Brands & Strategies: Insomnia

Brands & Strategies -- November 2007

  In This Issue...

Introduction

The insomnia market, valued at almost $3.9 billion in 2006 in the United States, Europe, and Japan, is expected to expand to over $5.2 billion by 2011. The primary drivers of market growth will be the addition of 11 novel products, along with the launches of Sanofi-Aventis’s Ambien CR, Sepracor’s Lunesta (Lunivia in Europe), and Takeda’s Rozerem beginning in 2008 throughout Europe. Additionally, diagnosis rates of the disorder are expected to continue to climb because of the aggressive primary-care focused marketing efforts put forth by existing and emerging competitors. Although the insomnia market remains underpenetrated and lucrative for companies with vested central nervous system (CNS) interests, we caution that sales of "me-too" agents will be limited by price sensitivity and availability of consistently effective generic products (e.g., immediate-release zolpidem). Instead, the most commercially successful insomnia products will be those with clearly defined safety and efficacy advantages over existing therapies--such as Sanofi-Aventis’s 5-HT₂ antagonists eplivanserin and volinanserin, and Eli Lilly’s dual histamine 1/5-HT₂ receptor blocking agent HY-10275.

Questions Answered in This Report

- In 2006, the insomnia market was dominated by Sanofi-Aventis’s Ambien franchise, which represented well over half of the total insomnia market. Though Sepracor enjoyed a robust market launch of Lunesta due to its unprecedented direct-to-consumer campaign, growth of the brand has recently slowed due to the arrival of generic zolpidem products in April 2007 and Sanofi-Aventis’s increase in detailing efforts for Ambien CR. How will the plethora of post-marketing clinical trials supported by Sepracor for Lunesta further differentiate the brand? Will Sepracor change its U.S. messaging for Lunesta now that it has become an established brand? What tactics will Sepracor and GlaxoSmithKline employ to ensure commercial success when Lunivia launches in Europe?

- Despite having a superior safety and tolerability profile in comparison to other prescription sleep aids, Takeda’s Rozerem has suffered commercially from being less efficacious than the non-benzodiazepine and benzodiazepine GABA-A receptor agonist hypnotics. In the opinion of U.S.-based primary care physicians, which type of insomnia patients are best served by Rozerem? How can Takeda capture more of the insomnia market with Rozerem before the arrival of other products that are also expected to lack tolerance and abuse potential (e.g., Sanofi-Aventis’s eplivanserin, Somaxon’s Silenor, Eli Lilly’s HY-10275)?

- Sanofi-Aventis will attempt to remain a leading player in the market after the generic erosion of its Ambien franchise by being the first competitor to launch a 5-HT₂ antagonist for the treatment of insomnia. Sanofi-Aventis will launch eplivanserin in 2009, and its follow-on 5-HT₂ antagonist volinanserin will launch in 2011. What share of the insomnia market will Sanofi-Aventis retain with the launches of eplivanserin and volinanserin? How will Sanofi-Aventis position its 5-HT₂ antagonist products in the insomnia market? Which patient segments of the insomnia market is the company most likely to target for its novel compounds?

- Despite indiplon’s troubled history with the U.S. Food and Drug Administration, Neurocrine remains committed to bring immediate- and controlled-release formulations of its non-benzodiazepine GABA-A agonist to the U.S., European, and Japanese markets within the next five years. Neurogen also plans on initiating Phase III trials for its non-benzodiazepine GABA-A agonist adipiplon by the end of 2008. Will either of these compounds have commercial advantages over already-marketed non-benzodiazepine GABA-A agonists? Has the non-benzodiazepine GABA-A agonist class reached its saturation point in the insomnia market?

- Eli Lilly demonstrated that it is committed to entering the insomnia market over the next five years with its purchase of Hypnion in early 2007. We forecast that Eli Lilly’s HY-10275 will launch in the U.S. market in 2010. What challenges will Eli Lilly face when formulating a commercial strategy for HY-10275?

Scope

Markets Covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.

Detailed discussion of major competitors including Sanofi-Aventis, Sepracor, Takeda, and King Pharmaceuticals; as well as emerging competitors Neurocrine, Somaxon, Neurogen, Eli Lilly, Biovail, Orexo, Novadel, and Vanda Pharmaceuticals. Included for each competitor is an analysis of each company’s CNS product portfolio, strategic positioning, and development pipeline in insomnia. The report features an in-depth discussion of leading brands, sales and market position, strengths/weaknesses/opportunities/threats (SWOT) analysis, ongoing postmarketing clinical trials, and strategic initiatives.

Physician Perception of Key Brands: Analysis of physician perceptions of the insomnia market based on a custom survey of 55 U.S.-based primary care physicians. The survey is brand-focused and examines physician perceptions of key competitors, brand attributes, and messaging.

Epidemiology: Total prevalent and diagnosed cases for each of the major markets are presented in an annualized forecast from 2006 to 2011.

Market Forecast: Annualized sales forecasts for branded agents, including the uptake of new agents, presented by region, drug class, molecule, and brand for 2006 to 2011.