Introduction:Last Updated 31 December 2013
With approximately 5.3 million patients diagnosed in the seven major pharmaceutical markets, epilepsy is a common, debilitating neurological condition that affects patients’ quality of life and imparts a social and economic burden on patients and their families, as well as healthcare institutions. Despite the availability of numerous established first-, second-, and third-generation antiepileptic drugs (AEDs)—many of which are, or are soon to be, generically available—considerable unmet need remains for effective treatment alternatives for 20-30% of drug-treated patients with refractory epilepsy who do not respond to current therapies. Ongoing efforts to better understand the basic science of epilepsy and seizures could uncover promising new targets and biomarkers to facilitate drug development in the future, but the near-term impact of such efforts on epilepsy treatment will be limited.
Questions Answered in This Report:
Premium-priced third-generation AEDs including lacosamide (UCB’s Vimpat) and perampanel (Eisai’s Fycompa) are expected to help drive market expansion throughout the forecast period. How do interviewed experts perceive the efficacy, safety, and tolerability of available third-generation therapies? How do developers of third-generation drugs differentiate their products within the crowded, heavily-genericized epilepsy market? Which third-generation AEDs will see the greatest uptake during the forecast period and what factors will drive their use? What market and patient shares will these agents garner at their peak? How will the growing presence of generics across all drug classes affect the uptake of novel, premium-priced AED brands?
Although first-generation AEDs maintain a prominent position in the epilepsy treatment algorithm, second-generation AEDs including market-leading levetiracetam (UCB/Otsuka Pharmaceutical’s Keppra/E Keppra, generics) dominate patient share across the major markets. What factors have promoted the early-line uptake of second-generation drugs? How will these drugs fare during the forecast period, in light of increasing market pressure from new branded and generic competitors? Has growing generic availability of second-generation AEDs affected the uptake of second-generation AEDs overall?
We forecast the launch of one new molecular entity during the forecast period, UCB’s brivaracetam (Rikelta); several reformulations of current AEDs are also expected to enter the market. How might brivaracetam be differentiated from its highly successful predecessor, levetiracetam? How do interviewed experts perceive the utility of emerging extended-release reformulations in epilepsy? What market and patient shares will these emerging agents garner in the epilepsy market? What are the unique market-entry challenges faced by new molecular entities and emerging reformulations?
Unmet needs in epilepsy are many, ranging from better antiseizure drugs and improved treatments for refractory patients, to disease-modifying therapeutics that prevent or reverse the mechanisms underlying recurrent seizures. To what extent will newly launched and emerging AEDs meet the need for improved treatments? What factors constrain the development of novel therapeutics, and in which areas of epilepsy research do interviewed experts expect new innovations to occur?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 27 country-specific interviews with adult and pediatric neurologists who specialize in epilepsy.
Epidemiology: Diagnosed and drug-treated prevalence of epilepsy; diagnosed prevalence of epilepsy segmented by seizure type (partial-onset and generalized-onset) and age; drug-treated prevalent cases with drug-resistant epilepsy.
Emerging therapies: Phase II: 8 drugs; Phase III: 6 drugs; preregistration and registration: 1 drug. Coverage of 10 select preclinical and Phase I products.
Market forecast features: Using market research, primary research with key opinion leaders, and our proprietary forecasting model, we provide an in-depth examination of current and future epilepsy drug-treatment trends and market performance over a ten-year forecast period (2012-2022).