Introduction:
Last Updated 10 August 2010The multiple sclerosis (MS) market is poised to undergo a
dramatic transformation as eight new therapies enter the market, including the
first—and highly anticipated—orally delivered, disease-modifying agents. These
new therapies will drive modest growth of the MS market through 2019, but use
of many of these agents will be constrained by drawbacks in safety and/or
efficacy. Thus, current agents will remain entrenched as key players in the MS
market. Moreover, ample opportunity will remain for therapies to treat the
underserved population of patients who suffer progressive forms of MS.
Questions Answered in This Report:
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The number of postmarketing cases of progressive multifocal
leukoencephalopathy (PML) that have developed in MS patients treated with
natalizumab (Biogen Idec/Elan’s Tysabri) has continued to increase since the
drug’s return to market.
How has the increasing number of PML cases affected
interviewed neurologists’ perception of natalizumab? What shifts in medical
practice have occurred regarding natalizumab use in light of the PML cases?
What impact will the new cases have on natalizumab’s market potential? How will
the drug fare against emerging therapies that also carry significant safety
risks?
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FTY-720 (Novartis/Mitsubishi Tanabe Pharma’s fingolimod
[Gilenia]) is forecast to be the first oral disease-modifying therapy to enter
the
MS market, followed closely by oral
cladribine (Merck Serono/EMD Serono). However, despite these agents’ robust
efficacy, questions remain about their respective safety profiles.
How will
neurologists balance the benefits of these agents’ robust efficacy and oral
formulation against their safety risks? How will the unique risks associated
with each drug affect their respective market potential? How will each agent
fit into an increasingly complex MS treatment algorithm?
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Interferon-beta (IFN-β) therapies and glatiramer acetate
(Teva’s Copaxone) are the primary therapies used to treat MS, and the marketers
of each of these agents continue to devise ways to differentiate their drug
from other current agents.
What factors will promote continued use of
current IFN-β therapies and glatiramer acetate? How will the launch of
follow-on and me-too products impact the market performance of these current
agents? What advantages and disadvantages do follow-on therapies and me-too
agents have that will influence their market success, particularly in light of
the entrance of multiple novel drugs?
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We expect that biosimilar versions of the IFN-β therapies
will launch in Europe in 2014 and in the United States in 2015.
What
development, regulatory, and marketing hurdles will biosimilars face in the MS
market? Are neurologists receptive to the idea of biosimilars? To what extent
will biosimilars impact the branded IFN-β products? Which emerging drugs will present the greatest threat to
biosimilars’ uptake?Scope:
Markets 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
(including clinically isolated syndrome [CIS] patients); prevalence of chronic
progressive MS.
Population segments in market forecast:
Relapsing-remitting MS (including CIS); chronic progressive MS.
Emerging therapies: Phase II: 23 drugs; Phase
III: 6 drugs; Preregistered: 2 drugs. Coverage of 28 select preclinical and
Phase I products.
Market forecast features: We provide an in-depth
examination of current and future MS diagnosis/drug-treatment trends and market
performance over a ten-year forecast period (2009-2019). Using a proprietary
generic erosion model, we also forecast the effect of biosimilar/generic
launches for leading current therapies on the U.S. and European markets through
2019.
Alternative market scenario: Roche/Biogen Idec’s
monoclonal antibody ocrelizumab is approved for the treatment of
relapsing-remitting MS.