World MS Day 2025: Exploring the MS Pipeline and Competitive Landscape
Today is World Multiple Sclerosis Day, and we’re taking a closer look at the evolving MS competition landscape.
Key facts about MS
Multiple Sclerosis (MS) is a chronic neurodegenerative disorder that affects nearly 2.9 million people globally and an estimated 1.4 million across the 7 Major Markets. While the exact cause of MS is still unclear, the disease is understood to involve autoimmune-driven inflammation and progressive neurodegeneration. Although there are now several approved therapies, primarily targeting relapsing forms of MS, the disease remains incurable, and treatment options for progressive forms are still limited.
Notably, Ocrelizumab (Ocrevus) is the only disease-modifying therapy (DMT) approved for all three major subtypes: Relapsing-Remitting MS (RRMS), Primary Progressive MS (PPMS), and Secondary Progressive MS (SPMS), targeting B-cell-mediated autoimmunity via CD20.
So, what’s happening in the MS pipeline?
Figure 1. Overview of clinical development in MS
We performed a high-level analysis of the current MS pipeline, categorizing approximately 60 different agents by their mechanism of action (MoA), development phase, and target subtype. The pipeline is particularly crowded in Phase 2 and Phase 3 for RRMS, with 23 drugs currently in clinical development for RRMS (Figure 1). Progressive forms are also seeing activity, however, often include the same drugs as in RRMS. Notably, a large share of Phase 1 programs targets unspecified MS subtypes, reflecting early exploratory trials, many of which focus not on disease modification but on symptom management.
Figure 2. Mechanistic innovation across the MS pipeline
To explore the "innovation level" of MoAs in development, we examined which mechanisms are already approved in MS (overall or for specific subtypes) versus those that are entirely new to the space. Figure 2 visualizes the degree of MoA novelty for each subtype and phase. Bubbles represent (a) already approved MoAs in the specific subtype (in brown), (b) mechanisms approved only in other MS subtypes (i.e., relative innovation, in light blue), and (c) completely novel MoAs not yet approved for MS (in dark blue). Bubble size reflects the proportion of each category, with fractions noted for transparency. Most pipeline drugs are built on MoAs not yet approved in MS, highlighting a strong innovation trend, particularly in progressive forms.
However, despite progressive MS having the highest unmet medical need, RRMS still dominates drug development activity, with more candidates and more relative innovation density. SPMS and PPMS are experiencing increasing focus, but often from drugs already tested in RRMS. This suggests that while the field is evolving, it may not be diversifying as much as it could. Promising agents like tolebrutinib, a potentially first-in-class BTK inhibitor currently in late-stage trials for all three main subtypes with results expected later this year, may signal a shifting field.
MS remains a challenging and complex field, but 2025 could be a pivotal year. Let’s see what it brings!
If you're working in the neurological space — or in another complex therapeutic area — and need strategic support, feel free to reach out! We’re always happy to explore how we can help you move forward.
Links and interesting recent publications:
- https://worldmsday.org/
- https://www.nationalmssociety.org/
- Albelo-Martínez M, Rizvi S. Progressive multiple sclerosis: Evaluating current therapies and exploring future treatment strategies. Neurotherapeutics. Published online May 9, 2025. doi:10.1016/j.neurot.2025.e00601
- Woo MS, Engler JB, Friese MA. The neuropathobiology of multiple sclerosis. Nat Rev Neurosci. 2024;25(7):493-513. doi:10.1038/s41583-024-00823-z