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Home > Healthcare > Pharmaceutical > Allergy/Immunology
Commercial Insight: Asthma/COPD - ICS/LABA Combinations Continue To Dominate
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| Published Date:
July 2006
Published By:
Datamonitor
Page Count:
168
Order Code:
R313-16742
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- 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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