With approximately 5 million patients diagnosed in the seven major pharmaceutical markets, epilepsy is a common, debilitating collection of seizure disorders that affect patients’ quality of life and impart a social and economic burden on patients and their families, as well as healthcare institutions. Despite the availability of numerous established antiepileptic drugs (AEDs) and the expected influx of new agents designed for the acute treatment or chronic prevention of seizures over the next decade, considerable unmet need exists in epilepsy; such needs include transformative disease-modifying therapeutics, biomarkers to guide treatment selection, and effective alternatives for the 20-30% of drug-treated patients who do not respond to current agents.
Questions Answered in This Report:
- We forecast the launch of six new products designed for the acute treatment or chronic prevention of seizures: brivaracetam (UCB’s Rikelta), ganaxolone (Marinus Pharmaceuticals), YKP-3089 (SK Life Science), intranasal diazepam (Acorda Therapeutics’ Plumiaz), intranasal midazolam (Upsher-Smith Laboratories’ USL-261), and intramuscular diazepam (Pfizer’s Vanquix). How might brivaracetam be differentiated from its highly successful predecessor, levetiracetam (UCB/Otsuka Pharmaceutical’s Keppra/E Keppra, generics)? How do interviewed experts perceive the clinical profile of ganaxolone and YKP-3089 based on available data? What characteristics of emerging agents will be the strongest drivers of uptake? What are the differentiating features of emerging outpatient rescue therapies? 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?
- We expect that the uptake of marketed third-generation AEDs (e.g., lacosamide [UCB’s Vimpat], perampanel [Eisai’s Fycompa]), and emerging third-generation AEDs will help drive market expansion throughout the forecast period. How do interviewed experts perceive the efficacy, safety, and tolerability of third-generation therapies? How will 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?
- Second-generation AEDs, including 2013 market leader levetiracetam, 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 this class overall? What impact will branded reformulations of second-generation AEDs have on class patient share and sales?
- Unmet needs in epilepsy include improved antiseizure drugs, effective treatments for refractory patients, and 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: 33 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), risk of acute repetitive seizures, and age; drug-treated prevalent cases with drug-resistant epilepsy.
Emerging therapies: Phase II: 9 drugs; Phase III: 5 drugs; preregistration and registration: 2 drugs. Coverage of 15 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 (2013-2023).
Wouter van der Plujm, M.P.H.