Table of Contents
- About Datamonitor healthcare
- About the Respiratory & Infectious Disease (RID) analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope
- Datamonitor insight into the disease market
- CHAPTER 2 MARKET OVERVIEW
- Asthma/COPD market third fastest growing therapeutic category
- Global forecast in 2014 is $23 billion
- Performance by class: ICS/LABA combinations leading class by value
- Products: Symbicort to become the top-selling brand
- Form of drug: majority of therapies delivered by inhaled route, except in Japan
- Geographical sales split: US continues to bear majority of drug costs
- Top performance by indication: COPD to account for 34% of global sales
- Company position: GSK has hit its maximal market share
- CHAPTER 3 MARKET ENVIRONMENT
- Global opportunities and threats
- HFA reformulations protect against generic entry
- Monoclonal antibody market is one of the fastest growing classes
- The cost of non-compliance
- Generic competition less intense in EU versus US
- Asthma/COPD prevalence rates stabilizing
- Safety and dosing are key clinical attributes
- US: opportunities and threats
- FDA sanctions LABA use with ICS - but does not go far enough
- Medicare reforms boosts sales
- FDA accepts new endpoints for novel asthma drugs
- Medicare Modernization Act has implications for brand defense
- Japan: opportunities and threats
- Acceleration of drug approval process
- Flat-sum reimbursement
- Greater pricing restrictions
- Under diagnosis and under treatmment of COPD
- Europe: opportunities and threats
- Impact of pricing controls reduced due to lack of generics
- Poor representation of pulmonologists in Europe
- CHAPTER 4 FORECAST ANALYSIS
- ICS/LABA combinations
- Symbicort SMART indication shifts initiative to AstraZeneca
- Symbicort has billion-dollar potential in US
- Super-Advair: generic defense
- Seretide launch in Japan will boost sales
- Novel ICS/LABA combinations need a strong differentiation profile based on improved safety
and/or dosing
- Altanas ciclesonide/formoterol should have the strongest clinical profile
- Novartis and SkyePharma combinations compete on price
- Chiesi combination undercuts Symbicort
- Biologicals
- Xolair to achieve peak sales of $1 billion
- Oral anti-inflammatories
- Singulair to remain dominant in the oral US asthma market until patent expiry
- Daxas results disappoint
- Anticholinergics
- Spiriva opens up the COPD market
- Beta-2 agonists
- Long-acting beta-2 agonist sales remain flat
- Short-acting beta-2 agonist class: Xopenex fuels growth
- Inhaled corticosteroids
- Pulmicort Respules challenged by IVAX
- Asmanex - late-comer to a crowded market
- Alvesco success hangs on FDA approval of highest dose
- CHAPTER 5 CASE STUDY
- Symbicort: pricing for success
- Symbicort discount to components the major influence on launch performance
- Strong exisiting R3 presence not vital to success
- Total molecule sales, rather than brand sales, important in LABA class
- Positive correlation between high Pulmicort Turbuhaler market share and success
- Promotional spend in launch period should aim to achieve 50% market share
- CHAPTER 6 SALES FORECASTS
- Global forecasts
- US forecasts
- Japan forecasts
- France forecasts
- Germany forecasts
- Italy forecasts
- Spain forecasts
- UK forecasts
- CHAPTER 7 APPENDIX
- Market definition
- Indication sales split
- Forecasting assumptions and estimates
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- General event information
- Generic erosion and pricing assumptions
- Predicted market share for new products
- References
- About Datamonitor
- About Datamonitor Healthcare
- About the Respiratory team
- Disclaimer
- List of Tables
- Table 1: Global sales split by indication by class, 2004
- Table 2: Global performance by class, 2004 and 2014
- Table 3: Top 15 brands in the global markets, 2004
- Table 4: Sales of major brands, 2004-14
- Table 5: Global sales by delivery route, 2004
- Table 6: Geographical sales split, 2004-14
- Table 7: Global sales by split indication by class, 2004-2014
- Table 8: Sales of Seretide/Advair by indication in 5EU and US, 2004-08
- Table 9: Global company sales and market share, 2004-14
- Table 10: Sales of inhaled products by delivery device, US, 2004
- Table 11: US approved HFA-MDIs
- Table 12: Monoclonal antibodies in clinical development for asthma
- Table 13: Sales growth due to 2003 Medicare Act reforms
- Table 14: Number of chest physicians per 100,000 population in 5EU
- Table 15: Symbicort and Seretide sales, 5EU, 2004-14
- Table 16: Launch price of Symbicort in the US
- Table 17: Sales and market share of inhaled corticosteroids, US, 2004
- Table 18: Symbicort and Seretide/Super-Advair sales, US, 2004-14
- Table 19: Seretide and Super-Advair sales, 5EU, 2004-14
- Table 20: Fluticasone/salmeterol generic entry, price differential and erosion rate, 5EU and US
- Table 21: Seretide and Super-Advair sales, US, 2004-14
- Table 22: Ratio of Flixotide sales in 2000 to Seretide sales in 2004
- Table 23: Global ICS/LABA combination sales, 2004-14
- Table 24: Market share of ICS/LABA class of Chiesis beclomethasone/formoterol in 5EU
- Table 25: Xolair sales, US, 2003-05
- Table 26: Xolair patient model, US and 5EU, 2004-14
- Table 27: Global antileukotriene sales, 2004
- Table 28: Global Singulair sales by indication, 2004-14
- Table 29: Global sales of anticholinergics, 2004
- Table 30: Global sales of short-acting and long-acting beta-2 agonists, 2004
- Table 31: Global sales of inhaled corticosteroids, 2004
- Table 32: Symbicort launch phase market share of ICS/LABA combination class, 5EU
- Table 33: Symbicort launch phase price discount to Seretide, Pulmicort/Oxis and generic ICS/Oxi
- Table 34: Market share, sales and average cost per day of generic ICS in 5EU, 2001
- Table 35: Market share, sales and average cost per day of Pulmicort Turbuhaler in 5EU, 2001
- Table 36: Forecast sales, Global, 2004-14
- Table 37: Forecast sales, US, 2004-14
- Table 38: Forecast sales, Japan, 2004-14
- Table 39: Forecast sales, France, 2004-14
- Table 40: Forecast sales, Germany, 2004-14
- Table 41: Forecast sales, Italy, 2004-14
- Table 42: Forecast sales, Spain, 2004-14
- Table 43: Forecast sales, UK, 2004-14
- Table 44: Generic erosion and pricing assumptions
- Table 45: First-year market share for second to market and "me-too" products
- List of Figures
- Figure 1: Global asthma/COPD sales growth, 2001-04
- Figure 2: Global market share by ATC class by value, 2001-04
- Figure 3: Global sales split by indication by class, 2004
- Figure 4: Global sales split by indication for key brands, 2004
- Figure 5: Positive outlook for respiratory market
- Figure 6: Global sales forecast, 2004-14
- Figure 7: Global performance of respiratory R3 classes, 2004-14
- Figure 8: Top five brands by sales in global market, 2004
- Figure 9: Global sales by delivery route, 2004-14
- Figure 10: Asthma/COPD value market share by country, 2004
- Figure 11: Percentage of global sales by indication, 2004-14
- Figure 12: Pricing controls in Europe
- Figure 13: Global ICS/LABA combination sales, 2004
- Figure 14: Adjustable maintenance dosing versus stable dosing regimes
- Figure 15: Symbicort adjustable maintenance dosing (AMD) regime
- Figure 16: Symbicort SMART dosing regime
- Figure 17: Symbicort, Seretide and Super-Advair sales, 5EU, 2004-14
- Figure 18: Symbicort and Seretide/Super-Advair sales, US, 2004-14
- Figure 19: Potential "dream ticket": ciclesonide/QAB-149 combination
- Figure 20: Global ICS/LABA combination sales, 2004-14
- Figure 21: Global Singulair sales by indication, 2004-14
- Figure 23: Results from roflumilast RECORD and RATIO studies
- Figure 23: Global sales of Spiriva, Atrovent and Combivent franchise, 2004-14
- Figure 24: Xopenex sales, US, 2004-14
- Figure 25: Global sales of inhaled corticosteroids products, 2004-14
- Figure 26: Advantages and disadvantages of Altanas Alvesco
- Figure 27: Sales of Symbicort, 5EU, 2001-04
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