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Biosimilars Market Analysis

The Global Biosimilars Market size is estimated at USD 35.47 billion in 2024, and is expected to reach USD 82.27 billion by 2029, growing at a CAGR of 18.32% during the forecast period (2024-2029).

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 approval by regulatory bodies of non-COVID therapeutics during the current pandemic is expected to delay the process of product approvals and launches, hindering the biosimilars market growth. Additionally, as per the research article titled "Impact of Covid-19 on Cancer Care: A Global Collaborative Study" published in September 2020, 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 shortages due to COVID-19. As biosimilars are injections that need experts to be administered and as the supply chain was greatly impaired in the early pandemic phase, it has significantly impacted the market growth. Therefore, COVID-19 impacted the growth of the biosimilars industry in its initial phase, however, the resumption of supply chain activities and clinical trials for drug development globally will boost the biosimilars market growth rate over the coming years. 

Moreover, several blockbuster biologic drugs of major pharmaceutical companies, such as Truvada, Chantix, Forteo, Ciprodex, Afinitor, and many other drugs, lost United States exclusivity in 2020. In the coming decade, there will 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 biosimilar companies as well as generic manufacturers to offer services specially tailored toward biosimilars. Factors such as the cost-effective nature of biosimilars, rising acceptance and adoption by various stakeholders, the need for diversification in technology and business models, and the growing prevalence of chronic diseases are expected to drive the global biosimilar market. 

Furthermore, the growing burden of cancer and increasing deaths due to it create the need for affordable treatment and thus boost the growth of the biosimilars in the market. For instance, according to GLOBOCAN 2020, in the United States, there were 2,281,658 estimated new cases of cancer and nearly 612,390 deaths in 2020. Additionally, the largest biosimilar companies anticipated market growth over the forecast period through 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). 

On the other hand, factors such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, discourage many companies from investing in this market, thereby impeding the growth of the biosimilars market. 

Biosimilars Industry Segmentation

As per the scope of the report, a biosimilar is a biologic that is "similar" to another biologic medicine (known as a reference product) that 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 global biosimilar market sizes and trends for 17 countries across various regions. The report offers the value (USD million) for the above-mentioned segments.