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Asthma

Commercial Insight: Asthma/COPD

ICS/LABA combinations continue to dominate

Publication Date   August 2006
Publisher   Datamonitor
Product Type   Report
Pages   168
ISBN Number   not applicable
Product Code   DAT529
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Price £8,440.00

approximately: $12,534 | €9,932

Summary


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.

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.

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

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

Content


  • Chapter 1 Executive Summary
    • Objective of the analysis
    • 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
  • 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