"The
Report Frontier Pharma: Asthma - Identifying and Commercializing
First-in-Class Innovation provides information on pricing, market
analysis, shares, forecast, and company profiles for key industry
participants. - MarketResearchReports.biz"
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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:http://www.marketresearchreports.biz/analysis/285641
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.
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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 buy
- 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
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
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 M
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