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Last Updated: February 12, 2025

Rituximab - Biologic Drug Details


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Summary for rituximab
Recent Clinical Trials for rituximab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Alexion Pharmaceuticals, Inc.Phase 4
University of California, Los AngelesPhase 1
Janssen Inc.Phase 2

See all rituximab clinical trials

Recent Litigation for rituximab

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
AbbVie Inc. v. Hetero USA, Inc.2024-08-08
Acerta Pharma B.V. v. Cipla Limited2024-05-16
AbbVie Inc. v. Hetero USA, Inc.2023-11-20

See all rituximab litigation

PTAB Litigation
PetitionerDate
Sandoz Inc.2023-02-03
Celltrion, Inc. et al.2022-02-21
Fresenius Kabi USA, LLC2021-09-24

See all rituximab litigation

Pharmacology for rituximab
Mechanism of ActionCD20-directed Antibody Interactions
Established Pharmacologic ClassCD20-directed Cytolytic Antibody
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for rituximab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for rituximab Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for rituximab Derived from Patent Text Search

No patents found based on company disclosures

Rituximab Market Dynamics and Financial Trajectory

Introduction

Rituximab, a monoclonal antibody, has been a cornerstone in the treatment of various autoimmune diseases and hematologic malignancies, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. The market for rituximab is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The rituximab market was valued at over USD 3.48 billion in 2023 and is projected to reach USD 23.67 billion by 2036, growing at a compound annual growth rate (CAGR) of 15.9% during the forecast period of 2024-2036[1].

Growth Drivers

Increasing Incidence of Non-Hodgkin’s Lymphoma

The rising incidence of non-Hodgkin’s lymphoma (NHL) is a major driver of the rituximab market. According to the American Cancer Society, NHL is one of the most common cancers in the USA, with around 77,200 cases registered in 2020. This trend is expected to continue, fueling the demand for rituximab[1].

Rising Prevalence of Autoimmune Diseases

Autoimmune diseases, such as rheumatoid arthritis, are also driving the market growth. Approximately 22 million people are affected by autoimmune diseases annually, as reported by the University of Oxford. This increasing prevalence is likely to accelerate the growth of the rituximab market[1].

Expanding Indications and Patient Populations

Rituximab is approved for a broad range of indications, including various autoimmune diseases and hematologic malignancies. As its use expands across different therapeutic areas, the demand for both the original biologic and its biosimilars is expected to increase[3].

Distribution Channels

The hospital pharmacies segment is expected to dominate the rituximab market, accounting for a total market share of 39.7% by 2036. This is due to the growing use of rituximab in hospitals, increased healthcare spending, higher patient awareness, and the availability of superior hospital infrastructure in high-income countries[1].

Regional Market Dynamics

North America

North America is expected to hold the largest revenue share in the rituximab market, accounting for an overall market share of 46.1% by 2036. This is attributed to the advanced healthcare infrastructure, higher patient knowledge, and increased government spending on cancer research in the region. Major pharmaceutical companies such as Pfizer Inc., Amgen Inc., and Merck & Co. also contribute to the market growth in this region[1].

Asia Pacific

The Asia Pacific region is expected to be the second-largest market for rituximab, with the highest growth rate during the forecast period at 12.1%. Factors such as rising disposable incomes, a large patient population for monoclonal antibody cancer treatments, and increased focus on healthcare are driving this growth. Countries like India and China are particularly significant due to their investment opportunities in clinical research and R&D prospects for monoclonal antibodies[1].

Rituximab Biosimilars Market

Market Size and Growth

The global rituximab biosimilars market is projected to grow significantly, driven by the demand for cost-effective treatment options. The market size is expected to reach USD 6.065 billion by 2031, growing at a CAGR of 12.98% during the forecast period of 2023-2031[3].

Key Drivers

  • Cost-Effectiveness: Biosimilar versions of rituximab offer comparable efficacy and safety at reduced costs, making them attractive for healthcare systems aiming to optimize resource allocation and improve patient access to essential therapies[3].
  • Expanding Indications: The broad range of indications for rituximab, including various autoimmune diseases and hematologic malignancies, is driving the demand for biosimilars[3].
  • Supportive Regulatory Environment: Favorable regulatory pathways for biosimilar approval are facilitating the growth of the rituximab biosimilars market[3].

Cost-Effectiveness and Economic Impact

Comparative Cost-Effectiveness

Studies have shown that rituximab is highly cost-effective, especially for patients who have failed to respond to other biologic DMARDs. For instance, the Incremental Cost-Effectiveness Ratio (ICER) for rituximab followed by DMARDs was £14,690 per Quality-Adjusted Life Year (QALY) compared to conventional DMARDs only[2].

Economic Benefits

The adoption of rituximab biosimilars is expected to drive healthcare cost savings. By offering significant cost reductions compared to the originator biologic, biosimilars can help healthcare systems allocate resources more efficiently and improve patient access to life-saving therapies[3].

Challenges and Opportunities

Regulatory Hurdles

Despite the promising outlook, the rituximab biosimilars market faces challenges such as regulatory hurdles and intellectual property issues. However, opportunities exist to address these challenges through innovation, investment in R&D, and collaboration with stakeholders across the healthcare ecosystem[3].

Emerging Markets

Emerging markets, including Asia-Pacific and Latin America, present significant growth opportunities for rituximab biosimilar manufacturers. These regions are characterized by increasing disease prevalence, healthcare infrastructure development, and government initiatives to promote biosimilar adoption[3].

Key Takeaways

  • The rituximab market is projected to grow significantly, driven by the increasing incidence of NHL and autoimmune diseases.
  • Hospital pharmacies are expected to dominate the distribution channels.
  • North America and the Asia Pacific region are key markets, with North America holding the largest revenue share.
  • Rituximab biosimilars are driving cost savings and improving patient access to therapies.
  • Regulatory support and emerging markets are crucial for the growth of the rituximab biosimilars market.

FAQs

What is the projected market size of rituximab by 2036?

The rituximab market is projected to reach USD 23.67 billion by 2036, growing at a CAGR of 15.9% during the forecast period of 2024-2036[1].

What are the main drivers of the rituximab market growth?

The main drivers include the increasing incidence of non-Hodgkin’s lymphoma, rising prevalence of autoimmune diseases, and expanding indications and patient populations[1].

How significant is the rituximab biosimilars market?

The global rituximab biosimilars market is expected to reach USD 6.065 billion by 2031, growing at a CAGR of 12.98% during the forecast period of 2023-2031[3].

What are the key challenges facing the rituximab biosimilars market?

The key challenges include regulatory hurdles, intellectual property issues, and manufacturing complexities. However, opportunities exist through innovation, R&D investment, and stakeholder collaboration[3].

Which regions are expected to drive the growth of the rituximab market?

North America is expected to hold the largest revenue share, while the Asia Pacific region is expected to show the highest growth rate during the forecast period[1].

Sources

  1. Research Nester: Rituximab Market Size & Share, Global Forecast Report 2036[1].
  2. NCBI: Assessment of cost-effectiveness[2].
  3. GlobeNewswire: Rituximab Biosimilars Market Size to Surpass US$ 6.065 billion by 2031[3].
  4. The Business Research Company: Global Rituximab Biosimilars Market Report 2024[4].

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.