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Last Updated 14 October 2014 The market for disease-modifying multiple sclerosis (MS) therapies is in the midst of transformation: three oral agents are now available—fingolimod (Novartis/Mitsubishi Tanabe Pharma’s Gilenya/Imusera), teriflunomide (Genzyme’s/Sanofi’s Aubagio), and dimethyl fumarate (Biogen Idec’s Tecfidera)—and alemtuzumab (Genzyme/Sanofi/Bayer HealthCare’s Lemtrada) has reached the European market; and additional novel products and useful follow-ons are poised to launch. Over the next ten years, the wave of new product launches for the treatment of relapsing forms of MS will lead to meaningful shifts in an already complicated treatment algorithm and further fragment the market. Meanwhile, drug developers have renewed their focus on identifying treatments for progressive forms of MS, a perennially underserved population with few therapeutic options. The launch of premium-priced novel therapies, coupled with anticipated price increases, will drive considerable growth in the market by 2018. Nevertheless, we expect that uptake of novel therapies will be tempered by a conservative prescriber base biased (at least initially) toward time-tested parenteral agents—especially given the relative lack of long-term safety data and clinical experience with novel agents, as well as the absence of prognostic and theranostic markers needed to help guide tough treatment decisions. Last, the progressive introduction of generic and biosimilar competitors will mark a historic shift in this high-cost market as reimbursement authorities embrace the opportunity to lower drug-related healthcare expenditures in MS.
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 21 country-specific interviews with MS thought-leading neurologists and MS specialists.
Epidemiology: Diagnosed prevalent and drug-treated cases of relapsing-remitting MS (RR-MS); diagnosed prevalent and drug-treated cases of chronic-progressive MS (CP-MS), separate estimates for secondary-progressive and primary-progressive MS.
Population segments in market forecast: RR-MS; CP-MS.
Emerging therapies: Phase II: 22 drugs; Phase III: 7 drugs; preregistration: 1 drug. Coverage of 26 select preclinical and Phase I products.
Market forecast features: We provide an in-depth examination of current and future MS drug-treatment trends and market performance over a ten-year forecast period (2013-2023). We also forecast the effect of generic and potential biosimilar launches of leading current therapies on the U.S. and European markets through 2023. Future U.S. price increases are modeled.
Alternative market scenarios: Natalizumab receives expanded labeling for SP-MS; siponimod is approved for SP-MS; fingolimod receives expanded labeling for PP-MS; ocrelizumab receives expanded labeling for PP-MS.