The multiple sclerosis (MS) disease-modifying therapy (DMT) market across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) is poised to grow at a compound annual growth rate of 1.7% from $22.0bn in 2024 to $25.9bn in 2034, according to leading data and analytics company GlobalData’s recently published report, Multiple Sclerosis: Seven-Market Drug Forecast and Market Analysis. This modest growth will be driven by the anticipated launches of seven late-stage pipeline products during the forecast period.
With an estimated $15.7bn in drug sales, the US dominated the MS DMT market in 2024, representing 71.6% of the 7MM sales. GlobalData expects the US to remain as the leading market throughout the forecast period, generating sales of $19.5bn in 2034, representing 75.0% of the overall market across the 7MM. This dominating position within the 7MM is a result of the significantly higher costs of marketed products in the US and a high diagnosed prevalence.
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Most marketed DMTs for MS target peripheral inflammation to reduce relapses, but few possess neuroprotective effects and, as such, have insufficient impact on the underlying neurologic deterioration caused by MS. Key opinion leaders (KOLs) interviewed by GlobalData noted that while the marketed anti-CD20 monoclonal antibodies are high-efficacy treatments for reducing annualised relapse rates, they have modest efficacy at targeting progressive MS. However, the MS therapeutics market has entered an exciting phase, with the anticipated launches of seven late-stage pipeline products that show promise on neuroprotection and progressive forms of MS. One of the novel emerging groups is the Bruton’s tyrosine kinase inhibitor (BTKI) class of drugs, which includes four agents in late-stage development for MS: Sanofi’s tolebrutinib, Genentech/Roche’s fenebrutinib, Novartis’ remibrutinib, and InnoCare Pharma’s orelabrutinib. While BTKIs are a new player in the MS field, they have been successfully used in oncology for many years. KOLs interviewed by GlobalData were excited about the mechanism of action (MoA) of BTKIs and their potential to target the innate and adaptive immune system. Other late-stage pipeline products with novel MoAs being investigated in reducing disability progress or disease activity include Sanofi’s frexalimab, Immunic’s vidofludimus calcium, and AB Science’s masitinib. Furthermore, the MS pipeline offers small molecules that are orally administered, an alternative to the injectable biologics currently dominating the MS market.
GlobalData forecasts that the late-stage pipeline will capture a significant portion of the MS market and could drive combined sales of approximately $7.8bn by 2034 in the 7MM. However, as DMTs for the treatment of MS have not been investigated in an adjunctive setting, new products will have to compete with established products that are well entrenched in physicians’ treatment algorithms.
While the MS market is projected to grow during the forecast period across the 7MM, it will face some challenges that will curtail its growth. Potential barriers to the growth of the global MS market include the loss of exclusivity of several key branded products that are expected to face patent and data exclusivity expiration, leading to brand erosion due to the emergence of biosimilars and generic small molecules. Nonetheless, the launches of the pipeline therapies will fuel overall market growth in the MS space.
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