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Exceptionally Large and
Innovative Pipeline
The breast cancer pipeline is
the largest in the pharmaceutical industry with 815 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 in this pipeline is
exceptional; GBI Research analysis identified 253 first-in-class
programs in the breast cancer pipeline, acting on 176 first-in-class
molecular targets. This accounts for some 39% of all products with a
disclosed molecular target and is reflective of the high degree of
innovation in this indication. This has far-reaching strategic
implications for all market participants, as, despite the high
attrition rate in breast cancer, it is highly likely 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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Alignment of First-in-Class
Molecular Target with Disease Causation
One of the key trends in
oncology and in breast cancer in particular over the last decade is
the clinical and commercial impact of targeted therapies designed to
target proteins in signaling pathways that are frequently mutated in
a significant proportion of the patient population. By aligning the
molecular targets for therapeutic intervention with disease causation
and/or propagation, these therapies limit the systemic cytotoxic
effects whilst inhibiting tumor-promoting signaling pathways. Such
strategies thereby typically achieve superior efficacy and safety
profiles.
Our proprietary analyses
demonstrate significant levels of differentiation as to how well the
first-in-class products and their respective molecular targets align
to underlying gene and protein level mutations and dysfunction. More
advanced analytics further substantiated these findings as strong
levels of differentiation in the scientific and clinical rationale
for first-in-class molecular targets emerged. Furthermore, clear
frontrunners were identified by integrating analyses to assess the
accessibility of molecular targets for therapeutic compounds, the
size of the target patient population that would benefit from
therapeutic intervention, and the expected positioning of the
first-in-class products based on the molecular targets and mechanisms
of action of currently marketed products.
These insights and a detailed
review of the available evidence from scientific studies substantiate
the perspective that first-in-class-product technology in its own
right is not sufficient to offer a compelling scientific and clinical
rationale. However, a range of products offer very significant
scientific and clinical promise and could therefore result in a
strong commercial proposition with the prospect of clinically and
commercially transformative products in the future.
A Highly Active Deals
Landscape with Numerous Investment Opportunities
The breast cancer deals
landscape is highly dynamic, with both deal number and aggregate
value exceeding industry benchmarks, reflecting the large and highly
competitive marketed and pipeline product environments. Moreover,
with 40 first-in-class products that are currently in development
having been involved in a licensing or co-development deal, the
capital being committed to breast cancer partnership deals is not
limited to products with established mechanisms of action in the
marketed product landscape. On the contrary, breakthrough innovations
are highly desirable as an investment option. Analysis shows that the
licensing deal values can exceed the mean and median deal values for
licensing deals in Phase I, II and III, suggesting that premium deals
can be achieved by smaller firms with the capacity to advance strong
products to one of the clinical stages of development. However, most
deals involving first-in-class products were either preclinical or
Phase I development, whereas advance-in-class and addition-to-class
product deals were typically made in Phases II and III, therefore
showing 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.
With the remaining 213
first-in-class products that are currently in development having not
yet been involved in a licensing or co-development deal, there are
numerous opportunities for in-licensing or co-development in this
indication, which already has a strong track record of breakthrough
innovation yielding highly commercially and clinically successful
therapies. Although many act on targets that are not yet strongly
substantiated in terms of their therapeutic potential in breast
cancer in clinical studies, there are many which are supported by
very robust and promising in vivo and in vitro preclinical evidence,
and as such are highly promising breast cancer therapies.
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Scope
The
report analyzes innovation in breast cancer, in the context of the
overall pipeline and current market landscape. In addition, it
analyzed the deals landscape surrounding first-in-class products in
breast cancer, and pinpoints opportunities for in-licensing. The
report covers and includes
- A brief introduction to breast cancer, including symptoms, pathophysiology, and 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 on the basis 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 breast cancer 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
- Understanding of the focal shifts in molecular targets in the breast cancer pipeline.
- Understanding of 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 breast cancer, benchmarked against non-first-in-class targets.
- Assess the valuations of licensed and co-developed breast cancer treatments.
- 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 Exceptionally Large and
Innovative Pipeline 4
2.2 Alignment of First-in-Class
Molecular Target with Disease Causation 4
2.3 A Highly Active Deals
Landscape with Numerous Investment Opportunities 4
3 The Case for Innovation in
the Breast Cancer Market 5
3.1 Growing Opportunities for
Biologic Products 5
3.2 Diversification of
Molecular Targets 5
3.3 Innovative First-in-Class
Product Developments Remain Attractive 5
3.4 Changes in the Clinical and
Commercial Environment to be More Favorable to Products Targeting
Niche Patient Populations and Indications 6
3.5 Sustained Innovation 6
3.6 Report Guidance 6
4 Clinical and Commercial
Landscape 8
4.1 Disease Overview 8
4.2 Disease Symptoms 8
4.3 Etiology 8
4.4 Pathophysiology 9
4.4.1 Tumor Initiation, and
Aberrant Cell Proliferation and Survival 10
4.4.2 Tumor Metabolic Shift 11
4.4.3 Tumor Progression,
Microenvironment Alteration and Angiogenesis 11
4.4.4 Cancer Stem Cells 12
4.5 Diagnosis 13
4.6 Prognosis and Disease
Staging 13
4.6.1 Classification 14
4.7 Introduction to Breast
Cancer Treatments 15
4.8 Surgery and Radiation
Therapy 16
4.9 Overview of Marketed
Products for Breast Cancer 16
4.9.1 Chemotherapy 17
4.9.2 Efficacy of Chemotherapy
Regimens 18
4.9.3 Hormonal Therapies 20
4.9.4 Efficacy of Endocrine
Therapies 20
4.9.5 Targeted Therapies 22
4.9.6 Efficacy of Targeted
Therapies 23
4.10 Treatment Guidelines 26
4.11 Current Unmet Need in the
Breast Cancer Market 29
5 Assessment of Pipeline
Product Innovation 31
5.1 Breast Cancer Pipeline by
Phase, Molecule Type and Molecular Target 31
5.2 First-in-Class Pipeline
Programs 35
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