Liver cancer is the sixth most common cancer in the world, according to the World Cancer Research Fund International. In 2012, around 782,000 new cases of liver cancer were diagnosed globally. Hepatocellular carcinoma (HCC) is cancer that starts in the liver and according to the U.S. National Cancer Institute there will be 35,660 new cases of HCC diagnosed and 24,550 HCC-caused deaths in the U.S. in 2015.

Research, studies, and reports on liver cancer therapeutics show that the incidence of liver cancer is higher in men than in women and is commonly seen in people over the age of 50. The five-year survival rate for patients battling liver cancer or HCC has been 10% to 15% for many decades and the prospects for better treatment options are rather slim. Presently, the treatment methods for liver cancer at different stages include liver transplantation, surgical resection, transcatheter arterial chemoembolization, radiofrequency ablation, selective internal radiation therapy, and portal vein embolization.

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As far as drug therapies are concerned, the gap between the liver cancer market and the pipeline is widening and of the 70 therapeutic products available in the market today, most are mere generic formulations of chemotherapies. Sorafenib (or Nexavar as marketed by Bayer and Onyx Pharmaceuticals) is the leading therapeutic product available in the liver cancer market and is most frequently used for patients with advanced-stage cancer. Sorafenib is a tyrosine kinase inhibitor drug approved by the in the U.S. in 2005 and in Europe in 2006 for the treatment of advanced primary liver cancer or HCC. Sorafenib is proven to add two to three months to the lifespan of a patient with late-stage HCC and a 31% relative reduction in the risk of death.

It is drugs like this that bring a certain level of hope for patients around the world and for manufacturers to push themselves to develop novel treatment methods.
The scenario of clinical trials for the treatment of liver cancer or HCC is divided. There are about 80 agents in the HCC drug pipeline, most of which are in the early phases of development and some have even reached phase III clinical trials. However, studies show that setbacks in later-stage compounds in recent years threaten to inhibit the growth of the liver cancer market.

In 2010, Pfizer stopped its phase III study of sunitinib (marketed by the company as Sutent) in advanced-stage HCC because the drug failed to demonstrate its superiority over sorafenib. In 2011, it was reported that brivanib, an HCC candidate of Bristol-Myers Squibb, failed to increase the overall survival rate of the patient in a phase III trial when compared to placebo.

Nevertheless,MRRSE identifies what could be a promising sign for new and innovative therapeutics in the liver cancer market. The liver cancer pipeline currently
comprises 238 products in active development, with about 47% falling in the first-in-class drug category. This shows that the proportion of pipeline dedicated to novel and innovative products is much greater than the oncology as well as industry average. This only goes to reflect the growing potential and capacity of the liver cancer market landscape.

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Executive Summary
2.1 Unmet Needs and Limited Market Drive an Innovative Pipeline
2.2 Targeted Therapies Segment to Expand over the Coming Decade
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 MRRSE Research Report Guidance

4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Symptoms
4.3 Epidemiology and Etiology
4.4 Pathophysiology
4.4.1 Hepatocellular Carcinoma
4.4.2 Cholangiocarcinoma
4.4.3 Conclusion
4.5 Diagnosis
4.5.1 Clinical Presentation
4.5.2 Alpha-Fetoprotein
4.5.3 Diagnostic Imaging and Scans
4.5.4 Screening
4.5.5 Biopsy
4.5.6 Classification
4.6 Treatment Options
4.7 Treatment Algorithm
4.7.1 First Line
4.8 Overview of Marketed Products for Liver Cancer
4.8.1 Molecular Type and Target Analysis
4.8.2 Innovative Products in the Liver Cancer Market
4.8.3 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 Targeting Novel Molecular Targets

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6 Liver Cancer Patent Family Analysis

7 Signaling Network, Disease Causation and Innovation Alignment
7.1 The Complexity of Signaling Networks in Oncology
7.2 Signaling Pathways Disease-Causing Mutations and First-in-Class Molecular Target Integration
7.3 First-in-Class Target Matrix Assessment

8 First-in-Class Target Evaluation
8.1 Pipeline Programs Targeting ß-Catenin
8.2 Pipeline Programs Targeting FGFR4
8.3 Pipeline Programs Targeting GPR55
8.4 Pipeline Programs Targeting Protein Disulfide Isomerase
8.5 Pipeline Programs Targeting Telomerase
8.6 Pipeline Programs Targeting Delta-Like 1 Homolog
8.7 Pipeline Programs Targeting eIF5A
8.8 Pipeline Programs Targeting FAK
8.9 Pipeline Programs Targeting TGFß Receptor
8.10 Conclusion

9 Deals and Strategic Consolidations
9.1 Industry-wide First-in-Class Deals
9.2 Liver Cancer Deals Landscape
9.3 Licensing Deals
9.3.1 Molecule Types
9.3.2 Mechanism of Action
9.4 Co-Development Deal

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