(Albany, US) On November 10, 2026, DelveInsight’s “Primary Progressive Multiple Sclerosis Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Primary Progressive Multiple Sclerosis (PPMS) market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.
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Key Takeaways from the Primary Progressive Multiple Sclerosis Report
In September 2026, Roche announced that the FDA accepted its NDA for fenebrutinib in PPMS under priority review, based on the Phase III FENtrepid study.
In February 2026, Roche reported that FENtrepid met its primary endpoint of non-inferiority versus ocrelizumab in reducing disability progression in PPMS, with a hazard ratio of 0.88.
In August 2026, Zenas BioPharma announced that four orelabrutinib abstracts were accepted for poster presentation at MSToronto 2026. In October 2025, Zenas licensed global rights to orelabrutinib for multiple sclerosis and non-oncology areas from InnoCare, and the Phase III PriMroSe trial began in Q3 2025.
In December 2025, Sanofi’s tolebrutinib missed the primary endpoint in the Phase III PERSEUS study in PPMS, and Sanofi dropped plans to seek PPMS approval. AB Science suspended its late-stage masitinib program in multiple sclerosis.
Ocrelizumab (OCREVUS, Roche) is the only approved disease-modifying therapy for PPMS, with global sales of about USD 8.5 billion in 2025 across indications.
DelveInsight estimates about 229,600 diagnosed prevalent PPMS cases in the 7MM in 2025, including about 125,000 in the US.
DelveInsight’s report depicts a concentrated market with a narrow pipeline now centered on CNS-penetrant BTK inhibitors.
Leading Primary Progressive Multiple Sclerosis companies include Roche, Zenas BioPharma, InnoCare, and others.
Promising therapies include ocrelizumab (OCREVUS), fenebrutinib, orelabrutinib, and others.
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Primary Progressive Multiple Sclerosis Overview
PPMS is a chronic, immune-mediated neurodegenerative disorder with gradual worsening of neurological function from onset, without distinct relapses or remissions. It makes up about 10 to 15% of multiple sclerosis cases and results from chronic inflammation, demyelination, axonal loss, and neurodegeneration. Compared with relapsing forms, it appears at an older age and affects men and women more equally. Diagnosis relies on continuous progression for at least 12 months, supported by brain and spinal cord MRI and cerebrospinal fluid oligoclonal bands. Ocrelizumab is the main disease-modifying therapy, alongside rehabilitation and symptom management for spasticity, pain, fatigue, and bladder dysfunction.
Common symptoms include:
Progressive gait impairment
Lower-limb weakness and spasticity
Balance difficulties
Fatigue
Bladder dysfunction and cognitive impairment
Primary Progressive Multiple Sclerosis Emerging Drugs Profile
Fenebrutinib: Roche Fenebrutinib is an investigational oral, CNS-penetrant, reversible, non-covalent BTK inhibitor with high selectivity for BTK over other kinases. In the Phase III FENtrepid study, it met its primary endpoint of non-inferiority to ocrelizumab on disability progression. The FDA accepted its NDA under priority review in September 2026. Currently, the drug is in Phase III, with an NDA under review.
Orelabrutinib: Zenas BioPharma Orelabrutinib is an oral, highly selective, CNS-penetrant BTK inhibitor aimed at compartmentalized inflammation and disease progression in multiple sclerosis. The Phase III PriMroSe trial began in Q3 2025, with no pivotal PPMS readout yet. Currently, the drug is in Phase III.
Explore groundbreaking therapies and clinical trials in the Primary Progressive Multiple Sclerosis Pipeline @ Primary Progressive Multiple Sclerosis Treatment Drugs
Primary Progressive Multiple Sclerosis Market Drivers
Focus on disease-modifying therapy: Ocrelizumab’s success and next-generation BTK inhibitors are expanding options to slow disability progression.
Late-stage progress: Fenebrutinib has an NDA under priority review, and orelabrutinib is in Phase III.
Aging population and disease burden: Long-term disability drives demand for therapies that preserve function.
Oral convenience: Oral BTK inhibitors could offer an alternative to infused ocrelizumab.
Supportive regulatory environment: Orphan incentives, expedited pathways, and academia-industry collaboration encourage development.
Large unmet need: Current therapy slows but does not stop progression.
Strategic deals: Zenas’s license for orelabrutinib shows continued investment.
Learn about new drugs, pipeline developments, and key players with DelveInsight’s expert analysis @ Primary Progressive Multiple Sclerosis Market Drivers and Barriers
Primary Progressive Multiple Sclerosis Market Barriers
Pipeline failures: Tolebrutinib’s PERSEUS miss and masitinib’s suspension show how hard late-stage PPMS trials are.
Entrenched leader: Ocrelizumab is well established, and new agents must show clear differentiation.
Slow-progressing disease: Long trials with disability endpoints and limited inflammatory activity complicate development.
Limited biomarkers: Gradual onset and few disease-specific markers delay diagnosis.
Narrow pipeline: Only a few candidates are in late-stage development.
Limited repair options: No therapy yet prevents neuronal loss or restores myelin.
High treatment cost: An annual cost near USD 97,200 is assumed, so payers may scrutinize new agents.
Scope of the Primary Progressive Multiple Sclerosis Report
Coverage: 7MM (US, EU4, UK, Japan)
Companies: As listed above
Therapies: Ocrelizumab (OCREVUS), fenebrutinib, orelabrutinib, and others
Study Period: 2022–2036 (Historical: 2022–2025; Forecast: 2026–2036; Base Year: 2026)
Analysis: Epidemiology segmentation, market size by therapy, drug uptake, KOL views, SWOT, conjoint analysis, reimbursement, unmet needs
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Table of Contents
Introduction
Executive Summary
Primary Progressive Multiple Sclerosis: Overview
Pipeline Therapeutics
Therapeutic Assessment
DelveInsight’s Analytical Perspective
Late Stage Products (Phase III): Fenebrutinib (Roche), Orelabrutinib (Zenas BioPharma)
Mid Stage Products (Phase II): None specified
Early Stage Products (Phase I): None specified
Preclinical and Discovery Stage Products
Inactive Products
Key Companies
Key Products
Unmet Needs
Market Drivers and Barriers
Future Perspectives and Conclusion
Analyst Views
Appendix
About Us
About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.
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