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. The disease has significant global incidence and there is currently no cure. Pharmacotherapeutic intervention aims to provide patients with an increased level of disease control and reduce the severity of symptoms, and a number of inhalational therapeutic options are available.
Asthma treatment can be classed as either long-term control medication, aimed at controlling persistent asthma, or 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 (LABA) can be used in combination with ICSs – but not as monotherapies – for moderate or severe persistent asthma. Currently, only two biologics – Xolair (omalizumab) and Nucala (mepolizumab) – are approved as add-on therapy for the treatment of allergic and severe refractory eosinophilic asthma in the Asia-Pacific region. Unmet need therefore remains in the form of patients that do not respond well to current therapeutics.
The Asia-Pacific asthma market was valued at $4.1 billion in 2016. The large size of the market is driven by high prevalence rates, particularly among children and the aging population; the need for long-term reliever and maintenance medication; and the expected launch of high-cost biological therapies.
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, another ICS-LABA combination therapy; and Spiriva, a LAMA.
– What are the competitive advantages of the existing novel drugs?
With over 290 active pipeline molecules, most of the late-stage investigational drug candidates offer improved dosing regimens and administration routes in comparison to currently marketed products.
– Which classes of novel drugs are most prominent within the pipeline?
– How much potential is there for the pipeline to address unmet needs within the asthma market?
Analysis of clinical trials since 2006 has identified that the failure rates of asthma molecules were highest in Phase III (60%).
– 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 2016-2023 forecast period the asthma therapeutics market in the Asia-Pacific region is expected to increase in value at a compound annual growth rate of 5.4%, from $4.1 billion to over $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?
Reasons to buy
– 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. Analyze the asthma pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There are signs in the pipeline that the industry is seeking novel approaches to meet unmet needs within asthma.
– 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 5
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Symptoms 11
2.4 Etiology and Pathophysiology 11
2.4.1 Pathophysiology 12
2.5 Diagnosis 14
2.6 Disease Stages 15
2.7 Prognosis 17
2.8 Treatment Guidelines and Options 18
2.8.1 Treatment Algorithm 18
2.8.2 Pharmacological Treatments 21
2.8.3 Non-Pharmacological Treatments 25
3 Marketed Products 27
3.1 Overview 27
3.2 ICS for the Maintenance Treatment of Asthma 27
3.2.1 Arnuity (fluticasone furoate) – GlaxoSmithKline 27
3.3 ICS-LABA Combination Therapy for the Maintenance Treatment of Asthma 28
3.3.1 Seretide/Adoair (fluticasone propionate and salmeterol xinafoate) – GlaxoSmithKline 28
3.3.2 Symbicort (budesonide and formoterol fumarate) – AstraZeneca, Co-promotion with Astellas Pharma 29
3.3.3 Relvar/Breo (vilanterol trifenatate and fluticasone furoate) – GlaxoSmithKline 30
3.3.4 Flutiform (fluticasone propionate and formoterol fumarate) – SkyePharma 31
3.4 Add-on Therapy to ICS or ICS-LABA Therapies for the Maintenance Treatment of Asthma 31
3.4.1 Xolair (omalizumab) – Novartis and Genentech 31
3.4.2 Montelukast Sodium – Merck & Co 33
3.4.3 Spiriva (tiotropium bromide) – Boehringer Ingelheim 34
3.4.4 Nucala (mepolizumab) – GlaxoSmithKline 35
3.5 Comparative Efficacy and Safety of Marketed Products 36
4 Pipeline Analysis 39
4.1 Overview 39
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