Commercial Insight: Asthma & COPD - On the verge of generic entry: Industry Research

Commercial Insight: Asthma & COPD - On the verge of generic entry

Published Date: June 2009

Published By: Datamonitor

Page Count: 199

Order Code: R313-52322

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ABOUT DATAMONITOR HEALTHCARE: About the Infectious Disease and Respiratory (ID&R) pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Strategic scoping and focus; Datamonitor insight into the disease market; Contributing experts; Related reports; Upcoming related reports
CHAPTER 2 MARKET DEFINITION: Asthma/COPD market definition; Asthma/COPD indication split
CHAPTER 3 MARKET OVERVIEW: Seven major markets; Current and future market overview; Total asthma/COPD market is expected to decline from $24 billion in 2008 to $23 billion in 2018; Beyond Advair will take over top-position from Advair/Seretide; The US will remain the largest market, but growth in Europe will be higher; Opportunities; Need for novel anti-inflammatories in COPD and severe asthma is high; Possible trend towards more aggressive treatment of mild asthma and COPD; COPD prevalence is increasing in the short- to medium-term; Underdiagnosis of COPD represents an untapped patient population; Threats; Lucrative ICS/LABA market will soon break down into many pieces, leaving relatively low sales for new entries; Asthma prevalence likely to have reached plateau; Decreasing number of smokers may eventually lead to fewer smoking-related COPD patients; Ongoing cost-containment measures will continue to drive use of generics; US; Current and future market assessment; Opportunities; CFC-HFA switch converts heavily genericized salbutamol market back into a branded market; Stricter requirements for ANDA applicants may complicate and lengthen review process for generics; Threats; FDA continues to investigate the link between LABA monotherapy and asthma-related deaths; Low-income communities with asthma are likely to be worse off due to changes in healthcare insurance policies; Japan; Current and future market assessment; Opportunities; Japanese ICS/LABA market still has room for expansion; Threats; Increased awareness of generic products among Japanese consumers; Big Pharma scales back R&D activities in Japan, except for Boehringer Ingelheim; Five major European markets; Current and future market assessment; Opportunities; UK: 2009 Pharmaceutical Price Regulation Scheme (PPRS) will allow flexible pricing after product launch; Spain: government to spend extra on respiratory research in 2009; Threats; European Commission accuses the pharmaceutical industry of tactics to delay generic entry; Germany: IQWIG review does not show advantage of ICS/LABA combination products over separate inhalers in asthma; France; Current and future market assessment; Germany; Current and future market assessment; Italy; Current and future market assessment; Spain; Current and future market assessment; UK; Current and future market assessment; Rest of the world snapshot; Current market assessment; The asthma/COPD market in the BRIC countries, plus Australia and Canada; Opportunities; COPD to become more prevalent in countries with high smoking rates; Asthma prevalence in emerging markets are increasing towards seven major market levels; Study shows that low-income countries have reduced access to generics and pay too much for drugs; Threats; Barriers to uptake of treatment guidelines in emerging markets; History and tradition of alternative medicine may hamper new drug uptake
CHAPTER 4 BRAND DYNAMICS: Overview of competitive landscape; Patient acquisition process; Points of influence in the patient care path; Trigger point 1: increase disease awareness among the general public; Trigger point 2: increase disease awareness among physicians; Trigger point 3: influence initial brand choice; Trigger point 4: influence switching decisions; Drivers of brand choice - the inhaler device; US formulary tier status for leading brands; Trends in marketing strategies; Promotional spend; Advair/Seretide (fluticasone/salmeterol, GlaxoSmithKline); Drug profile; Product positioning; Advair/Seretide's main competitor is AstraZeneca's Symbicort; SWOT analysis; Brand forecast to 2018; The Diskus may somewhat protect Advair/Seretide's sales; Me-too products are likely to compete on price; Once-daily product is GlaxoSmithKline's hope to continue successful franchise; First generics will enter the US market in 2010; Recent launch and additional indications will lead to growth in Japan; Pulmicort Respules (nebulized budesonide, AstraZeneca); Drug profile; Product positioning; SWOT analysis; Brand forecast to 2018; Important US market will be decimated by early introduction of generics; Failure of Unit Dose Budesonide represents a lack of follow-on products; Spiriva (tiotropium bromide, Boehringer Ingelheim); Drug profile; Product positioning; SWOT analysis; Brand forecast to 2018; Further rollout of the Respimat expected to somewhat protect Spiriva's sales; Launch of at least three competitor once-daily LAMAs is imminent; LABA/LAMA combinations to threaten sales; First generics will enter the European market in 2015; Singulair (montelukast, Merck & Co); Drug profile; Product positioning; SWOT analysis; Brand forecast to 2018; First generics will enter the US and European market in 2012; Additional studies are unlikely to have significant impact on Singulair sales; Other marketed brands; Inhaled corticosteroids; Long-acting beta2-agonists (LABAs); Others; Beyond Advair (fluticasone furoate/642444, GlaxoSmithKline); Drug profile; Development overview; Product positioning; SWOT analysis; Drug forecast to 2018; QVA149 (indacaterol/glycopyrrolate, Novartis); Drug profile; Development overview; Product positioning; SWOT analysis; Drug forecast to 2018; Daxas; Drug profile; Development overview; Product positioning; SWOT analysis
CHAPTER 5 KEY DEVELOPERS: Strategic overview; Trends in corporate strategy; Low-revenue monotherapies are being developed for use in high-selling combinations; Smaller companies enter the market with me-too products; Recent strategic partnerships; GlaxoSmithKline; Corporate strategy; Asthma/COPD portfolio assessment; Novartis; Corporate strategy; Asthma/COPD portfolio assessment; BIBLIOGRAPHY; Articles; Press releases; Websites; Datamonitor reports
APPENDIX A - MARKET ASSUMPTIONS: New product launches; Patent expiries; Pricing assumptions; Data definitions, limitations and assumptions; Standard units; Sales indication split using IMS medical data; Country group definitions; All other EU countries; Middle East; Rest of World; Derivation of sales forecasts and pricing trends; Forecast methodology
APPENDIX B: Contributing experts; Report methodology; About Datamonitor; About Datamonitor Healthcare; About the Respiratory & Infectious Diseases analysis team; Disclaimer; Disclaimer
List of Tables: Table 1: Sales and growth of asthma/COPD drug classes in the seven major markets, 2008-2018; Table 2: Summary of opportunities and threats in the asthma/COPD market across the seven major markets, 2009; Table 3: Sales and growth of asthma/COPD drug classes in the US, 2008-2018; Table 4: Sales forecasts of key asthma/COPD brands in the US ($m), 2008-2018; Table 5: Price per standard unit for salbutamol products delivered in a HFA-containing device in the US, 2005-08; Table 6: Summary of key trends in US health insurance and likely impact on asthma disparities, 2009; Table 7: Summary of opportunities and threats in the asthma/COPD market in the US, 2009; Table 8: Sales and growth of asthma/COPD drug classes in Japan, 2008-2018; Table 9: Sales forecasts of key asthma/COPD brands in Japan ($m), 2008-2018; Table 10: Summary of opportunities and threats in the asthma/COPD market in Japan, 2009; Table 11: Sales and growth of asthma/COPD drug classes in the five major European markets, 2008-2018; Table 12: Sales forecasts of key asthma/COPD brands in the five major European markets ($m), 2008-2018; Table 13: Summary of opportunities and threats in the asthma/COPD market in the five major European markets, 2009; Table 14: Sales forecasts of key asthma/COPD brands in France ($m), 2008-2018; Table 15: Sales forecasts of key asthma/COPD brands in Germany ($m), 2008-2018; Table 16: Sales forecasts of key asthma/COPD brands in Italy ($m), 2008-2018; Table 17: Sales forecasts of key asthma/COPD brands in Spain ($m), 2008-2018; Table 18: Sales forecasts of key asthma/COPD brands in the UK ($m), 2008-2018; Table 19: Asthma/COPD-specific sales (2008), CAGR (2004-08) and price per standard unit (2008) of key asthma/COPD brands in BRIC+; Table 20: Adult prevalence of tobacco smoking and COPD prevalence in Brazil, Russia, India and China, 2009; Table 21: (Changes in the) prevalence of parental-reported (for the 6-7 year olds) and self-reported (for the 13-14 year olds) asthma between Phase One and Phase Three of the ISAAC study; Table 22: (Changes in the) prevalence of parental-reported (for the 6-7 year olds) and self-reported (for the 13-14 year olds) asthma between Phase One and Phase Three of the ISAAC study; Table 23: Availability and affordability of salbutamol 0.1mg/dose inhaler in low-income countries by region, 2009; Table 24: Summary of opportunities and threats in the asthma/COPD market across the small and emerging markets, 2009; Table 25: Leading branded drug sales for asthma/COPD in the seven major markets ($m), 2008-2018; Table 26: Representative formulary tier status in the US for leading brands in asthma/COPD, 2009; Table 27: Marketing strategies employed by US product websites of key asthma/COPD brands, 2008; Table 28: Advair/Seretide - drug profile, 2009; Table 29: Impacting factors on the revenues of Advair/Seretide in the seven major markets, 2008-2018; Table 30: Market share and price discount of Foster compared to other ICS/LABA products in the five major European markets, 2008; Table 31: Pulmicort Respules - drug profile, 2009; Table 32: Volume market share (%) of nebulized versus inhaled corticosteroids in the seven major markets, 2004-08; Table 33: Impacting factors on the revenues of Pulmicort Respules in the seven major markets, 2008-2018; Table 34: Spiriva - drug profile, 2009; Table 35: Outcomes of Spiriva's UPLIFT trial, 2008; Table 36: Impacting factors on the revenues of Spiriva in the seven major markets, 2008-2018; Table 37: Singulair - drug profile, 2009; Table 38: Impacting factors on the revenues of Singulair in the seven major markets, 2008-2018; Table 39: Beyond Advair - drug profile, 2009; Table 40: Clinical trial summary for the separate components of Beyond Advair; Table 41: Impacting factors on the revenues of Beyond Advair in the seven major markets, 2008-2018; Table 42: QVA149 - drug profile, 2009; Table 43: Impacting factors on the revenues of QVA149 in the seven major markets, 2008-2018; Table 44: Daxas - drug profile, 2009; Table 45: Leading companies in the seven major market asthma/COPD market, 2008-2018; Table 46: GlaxoSmithKline portfolio assessment of key asthma and COPD agents, 2009; Table 47: Novartis portfolio assessment of key asthma and COPD agents, 2009; Table 48: New product launches in the asthma/COPD market in the seven major markets, 2008-2018; Table 49: Patent expiry dates for key asthma/COPD brands in the seven major markets, 2008-2018; Table 50: Pricing assumptions for key asthma/COPD pipeline products in the seven major markets, 2008-2018
List of Figures: Figure 1: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in the seven major markets, 2004-2018; Figure 2: Top five asthma/chronic obstructive pulmonary disease (COPD) brands in the seven major markets, 2008 and 2018; Figure 3: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by country in the seven major markets, 2004-2018; Figure 4: Patients with diagnosed chronic obstructive pulmonary disease (COPD) versus those with airflow limitation pointing to COPD in the US, 2000; Figure 5: Total sales for ICS/LABA products in the seven major markets, 2008-2018; Figure 6: Prevalence of smoking adults in the US and five major European markets, 1997-2008; Figure 7: Prevalence of smoking among adults aged 20 years and older in Japan, 1958-1998; Figure 8: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in the US, 2004-2018; Figure 9: Total volume sales for (levo)salbutamol delivered in CFC- and HFA-containing inhaler devices in the US, 2004-08; Figure 10: Total volume sales for (levo)salbutamol products in the US, 2008-2018; Figure 11: Timeline of FDA actions concerning the safety issues of long-acting beta2-agonists (LABAs), July 2005-January 2009; Figure 12: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in Japan, 2004-2018; Figure 13: Total sales for Advair/Seretide in Japan, 2007-08; Figure 14: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in the five major European markets, 2004-2018; Figure 15: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by country in the five major European markets, 2004-2018; Figure 16: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in France, 2004-2018; Figure 17: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in Germany, 2004-2018; Figure 18: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in Italy, 2004-2018; Figure 19: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in Spain, 2004-2018; Figure 20: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in the UK, 2004-2018; Figure 21: Global asthma/chronic obstructive pulmonary disease (COPD) sales split by region, 2004-08; Figure 22: Asthma/chronic obstructive pulmonary disease (COPD) sales in the BRIC+ region, split by country, 2004-08; Figure 23: Prevalence of current tobacco use in adults (male and female) in the top 27 countries, 2009; Figure 24: Asthma/chronic obstructive pulmonary disease (COPD) patient care path; Figure 25: Trends in promotional spend for key asthma/chronic obstructive pulmonary disease (COPD) brands in the US, Q1 2007-Q2 2008; Figure 26: Advair/Seretide SWOT analysis, 2009; Figure 27: Advair/Seretide total brand sales by country in the seven major markets, 2008-2018; Figure 28: Total volume sales for GlaxoSmithKline's ICS/LABA franchise and generic Advair/Seretide in the US, five major European markets and Japan, 2008-2018; Figure 29: Pulmicort Respules SWOT analysis, 2009; Figure 30: Pulmicort Respules total brand sales by country in the seven major markets, 2008-2018; Figure 31: Spiriva SWOT analysis, 2009; Figure 32: Spiriva total brand sales by country in the seven major markets, 2008-2018; Figure 33: Volume sales of Spiriva in a dry powder inhaler (DPI) and the Respimat in Germany and the UK, 2004-08; Figure 34: Total volume sales for Spiriva, pipeline LAMA products, generic tiotropium bromide and LABA/LAMA combination products in the seven major markets, 2008-2018; Figure 35: Asthma/chronic obstructive pulmonary disease (COPD)-specific volume sales of Singulair and Onon in Japan, 2004-08; Figure 36: Singulair SWOT analysis, 2009; Figure 37: Singulair total brand sales by country in the seven major markets, 2008-2018; Figure 38: Asthma/chronic obstructive pulmonary disease (COPD)-specific volume sales of Alvesco in Germany, 2004-08; Figure 39: Overview of patent challenges to Sepracor's Xopenex inhalation solution, 2005-09; Figure 40: Beyond Advair SWOT analysis, 2009; Figure 41: Beyond Advair sales by country in the seven major markets, 2008-2018; Figure 42: QVA149 SWOT analysis, 2009; Figure 43: QVA149 sales by country in the seven major markets, 2008-2018; Figure 44: Overview of the development of Daxas, 2004-09; Figure 45: Daxas SWOT analysis, 2009

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