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

Publisher Name :
Date: 01-Jun-2017
No. of pages: 70

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.

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

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 High Unmet Need and a Limited Number of Marketed Options 4
2.2 Large, Diverse and Highly Innovative Pipeline 4
2.3 Active Deals Landscape Reflects the Dynamic Pipeline 4

3 The Case for Innovation 5
3.1 Growing Opportunities for Biologic Products 6
3.2 Diversification of Molecular Targets 6
3.3 Innovative First-in-Class Product Developments Remain Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9
4.1 Disease Overview 9
4.2 Symptoms 9
4.3 Diagnosis 10
4.3.1 Clinical Presentation 10
4.3.2 Alpha-Fetoprotein 10
4.3.3 Diagnostic Imaging and Scans 10
4.3.4 Screening 10
4.3.5 Biopsy 11
4.3.6 Staging, Classification and Prognosis 11
4.4 Epidemiology and Etiology 11
4.5 Pathophysiology 13
4.6 Risk Factors and Co-Morbidities 17
4.7 Treatment Options 17
4.8 Treatment Algorithm 18
4.9 Overview of Marketed Products for Liver Cancer 19
4.9.1 Innovative Products in the Liver Cancer Market 20
4.9.2 Unmet Needs 21

5 Assessment of Pipeline Product Innovation 22
5.1 Liver Cancer Pipeline by Molecule Type, Phase and Therapeutic Target 22
5.2 Comparative Distribution of Programs between the Liver Cancer Market and Pipeline by Therapeutic Target Family 26
5.3 First-in-Class Pipeline Programs 26

6 Signaling Network, Disease Causation and Innovation Alignment 34
6.1 The Complexity of Signaling Networks in Oncology 34
6.2 Signaling Pathways Disease-Causing Mutations and First-in-Class Molecular Target Integration 35
6.3 First-in-Class Target Matrix Assessment 35

7 First-in-Class Target Evaluation 38
7.1 Pipeline Programs Targeting PIK3CA, PIK3CB and PIK3CG 38
7.2 Pipeline Programs Targeting Protein Kinase C Delta 39
7.3 Pipeline Programs Targeting AKT1 40
7.4 Pipeline Programs Targeting HER3/ERBB3 42
7.5 Pipeline Programs Targeting ROR1 43
7.6 Pipeline Programs Targeting PRKACA fusions 44
7.7 Pipeline Programs Targeting Frizzled 2 44
7.8 Pipeline Programs Targeting CDK1 and 2 45
7.9 Pipeline Programs Targeting PTK2/FAK 46
7.10 Conclusion 47

8 Deals and Strategic Consolidations 48
8.1 Industry-Wide First-in-Class Deals 48
8.2 Liver Cancer Deals Landscape 49
8.3 Licensing Deals 50
8.3.1 Molecule Type 52
8.3.2 Molecular Target 52
8.4 Co-development Deals 55
8.4.1 Molecule Type 56
8.4.2 Molecular Target 56
8.5 First-in-Class Programs Not Involved in Licensing or Co-development Deals 58

9 Appendix 64
9.1 Abbreviations 64
9.2 References 65
9.3 Research Methodology 68
9.4 Secondary Research 69
9.4.1 Market Analysis 69
9.4.2 Pipeline Analysis 69
9.4.3 First-in-Class Matrix Assessment 69
9.4.4 First-in-Class Target Profiles 70
9.4.5 Licensing and Co-development Deals 70
9.5 Contact Us 70
9.6 Disclaimer 70

List of Tables

Table 1: Symptoms of Liver Cancer 10
Table 2: Tumor, Regional Lymph Node and Metastasis Staging 11
Table 3: Risk Factors and Comorbidities for Liver Cancer 17
Table 4: Liver Cancer, Key Features and Pipeline Activity of PIK3CA/PIK3CB/PIK3CG 39
Table 5: Liver Cancer Key Features and Pipeline Activity of PRCKD 40
Table 6: Liver Cancer, Key Features and Pipeline Activity of AKT1 42
Table 7: Liver Cancer, Key Features and Pipeline Activity of HER3 43
Table 8: Liver Cancer, Key Features and Pipeline Activity of ROR1 43
Table 9: Liver Cancer, Key Features and Pipeline Activity of PRKACA Fusions 44
Table 10: Liver Cancer, Key Features and Pipeline Activity of FZD2 45
Table 11: Liver Cancer, Key Features and Pipeline Activity of CDK1/2 46
Table 12: Liver Cancer, Key Features and Pipeline Activity of PTK2/FAK 47

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 6
Figure 2: Sales Performance After Marketing Approval of First-in-Class and Non-First-in-Class Products, 2006-2013 ($m) 7
Figure 3: Liver Cancer, Marketed Product Overview, 2017 19
Figure 4: Liver Cancer, Pipeline Products by Therapy Area, 2017 22
Figure 5: Liver Cancer, Developmental Pipeline Overview, 2017 23
Figure 6: Liver Cancer, Developmental Pipeline Overview, 2017 25
Figure 7: Liver Cancer, Molecular Target Category Comparison, Pipeline and Marketed Products, 2017 26
Figure 8: Liver Cancer Drug Market, Global, Percentage Distribution of First-in-Class Products in Pipeline by Stage of Development (%), 2017 27
Figure 9: Liver Cancer Drug Market, Global, Distribution of First-in-Class Products in Pipeline by Molecular Target (%), 2017 27
Figure 10: Liver Cancer, Products in the Pipeline (Part 1), 2017 28
Figure 11: Liver Cancer, Products in the Pipeline Part 2, 2017 29
Figure 12: Liver Cancer, Products in the Pipeline Part 3, 2017 30
Figure 13: Liver Cancer, Products in the Pipeline Part 4, 2017 31
Figure 14: Liver Cancer, Products in the Pipeline Part 5, 2017 32
Figure 15: Liver Cancer, Products in the Pipeline Part 6, 2017 33
Figure 16: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 1 2017 36
Figure 17: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 2 2017 37
Figure 18: Liver Cancer, First-in-Class Molecular Target Analysis Matrix, Part 3 2017 37
Figure 19: Liver Cancer, PIK3CA/PIK3CB/PIK3CG Targeting Products, 2017 39
Figure 20: Liver Cancer, PRKCD Targeting Products 40
Figure 21: Liver Cancer, AKT1 Targeting Products, 2017 41
Figure 22: Liver Cancer, HER3 Targeting Products, 2017 42
Figure 23: Liver Cancer, ROR1 Targeting Products, 2017 43
Figure 24: Liver Cancer, PRKACA Fusion Targeting Products, 2017 44
Figure 25: Liver Cancer, FZD2 Targeting Products, 2017 45
Figure 26: Liver Cancer, CDK1/2 Targeting Products, 2017 46
Figure 27: Liver Cancer, PTK2/FAK Targeting Products, 2017 47
Figure 28: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 48
Figure 29: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014 49
Figure 30: Liver Cancer, Global, Licensing Deals by Region and Value, 2006-Q1 2017 51
Figure 31: Liver Cancer, Global, Licensing Deals by Stage and Value, 2006-Q1 2017 52
Figure 32: Liver Cancer, Licensing Deals by Molecular Type, 2006-Q1 2017 52
Figure 33: Liver Cancer, Licensing Deals by Molecular Target, 2006-Q1 2017 53
Figure 34: Liver Cancer, Licensing Deals with Disclosed Values, 2006-Q1 2017 54
Figure 35: Liver Cancer Drug Market, Global, Co-development Deals by Region, Value and Year, 2006-Q1 2017 55
Figure 36: Liver Cancer, Co-development Deals by Stage and Value, 2006-Q1 2017 56
Figure 37: Liver Cancer, Co-development Deals by Molecule Type, 2006-Q1 2017 56
Figure 38: Liver Cancer, Co-development Deals by Molecular Target, 2006-Q1 2017 57
Figure 39: Liver Cancer, Co-development Deals with Disclosed Values, 2006-Q1 2017 57
Figure 40: Liver Cancer Market, Global, Pipeline Programs in Active Development Involved in Previous Deals, 2017 58
Figure 41: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 1) 59
Figure 42: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 2) 60
Figure 43: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 3) 61
Figure 44: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 4) 62
Figure 45: Liver Cancer Market, Global, Pipeline Programs in Active Development Without Recorded Prior Deal Involvement, 2016 (Part 5) 63

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