Rituximab Biosimilars Market
Number of pages: 100 | Report Format: PDF | Published date: 07 March, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
|
Report Attribute |
Details |
|
Market size value in 2022 |
US$ 2,284.8 million |
|
Revenue forecast in 2031 |
US$ 6,065.5 million |
|
Growth Rate |
CAGR of 12.98% from 2023 to 2031 |
|
Base year for estimation |
2022 |
|
Forecast Period |
2023-2031 |
|
Historical Year |
2021 |
|
Segments covered |
Indications, Route of Administration, Distribution Channel, and Region |
|
Regional scope |
North America, Europe, Asia Pacific, and the Rest of the World (ROW) |
According to the deep-dive market assessment study by Growth Plus Reports, the global rituximab biosimilars market was valued at US$ 2,284.8 million in 2023 and is expected to register a revenue CAGR of 12.98% to reach US$ 6,065.5 million by 2031.
Market Fundamentals
Rituximab is a monoclonal antibody targeting the B cell surface protein CD20. It treats certain cancers, such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. It is also used to treat autoimmune conditions like lupus and rheumatoid arthritis.
Rituximab biosimilars are biologic drugs that are like the reference product, Rituxan. There are currently two approved biosimilars in the United States: CT-P10 and infliximab-dyyb. In 2018, the Food and Drug Administration approved two additional biosimilar versions of rituximab: GP0010 from Sandoz (a Novartis company) and Rixathon from Pfizer. Rituximab biosimilars are becoming increasingly popular as an alternative to the more expensive brand-name version of the drug. Currently, four types of rituximab biosimilars are available in the market: CT-P10, SB2, GP2015, and MabThera/Rituxan.
The development of rituximab biosimilars has been a major focus for researchers worldwide. Several advancements have been made in recent years, including improved production methods, a better understanding of the drug's pharmacokinetics, and methods for reducing immunogenicity. Recent clinical trials have found that rituximab biosimilars are an effective alternative to the original biologic drug. Clinical trials conducted in the U.S. and Europe have found that biosimilars effectively reduce symptoms of rheumatoid arthritis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia as the original biologic drug. Additionally, these clinical trials found that the biosimilars are generally well tolerated and have a favorable safety profile.
[5675675]
Market Dynamics
Rituximab biosimilars are considered a blockbuster specialty drug in treating many chronic diseases, such as non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and autoimmune diseases like rheumatoid arthritis. The increasing prevalence of these diseases will contribute to the high demand for rituximab biosimilars. According to the American cancer society, in 2023, non-Hodgkin’s lymphoma (NHL) will be identified in about 80,550 people (44,880 men and 35,670 women). Adults and children are both included in this. 20.180 individuals will die from this malignancy (11,780 males and 8,400 females). Moreover, the demand is increasing as rituximab is now listed on the World Health Organization (WHO) model list of essential medicines, with comparable pharmacokinetic, safety, and effectiveness data.
Additionally, the global rituximab biosimilars market is anticipated to rise in the forecast period as many top players emphasize organic development strategies, including product launches, product approvals, partnerships, and collaborations. For instance, in 2016, Teva pharmaceuticals and Celltrion Inc. announced an exclusive biosimilar commercial partnership to commercialize Celltrion’s two monoclonal antibody biosimilar products in the United States and Canada. The collaboration in May 2020 launched a TRUXIMA injectable for treating rheumatoid arthritis. TRUXIMA is the only biosimilar of the reference medicine Rituxan®1 (rituximab) approved in the United States for treating rheumatoid arthritis.
Off-label use of rituximab for the treatment of autoimmune disorders, such as rheumatoid arthritis, lupus, and multiple sclerosis, is very common. According to a study conducted by the AJMC, the center for biosimilars in 2020 estimated that off-label use of rituximab is the most commonly prescribed therapy for multiple sclerosis in Sweden. Its use has increased due to studies suggesting it reduces inflammatory brain lesions. Conversely, the high costs of rituximab biosimilars make its affordability difficult for low-income patients.
Market Ecosystem
The global rituximab biosimilar market has been analyzed from four perspectives: Indications, Route of Administration, Distribution Channel, and Region.
Rituximab Biosimilars Market by Indications
[7565445]
Based on Indications, the global rituximab biosimilars market has been segmented into non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and others.
Non-Hodgkin’s lymphoma had the majority of the market revenue share in 2022. In recent years, non-Hodgkin's lymphoma treatment has seen an increase in the usage of rituximab biosimilars. This is due to their efficiency in destroying cancerous cells and their capacity to reduce the undesirable effects of conventional chemotherapy. Moreover, rituximab biosimilars are a more cost-effective alternative to the original biologic medicine.
However, the rheumatoid arthritis segment is anticipated to increase in the forecast period. This is majorly attributed to increased prescriptions of rituximab biosimilars in treating rheumatoid arthritis. Many studies suggest that rituximab biosimilars selectively target cells involved in the immune response without affecting healthy cells. This makes them a powerful option for suppressing inflammation in patients with rheumatoid arthritis.
Rituximab Biosimilars Market by Route of Administration
Based on the route of administration, the global rituximab biosimilars market has been segmented into subcutaneous and intravenous.
Subcutaneous rituximab biosimilars dominated the global rituximab biosimilars market with the largest revenue share in 2022. This is majorly due to more convenience and less invasive methods of administration for patients. Rituximab biosimilars in the subcutaneous route of administration are absorbed more slowly into the bloodstream, resulting in a longer duration of action. It is also often preferred by patients who have difficulty tolerating intravenous injections. Moreover, the subcutaneous route of administration can reduce the risk of infections and medical complications. The subcutaneous route of administration offers the potential for decreased patient treatment burden and greater healthcare efficiency.
Rituximab Biosimilars Market by Distribution Channel
Based on the distribution channel, the global rituximab biosimilars market has been segmented into hospital pharmacies, retail pharmacies, and online pharmacies.
The hospital pharmacies segment had the majority of the global rituximab biosimilars revenue share in 2022. Hospital pharmacies have strict regulations and procedures to ensure the quality and safety of the drugs they dispense. They also have the necessary equipment and expertise to handle and store biosimilars appropriately. In addition, patients are more likely to receive the right dosage and have better access to information and support when obtaining their biosimilars from hospital pharmacies. Furthermore, obtaining rituximab biosimilars from hospital pharmacies is a safer and more reliable option than other sources.
Rituximab Biosimilars Market by Region
Based on region, the global rituximab biosimilars market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominated the global rituximab biosimilars market with the largest revenue share in 2022. The increased frequency of non-Hodgkin's lymphoma (NHL) is expected to boost North America's global rituximab biosimilars market. According to the American Cancer Society, non-Hodgkin's lymphoma makes up around 4% of all cancer cases in the United States. In the U.S., 81,560 people (45,630 men and 35,930 women) were diagnosed with non-Hodgkin's lymphoma in 2021. Moreover, a strong clinical trial/product pipeline, and increasing research and drug development activities propels the rituximab biosimilar market growth in North America.
European region for the rituximab biosimilars market is characterized by increasing healthcare standards offering better diagnosis and treatment. Moreover, the rising approval for effective drugs in the market is also increasing Europe's global rituximab biosimilar market. For instance, in 2020, The European Commission (EC) authorized the rituximab biosimilar Ruxience for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and pemphigus vulgaris. In January 2023, Dr. Reddy's Laboratories completed a full set of clinical studies of its proposed rituximab biosimilar candidate, 'DRL_RI', for approval in the European Union, and other regions for various indications, including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, and chronic erythematosus.
The global rituximab biosimilar market in Asia is anticipated to increase in the forecast period. This is due to increased clinical trials, research, and development on rituximab biosimilars, and rising healthcare standards. Furthermore, in regions such as Japan, the adoption rate of rituximab biosimilars is significantly increasing. The use of rituximab biosimilars in the nation has undergone a significant transformation.
Strategic development
Competitive Landscape
Some of the prominent market players in the global rituximab biosimilars market include:
North America dominated the global rituximab biosimilars market in 2022 in terms of revenue share.
The global rituximab biosimilars market is expected to register a revenue CAGR of 12.98%.
Novartis AG, Amgen, Teva Pharmaceuticals Industries Ltd., Pfizer Inc., and BIOCAD Biopharmaceuticals Co are major players in the rituximab biosimilars market.
The high cost of rituximab biosimilars is a key obstacle to the revenue growth of the market, especially in the low-income countries.
*Insights on financial performance are subject to the availability of information in the public domain
Using the fundamental research and knowledge services capabilities of GRG Health, Growth Plus Reports may now be tailored based on client needs.
GRG Health's unique GrowthMIX strategy and comprehensive research methodology enable us to provide unique and valuable insights to our clients while uncovering trends that would not be discovered using traditional techniques.
Snehal Deshmukh
Principle Consultant
Speak to analyst