Rituximab Biosimilars Global Market Report 2024

The rituximab biosimilars market size has grown rapidly in recent years. It will grow from $2.66 billion in 2023 to $3.02 billion in 2024 at a compound annual growth rate (CAGR) of 13.3%. The expansion observed in the historical period can be ascribed to government initiatives, heightened healthcare spending, growth in research and development expenditure for biopharmaceuticals, the cost-effectiveness of biosimilars, and the burgeoning growth in emerging markets.

The rituximab biosimilars market size is expected to see rapid growth in the next few years. It will grow to $4.89 billion in 2028 at a compound annual growth rate (CAGR) of 12.8%. The anticipated growth in the forecast period can be linked to the aging population, improved access to healthcare, and an increasing prevalence of chronic diseases. Noteworthy trends during this period involve capitalizing on updated FDA regulations for the development of biosimilar drugs, forging strategic partnerships and collaboration agreements with major players to broaden research and development initiatives for new drug developments, and making substantial investments in research and development activities to create effective and innovative biosimilars.

The increasing incidence of non-Hodgkin's lymphoma (NHL) is anticipated to contribute to the expansion of the rituximab biosimilars market. Non-Hodgkin's lymphoma, or lymphoma, is a form of cancer that originates in white blood cells and lymphocytes, integral components of the body's immune system. According to the American Cancer Society, NHL ranks as the most prevalent cancer in the USA, constituting approximately 4% of all cancers. In the United States, an estimated 81,560 individuals (45,630 men and 35,930 women) were expected to receive a NHL diagnosis in 2021. Consequently, the increasing instances of non-Hodgkin's lymphoma are projected to result in a heightened demand for rituximab biosimilars throughout the forecast period.

The upsurge in the prevalence of autoimmune diseases is poised to drive the growth of the rituximab biosimilars market in the future. Autoimmune diseases encompass disorders wherein the body's immune system attacks healthy tissues under the misconception that they are foreign. Rituximab biosimilars find application in treating autoimmune diseases by targeting specific B cells, thereby mitigating inflammation and autoimmune responses. For example, as of July 2021, the Cleveland Clinic reported that in the United States, 1.4 million people are affected by Crohn's disease or ulcerative colitis, and one million are diagnosed with lupus. Moreover, autoimmune diseases rank among the top 10 causes of death for women across all age groups up to 64. Hence, the surge in autoimmune diseases' prevalence is a significant driver of the rituximab biosimilars market's growth.

Companies in the biosimilars industry continue to prioritize new product development through collaborations with industry peers. This trend is particularly evident in the rituximab biosimilars market. An example of such collaboration occurred in July 2023 when Dr. Reddy's Laboratories partnered with Fresenius Kabi to commercialize their proposed rituximab biosimilar in the US. The goal of this collaboration is to introduce a more affordable and accessible biosimilar version of rituximab to the market, offering an alternative treatment option for patients. The introduction of a biosimilar rituximab in the United States has the potential to enhance access to this crucial treatment for various conditions, including rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis, and microscopic polyangiitis.

Key players in the rituximab biosimilars market are actively engaged in the development of FDA-approved rituximab biosimilars to establish a competitive advantage. A rituximab biosimilar that receives FDA approval is used in the treatment of specific immune-related conditions and malignancies. For instance, in June 2022, the US-based biopharmaceutical company Amgen Inc. obtained FDA approval for RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab). RIABNI is the only FDA-approved rituximab biosimilar for all available Rituxan indications, encompassing Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), Microscopic Polyangiitis (MPA), and moderately to severely active rheumatoid arthritis (RA) with an inadequate response to TNF antagonist therapies.


Major companies operating in the rituximab biosimilars market report are Cellitron, Novartis AG, Pfizer, BIOCAD, Shanghai Henlius Biotech Inc., Sandoz, Innovent Biologics Inc., Sinocelltech, Cadila Pharmaceuticals, Hetero Drugs Limited, Dr. Reddy’s Laboratories, Shanghai Fosun Pharmaceutical (Group) Co. Ltd., Reliance Life Sciences India, Zenotech Laboratories, NAPP Pharmaceuticals Limited, Mundipharma Deutschland GmbH & Co. KG, Celltrion, Biocad, MABION S.A., Janssen Pharmaceutical, Amgen, Teva Pharmaceuticals, Celltrion Healthcare, Coherus BioSciences, Innovent Biologics, Mylan, Aryogen Biopharma, TR-Pharm, Hikma Pharmaceuticals plc.

North America was the largest region in the rituximab biosimilars market in 2023. Middle East is expected to be the fastest-growing region in the rituximab biosimilars market report during the forecast period. The regions covered in the rituximab biosimilars market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the rituximab biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Canada, Spain. The rituximab biosimilar market consists of sales of mabthera, truxima, ruxience, or rixathon. Values in this market are ''factory gate values,'' that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

Rituximab biosimilars can be administered through various routes, including subcutaneous, intravenous, and molecular methods. Intravenous therapy involves the direct delivery of fluids, medications, and nutrients into a patient's vein. The applications of rituximab biosimilars span across medical conditions such as non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and others. These biosimilars are distributed through different channels, including hospital pharmacies, online pharmacies, retail pharmacies, and various direct distribution channels.

The rituximab biosimilars market research report is one of a series of new reports that provides rituximab biosimilars market statistics, including rituximab biosimilars industry global market sizes, regional shares, competitors with a rituximab biosimilars market share, detailed rituximab biosimilars market segments, market trends and opportunities, and any further data you may need to thrive in the rituximab biosimilars industry. This rituximab biosimilars market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.