Global Rituximab Biosimilars Market Report and Forecast 2024-2032

Global Rituximab Biosimilars Market Outlook

The global rituximab biosimilars market size was valued at USD 2.37 billion in 2023 and is projected to grow at a CAGR of 15.7% during the forecast period of 2024-2032 to reach a value of USD 8.81 billion by 2032. The market growth can be attributed to the increasing prevalence of autoimmune diseases, cancer, and the rising demand for cost-effective alternatives to branded biologics.

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Rituximab: One of the Earliest Approved Biosimilars

Biosimilar drugs possess a close resemblance with biological drugs. These drugs are exact copies of the original medications manufactured by the company. Biosimilar drugs have minimal therapeutic costs and thus provide easy accessibility to everyone for treatment.

Rituximab was licensed as Rituxan in 1997 by the United States. This was subsequently approved in 1998 by European Union as MabThera.

The reference Rituximab is approved by the European Medicine Agency for treating several types of lymphomas and leukemias. It is a chimeric anti-CD20 monoclonal antibody typically used to treat chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. Rituximab is primarily administered by subcutaneous bolus injection or through an intravenous infusion.

Currently, three biosimilar rituximab products are approved by the European Medicines Agency. The first biosimilar, CT-P10 (Truxima), was approved by EMA in 2017. This drug was approved for treating all the indications as the reference biological drug. 

GP2013 (Rixathon), a second biosimilar was approved by EMA for the treatment of rheumatoid arthritis. The third approved biosimilar for rituximab is Ruxience, primarily used for treating lymphoma and leukemia.

Pharmacokinetics and Pharmacodynamics

Rituximab possesses the B-cells destroying mechanism and is used to treat disorders consisting of overconcentration of B cells. Rituximab destroys B cells and is used to treat diseases characterised by an excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukemia, transplant rejection, and autoimmune disorders.

The pharmacokinetics of rituximab is very complex. The ELISA (Enzyme-Linked Immune Sorbent Assay) measures rituximab concentrations. These analytical tests incorporate the monoclonal antibodies targeted against the idiotype in a molecule. The patient’s body’s rituximab levels are affected by ethnicity, type, area, and size of a tumour.

According to the rituximab biosimilars market research report, the market can be categorised into the following segments:

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Rituximab Biosimilars Market Breakup by Product Type

• Blitzima

• Rixathon

• Others

Rituximab Biosimilars Market Breakup by Indication Type

• Non-Hodgkin’s Lymphoma

• Chronic Lymphocytic Leukaemia

• Rheumatoid Arthritis

• Others

Rituximab Biosimilars Market Breakup by Distribution Channels

• Hospital Based Pharmacies

• Online Pharmacies

• Retail Pharmacies

Rituximab Biosimilars Market Breakup by Region

• North America
  • Unitd States of America
  • Canada
• Europe
  • United Kingdom
  • Germany
  • France
  • Italy
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • ASEAN
  • Australia
  • Others
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Others
• Middle East and Africa
  • Saudi Arabia
  • United Arab Emirates
  • Nigeria
  • South Africa
  • Others

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Increasing Prevalence of Non-Hodgkin’s Lymphoma, Novel Product Launches, and Increased Funding to be the Key Market Trends

The key factor driving the growth of the rituximab biosimilars market is the rising prevalence of non-Hodgkin’s lymphoma. This lymphoma affects the white blood cells and hence, the weakening of the immune system. 

According to World Health Organisation, more than 5,00,00 new cases were diagnosed with NHL in 2020. In the United States, non-Hodgkin’s lymphoma accounts for nearly 4% of cancer cases. Thus, this rising incidence of non-Hodgkin’s lymphoma is anticipated to generate significant demand for the rituximab biosimilars market over the forecast period. 

Pharmaceutical companies are tremendously working on inventing new rituximab biosimilar drugs. Increased acquisitions and collaborations among top firms are also driving the market growth. For Example, in 2020, Teva pharmaceuticals and Celltrion Healthcare Co. announced the launch of Truxima, a biosimilar for treating Rheumatoid Arthritis.

The additional factors stimulating the development of the market include increased government initiatives, optimal biosimilar costs, and a rise in R&D expenditure in biopharmaceutical companies.

The expansion in healthcare accessibility, rising incidence of chronic disorders, and increased ageing population are also expected to boost the rituximab biosimilars market size.

Fewer drug approvals, stringent government regulations, and lack of awareness are the suspected reasons hindering the growth of this market. The high costs of biosimilars are also responsible for the slow growth of the market.

North America Accounts for the Largest Share

North America is responsible for the maximum share in the rituximab biosimilars market due to the American government's significant expenditure in the health sector. The Middle East and Africa is the fastest growing market in this region due to the escalating clinical trials in this sector.

Therapeutic Landscape

Rituximab is a monoclonal antibody primarily targeted against the CD20 antigen of B cells. This is used for treating all types of non-Hodgkin’s lymphomas. Rituximab is generally prescribed as a monotherapy or in combination with the traditional chemo-targeted medications. It also treats many indications, including lymphocytic leukaemia, B-cell, and follicular lymphoma.

Approved Biosimilars of Rituximab

The regulatory authorities have approved only a few numbers of biosimilars to be used for treatment purposes. CT-P10, GP2013, and Ruxience are the three biosimilars of rituximab approved by the FDA for rheumatological and oncological indications. All these biosimilars are intravenous and marketed under different product names.

The biosimilars marketed by Celltrion under CT-P10 are Ritemvia, Truxima and Blitzima. The GP2013 rituximab biosimilar includes Riximyo and Rixathon, which are sold by Sandoz. The recently approved Ruxience is being marketed by Pfizer. All these rituximab reference drugs can be incorporated as a monotherapy or a combination of the targeted therapies. 

European Medicine Agency has also approved more than twenty biosimilars, comprising the biosimilars of monoclonal antibodies. Rituximab is a monoclonal antibody broadly used in various disciples from nephrology, haematology, rheumatology, and oncology.

With the expiry of the currently available rituximab patents, there is a need for the development of new biosimilars. Scientists are also investigating the potential applications of rituximab biosimilars in inflammation. This invention of new biosimilars and novel plausible applications will help boost the growth of the rituximab biosimilars market.

Rituximab is generally incorporated with methotrexate to treat moderate to severe RA in adult patients. Rituximab is also subsequently approved for treating microscopic polyangiitis and granulomatosis with polyangiitis. With the new advancements, rituximab is the first-line drug in USA and Europe.

The invention and development of novel biosimilars are essential to delivering a potent and cost-effective therapy. Thus, these economic benefits will help augment the better accessibility of healthcare services. The new targeted rituximab biosimilar therapies will push the development of the rituximab biosimilars market during the forecast period.

Clinical Trials: Major Industry Focus

A biosimilar must be significantly similar to its original reference product in terms of efficacy and safety. The exploratory and confirmatory clinical trials are being done to establish similarity with the reference product.

Rituximab is primarily used for treating follicular lymphoma and rheumatoid arthritis. Thus, the trials for rituximab biosimilars were conducted mainly on patients with FL and RA indications.

The clinical trials for biosimilars are a bit different from their biological ones. In biosimilar trials, there is an exemption for in-vivo clinical studies. Pharmacological and pharmacokinetic studies are done to ensure the efficacy and safety of the newly developed product relative to the reference product. The final step of rituximab biosimilar drugs involves the comparison of their PK and PD value with the RMP. 

Rituximab Biosimilars in Pipeline

The two approved rituximab biosimilars are GP2013 and CT-P10, successfully passed the last phase of clinical trials. The Phase III study for GP2013 was done on patients with follicular lymphoma, while CT-P10 tests were performed on patients with rheumatoid arthritis.

Apart from the three approved rituximab biosimilars, five more potential biosimilars are in the last stage of clinical development. The approval of these biosimilars will lead to the rituximab biosimilars market expansion.

Out of the five biosimilars, the approved proposal for MabionCD20 has been sent to the European Medicine Agency, while the rest four are still in the last stage of clinical testing.

The rituximab and its biosimilars have significantly influenced patient outcomes and have facilitated growth in the healthcare sector. These drugs in the developmental stage seem to provide magnificent advantages regarding social and economic inputs.

The proposed rituximab biosimilars are in the last stage of clinical trials and under observation by the regulatory authorities. The invention of novel rituximab biosimilars will help in better treatments at lesser costs. 

These novel targeted therapies seem to grab the attention of key companies and investors, which will directly influence the advancements in this sector. This will help enable patient access and growth of the rituximab biosimilars market.

Competitive Landscape

The report gives an in-depth analysis of the key players involved in the rituximab biosimilars market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows:

• Innovent Biologics Inc

• Gedeon Richter Plc.

• BioXpress Therapeutics SA

• Teva Pharmaceutical Industries Ltd.

• Takeda Pharmaceutical Company Limited

• Sandoz International GmbH (Novartis)

• Zydus Lifesciences Ltd.

• Hetero Drugs Limited

• Dr Reddy's Laboratories Ltd

• Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

• Zenotech Laboratories

• Napp Pharmaceuticals Limited

• Mundipharma International Limited

Key Highlights of the Report

Rituximab Biosimilars Market Report Snapshots

Rituximab Biosimilars Market Size

Rituximab Biosimilars Market Trends

 Rituximab Biosimilars Market Companies