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

  • ID: 3250622
  • Report
  • Region: Global
  • 67 Pages
  • GBI Research
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Large and Innovative Pipeline:

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. This 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.

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).

Xolair is also the only targeted therapy indicated for the treatment of a specific asthma phenotype. Its launch therefore addressed a significant unmet need for personalized therapy in asthma. Approximately 60% of asthmatics have allergic asthma, and may therefore benefit from Xolair treatment. However, only a minority of these patients has moderate-to-severe disease that is inadequately controlled with standard-of-care therapies, and is therefore eligible for treatment. Despite this, the drug has achieved blockbuster status, and although this can be attributed to a high Annual Cost of Therapy (ACoT), it is also reflective of how innovative drug development that targets unmet clinical needs can result in strong commercial outcomes. Indeed, drug developers are now looking to follow this example by developing highly specific biologics aimed at specific patient sub-types with the hope of benefiting previously underserved patients and generating strong revenues. Notable examples are mepolizumab, reslizumab, lebrikizumab and dupilumab, all of which target Interleukins (IL) heavily implicated in the inflammatory response.

A Deals Landscape with Numerous Investment Opportunities:

Analysis has confirmed that 52 of the 59 first-in-class products have not been involved in a licensing or co-development deal. Although a number act on targets that are not yet strongly substantiated in terms of their therapeutic potential in asthma in clinical studies, many are supported by promising in vivo and in vitro preclinical evidence, and as such are highly promising asthma therapies. Indeed, breakthrough innovations are highly desirable as an investment option.

However, many deals involving first-in-class products were in early-stage development, whereas advance-in-class and addition-to-class product deals were typically made in late-stage development, indicating significant differentiation. These findings have significant strategic implications for both biotech companies seeking to out-license products and firms with an interest in in-licensing first-in-class products with strong clinical and commercial prospects.

Scope:

The report analyzes innovation in asthma in the context of the overall pipeline and the current market landscape. In addition, it analyzes the deals landscape surrounding first-in-class products in asthma, and pinpoints opportunities for in-licensing. The report covers and includes:
- A brief introduction to asthma, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
- The changing molecular target landscape between market and pipeline and particular focal points of innovation in the pipeline
- Comprehensive review of the pipeline for first-in-class therapies, analyzed by of stage of development, molecule type, and molecular target
- Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs of which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets
- Assessment of the licensing and co-development deal landscape for asthma therapies and benchmarking of deals involving first-in-class versus non-first-in-class-products

Reasons to Purchase:

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to:
- Understand the focal shifts in molecular targets in the asthma pipeline
- Understand the distribution of pipeline programs by phase of development, molecule type and molecular target
- Access a scientific and clinical analysis of first-in-class developmental programs for asthma, benchmarked against non-first-in-class targets
- Access a list of the first-in-class therapies potentially open to deal-making opportunities
Note: Product cover images may vary from those shown
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1 Table of Contents
1.1 List of Tables
1.2 List of Figures

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

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

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

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

6 Signaling Network, Disease Causation and Innovation Alignment
6.1 The Complexity of Signaling Networks in Asthma
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration
6.3 First-in-Class Target Matrix Assessment

7 First-in-Class Target and Pipeline Program Evaluation
7.1 Pipeline Programs Targeting Leukotriene A4 Hydrolase
7.2 Pipeline Programs Targeting P-selectin
7.3 Pipeline Programs Targeting Spleen Tyrosine Kinase
7.4 Pipeline Programs Targeting Prostaglandin D2 Receptor 2
7.5 Pipeline Programs Targeting OX40 Ligand
7.6 Pipeline Programs Targeting Interleukin-33
7.7 Pipeline Programs Targeting Interleukin-10
7.8 Pipeline Programs Targeting Mast Stem Cell Growth Factor Receptor
7.9 Pipeline Programs Targeting Bradykinin B1 Receptor
7.10 Conclusion

8 Deals and Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.3 Co-development Deals
8.4 First-in-Class Programs not Involved in Licensing or Co-Development Deals

9 Appendix
9.1 References
9.2 Abbreviations
9.2.1 Expert Panel Validation
9.3 Contact Us
9.4 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

1.2 List of Figures:
Figure 1: Innovation Trends in Product Approvals
Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval
Figure 3: Asthma, Global Pipeline Overview
Figure 4: Asthma, Molecular Target Classes of Pipeline Products
Figure 5: Asthma, Molecular Targets
Figure 6: Asthma, Molecular Target Category Comparison, Pipeline and Marketed Products
Figure 7: Asthma, Comparative Pipeline
Figure 8: Asthma, First-in-Class Products in the Asthma Pipeline
Figure 9: Signaling Networks of Functional Families in Asthma - Part 1
Figure 10: Signaling Networks of Functional Families in Asthma - Part 2
Figure 11: First-in-Class Molecular Target Analysis Matrix
Figure 12: Leukotriene A4 Hydrolase as a Therapeutic Target
Figure 13: Pipeline Programs Targeting Leukotriene A4 Hydrolase
Figure 14: P-selectin as a Therapeutic Target
Figure 15: Pipeline Programs Targeting P-Selectin
Figure 16: Spleen Tyrosine Kinase as a Therapeutic Target
Figure 17: Pipeline Programs Targeting Spleen Tyrosine Kinase
Figure 18: Prostaglandin D2 Receptor 2 as a Therapeutic Target
Figure 19: Pipeline Programs Targeting Prostaglandin D2 Receptor 2
Figure 20: OX40 Ligand as a Therapeutic Target
Figure 21: Pipeline Programs Targeting OX40 Ligand
Figure 22: Interleukin-33 as a Therapeutic Target
Figure 23: Pipeline Programs Targeting Interleukin-33
Figure 24: Interleukin-10 as a Therapeutic Target
Figure 25: Pipeline Programs Targeting Interleukin-10
Figure 26: Mast stem Cell Growth Factor Receptor as a Therapeutic Target
Figure 27: Pipeline Programs Targeting Mast Stem Cell Growth Factor Receptor
Figure 28: Bradykinin B1 Receptor as a Therapeutic Target
Figure 29: Pipeline Programs Targeting Bradykinin B1 Receptor
Figure 30: Industry-Wide Deals by Stage of Development, 2006-2014
Figure 31: Industry-wide Deals by Stage of Development, 2006-2014
Figure 32: Asthma, Licensing Deals by Region, 2006-2015
Figure 33: Asthma, Licensing Deals, 2006-2015
Figure 34: Asthma, First-in-Class and Non-First-in-Class Comparison, 2006-2015
Figure 35: Asthma, Licensing Deals by Mechanism of Action, 2006-2015
Figure 36: Asthma, Co-development Deals by Region, 2006-2015
Figure 37: Asthma, Co-development Deals, 2006-2015
Figure 38: Asthma, Co-development Deals by Mechanism of Action, 2004-2015
Figure 39: Asthma, First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2015
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