Secondary Progressive Multiple Sclerosis (SPMS) Drug Market Grows as Oral S1P Modulators and Next-Generation BTK Inhibitors Target Disability Progression

The Secondary Progressive Multiple Sclerosis (SPMS) drug market is entering a more innovation-rich phase. As better diagnostics and longer survival increase the number of patients transitioning from relapsing-remitting MS (RRMS) to SPMS, demand is rising for therapies that slow disability progression, not just reduce relapses. Oral S1P modulators like siponimod, high-efficacy monoclonal antibodies, and late-stage BTK inhibitors are reshaping the treatment landscape and expanding the value of the SPMS segment within the broader multiple sclerosis (MS) market.

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Keyword Definition
Secondary Progressive Multiple Sclerosis (SPMS) is a stage of MS that follows an initial relapsing-remitting course. Over time, many patients experience:
• A gradual worsening of neurological disability
• With or without superimposed relapses

Clinically, SPMS is often divided into:
• Active SPMS: Disease still shows relapses and/or MRI activity
• Non-relapsing / non-active SPMS: Disability progresses without overt relapses

Treatment goals in SPMS focus on:
• Slowing disability progression
• Reducing relapses in active forms
• Managing symptoms (spasticity, gait issues, cognition, bladder function, fatigue)
• Maintaining function and quality of life
Key approved disease-modifying therapies (DMTs) for SPMS (depending on region/label) include siponimod (Mayzent), some high-efficacy monoclonal antibodies (used for "active SPMS" within relapsing MS labels), and supportive symptomatic drugs.

Market Size, CAGR and Outlook
Dedicated SPMS-focused reports indicate that:
• The global Secondary Progressive Multiple Sclerosis drug market is estimated at around USD 5.6 billion in 2024.
• It is projected to reach about USD 9.8 billion by 2033, reflecting a CAGR of roughly 6.5% from 2026 to 2033.
This SPMS-specific growth sits inside a broader MS therapeutics market valued at roughly USD 27-32 billion in 2024-2025, with forecasts to reach USD 38-50 billion by 2030-2034 at CAGRs around 4-6%.

Key points:
• As DMTs improve survival in early RRMS, more patients live long enough to enter the SPMS phase, expanding the SPMS drug-eligible population.
• Payers and clinicians are prioritizing therapies that demonstrate clear slowing of disability, particularly in active SPMS and non-relapsing SPMS.

Key Players and Leading Products
The SPMS segment is anchored by large global MS players plus generics/biosimilars:
• Novartis - Mayzent (siponimod), the first oral drug specifically approved for adult patients with SPMS with active disease in Europe and for relapsing forms of MS including active SPMS in the US.
• Roche - Ocrevus (ocrelizumab), a CD20 monoclonal antibody indicated for relapsing MS and primary progressive MS; widely used in active SPMS populations even though its core label is broader relapsing disease. Ocrevus generated ~CHF 6.7-7.4 billion revenue in 2024.
• Biogen, Novartis, Sanofi, TG Therapeutics - high-efficacy monoclonal antibodies and B-cell-depleting drugs (e.g., natalizumab, ofatumumab, Briumvi) used across aggressive forms of relapsing MS that overlap with active SPMS.
• BTK inhibitor developers - including Roche and others; tolebrutinib has shown positive phase 3 results in non-relapsing SPMS (nrSPMS) in the HERCULES trial, a population with few or no approved options.
• Generics and biosimilars manufacturers - following patent expiries of older injectables and upcoming expiries for some monoclonal antibodies, these players will gradually influence pricing dynamics in progressive MS as well.

Recent Developments and Pipeline Trends
A few developments are particularly important for the SPMS market:
• Oral S1P modulators for SPMS:
o Siponimod's EU approval in 2020 as the first oral drug specifically for active SPMS, and its FDA approval for relapsing forms including active SPMS, set a new standard in convenience and label clarity for this population.
o Generic competition is emerging; for example, a large Indian manufacturer recently received tentative US FDA approval for generic siponimod tablets, with US reference sales estimated around USD 195 million annually, which will add pricing pressure in the later forecast years.
• BTK inhibitors in non-relapsing SPMS:
o The HERCULES phase 3 trial showed that tolebrutinib delayed disability progression in non-relapsing SPMS patients, a group with no specific approved DMTs today. This opens a potential first-in-class opportunity and could materially expand the treated SPMS population if regulators grant an nrSPMS label.
• Broader MS innovation spillover:
o New mechanisms (BTK inhibitors, neuroprotective and remyelination agents) being tested across relapsing MS, SPMS, and PPMS will likely increase the therapeutic options for progressive stages, supporting long-term SPMS market growth.
• Digital and support solutions:
o Digital onboarding and patient-support programs built around SPMS drugs (e.g., Mayzent digital onboarding platforms) improve adherence and persistence, increasing real-world value per treated patient.

Market Segmentation and Growth Insights
By Disease Activity
• Active SPMS:
o Patients with relapses and/or MRI activity.
o Currently the most commercially relevant segment, as labels for siponimod and many monoclonal antibodies explicitly include "relapsing forms of MS including active SPMS."
• Non-active / non-relapsing SPMS:
o Historically undertreated due to lack of clear evidence of benefit with many DMTs.
o Expected to become an important new growth pocket if BTK inhibitors like tolebrutinib gain approval for nrSPMS.

By Drug Class
• S1P receptor modulators:
o Siponimod specifically oriented to SPMS; other S1Ps (fingolimod, ozanimod, ponesimod) are mainly RRMS but sometimes used in active SPMS.
• CD20 and other monoclonal antibodies:
o Ocrevus, ofatumumab, Briumvi and others used across aggressive relapsing disease, including active SPMS.
• BTK inhibitors (pipeline):
o Tolebrutinib and peers are the fastest-growing future class, targeting both inflammatory and progressive components of SPMS.
• Legacy injectables and orals:
o Interferons, glatiramer acetate, teriflunomide, dimethyl fumarate-still used in earlier phases; declining relevance in established SPMS but still present in some treatment pathways.

By Region
• North America:
Largest share of MS drug spending, with rapid uptake of new high-efficacy agents, high diagnostic rates, and broad access to siponimod and monoclonal antibodies.
• Europe:
Strong guideline-driven care, early adoption of Mayzent for SPMS, and growing interest in BTK inhibitors, balanced by tight HTA and cost-effectiveness reviews.
• Asia-Pacific:
Fastest relative growth, with rising MS diagnosis, expanding reimbursement in countries like Japan, Australia, and select middle-income markets, and gradual uptake of advanced DMTs.
• Latin America & Middle East/Africa:
Emerging markets for SPMS drugs, constrained by budget and access, but benefiting from increasing availability of generics and international assistance programs.

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Key Market Drivers
• Rising global prevalence of MS and an expanding cohort of patients transitioning from RRMS to SPMS.
• Strong clinical and payer focus on slowing disability progression, not just relapse control, especially in mid-life and older patients.
• Launch and wider adoption of oral SPMS-specific therapies like siponimod, which offer convenience and targeted labeling.
• Pipeline depth: at least 30+ drugs in development for SPMS across 30+ sponsors, including BTK inhibitors and other novel mechanisms.
• Expansion of digital support, adherence programs, and real-world evidence, helping demonstrate value and secure reimbursement for premium therapies.

Conclusion
The Secondary Progressive Multiple Sclerosis (SPMS) drug market is evolving from a relatively neglected corner of MS care into a strategic growth segment:
• 2024 market size around USD 5.6 billion,
• Forecast to reach nearly USD 10 billion by 2033,
• With a CAGR of about 6.5%.

Over the next decade, value will increasingly concentrate in:
• Oral SPMS-focused agents like siponimod,
• BTK inhibitors and other next-generation mechanisms that demonstrate disability-slowing effects, including in non-relapsing SPMS,
• High-efficacy monoclonal antibodies used in active SPMS populations,
• And integrated digital support ecosystems that improve adherence and outcomes.
Companies that can combine differentiated efficacy in progression, convenient dosing, robust long-term data, and payer-friendly value propositions will be best positioned to lead the SPMS market and capture a growing share of the broader MS therapeutics opportunity.

This report is also available in the following languages : Japanese (二次進行性多発性硬化症市場), Korean (2차 진행성 다발성 경화증 시장), Chinese (继发性进展型多发性硬化症市场), French (marché de la sclérose en plaques progressive secondaire), German (Markt für sekundär progrediente Multiple Sklerose), and Italian (Mercato della sclerosi multipla secondaria progressiva), etc.

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