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Multiple Sclerosis market

The Multiple Sclerosis (MS) market across the seven major markets (7MM) — the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan — is projected to experience steady growth over the coming decade. Valued at approximately USD 21,831 million in 2025, the market is expected to reach USD 30,597 million by 2034, expanding at a CAGR of 3.8% during the forecast period.

The United States will continue to dominate the MS market, accounting for the largest share, driven by a high diagnosed patient pool and the anticipated launch of next-generation therapies. Meanwhile, the EU4 and the UK together represent a substantial segment of the global MS burden, with Japan also contributing meaningfully to the overall market landscape.

Despite the availability of multiple approved therapies, including OCREVUS (Ocrelizumab) by Roche, LEMTRADA (Alemtuzumab) by Sanofi, MAYZENT (Siponimod) by Novartis, and VUMERITY (Diroximel fumarate) by Biogen, unmet needs persist in achieving long-term disease remission, halting progression, and improving neurological recovery.

The future of the Multiple Sclerosis market appears promising with the upcoming introduction of several innovative therapies such as remibrutinib, tolebrutinib, fenebrutinib, frexalimab, vidofludimus calcium, CNM-Au8, and masitinib, among others. The rising disease prevalence — influenced by modifiable factors like Epstein-Barr virus infection, low vitamin D levels, smoking, obesity, and irregular sleep patterns — along with genetic and geographical factors, continues to fuel market growth and research activity.

Leading pharmaceutical players such as Roche, Sanofi, Novartis, AB Science, and others are actively advancing their pipelines through various stages of clinical development, driving innovation and fostering competition in the MS therapeutic landscape.

Overall, the Multiple Sclerosis market is poised for sustainable expansion through 2034, supported by ongoing clinical research, increased disease awareness, and a shift toward targeted, high-efficacy therapies that aim to modify disease progression and enhance patient quality of life.

DelveInsight’s report, “Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast—2034,” provides an in-depth analysis of the evolving MS landscape. The report delivers comprehensive insights into disease epidemiology, market dynamics, current treatment practices, and emerging trends across the 7MM — equipping stakeholders with valuable intelligence for strategic planning, investment decisions, and future research initiatives.

Some of the key facts of the Multiple Sclerosis Market Report:

• The leading Multiple Sclerosis Companies developing therapies include Novartis, Sanofi, AB Science, Roche, Clene Nanomedicine, InnoCare Pharma, and others.

• Potential future therapies for Multiple Sclerosis include OCREVUS (ocrelizumab), OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq), LEMTRADA (alemtuzumab), Tolebrutinib (SAR442168), Fenebrutinib, Remibrutinib, and others.

• The future of Multiple Sclerosis treatment holds promise, driven by ongoing research and the development of innovative therapies. Current management strategies, such as symptomatic medications, physical therapy, and supportive care, remain essential.

Multiple Sclerosis Overview

Multiple sclerosis (MS) is a chronic and unpredictable condition that manifests differently in every individual. While some people experience a relatively mild form with minimal disability, others face a progressively worsening course that can cause significant physical and cognitive challenges. Most patients experience alternating periods of symptom flare-ups, such as vision disturbances, muscle weakness, or numbness, followed by partial or complete recovery phases.

The disease affects women more frequently than men. Although MS is rarely life-threatening and many individuals lead long, fulfilling lives, its impact can be profound without timely intervention. Early symptoms often include blurred or double vision, eye pain due to optic neuritis, or weakness and stiffness in the limbs, sometimes accompanied by painful muscle spasms. Other common issues include tingling sensations, balance difficulties, and bladder dysfunction. Over time, fatigue often intensifies, and emotional well-being may be affected, leading to depression, mood changes, or cognitive difficulties.

Fortunately, advances in treatment have brought new hope — emerging therapies can now slow disease progression and reduce disability, particularly when initiated early. This underscores the importance of prompt diagnosis and individualized care in improving long-term outcomes for people living with MS.

Learn more about Multiple Sclerosis treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ Multiple Sclerosis Treatment Market

Key Factors Driving Growth in the Multiple Sclerosis Market

• Rising Prevalence of Multiple Sclerosis: The global burden of multiple sclerosis (MS) continues to rise, supported by earlier and more accurate detection enabled through advanced imaging tools such as MRI. In 2024, the total diagnosed prevalent population across the seven major markets (7MM) was estimated at around 1.6 million cases, with this number expected to increase steadily over the 2025–2034 forecast period.

• Advancements in Disease-Modifying Therapies: The availability of a broad range of disease-modifying therapies (DMTs) has significantly improved MS management by reducing relapse rates and slowing disease progression, contributing to better long-term outcomes and quality of life for patients.

• Expanding Multiple Sclerosis Clinical Pipeline: The MS treatment landscape is experiencing dynamic research activity, with a strong and growing pipeline of investigational drugs at various stages of development. Notable therapies under evaluation include remibrutinib (Novartis), frexalimab and tolebrutinib (Sanofi), fenebrutinib (Genentech), vidofludimus calcium (Immunic Therapeutics), masitinib (AB Science), and CNM-Au8 (Clene Nanomedicine), among others.

• Promise of Tolebrutinib in Slowing Disease Progression: Among emerging candidates, tolebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, has shown encouraging results, demonstrating a 31% reduction in disease progression in patients with progressive MS. These findings highlight its potential to reshape treatment strategies and deliver meaningful improvements in outcomes for individuals with advanced forms of the disease.

Recent Developments in Multiple Sclerosis Clinical Trials:

• In August 2025, Hope Biosciences secured FDA RMAT designation for its HB-adMSCs stem cell therapy, developed for the treatment of relapsing-remitting multiple sclerosis (RRMS).

• In May 2025, Neuralink announced that its brain–computer interface device had received the FDA’s Breakthrough Device designation. The technology is designed to restore communication abilities in individuals with severe speech impairments resulting from conditions such as amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, and multiple sclerosis, marking a major advancement in neurotechnology.

• Earlier, in April 2025, the New England Journal of Medicine (NEJM) published results from the Phase III GEMINI 1 and 2 trials, which assessed tolebrutinib in patients with relapsing multiple sclerosis (RMS). These findings were also highlighted during the Clinical Trials Plenary Session at AAN 2025, reinforcing the growing clinical significance of BTK inhibitors in MS management.

Learn more about the recent advancements in Multiple Sclerosis treatment landscape @ Multiple Sclerosis Recent Developments

Multiple Sclerosis Epidemiology

• According to DelveInsight’s estimates, there were around 1.65 million diagnosed prevalent cases of Multiple Sclerosis (MS) across the seven major markets (7MM) in 2024. This number is expected to increase at a CAGR of 1.5% over the 2025–2034 forecast period.

• In the United States, approximately 920,000 adults were living with diagnosed MS in 2024, and this figure is anticipated to grow further by 2034, reflecting the rising awareness, improved diagnostics, and expanding patient population.

Multiple Sclerosis Epidemiology Segmentation

• Total Multiple Sclerosis Diagnosed Prevalent Cases

• Multiple Sclerosis Gender-specific Diagnosed Prevalent Cases

• Multiple Sclerosis Phenotype-specific Diagnosed Prevalent Cases

• Multiple Sclerosis EDSS-specific Diagnosed Prevalent Cases

Multiple Sclerosis Marketed Drugs

• OCREVUS (ocrelizumab): Roche (Genentech)

• OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq): F. Hoffmann-La Roche (Genentech)

• LEMTRADA (alemtuzumab): Sanofi

Multiple Sclerosis Emerging Drugs

• Tolebrutinib (SAR442168): Sanofi

• Fenebrutinib: Roche (Genentech)

• Remibrutinib : Novartis

Multiple Sclerosis Market Barriers

• High Cost of Therapies: Most disease-modifying therapies (DMTs) for MS are associated with substantial treatment costs, placing a significant financial burden on patients and healthcare systems. Limited reimbursement in certain regions further restricts accessibility, particularly for emerging therapies.

• Complex Disease Heterogeneity: MS presents with diverse clinical forms and progression patterns, making it difficult to predict treatment response or standardize care. This heterogeneity complicates therapy selection and hinders the development of universally effective treatments.

• Limited Options for Progressive MS: While several therapies effectively manage relapsing forms, progressive MS remains an area of high unmet need. Few approved treatments can significantly slow or reverse disease progression in this subset of patients.

• Adherence and Tolerability Issues: Long-term therapy adherence remains a challenge due to side effects, administration routes (e.g., injectables or infusions), and perceived lack of immediate benefits. This often leads to treatment discontinuation or reduced efficacy over time.

Request a free sample copy or view report summary: Multiple Sclerosis Market Report

Scope of the Multiple Sclerosis Market Report:

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Multiple Sclerosis Companies: Novartis, Sanofi, AB Science, Roche, Clene Nanomedicine, InnoCare Pharma, and others

• Key Multiple Sclerosis Therapies: OCREVUS (ocrelizumab), OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq), LEMTRADA (alemtuzumab), Tolebrutinib (SAR442168), Fenebrutinib, Remibrutinib, and others

• Multiple Sclerosis Therapeutic Assessment: Multiple Sclerosis current marketed and Multiple Sclerosis emerging therapies

• Multiple Sclerosis Market Dynamics: Multiple Sclerosis market drivers and Multiple Sclerosis market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Multiple Sclerosis Unmet Needs, KOL’s views, Analyst’s views, Multiple Sclerosis Market Access and Reimbursement

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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