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Breast Cancer - First-in-Class Innovation Underlies Immunotherapeutic Potential and Pipeline Diversification for Late-Stage Breast Cancer

  • ID: 4606288
  • Report
  • 122 pages
  • GBI Research
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Breast Cancer - First-in-Class Innovation Underlies Immunotherapeutic Potential and Pipeline Diversification for Late-Stage Breast Cancer

Summary

Breast cancer remains a major global healthcare concern despite exceptional levels of public awareness about the disease. A lack of clear causative environmental factors and hereditary dispositioning have resulted in the incidence of breast cancer continuing to rise, a trend which is expected to continue into the immediate future.

In the UK, breast cancer is the leading type of cancer in women, with there being over 54,900 cases diagnosed each year. Although early-stage cancer is relatively treatable and has good 5- and 10-year disease-free survival rates, 10% of cancers are diagnosed late. Additionally, there are no treatments for metastatic breast cancer, which ultimately results in death.

As a whole, this presents a huge unmet clinical need in the breast cancer treatment algorithm. The treatment algorithm for breast cancer focuses on two main themes: standard chemotherapy and drugs that target hormones, namely estrogen and progesterone. However, chemotherapy and hormone drugs only make up a small percentage of the drug pipeline and an even smaller percentage of first-in-class products.

New trends in oncology are present in the breast cancer pipeline, in particular the focus on extracellular matrix degradation and improving the immune response to tumors. This report focuses on the epidemiology, pathophysiology and existing treatment options for breast cancer before giving detailed insight into promising pipeline targets and deal activity in the breast cancer market.

Scope

  • Unmet need is extremely high in late-stage breast cancer.
  • What are the most important etiological risk factors and pathophysiological processes implicated in breast cancer?
  • What is the current treatment algorithm?
  • How effective are current therapies for these indications, and how does this impact prognosis?
  • The breast cancer pipeline is large and contains a very high proportion of first-in-class product innovation.
  • Which molecule types and molecular targets are most prominent across the breast cancer pipeline?
  • What are the relationships between established and up-coming molecular targets in breast cancer?
  • Which first-in-class targets are most promising?
  • How does first-in-class target diversity differ by stage of development and molecular target class?
  • The deals landscape is active and dominated by very high and very low deal values.
  • Which indications attract the highest deal values?
  • How has deal activity fluctuated over the past decade?
  • Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

Reasons to buy

  • Appreciate the current clinical and commercial landscapes by considering disease symptoms, pathogenesis, etiology, co-morbidities and complications, epidemiology, diagnosis, prognosis and treatment options.
  • Identify leading products and key unmet needs within the market.
  • Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.
  • Assess the therapeutic potential of first-in-class targets. Using proprietary matrix assessments, first-in-class targets in the pipeline have been assessed and ranked according to clinical potential.
  • Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals, which may represent potential investment opportunities.
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1.1 List of Tables
1.2 List of Figures

2 Executive Summary
2.1 Exceptionally Large and Innovative Pipeline
2.2 Alignment of First-in-Class Molecular Target with Disease Causation
2.3 Highly Active Deals Landscape with Numerous Investment Opportunities

3 The Case for Innovation
3.1 Growing 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 Innovation
3.5 Sustained Innovation in Breast Cancer
3.6 Report Guidance

4 Clinical and Commercial Landscape
4.1 Overview of Breast Cancer
4.2 Symptoms
4.3 Diagnosis
4.4 Etiology
4.4.1 Age and Gender
4.4.2 Genetics
4.4.3 Environmental
4.5 Pathophysiology
4.5.1 Tumor Initiation and Aberrant Cell Proliferation and Survival
4.5.2 Tumor Metabolic Shift
4.5.3 Tumor Progression, Micro-environment Alteration and Angiogenesis
4.5.4 Cancer Stem Cells
4.6 Epidemiology
4.7 Complications
4.8 Prognosis and Disease Staging
4.8.1 Classification
4.9 Introduction to Breast Cancer Treatments
4.9.1 Treatment Algorithm
4.9.2 Treatment Options for Breast Cancer
4.10 Overview of Marketed Products in Breast Cancer
4.11 Current Unmet Needs in the Breast Cancer Market

5 Assessment of Pipeline Product Innovation
5.1 Overview
5.2 Breast Cancer Pipeline by Phase of Development and Molecule Type
5.3 Pipeline by Molecular Target
5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class
5.5 Comparative Distribution of First-in-Class and Non-First-in-Class Pipeline Programs by Molecular Target Class
5.5.1 Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Programs
5.6 Ratio of First-In-Class Programs to First-in-Class Molecular Targets within the Pipeline
5.7 List of All First-in-Class Pipeline Programs

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

7 First-in-Class Target Evaluation 70
7.1 Pipeline Programs Targeting PI3K Catalytic Subunit Alpha Isoform (PI3KCA)
7.2 Pipeline Programs Targeting GTPase KRAS (K-ras)
7.3 Pipeline Programs Targeting Cluster of Differentiation 47 (CD47)
7.4 Pipeline Programs Targeting CD278 (ICOS gene product)
7.5 Pipeline Programs Targeting Stimulator of Interferon Genes (TMEM173 gene product)
7.6 Pipeline Programs Targeting Receptor Tyrosine Protein Kinase ERBB 3 (HER3)
7.7 Pipeline Programs Targeting Neuregulin-1 (NRG1)
7.8 Pipeline Programs Targeting Calcium Release-Activated Calcium Channel Protein 1 (ORAI1)
7.9 Conclusion

8 Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Breast Cancer Deals Landscape
8.3 Licensing Deals
8.3.1 Deals by Region, Value and Year
8.3.2 Deals by Stage of Development and Value
8.3.3 Deals by Molecule Type and Molecular Target
8.3.4 List of Deals with Disclosed Deal Values
8.4 Co-development Deals
8.4.1 Deals by Region, Value and Year
8.4.2 Deals by Stage of Development and Value
8.4.3 Deals by Molecule Type and Molecular Target
8.4.4 List of Deals with Disclosed Deal Values
8.5 First-In-Class Programs with and without Prior Licensing or Co-development Deal Involvement

9 Appendix
9.1 Abbreviations
9.2 References
9.3 Methodology
9.3.1 Data integrity
9.3.2 Innovative and Meaningful Analytical Techniques and Frameworks
9.3.3 Evidence Based Analysis and Insight
9.4 Secondary Research
9.4.1 Market Analysis
9.4.2 Pipeline Analysis
9.4.3 Licensing and Co-development Deals
9.5 Contact Us
9.6 Disclaimer

1.1 List of Tables
Table 1: Breast Cancer, Global, Tumor, Regional Lymph Node and Metastasis Staging, 2010-2013
Table 2: Breast Cancer, Global, US, Disease Stage at Diagnosis and Five-year Relative Survival (%), 2013
Table 3: Breast Cancer, Global, Breast Cancer Histopathological and Molecular Classification, 2018
Table 4: Breast Cancer, Global, Key Features of Phosphoinositide 3-kinase Catalytic Subunit Alpha Isoform (PI3K), 2018 70
Table 5: Breast Cancer, Global, Pipeline Programs Targeting Phosphoinositide 3-kinase Catalytic Subunit Alpha Isoform (PI3K), 2018
Table 6: Breast Cancer, Global, Key Features of GTPase KRAS (K-ras), 2018
Table 7: Breast Cancer, Global, Pipeline Programs Targeting GTPase KRAS (K-ras), 2018
Table 8: Breast Cancer, Global, Key Features of Cluster of Differentiation 47 (CD47), 2018
Table 9: Breast Cancer, Global, Pipeline Programs Targeting Cluster of Differentiation 47 (CD47), 2018
Table 10: Breast Cancer, Global, Key Features of Cluster of Differentiation 278 (CD278), 2018
Table 11: Breast Cancer, Global, Pipeline Programs Targeting Cluster of Differentiation 278 (CD278), 2018
Table 12: Breast Cancer, Global, Key Features of Stimulator of Interferon Genes (STING), 2018
Table 13: Breast Cancer, Global, Pipeline Programs Targeting Stimulator of Interferon Genes (STING), 2018
Table 14: Breast Cancer, Global, Key Features of Tyrosine Protein Kinase ERBB3 (HER3), 2018
Table 15: Breast Cancer, Global, Pipeline Programs Targeting Tyrosine Protein Kinase ERBB3 (HER3), 2018
Table 16: Breast Cancer, Global, Key Features of Neuregulin-1 (NRG-1), 2018 80
Table 17: Breast Cancer, Global, Pipeline Programs Targeting Neuregulin-1 (NRG-1), 2018 80
Table 18: Breast Cancer, Global, Key Features of Calcium Release Activated Calcium Channel Protein 1 (ORAI1), 2018
Table 19: Breast Cancer, Global, Pipeline Programs Targeting Calcium Release Activated Calcium Channel Protein 1 (ORAI1), 2018

1.2 List of Figures
Figure 1: Breast Cancer, Global, Innovation Trends in Product Approvals Across the Pharmaceutical Market, 1987-2014
Figure 2: Breast Cancer, Global, Post-Marketing-Approval Sales Performance of First-in-Class Products Across the Pharmaceutical Industry ($m), 2006-2013
Figure 3: Breast Cancer, Global, Treatment Algorithm for Cancer Diagnosed at Stages I to III, 2018
Figure 4: Breast Cancer, Global, Treatment Algorithm for Cancer Diagnosed at Stage IV, 2018
Figure 5: Breast Cancer, Global, Market by Molecule Type and Molecular Target, 2018
Figure 6: Breast Cancer, Global, Pipeline Size by Therapy Area, 2018
Figure 7: Breast Cancer, Global, Pipeline by Stage of Development and Molecule Type, 2018
Figure 8: Breast Cancer, Global, Pipeline by Molecular Target and Breakdown of Growth Factor Antagonist Molecular Target Class, 2018
Figure 9: Breast cancer, Global, Distribution of Pipeline and Marketed Products by Molecular Target Class, 2018
Figure 10: Breast Cancer, Global, Distribution of Pipeline Products by First-in-Class Status and Molecular Target Class, 2018
Figure 11: Breast Cancer, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target Class, 2018
Figure 12: Breast Cancer, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2018
Figure 37: Breast Cancer, Global, First-in-Class Molecular Target Matrix Assessment for Breast Cancer, 2018 (part 1)
Figure 44: Breast Cancer, Global, Industry-Wide Licensing Deals by First-in-Class Status and Stage of Development, 2006-2015
Figure 45: Breast Cancer, Global, Industry-Wide Licensing Deals by First-in-Class Status, Deal Value, Upfront Payment Value and Stage of Development, 2006-2014
Figure 46: Breast Cancer, Global, Licensing Deals by Region, Value and Year, 2006-2018
Figure 47: Breast Cancer, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2018
Figure 48: Breast Cancer, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type and Molecular Target Class, 2006-2018
Figure 52: Breast Cancer, Global, Co-development Deals by Region, Value and Year, 2006-2018
Figure 53: Breast Cancer, Global, Number and Aggregate Deal Value of Co-development Deals by Stage of Development and Year, 2006-2018
Figure 54: Breast Cancer, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type and Molecular Target Class, 2006-2018
Figure 55: Breast Cancer, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type and Molecular Target Class, 2006-2018

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