Global biosimilar market set to explode to $458 trillion over 10 years

The global market for biosimilars, or duplicate biologic drugs, is poised for substantial growth, with projections indicating an expansion to approximately $320 billion (458 trillion won) over the next ten years. This surge is attributed to significant deregulation by the U.S. government and the upcoming expiration of patents for several blockbuster biologic medications. These developments present a considerable opportunity for South Korean pharmaceutical and biotech firms to enhance their global market share.

A pivotal factor in this optimistic outlook is the significantly lowered barrier to entry in the U.S. market. The U.S. Senate's Committee on Health, Education, Labor, and Pensions recently passed the "Biosimilar Competition Act" unanimously. This legislation aims to streamline the approval process, allowing for the interchangeability of all FDA-approved biosimilars with their originator biologic products without requiring separate clinical trials for cross-administration. Once enacted, existing approved biosimilars will gain automatic interchangeability status, enabling substitution at pharmacies nationwide.

This regulatory shift is expected to reduce the substantial clinical trial costs for domestic bio-companies already operating in the U.S. market, facilitating a faster increase in market share. The timing of this legislation's enactment coincides with patent expirations for major biologic drugs, government policies aimed at reducing drug prices, and broader regulatory easing. Consequently, the global biosimilar market is forecasted to expand rapidly to the projected $320 billion mark.

South Korean companies are already demonstrating a strong presence in this evolving landscape. As of June 2026, biosimilar products approved by the FDA numbered 86 in total. Among these, Celltrion secured 10 approvals, Samsung Bioepis obtained 9, and Dong-A ST received 1. Celltrion has also climbed to third place in global biosimilar sales rankings, surpassing multinational pharmaceutical giant Pfizer. Factors such as South Korea's robust contract development and manufacturing organization (CDMO) infrastructure, advanced formulation technologies that enhance patient convenience, and the U.S. government's increasingly stringent sanctions against Chinese biotech firms are expected to further bolster the competitiveness of the South Korean bio-ecosystem.