Global Multiple Sclerosis Therapeutic Market Outlook to 2024
Global Multiple Sclerosis (MS) therapeutic market was valued at $19.5bn in 2015, driven by improved diagnostic criteria, greater disease awareness, novel treatment options, aggressive U.S. price hikes and expansion in ex-U.S. territories. However, with increased competition, payers’ cutback on drug spending and availability of generic formulations of market leading drug Copaxone, global branded MS therapeutic market is expected to grow at a modest 2.1% CAGR between 2015 and 2024, resulting in 2024 global sales of $23.5bn.
The market sees upward trend with rising prevalence and onset of MS in women and children. MS affects estimated 400,000 patients in the U.S. and over 1 million people worldwide. The MS market is broadly split in to two categories based on the treatment approaches and routes of administration namely oral agents and injectables. Currently, the injectable category is accounting for a major share of ~88% in the MS drug market, and is clearly ahead of the oral agents. However the market share of oral therapies is continually rising with the approval of newer oral agents. Older injectable therapies have begun to lose significant market share to newer oral entrants.
Global Multiple Sclerosis Market Share, By Routes of Administration 2015-2024
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MS is a progressive neurological condition of unclear etiology. The best understood theory so far explains it as a combination of some genetic and environmental factors (infectious agents). After its discovery in 1868 by Jean-Martin Charcot, MS has claimed a very significant number of lives including the death of 20,000 people worldwide in the year 2013. The unclear etiology of the disease and the unmet medical needs play as a catalyst of growth of multiple sclerosis drug market for next several years. Companies working on innovative therapeutic approaches and novel mechanism of action will be strongly positioned in an otherwise increasingly crowded and competitive marketplace.
MS accounts for the progressive loss of the myelin layer resulting in demyelination, lesion/plaque formation in the brain white matter and inflammation. MS is broadly characterized into the following four disease classifications, namely (a) Relapsing-Remitting MS (RRMS), Secondary-Progressive MS (SPMS), (c) Primary-Progressive (PPMS), Progressive Relapsing (PRMS).
The common symptoms associated with multiple sclerosis are fatigue, numbness, spasticity, ataxia, bladder dysfunction, cognitive changes, emotional changes, and depression.
In 2015, Scientists came up with a promising new approach to treat multiple sclerosis. For the first time the researchers have shown evidence of repair of damaged myelin. Biogen’s new poduct ‘Anti-lingo-1’, which is all set to get FDA approval, is leading in this category. Other major pipeline products in both the forms of treatment include Daclizumab, Ocrelizumab, RPC1063, Cladribine (all in phase III trials), ATX-MS-1467, Minocyclin, Raltegravir, Clemastine, Vatelizumab (all in phase II trials). The pipeline product development of major pharmaceutical companies indicates an active oral drug pipeline in MS therapies.
“Optimal price point (OPP) for MS Treatment”
The medications used to treat MS cost between $20,000 and $30,000 per year and the cost for treatment of a disease flare-up is estimated at $12,870. MS imposes significant physical, economic, and psychosocial burden on individuals, their families and society. The direct and indirect costs of MS are now estimated at $57,500 per patient per year. It is always our endeavor at Optima Insights to continuously track these prices with our proprietary pricing model.
“Drivers and Restraints”
The growing environmental pollution, increasing awareness among people to stay healthy, growing expenditure in healthcare sector, favorable pricing and reimbursement would drive the MS market. However, lingering safety concerns of many approved injectable and oral therapies continue to pose headwinds and stifle adoption in this market.
"Bayer, Biogen, Merck Serono, Novartis, Sanofi, and Teva are some of the key players in the MS Therapeutics market"
Biogen’s Tecfidera (2013 launch) is seeing increased uptake in the oral segment. The early launches from Novartis Gilenya (2010) and Sanofi’s Aubagio (2012) however are faced with lingering side-effect concerns. Alkermes is working on the promising next-gen Tecfidera which if approved could give Biogen a strong competition.
Although North American region leads the market worldwide followed by Europe in MS drug sales, the focus remains a hotbed of growth, driven by rising incidence of MS and growing demand for affordable drugs. We can witness strong momentum by branded generics companies actively playing this space.
The companies are launching novel therapeutics agents which are cost effective and superior clinical profile. The work around remyelinating therapies that seek to reverse the auto-immune mediated attack on neurons can redefine the treatment approaches of MS therapies.
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