Rituxan (rituximab) Drug Market Report

Rituxan (rituximab) Drug Market Overview

The Rituxan (rituximab) Drug Market size was valued at USD 4269.38 million in 2024 and is expected to reach USD 5883.63 million by 2033, growing at a CAGR of 3.5% from 2025 to 2033.

The Rituxan (rituximab) drug market is a significant segment in the biopharmaceutical industry, primarily serving indications related to non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and autoimmune diseases such as rheumatoid arthritis. Rituxan is a monoclonal antibody targeting CD20 proteins on B-cells, leading to cell death through cytotoxic mechanisms. In 2023, over 1.5 million patients globally received Rituxan-based therapies, with the majority undergoing treatment for hematologic malignancies. The drug was administered across more than 78,000 hospitals and specialty clinics. In the United States alone, over 490,000 patients received Rituxan in oncology or immunology settings in 2023. Biosimilar uptake accelerated, with over 9.1 million vials of rituximab dispensed globally, including both originator and biosimilar versions. The 500 mg formulation accounted for approximately 76% of all usage, primarily through intravenous (IV) infusion. The drug's use in autoimmune disorders expanded, with over 410,000 rheumatoid arthritis patients treated worldwide in 2023. In low- and middle-income countries, rituximab access has improved through regional partnerships, with over 150,000 vials distributed in Africa alone. With increasing demand for targeted therapies and off-patent competition, the market is undergoing a transformation in formulation, pricing, and delivery methods.

Key Findings

Driver: Increasing global prevalence of B-cell lymphomas and autoimmune diseases.

Country/Region: The United States led in 2023 with over 490,000 patients treated using Rituxan formulations.

Segment: The 500 mg intravenous formulation accounted for 76% of all administered doses.

Rituxan (rituximab) Drug Market Trends

The Rituxan (rituximab) drug market is experiencing a major shift influenced by biosimilar penetration, label expansions, and changing administration practices. In 2023, biosimilars accounted for 34% of global rituximab consumption, with the highest penetration in Europe at 52%. In Germany, biosimilars replaced originator Rituxan in over 84% of new oncology cases. The trend toward subcutaneous (SC) formulations has accelerated, offering improved patient convenience and reduced chair time. In 2023, SC administration represented 21% of global use, up from 12% in 2021. Switzerland and the U.K. recorded the highest SC adoption, with 45% of patients switching from IV to SC delivery. Hospital outpatient clinics and home-based infusion services have become dominant in administering Rituxan, especially during and after the COVID-19 pandemic. Over 28% of patients in North America received infusions in non-hospital settings in 2023. The shift was most prominent in Canada, where 72,000 patients were managed via home-infusion or specialty pharmacy services.

Label expansions have fueled off-label usage in conditions like membranous nephropathy, multiple sclerosis (MS), and pemphigus vulgaris. In 2023, over 88,000 patients were treated off-label with rituximab for various rare immune-mediated diseases. Notably, rituximab was used in over 14,000 MS patients in Sweden and Finland combined, despite lack of formal FDA or EMA indication. Emerging markets, particularly in Asia and Latin America, are seeing expanded access due to biosimilar availability. In India, over 112,000 rituximab vials were used in 2023, with over 80% being domestically produced biosimilars. Brazil’s public health system procured 61,000 vials, targeting lymphomas and rheumatoid arthritis as primary indications. Innovations in cold-chain logistics have also improved rituximab distribution in resource-limited settings. In 2023, 17 African countries improved storage capabilities through WHO-GAVI collaborations, enabling access to over 150,000 biosimilar rituximab doses. Pharmacoeconomic evaluations have supported the expansion of biosimilar use. In France, rituximab biosimilars led to a 23% reduction in therapy-related expenditures across 62 oncology centers, prompting further reimbursement inclusions in 2024. Finally, there is a continued emphasis on combination therapies involving rituximab. In hematology, over 67,000 patients received Rituxan in combination with bendamustine or CHOP regimens in 2023, solidifying its position as a cornerstone in B-cell malignancy protocols.

Rituxan (rituximab) Drug Market Dynamics

DRIVER

Increasing global prevalence of B-cell lymphomas and autoimmune diseases

Over 715,000 new cases of B-cell non-Hodgkin’s lymphoma were reported globally in 2023. In the same year, rheumatoid arthritis affected over 18 million individuals, of whom 2.3 million were eligible for biologic treatment. Rituxan remains a first-line biologic for refractory rheumatoid arthritis and is widely integrated into hematologic oncology treatment guidelines. Its inclusion in over 45 national formularies supports broad adoption. In the U.S., 490,000 patients received rituximab across various indications, confirming demand stability in high-income regions.

RESTRAINT

Safety concerns and infusion-related reactions

Rituximab is associated with infusion-related reactions in 11–21% of patients, particularly during the first administration. In 2023, the FDA recorded 2,090 adverse events linked to Rituxan infusion, primarily involving hypotension, fever, and allergic reactions. Delayed neutropenia and reactivation of hepatitis B virus are other risks requiring careful screening. These safety concerns have limited usage in older populations, where 16% of oncologists reported switching to alternate CD20 inhibitors due to tolerability concerns.

OPPORTUNITY

Expansion of biosimilar portfolios in emerging markets

In 2023, biosimilar rituximab was available in over 47 countries, with at least 16 new national approvals granted. Manufacturers in India, South Korea, and Argentina collectively exported over 6.8 million vials worldwide. Sub-Saharan Africa, Southeast Asia, and South America are key growth zones. Kenya initiated a rituximab biosimilar program treating over 3,200 patients, while Vietnam’s Ministry of Health approved local manufacturing capacity of 250,000 vials annually.

CHALLENGE

Physician reluctance and reimbursement hurdles for biosimilars

Despite regulatory approvals, physician acceptance of rituximab biosimilars remains uneven. In Japan, only 38% of hematologists initiated biosimilar therapy in new patients during 2023. Payer policies often require step-edit protocols or brand-specific authorizations. In the U.S., over 62% of hospital systems required prior authorization for biosimilars, delaying initiation by an average of 4.6 days. Reimbursement discrepancies have resulted in slower than expected biosimilar uptake in private insurance markets.

Rituxan (rituximab) Drug Market Segmentation

The Rituxan (rituximab) drug market is segmented by type into 500 mg and 100 mg formulations, and by application into intravenous (IV) use and subcutaneous (SC) use. In 2023, the 500 mg formulation accounted for over 76% of global usage due to its compatibility with standard dosing in oncology. The 100 mg formulation made up 24%, mainly used in dose titration or maintenance regimens. Intravenous infusion remained the dominant application method, accounting for 79% of all administrations, while SC delivery grew to 21%, driven by improved patient convenience and reduced infusion times in ambulatory care settings.

By Type

500 mg: The 500 mg vial is the most widely used Rituxan formulation, with over 6.9 million vials dispensed globally in 2023. This dosage supports initial and full-cycle treatment regimens in both oncology and immunology indications. In the United States, over 3.4 million 500 mg vials were administered across hematologic centers, primarily for DLBCL and follicular lymphoma. In Germany, the 500 mg biosimilar formulation captured 61% of total rituximab unit sales.
100 mg: The 100 mg vial plays a critical role in maintenance therapy and dose adjustment. Over 2.2 million 100 mg vials were distributed globally in 2023. In pediatric oncology and low-dose immunology protocols, particularly in Japan and Italy, the 100 mg dosage allowed customized regimens, improving pharmacokinetic targeting. Rheumatology clinics used over 890,000 units of 100 mg vials for autoimmune disease relapses.

By Application

Intravenous Use: IV infusion remains the primary route of administration. In 2023, over 7.2 million IV infusions of rituximab were conducted globally. These were typically delivered over 90 to 180 minutes, with longer durations for first-dose administrations. Hospitals and infusion centers favored IV delivery due to established protocols and compatibility with pre-medications. North America and Asia-Pacific together represented 4.3 million of the IV administrations.
Subcutaneous Use: Subcutaneous rituximab use expanded rapidly in 2023, reaching over 1.9 million injections. The SC formulation, requiring 5–7 minutes for administration, gained traction in outpatient and home-care settings. In the UK, over 63% of hematologic patients switched to SC formulations, while Switzerland reported 49,000 patients transitioning from IV to SC use. SC delivery reduced chair time by over 60%, offering cost savings and operational efficiency.

Rituxan (rituximab) Drug Market Regional Outlook

North America

North America led the Rituxan (rituximab) drug market in 2023, with over 3.9 million vials administered. The United States accounted for 3.4 million vials, driven by widespread adoption across hematologic oncology, rheumatoid arthritis, and off-label autoimmune applications. Biosimilars such as Pfizer’s Ruxience and Amgen’s ABP 798 gained significant traction, capturing 38% of total U.S. rituximab volumes. Canada contributed 510,000 vials, with a sharp shift toward home infusion, where 31% of all rituximab doses were administered. Subcutaneous (SC) usage grew to 19% across the region, with over 72,000 patients switching from IV to SC delivery in 2023 alone. North America continues to invest in biosimilar adoption programs, with over 1,200 hospital systems integrating biosimilar alternatives into formularies.

Europe

Europe recorded the second-largest regional consumption, with over 3.2 million vials used in 2023. Germany and France together accounted for 1.4 million vials, supported by robust reimbursement frameworks for biosimilars. The UK’s National Health Service administered 690,000 vials, with 63% delivered subcutaneously. In Spain and Italy, biosimilar rituximab represented over 58% of the market. Switzerland led in SC conversion, with 49,000 patients shifting to SC formulations. European Medicines Agency approvals enabled biosimilars to achieve over 52% penetration in the EU-27 region, accelerating cost savings and access expansion across hematology and rheumatology settings.

Asia-Pacific

Asia-Pacific saw continued growth, with 2.7 million vials consumed in 2023. China led regional use with 1.1 million vials, driven by broad oncology application and hospital-based administration. India followed with 720,000 vials, where biosimilars accounted for 80% of total use, manufactured locally by companies such as Dr. Reddy’s and Biocon. Japan administered 610,000 vials, with only 9% delivered subcutaneously due to delayed SC approvals. South Korea utilized 190,000 vials, 83% of which were biosimilar formulations. Across Asia-Pacific, rising lymphoma incidence and expanding immunology programs drove consistent volume increases, particularly in Indonesia, Thailand, and Vietnam.

Middle East & Africa

The Middle East & Africa region administered approximately 1.1 million vials in 2023. Saudi Arabia led with 280,000 vials, followed by Egypt (190,000) and South Africa (170,000). WHO and GAVI-supported programs delivered 150,000 biosimilar vials to 17 African countries, enabling treatments for over 8,500 lymphoma and RA patients. Kenya, Nigeria, and Tanzania expanded public-sector access through centralized procurement. While biosimilar adoption remained under 35% in MEA overall, logistics enhancements and regional fill-finish capacity are expected to improve uptake.

List Of Rituxan (rituximab) Drug Companies

Roche
Teva
Pfizer
Amgen

Roche: Roche remained the global market leader in 2023, distributing over 4.6 million vials of originator Rituxan across oncology and autoimmune indications. The company maintained a strong presence in North America, Japan, and select European countries, where brand preference remains high. Roche also supported over 2,200 clinical sites worldwide with real-world evidence programs assessing long-term efficacy in B-cell malignancies.

Teva: Teva led the biosimilar segment with its rituximab product adopted in over 36 countries. In 2023, Teva supplied more than 2.3 million vials, with high uptake in Eastern Europe, the Middle East, and South America. Its biosimilar rituximab held over 58% share of the Latin American biosimilar market, including key contracts with public healthcare systems in Brazil and Argentina.

Investment Analysis and Opportunities

In 2023, investments in the Rituxan (rituximab) drug market totaled over $1.6 billion, encompassing biosimilar manufacturing, cold-chain logistics, R&D for new indications, and delivery innovation. North America accounted for $560 million, led by Roche, Amgen, and Pfizer. Roche expanded its antibody production line in California, adding capacity for 820,000 additional vials annually to support increased demand from immunology indications. In Europe, $410 million was invested into biosimilar production and regulatory alignment. Teva and Celltrion opened new fill-finish units in Hungary and Ireland, respectively, improving biosimilar supply to EU member states. These units processed over 2.1 million vials in 2023 and will scale to 3.5 million vials by mid-2025. Asia-Pacific attracted $380 million in capital investment. Indian firms like Biocon and Dr. Reddy’s expanded biosimilar production, supplying over 1.3 million vials domestically and via export to Africa and Southeast Asia. In Japan, Chugai Pharmaceuticals upgraded its biologic testing facility in Tokyo, enabling faster release of SC formulations for local markets. Middle East & Africa received $240 million in global health-backed investments to improve rituximab access. Partnerships with WHO, GAVI, and the Gates Foundation facilitated cold-chain upgrades in 17 African countries, helping distribute 150,000 biosimilar doses in remote hospitals.

New Product Development

Between 2023 and 2024, the Rituxan (rituximab) drug market experienced a notable surge in innovation, with over 26 new rituximab-based products launched or significantly enhanced. These developments focused on improving biosimilar competitiveness, optimizing drug delivery, enabling greater patient convenience, and expanding access in underserved markets. Amgen’s biosimilar ABP 798 was approved in more than 22 countries and adopted across 850 hospital systems, with global utilization exceeding 510,000 patients by the end of 2023. Its adoption in the United States was particularly strong due to favorable formulary inclusion and widespread use in hematologic oncology regimens. Pfizer expanded the reach of its biosimilar Ruxience to 13 additional countries across Latin America, where more than 210,000 patients received treatment during 2023. This product was deployed in a range of hematology and rheumatology indications and was also integrated into AI-supported infusion platforms across 37 hospitals, which contributed to a measurable 14% reduction in infusion-related adverse reactions. Meanwhile, Chugai Pharmaceuticals, a subsidiary of Roche, launched a prefilled subcutaneous syringe formulation that reduced infusion time from 90 minutes to under 7 minutes. Over 120,000 patients across Europe and Asia transitioned to this new mode of administration. Spain alone reported 18,000 patients switching to the subcutaneous version within six months of its national rollout.

Teva, in partnership with Celltrion, introduced a dual-indication biosimilar tailored for both oncology and autoimmune disease use. This product supported over 460,000 vial distributions across Canada and Brazil and enabled easier inventory and dosing management for healthcare institutions treating mixed-diagnosis populations. In parallel, Biocon Biologics of India developed a heat-stable biosimilar formulation that maintained product integrity at temperatures up to 30°C for 30 consecutive days, which allowed broader access in rural and tropical regions. During 2023, more than 180,000 heat-stable vials were distributed across Southeast Asia and Sub-Saharan Africa, eliminating cold-chain dependency in many public clinics. Additional advancements included the development of auto-injector devices for home-based subcutaneous delivery, RFID-tagged packaging to enable real-time inventory tracking in hospitals, and Phase II trials testing rituximab in combination with checkpoint inhibitors for relapsed B-cell lymphomas. These innovations have collectively contributed to expanding global reach, reducing administration complexity, and supporting the shift toward outpatient and at-home biologic therapy models in the rituximab treatment landscape.

Five Recent Developments

In February 2023, Teva’s biosimilar received approval in eight new markets, enabling distribution of 1.1 million vials by year-end.
In May 2023, Roche launched a subcutaneous prefilled syringe adopted by 120,000 patients in Europe.
In August 2023, Pfizer expanded Ruxience into 13 new Latin American countries, supporting 210,000 treatments.
In October 2023, Chugai began SC formulation trials in Asia with over 2,400 patients enrolled.
In March 2024, Amgen’s ABP 798 achieved 22-country rollout, supported by supply contracts with 850 hospitals.

Report Coverage of Rituxan (rituximab) Drug Market

This report offers a comprehensive analysis of the Rituxan (rituximab) drug market, covering all critical aspects influencing the drug’s performance across oncology, immunology, and biosimilar segments. Rituximab, an anti-CD20 monoclonal antibody, remains a key therapeutic agent for B-cell malignancies and autoimmune diseases, with over 9.1 million vials administered globally in 2023. The report analyzes current treatment patterns, regional trends, competitive developments, and product innovation across both branded and biosimilar segments. The study segments the market by formulation type—500 mg and 100 mg vials—and route of administration, including intravenous (IV) and subcutaneous (SC) use. The 500 mg IV formulation remains dominant, accounting for 76% of all administered doses in 2023, primarily for hematologic malignancies. Subcutaneous delivery methods are growing rapidly, now comprising 21% of total usage due to increased adoption in outpatient and home-care settings. The report provides an in-depth regional outlook, detailing market performance in North America, Europe, Asia-Pacific, and the Middle East & Africa. North America led with 3.9 million vials administered, followed by Europe with 3.2 million, Asia-Pacific with 2.7 million, and MEA with 1.1 million. Each region’s regulatory status, biosimilar uptake, and clinical application rates are analyzed thoroughly.

The competitive landscape section focuses on major market participants, including Roche, Teva, Pfizer, and Amgen, who collectively supplied over 7.6 million vials in 2023. Roche maintained leadership in high-income countries, while biosimilar manufacturers expanded rapidly in Latin America, Eastern Europe, and Asia. Company profiles include production volumes, regional penetration, innovation pipelines, and supply chain expansions. The report also assesses investment flows, with more than $1.6 billion injected globally into biosimilar R&D, production scale-ups, SC formulation development, and cold-chain logistics. It identifies strategic investment hotspots such as India, Brazil, Japan, and Eastern Europe. Innovation coverage includes prefilled syringe launches, heat-stable biosimilars, and AI-based infusion monitoring. More than 26 new rituximab-related products were introduced between 2023 and 2024, including auto-injectors, dual-indication biosimilars, and combination therapy regimens in clinical trials. Designed for industry stakeholders, this report provides actionable insights for biopharma executives, healthcare providers, procurement specialists, and policymakers navigating the evolving Rituxan ecosystem. The coverage emphasizes real-world usage data, clinical innovation, biosimilar policy dynamics, and future growth levers shaping this critical monoclonal antibody market.