Multiple Sclerosis Competitive Landscape, 2025: Over 75+ Assets Shaping the Future of CNS Autoimmune Therapy | DelveInsight

DelveInsight's "Multiple Sclerosis - Competitive Landscape, 2025" offers a deep dive analysis into the evolving therapeutic ecosystem for this chronic autoimmune disorder of the central nervous system. With 60+ drugs and 75+ companies featured, the report delivers an authoritative review of the competitive dynamics, treatment innovations, and strategic positioning of key assets across relapsing and progressive forms of MS.

The landscape is becoming increasingly diverse with new entrants challenging legacy DMTs (Disease-Modifying Therapies). This report evaluates interferons, monoclonal antibodies, oral S1P receptor modulators, BTK inhibitors, remyelination therapies, and neuroprotective agents. With growing interest in non-immunosuppressive and remyelinating mechanisms, the competitive field is expanding beyond inflammation control.

DelveInsight provides segmentation by product type, developmental stage, route of administration, and molecule type. It also examines discontinued and inactive programs, offering clues to potential pitfalls and emerging white spaces in the MS market.

Prominent players, including Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, and others, are investing in next-gen approaches to enhance efficacy, reduce treatment burden, and improve long-term safety profiles. Meanwhile, BTK inhibitors (like evobrutinib and tolebrutinib) and cell-based remyelination therapies are progressing through mid-to-late clinical stages, offering promising new avenues for patient care.

In a market challenged by treatment-resistant forms, long-term disability, and the need for early intervention, DelveInsight's competitive landscape analysis provides a strategic lens to assess pipeline potential, partnerships, and future disruptors-equipping pharma stakeholders with the intelligence to lead in the competitive race for MS innovation.

Interested in learning more about the current treatment landscape and the key drivers shaping the multiple sclerosis pipeline? Click here: https://www.delveinsight.com/report-store/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Multiple Sclerosis Competitive Landscape Report
• DelveInsight's multiple sclerosis competitive analysis depicts a strong space with 60+ active players working to develop 75+ drugs for multiple sclerosis treatment.
• The leading Multiple Sclerosis companies include Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., ImCyse, and others are evaluating their lead assets to improve the Multiple Sclerosis treatment landscape.
• Key Multiple Sclerosis pipeline therapies in various stages of development include Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, Evobrutinib, Masitinib, Adezunap, BIIB091, Foralumab, WP1303, ATL1102, RC18, ATA188, PIPE-307, SCM-010, UMSC01, IMCY-0141, and others.
• In May 2025, Neuralink announced that it received the FDA's "breakthrough" designation for its device aimed at restoring communication for individuals with severe speech impairment. The device, designed to assist patients with conditions like amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, and multiple sclerosis, represents a significant step forward in neurotechnology.
• In March 2025, the FDA began priority review of the regulatory submission for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation in adult patients, independent of relapse activity.
• In January 2025, the FDA added a new boxed warning to multiple sclerosis therapies, including Teva Pharmaceuticals' Copaxone, regarding the risk of severe and potentially life-threatening allergic reactions. The warning applies to glatiramer acetate, an immunomodulatory peptide therapy used for MS, though its exact mechanism of action is not fully understood. Other brands using glatiramer acetate for MS include Pendopharm's Glatect and Sandoz's Glatopa.
• In January 2025, Century Health and Nira Medical announced a partnership to curate data from more than 3,000 patients with multiple sclerosis to advance the understanding of the disease and treatment outcomes. Based on data from Nira Medical's network of clinics, Century Health's AI platform will create structured datasets that will be analyzed in partnership with life sciences companies to accelerate research into MS treatment and improve patient outcomes.
• In January 2025, Pheno Therapeutics Limited announced that it received Clinical Trial Authorization (CTA) from the UK's MHRA (Medicines and Healthcare products Regulatory Agency) for its lead candidate, PTD802.

Request a sample and discover the recent breakthroughs happening in the multiple sclerosis competitive landscape at https://www.delveinsight.com/report-store/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Multiple Sclerosis Overview
Multiple sclerosis (MS) is the most common immune-mediated neurological disorder in young adults, typically presenting between ages 20 and 40, and affecting around 400,000 people in the U.S. and 2.5 million globally. It is three times more common in women and has a higher prevalence among individuals of European descent.

MS targets the central nervous system, damaging the myelin sheath that protects nerve axons. The most common form, relapsing-remitting MS (RRMS), accounts for about 85% of cases and is characterized by flare-ups of symptoms followed by periods of remission. Common early symptoms include vision disturbances, muscle weakness, stiffness, tingling, and pain.

The exact cause is unknown, but genetic, environmental, and infectious factors are believed to contribute. Inflammation in the CNS is central to disease progression, and animal models like experimental autoimmune encephalomyelitis (EAE) help researchers study immune responses involved.

Diagnosis involves a combination of clinical evaluation, MRI, evoked potentials, and cerebrospinal fluid (CSF) analysis, as no single definitive test exists. Treatment focuses on disease-modifying therapies (DMTs) to slow progression and symptomatic management. Currently, 12 therapies are approved by the FDA and EMA, including dimethyl fumarate, alemtuzumab, pegylated interferon-ß, and glatiramer acetate.

Find out more about multiple sclerosis medication at https://www.delveinsight.com/report-store/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Multiple Sclerosis: Company and Product Profiles (Marketed Therapies)
Company Overview: TG Therapeutics
TG Therapeutics is a biopharmaceutical company focused on the development and commercialization of innovative therapies for B-cell diseases, including autoimmune disorders such as multiple sclerosis and B-cell malignancies like non-Hodgkin lymphoma. Established in 2011 and headquartered in New York, the company leverages advancements in B-cell biology to enhance patient outcomes. Its key products include ublituximab, a glycoengineered monoclonal antibody targeting CD20-expressing B-cells, and umbralisib. A major milestone for the company is the FDA approval of BRIUMVI, a treatment for relapsing forms of multiple sclerosis. TG Therapeutics supports widespread patient access to its medicines through an extensive network of global clinical trial sites. With a strong focus on research and development, the company is committed to delivering effective and convenient treatment options for B-cell-mediated diseases.

Product Description: BRIUMVI
BRIUMVI is a novel monoclonal antibody that targets a specific epitope on CD20-expressing B-cells. The CD20-targeting approach with monoclonal antibodies has become a key strategy in managing autoimmune diseases like RMS. Uniquely glycoengineered to lack certain sugar molecules typically found on antibodies, BRIUMVI achieves efficient B-cell depletion at low doses. It is approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Multiple Sclerosis: Company and Product Profiles (Pipeline Therapies)
1. Company Overview: Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies using alternative drug delivery methods. Its lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development. This nasal delivery approach may offer improved efficacy, safety, and tolerability compared to traditional intravenous (IV) methods. Tiziana's patented platform enables broad pipeline applications, with several patent filings pending.

Product Description: Foralumab
Foralumab is a fully human anti-CD3 mAb designed to modulate immune responses by targeting the T cell receptor, promoting T regulatory cell activation and reducing inflammation. In an Expanded Access Program for non-active secondary progressive multiple sclerosis (na-SPMS), all 10 patients showed either improvement or disease stability. The program is expanding to include 20 more patients, alongside a Phase IIa trial. Intranasal foralumab has shown positive immunomodulatory effects in MS, COVID-19, and healthy subjects, supporting its potential in treating neuroinflammatory and neurodegenerative diseases.

2. Company Overview: J-Pharma Co., Ltd.
J-Pharma Co., Ltd. is a clinical-stage biotech company based in Yokohama, Japan, founded in 2005 by Dr. Hitoshi Endou. The company pioneers therapies targeting solute carrier (SLC) transporters, especially LAT1 (L-type amino acid transporter 1), which is overexpressed in cancers and autoimmune diseases. Lead candidates include nanvuranlat (JPH203) for biliary tract cancer and JPH034 for multiple sclerosis and brain tumors. J-Pharma also operates a U.S. subsidiary to support its global development strategy.

Product Description: JPH034
JPH034 is a small-molecule LAT1 inhibitor targeting L-type amino acid transporter 1, essential for nutrient uptake in cancer cells. By blocking LAT1, JPH034 aims to inhibit tumor growth, with early clinical trials showing promise in solid tumors, including glioblastoma. The drug is part of J-Pharma's broader effort to advance LAT1-targeted therapies as novel treatments for cancer and CNS diseases.

Discover how emerging multiple sclerosis therapies stack up against current treatments in the evolving market landscape: https://www.delveinsight.com/report-store/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Multiple Sclerosis Therapeutics Assessment
Company Analysis
Therapeutic Assessment
Pipeline Assessment
Inactive drugs assessment
Unmet Needs

Scope of the Multiple Sclerosis Competitive Landscape Report
• Coverage: Global
• Key Multiple Sclerosis Companies: Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., ImCyse, and others.
• Key Multiple Sclerosis Pipeline Therapies: Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, Evobrutinib, Masitinib, Adezunap, BIIB091, Foralumab, WP1303, ATL1102, RC18, ATA188, PIPE-307, SCM-010, UMSC01, IMCY-0141, and others.

To dive deep into rich insights for drugs used for multiple sclerosis treatment, visit: https://www.delveinsight.com/report-store/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Multiple Sclerosis Overview
4. Analytical & Commercial Assessment
5. Competitive Landscape
6. Marketed Therapies
7. Pipeline Therapies (by development stage)
8. Unmet Needs
9. Market Drivers & Barriers
10. Appendix

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Jatin Vimal
jvimal@delveinsight.com
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Healthcare Consulting
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About DelveInsight
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This release was published on openPR.