Asthma Therapeutic and Drug Pipeline Review H1

Asthma Assessment and Therapeutics Pipeline Review H1 2017

PUNE, INDIA, May 23, 2017 / -- Summary
Asthma is a common chronic inflammatory disease of the airways, characterized by recurrent attacks of breathlessness and wheezing, which vary in frequency and severity from patient to patient. The exact causes of asthma are currently unknown, and may be the result of a combination of factors, although two major factors thought to be involved are environmental exposure and host factors, particularly genes.


Asthma treatment can be classed as either a long-term control medication, aimed at controlling persistent asthma, or a quick-relief medication, for the relief of exacerbations and acute symptoms. Long-term control medication includes Inhaled Corticosteroids (ICS), immunomodulators, leukotriene modifiers, cromolyn sodium, nedocromil and methylxanthines. In addition, Long-Acting Beta-Adrenoceptor Agonists (LABAs) can be used in combination with ICSs – but not as monotherapies – for moderate or severe persistent asthma. Currently, only one biologic – Xolair (omalizumab) – is approved as an add-on therapy for the treatment of allergic asthma in the Asia-Pacific region. Nevertheless, significant unmet need remains for the treatment of severe eosinophilic asthma.

The current asthma market in the Asia-Pacific region contains novel products, including Xolair, a recombinant humanized monoclonal anti-IgE antibody; Seretide/Adoair, an ICS-LABA combination therapy; Relvar/Breo, an ICS-LABA combination therapy, and Spiriva, a LAMA.
- What are the competitive advantages of the existing novel drugs?
With over 274 active pipeline molecules, most of the late-stage investigational drug candidates are being evaluated, with improved dosing regimens and administration routes in comparison to currently marketed products.
- Which classes of novel drugs are most prominent within the pipeline?
- Is there strong potential for the pipeline to address unmet needs within the asthma market – specifically for severe eosinophilic asthma?
Analysis of clinical trials since 2006 has identified that the failure rates of asthma molecules were highest in Phase III (46%), with the overall attrition rate for asthma in development being 78%.
- How do failure rates vary by product stage of development, molecule type, and mechanism of action?
- How do other factors, such as average trial duration and trial size influence the costs and risks associated with product development?
Over the 2014–2021 forecast period, the asthma therapeutics market in the Asia-Pacific region is expected to increase in value at a Compound Annual Growth Rate (CAGR) of 7.2%, from $3.5 billion to over $5.6 billion.
- Which markets make the most significant contribution to the current market size?
- What are the epidemiology trends in these markets?
- Will new market entrants lead to substantial changes in annual therapy costs?
- How will different treatment usage patterns impact growth in the five assessed Asia-Pacific markets?
Rising asthma prevalence and uptake of newer biologics will lead to significant market growth over the forecast period, in spite of affordability concerns.
- Will affordability threaten the commercial success of existing drugs as well as newer biologics?
- Which of the assessed countries have affordability concerns?

Reasons to buy
This report will enable you to -
- Understand the clinical context of asthma by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options.
- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
- Identify key pipeline trends in molecule type, administration route, mechanism of action, and novelty.
- Consider market opportunities and potential risks by examining trends in asthma clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action.
- Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in asthma by examining clinical trial data and multi-scenario product forecast projections.
- Compare treatment usage patterns, annual therapy costs, and market growth projections for China, India, Australia, South Korea and Japan.
- Discover trends in licensing and co-development deals concerning asthma products and identify the major strategic consolidations that have shaped the commercial landscape.
Table of Content: Key Points
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 9
2.1 Disease Introduction 9
2.2 Epidemiology 9
2.3 Symptoms 10
2.4 Etiology and Pathophysiology 10
2.5 Diagnosis 11
2.6 Classification 12
2.7 Treatment Guidelines and Options 13
2.7.1 ICS Monotherapy for the Maintenance Treatment of Asthma 16
2.7.2 Montelukast sodium as First-Line Maintenance Therapy 19
2.7.3 ICS/LABA Combination Therapy 20
2.7.4 Add-on Therapies 25
3 Marketed Products 30
3.1 Overview 30
3.2 ICS for the Maintenance Treatment of Asthma 30
3.2.1 Arnuity (fluticasone furoate) 30
3.3 ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma 31
3.3.1 Seretide/Adoair (fluticasone propionate and salmeterol xinafoate) - GlaxoSmithKline 31
3.3.2 Symbicort (budesonide and formoterol fumarate) - AstraZeneca, Co-Promotion with Astellas Pharma 32
3.3.3 Relvar/Breo (vilanterol trifenatate and fluticasone furoate) - GlaxoSmithKline 33
3.3.4 Flutiform (fluticasone propionate and formoterol fumarate) - SkyePharma 34
3.4 Add-on Therapy to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma 35
3.4.1 Xolair (omalizumab) - Novartis and Genentech 35
3.4.2 Montelukast sodium 36
3.4.3 Spiriva (tiotropium bromide) - Boehringer Ingelheim 37
3.5 Comparative Efficacy and Safety of Marketed Products 38
4 Pipeline Analysis 41
4.1 Overview 41


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