News | November 24, 2021

Increasing Aging Population Is Notably Impacting Rituximab Biosimilars Industry Growth

The Business Research Company’s Rituximab Biosimilars Market 2021 - Opportunities And Strategies – Global Forecast To 2030

The population profile of most countries is becoming older, thus driving the demand for diagnosing and treating various diseases including cancer. The proportion of people above the age of 65 years increased globally and age-related chronic ailments also increased. For example, the percentage of seniors is expected to grow from 28% in 2019 to 38% in 2050 in Japan. The increase in the aging population has increased the patient pool of many chronic diseases such as cancer. People suffering from these diseases are expected to be more vulnerable to chronic diseases, thus significantly impacting market growth during this period.

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

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The US Food and Drug Administration (FDA) has revised its regulations to eliminate outdated biologics and biosimilar requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities.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 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 (Section 610.21 of FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, the FDA is also updating regulations (Section 610.53 of FDA code) 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.

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North America was the largest region in the rituximab biosimilar market, accounting for 48.0% 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 CAGRs of 36.7% and 29.2% respectively. These will be followed by North America, and Western Europe where the rituximab biosimilar markets are expected to grow at CAGRs of 18.3% and 13.6% respectively.

Major players covered in the global rituximab biosimilars market are Teva/Cellitron, Novartis AG, Pfizer, BIOCAD, Shanghai Henlius Biotech, Inc.

TBRC’s global rituximab biosimilars market report is segmented by application into non-hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, others, by distribution channel into hospital pharmacy, online pharmacy, retail pharmacy, other direct distribution channels, by route of administration into subcutaneous, intravenous, molecular type.

Rituximab Biosimilars Market 2021 - By Application (Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis), By Distribution Channel (Retail Pharmacies, Hospital Pharmacies, Mail Orders) And By Region, Opportunities And Strategies – Global Forecast To 2030 is one of a series of new reports from The Business Research Company that provides rituximab biosimilars market overview, forecast rituximab biosimilars market size and growth for the whole market, rituximab biosimilars market segments, and geographies, rituximab biosimilars market trends, rituximab biosimilars market drivers, restraints, leading competitors’ revenues, profiles, and market shares.

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Source: Rituximab Biosimilars Market