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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The market potential for high-potency active ingredients will be influenced by growth patterns in the cytotoxic drug market. Strong growth is projected for cytotoxics through 2009, but the market then will see generic drug erosion, according to Sarah Terry Johnston, vice-president, healthcare, Datamonitor PLC.
Newark, NJ (Sept. 14)-The market potential for high-potency active ingredients will be affected by growth patterns in the cytotoxic drug market. Strong growth is projected for cytotoxics through 2009, but the market then will see generic drug erosion, according to Sarah Terry Johnston, vice-president of healthcare at Datamonitor PLC (London, UK, www.datamonitor.com). Johnston spoke at “High-Potency Active Ingredients: Realizing the Opportunities,” organized by the Drug, Chemical, and Associated Technologies Association (Robbinsville, NJ, www.dcat.org) in conjunction with Pharmaceutical Technology.
The value of the cytotoxic drug market in the seven major pharmaceutical markets (Spain, France, Germany, Italy, Japan, the United Kingdom, and the United States) is $9.6 billion, according to Datamonitor, with roughly $8 billion of the total $9.6 billion generated by 15 products. The United States represents the largest single market for cytotoxic drugs, accounting for more than half of total sales, she reported. Cytotoxics dominate the anticancer therapy market, representing roughly 40% of the anticancer market (based on sales of the top 32 anticancer therapeutics), followed by targeted therapies at 36%, and antihormonal therapies at 24%.
Generic drug penetration in cytotoxics market
The cytotoxic drug market will, like other drug categories, see increasing penetration of generic drugs. Cytotoxics sales are expected to reach a peak of $12.8 billion by 2009, but then shrink to $11.3 billion by 2014 because of major patent expiries, outlined Johnston. In turn, the generic drug market for anticancer therapies is expected to grow substantially at a compound annual growth rate of 23.5%, from $1.3 billion in 2004 to $10.9 billion by 2014. The generic drug market is defined to include cytotoxics, antihormonal therapies, immunostimulating agents, targeted therapies, and supportive care products (growth factors). Despite this competition, however, cytotoxics will remain the mainstay of cancer therapy, being used in combination with other drug classes.
Three anticancer drugs in particular will contribute to the generic cytotoxic drug market. Sanofi-Aventis's (Paris, France, www.en.sanofi-aventis.com) “Taxotere” (docetaxel), Eli Lilly and Company's (Indianapolis, IN, www.lilly.com) “Gemzar” (gemcitabine), and Schering-Plough Corporation's (Kenilworth, NJ, www.schering-plough.com) “Temodar” (temozolomide) will experience more than a 50% decline in sales between 2010 and 2014 from the loss of patent protection, at an average loss of $667 million, Johnston said.
In the cytotoxic anticancer market, only Eli Lilly's “Alimta” (pemetrexed) and Abraxane Bioscience, Inc.'s “Abraxis” (paclitaxel protein-bound particles for injectable suspension, albumin-bound) are expected to achieve positive growth during the latter half of the forecast period of 2010–2014, but achieving only average or $61 million in growth.
Key APIs in cytotoxic drug market
Johnston also highlighted three up-and-coming cytotoxic drugs. They include “Javlor” (vinflunine) developed by Pierre-Fabre Medicament SA (Paris, France, www.pierre-fabre.com), which will also be marketed by Bristol-Myers Squibb Company (BMS, New York, NY, www.bms.com), GPC Biotech's (Munich, Germany, www.gpc-biotech.com) satraplatin, and BMS's ixabepilone, all expected to launch in 2006 or later. Johnston sees modest growth for these products to 2014, with Javlor experiencing the “swiftest uptake,” she says.
Despite increased generic penetration and the advent of molecular targeted therapies, Johnston sees continual market potential for cytotoxic drugs: “For treatment of the 11 most-prevalent solid tumor types, cytotoxics still form 35% of the developmental pipeline, suggesting that they will continue to remain the cornerstone of treatment.”