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

Table of Contents

EXECUTIVE SUMMARY

• Strategic scoping and focus
• Datamonitor insight into the disease market
• Contributing experts
• Related reports
• Upcoming related reports

MARKET DEFINITION

• Asthma/COPD market definition
• Asthma/COPD indication split

MARKET OVERVIEW

• Seven major markets
  • Current and future market overview
  • Opportunities
  • Threats

• US
  • Current and future market assessment
  • Opportunities
  • Threats

• Japan
  • Current and future market assessment
  • Opportunities
  • Threats

• Five major European markets
  • Current and future market assessment
  • Opportunities
  • Threats

• 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
  • Opportunities
  • Threats

BRAND DYNAMICS

• Overview of competitive landscape
• Patient acquisition process
  • Points of influence in the patient care path

• 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
  • SWOT analysis
  • Brand forecast to 2018

• Pulmicort Respules (nebulized budesonide, AstraZeneca)
  • Drug profile
  • Product positioning
  • SWOT analysis
  • Brand forecast to 2018

• Spiriva (tiotropium bromide, Boehringer Ingelheim)
  • Drug profile
  • Product positioning
  • SWOT analysis
  • Brand forecast to 2018

• Singulair (montelukast, Merck & Co)
  • Drug profile
  • Product positioning
  • SWOT analysis
  • Brand forecast to 2018

• 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

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
  • Derivation of sales forecasts and pricing trends

• Forecast methodology

APPENDIX B

• Contributing experts
• Report methodology

TABLES

• Table: Sales and growth of asthma/COPD drug classes in the seven major markets, 2008 - 2018
• Table: Summary of opportunities and threats in the asthma/COPD market across the seven major markets, 2009
• Table: Sales and growth of asthma/COPD drug classes in the US, 2008 - 2018
• Table: Sales forecasts of key asthma/COPD brands in the US ($m), 2008 - 2018
• Table: Price per standard unit for salbutamol products delivered in a HFA-containing device in the US, 2005 - 08
• Table: Summary of key trends in US health insurance and likely impact on asthma disparities, 2009
• Table: Summary of opportunities and threats in the asthma/COPD market in the US, 2009
• Table: Sales and growth of asthma/COPD drug classes in Japan, 2008 - 2018
• Table: Sales forecasts of key asthma/COPD brands in Japan ($m), 2008 - 2018
• Table: Summary of opportunities and threats in the asthma/COPD market in Japan, 2009
• Table: Sales and growth of asthma/COPD drug classes in the five major European markets, 2008 - 2018
• Table: Sales forecasts of key asthma/COPD brands in the five major European markets ($m), 2008 - 2018
• Table: Summary of opportunities and threats in the asthma/COPD market in the five major European markets, 2009
• Table: Sales forecasts of key asthma/COPD brands in France ($m), 2008 - 2018
• Table: Sales forecasts of key asthma/COPD brands in Germany ($m), 2008 - 2018
• Table: Sales forecasts of key asthma/COPD brands in Italy ($m), 2008 - 2018
• Table: Sales forecasts of key asthma/COPD brands in Spain ($m), 2008 - 2018
• Table: Sales forecasts of key asthma/COPD brands in the UK ($m), 2008 - 2018
• Table: Asthma/COPD-specific sales (2008), CAGR (2004 - 08) and price per standard unit (2008) of key asthma/COPD brands in BRIC+
• Table: Adult prevalence of tobacco smoking and COPD prevalence in Brazil, Russia, India and China, 2009
• Table: (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: (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: Availability and affordability of salbutamol 0.1mg/dose inhaler in low-income countries by region, 2009
• Table: Summary of opportunities and threats in the asthma/COPD market across the small and emerging markets, 2009
• Table: Leading branded drug sales for asthma/COPD in the seven major markets ($m), 2008 - 2018
• Table: Representative formulary tier status in the US for leading brands in asthma/COPD, 2009
• Table: Marketing strategies employed by US product websites of key asthma/COPD brands, 2008
• Table: Advair/Seretide - drug profile, 2009
• Table: Impacting factors on the revenues of Advair/Seretide in the seven major markets, 2008 - 2018
• Table: Market share and price discount of Foster compared to other ICS/LABA products in the five major European markets, 2008
• Table: Pulmicort Respules - drug profile, 2009
• Table: Volume market share (%) of nebulized versus inhaled corticosteroids in the seven major markets, 2004 - 08
• Table: Impacting factors on the revenues of Pulmicort Respules in the seven major markets, 2008 - 2018
• Table: Spiriva - drug profile, 2009
• Table: Outcomes of Spiriva' s UPLIFT trial, 2008
• Table: Impacting factors on the revenues of Spiriva in the seven major markets, 2008 - 2018
• Table: Singulair - drug profile, 2009
• Table: Impacting factors on the revenues of Singulair in the seven major markets, 2008 - 2018
• Table: Beyond Advair - drug profile, 2009
• Table: Clinical trial summary for the separate components of Beyond Advair
• Table: Impacting factors on the revenues of Beyond Advair in the seven major markets, 2008 - 2018
• Table: QVA149 - drug profile, 2009
• Table: Impacting factors on the revenues of QVA149 in the seven major markets, 2008 - 2018
• Table: Daxas - drug profile, 2009
• Table: Leading companies in the seven major market asthma/COPD market, 2008 - 2018
• Table: GlaxoSmithKline portfolio assessment of key asthma and COPD agents, 2009
• Table: Novartis portfolio assessment of key asthma and COPD agents, 2009
• Table: New product launches in the asthma/COPD market in the seven major markets, 2008 - 2018
• Table: Patent expiry dates for key asthma/COPD brands in the seven major markets, 2008 - 2018
• Table: Pricing assumptions for key asthma/COPD pipeline products in the seven major markets, 2008 - 2018

FIGURES

• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in the seven major markets, 2004 - 2018
• Figure: Top five asthma/chronic obstructive pulmonary disease (COPD) brands in the seven major markets, 2008 and 2018
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by country in the seven major markets, 2004 - 2018
• Figure: Patients with diagnosed chronic obstructive pulmonary disease (COPD) versus those with airflow limitation pointing to COPD in the US, 2000
• Figure: Total sales for ICS/LABA products in the seven major markets, 2008 - 2018
• Figure: Prevalence of smoking adults in the US and five major European markets, 1997 - 2008
• Figure: Prevalence of smoking among adults aged 20 years and older in Japan, 1958 - 1998
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in the US, 2004 - 2018
• Figure: Total volume sales for (levo)salbutamol delivered in CFC- and HFA-containing inhaler devices in the US, 2004 - 08
• Figure: Total volume sales for (levo)salbutamol products in the US, 2008 - 2018
• Figure: Timeline of FDA actions concerning the safety issues of long-acting beta2-agonists (LABAs), July 2005 - January 2009
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in Japan, 2004 - 2018
• Figure: Total sales for Advair/Seretide in Japan, 2007 - 08
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in the five major European markets, 2004 - 2018
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by country in the five major European markets, 2004 - 2018
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in France, 2004 - 2018
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in Germany, 2004 - 2018
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in Italy, 2004 - 2018
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in Spain, 2004 - 2018
• Figure: Indexed total asthma/chronic obstructive pulmonary disease (COPD) drug sales by class in the UK, 2004 - 2018
• Figure: Global asthma/chronic obstructive pulmonary disease (COPD) sales split by region, 2004 - 08
• Figure: Asthma/chronic obstructive pulmonary disease (COPD) sales in the BRIC+ region, split by country, 2004 - 08
• Figure: Prevalence of current tobacco use in adults (male and female) in the top 27 countries, 2009
• Figure: Asthma/chronic obstructive pulmonary disease (COPD) patient care path
• Figure: Trends in promotional spend for key asthma/chronic obstructive pulmonary disease (COPD) brands in the US, Q1 2007 - Q2 2008
• Figure: Advair/Seretide SWOT analysis, 2009
• Figure: Advair/Seretide total brand sales by country in the seven major markets, 2008 - 2018
• Figure: 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: Pulmicort Respules SWOT analysis, 2009
• Figure: Pulmicort Respules total brand sales by country in the seven major markets, 2008 - 2018
• Figure: Spiriva SWOT analysis, 2009
• Figure: Spiriva total brand sales by country in the seven major markets, 2008 - 2018
• Figure: Volume sales of Spiriva in a dry powder inhaler (DPI) and the Respimat in Germany and the UK, 2004 - 08
• Figure: Total volume sales for Spiriva, pipeline LAMA products, generic tiotropium bromide and LABA/LAMA combination products in the seven major markets, 2008 - 2018
• Figure: Asthma/chronic obstructive pulmonary disease (COPD)-specific volume sales of Singulair and Onon in Japan, 2004 - 08
• Figure: Singulair SWOT analysis, 2009
• Figure: Singulair total brand sales by country in the seven major markets, 2008 - 2018
• Figure: Asthma/chronic obstructive pulmonary disease (COPD)-specific volume sales of Alvesco in Germany, 2004 - 08
• Figure: Overview of patent challenges to Sepracor' s Xopenex inhalation solution, 2005 - 09
• Figure: Beyond Advair SWOT analysis, 2009
• Figure: Beyond Advair sales by country in the seven major markets, 2008 - 2018
• Figure: QVA149 SWOT analysis, 2009
• Figure: QVA149 sales by country in the seven major markets, 2008 - 2018
• Figure: Overview of the development of Daxas, 2004 - 09
• Figure: Daxas SWOT analysis, 2009