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Published by: Datamonitor
Published: Apr. 26, 2005 - 124 Pages
Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the disease market
- Market definition for this report
- CHAPTER 2 MARKET DYNAMICS
- Current market: US accounts for 63% of global respiratory sales
- Asthma/COPD: GSK's "Super Advair" sets the new gold standard
- Allergic rhinitis: Merck develops a "Super Singulair" combination?
- CHAPTER 3 PATIENT POTENTIAL
- Asthma patient potential
- Definition and etiology of asthma
- Treatment options
- Prevalence of asthma
- Segmentation of asthma
- COPD patient potential
- Definition and etiology of COPD
- Treatment options
- Prevalence of COPD
- Segmentation of COPD
- Allergic rhinitis patient potential
- Definition and etiology of allergic rhinitis
- Treatment options
- Prevalence of allergic rhinitis
- Segmentation of allergic rhinitis
- CHAPTER 4 ASTHMA R&D PIPELINE
- Combination ICS/LABAs: GSK race to develop once-daily formulation
- GSK first to market with once-daily LABA/ICS, but US launch ominously close to Advair patent expiry
- Novartis/Schering-Plough alliance most significant threat to GSK
- Sanofi-Aventis/Altana lack once-daily LABA; AstraZeneca US launch of Symbicort delayed
- AstraZeneca Symbicort US launch uncertain
- Sanofi-Aventis/Altana's ciclesonide/formoterol combination dependant on gaining US approval at the highest 320ìg dose for Alvesco monotherapy
- Boehringer Ingelheim unlikely to develop ICS/LABA combination
- Few in-licensing opportunities in long-acting beta-2 agonist class
- Inhaled Corticosteroids: Alvesco and Asmanex will struggle with positioning
- Alvesco's EU launch handicapped by 160µg maximum dose
- Asmanex finally gains approval in US
- Oral non-steroidal anti-inflammatories: Singulair to face competition before patent expiry in 2012
- Merck targeting a Singulair/PG-D2 combination?
- CCR3 antagonists most likely to threaten Singulair
- Future of oral VLA-4 antagonists decided in 2005
- PDE-IV inhibitors - limited prospects in asthma
- The mast cell: time for revaluation in asthma
- Severe asthmatics remain a challenging population
- Monoclonal antibodies: can blockade of a single target work?
- Xolair to achieve peak sales of $890m
- Anti-IL-13 mAb offers potential for disease modification
- Roche and Wyeth target severe asthma with Zenapax and Enbrel
- Inhaled immunostimulatory DNA - correcting the Th1/Th2 imbalance
- Can Novartis's Elidel reduce the risk of developing asthma?
- Role for novel COPD therapies in severe neutrophilic asthma?
- Short-acting B2-agonists: generic CFC converts to a HFA branded market
- Sepracor's Xopenex to capture 50% of albuterol HFA market
- Gene therapy: Topigen's ASM-8 enters Phase I
- Airway remodeling: dominant molecular mechanism yet to emerge
- CHAPTER 5 COPD R&D PIPELINE
- Long-acting antimuscarinics: novel inhaled "Spiriva" combinations the next battleground
- GSK develop next-generation Spiriva
- Pfizer/BI, GSK and Novartis target novel long-acting LAMA/LABA combinations
- Novel triple combinations on the horizon
- Limited licensing opportunities in antimuscarinic class
- Novel oral anti-inflammatories: modest uptake will generate significant revenues
- PDE-IV inhibitors: Daxas to reach market in 2006
- Daxas - awaiting 12-month efficacy data
- Ono or Merck expected to launch second-to-market oral PDE-IV inhibitor
- CXCR2 antagonists - a focus for GSK, AZ and Schering-Plough?
- Restoring the proteinase-antiproteinase balance
- Search for disease-modifying therapy continues
- CHAPTER 6 ALLERGIC RHINITIS R&D PIPELINE
- Novel oral anti-inflammatories: Singulair/PG-D2 combination for allergic rhinitis?
- Singulair's status as an asthma drug protects its low co-pay classification
- PG-D2 antagonists may address nasal congestion
- Novel intranasal non-steroidal therapies
- Pfizer has limited option to license Rigel's R-112 for allergic rhinitis
- Evolutec's "Tick saliva" - the new antihistamine?
- Biolipox's NCX-1510 - the gold standard intranasal antihistamine?
- Incremental innovation in established classes
- GSK's Allermist US launch most significant near-term event
- Novel oral antihistamines struggle to offer differentiation to current market leaders
- Xyzal succeeds Zyrtec in US?
- Gap in market for improved allergen vaccination technologies
- Oral allergen tablets will considerably simplify treatments
- Novel "Immunodrug" approaches may have vastly improved delivery schedules
- CHAPTER 7 COMPANY PORTFOLIO ANALYSIS
- GSK leads in inhaled therapy, but lacks an oral anti-inflammatory
- AstraZeneca has a broad early development pipeline in asthma and COPD
- Novartis requires partner to be successful in inhaled therapies
- Merck's future lies in developing a Singulair/PG-D2 combination product
- Pfizer/BI building franchise in COPD around Spiriva combinations
- Sanofi-Aventis's pipeline lacks a blockbuster product
- CHAPTER 8 APPENDIX
- Asthma/COPD sales mix - what are asthma and COPD products used for?
- Launch forecasting methodology
- Compounds in clinical development for asthma, COPD and allergic rhinitis
- References
- About Datamonitor
- About Datamonitor Healthcare
- About the Respiratory & Infectious Diseases analysis team
- Disclaimer
- List of Figures
- Figure 1: Asthma/COPD and allergic rhinitis sales ($m) and market share (%) by class, in US and 5EU, 2004
- Figure 2: Global sales in asthma/COPD 2005-15, by launched and development products
- Figure 3: Global sales in asthma/COPD ($m), 2005 & 2015, by class
- Figure 4: Global sales in allergic rhinitis ($m), 2005 & 2015, by class
- Figure 5: Eosinophils and mast cells are central to the pathophysiology of atopic asthma
- Figure 6: The inflammation associated with COPD involves neutrophils and alveolar macrophages
- Figure 7: Global forecast sales of combination ICS/LABA products ($m), 2005-15
- Figure 8: GSK will set the new gold standard in the combination therapy class from 2010
- Figure 9: Launch forecasts for inhaled corticosteroid/long-acting beta-2 agonist fixed combinations
- Figure 10: Advantages and disadvantages of Altana's Alvesco
- Figure 11: Novel oral anti-inflammatories - balancing safety with efficacy
- Figure 12: Global forecast sales in asthma for Singulair and Singulair/PG-D2 combination product ($m), 2005-15
- Figure 13: CCR3 antagonists and Singulair/PG-D2 combination hold greatest promise in oral anti-inflammatory class
- Figure 14: Launch forecasts for novel oral anti-inflammatories
- Figure 15: Wyeth's efipladib has a broad anti-inflammatory profile
- Figure 16: Forecast sales of Xolair and second-to-market monoclonal antibody ($m), 2005-15
- Figure 17: 74,000 patients treated with Xolair by 2010, 74% in US market
- Figure 18: Global forecast sales of Xopenex-HFA and Xopenex inhalation solution ($m), 2000-10
- Figure 19: Launch forecasts for compounds in clinical development for asthma
- Figure 20: Global forecast sales of antimuscarinic class ($m), 2005-15
- Figure 21: Novel triple combinations on the horizon
- Figure 22: Results from roflumilast RECORD study in patients with moderate-to-severe COPD
- Figure 23: Sales forecast for Daxas in EU and US ($m), 2005-15
- Figure 24: Targets for future COPD therapy
- Figure 25: Launch forecasts for products in clinical development for COPD
- Figure 26: Global forecast sales for Singulair and Singulair/PG-D2 combination product in allergic rhinitis ($m), 2005-15
- Figure 27: US sales for intranasal corticosteroid ($m), 2005-15
- Figure 28: EU sales of Zyrtec and Xyzal in allergic rhinitis ($m), 2000-04
AbstractIntroduction
The asthma, COPD and allergic rhinitis global market was $25.5 billion in 2004, with five brands selling over $1.0 billion. While a number of moderately successful launches are expected within the next five years, companies are seeking novel combination therapies to create the next generation of blockbuster drugs.
Scope
- Evaluation of over 75 drugs in clinical development for asthma, COPD, and allergic rhinitis, including launch forecasts
- Opinion leader insight into early stage therapies and treatment strategies
- Forecasts of key late-stage therapies: Alvesco (ciclesonide), Daxas (roflumilast), Xolair (omalizumab), Xopenex (levalbuterol)
- Forecasted sales of the respiratory market in the next 10 years, exploring the potential impact of early phase therapies
Highlights
Inhaled corticosteroid/long-acting b2-agonist fixed combinations will remain the leading asthma/COPD class in 2015, almost exclusively represented by sales of GSK's "Super Advair", with its once-daily profile setting the new gold standard.
Merck may invigorate the oral asthma market through the development of a Singulair/ prostaglandin-D2 combination product, while monoclonal antibodies will be the fastest growing asthma class, with therapies that are effective in non-atopic asthma having a $1.0 billion sales opportunity.
Novel, long-acting, dual-action bronchodilator combinations will expand the COPD market from 2012, with novel triple combinations on the horizon. Altana/Pfizer's Daxas will achieve peak sales of $750 million by 2010, although 12-month data and combination trials with Spiriva will be key to success.
Reasons to Purchase
- Understand unmet needs in the respiratory market, and how late-stage compounds address these needs
- Identify potential licensing opportunities for respiratory market entry or portfolio expansion
- Benchmark key late-stage asthma and COPD compounds against market leaders
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