In 2025, an estimated 1.4 million diagnosed prevalent cases of multiple sclerosis (MS) were recorded across the United States, Japan, and the five major European markets (France, Germany, Italy, Spain, and the UK), with prevalence expected to rise to approximately 1.72 million cases by 2043. The MS treatment landscape is well established, with a broad range of disease?modifying therapies (DMTs) offering varying efficacy, safety, and administration profiles. While first?generation injectable therapies, such as Avonex, Betaseron, Copaxone, and Rebif, are increasingly displaced by more effective agents, they continue to retain limited use in first?line settings, particularly for milder disease and in cost?constrained environments.

Since its launch in 2017, Roche’s Ocrevus has emerged as the gold?standard therapy in MS, driven by strong efficacy, infrequent dosing, and its status as the only approved treatment for primary progressive MS. Its dominance has been further reinforced by the approval of the subcutaneous formulation Ocrevus Zunovo in 2024, though impending patent expiry in 2028 has prompted multiple biosimilar programs to advance into late?stage development. At the same time, the market continues to absorb the impact of generic entry across legacy oral therapies, including fingolimod, dimethyl fumarate, and teriflunomide, as well as the introduction of the first natalizumab biosimilar, Tyruko. Pipeline development remains active but selective, with safety concerns constraining progress for BTK inhibitors such as tolebrutinib, while Roche’s fenebrutinib stands out following positive Phase III results. Overall, competitive intensity is increasing as the MS market transitions into a more mature phase characterized by biosimilar entry, generic erosion, and incremental innovation from late?stage pipeline assets.