North America Accounts For Almost Half Of The Global Rituximab Biosimilars Market, Europe Follows With Second-Largest Share

Segments covered: By Application – Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Others; Hospital Pharmacy – Hospital Pharmacy, Online Pharmacy, Retail Pharmacy, Other Direct Distribution Channels.

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According to The Business Research Company’s research report on the rituximab biosimilars market, North America was the largest region in the rituximab biosimilar market, accounting for 48% of the total in 2020. It was followed by Western Europe and Eastern Europe, and then the other regions. Going forward, the fastest-growing regions in the rituximab biosimilar market will be South America and Asia Pacific, where growth will be at compound annual growth rates (CAGRs) of 36.7% and 29.2% respectively. These will be followed by North America and Western Europe, where the markets are expected to grow at CAGRs of 18.3% and 13.6% respectively.

The rituximab biosimilar market reached a value of nearly $1.60 billion in 2020, having increased at a compound annual growth rate of 67.9% since 2015. The market is expected to grow from $1.60 billion in 2020 to $3.47 billion in 2025 at a rate of 16.7%. The market is then expected to grow at a CAGR of 10.5% from 2025 and reach $5.72 billion in 2030.

The rituximab biosimilar market growth is supported by the large consumer population in both developed and developing countries, growing awareness about the use of biosimilars, and high spending on healthcare. North America and Europe are well-established and mature markets where there is a well-established system for healthcare including the use of rituximab biosimilars and wherein the major companies of the market are located.

The Business Research Company’s report titled Rituximab Biosimilars Market Global Report 2020-30: COVID-19 Growth And Change covers major rituximab biosimilars companies, rituximab biosimilars market share by company, rituximab biosimilars manufacturers, rituximab biosimilars infrastructure market size, and rituximab biosimilars market forecasts. The report also covers the global rituximab biosimilars market and its segments.

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The US Food and Drug Administration (FDA), a federal agency of the Department of Health and Human Services, has revised its regulations to eliminate outdated biologics and biosimilar requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities. Standard preparations (standard solutions containing a precisely known concentration of an element), which help to ensure safety, purity, and potency of a biologics/biosimilar, can now be obtained from sources other than the FDA’s Center for Biologics Evaluation and Research (CBER), or can be developed internally by the biologics license applicant. The FDA has also removed a rule which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, the FDA is also updating regulations regarding storage periods and storage conditions for biologics. These amendments in regulations are expected to increase regulatory flexibility by allowing the pharmaceutical industry and the FDA to incorporate current scientific technologies in the manufacture of licensed biological products. The average yearly number of new drug approvals was 25 between 2000 and 2009, and 41 between 2010 and 2018. The new biologic product approvals increased from a median of 5 between 2000 and 2013, to 12 between 2014 and 2018. Also, by mid- November 2020, 42 new medicines and biologics got approved by FDA and EMA.

Other actions and initiatives taken by government agencies help advance the biosimilars industry as well. In 2020, the U.S. Food and Drug Administration (FDA) in partnership with U.S. Federal Trade Commission (FTC), an agency of the United States government, announced a public workshop. The workshop was named "FDA/FTC Workshop on a Competitive Marketplace for Biosimilars." The aim of the workshop was to discuss FDA and FTC’s collaborative efforts to discourage false or misleading statements about biosimilars, support appropriate adoption of biosimilars, and deter anticompetitive behaviors in the biologic marketplace. Before this, in 2018, the U.S. FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

Rituximab Biosimilars Market Global Report 2020-30: COVID-19 Growth And Change is one of a series of new reports from The Business Research Company that provide market overviews, analyze and forecast market size and growth for the whole market, segments and geographies, trends, drivers, restraints, leading competitors’ revenues, profiles and market shares in over 1,000 industry reports, covering over 2,500 market segments and 60 geographies. The report also gives in-depth analysis of the impact of COVID-19 on the market. The reports draw on 150,000 datasets, extensive secondary research, and exclusive insights from interviews with industry leaders. A highly experienced and expert team of analysts and modelers provides market analysis and forecasts. The reports identify top countries and segments for opportunities and strategies based on market trends and leading competitors’ approaches.

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