The maturing, but highly lucrative, market for multiple sclerosis (MS) disease-modifying therapies (DMTs) is becoming increasingly fragmented as attractive new options enter a powerful armamentarium—one transformed by oral drugs but in which injectable mainstays have given way only slowly. Beginning in 2017, we expect Novartis’s siponimod and Roche/Genentech’s ocrelizumab (Ocrevus) to become the first compelling approved agents to treat progressive MS, which will expand DMT use in these underserved populations. In relapsing MS, Novartis/Mitsubishi Tanabe Pharma’s Gilenya/Imusera, Biogen’s Tecfidera, and Sanofi Genzyme’s Aubagio are now well established in early lines of therapy, although the safety experience with these drugs prolongs a clinical role for platform injectable therapies (e.g., interferon-βs, Teva’s Copaxone). In later lines of treatment, Genzyme/Sanofi’s Lemtrada and Biogen/AbbVie’s Zinbryta vie for use with Biogen’s Tysabri; standout Ocrevus will drive further competition late-line but will also stoke the perennial debate about induction. The first generic MS DMT, Sandoz/Momenta’s Glatopa (glatiramer acetate 20 mg/mL), has done little to date to change the U.S. market access landscape in MS, but additional generics, namely orals, loom; we expect that generic competition will limit the market potential for a growing wave of follow-on products in the late-stage MS pipeline. Meanwhile, drug developers have resharpened their focus on developing “next frontier” neuroprotective or reparative treatments, although major challenges remain. Ultimately, the launch of premium-priced novel therapies, coupled with U.S. price increases and growth in the drug-treatment rate for progressive MS, will combine to drive relatively steady growth in the market through 2025; however, this growth will be tempered by a conservative prescriber base faced with a relative lack of long-term safety data and clinical experience with novel agents, as well as a lack of prognostic and theranostic markers needed to help guide tough treatment decisions.
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 31 country-specific interviews with experts.
Epidemiology: Prevalence of relapsing-remitting MS and clinically isolated syndrome (RR-MS + CIS); prevalence of chronic-progressive MS (CP-MS).
Population segments in market forecast: RR-MS + CIS; CP-MS.
Emerging therapies: Phase II: 17 drugs; Phase III: 7 drugs; preregistration: 2 drugs. Coverage of 11 select preclinical and Phase I products.