Epilepsy | Disease Landscape and Forecast | G7 | 2017

Approximately million patients in the seven major pharmaceutical markets under study are diagnosed with epilepsy, a 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 ( AED s) and the expected influx of new agents designed for the acute treatment or chronic prevention of seizures over the forecast period, considerable unmet need remains in the indication, including the need for transformative disease-modifying therapies, 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 2017, the International League of Epilepsy published an updated classification scheme for seizure types and epilepsy syndromes. How is the new classification scheme different from previous iterations?
• What do key opinion leaders ( KOL s) think about the new classification scheme and its potential impact, if any, on diagnosis, drug treatment, and trial recruitment for epilepsy? 
• Most epilepsy therapies in late-phase development target niche populations (, acute repetitive seizures [ ARS ], Lennox-Gastaut syndrome [ LGS ], Dravet syndrome). How will these emerging agents compete with marketed AED s and each other? Will physicians use these targeted agents in place of current broad-spectrum therapies that lack labeling for niche populations, or will these drugs be relegated to use as later-line adjuncts? 
• Head-to-head clinical trials are rare in drug development for epilepsy, a drawback that has caused several market access stumbles. What role can emerging drugs play in the increasingly crowded landscape without demonstrating clear clinical differentiation in comparator trials? 
• The epilepsy therapy market is highly generic, and we expect that the next ten years will see the launch of additional generic competitors, including UCB’s market leader, Vimpat (lacosamide). What will be the commercial impact of these lower-priced alternatives on the market, and when will it occur? 

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan. 
Primary research: 26 country-specific interviews with epilepsy specialists. Data from recent surveys conducted for this and other DRG research in epilepsy were leveraged to inform market estimates. 
Epidemiology: Diagnosed prevalent cases, drug-treated prevalent cases, partial-onset and generalized-onset seizure rates. 
Emerging therapies: Phase II: 9 drugs; Phase III: 6 drugs; preregistration: 0 drugs; registered: 37 drugs. Coverage of 23 select preclinical and Phase I products. 
Market forecast features: Patient-based market forecast extending through 2026. 
Alternative market scenarios: Proximagen’s USL-261 (intranasal midazolam) launches in Europe for the treatment of ARS . 
Key companies: Eisai, GlaxoSmithKline, GW Pharmaceuticals, Insys Therapeutics, Lundbeck, Neurelis, Pfizer, Proximagen, Sanofi, SK Biopharmaceuticals, Sunovion, Supernus, UCB, Upsher-Smith, Zogenix. 
Key drugs: levetiracetam, lamotrigine, carbamazepine, valproates, Vimpat (lacosamide), Aptiom/Zebinix (eslicarbazepine acetate), Fycompa (perampanel), Briviact (brivaracetam), Epidiolex (plant-derived cannabidiol), synthetic cannabidiol, ZX-008 (fenfluramine), YKP-3089 (cenobamate), NRL-1 (intranasal diazepam), USL-261 (intranasal midazolam). 
Recent events: Phase III data have been announced for GW Pharmaceuticals’ widely anticipated Epidiolex, a cannabidiol for the treatment of pediatric epilepsy syndromes such as LGS and Dravet syndrome. In this report, we analyze physician perception of Epidiolex compared with its marketed and emerging competitors, the size of its market opportunity, and its likely positioning and uptake over the next several years.