November 5th 2009
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The prostate cancer market is on the verge of considerable change with the imminent arrival of new targeted therapies that will prolong patient survival.
Prostate cancer (PCA) is the second leading cause of new cancer cases in men worldwide and the sixth leading cause of cancer death in men. In the US, over two million men currently suffer with PCA and it is estimated that there were 192,311 new cases and 29,698 deaths due to the disease in 2008. There have been dramatic improvements in PCA survival over the last 25 years, mainly due to a combination of earlier diagnosis and improvements in treatments, although rates vary between countries.
The PCA market was estimated to be worth US$5.2 billion in 2008; it is one of the larger segments of the oncology market, alongside breast, non-small cell lung and colorectal cancers. The market is currently driven by the use of hormonal therapies, which are prescribed mainly for advanced hormone-dependent PCA, and include AstraZeneca’s Zoladex (goserelin) and Casodex (bicalutamide), Abbott/Takeda’s Lupron/Lupron Depot (leuprolide subcutaneous injection or intramuscular depot) and sanofi-aventis/Astellas Pharma’s Eligard (leuprolide subcutaneous depot). In addition, sanofi-aventis’ Taxotere (docetaxel) has become the standard treatment for hormone-refractory prostate cancer (HRPCA).
However, the market dynamics will change considerably over the next six years as patents expire and generic competition intensifies. Research into new therapies is extremely active and new agents with novel modes of action are being evaluated in clinical trials, including Dendreon’s Provenge, which is likely to be the first therapeutic cancer vaccine to market, and Bristol-Myers Squibb’s fully-human monoclonal antibody, ipilimumab. Other companies are extending existing products’ indications into PCA, with Roche’s angiogenesis inhibitor, Avastin (bevacizumab), and GlaxoSmithKline’s preventative treatment, Avodart (dutasteride), as the most notable examples.
Espicom estimates that sales of prostate cancer treatments will increase to over US$7.7 billion by 2015, with a compound annual growth rate of 5.9%
There is currently a huge interest in developing new treatments for PCA, with 96 drugs estimated to be in clinical development. The majority of these are the new targeted therapies, including small-molecule tyrosine kinase inhibitors, monoclonal antibodies and therapeutic vaccine candidates. In addition to the development of novel products, some companies are seeking to optimise the life-cycle of drugs already approved in other indications such as Roche’s Avastin (bevacizumab), Pfizer’s Sutent (sunitinib) and Novartis’ Glivec/Gleevec (imatinib).
Hormone-refractory prostate cancer (HRPCA) – a focus of attention
Market opportunities are largest for novel treatment strategies that prolong survival. Many of the new targeted approaches are focused on the treatment of hormone-refractory PCA (HRPCA), an area where, up until the recent approval of Taxotere, there were very few options for patients. Whereas previous research has focused mainly on the hormone-dependency of PCA, the rationale for new drugs coming through research is based on the increasing knowledge of the molecular abnormalities underlying PCA.
The arrival of innovative targeted therapies will not make traditional hormonal or chemotherapies redundant. Rather, targeted therapies will be used in combination with traditional therapies and each other. The limits to combinations will likely be cost, as the novel therapies can be expected to be comparable to recently-launched novel therapies in other cancers, for example Avastin at over US$50,000 per annum.
Shape of the industry in 2008...
The PCA market is currently dominated by a handful of pharmaceutical companies, the most significant of which is AstraZeneca. In 2008, AstraZeneca had a 41% share of the PCA market through the marketing of the LHRH analogue, Zoladex, and the anti-androgen, Casodex. AstraZeneca’s leadership position has been untouchable for many years and is primarily due to the combined androgen blockade therapeutic approach in PCA and expanded licenses for both advanced and locally-advanced PCA in some markets.
...and in 2015
With the advent of the new targeted therapies, the PCA market will change considerably by 2015. In 2008, most drug treatment occurred in the advanced hormone-responsive PCA market segment. By 2015, we expect the balance to shift to the HRPCA segment of the PCA market as more effective products are introduced and combined to address the unmet clinical need for patients in this sector. In addition, there will be significant opportunities to expand within the early PCA market. In addition to HRCPA treatments, Dendreon’s novel therapeutic cancer vaccine, Provenge, should achieve blockbuster sales and ensure a substantial market share for the company.
About the Author
This report has been researched and written by senior Espicom pharmaceutical analyst, Sue Viney. For over 10 years she has played a pivotal role in tracking trends in drug development and corporate performance. In addition to this report she has produced detailed product analysis in the CNS, Breast/Lung Cancer and Rheumatoid Arthritis sectors.