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Asthma Therapeutics in Major Developed Markets to 2020 - Personalized Treatment for Severe Asthma to Drive Market Growth despite Patent Expirations

  • ID: 3196281
  • Report
  • Region: Global
  • 142 Pages
  • GBI Research
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US Asthma Treatment Market Value to Hit $14 Billion by 2020

FEATURED COMPANIES

  • AB Science
  • AstraZeneca
  • GSK
  • Merck
  • Nycomed
  • Sanofi
  • MORE
The asthma therapeutics market is forecast to grow marginally over the forecast period across the top eight developed nations, from $18.4 billion in 2013 to a projected value of $21.7 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 2.4%. This is in spite of generic erosion facing several of the leading asthma brands, such as Advair (fluticasone propionate/salmeterol xinafoate), Symbicort (budesonide/formoterol fumarate) and Xolair (omalizumab), and is a consequence of new market entrants and rising disease prevalence.

The global prevalence of asthma is significant, believed to affect approximately 300 million people worldwide. This burden is predicted to increase in future, reaching 400 million by 2025.

Although the majority of asthma patients are able to manage their symptoms effectively using currently marketed products, some remain inadequately controlled with these same products. This unmet need, coupled with rising global prevalence, has resulted in strong industry interest.

Consequently, the current asthma pipeline is highly innovative, featuring several promising molecules in late-stage drug development. Biologics and monoclonal antibodies, the latter in particular, are gaining prominence within the indication. Novel monoclonal antibodies such as mepolizumab, reslizumab, lebrikizumab, and dupilumab target Interleukins (IL), or IL receptors, and have demonstrated potential in severe and inadequately controlled eosinophilic asthma, in turn representing a shift towards personalized therapy. Despite the fact that they target only a small patient sub-set, they are likely to be priced highly and to drive market growth, offsetting the impact of generic erosion.

Scope:

The report covers and includes:

- An introduction to asthma, including discussion of disease epidemiology, etiology pathophysiology, symptoms, diagnosis, and treatment, with clinical data for drugs featured in the current treatment algorithm discussed in detail
- In-depth analysis of the current marketed products landscape, including product profiles of the main drugs used and heat maps that compare their safety and efficacy parameters
- Comprehensive analysis of the asthma pipeline by phase of development, molecule type, and molecular target and novelty, and comparative analysis of the most promising late-stage pipeline drugs, as well as heat maps and a competitor matrix that compares safety and efficacy parameters
- Additional in-depth analysis of the asthma clinical trials landscape, including trends in size, duration and failure rate
- Forecast projections for the asthma market to 2020, including analysis of the global market and each of the eight major markets and incorporating projected, low, and high-variance scenarios based on treatment usage patterns and annual cost of therapy in each of the major markets
- Discussion of the strategic consolidations landscape, including trends in co-development and licensing deals relevant to asthma drug products

Reasons to purchase:

The report will assist business development and enable marketing executives to strategize their product launches by allowing them to:

- Gain a comprehensive understanding of asthma, including diagnosis, disease severity, and treatment algorithms
- Understand the current asthma marketed products landscape and recognize the dominant therapeutic agents and pharmaceutical players involved
- Identify trends, developments, and prominent molecule types and molecular targets within the asthma pipeline
- Gain an appreciation of the clinical and commercial aspects of the most promising late-stage pipeline molecules and their potential competitive impact on the future market
- Consider market opportunities and potential risks by examining trends in asthma clinical trial size, duration and failure rate, phase of development, molecule type, and molecular target
- Observe projections for treatment usage patterns, annual therapy costs, and market growth in the eight major markets and understand reasons for variance in projected patterns of growth
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Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • AB Science
  • AstraZeneca
  • GSK
  • Merck
  • Nycomed
  • Sanofi
  • MORE
1 Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 Disease Introduction
2.2 Epidemiology
2.3 Etiology
2.4 Pathophysiology
2.5 Symptoms
2.6 Diagnosis
2.7 Assessment of Disease Severity
2.8 Treatment
2.9 Treatment Algorithm
2.10 Treatment Segments
2.10.1 ICS Monotherapy for the Maintenance Treatment of Asthma
2.10.2 Singulair (montelukast sodium) as First-Line Maintenance Therapy
2.10.3 ICS/LABA Combination Therapy
2.10.4 Add-on Therapies

3 Marketed Products
3.1 Overview
3.2 ICS for the Maintenance Treatment of Asthma
3.2.1 Arnuity (fluticasone furoate) - GSK
3.3 ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma
3.3.1 Advair (fluticasone propionate and salmeterol xinafoate) - GSK
3.3.2 Symbicort (budesonide and formoterol fumarate) - AstraZeneca, Co-Promotion with Astellas Pharma
3.3.3 Dulera (mometasone furoate and formoterol fumarate) - Merck
3.3.4 Relvar/Breo (vilanterol trifenatate and fluticasone furoate) - GlaxoSmithKline/Theravance
3.4 Add-on Therapy to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma
3.4.1 Xolair (omalizumab) - Novartis and Genentech
3.4.2 Singulair (montelukast) - Merck
3.4.3 Spiriva (tiotropium bromide) - Boehringer Ingelheim
3.5 Heat Maps for Marketed Products

4 Asthma Pipeline
4.1 Overview
4.2 Pipeline Analysis by Stage of Development, Molecule Type and Program Type
4.3 Pipeline Analysis by Molecular Target
4.4 Asthma Clinical Trial Landscape
4.4.1 Clinical Trial Failure Rates
4.4.2 Clinical Trial Duration
4.4.3 Clinical Trial Size
4.4.4 Comparative Clinical Trial Metrics Analysis
4.5 Promising Pipeline Molecules
4.5.1 Mepolizumab - GSK
4.5.2 Reslizumab - Teva Pharmaceutical
4.5.3 Lebrikizumab - Roche/Genentech
4.5.4 Dupilumab - Regeneron Pharmaceuticals in Collaboration with Sanofi
4.5.5 Masitinib - AB Science
4.6 Heat Map and Competitor Matrix for Pipeline Products

5 Market Forecast to 2020
5.1 Geographical Markets
5.2 Global Market
5.3 North America
5.3.1 Treatment Usage Patterns
5.3.2 Annual Cost of Therapy
5.3.3 Market Size
5.4 Top Five Countries of Europe
5.4.1 Treatment Usage Patterns
5.4.2 Annual Cost of Therapy
5.4.3 Market Size
5.5 Japan
5.5.1 Treatment Usage Patterns
5.5.2 Annual Cost of Therapy
5.5.3 Market Size
5.6 Drivers and Barriers for the Asthma Market
5.6.1 Drivers
5.6.2 Barriers

6 Strategic Consolidations
6.1 Co-development Deals
6.1.1 Sepracor Enters into Co-Development Agreement with Nycomed for Ciclesonide
6.1.2 NeoStem Enters into Agreement with University of California to Develop Human Regulatory T Cells
6.1.3 Amgen Enters into Co-Development Agreement with AstraZeneca for Five Monoclonal Antibodies
6.2 Licensing Deals
6.2.1 Amgen Enters into Licensing Agreement with Kyowa Hakko Kirin - Terminated
6.2.2 Mundipharma Enters into Licensing Agreement with SkyePharma
6.2.3 MAP Pharmaceuticals Enters into Licensing Agreement with AstraZeneca - Terminated
6.2.4 Orexo Enters into Licensing Agreement with Janssen Pharmaceuticals - Terminated
6.2.5 Aslan Pharma Enters into Licensing Agreement with CSL for CSL-334

7 Appendix
7.1 All Pipeline Drugs by Phase of Development
7.1.1 Discovery
7.1.2 Preclinical
7.1.3 Phase I
7.1.4 Phase II
7.1.5 Phase III
7.1.6 Pre-registration
7.2 Market Forecasts to 2020
7.2.1 Global
7.2.2 US
7.2.3 Canada
7.2.4 UK
7.2.5 France
7.2.6 Germany
7.2.7 Italy
7.2.8 Spain
7.2.9 Japan
7.3 References
7.4 Abbreviations
7.5 Research Methodology
7.5.1 Secondary Research
7.5.2 Marketed Product Profiles
7.5.3 Late-Stage Pipeline Candidates
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
7.5.5 Product Competitiveness Framework
7.5.6 Pipeline Analysis
7.5.7 Forecasting Model
7.5.8 Deals Data Analysis
7.6 Expert Panel Validation
7.7 Contact Us
7.8 Disclaimer

1.1 List of Tables
Table 1: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children of 0-4 Years of Age
Table 2: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children of 5-11 Years of Age
Table 3: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Youths = 12 Years of Age and Adults
Table 4: Management of Chronic Asthma
Table 5: Management of Acute Asthma
Table 6: Asthma Clinical Trial Endpoints
Table 7: Asthma Therapeutics, Global, All Pipeline Products, Discovery Phase, 2015
Table 8: Asthma Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2015
Table 9: Asthma Therapeutics, Global, All Pipeline Products, Phase I, 2015
Table 10: Asthma Therapeutics, Global, All Pipeline Products, Phase II, 2015
Table 11: Asthma Therapeutics, Global, All Pipeline Products, Phase III, 2015
Table 12: Asthma Therapeutics, Global, All Pipeline Products, Pre-registration Phase, 2015
Table 13: Asthma Therapeutics Market, Global, Market Forecast, 2013-2020
Table 14: Asthma Therapeutics Market, US, Market Forecast, 2013-2020
Table 15: Asthma Therapeutics Market, Canada, Market Forecast, 2013-2020
Table 16: Asthma Therapeutics Market, UK, Market Forecast, 2013-2020
Table 17: Asthma Therapeutics Market, France, Market Forecast, 2013-2020
Table 18: Asthma Therapeutics Market, Germany, Market Forecast, 2013-2020
Table 19: Asthma Therapeutics Market, Italy, Market Forecast, 2013-2020
Table 20: Asthma Therapeutics Market, Spain, Market Forecast, 2013-2020
Table 21: Asthma Therapeutics Market, Japan, Market Forecast, 2013-2020

1.2 List of Figures
Figure 1: Asthma Therapeutics Market, Global, Heat Map for Marketed Products, 2015
Figure 2: Asthma Therapeutics Market, Global, Heat Map for Marketed Products (continued), 2015
Figure 3: Asthma Therapeutics Market, Global, Pipeline, 2015
Figure 4: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, 2015
Figure 5: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Immune/Inflammatory System Targets and Cytokine/Cytokine Receptor Targets, 2015
Figure 6: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Enzyme and Kinase Molecular Targets, 2015
Figure 7: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Adrenergic and Cholinergic Receptors, 2015
Figure 8: Asthma Therapeutics Market, Global, Clinical Trial Failure Rate, 2006-2014
Figure 9: Asthma Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2014
Figure 10: Asthma Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2014
Figure 11: Asthma Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, (months), 2006-2014
Figure 12: Asthma Therapeutics Market, Global, Phase I Clinical Trial Duration by Molecular Target (months), 2006-2014
Figure 13: Asthma Therapeutics Market, Global, Phase II Clinical Trial Duration by Molecular Target (months), 2006-2014
Figure 14: Asthma Therapeutics Market, Global, Phase III Clinical Trial Duration by Molecular Target (months), 2006-2014
Figure 15: Asthma Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type for Individual Asthma Products (participants), 2006-2014
Figure 16: Asthma Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type for Individual Asthma Clinical Trials (participants), 2006-2014
Figure 17: Asthma Therapeutics Market, Global, Phase I Clinical Trial Recruitment Size by Molecular Target (participants), 2006-2014
Figure 18: Asthma Therapeutics Market, Global, Phase II Clinical Trial Recruitment Size by Molecular Target (participants), 2006-2014
Figure 19: Asthma Therapeutics Market, Global, Phase III Clinical Trial Recruitment Size by Molecular Target (participants), 2006-2014
Figure 20: Asthma Therapeutics Market, Global, Failure Rate (%), Average Clinical Trial Duration (months) and Average Recruitment Size for Asthma by Molecule Type, 2006-2014
Figure 21: Asthma Therapeutics Market, Global Failure Rate (%), Average Clinical Trial Duration (months) and Average Trial Recruitment Size (participants) for Asthma by Molecular Target, 2006-2014
Figure 22: Asthma Therapeutics Market, Global, Mepolizumab Forecast ($bn), 2015-2020
Figure 23: Asthma Therapeutics Market, Global, Reslizumab Forecast ($bn), 2016-2020
Figure 24: Asthma Therapeutics Market, Global, Lebrikizumab Forecast ($m), 2018-2020
Figure 25: Asthma Therapeutics Market, Global, Dupilumab Forecast ($m), 2018-2020
Figure 26: Asthma Therapeutics Market, Global, Masitinib Forecast ($m), 2017-2020
Figure 27: Asthma Therapeutics Market, Global, Heat Map for Pipeline Products, 2015
Figure 28: Asthma Therapeutics Market, Global, Competitor Matrix for Marketed and Pipeline Products, 2015
Figure 29: Asthma Therapeutics Market, Global, Treatment Patterns, 2013-2020
Figure 30: Asthma Therapeutics Market, Global, Market Size ($bn), 2013-2020
Figure 31: Asthma Therapeutics Market, North America, Treatment Patterns, 2013-2020
Figure 32: Asthma Therapeutics Market, North America, Annual Cost of Therapy ($), 2013-2020
Figure 33: Asthma Therapeutics Market, North America, Market Size, 2013-2020
Figure 34: Asthma Therapeutics Market, Top Five EU Countries, Treatment Patterns, 2013-2020
Figure 35: Asthma Therapeutics Market, Top Five EU Countries, Annual Cost of Therapy ($), 2013-2020
Figure 36: Asthma Therapeutics Market, Top Five EU Countries, Market Size, 2013-2020
Figure 37: Asthma Therapeutics Market, Japan, Treatment Patterns, 2013-2020
Figure 38: Asthma Therapeutics Market, Japan, Annual Cost of Therapy ($), 2013-2020
Figure 39: Asthma Therapeutics Market, Japan, Market Size ($bn), 2013-2020
Figure 40: Asthma Therapeutics Market, Global, Co-Development Deals by Region, 2006-2014
Figure 41: Asthma Therapeutics Market, Global, Co-Development Deals by Value ($m), 2006-2014
Figure 42: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-Development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2014
Figure 43: Asthma Therapeutics Market, Global, Co-Development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2014
Figure 44: Asthma Therapeutics Market, Global, Co-Development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2014
Figure 45: Asthma Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2014
Figure 46: Asthma Therapeutics Market, Global, Licensing Deals by Region, 2006-2014
Figure 47: Asthma Therapeutics Market, Global, Licensing Deals by Value ($m), 2006-2014
Figure 48: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2014
Figure 49: Asthma Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2014
Figure 50: Asthma Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2014
Figure 51: Asthma Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2014
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FEATURED COMPANIES

  • AB Science
  • AstraZeneca
  • GSK
  • Merck
  • Nycomed
  • Sanofi
  • MORE
US Asthma Treatment Market Value to Hit $14 Billion by 2020.

The US treatment market for asthma will rise in value from $11.7 billion in 2013 to an estimated $14 billion by 2020, representing a Compound Annual Growth Rate (CAGR) of 2.6%.

The company’s latest report* states that the US is the single biggest asthma treatment market globally, reflecting the country’s large population size, high disease prevalence and the inflated cost of therapeutics in comparison with other major markets.

However, according to Fiona Chisholm, Associate Analyst, the asthma therapeutics market will be strongly characterized by generic erosion that will impact several of the leading brands over the forecast period, including Singulair (montelukast sodium), Advair (fluticasone propionate/salmeterol xinafoate), and Symbicort (budesonide/formoterol fumarate).

Chisholm explains: “Singulair’s patent expired in 2012, with the US Food and Drug Administration subsequently granting approval to several manufacturers, including Teva, Sandoz and Mylan, to market generic versions of the drug. As a consequence, sales revenue for Singulair has declined substantially in recent years.

“Advair and Symbicort have also recently lost patent protection in the US. However, substantial generic erosion has not occurred, due to regulatory hurdles and the difficulties inherent in trying to produce a bioequivalent Inhaled Corticosteroid/Long-Acting Beta Agonist (ICS/LABA) combination drug and inhaler device.”

While patent expirations are set to limit market growth to 2020, the impact of this will be offset by the uptake of recently approved and promising pipeline drugs.

Chisholm continues: “Arnuity, the follow-on product to the current ICS market leader Flovent, was approved in the US in August 2014, while Relvar, the follow-on product to the current ICS/LABA market leader Advair, is at the pre-registration phase. It is believed both drugs will help to maintain sales revenue for their respective classes.

“Furthermore, the potential approval of several premium-priced, novel IL-targeting monoclonal antibodies, although limited by their target populations, will also contribute to growth.”

The analyst adds that the development of these IL-targeting therapies, as well as other novel drugs, also gives rise to potential phenotype-targeted treatment, which could be particularly useful for patients with severe asthma.

“If approved, these drugs will represent a significant step forward in asthma therapeutics, helping to achieve personalized treatment tailored to each individual patient,” Chisholm concludes.

*Asthma Therapeutics in Major Developed Markets to 2020 - Personalized Treatment for Severe Asthma to Drive Market Growth despite Patent Expirations

This report provides analysis of the current marketed and pipeline products landscape for asthma treatment, including annualized market data from 2013 and forecast to 2020 across eight major markets, namely the US, France, Spain, Germany, Italy, UK, Japan and Canada.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by a team of industry experts.
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- AB Science
- Amgen
- Aslan Pharma
- Astellas Pharma
- AstraZeneca
- Boehringer Ingelheim
- CSL
- GSK
- Genentech
- GlaxoSmithKline/Theravance
- Janssen Pharmaceuticals
- Kyowa Hakko Kirin
- MAP Pharmaceuticals
- Merck
- Mundipharma
- NeoStem
- Novartis
- Nycomed
- Orexo
- Regeneron Pharmaceuticals
- Roche/Genentech
- Sanofi
- Sepracor
- SkyePharma
- Teva Pharmaceutical
- University of California
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