The
Multiple Sclerosis (MS) market has been growing consistently over the last two
decades and is forecast to continue to grow from $8.1 billion in 2012 to $17.6
billion by 2019 at a CAGR of 11.6%. The US will remain the biggest market,
constituting approximately 65% of the total by 2019, although this represents
little change in the intervening years. Despite some countries in the EU
growing more slowly in terms of prevalence than others (such as Germany and
Spain), the European market in general will grow due to population growth and
subsequent patient-population growth, higher drug prices, and strong uptake due
to more expensive and efficacious pipeline drugs. Japan will remain of little
significance owing to the very low prevalence population and continued
negligible percentage of the overall market, despite high drug prices.
The Multiple Sclerosis Therapeutic Landscape is in a State of Transition
The therapeutic landscape for MS is undergoing profound change in terms of drug
types, drug targets, drug safety, and above all, drug efficacy. The current
treatment options, namely Copaxone (glatiramer acetate), Avonex (interferon
beta 1a IM), Rebif (interferon beta 1a SC) and Betaseron (interferon beta 1b),
are beginning to be supplanted by both recently approved and, within the
forecast period, late-stage pipeline molecules, such as Gilenya (fingolimod
hydrochloride), Tecfidera (dimethyl fumarate), Lemtrada (alemtuzumab) and
Aubagio (teriflunomide), which offer better overall efficacy and safety
profiles. Additionally, a high proportion of newly approved drugs are oral
therapies, rather than the previously used injectable therapies. They offer
greater convenience, which, coupled with the increased efficacy, is expected to
result in a new standard of treatment as older drugs are gradually replaced
with first-line options in the treatment algorithm. This is already happening
as new oral drug Tecfidera begins to establish itself in the market. The
pipeline also offers more in terms of second-line therapies, as a swathe of
effective monoclonal Antibody (mAb) therapies make their way through clinical
trials. This will further contribute to the reshuffle, offering patients a more
diverse and, more importantly, safer selection of second-line therapies that
had, until now, been dominated by Tysabri.
High Levels of Innovation Results in a Strong Pipeline
The overall pipeline for MS is strong, with multiple molecules of varying
classes and targets across all stages of development. It should be of
particular note that of the 228 molecules in the MS pipeline, 112 are in the
preclinical stage with many of these drugs targeting novel proteins or
employing novel mechanisms of action. This is also true of Phases I and II,
respectively.
Late-stage drugs are of particular interest due to the large number of oral
drugs currently occupying both Phases II and III. These drugs appear to offer a
profound improvement over the currently available treatments (as previously
outlined). This plethora of diverse drugs should result in yet more
improvements in the standard of therapy available to patients with MS in the
future.
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