Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the respiratory pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the asthma/COPD market
- Contributing experts
- Related reports
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Indication sales split
- Current market situation
- Strategic scoping and focus
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- Summary of environmental issues affecting the asthma/COPD market
- Opportunities and threats in the seven major markets
- Opportunities
- Off-label prescribing is popular in the pediatric asthma market
- EMEA harmonizes drug approval process
- Smaller companies helped by European regulators
- Threats
- Governments try to stop increasing healthcare expenditure by
controlling pricing and reimbursement
- Parallel trading threatens return on investment
- Asthma and COPD prevalence will remain stable
- Non-compliance is particularly common in asthma
- Difficulty in conducting clinical trials in COPD
- US: opportunities and threats
- Asthma/COPD market overview
- Opportunities
- New asthma clinical trial endpoints open doors
- The CFC-HFA switch will lead to a branded salbutamol market
- FDA initiatives to decrease product development times
- US is the only country to allow direct-to-consumer (DTC) advertising
of prescription medicines
- Threats
- Reimbursement controls are important in decreasing healthcare
expenditure in the US
- Implementation of Medicare Part D influences US healthcare market
- Parallel trading could increase due to Medicare D' s ' donut hole'
- Prescription Drug User Fee Act (PDUFA) likely to increase fees
- Reimbursement of nebulized beta2-agonists in COPD are under pressure
- Japan: opportunities and threats
- Asthma/COPD market overview
- Opportunities
- Characteristics of Japanese society impact the COPD market in
particular
- Separation of manufacturing and marketing entities benefits both
Japanese and foreign companies
- Japan shows initiatives to open their market
- Threats
- Price cuts still dominate pricing and reimbursement in Japan
- Increasing uptake of generics
- Lengthy approval process slows down access to the Japanese market
- COPD remains underdiagnosed and undertreated
- France: opportunities and threats
- Asthma/COPD market overview
- Opportunities
- Generics use is still relatively low in France
- Pricing and reimbursement negotiations to be shortened by new agency
- Threats
- France increases its pricing and reimbursement efforts
- Varying formularies influence hospital prescribing
- Germany: opportunities and threats
- Asthma/COPD market overview
- Opportunities
- Encouraging environment for novel drug development
- ePharmacy and mail-order drugs legalized
- Disease management programs encourage patients to be more involved
- Threats
- Reimbursement controls are important in decreasing healthcare
expenditure in Germany
- Generic penetration in Germany is relatively high
- Germany focuses attention on high doses of medicines for elderly
patients
- ICS/LABA combinations under scrutiny
- Italy: opportunities and threats
- Asthma/COPD market overview
- Opportunities
- Generic drugs play a small role in Italy
- Reimbursement negotiations are less restrictive
- Threats
- Italy increases its pricing and reimbursement efforts
- Spain: opportunities and threats
- Asthma/COPD market overview
- Opportunities
- The pharmaceutical industry implements strategies to reduce parallel
exportation
- Health ministry introduces ' Spanish national formulary'
- Threats
- The introduction of a new medicines bill increases the focus on cost
containment in Spain
- The profile of generics is being raised in Spain
- UK: opportunities and threats
- Asthma/COPD market overview
- Opportunities
- The UK offers an attractive market
- The pricing and reimbursement environment in the UK is relatively
non-restrictive
- Threats
- The UK enjoys a strong generics market
- The post-guidance and pre-guidance effects of NICE are a significant
concern
- CHAPTER 4 FORECAST ANALYSIS
- Key events
- Inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA)
combinations
- Advair/Seretide will lose first position in ICS/LABA class
- Symbicort US approval and SMART approach will boost sales
- Foster competes on price
- New product launches
- Major clinical trials
- Additional indications
- Patent expiries
- Oral anti-inflammatories
- Singulair will remain highest selling NSAID but will suffer from
generic entry and new competitors
- New product launches
- Additional indications
- Patent expiries
- Long-acting anticholinergics (LAMAs)
- BI tries to differentiate Spiriva before the entry of new competitors
- New product launches
- Major clinical trials
- Additional indications
- Patent expiries
- Inhaled corticosteroids (ICS)
- Pulmicort and Flixotide remain the highest-selling ICS products
- New product launches
- Additional indications
- Patent expiries
- Long-acting beta2-agonists (LABAs)
- Serevent and Foradil lead the LABA class
- New product launches
- Major clinical trials
- Patent expiries
- Biologicals
- Xolair to become blockbuster by 2014
- New product launches
- Additional indications
- Patent expiries
- Short-acting beta2-agonists (SABAs)
- Sepracor' s Xopenex franchise to reach revenues of over $1 billion
- IVAX/Teva' s ProAir set to make most out of CFC-HFA switch in the US
- Combivent sales to decline slightly
- Short-acting anticholinergics (SAMAs)
- Other asthma and COPD therapies
- Bronchial thermoplasty
- Antibiotics
- Immunotherapy
- Data definitions, limitations and assumptions
- Standard Units
- Japanese Market Data
- Derivation of Sales Forecasts and Pricing Trends
- Regional launch dates for new products
- Generic Erosion and Pricing Assumptions
- The ' Others' class
- Forecasts
- Forecast methodology
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
- The strategies behind combination products
- Pricing
- First-to-market advantage
- Patent protection
- Combinations are here to stay
- The impact of the CFC-HFA switch in the US
- HFA as alternative to CFC
- 3M' s patents will prevent entry of other HFA SABAs
- ProAir will be highest-selling SABA after 2009 with peak sales of $650m
- The increasing importance of inhaler devices in the asthma/COPD market
- Lack of detailed guidelines and physician skills
- pMDIs versus DPIs
- The ideal inhaler
- The Novolizer and the Respimat SMI
- The Novolizer - optimal patient feedback and fine particles
- The Respimat SMI - slow moving mist with deep lung penetration
- BIBLIOGRAPHY
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
- Summary asthma/COPD market data
- ICS/LABA combinations market data
- ICS/LABA combinations market data
- Anticholinergics market data
- Biologicals market data
- Oral anti-inflammatories market data
- Beta2-agonists market data
- Inhaled corticosteroids (ICS) market data
- APPENDIX B - MARKET FORECAST DATA
- APPENDIX C
- Contributing experts
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the respiratory and infectious disease analysis team
- Disclaimer
- List of Tables
- Table 1: Prescription of off-label and unlicensed drugs in pediatrics
- Table 2: Sales of ICS/LABA combination products in the seven major
markets ($m), 2006-2016
- Table 3: Price difference between launched ICS/LABA combination
products in Germany, 2007
- Table 4: Sales of oral anti-inflammatory products in the seven major
markets ($m), 2006-2016
- Table 5: Sales of long-acting anticholinergic products in the seven
major markets ($m), 2006-2016
- Table 6: Sales of inhaled corticosteroid products in the seven major
markets ($m), 2006-2016
- Table 7: Sales of long-acting beta2-agonist products in the seven
major markets ($m), 2006-2016
- Table 8: GSK pool of LABA candidates in Phase II trials, 2006
- Table 9: Sales of monoclonal antibody products in the seven major
markets ($m), 2006-2016
- Table 10: Sales of short-acting betas2-agonist products in the seven
major markets ($m), 2006-2016
- Table 11: Sales of short-acting anticholinergic products in the seven
major markets ($m), 2006-2016
- Table 12: Costs per bronchoscopy
- Table 13: Launch forecast assumptions used in the asthma/COPD market,
2007
- Table 14: Generic erosion in the seven major markets over 3 years (%)
- Table 15: Generic price discounts in the seven major markets (%)
- Table 16: Classes rolled up into the ' Others' category by country
- Table 17: Prices of HFA (levo)salbutamol products in 2006
- Table 18: US - Summary market data, 2006 and 2016
- Table 19: Japan - Summary market data, 2006 and 2016
- Table 20: France - Summary market data, 2006 and 2016
- Table 21: Germany - Summary market data, 2006 and 2016
- Table 22: Italy - Summary market data, 2006 and 2016
- Table 23: Spain - Summary market data, 2006 and 2016
- Table 24: UK - Summary market data, 2006 and 2016
- Table 25: Advair/Seretide: key facts
- Table 26: Symbicort: key facts
- Table 27: Foster: key facts
- Table 28: Spiriva: key facts
- Table 29: Atrovent: key facts
- Table 30: Combivent: key facts
- Table 31: Duoneb: key facts
- Table 32: Berodual: key facts
- Table 33: Xolair: key facts
- Table 34: Singulair: key facts
- Table 35: Accolate: key facts
- Table 36: Onon: key facts
- Table 37: Zyflo: key facts
- Table 38: Serevent: key facts
- Table 39: Foradil: key facts
- Table 40: Ventolin: key facts
- Table 41: Proventil: key facts
- Table 42: Xopenex: key facts
- Table 43: ProAir: key facts
- Table 44: Pulmicort: key facts
- Table 45: Flixotide/Flovent: key facts
- Table 46: Becotide: key facts
- Table 47: Qvar: key facts
- Table 48: Beclazone: key facts
- Table 49: Clenil: key facts
- Table 50: Azmacort: key facts
- Table 51: Aerobid: key facts
- Table 52: Alvesco: key facts
- Table 53: Asmanex: key facts
- Table 54: Seven major markets - forecast sales in the asthma/COPD
market, 2006-2016 ($m; 2006 figures are actuals)
- Table 55: Five major European markets - forecast salesin the
asthma/COPD market, 2006-2016 ($m; 2006 figures are actuals)
- Table 56: US - forecast sales in the asthma/COPD amrket, 2006-2016
($m; 2006 figures are actuals)
- Table 57: Japan - forecast sales in the asthma/COPD market, 2006-2016
($m; 2006 figures are actuals)
- Table 58: France - forecast sales in the asthma/COPD market, 2006-2016
($m; 2006 figures are actuals)
- Table 59: Germany - forecast sales in the asthma/COPD market,
2006-2016 ($m; 2006 figures are actuals)
- Table 60: Italy - forecast sales in the asthma/COPD market, 2006-2016
($m; 2006 figures are actuals)
- Table 61: Spain - forecast sales in the asthma/COPD market, 2006-2016
($m; 2006 figures are actuals)
- Table 62: UK - forecast sales in the asthma/COPD market, 2006-2016
($m; 2006 figures are actuals)
- List of Figures
- Figure 1: Total sales in the seven major markets, by class ($bn),
2002-2006
- Figure 2: Asthma/COPD market by class and value in the seven major
markets, 2006
- Figure 3: Top five brands by sales in seven major markets ($bn), 2006
- Figure 4: Respiratory market sales split by country ($m), 2006-2016
- Figure 5: Summary of environmental issues affecting the asthma/COPD
market, 2007
- Figure 6: Healthcare spending as a proportion of GDP in the seven
major markets, 2004
- Figure 7: Key pricing controls used globally, 2006
- Figure 8: Trends in the prevalence of asthma symptoms according to the
ISAAC Phase Three study, 2006
- Figure 9: Percentage of daily smokers among adult population
- Figure 10: US sales of asthma/COPD treatments by class ($bn), 2002-2006
- Figure 11: Different endpoints show different profile of high versus
low dose budesonide
- Figure 12: Traditional and possible novel endpoints in asthma and COPD
trials
- Figure 13: Decrease of FDA' s mean total approval time, 1995-2005
- Figure 14: Japan sales of asthma/COPD treatments by class ($bn),
2002-2006
- Figure 15: Increase in life expectancy between 1960 and 2003 across
the seven major markets
- Figure 16: France sales of asthma/COPD treatments by class ($bn),
2002-2006
- Figure 17: Germany sales of asthma/COPD treatments by class ($bn),
2002-2006
- Figure 18: Italy sales of asthma/COPD treatments by class ($bn),
2002-2006
- Figure 19: Spain sales of asthma/COPD treatments by class ($bn),
2002-2006
- Figure 20: UK sales of asthma/COPD treatments by class ($bn), 2002-2006
- Figure 21: Sales of the ICS/LABA combination class compared to overall
asthma/COPD sales in the seven major markets ($bn), 2006-2016
- Figure 22: Sales of Advair/Seretide, Symbicort and Foster in the seven
major markets ($bn), 2006-2016
- Figure 23: Once daily QAB149 is comparable to twice-daily formoterol
- Figure 24: Sales of Advair/Seretide, Beyond Advair, Advair family and
QMF149 in the seven major markets ($bn), 2006-2016
- Figure 25: Sales of Alvesco Combo, Flutiform and MFF258 in the seven
major markets ($m), 2006-2016
- Figure 26: Sales of the oral anti-inflammatories class compared to
overall asthma/COPD sales in the seven major markets ($bn), 2006-2016
- Figure 27: Sales of Singulair, Onon and Accolate in the seven major
markets ($m), 2006-2016
- Figure 28: Sales of Zyflo, Zileuton CR and MN-001 in the seven major
markets ($m), 2006-2016
- Figure 29: Sales of the long-acting anticholinergic class compared to
overall asthma/COPD sales in the seven major markets ($bn), 2006-2016
- Figure 30: The Respimat Soft Mist Inhaler
- Figure 31: Sales of Spiriva in the seven major markets ($bn), 2006-2016
- Figure 32: Sales of LAS 34273, NVA237 and GSK' s LAMA in the seven
major markets ($m), 2006-2016
- Figure 33: Sales of QVA149 in the seven major markets ($m), 2006-2016
- Figure 34: Sales of the inhaled corticosteroid class compared to
overall asthma/COPD sales in the seven major markets ($bn), 2006-2016
- Figure 35: Sales of Pulmicort and Flixotide/Flovent in the seven major
markets ($m), 2006-2016
- Figure 36: Sales of beclometasone-based inhalers in the seven major
markets ($m), 2006-2016
- Figure 37: Sales of Asmanex and Alvesco in Germany ($m), 2003-2006
- Figure 38: Sales of Asmanex and Alvesco in the seven major markets
($m), 2006-2016
- Figure 39: Patient potential for a once-daily anti-inflammatory for
the treatment of COPD in the seven major markets, 2007
- Figure 40: Sales of the long-acting beta2-agonist class compared to
overall asthma/COPD sales in the seven major markets ($bn), 2006-2016
- Figure 41: Sales of Serevent and Foradil in the seven major markets
($m), 2006-2016
- Figure 42: Sales of QAB149, GSK' s LABA and CHF 4226 in the seven major
markets ($m), 2006-2016
- Figure 43: Trials on safety and efficacy of Brovana and Perforomist,
2007
- Figure 44: Sales of Brovana and Perforomist in the seven major markets
($m), 2006-2016
- Figure 45: Sales of the biologicals class compared to overall
asthma/COPD sales in the seven major markets ($bn), 2006-2016
- Figure 46: Patient potential for Xolair in the US, 2007
- Figure 47: Patient potential for Xolair in Europe, 2007
- Figure 48: Sales of Xolair in the seven major markets ($m), 2006-2016
- Figure 49: Patient potential for a once-daily monoclonal antibody for
the treatment of severe/refractory asthma in the seven major markets, 2007
- Figure 50: Sales of the short-acting beta2-agonist class compared to
overall asthma/COPD sales in the seven major markets ($bn), 2006-2016
- Figure 51: Sales of Xopenex Nebulized and HFA in the seven major
markets ($m), 2006-2016
- Figure 52: Sales of Ventolin, Proventil and ProAir in the seven major
markets ($m), 2006-2016
- Figure 53: Sales of Combivent and Duoneb in the seven major markets
($m), 2006-2016
- Figure 54: Sales of Atrovent in the seven major markets ($m), 2006-2016
- Figure 55: Possible patient potential for bronchial thermoplasty in
the US, 2007
- Figure 56: Possible revenues for Asthmatx in the US
- Figure 57: The roles of viral and bacterial infections in asthma
- Figure 58: Cannibalization versus expansion strategy
- Figure 59: Sales of Advair/Seretide versus its components in the US
($bn), 2002-2006
- Figure 60: First-year of launch and 2016 sales of marketed and
pipeline combination products
- Figure 61: Generic CFC salbutamol market will revert to branded HFA
salbutamol market in the US after December 2008
- Figure 62: Overview of the salbutamol and levosalbutamol market, HFA
versus other, and the impact of the CFC-HFA switch, 2006-2008
- Figure 63: Sales of HFA (levo)salbutamol products, 2006-2016
- Figure 64: The Novolizer has the characteristics of an ideal inhaler
device
- Figure 65: Respimat SMI demonstrates better lung deposition compared
with conventional MDIs
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