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Charting API Market Growth and Opportunity
Product positioning for the top spots
Two biologics—Amgen's (Thousand Oaks, CA) and Wyeth's (Madison, NJ) "Enbrel" (etanercept) and Amgen's "Aranesp" (darbepoetin alfa)—kept their billing among the top 10. Moving up from ninth in 2006, Enbrel took the fifth spot with 2007 global sales of $5.3 billion. Aranesp dropped from sixth in 2006 to tenth in 2007 on sales of $4.4 billion, down 12.9% from 2007.
Last year saw two newcomers to the global top 10. With a sales gain of 16.2% to $4.6 billion, AstraZeneca's "Seroquel" (quetiapine) ranked eighth in 2007. Merck & Co.'s (Whitehouse Station, NJ) "Singulair" (montelukast sodium) closely followed with sales of $4.5 billion, up 14.7% from 2006, and enough for the ninth position.
Facing potential generic competition and dropping out of the top 10 in 2007 from 2006 were Pfizer's "Norvasc" (amlodipine) and Wyeth's (Madison, NJ) "Effexor" (venlafaxine).
The rise of biotech drugs
Global sales of prescription biotechnology drugs increased 12.5% to more than $75 billion in 2007, according to IMS Health. This rate of growth was nearly double the rate of growth of 6.4% for the overall global pharmaceutical market, but down from the 18.2% growth for biotech products experienced in 2006. The biotech drug market, however, represents only about 10% of the global pharmaceutical market, which was valued at $712 billion in 2007. The US remains the largest market for biotech products and holds 56% of the global market.
Twenty-two biotech products generated sales exceeding $1 billion in 2007, compared with just six products in 2002, according to IMS. Enbrel was the top biotech product in 2007, followed by Aranesp. J&J's and Schering-Plough's (Kenilworth, NJ) "Remicade" (infliximab ) was third with global sales of $4.2 billion, and Roche's (Basel, Switzerland) "Mabthera"/"Rituxan" (rituximab) was fourth with sales of $3.7 billion. Amgen's "Neulasta" (pegfilgrastim) ranked fifth with global sales of $3.5 billion.
IMS estimates biotech products represent 25% of the total pharmaceutical pipeline. The firm projects that six products with market potential of $1 billion are expected to be launched by 2009.
As innovator companies struggle, opportunities for generic-drug companies are fairly strong. Over 150 products, including 20 blockbusters, with $77 billion in total branded drug sales in the US, are coming off patent through 2012, according to data from the scientific business of Thomson Reuters. Some major new generic launches in 2007 included: ceterizine hydrogen chloride (HCl), carvediol, pantoprazole sodium, zolpidem tartrate, risedronate sodium, and valacyclovir HCl. In 2008, 25 products will lose patent protection in the US. Some anticipated generic launches of 2008 include memantine HCl, topiramate, risperidone, levetiracetam, ropinirole HCl, alfuzolin HCl, eplerenone, and rocuronium bromide. For 2009, there are 29 molecules with new chemical entity exclusivity expiring and therefore exposed to Paragraph IV patent challenge in 2008. Some possible patent challenges in 2008 are for duloxetine HCL, pregabalin, and tiotropium bromide (1).
Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072, email@example.com
1. P. Van Arnum, "Rocky Outlook for Pharmaceuticals," Pharm. Technol. Sourcing and Management 4 (4), 2008.