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Forecast Insight: Fibromyalgia - Regulatory Caution Threatens EU Market Expansion
Datamonitor, June 2009, Pages: 80
Until regulatory hurdles in the EU are overcome, the US offers the greatest commercial potential and will be the primary growth market for all current and future brands indicated for fibromyalgia. The author forecasts the fibromyalgia market to more than double in value from 2008 to total $2.5 billion by 2018 across the seven major regions.
Scope
- Strategic analysis of the likely impact that recent events, such as regulatory decisions, will have on the future fibromyalgia market
- Fibromyalgia-specific prescription sales data analysis across the seven major markets from 2005-08
- Sales forecasts for key brands (Lyrica, Cymbalta, Savella), generics, and key pipeline agents across the seven major markets to 2018
- Scenario forecasts assessing the potential outcome of EU non-approvals for key brands, supported by key opinion leader comments
Highlights of this title
The probability of non-approval for fibromyalgia in the EU appears to be higher than in the US. Since 2008, the EMEA has declined marketing applications for both Cymbalta (duloxetine, Eli Lilly/Boehringer Ingelheim) and Lyrica (pregabalin, Pfizer).
Savella (milnacipran, Pierre Fabre, Cypress and Forest) became the third FDA-approved product for fibromyalgia. With a response from the EMEA anticipated shortly, the author believes the unique development program involving a composite analysis endpoint and specific EU-based Phase III study will be viewed favorably by the regulatory body.
The author has marginally downgraded its sales forecast for Xyrem (sodium oxybate, Jazz Pharma and UCB). This stems from a newly-highlighted concern over the robustness of the Phase III development program design and the negative perception surrounding the drugs formulation, its prescription constraints and abuse potential.
Key reasons to purchase this title
- Quantify the current and future size of the fibromyalgia market
- Assess the impact of recent and anticipated events (patent expiries, new product launches, regulatory approval) on the fibromyalgia market
- Understand the country-specific impact of key events in the fibromyalgia market during the forecast period 2009 to 2018
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