Forecast Insight: Asthma/COPD – Pipeline potential outweighs downward pressure from generics
COPD Market
Clinical Trials Market
Report Summary
Datamonitor estimates that in 2009 asthma/COPD sales reached $21.5 billion in the seven major markets. The next 10 years will see the dynamic pipeline fracture a market currently dominated by a handful of blockbuster brands. While patent expiries will create downward pressure, Datamonitor forecasts the asthma/COPD market will reach sales of $24.2 billion by 2019, with a 2009-2019 CAGR of 1.2%.
Insight into market potential including current market trends, changing regulations and recent pipeline developments
10 year country, indication, and device specific forecasts for individual products, taking into account competitive positioning and key market events
Profiles of currently marketed products including discussion of key opportunities and threats, with in-depth analysis of potential generic erosion
Insight into late-stage pipeline products including analysis of the latest data from the European Respiratory Society September 2010 CongressSubstantial growth was seen in the asthma/COPD market from 2006-09, driven by combination products, with a CAGR of 10.4% in the seven major markets. Datamonitor estimates that 2009 sales reached $21.5 billion. Generic erosion will impact key brands, but pipeline products are forecast to drive growth, with the market reaching $24.2 billion by 2019.
In 2009, the ICS/LABA class made up 36% of asthma/COPD sales in the seven major markets, reaching $7.8 billion. Future blockbuster potential lies in once-daily ICS/LABAs, and GlaxoSmithKline’s Relovair is the most advanced once-daily ICS/LABA, now in Phase III. It is expected to reach asthma/COPD sales of $3.2 billion by 2019.
The COPD market will see the first long-acting bronchodilator combinations, which will threaten the current gold standard Spiriva (tiotropium; Boehringer Ingelheim) and reach sales of $1.9 billion by 2019. With companies developing molecules for both monotherapies and combinations, careful brand positioning will be crucial.
Quantify the size and scope of the asthma and COPD market and the changing market dynamics from 2009-2019
Understand asthma and COPD market trends including drivers of success and the impact of changing regulations
Gain insight into the recent advances in the asthma and COPD pipeline and access forecasts of 13 novel products
Datamonitor estimates that in 2009 asthma/COPD sales reached $21.5 billion in the seven major markets. The next 10 years will see the dynamic pipeline fracture a market currently dominated by a handful of blockbuster brands. While patent expiries will create downward pressure, Datamonitor forecasts the asthma/COPD market will reach sales of $24.2 billion by 2019, with a 2009-2019 CAGR of 1.2%.
Insight into market potential including current market trends, changing regulations and recent pipeline developments
10 year country, indication, and device specific forecasts for individual products, taking into account competitive positioning and key market events
Profiles of currently marketed products including discussion of key opportunities and threats, with in-depth analysis of potential generic erosion
Insight into late-stage pipeline products including analysis of the latest data from the European Respiratory Society September 2010 CongressSubstantial growth was seen in the asthma/COPD market from 2006-09, driven by combination products, with a CAGR of 10.4% in the seven major markets. Datamonitor estimates that 2009 sales reached $21.5 billion. Generic erosion will impact key brands, but pipeline products are forecast to drive growth, with the market reaching $24.2 billion by 2019.
In 2009, the ICS/LABA class made up 36% of asthma/COPD sales in the seven major markets, reaching $7.8 billion. Future blockbuster potential lies in once-daily ICS/LABAs, and GlaxoSmithKline’s Relovair is the most advanced once-daily ICS/LABA, now in Phase III. It is expected to reach asthma/COPD sales of $3.2 billion by 2019.
The COPD market will see the first long-acting bronchodilator combinations, which will threaten the current gold standard Spiriva (tiotropium; Boehringer Ingelheim) and reach sales of $1.9 billion by 2019. With companies developing molecules for both monotherapies and combinations, careful brand positioning will be crucial.
Quantify the size and scope of the asthma and COPD market and the changing market dynamics from 2009-2019
Understand asthma and COPD market trends including drivers of success and the impact of changing regulations
Gain insight into the recent advances in the asthma and COPD pipeline and access forecasts of 13 novel products
TABLE OF CONTENTS
Overview 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Respiratory pharmaceutical analysis team 2
Chapter 1 Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 4
Upcoming related reports 4
Table of Contents 5
Chapter 2 Market Definition and Overview 8
Asthma/COPD ATC market definition for this report 8
Asthma/COPD ICD-10 indication split for this report 8
Countries and regions included in this report 9
Seven major market assessment 10
Country comparison 10
Class and brand comparison 15
Device comparison 21
Respiratory sales by indication 22
Comparison with previous forecast 24
Rest of world snapshot 27
Chapter 3 Brand Dynamics 32
Overview of competitive landscape 32
Multiple FDA review cycles often required for approval of respiratory treatments 33
Inhaled corticosteroid/long-acting beta-2 agonist combinations (ICS/LABAs) 34
Generic erosion in the US delayed by lack of regulatory guidance 34
Generic development in the EU aided by European Medicines Agency guidelines 35
Advair/Seretide (fluticasone/salmeterol; GlaxoSmithKline) 37
Symbicort (budesonide/formoterol; AstraZeneca) 42
Relovair (fluticasone furoate/GSK642444, GlaxoSmithKline) 45
Flutiform (fluticasone propionate/formoterol; SkyePharma) 52
Dulera (mometasone/formoterol; Merck & Co.) 56
QMF149 (mometasone/indacaterol; Novartis) 60
Inhaled corticosteroids 64
Shrinking market leaves little potential for generics 64
Monotherapy bronchodilators 68
FDA strengthens warnings against the use of LABAs for asthma 69
CFC inhalers predominantly off the market 70
Spiriva (tiotropium; Boehringer Ingelheim) 71
Onbrez (indacaterol; Novartis) 76
Eklira (aclidinium; Almirall) 80
NVA237 (glycopyrrolate; Sosei/Novartis) 82
GSK573719 (GlaxoSmithKline) 85
GSK642444 (GlaxoSmithKline) 86
Combination bronchodilators 87
QVA149 (indacaterol/glycopyrrolate; Novartis) 87
GSK573719/GSK642444 (GlaxoSmithKline) 89
Olodaterol/tiotropium (Boehringer Ingelheim) 90
PDE4 inhibitors 92
Daxas (roflumilast; Nycomed/Forest) 92
Bibliography 97
Websites 97
Books 106
Datamonitor reports 106
Appendix A – Market Assumptions 107
New product launches 107
Patent expiries 107
Data definitions, limitations and assumptions 109
Standard units 109
Derivation of sales forecasts and pricing trends 109
Exchange rates 109
Forecast methodology 110
Appendix B 111
Contributing experts 111
Conferences attended 111
Report methodology 111
About Datamonitor 111
About Datamonitor Healthcare 112
About the Respiratory analysis team 113
Disclaimer 115
Market Research News
Overview 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Respiratory pharmaceutical analysis team 2
Chapter 1 Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 4
Upcoming related reports 4
Table of Contents 5
Chapter 2 Market Definition and Overview 8
Asthma/COPD ATC market definition for this report 8
Asthma/COPD ICD-10 indication split for this report 8
Countries and regions included in this report 9
Seven major market assessment 10
Country comparison 10
Class and brand comparison 15
Device comparison 21
Respiratory sales by indication 22
Comparison with previous forecast 24
Rest of world snapshot 27
Chapter 3 Brand Dynamics 32
Overview of competitive landscape 32
Multiple FDA review cycles often required for approval of respiratory treatments 33
Inhaled corticosteroid/long-acting beta-2 agonist combinations (ICS/LABAs) 34
Generic erosion in the US delayed by lack of regulatory guidance 34
Generic development in the EU aided by European Medicines Agency guidelines 35
Advair/Seretide (fluticasone/salmeterol; GlaxoSmithKline) 37
Symbicort (budesonide/formoterol; AstraZeneca) 42
Relovair (fluticasone furoate/GSK642444, GlaxoSmithKline) 45
Flutiform (fluticasone propionate/formoterol; SkyePharma) 52
Dulera (mometasone/formoterol; Merck & Co.) 56
QMF149 (mometasone/indacaterol; Novartis) 60
Inhaled corticosteroids 64
Shrinking market leaves little potential for generics 64
Monotherapy bronchodilators 68
FDA strengthens warnings against the use of LABAs for asthma 69
CFC inhalers predominantly off the market 70
Spiriva (tiotropium; Boehringer Ingelheim) 71
Onbrez (indacaterol; Novartis) 76
Eklira (aclidinium; Almirall) 80
NVA237 (glycopyrrolate; Sosei/Novartis) 82
GSK573719 (GlaxoSmithKline) 85
GSK642444 (GlaxoSmithKline) 86
Combination bronchodilators 87
QVA149 (indacaterol/glycopyrrolate; Novartis) 87
GSK573719/GSK642444 (GlaxoSmithKline) 89
Olodaterol/tiotropium (Boehringer Ingelheim) 90
PDE4 inhibitors 92
Daxas (roflumilast; Nycomed/Forest) 92
Bibliography 97
Websites 97
Books 106
Datamonitor reports 106
Appendix A – Market Assumptions 107
New product launches 107
Patent expiries 107
Data definitions, limitations and assumptions 109
Standard units 109
Derivation of sales forecasts and pricing trends 109
Exchange rates 109
Forecast methodology 110
Appendix B 111
Contributing experts 111
Conferences attended 111
Report methodology 111
About Datamonitor 111
About Datamonitor Healthcare 112
About the Respiratory analysis team 113
Disclaimer 115
Market Research News
Related Reports
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