BIOSIMILARS MARKET ANALYSIS

Biosimilars Market Size and Trends

Global biosimilars market is estimated to be valued at USD 36.01 Bn in 2024 and is expected to reach USD 114.02 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 17.9% from 2024 to 2031.

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 Growing demand for affordable biological drugs along with patent expiries of major biologics drugs can drive the market growth. Increasing investments by market players for research & development and production of biosimilars coupled with supportive regulatory framework can also boost demand for biosimilars. Moreover, biosimilars provide similar therapeutic efficacy in comparison to reference biologics with significant cost savings, which makes them an attractive alternative. However, manufacturing challenges associated with biosimilars can hinder the market growth over the forecast period.

Global Adoption of Biosimilars

Rising healthcare costs in many countries across the globe has increased pressure on governments and private healthcare payers to reduce prescription drug costs. Biosimilars provide significant cost savings as compared to their referenced biologic drugs while providing similar clinical outcomes. Over the past decade, major markets like EU and countries like India, China, Brazil and others have laid out a structured pathway and clear guidelines for the development and approval of biosimilars. This not only boosted investor confidence but also encouraged many generic drug makers to enter this space. As more biosimilars get approved and commercialized in these regions, their cost effectiveness is persuading physicians, hospitals as well as private and public payers to increase their usage over their biologic counterparts for treatment of chronic diseases. This growing acceptance and uptake of affordable biosimilars instead of biologics can drive the market growth.

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Patent expiry of blockbuster biologics

The expiry of patents on major biologic drugs known as blockbusters can drive the biosimilars market growth. When the original manufacturer's patent expires, it offers opportunity for other companies to develop and market biosimilar versions. Notable patent expires in recent years have included Humira, Remicade, Herceptin, Rituxan and MabThera. For instance, AbbVie's Humira, the world's top-selling prescription drug, had worldwide sales of over US$ 20 billion in 2020, according to the STAT Medical Research Guide. With Humira losing exclusivity in Europe in 2018 and the U.S. in 2023, this has encouraged many biosimilar manufacturers to enter the market. In the European Union, biosimilar competition has led to price reductions as high as 80% off the original biologic drug. Greater patient access as well as savings for healthcare systems boosts adoption of lower-cost biosimilars.

According to the WHO Essential Medicines and Health Products List, between 2023 and 2026, blockbusters worth a combined estimated US$ 72 billion in annual sales are forecast to face upcoming patent cliffs. ,. This includes Enbrel, Lantus, Avastin and Harvoni. As more high-profile biologics complete their exclusivity period, their biosimilar counterparts are expected to capture greater market shares over the next decade.