Wednesday 4 November 2015

Frontier Pharma: Asthma - Identifying and Commercializing First-in-Class Innovation- Acute Market Reports

Analysis has confirmed the asthma pipeline to be highly active, with 252 products in active development across all stages. The range of mechanisms of action employed by these compounds is also highly diverse, especially in comparison to the existing market landscape. More pertinently, the degree and proportion of breakthrough innovations is significant. GBI Research analysis identified 59 first-in-class programs in the asthma pipeline, acting on 43 first-in-class molecular targets, accounting for 23% of all products with a disclosed molecular target and reflective of the high degree of innovation in this indication. This has far-reaching strategic implications for all market participants, as, despite the high clinical trial attrition rate, it is highly likely that many of the first-in-class technologies will reach the market over the coming decade and may transform the clinical and commercial landscape.

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Biologics Growing in Prominence in Asthma Treatment

While the current asthma market is almost exclusively dominated by small molecules, which account for approximately 99% (the exception being Xolair), the current asthma pipeline includes 64 biologics, accounting for 24%. Small molecules amount to 178 compounds, equating to 66%.

This highlights both the commercial and clinical appeal of developing drugs of this class, and follows trends seen in other therapy areas, particularly oncology. Xolair (omalizumab), a recombinant humanized anti-IgE monoclonal Antibody (mAb), was the first humanized therapeutic mAb to be indicated for asthma. It was approved by the FDA in 2003 as an add-on therapy for adults and adolescents aged 12 and over, with moderate-to-severe allergic asthma and symptoms not adequately controlled with Inhaled Corticosteroids (ICS).

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Table of Contents

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3

2 Executive Summary 4
2.1 Biologics Growing in Prominence in Asthma Treatment 4
2.2 Market Landscape to Grow in Diversity over Coming Years 4
2.3 Deals Landscape Offers Significant Investment Opportunities for First-in-Class Products 4

3 The Case for Innovation in Asthma 5
3.1 Growing Number of Opportunities for Biologic Products 6
3.2 Diversification of Molecular Targets 6
3.3 Innovative First-in-Class Product Developments Remain Attractive 6
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7
3.5 Sustained Innovation 7
3.6 GBI Research Report Guidance 8

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4 Clinical and Commercial Landscape 9
4.1 Disease Overview 9
4.1.1 Epidemiology 9
4.1.2 Etiology 10
4.1.3 Disease Pathophysiology 10
4.1.4 Disease Symptoms 11
4.1.5 Diagnosis 11
4.1.6 Assessment of Disease Severity 12
4.1.7 Treatment 14
4.1.8 Treatment Algorithm 14
4.2 Overview of Marketed Products 16
4.2.1 Quick-Relief Medication 17
4.2.2 ICSs for the Maintenance Treatment of Asthma 17
4.2.3 ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma 18
4.2.4 Add-on Therapy to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma 19
4.2.5 Conclusion 20

5 Assessment of Pipeline Product Innovation 21
5.1 Asthma Pipeline by Phase, Molecule Type and Therapeutic Target 21
5.2 Comparative Distribution of Programs between the Asthma Market and Pipeline by Molecular Target 26
5.3 First-in-Class Pipeline Programs Targeting Novel Molecule Targets 26



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