Multiple Sclerosis Therapeutics to 2019 - Treatment Diversification, Increasing Efficacy, and Pipeline Innovation Combine to Drive Growth

Thursday 12 September 2013, Amsterdam

Sustained Growth of the Multiple Sclerosis Market

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.