US sales of prescription pharmaceuticals tallied $286.5 billion in 2007, according to IMS Health (see Table II). Eight of
the top 10 global products (Lipitor, Nexium, Seretide/Advair, Plavix, Seroquel, Singulair, Enbrel, and Aranesep) were also
ranked in the top 10 in US sales. Lipitor took top billing with US sales of $8.1 billion in 2007. Two drugs—Wyeth's "Prevacid"
(lansoprazole) and Amgen's "Epogen" (epoetin alfa) made the top 10 US list but not the top 10 global rankings.
Table II: Top products by 2007 US sales.
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.
The level of product innovation, as measured by the number of approvals of new molecule entities (NMEs) and new biologics
license applications (BLAs) by CDER, reached a recent low in 2007. In 2007, CDER approved 19 new drugs (17 NMEs and 2 BLAs)
(see Table III). These levels represent a slight decline from approvals in 2006 and 2007 and a steep decrease from 2004. CDER
approved 22 new drugs in 2006 (18 NMEs and 4 BLAs), 20 new drugs in 2005 (18 NMEs and 2 BLAs), and 36 new drugs (31 NMEs and
5 BLAs) in 2004, according to FDA data.
Table III: New molecular entities approvals, January 2007–May 2008.*
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, firstname.lastname@example.org
1. P. Van Arnum, "Rocky Outlook for Pharmaceuticals," Pharm. Technol. Sourcing and Management
4 (4), 2008.