A new report indicates U.S. prescription drug sales increased by only 3.8 percent in 2007, down from an 8 percent increase the year before.
The annual U.S. Pharmaceutical Market Performance Review, released by IMS Health, a provider of market intelligence to the pharmaceutical and healthcare industries, reports that total U.S. prescription sales reached $286.5 billion in 2007, with total U.S. dispensed prescription volume growth at a 2.8 percent pace, compared with 4.6 percent in 2006.
The report found that antidepressants ranked as the leading therapy class by dispensed prescription volume in 2007. The top five therapeutic categories labeled by the report as continuing to lead the market in terms of prescription use were antidepressants, lipid regulators, codeine and combination pain medications, ace inhibitors and beta blockers.
Lipid regulators, with sales of $18.4 billion, continued to be the largest therapy class in the United States despite a 15.4 percent year-over-year sales decline. Ranking second were proton pump inhibitors, with sales of $14.1 billion and growth of 2.8 percent. Antipsychotics replaced antidepressants as the third-largest therapeutic class in 2007, with prescription sales growth of 12.1 percent to $13.1 billion.
"In 2007, the U.S. pharmaceutical market experienced its lowest growth rate since 1961," said Murray Aitken, IMS' senior vice president of Healthcare Insight. "The moderating growth trend that began in 2001 resumed last year following the one-time impact on market growth in 2006 from the implementation of Medicare Part D. Last year, we saw a continuing shift away from primary care classes to biotech and specialist-driven therapies, which grew at a 9 percent and 10 percent pace, respectively. Among the leading therapy classes, oncology drugs continued their rapid growth, at 14 percent - the result of innovative new medicines, expanded indications and accelerated uptake of products to fill unmet needs."
The report outlined the primary factors that contributed to the 2007 market slowdown:
• There was a loss of exclusivity in branded drugs, with sales representing only $17 billion in 2007, which helped to drive prescription volume growth of 10 percent for unbranded generics. In 2007, generics continued to replace branded prescriptions in the major therapeutic classes, increasing their share of total dispensed prescriptions to 67.3 percent.
• There was an uptake of new, innovative medicines representing just $441 million of total sales in 2007, reflecting both the fewest new product launches in the past three decades and slower adoption by physicians of these products.
• There was a contribution from Medicare Part D, whereby prescriptions dispensed through the program accounted for 19 percent of retail prescriptions at the end of last year, a modest increase over 2006 and reflective of a maturing program. Today, 65 percent of U.S. citizens age 65 and older are enrolled in the Medicare Part D program.
• Safety issues effected sales growth in 2007 through a significant number of "black box" warnings and product withdrawals, as well as safety concerns raised by the FDA for products in the erythropoietins, diabetes and antidepressant therapy classes. Safety issues contributed to significantly lower-than-expected sales for products, accounting for approximately 10 percent of the total prescription market.
"The U.S. pharmaceutical market has entered a new era - one characterized by more modest growth due to the continuing impact of new generic products, fewer and more narrowly indicated novel medications and closer scrutiny of safety issues," said Aitken. "We will see additional lower-cost treatment options for many patients, while new and innovative therapies are delivered to specific patient groups, such as those suffering with cancer. Safety issues will be closely monitored and are likely to bring added caution to the market over the next several years."
The U.S. Pharmaceutical Market Outlook in 2008 predicts an introduction of new, novel biologics and vaccines, as well as the launch of five to eight new products with potential global blockbuster status, which it says will help to offset the impact of lower generics pricing. Also, an additional $13 billion in branded products are likely to be exposed to generics this year.
IMS forecasts compound annual pharmaceutical sales growth through 2012 of 3 percent to 6 percent. IMS says dynamics that will shape the market during the next five years include the continued loss of exclusivity in major therapy areas, new specialist-driven products, greater levels of therapeutic substitution and greater awareness and focus on safety issues.