Rituximab is a chimeric anti-CD20 antibody that binds to the CD20 antigen present on the standard and malignant B cells surface. It is indicated for the treatment of blood cancer (CD20-positive) such as chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, as well as an autoimmune disorder such as Rheumatoid arthritis. Rituximab is marketed under the trade name of MabThera in Europe and the Rest of the World, except Japan by Roche. In the United States, it is marketed as Rituxan by Genentech in partnership with Biogen Idec. In Japan, it is marketed by Chugai and Zenyaku Kogyo Co. Ltd. It was approved in the U.S. in 1997 and by European Medical Agency in June 1998. Rituximab is one of the top selling pharmaceutical products of Roche Holding AG. Therefore many biosimilar pharmaceutical companies are focusing on product development of rituximab biosimilar to compel the biosimilar product market share. Some of the market players leading the global rituximab biosimilar market include Amgen Inc., Pfizer Inc., Sandoz International GmbH, Celltrion Healthcare Co., Ltd., Mylan Inc., Reliance Life Sciences, Teva Pharmaceutical Industries Ltd., Intas Biopharmaceuticals Ltd., C.H. Boehringer Sohn AG & Ko. KG, and BioXpress Therapeutics SA.
The rituximab biosimilar market is expected to grow at a higher pace during the forecast period since the rituximab is one of the best seller drug products that accounts for around 2.1 million prescriptions worldwide since the market launch. In addition, rituximab has lost its patent in the United States and Europe in 2016 and 2013, respectively. The presence of strong pipeline products such as ABP 789, MabTas, Redux, and JHL 101, increasing incidence of chronic disease (such as cancer, arthritis, and diabetes) are the other factor that boosts the demand for the rituximab biosimilar market. Furthermore, rising demand for biosimilar drugs and the entry of new pharmaceutical market players have increased the growth of the rituximab biosimilar market during the forecast period. However, a stringent regulatory approval process for the rituximab biosimilar is a major restraining factor that hampers the growth of the rituximab biosimilar market. In addition, IP strategies used by the product innovator companies to fight against the biosimilar competition, such as advancement in original formulation or screening for some new indications, restrain the growth of the rituximab biosimilar market. For instance, Roche announced the development of a new formulation for Rituxan as a strategy to fight against biosimilar competition.
Based on application, the global rituximab biosimilar market is segmented into non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and others. Other indication includes off-label use such as thrombocytopenia, macroglobulinemia, immune thrombocytopenic purpura, Burkitt lymphoma, autoimmune hemolytic anemia, and multiple sclerosis. Non-Hodgkin’s lymphoma and chronic lymphocytic leukemia segment are expected to grow at a rapid pace during the forecast period owing to the increasing incidence and prevalence rate of chronic disease. Based on distribution channels, the global rituximab biosimilar market is segmented as hospital pharmacy, online pharmacy, retail pharmacy, and others. The hospital pharmacy segment is expected to grow during the forecast period due to an increase in the number of hospital visits and hospital stays for the treatment of different chronic diseases.
At geographic level segmentation, the global rituximab biosimilar market has been categorized into Europe, Asia Pacific, North America, Latin America, and Middle East & Africa. In terms of revenue, Europe is a major contributor to the global rituximab biosimilar market. Europe is the major contributor to the global market owing to the loss of a rituximab patent in 2013. In June 2017, Sandoz announced the launch of the first rituximab biosimilar in Europe. Europe is followed by North America, which is the second major revenue generator during the forecast period. The growth of the rituximab biosimilar market in North America is owing to factors such as strong clinical trial/product pipeline, increasing research and drug development activities propels rituximab biosimilar market growth in the region. Asia Pacific is the third promising revenue contributor which is expected to grow at rapid pace in the upcoming year. Countries such as Japan, India, and China are major contributors to this market. Emerging and huge population base countries such as China and India offer tremendous market opportunities.