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Frontier Pharma: Liver Cancer - Identifying and Commercializing First-in-Class Innovation

Frontier Pharma: Liver Cancer - Identifying and Commercializing First-in-Class Innovation

Summary


Liver plays various vital roles within the body, including the removal of toxins from the blood, the production of bile to help digest fat and substances to help blood clot, in addition to making, storing and releasing sugar for energy. Primary liver cancer is a cancer that originates in the liver. Several histological subtypes make up liver cancer. The primary subtype is hepatocellular carcinoma (HCC), which accounts for approximately 80-90% of all cases (Nordenstedt et al., 2010). Others include cholangiocarcinoma, hepatoblastoma and hemangiosarcoma (McGlynn and London, 2011). As subtypes other than HCC are significantly less common, a substantial portion of clinical and commercial focus revolves around HCC.

Globally, liver cancer is the sixth most common cancer, but its poor prognosis makes it the second leading cause of cancer-related death (Globocan, 2012). It poses a much greater burden in countries with developing economies than in developed nations such as the US; East Asia and Sub-Saharan Africa are territories of particularly high incidence.

Liver cancer market is segmented in terms of its needs, as early-stage patients have access to curative therapies such as surgical resection, and therefore have a relatively strong outlook. However, at the opposite end of the spectrum patients that are diagnosed in later stages, who represent the majority of the patient population, are not eligible for surgery and have several major needs that are unmet by the current market.

In stark contrast to the relatively limited market landscape, which contains just 86 products, the liver cancer pipeline is large, diverse and highly innovative. The pipeline has 423 products in active development, with diversity of both molecule type and mechanism of action. Of these, 122 are first-in-class, and act on 109 distinct first-in-class molecular targets. These products span a very wide range of molecular target types including cancer immunotherapies, receptor tyrosine kinases, targeted cytotoxic agents and kinase inhibitors, far exceeding the scope of products present in the chemotherapy-dominated market.

The report “Frontier Pharma: Liver Cancer - Identifying and Commercializing First-in-Class Innovation” provides a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.

Specifically, this report provides the following -

  • Visualize the composition of the liver cancer market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed.
  • Analyze the liver cancer pipeline and stratify by stage of development, molecule type and molecular target..
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary molecular target matrix, first-in-class products have been assessed and ranked according to clinical potential.
  • Identify commercial opportunities in the liver cancer deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals.
Companies mentioned in this report: Bristol-Myers Squibbs, Novartis

Scope
  • The 423 products in active development, of which 122 are first-in-class and therefore act on completely novel targets, far exceed the scope of the current market. How will pipeline innovation affect the future liver cancer market?
  • There are 109 distinct first-in-class molecular targets currently being studied. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?
  • The majority of first-in-class products in development are cancer immunotherapies. Which of these are the most promising, and how does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?
  • A significant number of first-in-class products have been identified with some prior involvement in deals. How do deal frequency and value compare between target families and molecule types, and which first-in-class programs have not yet been involved in a licensing or co-development deal?
Reasons to buy
  • Understand the current clinical and commercial landscape. The report includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.
  • Visualize the composition of the liver cancer market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the market.
  • Analyze the liver cancer pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating liver cancer subtypes such as hepatocellular carcinoma and cholangiocarcinoma.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary molecular target matrix, first-in-class products have been assessed and ranked according to clinical potential.
  • Identify commercial opportunities in the liver cancer deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or co-development deals.


  • Executive Summary
    • High Unmet Need and a Limited Number of Marketed Options
    • Large, Diverse and Highly Innovative Pipeline
    • Active Deals Landscape Reflects the Dynamic Pipeline
  • The Case for Innovation
    • Table Figure 1: Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987–2015
    • Growing Opportunities for Biologic Products
    • Diversification of Molecular Targets
    • Innovative First-in-Class Product Developments Remain Attractive
      • Table Figure 2: Sales Performance After Marketing Approval of First-in- Class and Non-First-in-Class Products, 2006–2013 ($m)
    • Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
    • Sustained Innovation
    • GBI Research Report Guidance
  • Clinical and Commercial Landscape
    • Disease Overview
    • Symptoms
      • Table Symptoms of Liver Cancer
    • Diagnosis
      • Clinical Presentation
      • Alpha-Fetoprotein
      • Diagnostic Imaging and Scans
      • Screening
      • Biopsy
      • Staging, Classification and Prognosis
        • Table Tumor, Regional Lymph Node and Metastasis Staging
    • Epidemiology and Etiology
    • Pathophysiology
      • Molecular Characterization
    • Risk Factors and Co-Morbidities
      • Table Risk Factors and Comorbidities for Liver Cancer
    • Treatment Options
    • Treatment Algorithm
      • Nexavar
    • Overview of Marketed Products for Liver Cancer
      • Table Figure 3: Liver Cancer, Marketed Product Overview, 2017
      • Innovative Products in the Liver Cancer Market
      • Unmet Needs
  • Assessment of Pipeline Product Innovation
    • Table Figure 4: Liver Cancer, Pipeline Products by Therapy Area, 2017
    • Liver Cancer Pipeline by Molecule Type, Phase and Therapeutic Target
      • Table Figure 5: Liver Cancer, Developmental Pipeline Overview, 2017
      • Table Figure 6: Liver Cancer, Developmental Pipeline by molecular target, 2017
    • Comparative Distribution of Programs between the Liver Cancer Market and Pipeline by Therapeutic Target Family
      • Table Figure 7: Liver Cancer, Molecular Target Category Comparison, Pipeline and Marketed Products, 2017
    • First-in-Class Pipeline Programs
      • Table Figure 8: Liver Cancer Drug Market, Global, Percentage Distribution of First-in-Class Products in Pipeline by Stage of Development (%), 2017
      • Table Figure 9: Liver Cancer Drug Market, Global, Distribution of First-in- Class Products in Pipeline by Molecular Target (%), 2017
      • Table Figure 10: Liver Cancer, Products in the Pipeline (Part 1), 2017
  • Signaling Network, Disease Causation and Innovation Alignment
    • The Complexity of Signaling Networks in Oncology
    • Signaling Pathways Disease-Causing Mutations and First-in-Class Molecular Target Integration
    • First-in-Class Target Matrix Assessment
      • Table Figure 16: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 1 2017
  • First-in-Class Target Evaluation
    • Pipeline Programs Targeting PIK3CA, PIK3CB and PIK3CG
      • Table Figure 19: Liver Cancer, PIK3CA/PIK3CB/PIK3CG Targeting Products, 2017
      • Table Liver Cancer, Key Features and Pipeline Activity of PIK3CA/PIK3CB/PIK3CG
    • Pipeline Programs Targeting Protein Kinase C Delta
      • Table Figure 20: Liver Cancer, PRKCD Targeting Products
      • Table Liver Cancer Key Features and Pipeline Activity of PRCKD
    • Pipeline Programs Targeting AKT1
      • Table Figure 21: Liver Cancer, AKT1 Targeting Products, 2017
      • Table Liver Cancer, Key Features and Pipeline Activity of AKT1
    • Pipeline Programs Targeting HER3/ERBB3
      • Table Figure 22: Liver Cancer, HER3 Targeting Products, 2017
      • Table Liver Cancer, Key Features and Pipeline Activity of HER3
    • Pipeline Programs Targeting ROR1
      • Table Figure 23: Liver Cancer, ROR1 Targeting Products, 2017
      • Table Liver Cancer, Key Features and Pipeline Activity of ROR1
    • Pipeline Programs Targeting PRKACA fusions
      • Table Figure 24: Liver Cancer, PRKACA Fusion Targeting Products, 2017
      • Table Liver Cancer, Key Features and Pipeline Activity of PRKACA Fusions
    • Pipeline Programs Targeting Frizzled 2
      • Table Figure 25: Liver Cancer, FZD2 Targeting Products, 2017
      • Table Liver Cancer, Key Features and Pipeline Activity of FZD2
    • Pipeline Programs Targeting CDK1 and 2
      • Table Figure 26: Liver Cancer, CDK1/2 Targeting Products, 2017
      • Table Liver Cancer, Key Features and Pipeline Activity of CDK1/2
    • Pipeline Programs Targeting PTK2/FAK
      • Table Figure 27: Liver Cancer, PTK2/FAK Targeting Products, 2017
      • Table Liver Cancer, Key Features and Pipeline Activity of PTK2/FAK
    • Conclusion
  • Deals and Strategic Consolidations
    • Industry-Wide First-in-Class Deals
      • Table Figure 28: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006–2014
      • Table Figure 29: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006–2014
    • Liver Cancer Deals Landscape
    • Licensing Deals
      • Table Figure 30: Liver Cancer, Global, Licensing Deals by Region and Value, 2006–Q1 2017
      • Table Figure 31: Liver Cancer, Global, Licensing Deals by Stage and Value, 2006–Q1 2017
      • Molecule Type
        • Table Figure 32: Liver Cancer, Licensing Deals by Molecular Type, 2006–Q1 2017
      • Molecular Target
        • Table Figure 33: Liver Cancer, Licensing Deals by Molecular Target, 2006–Q1 2017
        • Table Figure 34: Liver Cancer, Licensing Deals with Disclosed Values, 2006–Q1 2017
    • Co-development Deals
      • Table Figure 35: Liver Cancer Drug Market, Global, Co-development Deals by Region, Value and Year, 2006–Q1 2017
      • Table Figure 36: Liver Cancer, Co-development Deals by Stage and Value, 2006–Q1 2017
      • Molecule Type
        • Table Figure 37: Liver Cancer, Co-development Deals by Molecule Type, 2006–Q1 2017
      • Molecular Target
        • Table Figure 38: Liver Cancer, Co-development Deals by Molecular Target, 2006–Q1 2017
        • Table Figure 39: Liver Cancer, Co-development Deals with Disclosed Values, 2006–Q1 2017
    • First-in-Class Programs Not Involved in Licensing or Co-development Deals
      • Table Figure 40: Liver Cancer Market, Global, Pipeline Programs in Active Development Involved in Previous Deals, 2017
      • Table Figure 41: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016
  • Appendix
    • Abbreviations
    • References
    • Research Methodology
    • Secondary Research
      • Market Analysis
      • Pipeline Analysis
      • First-in-Class Matrix Assessment
      • First-in-Class Target Profiles
      • Licensing and Co-development Deals
    • Contact Us
    • Disclaimer

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