The multiple sclerosis market is entering a competitive reshaping phase inside and beyond anti-CD20

Overview

This report evaluates the multiple sclerosis treatment landscape, focusing on long-acting subcutaneous and home-dosing innovation within the anti-CD20 category, the impact of biosimilars entering after Ocrevus and Kesimpta in the 2030s, and the competitive potential of BTK inhibitors and next-generation B-cell therapies outside anti-CD20. The report argues that anti-CD20 still has the strongest class efficacy and safety foundation, but the market will shift from single-player dominance to share reallocation based on dosing convenience, patent protection, pricing pressure, and clinical differentiation.

Core views

Core views include: first, anti-CD20 therapies remain the backbone of MS treatment, currently accounting for about 45% of the market and expected to rise to about 60% over time; second, Ocrevus OBI, long-acting Kesimpta, and Briumvi SC as long-acting home-dosing products may raise the self-administration share among patients; third, Ocrevus and Kesimpta biosimilars are expected to deliver moderate disruption in the 2030s, mainly impacting their respective reference products; fourth, BTK inhibitors can provide an oral option for patients who fear injections or need maintenance therapy, but uncertainties in efficacy and clinical-data complexity limit near-term disruptive potential; fifth, CAR-T and brain-shuttle therapies may become longer-term frontier avenues.

Analysis framework

The report combines proprietary physician interviews, IQVIA BrandImpact with roughly 200 treatment-decision samples per month, feedback from about 56 physicians, analogs from existing biologic exclusivity-loss cases, clinical data, and company pipeline catalysts to analyze anti-CD20 category share, biosimilar penetration, BTKi sales peaks, and TGTX valuation scenarios.

Methodology notes

• Market structure analysisMechanism and dosing-scenario segmentation

  Segment the MS market by anti-CD20, oral drugs, other monoclonal antibodies, and next-generation therapies, and further split by in-clinic dosing versus home dosing.

  This framework evaluates how long-acting subcutaneous and self-administered products change patient convenience, physician choice, and company market share.

• Physician researchProprietary physician survey

  Survey physicians' attitudes toward long-acting subcutaneous formulations, biosimilars, and treatment choices for newly diagnosed patients.

  The survey indicates about 60% of physicians are willing to use biosimilars in new patients, but 40% would restrict use unless payer mandates require it, suggesting payer policy is critical for biosimilar adoption.

• Comparable casesHumira and Lucentis/Eylea exclusivity-loss analogs

  Infer MS market price and share effects from biosimilar entry cases in TNF and wet AMD markets.

  Goldman believes biosimilars generally hit the reference product first; if competing brands maintain clinical or convenience differentiation, they can retain relatively strong revenue resilience.

Asset mapping & comparison

Structured mapping from thesis to named assets (strengths, weaknesses, peers, risks).

• Novartis (NOVN) / Kesimpta / remibrutinib

  Beneficiaries of anti-CD20 home dosing and BTKi oral therapies

  Strengths

  Kesimpta already has a home subcutaneous platform, and a long-acting version is expected to improve convenience; the peak sales forecast for Kesimpta has been raised to about USD 7.0 billion.

  Weaknesses

  remibrutinib is a covalent BTKi with no unblinded MS efficacy data yet, and its indication breadth is narrower than fenebrutinib’s.

  Comparison

  Compared with Ocrevus, Kesimpta is more patient self-dosing oriented; compared with TGTX, it has a much larger scale and stronger existing base.

  Risks

  Uncertainty around BTKi efficacy, MS safety at high doses, and long-term biosimilar erosion.

• Roche (ROPC) / Ocrevus / fenebrutinib

  Current anti-CD20 leader and key non-covalent BTKi participant

  Strengths

  Ocrevus is the CD20 category leader, covering RMS and PPMS; fenebrutinib reduced relapses by 51%-59% versus Aubagio in phase III data.

  Weaknesses

  Ocrevus faces biosimilar entry in the 2030s; fenebrutinib data package is complex, and mortality imbalance requires further explanation.

  Comparison

  Ocrevus is the largest in scale but faces convenience pressure from administration mode; fenebrutinib has more favorable data than covalent BTKis, but commercial ramp may be slower than expected.

  Risks

  Biosimilar pricing and share erosion, interpretation of AAN conference data, and infection-related safety concerns.

• TG Therapeutics (TGTX) / Briumvi IV / Briumvi SC

  High-sensitivity beneficiaries in long-acting home subcutaneous dosing and share migration

  Strengths

  Briumvi SC can offer 8-week or 12-week dosing intervals; the report raised TGTX's royalty-adjusted unadjusted Briumvi peak sales forecast to USD 2.6 billion, and Briumvi’s loss of exclusivity is in 2042.

  Weaknesses

  Briumvi SC still requires phase III confirmation and currently has a much smaller market share than Ocrevus and Kesimpta.

  Comparison

  Compared with Ocrevus and Kesimpta, TGTX starts from a lower base but has greater room for share expansion; the long patent period helps cushion biosimilar risk.

  Risks

  Clinical failure, payer-driven Ocrevus biosimilar promotion, and pricing/gross-to-net discount pressure.

• Sanofi / tolebrutinib / frexalimab

  Oral BTKi and CD40 next-generation competitors outside anti-CD20

  Strengths

  tolebrutinib shows about 29% reduction in disability progression risk; frexalimab could rejuvenate neuroscience franchises if phase III readouts in 2027 are successful.

  Weaknesses

  tolebrutinib has not shown relapse-rate advantage versus Aubagio, and frexalimab still awaits phase III data in 2027.

  Comparison

  Compared with CD20 therapies, oral or novel-mechanism candidates offer differentiation but must clear high efficacy and safety thresholds.

  Risks

  Clinical endpoint failure, low market expectations, insufficient efficacy, or safety issues.

Key data

• Global MS market sizeabout USD 21 billionThe report states the global multiple sclerosis market is currently about USD 21 billion.
• Global anti-CD20 salesabout USD 12 billionAnti-CD20 therapies are the leading category in the MS market.
• US MS market sizeabout USD 14 billionThe US market has about 25-30 approved therapies.
• Current CD20 market shareabout 45%The report expects long-term share to rise to about 60%.
• CD20 category NWRx shareabout 60%Based on IQVIA BrandImpact data from February 2026.
• Current dosing-setting structureabout 65% in clinic, about 35% at homeBased on 2025 revenue, net-price assumptions, and company commentary.
• Long-term dosing-setting outlookabout 55% in clinic, about 45% at homeAfter launch of long-acting subcutaneous formulations, patient self-dosing share is expected to rise.
• Ocrevus current share of CD20 revenueabout 57%, including Ocrevus ZunovoThe chart shows Ocrevus IV at about 52% and Ocrevus Zunovo at about 6%.
• Kesimpta current share of CD20 revenueabout 35%-37%The cited basis differs slightly across chart and text.
• Briumvi current share of CD20 revenueabout 5%-8%The report states Briumvi remains a later entrant but with clearly rising NWRx share.
• TGTX Briumvi unadjusted royalty-free peak salesUSD 2.6 billionHigher than the prior USD 2.0 billion forecast.
• Roche Ocrevus peak sales forecastCHF8.8bn / $11.1bnThe report expects 15%-20% biosimilar erosion after 2031.
• Roche fenebrutinib peak sales forecastCHF3.9bn / $4.9bnCovers RMS and PPMS, peaking in 2036.
• Novartis Kesimpta peak sales forecastabout USD 7.0 billionPreviously USD 6.7 billion.
• Novartis remibrutinib peak sales forecastabout USD 2.4 billionPeak in 2036, RMS indication only.

Impact & implications

On investment implications, NOVN benefits from Kesimpta becoming more long-acting and slower biosimilar erosion; ROPC’s Ocrevus still has a large-scale advantage, but fenebrutinib has a more complex near-term ramp and safety narrative; TGTX benefits from Briumvi SC, rising home-dosing share, and the 2042 loss of exclusivity date, with valuation highly sensitive to biosimilar erosion assumptions.

Risks

• Biosimilar entry speed and payer-enforced substitution policy could be faster than expected, leading to quicker price and share erosion for originator brands.
• BTK inhibitors carry efficacy uncertainty and safety concerns, especially mortality imbalance, infection-related events, and historical failures of covalent agents.
• Long-acting subcutaneous or home-dosing products still require clinical data, BLA filings, and commercialization validation; actual uptake may be lower than physician survey indications.
• MS B-cell therapies already have a high efficacy bar, and next-generation therapies could face limited commercial penetration if they cannot show clear differentiation.
• TGTX valuation is highly sensitive to assumptions around Briumvi SC success, pricing, gross-to-net discounts, and biosimilar erosion.

What to watch

• At the 2026 AAN meeting from April 18-22, full fenebrutinib data, Aubagio comparator performance, explanation of mortality imbalance, and confirmation of disability progression endpoints.
• Novartis remibrutinib REMODEL-1 and REMODEL-2 data readouts in the middle to late 2026 period.
• Full phase III data for Briumvi SC from late 2026 to early 2027, BLA filing in 2027, and potential launch in 2028.
• Key clinical readouts for long-acting Kesimpta in 2027 and potential launch in 2028.
• Entry timing in the 2030s, payer policies, and real replacement rates for Ocrevus OBI, Ocrevus biosimilars, and Kesimpta biosimilars.
• Sanofi frexalimab phase III readouts in 2027, plus early CART and brain-shuttle therapy data during 2028-2030.