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TMO Overview - Insomnia

Insomnia is a condition characterized by a person's subjective perception of dissatisfaction with the quantity and/or quality of his or her sleep. Insomnia is identified as a sub-category of conditions under the broad therapeutic umbrella of sleep disorders. The International Classification of Sleep Disorders, a diagnostic and coding manual developed by a global consortium of sleep research organizations, recognizes more than 80 types of sleep disorders caused by a variety of physical, medical, psychiatric, and environmental factors. AVOS predicts that this wide array of causes, compounded by a rapidly aging population, will contribute to significant growth in the U.S. theoretical insomnia population: growing from 76.9 million in 2008 (approximately one-quarter of the U.S. population) to 91.9 million in 2013. Despite ongoing concern among treating physicians over the potential for dependence on insomnia therapies, AVOS predicts that the U.S. market will grow from revenues of $2.5 billion in 2008 to $4.5 billion in 2013. This growth is expected despite increasing generic substitution and the relatively low number of individuals suffering from insomnia that will be diagnosed and treated during the forecast period. With the current treatment options' deficiencies in both efficacy and safety, and approximately 30 million insomnia sufferers who self-medicate, the field is open to innovative entrants which would inevitably drive future market growth. AVOS predicts that two late-stage candidates - Schering-Plough's ORG 50081 (esmirtazapine maleate, a serotonergic agent) and Actelion's almorexant (an orexin receptor antagonist) - will lead the next generation of branded insomnia drugs.

AVOS Life Sciences' TMO Insomnia report addresses each key aspect of a rigorous, disease-based market analysis:

Market Size & Expected Growth	In-depth epidemiological analysis and modeling Detailed review of current and projected treatment landscape at a class level
Treatment Cascade	Consideration of the treatment algorithms for primary indication Impact of manipulating treatment cascade through promotional and other initiatives
Drug Class Characteristics	Fundamentals: safety, efficacy, side effects, onset of action, duration, etc. Developer strengths and weaknesses (technology, marketing, sales, etc.)
Competitive Landscape	Comprehensive competitve pipeline overview at a drug level In-depth review of all major competing treatment mechanisms and drug classes
Pricing & Reimbursement Landscape	Where appropriate, price elaticity calculations based on payer and provider interviews Evaluation of reimbursement landscape for indication and similar projects
Class Position Effects	Detailed research and analysis for first-in-class products Scenario analysis of entrants into markets with existing products
Projected Market Share Shifts	Sophisticated uptake models (historical view, firm and product attributes) Predictions for shifts resulting from the use of several marketing levers

Key findings in AVOS's TMO Insomnia report include:

• Arrival of generic Ambien is the most impactful inflection point in this market over the forecast period: Ambien, the market's most popular insomnia drug for nearly 15 years, became available as a multi-source generic in April 2007. Over...
• While total prescriptions (TRx) are projected to grow by 8.6% per year (CAGR) during the forecast period, increased generic usage will shrink overall market revenue in the short-term: With generic zolpidem now accounting for the majority of scripts filled and loss of exclusivity (LOE) among further branded products inviting more generic competition into the market, the lower cost of generics are projected to...
• Large number of unmet needs leaves room for growth, though future branded success hinges on the ability of new products to demonstrate incremental safety and efficacy benefits: Increasing numbers of Americans are suffering from insomnia and the current treatment options' deficiencies in efficacy and safety leaves the market underserved. The insomnia population as a whole is largely untapped, with only...
• Basis of competition among branded Rx products is expected to migrate to a "head-to-head" battle for share: As Ambien CR and Sonata face LOE over the next two years...
• DTC spending drives overall market growth, but spending levels are unsustainable: Insomnia market growth is strongly driven by detailing, sampling, and DTC marketing campaigns. Lunesta, Ambien CR, and Rozerem spent a combined total of...

Despite the historical success of the current therapeutic options available for insomnia, the market appears to be largely unsatisfied and is looking for improvements, particularly with regard to safety and efficacy. The AVOS TMO Insomnia report explores the prescription and perception dynamics between these aging branded therapeutics and their new generic counterparts and delves into the promising new products in development that look to contribute to the potential growth of this market.