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Commercial Insight: Asthma and COPD - Combinations breathe life into the asthma and COPD markets

Published by: Datamonitor

Published: Oct. 31, 2003 - 236 Pages


Table of Contents


TABLE OF CONTENTS



CHAPTER 1 EXECUTIVE SUMMARY 3

Scope of the analysis 3

Datamonitor insight into the asthma/COPD market 4

The asthma/COPD market will increase by 35% to over $18 billion by 2011, largely driven by the success of the combination ICS & LABA class and expanding patent potential, rather than novel drug launches. Sales of Advair are forecast to surpass $5 billion in 2006, but investment by players with traditionally small asthma/COPD portfolios in combination therapies will see GSK becoming vulnerable to competition by the end of the decade. 4

Singulair's approval for allergic rhinitis has coincided perfectly with the advent of OTC antihistamines in the US. DTC promotion of its child-friendly formulations and safety properties, and the lack of significant competition from Allegra and oral pipeline therapies, will ensure that sales of Singulair reach $3 billion by 2007. 7

New product launches, including Spiriva and roflumilast, combined with an aging population and approval of combination ICS & LABA therapies in COPD, will see the market value of smoker’s lung rise to at least $5.5 billion by 2011, with Pfizer emerging as a major player. Given that approximately 50% of the 30 million COPD patients in the seven major markets are undiagnosed, increased awareness coupled with a reduction in lung function deterioration will prove critical to unlocking the true COPD patient potential. 9

Summary 12

Key metrics 13



CHAPTER 2 MARKET SEGMENTATION & DEFINITION 25

Strategic scoping and focus 25

Limited NCEs and growth in combination inhalers 25

Overlap between asthma and allergic rhinitis 25

Increase in asthma prevalence 26

Increase in COPD patients 26

Market definition 28

The gold-standard treatment 29

Asthma 29

COPD 30

Associated pharmaceutical markets 31



CHAPTER 3 GLOBAL MARKET OVERVIEW 32

Key findings 32

Global asthma/COPD market analysis 33

Global market forecast 37

Corticosteroid market performance 40

Top 10 leading corticosteroids 41

Recently launched/R&D drugs in corticosteroid class 43

Asmanex 43

Alvesco 44

Corticosteroid market forecast 45

Flovent analysis 47

Flovent: 12-month event screen 47

Flovent strategic analysis 48

Flovent forecasts to 2011 49

Pulmicort analysis 52

Pulmicort: 12-month event screen 52

Pulmicort strategic analysis 53

Pulmicort forecasts to 2011 55

Beta2-agonist market performance 57

Top 10 leading beta2-agonists 58

R&D drugs in beta2-agonist class 60

Sepracor’s enantiomer formulations 61

Beta2-agonist market forecast 62

Serevent analysis 64

Serevent: 12-month event screen 65

Serevent strategic analysis 65

Serevent forecasts to 2011 68

Foradil analysis 70

Foradil: 12-month event screen 71

Foradil strategic analysis 71

Foradil forecasts to 2011 72

Combination ICS & LABA inhalers market analysis 75

Top 10 leading ICS & LABA inhalers 75

R&D drugs in combination ICS & LABA class 78

Combination ICS & LABA inhaler market forecast 78

Advair analysis 80

Advair: 12-month event screen 81

Advair strategic analysis 82

Advair forecasts to 2011 85

Symbicort analysis 89

Symbicort: 12-month event screen 90

Symbicort strategic analysis 90

Symbicort forecasts to 2011 93

Leukotriene modifiers market analysis 96

Top 10 leading leukotriene modifiers 97

R&D drugs in leukotriene modifier class 98

Leukotriene modifier market forecast 99

Singulair analysis 101

Singulair: 12-month event screen 102

Singulair strategic analysis 102

Singulair forecasts to 2011 106

Anticholinergic market analysis 111

Top 10 leading anticholinergics 112

Anticholinergic market forecast 113

Spiriva analysis 115

Spiriva: 12-month event screen 116

Spiriva strategic analysis 117

Spiriva forecasts to 2011 119

All other respiratory drug class analysis 122

Xanthines 123

Spacer devices 124

Other recently launched/R&D drugs-Anti-IgE, PDE-4 inhibitors 124

Xolair 125

PDE-4 inhibitors-Ariflo, roflumilast 126

All other respiratory drug class forecasts 127



CHAPTER 4 PORTFOLIO AND LIFECYCLE MANAGEMENT 129

Key findings 129

Portfolio management 130

Market attractiveness 130

Comparative attractiveness of the asthma/COPD market 130

Class attractiveness in the asthma/COPD market 132

Positioning of the major asthma/COPD players 133

Portfolio analysis 135

GSK - respiratory marketing powerhouse 138

AstraZeneca - attention diverted by other drug launches 140

Merck - shrewd and savvy marketing expertise 141

Boehringer Ingelheim - COPD specialist 142

Emerging asthma/COPD players - the plot thickens… 144

Lifecycle management in asthma/COPD 147

Launch strategy and market penetration 147

Case study one: importance of Xolair’s pre-launch awareness campaign 148

Case study two: raising in-house awareness of Advair key to extraordinary sales performance 152

Optimizing peak sales 152

Case study: Flovent line extension and effective promotion 152

Revenue protection strategies 155

Reformulations, cross indications and brand loyalty keep Ventolin in top 10 best selling asthma/COPD drug list 155



CHAPTER 5 STRATEGIC PRODUCT POSITIONING 157

Key findings 157

Physician-focused product positioning 158

Physician-targeting strategies 158

Physician definition 158

Importance of treatment guidelines 159

Key conference themes 160

Brand positioning for key products in the major markets 162

Advair - “Reach higher” 162

Symbicort - “Tailored control - you’ve got it in one” 165

Singulair - “There’s excitement in the air” 165

Benchmarks and case studies 166

Using websites to promote core competency in respiratory disease 166

Physician detailing key to Singulair’s success 167

Pharmacist prescribing 168

Patient targeting and influence 169

Patient sub-group positioning analysis 169

Asthma 169

COPD 171

Brand imaging 171

Europe 172

DTC advertising 173

Pricing and reimbursement 177

Pricing threats 177

Europe 177

US 177

Pricing strategies - little room for maneuver 178

Europe 178

US 178

Japan 180

Pricing data for key products in the major markets 180

Treatment cost analysis 181

Case study: Advair shows cost effectiveness is the key benchmark of the future 183



APPENDIX A - MARKET DATA 185

Global asthma/COPD market data 185

Corticosteroid market data 186

Beta2-agonist market data 187

Combination corticosteroid & beta2-agonist market data 188

Leukotriene modifier market data 189

Anticholinergic market data 190

Xanthine market data 191

Respiratory NSAIDs market data 192

Combination beta2-agonist & respiratory NSAIDs market data 193

Other asthma/COPD drugs market data 194

Spacer devices market data 195



APPENDIX B 196

The CAM Group: data collation and methodology 196

Glossary of terms 197



APPENDIX C 199

Contributing experts 199

UK interview transcript 199

Dual asthma and allergic rhinitis indications 199

Combination ICS & LABA 200

Other drug classes 201

Triple therapy 202

Delivery devices 203

Off-label use 203

Enantiomers 203

Japan interview transcript 204

Japan 204

Dual asthma and allergic rhinitis indications 205

Combination ICS & LABA 206

Delivery devices 206

Off-label use 207

German interview transcript 207

Dual asthma and allergic rhinitis indications 207

Combination ICS & LABA 208

Delivery devices 210

Off-label use 210

Large-scale trials 210

US interview transcript 211

Dual asthma and allergic rhinitis indications 211

Combination ICS & LABA 212

Enantiomers 213

Delivery devices 214

Off-label use 215

Large-scale trials 215

List of tables 217

List of figures 222

List of figures 222

Glossary 225

Bibliography 226

Epidemiology 226

Clinical trial data 226

Report methodology 230

About Datamonitor 230

About Datamonitor Healthcare 230

Datamonitor Healthcare’s research and analysis methodologies 231

Datamonitor Healthcare’s therapy area capabilities 231

About the IDI analysis team 232

Datamonitor Healthcare’s Consulting expertise 233

Datamonitor’s Therapeutic Consulting expertise 234

Key therapy team members 234

Simon Wright, Director Immune Disorders and Inflammation 234

David Abramson, Therapeutic Lead Consultant 235

Disclaimer 236





Abstract

Introduction
An increase in asthma prevalence over the next decade will strain over-stretched healthcare budgets, leading to increased demand for cost-effective therapies. The COPD market will double in size by 2011, due to an aging population and new product launches. However, inhaler devices will remain the primary means of drug delivery, thereby maintaining extremely high barriers to market entry.

Scope
* IMS 2001/2002 data from 10 asthma/COPD drug classes, such as corticosteroids, beta2-agonists, combinations, anti-leukotrienes and spacer devices

* Sales forecasts of current and pipeline therapies, including Advair, Symbicort, Singulair, Xolair, Spiriva, Alvesco and roflumilast

* Case studies on Singulair’s promotional strategies, using CAM data, Advair’s pharmacoeconomic approach and Xolair’s pre-launch awareness campaign

* Extensive interviews with opinion leaders from the US, Japan, UK and Germany regarding changes in treatment patterns over the next decade

Report Highlights
The lack of effective oral therapies in the pipeline means that inhalation will remain the primary mode of delivery in the medium term. The significant barriers to market entry present a real opportunity for companies with inhaler expertise to expand their traditionally small asthma/COPD portfolios, like Schering-Plough, Aventis and Novartis.

Approval of Merck’s asthma drug Singulair for allergic rhinitis coincides perfectly with the launch of OTC generic Claritin in the US. In contrast, Aventis’ attempt to launch Allegra as a treatment for seasonal asthma will prove far less fruitful, due to the poor efficacy of antihistamines in a disease as complex as asthma.

The COPD market will double in value over the next decade, largely driven by new product launches, including Spiriva and roflumilast, the key promotional role of Pfizer in overcoming low diagnosis rates and an aging population. European approval of Advair and Symbicort in COPD will see prescribing rates rise above current off-label levels.

Reasons to Purchase
* Learn how the findings of the SMART trial and the black box warning recently assigned by the FDA will affect sales of Advair

* Determine the future of the PDE-4 inhibitor class following the FDA advisory committee’s rejection of GSK’s Ariflo

* Investigate the potential for widespread use of combination therapies in all adult and pediatric asthmatics



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