Introduction:Last Updated 21 November 2013
The market for disease-modifying multiple sclerosis (MS) therapies is in the midst of transformation: following the recent launches of the first oral agents, fingolimod (Novartis/Mitsubishi Tanabe Pharma’s Gilenya/Imusera), teriflunomide (Genzyme’s [a Sanofi company] Aubagio), and dimethyl fumarate (Biogen Idec’s Tecfidera), several highly efficacious parenteral products, including alemtuzumab (Genzyme/Bayer HealthCare’s Lemtrada), and additional injectables are poised to enter the market. 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 cause further fragmentation of 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 a near-doubling of the market by 2018. Nevertheless, we expect that uptake of novel therapies will be tempered by a conservative prescriber base favoring (at least initially) time-tested injectable agents given the relative lack of long-term safety data and clinical experience with novel drugs, as well as the absence of prognostic and theranostic markers needed to help guide tough treatment decisions. Last, the introduction of generic and biosimilar competition 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:
With the launches of teriflunomide (Genzyme’s Aubagio) and dimethyl fumarate (Biogen Idec’s Tecfidera), the number of oral disease-modifying therapies has tripled in recent months, bringing an end to the two years that fingolimod (Novartis/Mitsubishi Tanabe Pharma’s Gilenya/Imusera) enjoyed as the sole player in this arena. How do neurologists differentiate between 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 laquinimod (Teva/Active Biotech) compete?
Most physicians interviewed report that they incorporate risk stratification for progressive multifocal leukoencephalopathy (PML) when deciding to prescribe natalizumab. How is neurologists’ use of natalizumab changing? What is the market outlook for the drug in view of an increasing number of highly effective treatment alternatives (e.g., Genzyme/Bayer HealthCare’s alemtuzumab [Lemtrada], Roche/Genentech’s ocrelizumab)? With risk stratification tools in place and a potential label expansion to include first-line use, in what line of therapy will neurologists use natalizumab?
The marketers of the interferon-beta (IFN-β) therapies and glatiramer acetate (Teva’s Copaxone) continue to seek ways to maintain a competitive edge through new technologies, new formulations, long-term follow-up studies, and new clinical analyses. 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 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?
covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 29 country-specific interviews with thought leaders, MS specialists, and neurologists.
Epidemiology: Prevalence of relapsing-remitting MS (RR-MS); prevalence of chronic-progressive MS (CP-MS), including separate estimates for secondary-progressive and primary-progressive MS.
Population segments in market forecast: RR-MS; CP-MS.
Emerging therapies: Phase II: 23 drugs; Phase III: 5 drugs; Preregistered: 2. Coverage of 29 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 (2012-2022). We also forecast the effect of generic and potential biosimilar launches for leading current therapies on the U.S. and European markets through 2022. Future U.S. price increases are modeled.