Liver Cancer - Identifying and Commercializing First-in-Class Innovation

  • ID: 4370202
  • Report
  • 70 Pages
  • GBI Research
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Comprehensive Study of Disease Pathogenesis, Diagnosis, Prognosis and the Treatment Options Available

FEATURED COMPANIES

  • Bristol-Myers Squibbs
  • Novartis
  • MORE

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 “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.
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FEATURED COMPANIES

  • Bristol-Myers Squibbs
  • Novartis
  • MORE

1 Table of Contents

2 Executive Summary
2.1 High Unmet Need and a Limited Number of Marketed Options
2.2 Large, Diverse and Highly Innovative Pipeline
2.3 Active Deals Landscape Reflects the Dynamic Pipeline

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 Product Innovation
3.5 Sustained Innovation
3.6 Research Report Guidance

4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Symptoms
4.3 Diagnosis
4.3.1 Clinical Presentation
4.3.2 Alpha-Fetoprotein
4.3.3 Diagnostic Imaging and Scans
4.3.4 Screening
4.3.5 Biopsy
4.3.6 Staging, Classification and Prognosis
4.4 Epidemiology and Etiology
4.5 Pathophysiology
4.6 Risk Factors and Co-Morbidities
4.7 Treatment Options
4.8 Treatment Algorithm
4.9 Overview of Marketed Products for Liver Cancer
4.9.1 Innovative Products in the Liver Cancer Market
4.9.2 Unmet Needs

5 Assessment of Pipeline Product Innovation
5.1 Liver Cancer Pipeline by Molecule Type, Phase and Therapeutic Target
5.2 Comparative Distribution of Programs between the Liver Cancer Market and Pipeline by Therapeutic Target Family
5.3 First-in-Class Pipeline Programs

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

7 First-in-Class Target Evaluation
7.1 Pipeline Programs Targeting PIK3CA, PIK3CB and PIK3CG
7.2 Pipeline Programs Targeting Protein Kinase C Delta
7.3 Pipeline Programs Targeting AKT1
7.4 Pipeline Programs Targeting HER3/ERBB3
7.5 Pipeline Programs Targeting ROR1
7.6 Pipeline Programs Targeting PRKACA fusions
7.7 Pipeline Programs Targeting Frizzled
7.8 Pipeline Programs Targeting CDK1 and
7.9 Pipeline Programs Targeting PTK2/FAK
7.10 Conclusion

8 Deals and Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Liver Cancer Deals Landscape
8.3 Licensing Deals
8.3.1 Molecule Type
8.3.2 Molecular Target
8.4 Co-development Deals
8.4.1 Molecule Type
8.4.2 Molecular Target
8.5 First-in-Class Programs Not Involved in Licensing or Co-development Deals

9 Appendix
9.1 Abbreviations
9.2 References
9.3 Research Methodology
9.4 Secondary Research
9.4.1 Market Analysis
9.4.2 Pipeline Analysis
9.4.3 First-in-Class Matrix Assessment
9.4.4 First-in-Class Target Profiles
9.4.5 Licensing and Co-development Deals
9.5 Contact Us
9.6 Disclaimer

List of Tables
Table 1: Symptoms of Liver Cancer
Table 2: Tumor, Regional Lymph Node and Metastasis Staging
Table 3: Risk Factors and Comorbidities for Liver Cancer
Table 4: Liver Cancer, Key Features and Pipeline Activity of PIK3CA/PIK3CB/PIK3CG
Table 5: Liver Cancer Key Features and Pipeline Activity of PRCKD
Table 6: Liver Cancer, Key Features and Pipeline Activity of AKT1
Table 7: Liver Cancer, Key Features and Pipeline Activity of HER3
Table 8: Liver Cancer, Key Features and Pipeline Activity of ROR1
Table 9: Liver Cancer, Key Features and Pipeline Activity of PRKACA Fusions
Table 10: Liver Cancer, Key Features and Pipeline Activity of FZD2
Table 11: Liver Cancer, Key Features and Pipeline Activity of CDK1/2
Table 12: Liver Cancer, Key Features and Pipeline Activity of PTK2/FAK

List of Figures
Figure 1: Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987-2015
Figure 2: Sales Performance After Marketing Approval of First-in-Class and Non-First-in-Class Products, 2006-2013 ($m)
Figure 3: Liver Cancer, Marketed Product Overview, 2017
Figure 4: Liver Cancer, Pipeline Products by Therapy Area, 2017
Figure 5: Liver Cancer, Developmental Pipeline Overview, 2017
Figure 6: Liver Cancer, Developmental Pipeline Overview, 2017
Figure 7: Liver Cancer, Molecular Target Category Comparison, Pipeline and Marketed Products, 2017
Figure 8: Liver Cancer Drug Market, Global, Percentage Distribution of First-in-Class Products in Pipeline by Stage of Development (%), 2017
Figure 9: Liver Cancer Drug Market, Global, Distribution of First-in-Class Products in Pipeline by Molecular Target (%), 2017
Figure 10: Liver Cancer, Products in the Pipeline (Part 1), 2017
Figure 11: Liver Cancer, Products in the Pipeline Part 2, 2017
Figure 12: Liver Cancer, Products in the Pipeline Part 3, 2017
Figure 13: Liver Cancer, Products in the Pipeline Part 4, 2017
Figure 14: Liver Cancer, Products in the Pipeline Part 5, 2017
Figure 15: Liver Cancer, Products in the Pipeline Part 6, 2017
Figure 16: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 1 2017
Figure 17: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 2 2017
Figure 18: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 3 2017
Figure 19: Liver Cancer, PIK3CA/PIK3CB/PIK3CG Targeting Products, 2017
Figure 20: Liver Cancer, PRKCD Targeting Products
Figure 21: Liver Cancer, AKT1 Targeting Products, 2017
Figure 22: Liver Cancer, HER3 Targeting Products, 2017
Figure 23: Liver Cancer, ROR1 Targeting Products, 2017
Figure 24: Liver Cancer, PRKACA Fusion Targeting Products, 2017
Figure 25: Liver Cancer, FZD2 Targeting Products, 2017
Figure 26: Liver Cancer, CDK1/2 Targeting Products, 2017
Figure 27: Liver Cancer, PTK2/FAK Targeting Products, 2017
Figure 28: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014
Figure 29: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014
Figure 30: Liver Cancer, Global, Licensing Deals by Region and Value, 2006-Q1 2017
Figure 31: Liver Cancer, Global, Licensing Deals by Stage and Value, 2006-Q1 2017
Figure 32: Liver Cancer, Licensing Deals by Molecular Type, 2006-Q1 2017
Figure 33: Liver Cancer, Licensing Deals by Molecular Target, 2006-Q1 2017
Figure 34: Liver Cancer, Licensing Deals with Disclosed Values, 2006-Q1 2017
Figure 35: Liver Cancer Drug Market, Global, Co-development Deals by Region, Value and Year, 2006-Q1 2017
Figure 36: Liver Cancer, Co-development Deals by Stage and Value, 2006-Q1 2017
Figure 37: Liver Cancer, Co-development Deals by Molecule Type, 2006-Q1 2017
Figure 38: Liver Cancer, Co-development Deals by Molecular Target, 2006-Q1 2017
Figure 39: Liver Cancer, Co-development Deals with Disclosed Values, 2006-Q1 2017
Figure 40: Liver Cancer Market, Global, Pipeline Programs in Active Development Involved in Previous Deals, 2017
Figure 41: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 1)
Figure 42: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 2)
Figure 43: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 3)
Figure 44: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 4)
Figure 45: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 5)

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