Last Updated 2 October 2015
A new era in the market for multiple sclerosis (MS) disease-modifying therapies (DMTs) has dawned: Novartis/Mitsubishi Tanabe Pharma’s fingolimod (Gilenya/Imusera) and Biogen’s dimethyl fumarate (Tecfidera) have partially fulfilled a pent-up demand for effective oral DMTs, although evolving safety experience with these drugs underscores a persistent clinical role for platform injectable therapies (e.g., interferon-βs, Teva’s glatiramer acetate [Copaxone]). In later lines of treatment, Genzyme/Sanofi’s Lemtrada (alemtuzumab) is the first of several new and potent monoclonal antibodies set to reach the market as MS thought leaders increasingly question the paradigm of escalation in MS treatment. Moreover, the first generic MS DMT—Sandoz/Momenta’s Glatopa (glatiramer acetate 20 mg/mL)—has reached the U.S. market, providing payers with long-awaited leverage to begin to rein in the high cost of therapy in the U.S. MS market. Over the next ten years, a wave of new product launches for the treatment of relapsing forms of MS, including novel products and useful follow-ons, will further shift an already complicated treatment algorithm and further fragment the market. Meanwhile, drug developers have re-sharpened their focus on developing neuroprotective or reparative treatments and therapies for progressive forms of MS—a perennially underserved population with few therapeutic options. The launch of premium-priced novel therapies, coupled with moderating 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 faced with a relative lack of long-term safety data and clinical experience with novel agents, the absence of prognostic and theranostic markers needed to help guide tough treatment decisions, and the presence of generic oral therapies on the market.
Questions Answered in This Report:
- Generic glatiramer acetate 20 mg/mL has entered the U.S. market, and we expect that the next five years will see the launch of additional generic competitors, including oral DMTs. What will be the commercial impact of these lower-priced alternatives on the MS market?
- Oral disease-modifying products, led by Gilenya/Imusera and Tecfidera, increasingly penetrate the market, and follow-on agents are rapidly progressing through the pipeline. How will oral DMTs fare against platform injectables and monoclonal antibodies in the evolving MS treatment algorithm? How will ozanimod (Celgene/Receptos), ponesimod (Actelion), ALKS-8700 (Alkermes), and laquinimod (Teva/Active Biotech) compete with their first-generation counterparts?
- Potent—and acceptably safe—immune-targeted DMTs are necessary for treatment-refractory MS patients and those with an aggressive disease course. Thanks to risk stratification for progressive multifocal leukoencephalopathy (PML), Biogen’s Tysabri remains competitive and Lemtrada offers another late-line option. How is neurologists’ use of Tysabri changing? What is the market outlook for other higher risk/higher reward DMTs (e.g., Lemtrada)? Are physicians receptive to daclizumab (Biogen Idec/AbbVie’s Zinbryta), ocrelizumab (Roche/Genentech), and ofatumumab (Novartis/GlaxoSmithKline/Genmab)? How might these agents impact treatment paradigms? Among them, are any of these MAbs perceived to be superior?
- Injectable DMTs remain a component in the MS pipeline and a major force in current treatment; innovative follow-ons and reformulations aim to capitalize on the historical success of time-tested mainstays. How will IFN-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’s pegylated interferon-IFN-β (Plegridy) and Teva’s Copaxone 40 mg/mL? What clinical and commercial forces will shape the longevity of the platform injectable products?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 29 country-specific interviews with experts.
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: 21 drugs; Phase III: 6 drugs; preregistration: 1 drugs. Coverage of 17 select preclinical and Phase I products.
Bethany Christmann, Ph.D.
Kristin Dorfman, M.P.H., M.S.