The global biosimilars market was valued at USD 20.44 billion in 2022 and is expected to grow significantly, reaching USD 23.96 billion in 2023 and projected to surge to USD 73.03 billion by 2030. This reflects an impressive compound annual growth rate (CAGR) of 17.3% during the forecast period. In 2022, Europe led the global biosimilars market, accounting for a dominant share of 50.44%.

Biosimilars are safe, effective, and highly similar alternatives to approved biologic drugs. Unlike generic drugs—which are identical copies of chemically synthesized drugs—biosimilars are modeled after complex biological drugs, which are large protein molecules derived from living cells through intricate manufacturing processes. While biosimilars are not identical to their reference biologics, they closely match in terms of safety, purity, and efficacy. Once the patent on a reference biologic expires, biosimilars are eligible to enter the market. Regulatory approval for biosimilars is granted only after rigorous evaluation demonstrates their similarity and performance compared to the original biologic. Compared to the approval process for original biologics, biosimilars benefit from a more streamlined regulatory pathway.

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Global Biosimilars Market – Key Takeaways

Market Size & Forecast

• The global biosimilars market was valued at USD 20.44 billion in 2022 and grew to USD 23.96 billion in 2023.
• It is projected to reach USD 73.03 billion by 2030, expanding at a robust CAGR of 17.3% from 2023 to 2030.
• Growth is driven by rising healthcare cost pressures, increasing chronic disease prevalence, and the patent expiration of major biologic drugs.

Market Share

• Europe led the global biosimilars market in 2022 with a 44% share, supported by:
• A well-established regulatory environment.
• Patent cliffs for high-value biologics.
• Strong adoption of cost-saving measures across public health systems.
• The European Medicines Agency (EMA)’s proactive stance, with 86 biosimilar approvals since 2006, solidifying the region’s leadership.
• Monoclonal antibodies represented the largest product segment in 2022 due to:
• Broad therapeutic use in cancer, autoimmune disorders, and chronic diseases.
• High regulatory approval rates and expanding development pipelines.
• Strong revenue contributions and long-term growth potential.