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Frontier Pharma: Versatile Innovation in Oncology - Identifying and Commercializing Versatile First-in-Class Innovation

Frontier Pharma: Versatile Innovation in Oncology - Identifying and Commercializing Versatile First-in-Class Innovation

Summary


The oncology therapy area comprises a large and diverse range of indications, encompassing virtually all sites and tissues in the human body. These indications are the leading cause of death in economically developed countries and the second-leading cause of death in developing countries and present a major global health burden. Across the pharmaceutical industry as a whole, the oncology pipeline is far larger than any other therapy area, with 6,484 products in active development across all oncology indications, and 2,084 first-in-class products in development across all stages.

Due to a degree of crossover between oncology indications in terms of their underlying pathophysiology, it is not uncommon for products being developed for this therapy area to have developmental programs testing them across multiple indications. Some 473 first-in-class pipeline products are in concurrent development for two or more of the top 20 cancer sites ranked by incidence. The most promising versatile first-in-class molecular targets predominantly consist of receptor tyrosine kinases and their downstream signal transduction kinases, although a number of other cancer-related processes such as DNA repair, cancer immunosurveillance and apoptotic pathways are also targeted.

Scope

With 6,484 products in active development across all oncology indications, this is the largest therapy area pipeline by a considerable margin.

  • What factors are driving this high level of R&D activity?
  • Which indications have the highest concentration of pipeline products?
  • Although the unmet need varies between and within indications, this need is primarily for improved overall survival rates in patients, particularly those at the late stage of the disease.
  • Which first-in-class molecular targets appear able to best address the key unmet needs within oncology?
  • The variation in molecule type has shifted away from small molecules, the dominance of which has decreased from 94% across marketed products to 49% across the pipeline.
  • What are the dynamics of the remaining 51% of the pipeline?
  • How does this reflect the need for novel targeted therapies?
  • There has been a significant shift towards inhibitors of receptor tyrosine kinases, their ligands and signal transduction proteins, as well as drugs targeted against cancer antigens.
  • What is the scientific rationale behind these targets?
  • Across which indications are they being developed?
  • How successful have drugs against these targets been?
  • A number of versatile first-in-class targets appear to be particularly promising, including HER3, FGFR3, telomerase reverse transcriptase, and others.
  • Why are these targets considered to be particularly promising?
  • Why are these targets being developed across such a wide range of indications?
Reasons to buy
  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options across the key oncology indications
  • Acquire a detailed understanding of the 20 most common oncology indications by incidence, pinpointing the unmet needs for each indication
  • Assess the market for oncology in terms of the molecular targets that are approved across multiple indications and the predominant molecule types and targets
  • Analyze the oncology pipeline and stratify by stage of development, molecule type, molecular target, and first-in-class status
  • Understand the level of versatility across the pipeline and within each molecular target. Assess the pipeline activity of each versatile first-in-class product and the indications that they are in development for
  • Analyze the therapeutic potential and developmental footprint of versatile first-in-class targets and understand which are the most promising. Understand which targets are being developed in each indication, for how many pipeline products, and how well they align with the underlying pathophysiology of cancer
  • Identify commercial opportunities in the oncology deals landscape by analyzing trends in licensing and co-development deals for versatile first-in-class products
  • Identify versatile first-in-class pipeline products that have not been previously involved in licensing or co-development deals and are thus more likely to be available for in-licensing or co-development


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Executive Summary
2.1 A Large Therapy Area with Varying Unmet Needs Across Indications
2.2 A Large Pipeline with a High Degree of First-in-Class Innovation
2.3 A Number of Highly Promising First-in-Class Versatile Oncology Pipeline Targets
3 The Case for Innovation in the Oncology Market
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 Product Innovation
3.5 Sustained Innovation
3.6 Report Guidance
4 Clinical and Commercial Landscape
4.1 Therapy Area Overview
4.1.1 Epidemiology
4.1.2 Etiology
4.1.3 Pathophysiology
4.1.4 Diagnosis
4.1.5 Prognosis and Disease Staging
4.2 Treatment Options
4.2.1 Surgery and Radiation Therapy
4.2.2 Chemotherapy
4.2.3 Hormonal Therapies
4.2.4 Targeted Therapies
4.3 Overview of Marketed Products for Oncology
4.4 Current Unmet Needs across the Oncology Markets
5 Assessment of Pipeline Product Innovation
5.1 Oncology Pipeline by Phase, Molecule Type and Molecular Target
5.2 Comparative Distribution of Programs between the Oncology Market and Pipeline by Therapeutic Target Family
5.3 First-in-Class and Versatile Pipeline Programs
5.3.1 First-in-Class Oncology Products by Phase, Molecule Type and Molecular Target
5.3.2 Versatility of First-in-Class Pipeline Products
6 Signaling Pathways, Disease-Causing Mutations and Versatile First-in-Class Molecular Target Integration
6.1 The Complexity of Signaling Networks in Oncology
6.2 Signaling Pathways, Disease-Causing Mutations and Versatile First-in-Class Molecular Target Integration
6.3 Versatile First-in-Class Target Matrix Assessment
7 Versatile First-in-Class Target Assessment
7.1 Pipeline Programs that Target Fibroblast Growth Factor Receptor-3
7.2 Pipeline Programs that Target Human Epidermal Growth Factor Receptors-3 and -4
7.3 Pipeline Programs that Target Phosphoinositide 3-Kinase Alpha
7.4 Pipeline Programs that Target Akt1, 2 and 3
7.5 Pipeline Programs that Target Telomerase Reverse Transcriptase
7.6 Pipeline Programs that Target Heat Shock Protein 90
7.7 Pipeline Programs that Target Focal Adhesion Kinase
7.8 Pipeline Programs that Target DNA-Dependent Protein Kinase
7.9 Pipeline Programs that Target Programmed Death Ligand-1
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
9 Appendix
9.1 Abbreviations
9.2 References
9.2.1 Main
9.3 Contact Us
9.4 Disclaimer
1.1 List of Tables
Table 1: Epidemiology by Top 20 Most Common Cancer Sites, 2012
Table 2: Epidemiology by Top 20 Most Common Cancer Sites, 2012
Table 3: Epidemiology by Top 20 Most Common Cancer Sites, 2012
Table 4: Epidemiology by Top 20 Most Common Cancer Sites, 2012
Table 5: TNM Staging, 2015
Table 6: Karnofsky Scores and Equivalent ECOG Staging, 2015
Table 7: Optimal and Actual Radiation Therapy Usage Rates in US, 1995–2000
Table 8: Optimal and Actual Chemotherapy Usage Rates in Australia, 2010
Table 9: Optimal and Actual Chemotherapy Usage Rates in the US, 2008
Table 10: Frequency of Mutations in Components in PI3K Alpha Catalytic Isoform, by Cancer Type
Table 11: Frequency of Mutations in Components in Akt Proteins, by Cancer Type
1.2 List of Figures
Figure 1: Innovation Trends in Product Approvals, 1987–2013
Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006–2013
Figure 3: Relative Survival Rates for the Top 20 Cancers by Site, 2014
Figure 4: Molecule Types and Molecular Targets of Marketed Products for Oncology, 2015
Figure 5: Molecular Targets of Versatile Marketed Product for Oncology, 2015
Figure 6: Summary of Five-Year Survival Rate, Incidence and Mortality by Site, 2012
Figure 7: Pipeline Products by Therapy Area and Pipeline Oncology Products by Tumor Site, 2015
Figure 8: Developmental Pipeline Overview
Figure 9: Developmental Pipeline Overview by Molecular Target
Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products, 2015
Figure 11: First-in-Class Pipeline by Therapy Area and Site, 2015
Figure 12: Summary of Incidence, Mortality, Mortality Rates and Pipeline Activity by Tumor Site, 2015
Figure 13: Overview of First-in-Class Oncology Products, 2015
Figure 14: Overview of First-in-Class Oncology Products, 2015
Figure 15: Versatility of First-in-Class Oncology Pipeline Products
Figure 16: Versatility of First-in-Class Oncology Pipeline Products, as Inferred by Molecular Target
Figure 17: Versatility of First-in-Class Oncology Pipeline Products and Potential Additional Indications
Figure 18: Overview of Highly Versatile First-in-Class Pipeline Oncology Products, 2015
Figure 19: Overview of Highly Versatile First-in-Class Pipeline Oncology Products by Molecular Target, 2015
Figure 20: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets
Figure 21: Versatile First-in-Class Products in Oncology Pipeline, Part 1, 2015
Figure 22: Versatile First-in-Class Products in Oncology Pipeline, Part 2, 2015
Figure 23: Versatile First-in-Class Products in Oncology Pipeline, Part 3, 2015
Figure 24: Versatile First-in-Class Products in Oncology Pipeline, Part 4, 2015
Figure 25: Signaling Networks of Functional Families in Oncology, Part 1
Figure 26: Signaling Networks of Functional Families in Oncology, Part 2
Figure 27: Versatile First-in-Class Molecular Target Analysis Matrix, Part 1
Figure 28: Versatile First-in-Class Molecular Target Analysis Matrix, Part 2
Figure 29: Versatile First-in-Class Molecular Target Analysis Matrix, Part 3
Figure 30: Pipeline Programs Targeting Fibroblast Growth Factor Receptor-3
Figure 31: Pipeline Programs Targeting Human Epidermal Growth Factor Receptor-3
Figure 32: Pipeline Programs Targeting Human Epidermal Growth Factor Receptor-4
Figure 33: Pipeline Programs Targeting Phosphoinositide 3-Kinase Alpha
Figure 34: Pipeline Programs Targeting Akt-1
Figure 35: Pipeline Programs Targeting Akt-2
Figure 36: Pipeline Programs Targeting Akt-3
Figure 37: Pipeline Programs Targeting Telomerase Reverse Transcriptase
Figure 38: Pipeline Programs Targeting Heat Shock Protein 90
Figure 39: Pipeline Programs Targeting Focal Adhesion Kinase
Figure 40: Pipeline Programs Targeting DNA-Dependent Protein Kinase
Figure 41: Pipeline Program Targeting Programmed Death Ligand-1
Figure 42: Industry-Wide Deals by Stage of Development, 2006–2014
Figure 43: Industry Licensing Deal Values by Stage of Development ($m), 2006–2014
Figure 44: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2014
Figure 45: Regional Network of Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015
Figure 46: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products by Molecule Type, 2006–2015
Figure 47: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products by Molecular Target, 2006–2015
Figure 48: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015, Part 1
Figure 49: Licensing Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015, Part 2
Figure 50: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2014
Figure 51: Regional Network of Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015
Figure 52: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products by Molecule Type, 2006–2015
Figure 53: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products by Molecular Target, 2006–2015
Figure 54: Co-development Deals for Versatile Pipeline Oncology First-in-Class Products, 2006–2015

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