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Cytotoxics remain standard bearers Despite their side effects, the high unmet needs in cancer and the lack of treatment alternatives means that the cytotoxic drugs used in chemotherapy regimens have remained the cornerstone of cancer treatment for decades. While the emergence of new technologies has led to more molecular-targeted drugs becoming available, they will still be used in conjunction with cytotoxics in most cases.
The differentiation between malignant and normal cells is becoming increasingly apparent and as a result, a plethora of potential drug targets is presented, in the form of altered genes, proteins or corrupted pathways. The increased selectivity conferred by these unique targets offers developers the opportunity to produce more efficacious and less toxic cancer treatments. As a result, the cancer treatment paradigm may eventually shift away from the traditional cytotoxic therapies towards these innovative agents, conferring a significant threat to the current market in the long term. However it is likely that for the foreseeable future, molecular-targeted agents will be used in combination with cytotoxic drugs.
Cancer has been the focus of intense and ongoing R&D for a number of years. As of May 2005, there were 399 compounds in development for cancer. By comparison, there are 220 compounds in development for central nervous system therapy, the next most 'active' disease area. However despite the significant interest, this has yet to translate into consistently successful management of the disease, particularly in the more advanced stages.
Most primary tumors can be successfully treated if diagnosed in the early stages, however, the genetic instability associated with cancer confers a high risk of disease resistance and/or subsequent recurrence. Once a tumor has metastasized to secondary locations, the chances of curative treatment drop significantly.
Saturated market
Because cytotoxic therapies have remained at the core of cancer treatment for many years, the market has become somewhat saturated, with products launched decades ago occasionally still in use - also an indicator of high levels of generic competition. As a result, the cytotoxics market is highly competitive, presenting high barriers to entry for any novel pipeline agent unless significant clinical superiority is demonstrated. It is likely that any further breakthroughs within this market will be incremental, with physicians continuing to prescribe those well-established agents whose long-term side effects are known.
There is currently a plethora of cytotoxic drugs on the market-some dominate the market, whereas others are highly genericized and contribute little to the market in terms of sales. The current market size for cytotoxics is estimated to be $9.6 billion in the US, Japan, France, Germany, Italy, Spain and the UK.
Of the seven major markets in 2004, the US represents the largest single market for cytotoxics, accounting for 55% of the total, equating to $5.2 billion. It overshadows that of the five major EU markets combined, holding just 29% market share ($2.8 billion), followed by Japan with 16% of the total market, or $1.6 billion in sales.
There are five main cytotoxic classes covered by the Anatomical, Therapeutic, Chemical (ATC) classification. Of these, the antimetabolite (L1B), the vinca alkaloid and other plant-derived drugs (L1C) and the platinum (L1X2) classes combined make up more than four-fifths of the total cytotoxic market.
Patent expiries take their toll
Datamonitor forecasts the cytotoxic market size to grow to a peak of nearly $13 billion by 2010, mainly driven by the growth of Eli Lilly's Gemzar, and Sanofi-Aventis' Taxotere and Eloxatin. Currently, these drugs alone account for 34% of total cytotoxic sales but this is expected to increase to 37% by 2010 when the sales reach their peak. However, patent expiries will have a negative effect, not only on the sales of these drugs but also on the cytotoxic market as a whole. Patent expiries are expected to occur between 2009 and 2010 for Gemzar, 2010 for Taxotere and 2013 for Eloxatin.
As a result, Datamonitor expects sales of Taxotere, Eloxatin and Gemzar to drop 21%, 7% and 18% annually between 2010 and 2014 respectively, and market share for these drugs will decline from 37% of the total market in 2010 to 23% in 2014. As a whole, the cytotoxic market size will decline by 12% during this period, equating to a 3% decrease annually.
In order to minimize the damaging effects of patent expiries and maximize the commercial potential, it is imperative that pharmaceutical companies investigate cytotoxic drugs in combination with molecular-targeted agents.
Tightening purse strings
The uptake of new drugs is also set to be increasingly influenced by pharmacoeconomic constraints, particularly in financially conservative national health systems. This has recently been demonstrated in the UK and Germany, where respectively the Pharmaceutical Price Regulation Scheme (PPRS) and reference pricing schemes have resulted in increased discounting of brand name drugs. Even in the US, where pricing policies have traditionally been less restrictive, the economic difficulties resulting from escalating healthcare costs and the recent Medicare Modernization Act may lead to greater pricing regulation.
As a result, it is likely that governments will analyze the clinical benefits associated with cancer therapies in relation to cost pressure with increasing frequency. In those situations where these parameters are incongruent, it is likely that reimbursement will prove challenging.
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