Caduet

WASHINGTON -- The U.S. wholesale prescription market rose a solid 11.5 percent to $216.4 billion last year, driven in large part by generic and biotech sales, IMS Health reported. That figure represents more than $2-of-every-$5 spent in the $500 billion global pharmaceutical market and underscores the essential role Americans play in supporting drug development.

"As we predicted, 2003 pharmaceutical growth [in the U.S.] remains constant in comparison with 2002," said Paul Wilson, vice president of IMS Statistical Services. "This solid performance demonstrates the strength of the pharmaceutical industry given the economic climate this year and the scrutiny the industry has undergone by the government, the news media and the general public.

The U.S. pharmaceutical growth rate should hold up at a "solid and steady rate of between 11 and 12 percent" in 2004, topping projected global growth rates of 8 percent to 11 percent over the next four years, IMS predicted. New product innovation, population demographics, the FDA acceleration of new product approvals and an attractive list of potential blockbusters will help to drive this growth," the firm reported.

U.S. sales of generics and biotech drugs led the charge, growing by 22 percent each in 2003, according to the health research company. "Generics reached new highs in both dollars and prescriptions, in 2003, explained Doug Long, vice president of industry relations for IMS. Conversely, branded drugs accounted for 51 percent of prescription dispensed in 1999 and slipped to 47 percent in 2003, according to the latest data.

In a recent presentation, Long also noted the continuing, surge in biotech-derived medicines. It's a great time to be in biologics ... [and] you're going to see more," he said.

Long said biotechnology is behind 24 percent of the drugs currently under development in the new drug pipeline, and represents 11 percent of all pharmaceutical dollars spent.

Branded manufacturers, meanwhile, "faced continued challenges in 2002 and 2003 with some blockbusters, such as Prilosec, coming off patent and the subsequent strong gains made by their generic counterparts," said Long.

Cholesterol reducers were the bright spot in the branded arena. Pfizer's Lipitor, which posted sales of $6.8 billion and 10.8 percent growth over 2002, was the top selling prescription drug for the third year in a row. Merck's Zocor, another cholesterol reducer, with $4.4 billion was the second best seller. AstraZeneca's Prilosec didn't make the top 10 list this year after holding the No. 4 spot in 2002, noted IMS figures, due to the generic launch of omeprazole in 2002.

It's a more difficult, defensive time to be in the brand business.

This marketplace is not as strong as it was before the economy stalled and before managed care," Long noted.

Research and development hit $32 billion in 2002 with the cost to develop a new drug landing at $802 million. The pressure is on manufacturers to get these drugs to the finish line because they have invested so much R&D, plus not everybody is a blockbuster like Lipitor," said Long.

Looking ahead, Long sees an improved pipeline in the first quarter of 2004. Some of the promising innovations are Forest's Namenda for Alzheimer's and Genentech's Avastin indicated for colorectal cancer.

"It will also be interesting to see whether several new combination products have successful launches, including Pfizer's Caduet to treat hypertension and high cholesterol Eli Lilly's Symbyax to treat bipolar depression and Merck/Schering-Plough's Zocor/Zetia combination to treat high cholesterol," added Wilson.

IMS forecasts about 30 new chemical/molecular entities launching in the United States during 2004, with a dozen having the potential to reach blockbuster status. That compares with just three potential blockbusters launched here last year, including Crestor, Humira and Raptiva.

"Sales increases from these 2004 launches may, however, be offset by continuing generic penetration," noted Wilson. "2004 results will hinge on innovation, new products, the introduction of Medicare discount cards and trends in cost containment."

Nevertheless, Wilson added, "It looks to be another strong and exciting year for pharma."

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