Asthma and COPD - Get SMART
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- About Datamonitor healthcare - page 2
- About the Respiratory & Infectious Disease (RID) analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 4
- Scope - page 4
- Datamonitor insight into the disease market - page 4
- CHAPTER 2 MARKET OVERVIEW - page 11
- Asthma/COPD market third fastest growing therapeutic category - page 11
- Global forecast in 2014 is $23 billion - page 14
- Performance by class: ICS/LABA combinations leading class by value - page 16
- Products: Symbicort to become the top-selling brand - page 18
- Form of drug: majority of therapies delivered by inhaled route, except in Japan - page 21
- Geographical sales split: US continues to bear majority of drug costs - page 22
- Top performance by indication: COPD to account for 34% of global sales - page 24
- Company position: GSK has hit its maximal market share - page 27
- CHAPTER 3 MARKET ENVIRONMENT - page 30
- Global opportunities and threats - page 30
- HFA reformulations protect against generic entry - page 30
- Monoclonal antibody market is one of the fastest growing classes - page 33
- The cost of non-compliance - page 35
- Generic competition less intense in EU versus US - page 36
- Asthma/COPD prevalence rates stabilizing - page 36
- Safety and dosing are key clinical attributes - page 37
- US: opportunities and threats - page 38
- FDA sanctions LABA use with ICS - but does not go far enough - page 38
- Medicare reforms boosts sales - page 39
- FDA accepts new endpoints for novel asthma drugs - page 41
- Medicare Modernization Act has implications for brand defense - page 42
- Japan: opportunities and threats - page 43
- Acceleration of drug approval process - page 43
- Flat-sum reimbursement - page 44
- Greater pricing restrictions - page 44
- Under diagnosis and under treatmment of COPD - page 45
- Europe: opportunities and threats - page 45
- Impact of pricing controls reduced due to lack of generics - page 45
- Poor representation of pulmonologists in Europe - page 48
- Global opportunities and threats - page 30
- CHAPTER 4 FORECAST ANALYSIS - page 49
- ICS/LABA combinations - page 49
- Symbicort SMART indication shifts initiative to AstraZeneca - page 50
- Symbicort has billion-dollar potential in US - page 57
- Super-Advair: generic defense - page 63
- Seretide launch in Japan will boost sales - page 67
- Novel ICS/LABA combinations need a strong differentiation profile based on improved safety and/or dosing - page 68
- Altana's ciclesonide/formoterol should have the strongest clinical profile - page 70
- Novartis and SkyePharma combinations compete on price - page 72
- Chiesi combination undercuts Symbicort - page 73
- Biologicals - page 75
- Xolair to achieve peak sales of $1 billion - page 75
- Oral anti-inflammatories - page 78
- Singulair to remain dominant in the oral US asthma market until patent expiry - page 79
- Daxas results disappoint - page 81
- Anticholinergics - page 85
- Spiriva opens up the COPD market - page 86
- Beta-2 agonists - page 88
- Long-acting beta-2 agonist sales remain flat - page 88
- Short-acting beta-2 agonist class: Xopenex fuels growth - page 89
- Inhaled corticosteroids - page 92
- Pulmicort Respules challenged by IVAX - page 93
- Asmanex - late-comer to a crowded market - page 94
- Alvesco success hangs on FDA approval of highest dose - page 95
- ICS/LABA combinations - page 49
- CHAPTER 5 CASE STUDY - page 98
- Symbicort: pricing for success - page 98
- Symbicort discount to components the major influence on launch performance - page 101
- Strong exisiting R3 presence not vital to success - page 104
- Total molecule sales, rather than brand sales, important in LABA class - page 104
- Positive correlation between high Pulmicort Turbuhaler market share and success - page 105
- Promotional spend in launch period should aim to achieve 50% market share - page 105
- Symbicort: pricing for success - page 98
- CHAPTER 6 SALES FORECASTS - page 108
- Global forecasts - page 108
- US forecasts - page 111
- Japan forecasts - page 113
- France forecasts - page 115
- Germany forecasts - page 117
- Italy forecasts - page 119
- Spain forecasts - page 121
- UK forecasts - page 123
- CHAPTER 7 APPENDIX - page 125
- Market definition - page 125
- Indication sales split - page 127
- Forecasting assumptions and estimates - page 129
- Standard units - page 129
- Japanese market data - page 129
- Derivation of sales forecasts and pricing trends - page 130
- General event information - page 130
- Generic erosion and pricing assumptions - page 131
- Predicted market share for new products - page 131
- References - page 132
- About Datamonitor - page 134
- About Datamonitor Healthcare - page 134
- About the Respiratory team - page 135
- Disclaimer - page 136
- List of Tables
- Table 1: Global sales split by indication by class, 2004 - page 13
- Table 2: Global performance by class, 2004 and 2014 - page 17
- Table 3: Top 15 brands in the global markets, 2004 - page 19
- Table 4: Sales of major brands, 2004-14 - page 20
- Table 5: Global sales by delivery route, 2004 - page 21
- Table 6: Geographical sales split, 2004-14 - page 23
- Table 7: Global sales by split indication by class, 2004-2014 - page 24
- Table 8: Sales of Seretide/Advair by indication in 5EU and US, 2004-08 - page 26
- Table 9: Global company sales and market share, 2004-14 - page 28
- Table 10: Sales of inhaled products by delivery device, US, 2004 - page 31
- Table 11: US approved HFA-MDIs - page 32
- Table 12: Monoclonal antibodies in clinical development for asthma - page 34
- Table 13: Sales growth due to 2003 Medicare Act reforms - page 40
- Table 14: Number of chest physicians per 100,000 population in 5EU - page 48
- Table 15: Symbicort and Seretide sales, 5EU, 2004-14 - page 56
- Table 16: Launch price of Symbicort in the US - page 59
- Table 17: Sales and market share of inhaled corticosteroids, US, 2004 - page 60
- Table 18: Symbicort and Seretide/Super-Advair sales, US, 2004-14 - page 61
- Table 19: Seretide and Super-Advair sales, 5EU, 2004-14 - page 65
- Table 20: Fluticasone/salmeterol generic entry, price differential and erosion rate, 5EU and US - page 66
- Table 21: Seretide and Super-Advair sales, US, 2004-14 - page 67
- Table 22: Ratio of Flixotide sales in 2000 to Seretide sales in 2004 - page 68
- Table 23: Global ICS/LABA combination sales, 2004-14 - page 71
- Table 24: Market share of ICS/LABA class of Chiesi's beclomethasone/formoterol in 5EU - page 74
- Table 25: Xolair sales, US, 2003-05 - page 75
- Table 26: Xolair patient model, US and 5EU, 2004-14 - page 78
- Table 27: Global antileukotriene sales, 2004 - page 79
- Table 28: Global Singulair sales by indication, 2004-14 - page 80
- Table 29: Global sales of anticholinergics, 2004 - page 85
- Table 30: Global sales of short-acting and long-acting beta-2 agonists, 2004 - page 89
- Table 31: Global sales of inhaled corticosteroids, 2004 - page 93
- Table 32: Symbicort launch phase market share of ICS/LABA combination class, 5EU - page 99
- Table 33: Symbicort launch phase price discount to Seretide, Pulmicort/Oxis and generic ICS/Oxis - page 102
- Table 34: Market share, sales and average cost per day of generic ICS in 5EU, 2001 - page 102
- Table 35: Market share, sales and average cost per day of Pulmicort Turbuhaler in 5EU, 2001 - page 103
- Table 36: Forecast sales, Global, 2004-14 - page 108
- Table 37: Forecast sales, US, 2004-14 - page 111
- Table 38: Forecast sales, Japan, 2004-14 - page 113
- Table 39: Forecast sales, France, 2004-14 - page 115
- Table 40: Forecast sales, Germany, 2004-14 - page 117
- Table 41: Forecast sales, Italy, 2004-14 - page 119
- Table 42: Forecast sales, Spain, 2004-14 - page 121
- Table 43: Forecast sales, UK, 2004-14 - page 123
- Table 44: Generic erosion and pricing assumptions - page 131
- Table 45: First-year market share for second to market and "me-too" products - page 131
- List of Figures
- Figure 1: Global asthma/COPD sales growth, 2001-04 - page 11
- Figure 2: Global market share by ATC class by value, 2001-04 - page 12
- Figure 3: Global sales split by indication by class, 2004 - page 13
- Figure 4: Global sales split by indication for key brands, 2004 - page 14
- Figure 5: Positive outlook for respiratory market - page 15
- Figure 6: Global sales forecast, 2004-14 - page 16
- Figure 7: Global performance of respiratory R3 classes, 2004-14 - page 17
- Figure 8: Top five brands by sales in global market, 2004 - page 18
- Figure 9: Global sales by delivery route, 2004-14 - page 22
- Figure 10: Asthma/COPD value market share by country, 2004 - page 23
- Figure 11: Percentage of global sales by indication, 2004-14 - page 25
- Figure 12: Pricing controls in Europe - page 47
- Figure 13: Global ICS/LABA combination sales, 2004 - page 49
- Figure 14: Adjustable maintenance dosing versus stable dosing regimes - page 50
- Figure 15: Symbicort adjustable maintenance dosing (AMD) regime - page 51
- Figure 16: Symbicort SMART dosing regime - page 53
- Figure 17: Symbicort, Seretide and Super-Advair sales, 5EU, 2004-14 - page 57
- Figure 18: Symbicort and Seretide/Super-Advair sales, US, 2004-14 - page 62
- Figure 19: Potential "dream ticket": ciclesonide/QAB-149 combination - page 70
- Figure 20: Global ICS/LABA combination sales, 2004-14 - page 71
- Figure 21: Global Singulair sales by indication, 2004-14 - page 81
- Figure 23: Results from roflumilast RECORD and RATIO studies - page 83
- Figure 23: Global sales of Spiriva, Atrovent and Combivent franchise, 2004-14 - page 87
- Figure 24: Xopenex sales, US, 2004-14 - page 92
- Figure 25: Global sales of inhaled corticosteroids products, 2004-14 - page 95
- Figure 26: Advantages and disadvantages of Altana's Alvesco - page 97
- Figure 27: Sales of Symbicort, 5EU, 2001-04 - page 100
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