Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that increasing use of U.S. regulatory-approved agents -- Pfizer's Lyrica (pregabalin), Eli Lilly/Boehringer Ingelheim's Cymbalta/Xeristar (duloxetine) and Forest Laboratories' Savella (milnacipran) -- will drive 4.2 percent annual growth in the fibromyalgia drug market from 2009 to 2018. However, owing to the generic entry of sales-leading pregabalin, the market will decline sharply from $1.8 billion in 2018 to only $1.4 billion in 2019 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
The Pharmacor 2010 findings from the topic entitled Fibromyalgia reveal that an expanding drug-treated population, resulting from increasing diagnosis rates, will fuel annual market growth over the next several years in the world's major pharmaceutical markets. While the United States will account for more than two-thirds of major-market fibromyalgia drug sales in 2019, market expansion in Europe and Japan will be constrained by a dearth of approved therapies, lower diagnosis rates and less widespread recognition of the disorder.
The findings also reveal that duloxetine is now in close competition with pregabalin for market-leading status in the United States.
"Although pregabalin was the U.S. patient- and market-share leader in 2009, patient share of duloxetine grew significantly last year," said Decision Resources Analyst Andrea Buurma. "Sales of duloxetine are not projected to surpass pregabalin sales during our forecast period, owing in large part to market entry of generic duloxetine in the United States in 2013; however, we do expect duloxetine to supplant pregabalin as the U.S. patient-share leader by 2015."
The Pharmacor 2010 findings also reveal that, in light of the recent recommendation by an FDA advisory committee against the approval of sodium oxybate (Jazz Pharmaceuticals/UCB's JZP-6) for fibromyalgia, Decision Resources forecasts that it is unlikely the FDA will approve this agent for the indication. However, if the FDA issues a complete response letter and Jazz Pharmaceuticals is ultimately able to address the concerns voiced by the panel -- such as additional safety and efficacy data and a stricter Risk Evaluation and Mitigation Strategy -- sodium oxybate could have the potential to launch as a fibromyalgia therapy by late 2013.
About Pharmacor 2010
The newly redesigned Pharmacor advisory service offers clients in the biopharmaceutical industry the most up-to-date information available on commercially significant disease topics.
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