Biosimilars Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

Market Overview

The biosimilars market is expected to grow at a registered CAGR of 24.2% over the forecast period, 2022-2027.

The impact of COVID-19 on the biosimilars market may be significant, and it has imposed a great challenge on the pharmaceutical companies focused on biosimilar development. The reduction in the FDA approval of non-COVID therapeutics during the current pandemic is expected to delay the process of product approvals and launches, hindering the market growth. Also, as most of the clinical trials have been postponed to combat the COVID-19 situation and minimize the infection among participants, most pipeline products exhibit a slow pace of research and development activities. Also, due to the global lockdown and travel restrictions, there is a shortage in supply chain and raw materials, which would impact biosimilar production. Thus, COVID-19 greatly impacts the market because of the factors above.

Several blockbuster biologic drugs of major pharmaceuticals companies, such as Truvada, Chantix, Forteo, Ciprodex, Afinitor, and many other drugs, lost US exclusivity in 2020. In the coming decade, there would be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, and Orencia, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars. Besides, factors such as the cost-effective nature of biosimilars, rising acceptance and adoption by various stakeholders with the need for diversification in technology and business models, and the growing prevalence of chronic diseases are expected to drive the global biosimilar market. According to Globocan 2020, the estimated incidence of cancer cases in the United States accounted for 2,281,658, with 612,390 deaths, in 2020. The high incidence of cancer surges the demand for effective therapeutics and thus, drives the studied market.

Additionally, the key market players anticipated the market growth over the forecast period by various strategic activities, such as product launches, mergers, and acquisitions. For instance, in July 2021, the Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin-glargine-yfgn), a biosimilar to LANTUS (insulin glargine)

At the same time, with factors, such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, many companies are discouraged from investing in this market, thus, impeding the growth of the market studied.

Scope of the Report

A biosimilar is a biologic that is “similar” to another biologic medicine (known as a reference product), which is already licensed by the US Food and Drug Administration (FDA). Biosimilars are highly similar to the reference product in terms of safety, purity, and potency but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity, or potency in one or more uses for which the reference product is licensed, and the biosimilar seeks licensure. The biosimilars market is segmented by product class (monoclonal antibodies, recombinant hormones, immunomodulators, anti-inflammatory agents, and other product classes), application (blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, oncology, and other applications), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 countries across major global regions. The report offers the value (USD million) for the above segments.

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Key Market Trends

The Oncology Segment Holds the Major Share in the Global Biosimilars Market

The oncology segment is expected to hold the major share in the biosimilars market, and the high incidence of cancers worldwide is the major factor driving the growth of the studied market over the forecast period. According to the International Agency for Research on Cancer 2020, the estimated number of new leukemia cases in 2020 was 474,519 globally. According to the same source, the disease also had significantly high mortality, with total global deaths of 311,594.

In the COVID-19 era, nearly 88% of the cancer care centers faced challenges in delivering usual cancer care for many reasons, including preventive measures, lack of personal protective equipment, and staff shortage, as per the research article published in the JCO Global Oncology 2020. Additionally, this impact was more pronounced in low-income countries. Therefore, COVID-19 is expected to hinder the number of cancer therapies offered to cancer patients, indirectly impacting the studied segment.

Additionally, the increasing research and development activities by key players focused on oncology, along with rising FDA approvals, are expected to drive the studied market’s growth. For instance, in December 2020, Amgen received the United States Food and Drug Administration (USFDA) approval for its RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. Thus, because of the factors above, the biosimilars market is anticipated to witness significant growth over the forecast period.

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