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.
Questions Answered in This Report:
- Oral disease-modifying products, led by fingolimod and dimethyl fumarate, are increasingly penetrating the market. How do neurologists differentiate these oral therapies? Which of these agents will enjoy the greatest clinical and commercial success? How will these and other oral agents compete against platform injectables and monoclonal antibodies in the evolving MS treatment algorithm? How will RPC-1063 (Receptos) and laquinimod (Teva/Active Biotech) compete?
- The need for more-effective—and acceptably safe—immune-targeted DMT alternatives remains, but thanks to risk-stratification protocols regarding progressive multifocal leukoencephalopathy (PML), natalizumab (Biogen Idec’s Tysabri) is more-competitive and more-targeted than ever before. How is neurologists’ use of natalizumab changing? What is the market outlook for this and other higher risk/higher reward DMTs (e.g., alemtuzumab, Roche/Genentech’s ocrelizumab)? Are physicians receptive to ocrelizumab and daclizumab (Biogen Idec/AbbVie)?
- Injectable DMTs remain a prominent component in the MS pipeline; innovative follow-ons and reformulations aim to capitalize on the historical success of time-tested mainstays. How will IFN-β products and glatiramer acetate compete in a market being transformed by an influx of new and attractive treatments? What are neurologists’ opinions of and clinical expectations for Biogen Idec’s pegylated IFN-β-1a (Plegridy) and Teva’s 40 mg reformulation of glatiramer acetate?
- The next ten years will see the launch of the first generic MS therapies and the potential launch of biosimilar IFN-β products. Generic orals, in particular, will mark a key inflection point in this market. What will be the commercial impact of these lower-priced alternatives on the MS market??
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.
Donal Minihan, M.V.B., Ph.D.