February 3rd 2012
£1460 / $2265 / €1740
The end of 2011 saw the US approval of two new molecularly-targeted cancer drugs, alongside companion diagnostic tests that identify the patients most likely to benefit from treatment. Pfizer's Xalkori (crizotinib) and Roche's Zelboraf (vemurafenib) were both approved following a priority review, highlighting the importance that the FDA has placed on hastening the passage of these therapies to market. These approvals reflect the trend of treating cancers based on their molecular and genetic characteristics, rather than their location within the body.
Such developments have long been heralded as marking the future of cancer therapies and the benefits to patients, clinicians and health payers is clear – but are these approvals the benchmark for future developments?
With sales of many blockbuster drugs being cannibalised by generic competitors, pharmaceutical and biotechnology companies are populating their pipelines with candidates directed at novel targets, enhancing development and commercialisation potential. The opportunities for small and medium-sized companies is increasing as the dynamic of the market changes.
Packed with statistics, timelines and sector share comparisons, this report examines the current market for targeted cancer drugs, and provides an overview of both products and players into 2018. Looking ahead, the report identifies 79 new candidates that are currently under a minimum of Phase II development for solid tumours and provides a timeline detailing estimated launch dates to 2018. There is a review of the molecular targets on which industry attention is focused, and the companies involved in the development and commercialisation of the products directed against these targets. Finally, each product is considered individually in terms of its mode of action, current developmental status, clinical data, risks associated with development, developer and potential competition within the marketplace.
Current therapeutic approaches for targeted agents will dominate...
With the success of products directed against established targets, such as ErbB (HER) and VEGF, the search continues for new and improved agents within these groups. For example, Roche is capitalising on the success of its HER2 inhibitor, Herceptin (trastuzumab), with the development of an antibody-drug conjugate, trastuzumab emtansine, which consists of the monoclonal antibody, trastuzumab, linked to the antimicrotubule agent, DM1. Pfizer has developed a multi-kinase inhibitor, dacomitinib, that targets HER1, 2 and 4, and has shown superiority to Roche's Tarceva (erlotinib) in extending progression-free survival in advanced non-small cell lung cancer patients. In addition, a variety of smallmolecule kinase inhibitors that target multiple components of the VEGF pathway and/or other angiogenic pathways are progressing through clinical trials.
...but will candidates directed at novel targets gain ground?
By 2018, Espicom expects that these new developmental candidates will account for 50% of targeted agents on the market by number. Among the pathways - and the products being developed - examined in the report are:
How will the competitive landscape be affected?
A number of the larger players will continue to dominate the marketplace into 2018 with Roche, Takeda, Eli Lilly and BMS all estimated to have achieved five or more launches. However, significant opportunities exist for many smaller innovative pharma companies and biotechs, which by their very nature are proficient and well-suited to product development in niche markets.
Questions answered by the report
About the Author: This report has been written by Sue Viney, a senior writer on Espicom’s oncology analysis team. Sue has been evaluating companies, products and drugs in research for 12 years.