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Commercial Insight: Asthma/COPD - ICS/LABA Combinations Continue To Dominate

Product Type: Market Research Report
Published by: Datamonitor
Published: July 2006
Product Code: R313-16742
Description
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
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