary status for key brands for the treatment of obesity, 2009
Table 28: Contraindications, cautions, adverse reactions and drug interactions - orlistat, sibutramine and phentermine
Table 29: Xenical (orlistat) - drug profile, 2009
Table 30: Xenical (orlistat) - SWOT analysis, 2009
Table 31: Forecast sales performance for Xenical in the seven major markets, 2008-2018
Table 32: Alli (orlistat) - drug profile, 2009
Table 33: Alli (orlistat) - SWOT analysis, 2009
Table 34: Alli (orlistat) sales performance in the seven major markets, 2008-2018
Table 35: Reductil (sibutramine) - drug profile, 2009
Table 36: Reductil (sibutramine) - SWOT analysis, 2009
Table 37: Acomplia/Reductil (sibutramine) sales performance in the seven major markets, 2008-2018
Table 38: Sanorex (mazindol) - drug profile, 2009
Table 39: Sanorex (mazindol) - SWOT analysis, 2009
Table 40: Sanorex/Teronac (mazindol) sales performance in the seven major markets, 2008-2018
Table 41: Acomplia (rimonabant) - drug profile, 2009
Table 42: Acomplia/Zimulti (rimonabant) sales performance in the seven major markets, 2008-2018
Table 43: Late-stage pipeline summary for obesity, 2009
Table 44: Obesity pipeline product performance against generic and currently marketed products in the seven major markets, 2008-2018
Table 45: Contrave (bupropion and naltrexone) - drug profile, 2009
Table 46: Contrave (bupropion and naltrexone) SWOT analysis, 2009
Table 47: Forecast sales for Contrave (bupropion and naltrexone) in the seven major markets, 2008-2018
Table 48: Qnexa (phentermine and topiramate) - drug profile, 2009
Table 49: Qnexa (phentermine and topiramate) SWOT analysis, 2009
Table 50: Forecast sales for Qnexa (phentermine and topiramate) in the seven major markets , 2008-2018
Table 51: Lorcaserin - drug profile, 2009
Table 52: Lorcaserin SWOT analysis, 2009
Table 53: Forecast sales for lorcaserin in the seven major markets, 2008-2018
Table 54: Cetilistat - drug profile, 2009
Table 55: Cetilistat SWOT analysis, 2009
Table 56: Forecast sales for cetilistat in the seven major markets,, 2008-2018
Table 57: Obesity pipeline by phase of development and activity status, 2006-09
Table 58: Phase II obesity pipeline overview, 2009
Table 59: Average trial durations used for Datamonitor forecasts of obesity market launch dates
Table 60: Review periods for new approvals in months
Table 61: Forecast launch dates for late stage obesity products
Table 62: Generic share, generic pricing and branded price upon generic incursion in the cardiovascular market
Table 63: Key patent expiry dates for market exclusivity for currently marketed obesity products
List of Figures
Figure 1: Definition of body mass index
Figure 2: Principal drivers for obesity
Figure 3: Projected and forecast adult obesity prevalence (million) ) in the seven major markets, 2008-2018
Figure 4: Projected and forecast adult obesity prevalence rate in the seven major markets, 2008-2018
Figure 5: Critical opportunities for intervention during an individual's life course
Figure 6: Examples of child-focused interventions to target obesity
Figure 7: Generic treatment pathway for obesity
Figure 8: Long-term weight loss improvements with long-term maintenance therapy
Figure 9: Historic events in the obesity market, 1930-2009
Figure 10: Forecast events in the obesity market, 2010-2018
Figure 11: Historical and forecast obesity market performance in the seven major markets by volume and value 2004-2018
Figure 12: Historical and forecast seven major market obesity market performance by volume and value by region, 2004-2018f
Figure 13: Historical and forecast obesity market performance in the seven major market by volume and value of key brands versus new launches and generics, 2004-2018f
Figure 14: Impact of over-the-counter orlistat on the US obesity market, 2004-08
Figure 15: Historical and forecast obesity market in the US performance by volume and value, 2004-2018
Figure 16: Historical and forecast obesity market performance in Japan by volume and value, 2004-2018
Figure 17: Historical and forecast obesity market performance in the five major European markets by volume and value, 2004-2018
Figure 18: Historical and forecast obesity market performance in the five major European markets by country and value,2004-2018
Figure 19: Historical and forecast obesity market performance in France by volume and value, 2004-2018
Figure 20: Marketed obesity brand performance in France against generic and pipeline products, 2004-2018
Figure 21: Pipeline product performance in France against generic and currently marketed products, 2004-2018
Figure 22: Historical and forecast obesity market performance in Germany by volume and value, 2004-2018
Figure 23: Marketed obesity brand performance in Germany against generic and pipeline products, 2004-2018
Figure 24: Pipeline product performance in Germany against generic and currently marketed products, Germany, 2004-2018
Figure 25: Historical and forecast obesity market performance in Italy by volume and value, 2004-2018
Figure 26: Marketed obesity brand performance in Italy against generic and pipeline products, 2004-2018
Figure 27: Pipeline product performance in Italy against generic and currently marketed products, 2004-2018
Figure 28: Historical and forecast obesity market performance in Spain by volume and value, 2004-2018
Figure 29: Marketed product performance in Spain against generic and pipeline products, 2004-2018
Figure 30: Pipeline product performance in Spain against generic and currently marketed products, 2004-2018
Figure 31: Historical and forecast obesity market performance in the UK by volume and value, 2004-2018
Figure 32: Marketed product performance in the UK against generic and pipeline products, 2004-2018
Figure 33: Pipeline product performance in the UK against generic and currently marketed products,2004-2018
Figure 34: Brand dynamics of key marketed drugs for the treatment of obesity in the seven major markets, 2004-2018
Figure 35: Historic and forecast sales for Xenical (orlistat) in the seven major markets, 2004-2018
Figure 36: Historic and forecast sales for Alli (orlistat) in the seven major markets, 2004-2018
Figure 37: Historic and forecast sales for Reductil (sibutramine) in the seven major markets, 2004-2018
Figure 38: Historic and forecast sales for Sanorex (mazindol) in the seven major markets, 2004-2018
Figure 39: Obesity pipeline product performance against generic and currently marketed products in the seven major markets, 2004-2018
Figure 40: Datamonitor drug assessment summary for pipeline products in development for obesity, 2009
Figure 41: Contrave Phase III trial plan overview
Figure 42: Contrave (bupropion and naltrexone) Phase III trial overview
Figure 43: Contrave (bupropion and naltrexone) Phase III trial overview
Figure 44: Contrave (bupropion and naltrexone) Phase III trial overview
Figure 45: Contrave (naltrexone and bupropion) Phase IIb trial results overview
Figure 46: Contrave (naltrexone and bupropion) Phase II trial results overview
Figure 47: Forecast sales for Contrave (bupropion and naltrexone) in the seven major markets, 2008-2018
Figure 48: Qnexa (phentermine and topiramate) Phase III trial plan overview
Figure 49: Qnexa (phentermine and topiramate) EQUIP Phase III trial overview
Figure 50: Qnexa (phentermine and topiramate) CONQUER Phase III trial overview
Figure 51: Qnexa (phentermine and topiramate) EQUATE Phase III trial overview
Figure 52: Qnexa (phentermine and topiramate) Phase II trial overview
Figure 53: Forecast sales for Qnexa (phentermine and topiramate) in the seven major markets , 2008-2018
Figure 54: Lorcaserin trial plan overview
Figure 55: Lorcaserin Phase III BLOOM trial overview
Figure 56: Lorcaserin Phase III BLOSSOM trial overview
Figure 57: Lorcaserin Phase III BLOOM-DM trial overview
Figure 58: Forecast sales for lorcaserin in the seven major markets, 2008-2018
Figure 59: Cetilistat monotherapy Phase III trial overview
Figure 60: Other late-stage cetilistat trial plans
Figure 61: Cetilistat Phase II trial in obese adults
Figure 62: Cetilistat Phase II trial in obese adults with diabetes
Figure 63: Forecast sales for cetilistat in the seven major markets,, 2008-2018
Figure 64: Obesity pipeline by phase of development, 2006-09
Figure 65: Obesity pipeline by activity status, 2006-09

Abstract

Introduction

The obesity market is easily characterized as attractive, featuring a booming patient potential needing long term therapy, but repeated product withdrawals and failed pipeline candidates highlight the reality of increasingly cautious regulatory bodies, reluctant payers, and a clinical community that puts more stock in diet and exercise: $513.7m sales in 2008 fall far short of analyst predictions.

Scope
  • Defining the key clinical characteristics of the obesity sector that present a unique commercial challenge
  • Translation of critical clinical and regulatory issues into pertinent practical considerations for both incumbent players and new market entrants
  • Clinical and commercial analysis of existing and late stage products targeting the sector, qualified by key opinion leader interviews
  • Seven major market forecasts for key products to 2018
Highlights

The 125 million obese adults in 2008 across the US, Japan, France, Germany, Italy, Spain and UK will grow to at least 143 million by 2018. If just 25% of these adults were treated for one year with a dollar per day product, achieving 80% compliance rates, market potential would rise from $8.6 billion in 2008 to $10.5 billion in 2018

There may be some advantages to exploring head-to-head trials of existing therapies, the combination use of drugs or demonstrating longer term improvements to cardiovascular risks, but in the current environment this is unlikely to expand the proportion of the obese population in which existing and late stage pipeline products will be used.

GSK's Alli failed to sustain US launch sales, Sanofi-Aventis' Acomplia has been withdrawn. 27 clinical pipeline products discontinued between publication of this report and its predecessor (2006) have cost at least $1.1 billion in trial costs alone. Some developers will be facing administration or liquidation rather than arranging partnering deals.

Reasons to Purchase
  • Understand why predictions for this market have been repeatedly over-stated
  • Qualify market expectations against the practicalities of targeting this unyielding market
  • Assess the qualities of marketed and pipeline products and their commercial handling to determine their realistic prospects
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