Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that although Sanofi-Aventis's eplivanserin and Actelion's ACT- 078573 will be market leaders by 2016, the insomnia market is not likely to sustain multiple "me-too" drugs that lack definable safety or efficacy advantages.
The new Pharmacor report Insomnia finds that the 5-HT2 antagonist eplivanserin and the orexin receptor antagonist ACT-078573 are among 11 emerging therapies for insomnia that will enter the market during the next decade. Among the emerging therapies will be the launches (outside the United States) of Sepracor's Lunesta and Takeda's Ramelteon, both of which are forecasted to launch in Europe in 2008 and in Japan in 2010. Experts believe that the broadening recognition of insomnia as a treatable disorder by physicians and patients will help drive market growth in the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan.
The report finds that steadily growing diagnosis and drug-treatment rates, combined with a prevalent population of 140 million, make insomnia one of the few remaining markets with blockbuster potential. However, the availability of generic Ambien, combined with increased regulatory scrutiny for insomnia therapies, will constrain overall market sales.
"Compared with other large psychiatric markets, insomnia calls for agents that are more clearly differentiated from current drugs," said Natalie Taylor, Ph.D., analyst at Decision Resources. "Heightened regulatory benchmarks for new therapies and the generic availability of the well-entrenched Ambien will curtail the blockbuster potential of 'me-too' agents that do not clearly demonstrate advantages in safety and efficacy. Drugs with clinical trial data establishing efficacy in various insomnia populations-such as those with underlying psychiatric disorders, the elderly, and patients with chronic insomnia-will have the most commercial potential."
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