Pipeline Insight: Asthma/COPD - Targeted Therapies On The Horizon : Market Research Report

Pipeline Insight: Asthma/COPD - Targeted Therapies On The Horizon

Published by: Datamonitor

Published: Nov. 7, 2006

ABOUT DATAMONITOR HEALTHCARE: About the Infectious Disease and Respiratory pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Scope of the analysis; Contributing experts; Datamonitor insight into the asthma/COPD market
CHAPTER 2 PATIENT POTENTIAL: Definition and etiology of asthma; Segmentation of asthma; Epidemiology of asthma; Unmet needs in asthma; Definition and etiology of COPD; Segmentation of COPD; Epidemiology of COPD; Unmet needs in COPD
CHAPTER 3 R&D APPROACH: Classification of asthma/COPD pipeline products; Clinical trial design in asthma/COPD; Clinical trial endpoints in asthma/COPD
CHAPTER 4 ASTHMA/COPD PIPELINE ANALYSIS: Key companies involved in the asthma/COPD pipeline; Strategies for success
CHAPTER 5 FIXED DOSE ICS/LABA COMBINATIONS ANALYSIS & FORECASTS: Definition of current comparator therapy; Super Advair unable to repeat Advair's success; Symbicort SMART indication differentiates it from Advair; Foster - similar efficacy at half the price?; Alvesco combo - potentially best ICS/LABA combination held back by trial delays; Mometasone/formoterol and mometasone/indacaterol; Flutiform will need to compete on price
CHAPTER 6 INHALED CORTICOSTEROIDS ANALYSIS AND FORECAST: Definition of current comparator therapy; Alvesco's development fraught with uncertainties and setbacks; Asmanex too late to have a big impact
CHAPTER 7 NOVEL ANTI-INFLAMMATORIES ANALYSIS AND FORECASTS: Definition of current comparator therapy; Targeting the leukotriene cascade; Chemokine inhibitors are a mixed group; VLA-4 antagonists - many development failures; PDEIV inhibitors only promising in COPD?; Inhaled immunostimulatory DNA (ISS); Targeting oligonucleotides; Other novel anti-inflammatories
CHAPTER 8 BIOLOGICALS ANALYSIS AND FORECASTS: Anti-IgE - Xolair to remains unchallenged; Anti-TNF-á; Anti-IL-13; Anti-IL-5; Anti-IL-2; Other monoclonal antibodies targeting cytokines
CHAPTER 9 BRONCHODILATORS ANALYSIS AND FORECASTS: Competition for Spiriva on the horizon; Long-acting beta2-agonists will be once-daily; LABA/LAMA combination products have blockbuster potential in COPD; The SABA CFC-HFA switch in the US
APPENDIX A: Methodology; Bibliography
APPENDIX B: About Datamonitor; Datamonitor Healthcare's therapy area capabilities
List of Tables: Table 1: Asthma prevalence and diagnosed population by country and age, 2006; Table 2: COPD prevalence by country and severity among adults over 45 years old, 2006; Table 3: Outcome measures for COPD; Table 4: Overview of asthma/COPD drug development pipeline, 2006; Table 5: GSK's marketed respiratory portfolio, 2005; Table 6: AstraZeneca's marketed respiratory portfolio, 2005; Table 7: Boehringer-Ingelheim's marketed respiratory portfolio, 2005; Table 8: Key marketed and late-stage products for ICS/LABA combinations, 2006; Table 9: ICS/LABA combinations sales in the six major markets ($m), 2005-2015; Table 10: GSK is performing one study with 159797 and two with 642444; Table 11: Studies presented at the ERS Conference in September 2006 regarding Symbicort SMART; Table 12: Key marketed and late-stage products for inhaled corticosteroids, 2006; Table 13: ICS sales in the six major markets ($m), 2005-2015, $millions; Table 14: Key marketed and late-stage products for novel anti-inflammatories, 2006; Table 15: Key marketed and late-stage products for compounds affecting the leukotriene cascade, 2006; Table 16: Key products for CXCR2 agonists, 2006; Table 17: Key marketed and late-stage products for PDEIV inhibitors, 2006; Table 18: Key marketed and late-stage products for biologicals, 2006; Table 19: Key marketed and late-stage products for anticholinergics, 2006; Table 20: Long-acting anticholinergics sales in the six major markets ($m), 2005-2015; Table 21: Key marketed and late-stage products for LABAs, 2006; Table 22: Long-acting beta2-agonists sales in the six major markets ($m), 2005-2015; Table 23: GSK pool of LABA candidates in Phase II trials, 2006
List of Figures: Figure 1: Basic etiology of asthma; Figure 2: Classification of asthma by clinical, pretreatment features; Figure 3: Prevalence of asthma according to classification of severity; Figure 4: Key unmet needs in asthma, 2006; Figure 5: The allergic march is influences by several factors; Figure 6: Rate of decline of FEV1 with age in COPD patients; Figure 7: The inflammation associated with COPD involves neutrophils and alveolar macrophages; Figure 8: Classification of COPD as measured by airflow limitation; Figure 9: Prevalence of COPD at diagnosis according to classification of severity; Figure 10: Key unmet needs in COPD; Figure 11: Overview of asthma and COPD treatments, 2006; Figure 12: Appropriate LCM strategy depends on time and financial investment; Figure 13: Overview of forecasted asthma/COPD drugs in the pipeline, 2006; Figure 14: Key players in the asthma/CODP market, 2005; Figure 15: Pulmicort: a combination of strategies; Figure 16: GSK and AZ continue to develop their ICS/LABA combination products; Figure 17: Sepracor takes advantage of CFC-HFA switch in the US in 2008; Figure 18: ICS/LABA combinations sales in the six major markets ($m), 2005-2015; Figure 19: Warning in Advair prescribing information regarding salmeterol; Figure 20: Advair/Seretide and Symbicort sales in the six major markets, 2001-05; Figure 21: Formoterol is preferred LABA due to short onset of action, long duration and limited side effects; Figure 22: Characteristics of ICS/LABA drugs on the market and in development; Figure 23: ICS/LABA combination sales in the six major markets, 2005-15; Figure 24: Symbicort adjustable maintenance dosing; Figure 25: SMILE study design; Figure 26: ICS/LABA combinations sales in the six major markets, 2005-2015; Figure 27: Study design of two studies; Figure 28: Foster versus Advair/Seretide and Foster versus Symbicort, PEF; Figure 29: ICS/LABA combinations sales in the five major European markets, 2005-2015; Figure 30: ICS/LABA combinations sales in the six major markets, 2005-2015; Figure 31: Mometasone/indacaterol combination shows most promise for Novartis and Schering-Plough; Figure 32: ICS/LABA combinations sales in the six major markets, 2005-2015; Figure 33: ICS/LABA combinations sales in the six major markets, 2005-2015; Figure 34: ICS sales in the six major markets, 2005-2015; Figure 35: Study design and primary endpoint of ciclesonide 160�g versus 640�g; Figure 36: ICS sales in the six major markets, 2005-2015; Figure 37: ICS sales in the six major markets ($m), 2005-2015; Figure 38: Novel anti-inflammatory market is moving towards targeted therapy; Figure 39: Blockbuster potential of anti-inflammatories in COPD is uncertain, 2006-2020; Figure 40: Effect of tipelukast on inflammation cascade; Figure 41: Zileuton affects inflammatory cascade earlier than montelukast; Figure 42: Patient potential breakdown for Zileuton CR in the US; Figure 43: Singulair and Zileuton CR sales in the US ($m), 2005-2015; Figure 44: Efipladib affects inflammatory cascade earlier than montelukast and zileuton; Figure 45: Results from roflumilast RECORD and RATIO studies; Figure 46: Xolair sales in the six major markets, 2005-2015; Figure 47: Long-acting anticholinergics sales in the six major markets, 2005-2015; Figure 48: Respimat SMI demonstrates better lung deposition compared with conventional MDIs; Figure 49: The battle to be second to the once-daily LAMA market is between Almirall, Novartis and GSK; Figure 50: Long-acting anticholinergics sales in the six major markets, 2005-2015; Figure 51: Long-acting beta2-agonists sales in the six major markets ($m), 2005-2015; Figure 52: Long-acting beta2-agonists sales in the six major markets ($m), 2005-2015; Figure 53: Mean serum potassium over time; Figure 54: Patient potential breakdown for arformoterol in the US, 2006; Figure 55: Brovana sales in the US, 2005-2015; Figure 56: LABA/LAMA peak sales in the six major markets; Figure 57: Three possible LABA/LAMA combination drugs in development; Figure 58: The (levo)salbutamol market according to type of delivery device, 2005; Figure 59: The volume and sales values of the (levo)salbutamol market according to type of delivery device, 2005; Figure 60: Xopenex sales in the US, 2005-2015

Abstract

Introduction

The total asthma and COPD population in 2006 is estimated to be 44.8 million and 28.8 million respectively. While the majority of patients are well controlled with current therapies, the remaining unmet needs are twofold: first, to find better options for the 1.7 million patients with severe asthma; second, to identify effective anti-inflammatory drugs in COPD.

Scope of this report

Discussion and quantification of the patient potential and segmentation in both Asthma and COPD
Detailed overview and assessment of drugs in mid-to late stage clinical development, highlighting recent clinical trial results
Assessment of the remaining unmet clinical needs in both asthma and COPD, analyzing the potential of new targeted therapies
Ten year indication-based sales forecast to 2015 for major Phase III to recently launched drugs

Research and analysis highlights

Global asthma/COPD sales are forecast to grow to $30 billion by 2015, with ICS/LABA combinations set to retain their leading position by value, followed by anticholinergics. The ICS/LABA class was long dominated by GlaxoSmithKline's Advair/Seretide but will see dramatically increased competition in the future with several new product launches.

Despite many years and billions of dollars spent on finding drugs that slow or reverse disease progression in COPD, progress remains elusive. Several drugs that were initially hailed as breakthroughs have failed to live up to their initial promise, but conservative drug regulators and badly chosen clinical endpoints may have to share the blame.

Targeted therapies offer new hope for severe asthma sufferers. Despite several setbacks over the past years, the research pipeline remains full. Although it is still difficult to predict which approach may work for whom, Amgen/Wyeth's anti-TNF alpha therapy Enbrel is thought to be the next biological drug to be launched in asthma.

Key reasons to read this report

Identify the remaining opportunities in the Asthma and COPD market place and possible licensing partners
Learn about new biological targeted therapy approaches, shifting R&D approaches and changing clinical trial endpoints
Evaluate forecasts of the asthma/COPD market to 2015, and predict the performance of key drugs

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Pipeline Insight: Asthma/COPD - Targeted Therapies On The Horizon

Table of Contents

Abstract