Summary
Large and Diverse Pipeline
The liver cancer pipeline contains 238 products in active development, approximately 47% of which are first-in-class. The percentage of the pipeline devoted to innovative products is considerably larger than both the industry and oncology average, which is a promising sign for novel therapeutics reaching the liver cancer market.
The contrast between the market and pipeline is vast. Analysis showed that the market contains 70 products, the majority of which are generic formulations of chemotherapies that are not frequently used in treatment, particularly in advanced-stage patients. Nexavar (sorafenib) is the dominant therapeutic on the market, and is also the only targeted therapy that is in regular use for advanced-stage liver cancer patients. However, pipeline analysis revealed that targeted therapies aimed at the underlying oncogenic signaling pathways are under much greater focus in the pipeline than in the market. The success of targeted therapies across the oncology market as a whole implies that the diversity and innovation in the pipeline is a promising sign, with products currently in development having the potential to transform and improve the relatively open liver cancer market.
Alignment of First-in-Class Molecular Targets with Disease Causation
The liver cancer pipeline is showing signs of adapting to the increasing understanding of aberrant signaling pathways and causes of liver cancer. A large portion of pipeline products target components of known dysfunctional signaling pathways, such as Wnt/catenin signaling, which is commonly mutated in liver cancer tumor samples. By aligning the treatment with specific disease-causing features, the damaging off-target cytotoxic effects of treatment can be reduced, resulting in safer and more efficacious therapies.
GBI Researchs analysis identified substantial variation in the alignment of first-in-class products to underlying dysfunctional signaling at protein and genetic level. The first-in-class products were compared in an in-depth analysis using various parameters to measure the potential of each target, with the most promising targets being further substantiated by published clinical and scientific evidence. Results of the analysis suggested that first-in-class status is not a feature that, in its own right, will create a successful product. However, there are a large number of first-in-class products backed by clinical and Preclinical data that are exciting future prospects for the liver cancer market.
Analysis of Patent Data
The report features an analysis of granted patent applications in the liver cancer market, which was used as an indication of innovation at the earliest stage of product development. Patent analysis provides an insight into the pre-developmental landscape, and identifies long-term future trends within a disease market. In liver cancer, the trend in patent applications in terms of predominant molecular targets reflects the pipeline landscape, suggesting that liver cancer therapeutics will continue to target key oncogenic signaling pathways in the long term.
The frequency at which companies apply for patents within the market helps to identify companies that are trying to establish themselves or increase their liver cancer market share. This information identifies not only potential competitors, but also companies that may seek strategic partnerships to enter drug development.
First-in-Class Products in Licensing and Co-Development Deals
The deals landscape for liver cancer has been relatively active in recent years, with 62 licensing deals and 23 co-development deals between 2006 and 2014. However, the number pertaining to first-in-class products is very low.
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