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

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

Published By: Datamonitor
June 2009
R313-52322
Online Download $15,200.00
Global Site License $38,000.00

Description

Introduction

Although the respiratory market has expanded considerably from 2004 to 2008, growth in the seven major markets is slowing down from 2009 to 2011, after which sales will decline due to patent expiries of leading brands. Growth is driven by the expansion of sales in existing classes, the launch of major new products with safety and convenience advantages, and the results of several landmark trials.

Scope

Indication-based forecasts for marketed and late-stage pipeline asthma/COPD products by method of administration
Assessment of country-specific drivers and resistors likely to impact the market
Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates
Market overview by geographical area, with value analysis of clinical and commercial factors underlying product performance

Highlights

Following rapid growth in recent years, Datamonitor expects Asthma/COPD sales in the seven major markets slow down and start to decline to about $23 billion in 2018, due to several patent expiries. The ICS/LABA class is set to remain the leading class by value throughout, while the LABA/LAMA market will experience the strongest growth.

GlaxoSmithKline's once-daily ICS/LABA product Beyond Advair will be the top-selling single brand in the seven major markets in 2018, although its revenues will depend on the timing of its launch compared to generic Advair/Seretide and its main competitor, Novartis's QVA149.

With increasing competition within drug classes and few truly novel drugs in development, the choice of inhaler device has increased significantly. As an example, Datamonitor believes that the popularity of Advair/Seretide's Diskus will somewhat protect its sales from generics and competitors, especially in the elderly COPD segment.

Reasons to Purchase

Identify key opportunities and threats that will impact the use and uptake of new and existing products
Quantify the future size and scope of the asthma/COPD market and predict the performance of key compounds
Understand critical success factors in growing and defending respiratory brand franchises from new entrants and generics

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Table of Contents

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