Biosimilars Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

Market Overview

The biosimilars market was valued at approximately USD 28,235 million in 2020, and it is expected to witness a revenue of USD 103,638 million in 2026, with a CAGR of 24.2% over the forecast period.

The impact of COVID-19 on the biosimilars market may be significant, and it has imposed a great challenge to 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, thereby, 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 of the pipeline products are exhibiting a slow pace of research and development activities. Also, due to the lockdown and travel restrictions across the world, there is a shortage in supply chain and raw materials, which would impact biosimilar production. Thus, because of the above-mentioned factors, COVID-19 has a great impact on the market.

Several blockbuster biologic drugs of major pharmaceuticals companies, such as Truvada, Chantix, Forteo, Ciprodex, and Afinitor, and many other drugs lost the 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 growing prevalence of chronic diseases are expected to drive the global biosimilar market. 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 report offers the value (in 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 Globocan 2020, the incidence of new cancer cases was estimated to be 19,292,789 in 2020, with nearly 9,958,133 deaths due to cancers. Additionally, the new cancer incidence is estimated to reach 30.2 million by 2040, as per the International Agency for Research on Cancer (IARC).

In the COVID-19 era, nearly 88% of the cancer care centers faced challenges in delivering usual cancer care for many reasons, including precautionary 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, which indirectly is expected to impact the studied segment.

Additionally, the increasing research and development activities by key players focused on oncology, along with rising in FDA approvals, are expected to drive the studied market’s growth. For instance, in December 2020, Amgen received the US FDA 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 aforementioned factors, the biosimilars market is anticipated to witness significant growth over the forecast period.

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