Market Report Source

Overview

Introduction

The respiratory market will continue to experience strong growth for the next 6 years, driven by the expansion of sales in existing classes, the launch of major new products with safety and convenience advantages, and the results of several landmark studies. Despite patent expiries of three leading products, from 2010, the market will avoid a collapse like the one seen for oral antihistamines.

Scope

*Indication based forecasts for asthma/COPD products and significant pipeline drugs *Assessment of country-specific drivers and resistors likely to impact the market *Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates *Market overview by geographical area, with value analysis of clinical and commercial factors underlying product performance

Highlights

Global asthma/COPD sales should grow to over $30 billion by 2012 and remain flat thereafter, with inhaled corticosteroid/long-acting bronchodilator combinations set to remain the leading class by value throughout. Anticholinergics will experience the strongest growth, particularly in COPD, to become the second-best selling class.

GSK’s Super Advair should become the top-selling brand in the seven major markets in 2015 if the company manages to switch Seretide/Advair prescriptions successfully before Seretide’s US patent expires.

The phase-out of CFC-containing inhalers in the US after 2008 will have a big impact on the market for short-acting beta2 agonists (SABAs), more than doubling its size. The main beneficiary will be Sepracor’s Xopenex MDI.

Reasons to Purchase

*Identify key opportunities and threats that will impact the use and uptake of new and existing products *Quantify the future size and scope of the asthma/COPD market and predict the future performance of key compounds *Understand and capitalize on clinical unmet needs in the market, either through lifecycle management of marketed drugs or new product development

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Respiratory & infectious Disease (RID) analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the asthma/COPD market

CHAPTER 2 MARKET DEFINITION AND FORECASTING ASSUMPTIONS

Indication sales split

Strategic scoping and focus

Data definitions, limitations and assumptions

Standard Units

Japanese Market Data

Regional launch dates for new products

Derivation of Sales Forecasts and Pricing Trends

Patent expiries

General event information

Forecast methodology

Report methodology

CHAPTER 3 MARKET OVERVIEW

ICS/LABA combination class is and will remain largest class by value

Top-selling product in 2005 was Seretide/Advair ($4.7 billion)

Asthma remains most important indication in respiratory market

US represents 61% of respiratory market in seven major markets

Key events shape future of respiratory market

CHAPTER 4 COUNTRY MARKET ASSESSMENTS

Global opportunities and threats

Change to generic entry is delayed by new HFA formulations

Asthma/COPD patient populations are stabilizing

Stronger generic competition in US compared to EU

Non-compliance implies costs for patient and healthcare system

Improved safety and dosing is key to success of new products

Monoclonal antibody market is one of the fastest growing classes

Summary

US: opportunities and threats

FDA focuses on mortality associated with LABA monotherapy

Medicare Part D insures more senior citizens

Medicare Modernization Act stimulates generic entry

Medicare may limit reimbursement for nebulizers

FDA accepts new endpoints in asthma drug trials

Summary

Japan: opportunities and threats

PMDA still not up to speed

Generic penetration is slowly on the rise

New pricing restrictions to be implemented

COPD remains underdiagnosed and undertreated

Summary

Europe: opportunities and threats

Impact of pricing controls lowered by lack of generics

Pulmonologists less common in Europe

Summary

CHAPTER 5 FORECAST ANALYSIS

ICS/LABA combinations

Symbicort SMART indication may put AstraZeneca ahead

Success of anticipated Symbicort US launch will depend on price

TORCH study backs Advair/Seretide for COPD

Super Advair: generic defense or genuine progress?

Seretide is expected to generate $600 million in Japan

Symbicort and Advair profits will soon be threatened by several novel ICS/LABA combinations

Success of Altana’s ciclesonide/formoterol depends on US approval of highest dose

Novartis and SkyePharma combinations compete on price

Price is key to success for Chiesi’s combination

Anticholinergics

Spiriva expected to generate $1.9 billion in 2015

UPLIFT Trial may contribute to Spiriva’s success

Atrovent sales continue to decline

SABA/SAMA combinations sales remain stable

Anticholinergic pipeline drugs battle for second-to-market position

Biologicals

Xolair is expected to generate peak sales of $1.1 billion

Generic threat to Xolair is minimal

Pipeline products

Oral anti-inflammatories

Singulair to remain dominant in the oral US asthma market until patent expiry

Zileuton Controlled Release may achieve US peak sales of $228 million

Other pipeline drugs are unconvincing

Beta2-agonists

LABA sales will decline in near future

First once-daily LABA product expected to be launched in 2009

Generic CFC SABA market will convert into branded HFA SABA market

Xopenex is forecast to be best-selling SABA in 2015

Inhaled corticosteroids

Respules give boost to Pulmicort

Asmanex will have limited time before patent expiry

Approval of highest dose is key to Alvesco’s success in US

CHAPTER 6 BIBLIOGRAPHY

Bibliography

Presentations

Press releases

Websites

APPENDIX – MARKET FORECAST DATA

Seven major markets

Five major European markets

US

Japan

France

Germany

Italy

Spain

UK

ABOUT DATAMONITOR

About Datamonitor Healthcare

About the Respiratory analysis team

Key therapy team members

Disclaimer

List of Tables

Table 1: Generic erosion in the seven major markets (%) over three years

Table 2: Generic price discounts in the seven major markets (%)

Table 3: Sales of major brands 2005-2015

Table 4: Sales in seven major markets by indication, by class, 2005

Table 5: US approved HFA-MDIs, 2006

Table 6: Monoclonal antibodies in clinical development for asthma, 2006

Table 7: Number of chest physicians per 100,000 population in 5EU

Table 8: Symbicort, Seretide and Super Advair sales, 5EU, 2005-15

Table 9: Symbicort, Seretide and Super Advair sales, US, 2005-15

Table 10: Seretide, Super Advair and generics sales, 5EU, 2005-2015

Table 11: Seretide, Super Advair and generics sales, US, 2005-2015

Table 12: Ratio of Flixotide sales in 2000 to Seretide sales in 2004

Table 13: ICS/LABA combination sales in the seven major markets, 2005-2015

Table 14: Market share of ICS/LABA class of Chiesi’s beclometasone/formoterol in 5EU

Table 15: Xolair sales, US, 2003-2006

Table 16: Antileukotriene sales in the seven major markets, 2005-2015

Table 17: Pool of LABA candidates in Phase II trials

Table 18: Sales of short-acting beta2-agonists in the seven major markets, 2005-2015

Table 19: Inhaled corticosteroids sales in the seven major markets, 2005-2015

Table 20: Forecast sales, seven major markets, 2005-2015 ($m; 2005 figures are actuals)

Table 21: Forecast sales, five major European markets, 2005-2015 ($m; 2005 figures are actuals)

Table 22: Forecast sales, US, 2005-2015 ($m; 2005 figures are actuals)

Table 23: Forecast sales, Japan, 2005-2015 ($m; 2005 figures are actuals)

Table 24: Forecast sales, France, 2005-2015 ($m; 2005 figures are actuals)

Table 25: Forecast sales, Germany, 2005-2015 ($m; 2005 figures are actuals)

Table 26: Forecast sales, Italy, 2005-2015 ($m; 2005 figures are actuals)

Table 27: Forecast sales, Spain, 2005-2015 ($m; 2005 figures are actuals)

Table 28: Forecast sales, UK, 2005-2015 ($m: 2005 figures are actuals)

List of Figures

Figure 1: Classification of asthma disease severity

Figure 2: Classification of COPD disease severity

Figure 3: Asthma/COPD growth in the seven major markets, 2002?2005

Figure 4: Asthma/COPD market by class and value, 2005

Figure 5: Top three fastest-growing classes in the asthma/COPD market, 2002-2005

Figure 6: Top five brands by sales in seven major markets ($billion), 2005

Figure 7: Anticholinergics are popular in the treatment of COPD ($millions, 2005)

Figure 8: Geographical sales split of the respiratory market, 2005-2015

Figure 9: Outlook for the asthma and COPD market past 2006

Figure 10: Generic prices and erosion in the seven major markets

Figure 11: Global opportunities and threats for asthma/COPD market, 2006

Figure 12: Black box warning on Serevent Diskus package insert and Warnings section of the package insert

Figure 13: Opportunities and threats in the US asthma/COPD market, 2006

Figure 14: Opportunities and threats in the Japanese asthma/COPD market, 2006

Figure 15: Pricing controls in Europe

Figure 16: Opportunities and threats in the European asthma/COPD market, 2006

Figure 17: Symbicort adjustable maintenance dosing (AMD) regime

Figure 18: Adjustable maintenance dosing versus stable dosing regimes

Figure 19: Symbicort SMART dosing regime

Figure 20: Exacerbations should be treated sooner than current practice

Figure 21: Symbicort, Seretide and Super Advair sales, 5EU, 2005-2015

Figure 22: Symbicort, Seretide and Super Advair sales, US, 2005-2015

Figure 23: Potential dream ticket: ciclesonide/QAB-149 combination

Figure 24: ICS/LABA combination sales in the seven major markets, 2005-2015

Figure 25: The battle to be second to the once-daily LAMA market is between Almirall, Novartis and GSK

Figure 26: Patient potential breakdown for Xolair in the US

Figure 27: Patient potential breakdown for Xolair in Europe

Figure 28: Singulair and generic montelukast sales in the seven major markets, 2005-2015

Figure 29: Patient potential breakdown for Zileuton CR in the US

Figure 30: Results from roflumilast RECORD and RATIO studies

Figure 31: Adjusted mean time-standardized FEV1 AUC obtained on Days 1 and 8 of treatment with tiotropium (open-label extension period) compared with data for the same patients from Days 1 and 7 of double-blind treatment

Figure 32: Patient potential breakdown for arformoterol in the US

Figure 33: The (levo)salbutamol market according to type of delivery device

Figure 34: The volume and sales values of the (levo)salbutamol market according to type of delivery device

Figure 35: Xopenex sales, US, 2005-2015

Figure 36: Asmanex and generic mometasone sales in the seven major markets, 2005-2015

Figure 37: Advantages and disadvantages of Altana’s Alvesco

Figure 38: Alvesco and generic ciclesonide sales in the seven major markets, 2005-2015 134