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Ublituximab Market

The market for Ublituximab was estimated at $1.5 billion in 2025; it is anticipated to increase to $2.4 billion by 2030, with projections indicating growth to around $3.7 billion by 2035.

Report ID:DS1802545
Author:Debadatta Patel - Senior Consultant
Published Date:
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Life Science
Pharmaceutical
Ublituximab
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Market Data
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Table of Contents

Global Ublituximab Market Outlook

Revenue, 2025

$1.5B

Forecast, 2035

$3.7B

CAGR, 2026 - 2035

9.3%

The Ublituximab industry revenue is expected to be around $1.5 billion in 2026 and expected to showcase growth with 9.3% CAGR between 2026 and 2035. This trajectory positions Ublituximab as a strategically important monoclonal antibody therapy within the global biologic drugs market, underpinned by rising diagnosis rates, favorable safety and efficacy data, and expanding reimbursement coverage across key healthcare systems. Demand is primarily anchored in multiple sclerosis and hematologic malignancies, which together account for 89.9% of the therapeutic area mix, reflecting strong specialist confidence in anti-CD20 therapy for B-cell-mediated disease. The dominance of the intravenous infusion formulation type, which generated approximately $1.41 billion in Ublituximab sales in 2025, further illustrates its embedded role in infusion-center workflows and hospital treatment pathways. These factors collectively reinforce the therapy’s current significance and indicate sustained relevance as healthcare systems prioritize high-value, targeted immunotherapy options.

Ublituximab, also known as Briumvi, is a next-generation, glycoengineered anti-CD20 monoclonal antibody therapy designed to achieve deep and sustained B-cell depletion with relatively short intravenous infusion times and a streamlined dosing schedule. Its core features including enhanced antibody-dependent cellular cytotoxicity, targeted B-cell selectivity, and a favorable benefit-risk profile support its use as a high-value multiple sclerosis treatment and as a promising option in hematologic malignancies, particularly when used in rational combination therapy regimens. Recent market momentum is being driven by increasing adoption in relapsing multiple sclerosis, renewed interest in CD20-directed immunotherapy across B-cell-driven diseases, and a growing body of real-world evidence complementing pivotal clinical trials. Alignment with personalized medicine strategies and evolving treatment algorithms is further expected to broaden its role within neurology and oncology practice over the coming decade.

Ublituximab market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
Ublituximab Market Outlook

Market Key Insights

  • The Ublituximab market is projected to grow from $1.5 billion in 2025 to $3.7 billion in 2035. This represents a CAGR of 9.3%, reflecting rising demand across Treatment of Relapsing Forms of Multiple Sclerosis (RMS), Chronic Lymphocytic Leukemia (CLL) Intervention, and Non-Hodgkin Lymphoma (NHL) Treatment.

  • TG Therapeutics Inc. is the sole producer in this market, holding full control over supply and pricing.

  • U.S. and China are the top markets within the Ublituximab market and are expected to observe the growth CAGR of 6.8% to 9.8% between 2025 and 2030.

  • Emerging markets including Brazil, Indonesia and South Africa are expected to observe highest growth with CAGR ranging between 8.9% to 11.6%.

  • Slow adoption of Oncological Therapies Transformation transition within key players in Ublituximab market is creating a revenue window for adjacent and alternate markets like Rituximab and Ofatumumab to improve its use-case penetration in and applications and expected to capture $119 million revenue from existing Ublituximab market.

  • The Ublituximab market is set to add $2.2 billion between 2025 and 2035, with manufacturer targeting key segments projected to gain a larger market share.

  • With

    increasing prevalence of cancer, and

    Strategic Collaborations Bolstering Market Growth, Ublituximab market to expand 143% between 2025 and 2035.

ublituximab market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Ublituximab - Country Share Analysis

Opportunities in the Ublituximab

Ublituximab is also positioning itself as an anti-CD20 monoclonal antibody in multiple sclerosis treatment, with particularly strong upside in relapsing multiple sclerosis populations. The intravenous infusion segment is forecast to grow from $1.41 billion in 2025 to $2.22 billion by 2030, delivering a 9.5% CAGR as neurologists favor higher efficiency B-cell depletion and shorter infusion times. Underpenetrated community neurology practices and hospital pharmacies represent key white spaces, where education, real-world data, and patient-support programs can scale adoption and expand long-term treatment persistence.

Growth Opportunities in North America and Europe

In North America, Ublituximab demand is primarily anchored in multiple sclerosis therapy, where high diagnosis rates and strong neurologist familiarity with anti-CD20 monoclonal antibody classes support sustained uptake over time. Top opportunities center on positioning Ublituximab as a differentiated infusion therapy through streamlined outpatient administration, optimized pricing strategy for commercial and Medicare segments, and targeted access programs for relapsing MS patients switching from older disease-modifying drugs. Competitive pressure remains intense from incumbent anti-CD20 and oral MS agents, making head-to-head real-world evidence, tolerability messaging, and co-pay support essential to defend share. Key regional drivers include robust neurologist networks, sophisticated payer evaluation frameworks rewarding cost-effective biologic therapy, and patient advocacy efforts that accelerate guideline inclusion and drive faster treatment escalation in highly active disease.
In Europe, Ublituximab has its strongest potential in multiple sclerosis therapy with growing relevance in CIS management, where earlier intervention is increasingly favored by clinical guidelines and national neurology societies. The top opportunities lie in selective launches in markets with mature HTA systems receptive to budget-impact reductions, country-specific risk-sharing agreements, and hospital-based infusion therapy models that can absorb biologic volumes efficiently. Competition is shaped by entrenched anti-CD20 monoclonal antibodies and stringent biosimilar policies, requiring a clear value narrative on dosing convenience, service support, and health-economic benefits in both MS and hematologic malignancies treatment subsegments. Regional growth drivers include expanding MS registries that generate supportive real-world outcomes data, harmonization of treatment pathways across leading markets, and policy initiatives promoting timely access to innovative therapies for high-burden neurologic conditions, all of which enhance patient adoption of Ublituximab.

Market Dynamics and Supply Chain

01

Driver: Expansion of Targeted B-Cell Depletion Therapy Coupled with Growing Multiple Sclerosis Treatment Demand

A primary market driver for ublituximab is also the expansion of targeted B-cell depletion therapies alongside the increasing demand for effective multiple sclerosis treatment options. Ublituximab’s mechanism of selectively binding CD20 on B-cells and enhancing antibody-dependent cellular cytotoxicity positions it within a niche of highly potent, targeted immunotherapies that aim to achieve deeper and more sustained disease control with less frequent dosing. This trend aligns with broader industry shifts toward precision biologics that reduce systemic immunosuppression while maintaining strong efficacy. Concurrently, the global MS treatment landscape continues to evolve as prevalence rises and clinicians seek therapies that improve relapse rates and delay disability progression. With oral and injectable disease-modifying therapies facing adherence challenges, infusion-based options like ublituximab gain traction due to established efficacy and structured dosing schedules. Together, these growth factors elevate ublituximab’s relevance in the competitive neuroimmunology market.
The rising adoption of infusion therapies with enhanced safety profiles is also a key driver for ublituximab market uptake. Clinicians increasingly prefer biologics that balance high efficacy with manageable adverse event profiles, especially in chronic autoimmune conditions like relapsing MS. Ublituximab’s engineered design aimed at improving tolerability and reducing infusion-related complications resonates with prescribers seeking long-term disease control options. This trend supports greater clinician confidence and patient acceptance, helping to expand utilization.
02

Restraint: High Competition from Established CD20 Therapies and Emerging Alternatives Limits Market Penetration

One of the most significant restraints on ublituximab market expansion is intense competition from established CD20-targeting therapies and emerging treatment alternatives in relapsing multiple sclerosis . Ublituximab must compete with long-standing products such as ocrelizumab (Ocrevus) and ofatumumab (Kesimpta), which already have large physician familiarity and patient uptake. Competitive pressures are compounded by the anticipated entry of biosimilars and newer therapeutic classes like BTK inhibitors, which may undercut pricing and divert prescriber preference. This crowded landscape can restrict revenue growth and slow market share capture, especially where clinicians opt for established brands or novel mechanisms over ublituximab’s infusion-based regimen.
03

Opportunity: Oncology centers adopting Ublituximab combinations for chronic lymphocytic leukemia therapy and Rising demand for Ublituximab concentrate solution in outpatient infusion centers

Ublituximab offers a compelling value proposition in chronic lymphocytic leukemia therapy when paired with targeted oral agents, enabling chemotherapy-free regimens that appeal to oncology centers and payers. Combination protocols leveraging deep, durable B-cell depletion can address patients who are refractory or intolerant to existing anti-CD20 antibodies. As personalized medicine pathways expand, demand is set to rise fastest in intravenous infusion formats, supported by cooperative trials, pharma–clinic partnerships, and reimbursement models that de-risk adoption in community hematology practices across mature and emerging markets.
Outpatient and ambulatory infusion centers present an underpenetrated channel for Ublituximab concentrate solution, particularly for stable multiple sclerosis and hematology patients transitioning from inpatient care. This formulation segment is projected to increase from $0.13 billion in 2025 to $0.18 billion by 2030, posting a 7.02% CAGR as providers seek operational flexibility and lower chair-time costs. Streamlined compounding protocols, digital scheduling, and partnerships with specialty distributors will be critical to outpace competing anti-CD20 options and future biosimilar development in these cost-sensitive settings.
04

Challenge: Pricing and Reimbursement Challenges Constrain Patient Access and Adoption

Another major restraint affecting ublituximab’s market dynamics is pricing and reimbursement complexity, particularly in cost-sensitive healthcare systems. Biologic therapies like ublituximab are priced at a premium, and gaining favorable reimbursement status often requires extensive price negotiations or placement in special expensive medicinal product procedures before public coverage is granted. For example, in the Netherlands the National Health Care Institute advised reimbursement contingent on negotiated pricing not exceeding competitor net costs, delaying broad access and potentially reducing demand. Such constraints can limit patient access, suppress uptake rates, and negatively impact commercial performance in markets with strict healthcare budget controls.

Supply Chain Landscape

1

CD20 Antibody Inputs

Lonza GroupWuXi BiologicsSamsung Biologics
2

Ublituximab Manufacturing

TG Therapeutics Inc.Lonza GroupSamsung Biologics
3

Fill Finish Packaging

Catalent Pharma SolutionsBaxter BioPharma SolutionsRecipharm
4

Clinical End Users

Relapsing multiple sclerosisB-cell malignanciesHospital neurology clinics
Ublituximab - Supply Chain

Use Cases of Ublituximab in Treatment of Relapsing Forms of Multiple Sclerosis (RMS) & Non-Hodgkin Lymphoma (NHL) Treatment

Treatment of Relapsing Forms of Multiple Sclerosis (RMS) : Ublituximab, marketed primarily as BRIUMVI by TG Therapeutics, is a glycoengineered anti-CD20 monoclonal antibody indicated for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS. It binds to CD20 on B-cells, depleting them to reduce autoimmune activity, shorten disease progression, lower relapse rates, and decrease new lesion formation on MRI scans. Ublituximab’s biannual infusion schedule and enhanced antibody-dependent cellular cytotoxicity offer clinicians a potent alternative to other disease-modifying therapies, while patient support programs from TG Therapeutics and partnerships such as European commercialization through Neuraxpharm help extend access across global MS treatment landscapes.
Chronic Lymphocytic Leukemia (CLL) Intervention : Although ublituximab’s principal regulatory approvals center on MS, its development history includes investigation in chronic lymphocytic leukemia due to its CD20 targeting mechanism relevant to B-cell malignancies. TG Therapeutics explored ublituximab in combination with the PI3K inhibitor umbralisib in CLL and small lymphocytic lymphoma, reflecting efforts to enhance response rates in relapsed/refractory patients. While not yet approved for CLL monotherapy, these combination trials and mechanistic rationale position ublituximab as a potential future oncology option, especially where B-cell depletion remains central to hematologic cancer management.
Non-Hodgkin Lymphoma (NHL) Treatment : Ublituximab has also been evaluated in non-Hodgkin lymphoma settings, particularly where CD20 expression drives pathology. Early phase studies assessed its safety and activity in rituximab-relapsed or refractory patients with B-cell NHL, demonstrating manageable safety profiles and potential antitumor effects. Its glycoengineered design aimed to improve antibody-dependent cytotoxicity compared to traditional anti-CD20 therapies suggests future utility in NHL regimens pending further clinical validation. These investigational efforts highlight ublituximab’s versatility across B-cell-mediated conditions beyond MS.

Recent Developments

Recent strategic developments for ublituximab center on expanding its competitive position in immunotherapy for relapsing multiple sclerosis through enhanced clinical differentiation, real-world evidence generation, and market access initiatives. Key market trends include growing emphasis on targeted biologics, CD20-directed therapies, and infusion-based treatment regimens as neurologists seek options with robust relapse reduction and manageable safety profiles. Adoption is also influenced by evolving payer reimbursement frameworks and value-based contracting, which shape prescribing behavior and access in specialty neurology practices.

February 2024 : TG Therapeutics’ ex-U.S. partner Neuraxpharm launched BRIUMVI (ublituximab-xiiy) in Germany, marking the first European commercial launch of the therapy for relapsing multiple sclerosis. Under the existing ex-U.S. commercialization agreement, TG Therapeutics will receive a milestone payment upon this launch, strengthening its international market presence. BRIUMVI has also been approved in the EU and UK, supporting broader regional availability.
May 2025 : TG Therapeutics reported ongoing expansion of BRIUMVI commercialization outside the United States with its partner Neuraxpharm, with the therapy now commercially available in additional countries within the European Union, the United Kingdom, and Switzerland. This geographic expansion underscores the importance of the supply and distribution partnership in accelerating global uptake of ublituximab.

Impact of Industry Transitions on the Ublituximab Market

As a core segment of the Pharmaceutical industry, the Ublituximab market develops in line with broader industry shifts. Over recent years, transitions such as Oncological Therapies Transformation and Regulatory Advances in Biopharmaceuticals have redefined priorities across the Pharmaceutical sector, influencing how the Ublituximab market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Oncological Therapies Transformation

The gradual pace of oncological therapies transformation adoption in the Ublituximab market is diluting its first-mover advantage in monoclonal antibody therapy and opening a clear competitive window for adjacent B-cell targeted therapies such as Rituximab and Ofatumumab. While Ublituximab remains aligned with the shift toward targeted treatment of oncology and autoimmune disorders and supports the broader move to personalized medicine, hesitancy among key market players is enabling rivals to expand use-case penetration and clinical positioning. As a result, alternate therapies are projected to divert approximately $119 million from the existing Ublituximab revenue pool, reshaping the competitive landscape of the oncology market and underscoring the strategic urgency for manufacturers to accelerate adoption, optimize differentiation, and strengthen real-world evidence to defend share.
02

Regulatory Advances in Biopharmaceuticals

Regulatory advances in biopharmaceuticals are playing a pivotal role in accelerating the adoption of biologics such as ublituximab, reflecting broader transitional shifts in drug evaluation and approval pathways. Increasing regulatory confidence in complex biologics, supported by robust clinical trial designs and real-world evidence requirements, has strengthened the credibility of targeted monoclonal antibodies in chronic and immune-mediated diseases. For example, ublituximab’s regulatory approval in relapsing forms of multiple sclerosis underscores regulators’ growing acceptance of differentiated biologics with enhanced efficacy or dosing advantages. This transition is also influencing adjacent industries, including contract development and manufacturing organizations, which are expanding biologics capacity, and digital health firms supporting post-marketing surveillance. Collectively, these changes are fostering faster innovation cycles, higher investment in biologics R&D, and greater clinician trust across specialty therapeutics markets.