Multiple Sclerosis Market Forecast 2034: Competitive Landscape, FDA Approvals, Therapies, Emerging Drugs Highlighting Zenas Biopharma's Obexelimab Phase 2 Success and Market Insights

Key multiple sclerosis companies such as Sanofi, Immunic, InnoCare Pharma, Tiziana Life Sciences, Biogen, J-Pharma, Bristol-Myers Squibb, Polpharma Biologics, Repertoire Immune Medicines, Nervgen, Nucleome Therapeutics, Medsenic, TeraImmun, Autobahn Therapeutics, Guangzhou Lupeng Pharmaceutical, GlaxoSmithKline, ImCyse, Novartis, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, etc
DelveInsight, a premier healthcare market research and consulting firm, proudly highlights a landmark advancement in the fight against Multiple Sclerosis (MS) with the recently published phase 2 clinical trial results of Zenas Biopharma's novel autoimmune drug candidate, obexelimab. Alongside unveiling this revolutionary therapy's potential, DelveInsight provides an extensive overview of the current and future Multiple Sclerosis market dynamics, opportunities, and challenges shaping this rapidly evolving therapeutic landscape.

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Zenas Biopharma's Obexelimab: Redefining Multiple Sclerosis Treatment Outcomes

Multiple Sclerosis, a chronic autoimmune disorder characterized by inflammation, demyelination, and neurodegeneration in the central nervous system, remains a significant therapeutic challenge, affecting millions worldwide. Recent breakthroughs, however, have provided renewed hope for patients and clinicians alike.

In the midstage MoonStone phase 2 trial, Zenas Biopharma's obexelimab demonstrated an unprecedented 95% reduction in new gadolinium (Gd)-enhancing T1 hyperintense lesions, measurable markers of disease progression in relapsing MS patients. Over a 12-week period, 116 patients received either 250 mg of obexelimab or placebo via subcutaneous injection, with remarkable lesion suppression apparent by week 8 and sustained through week 12, meeting the primary endpoint with high statistical significance.

Lisa von Moltke, M.D., Chief Medical Officer at Zenas, described the findings as "highly statistically significant" and highlighted the drug's unique B-cell inhibitory mechanism, subcutaneous self-administration convenience, and favorable tolerability profile as strong differentiators positioning obexelimab as a capable therapy to broadly target B-cell pathogenicity in autoimmune diseases. Importantly, the safety profile aligned with expectations, with infection and hypersensitivity cases consistent with prior trials.

The study's success was warmly received by investors, with Zenas' stock surging 20% in premarket trading following the news. The positive results also fortified confidence from Royalty Pharma, which invested $75 million in Zenas for sales royalties, underscoring the high commercial and clinical potential stakes.

Zenas plans to report further 24-week data in early 2026, including secondary endpoints that could illuminate obexelimab's impact on disability progression and inform the drug's development roadmap in relapsing MS. Beyond this, the company is advancing phase 3 studies in other autoimmune diseases and expanding its MS pipeline with newly licensed BTK inhibitor orelabrutinib currently in phase 3 trials targeting progressive forms of Multiple Sclerosis.

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Key Takeaways from the Multiple Sclerosis Pipeline Report

* DelveInsight's multiple sclerosis competitive report depicts a robust space with 75+ active players working to develop 80+ pipeline multiple sclerosis treatments.
* Key multiple sclerosis companies such as Sanofi, Immunic, InnoCare Pharma, Tiziana Life Sciences, Biogen, J-Pharma, Bristol-Myers Squibb, Polpharma Biologics, Repertoire Immune Medicines, Nervgen, Nucleome Therapeutics, Medsenic, TeraImmun, Autobahn Therapeutics, Guangzhou Lupeng Pharmaceutical, GlaxoSmithKline, ImCyse, Novartis, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., and others are evaluating new multiple sclerosis medications to improve the treatment landscape.
* Promising pipeline multiple sclerosis treatment drugs, such as SAR 441344, IMU-838, Orelabrutinib, Foralumab, BIIB091, JPH 034, CC-97540, PB018, Autoimmune disorder vaccines, NVG300, NT-0002, Arscimed, TI-235, LL-341070, LP-168, GSK 3888130B, IMCY-0141, and others are under different phases of multiple sclerosis clinical trials.

Key Developments in the Multiple Sclerosis Treatment Space

* In August 2025, Hope Biosciences received FDA RMAT designation for its HB-adMSCs stem cell therapy for treating relapsing-remitting multiple sclerosis (RRMS).
* In June 2025, newly reported data from the Phase III OPTIMUM-LT open-label extension trial (NCT03232073) showed that treatment with Ponesimod (Vanda Pharmaceuticals) was safe and led to sustained reduction in relapses, MRI lesions, and low disability accumulation among patients with relapsing multiple sclerosis over a long-term period. At time points of up to 8.2 years, more than half of the patients included were still relapse-free.
* In May 2025, Neuralink announced that it has 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 February 2025, Quantum BioPharma Ltd. announced that it had completed its trial entitled "A Phase I, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants." A final safety review committee ("SRC") meeting was held after completion of the trial. The SRC found that Lucid-21-302 "(Lucid-MS") was well-tolerated with no safety concerns, and no serious adverse events were reported during the trial.
* In January 2025, Contineum Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation, and immunology (NI&I) indications, announced that it has completed the targeted enrollment of 168 patients in its Phase II PIPE-307 VISTA trial.
* 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 had received Clinical Trial Authorization (CTA) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its lead candidate, PTD802.
* In December 2024, the FDA granted Breakthrough Therapy Designation to Sanofi's BTK inhibitor candidate Tolebrutinib for the treatment of adults with Nonrelapsing Secondary Progressive Multiple Sclerosis (SPMS).
* In October 2024, Immunic announced a positive outcome from the non-binding, interim futility analysis of its Phase III ENSURE program, which investigated the lead asset, nuclear receptor-related 1 (Nurr1) activator vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.
* In October 2024, Hope Biosciences Research Foundation (HBRF) announced positive top-line results of a Phase II clinical trial to evaluate Hope Biosciences' adiposederived autologous mesenchymal stem cell therapy (HB-adMSCs) for patients with mild to moderate relapsing-remitting multiple sclerosis (MS).
* In March 2024, Immunic, Inc., announced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 16/981,122, entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium (IMU-838) and a related method of production of the material. The claims are expected to protect 2039, unless extended further. The patent was previously granted to the company in Australia, Canada, Indonesia, Japan, and Mexico.
* In January 2024, TG Therapeutics, Inc. announced that it has agreed with Precision BioSciences, Inc. to acquire a worldwide license to Precision's Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications.

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Multiple Sclerosis Market Outlook: Growth Drivers and Challenges

DelveInsight's comprehensive Multiple Sclerosis market report provides an in-depth analysis of the global MS therapeutic market, trends, and forecasts through 2034. Key insights include:

* The MS market is undergoing significant growth driven by advances in understanding MS pathophysiology, emergence of targeted therapies, and increasing patient diagnosis and awareness globally. Innovation in disease-modifying therapies (DMTs) is paramount.
* Key therapeutic areas include relapsing-remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS), each with distinct unmet needs and evolving treatment algorithms.
* The landscape features established players with injectable, oral, and infusion therapies and a growing pipeline of next-generation biologics, small molecules, and cell-based treatments aimed at halting or reversing disease progression.
* The launch of novel agents like obexelimab and BTK inhibitors represent a paradigm shift with potential to enhance efficacy, safety, and patient convenience.
* Market challenges persist, including high treatment costs, accessibility issues, long-term safety and efficacy uncertainties, and the heterogeneous nature of disease progression necessitating personalized approaches.
* Geographic market segmentation highlights that North America retains the largest share due to high healthcare expenditure and developed infrastructure, while growing opportunities emerge in Europe, Asia-Pacific, and emerging markets emphasizing diagnosis capacity build-out and awareness campaigns.
* Regulatory environments, reimbursement policies, and payer dynamics will continue to be critical determinants of market growth trajectories and product uptake.
* Patient-centric initiatives, real-world evidence generation, and digital health integration play increasingly important roles in shaping the MS market ecosystem.

DelveInsight's report delivers a detailed assessment of epidemiology, current treatment paradigms, pipeline developments, competitive landscape, and commercial insights to empower stakeholders with actionable intelligence for strategic planning.

Approved Multiple Sclerosis Drug Analysis

BRIUMVI: TG Therapeutics

BRIUMVI is an innovative monoclonal antibody that binds to a distinct epitope on CD20-positive B-cells. Targeting CD20 with monoclonal antibodies has become a key strategy in treating autoimmune diseases like relapsing multiple sclerosis (RMS). BRIUMVI is specifically engineered through glycoengineering to lack certain sugar molecules typically found on antibodies. This modification enhances its ability to deplete B-cells effectively at lower doses. BRIUMVI is approved for use in adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis.

Tyruko: Sandoz

Tyruko has been designed to closely resemble the reference medicine, a well-established and highly effective anti-4 integrin monoclonal antibody used for modifying disease progression in relapsing forms of multiple sclerosis. In the United States, Tyruko is approved as a standalone treatment for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis, as well as for treating Crohn's disease in adults. It is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis.

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Multiple Sclerosis Market Drivers

* Rising Prevalence of Multiple Sclerosis - Increasing global cases (~2.5 million worldwide) with higher incidence among women is driving demand for effective treatments.
* Strong Pipeline of Novel Therapies - Advances in disease-modifying therapies (DMTs), biologics, and oral agents (e.g., sphingosine-1-phosphate receptor modulators, monoclonal antibodies).
* Regulatory Approvals & Expanded Indications - Ongoing FDA/EMA approvals of innovative therapies and label expansions boost market growth.
* Advances in Diagnostics - Improved MRI technology, biomarkers, and CSF analysis enable earlier and more accurate detection.
* Increasing Awareness & Diagnosis Rates - Patient advocacy groups and healthcare programs promote better disease recognition and treatment uptake.
* Personalized & Precision Medicine - AI-driven biomarker research and genetic profiling enhance targeted treatment approaches.
* Supportive Reimbursement Policies - Coverage in developed markets encourages patient access to high-cost therapies.

Multiple Sclerosis Market Barriers

* High Treatment Costs - Premium pricing of biologics and DMTs limits accessibility, particularly in low- and middle-income countries.
* Adverse Effects & Safety Concerns - Long-term immunosuppressive therapies pose risks such as infections and malignancies, affecting compliance.
* Complex Diagnosis - Lack of a definitive test and overlapping symptoms with other conditions delay timely intervention.
* Patent Expirations & Biosimilars - Entry of generics/biosimilars threatens revenues of blockbuster drugs.
* Regional Disparities - Limited infrastructure, specialist availability, and healthcare funding in emerging markets restrict adoption.
* Regulatory Hurdles - Stringent approval processes and long trial durations slow market entry for new therapies.
* Unmet Needs in Progressive Multiple Sclerosis - Current therapies are more effective for RRMS, while primary progressive Multiple Sclerosis (PPMS) and secondary progressive Multiple Sclerosis (SPMS) have fewer treatment options.

Scope of the Multiple Sclerosis Pipeline Report

* Coverage: Global
* Key Multiple Sclerosis Companies: Sanofi, Immunic, InnoCare Pharma, Tiziana Life Sciences, Biogen, J-Pharma, Bristol-Myers Squibb, Polpharma Biologics, Repertoire Immune Medicines, Nervgen, Nucleome Therapeutics, Medsenic, TeraImmun, Autobahn Therapeutics, Guangzhou Lupeng Pharmaceutical, GlaxoSmithKline, ImCyse and others.
* Key Multiple Sclerosis Pipeline Therapies: SAR 441344, IMU-838, Orelabrutinib, Foralumab, BIIB091, JPH 034, CC-97540, PB018, Autoimmune disorder vaccines, NVG300, NT-0002, Arscimed, TI-235, LL-341070, LP-168, GSK 3888130B, IMCY-0141 and others.

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About DelveInsight

DelveInsight is a leading market research and consulting company specializing in pharmaceutical, biotechnology, and healthcare industries. With a strong focus on niche therapeutic segments including neurology and autoimmune diseases, DelveInsight provides comprehensive market intelligence, forecasts, competitive analysis, and strategic consultancy to support informed decision-making.

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