BIOSIMILARS MARKET ANALYSIS

Regional Analysis

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North America currently dominates the global biosimilars market, accounting for over 40.2% of the worldwide market share in 2024. With biosimilars expected to drive down healthcare costs in the U.S., the U.S. FDA has approved over 20 biosimilars to date in an effort to increase competition. Major players in the U.S. market include Pfizer, Novartis, and Merck who are well positioned to leverage their pharmaceutical expertise and capture market share as familiar biosimilars continue to go off-patent.

Despite facing initial payer resistance and slower than expected uptake in some therapeutic areas, revenue from biosimilars in the U.S. crossed US$ 1 billion in 2021. The U.S. market offers lucrative opportunities for biosimilar manufacturers due to its size, favorable regulatory guidelines, and the number of blockbuster biological drugs set to lose patent protection over the coming years. Additionally, incentives for U.S. consumers and payers to reduce drug costs will support ongoing transition to more affordable biosimilar options. The European Union is currently the fastest-growing regional market for biosimilars globally. Countries like Germany, France, and the U.K. have particularly strong biosimilar markets and industry presence. Europe was the first region to approve and adopt biosimilars at a commercial level and has progressed much further down the adoption curve compared to other regionss. Germany in particular has emerged as a biosimilars manufacturing powerhouse with several local companies, attracting global biosimilar developers through its strategically strong position in the value chain.