Global Rituximab Biosimilars Market is expected to grow at an 12.0 % CAGR during the forecast period for 2024-2031.
Global Rituximab Biosimilars Market is expected to grow at an 12.0 % CAGR during the forecast period for 2024-2031.
Rituximab is a monoclonal antibody with versatile applications, is involved in treating various conditions. It is administered alone or in combination therapies to combat non-Hodgkin’s lymphoma (NHL), aiding the immune system in cancer cell destruction.
Moreover, it addresses mature B-cell NHL and mature B-cell acute leukemia (B-AL), along with chronic lymphocytic leukemia (CLL) when combined with medications like fludarabine and cyclophosphamide. In rheumatoid arthritis management, it is paired with methotrexate to alleviate symptoms and halt joint damage progression. Additionally, in immune disorders like granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), rituximab, alongside steroids, quells inflammation in blood vessels. Its therapeutic range extends to treating moderate to severe pemphigus vulgaris (PV), offering relief from painful blisters on the skin and mucous membranes.
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This multifaceted profile underscores rituximab’s significance across diverse medical domains. Concurrently, the availability of rituximab biosimilars like RIABNI, FDA-approved for moderate to severe rheumatoid arthritis (RA), and others like Truxima and Herzuma, endorsed by the European Medicines Agency (EMA) for NHL and CLL, marks a significant stride in healthcare accessibility, particularly for long-term treatment needs.
Recent Developments:
- In January 2023, Dr. Reddy’s Laboratories announced the completion of clinical studies for its rituximab biosimilar, DRL_RI, preparing it for submission in regulated markets like the US and EU. The submission in April 2023 was supported by comprehensive data showing similarity to reference products in various parameters. This advancement underscores Dr. Reddy’s commitment to expanding biosimilar options for patients worldwide.
- In November 2019, Teva and Celltrion have jointly unveiled their biosimilar rituximab, Truxima, in the United States, offering it at a 10% discount compared to the list price of the reference product, Rituxan. Patients can expect to access Truxima starting November 11, with prices set at $845.55 for a 100-mg vial and $4227.75 for a 500-mg vial. These prices, however, exclude any potential rebates or discounts. This launch signifies a significant step forward in providing more affordable treatment options for patients in need of rituximab therapy.
- In June 2022, Amgen has received FDA approval for RIABNI (rituximab-arrx), expanding its use to treat moderate to severely active rheumatoid arthritis (RA) in combination with methotrexate for patients who have had inadequate responses to TNF antagonist therapies. RIABNI, already approved for Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis, offers a versatile treatment option for a broader range of patients. This approval signifies a significant step forward in addressing unmet medical needs in autoimmune disorders, reaffirming Amgen’s commitment to pioneering biotechnology solutions for improving patient outcomes.
List of Prominent Players in the Rituximab Biosimilar Market:
- Pfizer Inc.
- Mylan Inc.
- Amgen Inc.
- Teva Pharmaceutical Industries Ltd.
- Celltrion Healthcare Co. Ltd.
- Reliance Life Sciences
- Boehringer Ingelheim International GmbH
- BioXpress Therapeutics SA
- Intas Biopharmaceuticals Ltd.
- Dr. Reddy’s Laboratories Ltd.
- Novartis AG
- Innovent Biologics, Inc
- Cadila Pharmaceuticals
- Shanghai Fosun Pharmaceutical (Group)Co., Ltd.
- Other Prominent Players
Market Dynamics:
Drivers:
The growing prevalence of chronic diseases like B-cell lymphomas, T-cell lymphomas, chronic lymphocytic leukemia, and rheumatoid arthritis is driving demand for rituximab biosimilars. This demand, coupled with advancements in manufacturing processes and technologies, is a key driver for the market.
Technological improvements, such as the development of single-use or disposable technologies, have significantly reduced capital costs for plant construction and commissioning, while also minimizing the risk of product cross-contamination in multiproduct facilities. These advancements enhance the efficiency and quality of biosimilar production, making rituximab biosimilars more cost-effective and accessible to a broader patient population.
Challenges:
In the rituximab biosimilar market there are several challenges present. Firstly, there’s a notable lack of understanding among both physicians and patients regarding biosimilars compared to biologics, potentially hindering their adoption rate. Secondly, the approval process for biosimilars is intricate and demanding, especially in demonstrating their similarity to the reference product, adding layers of complexity.
Moreover, the high costs associated with the development and manufacturing of biosimilars can impact their pricing and competitiveness in the market, posing a significant challenge. Lastly, ensuring the quality and regulatory compliance of biosimilars remains challenging, particularly in regions with less developed regulatory frameworks, thereby posing additional hurdles to market entry and acceptance. These challenges collectively underscore the intricacies and hurdles within the rituximab biosimilar market, necessitating concerted efforts to address and overcome them for broader adoption and patient access.
Regional Trends:
North America stands out as a dominant region, commanding nearly half of the global market share, with the United States leading the pack as the largest market. This stronghold is propelled by various factors, including government initiatives, heightened healthcare spending, and a growing burden of chronic diseases.
Meanwhile, Europe emerges as the second-largest region in the rituximab biosimilars market, with Western European countries like Germany, the UK, and France spearheading the charge. Similar to North America, Europe’s market growth is fueled by governmental efforts, increased healthcare investments, and the escalating prevalence of chronic illnesses.
Segmentation of Rituximab Biosimilar Market-
Rituximab Biosimilar Market- By Application
- Non-Hodgkin’s Lymphoma
- Chronic Lymphocytic Leukemia
- Rheumatoid Arthritis
- Other Disease
Rituximab Biosimilar Market-By Route of Administration
- Subcutaneous
- Intravenous
- Parenteral
Rituximab Biosimilar Market- By Molecule Type
- Monoclonal antibodies
- Peptide
- Protein
- Small Molecule
Rituximab Biosimilar Market- By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
Rituximab Biosimilar Market- By Region
North America-
- The US
- Canada
- Mexico
Europe-
- Germany
- The UK
- France
- Italy
- Spain
- Rest of Europe
Asia-Pacific-
- China
- Japan
- India
- South Korea
- Southeast Asia
- Rest of Asia Pacific
Latin America-
- Brazil
- Argentina
- Rest of Latin America
Middle East & Africa-
- GCC Countries
- South Africa
- Rest of the Middle East and Africa
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