Last Updated 23 July 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 U.S. 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.