Abstract
Introduction
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. Datamonitor 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 of this research
- 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 200508
- 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
Research and analysis highlights
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, Datamonitor 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.
Datamonitor 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 drug' s formulation, its prescription
constraints and abuse potential.
Key reasons to purchase this research
- 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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