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Targeted Therapies Set to Top Cancer Drug Sales
Posted on 2006-08-18 16:14:00
A fundamental change in the treatment of cancer is underway, with the cytotoxic drugs used in chemotherapy regimes set to lose their pre-eminence and be used alongside targeted therapies that- as their name suggests- are being developed with the aim of more specifically targeting cancer cells. Because of the more selective nature of targeted therapies, they are theoretically more efficacious and less toxic than cytotoxics, which target all cells, including healthy ones. An examination of the Top 20 selling cancer therapeutics in 2005 by drug class reveals that of the total sales of $20 billion, cytotoxics constituted the largest proportion at 45%, with targeted therapies and antihormonal therapies trailing at 30% and 25% respectively. But according to a new report by Datamonitor, sales of targeted therapies are expected to constitute 55% of the Top 20 cancer drug sales by 2015, with the shift towards the inclusion of targeted therapies into standard treatment regimes having already begun.
Generics take toll
Datamonitor examined the Top 20 selling cancer therapeutic drugs in the UK, US, French, German, Italian, Spanish and Japanese markets—37 drugs in all, due to variations on the list between individual countries. Sales of these drugs are expected to peak at $31 billion in 2010, before declining slightly to $27 billion by 2015. While sales of targeted therapies will continue to grow during this period, the sales of cytotoxics and antihormonal therapies will decline, mainly due to patent expiries and generic competition.
Targeted therapies are novel therapeutic agents that target unique molecular changes that distinguish tumor cells from normal cells, namely altered genes, proteins and corrupted molecular pathways. The enhanced selectivity in targeting tumor-specific molecular abnormalities provides the potential for the creation of treatments with enhanced efficacy and reduced toxicity. By comparison, cytotoxic therapies attack all the body’s normal and fast growing cells, which is the reason for the harsh and unpleasant side effects of chemotherapy.
However, while the manufacturers of targeted therapies attempt to implement line extension and horizontal expansion strategies into other tumor types to increase exposure of their products, cytotoxics still have a role to play. Sanofi-Aventis’s Eloxatin (oxaliplatin) and Taxotere (docetaxel) ranked as the second and third best-selling oncology products in 2005, says Datamonitor oncology analyst Fleur Pijpers. “Eloxatin is a key product in the colorectal cancer market, which has high patient potential in both the adjuvant and first-line settings. While Taxotere is a leading cytotoxic in the treatment of breast cancer, as well as being used regularly in non-small cell lung cancer (NSCLC), prostate cancer and gastric cancer.”
However, Pijpers says, both products are likely to be victims of their own success, with eventual generic competition upon patent expiry expected to be significant. “Seven market sales of Eloxatin are forecast to rise from just over $1.5 billion in 2005 to a peak of $2.3 billion in 2011, before dropping to just over $1 billion by 2015. Sales of Taxotere are forecast to rise from just under $1.5 billion in 2005 to $2.1 billion in 2010, before dropping to $989 million in 2015,” she says.
Three targeted therapies have already achieved blockbuster sales across the seven major pharmaceutical markets in 2005: Genentech/Roche’s Rituxan (rituximab) and Herceptin (trastuzumab), and Novartis’s Gleevec (imatinib). In fact, Rituxan is already the best selling cancer therapeutic across the seven major markets. Sales of these three products will continue to increase up to 2015, maintaining their blockbuster status and presence in the Top 20 cancer therapeutics. By 2015 several other targeted therapies are forecast to achieve blockbuster sales across the seven markets and to appear in the Top 20 cancer therapeutics: Genentech/Roche’s Avastin (bevacizumab), OSI/Genentech/Roche’s Tarceva (erlotinib), and GlaxoSmithKline’s Tykerb (lapatinib).
Datamonitor also expects a number of emerging targeted therapies to make a significant impact on the oncology market by 2015, Pijpers says. “Onyx Pharmaceuticals/Bayer’s Nexavar (sorafenib), Pfizer’s Sutent (sunitinib), Bristol-Myers Squibb’s Sprycel (dasatinib) and Amgen’s panitumumab (ABX-EGF) all show great potential for the future treatment of cancer.”
“Datamonitor believes that by 2015 all four will be ranked amongst Top 20 in cancer therapeutic drug sales,” she says.
Between the currently marketed targeted therapies and key pipeline agents, it is clear that the future of cancer treatment is likely to rely heavily on these products. While fragmentation of the oncology market is set to occur as patient differentiation becomes based on tumor growth drivers rather than primary tumor site, the use of targeted therapies will occur in combination with traditional cytotoxic chemotherapy.
Genentech/Roche’s Avastin is a prime example of how a novel drug, directed against a molecular target that is expressed in a range of tumor types, can realize successful launch and subsequent indication expansion. The drug became the first angiogenesis inhibitor to reach the market upon its US FDA approval in 2004 for the treatment of colorectal cancer. Since then, by virtue of the commonality of the vascular endothelial growth factor (VEGF) and its receptors across cancer, Genentech and Roche have undertaken a program of extensive indication expansion for Avastin, which is now in development for 25 tumor types, Pijpers says. “The drug has since been filed for marketing approval in NSCLC and breast cancer.”
“Despite criticism over Avastin’s cost and its low but concerning incidence of bleeding and thrombotic events, the drug has been a commercial success , generating seven market sales of $967million in 2005, and forecast to increase to $3.8 billion by 2015, at a compound annual growth rate (CAGR) of 14.6%.”
While targeted therapies are set to emerge as key products in the future treatment of cancer, some biologic products in this class face a threat from the emergence of legislation pertaining to the establishment of a regulatory pathway for the approval of biosimilar products. “This will mainly affect the monoclonal antibodies, whose success to date will ensure that biosimilar versions of originator products will be launched onto the market,” Pijpers says.
“However, while the EU has agreed guidelines for the approval of biosimilars, to date, these have only included relatively simple biologics. Guidelines for the more complex monoclonal antibodies are not expected to be in place until at least 2010, with the US market lagging even further behind.”
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