IQVIA Report Highlights Growing ‘Biosimilar Void’ as Biologic Patent Expiries Accelerate

The US health care system is at risk of missing out on significant cost savings due to a growing "biosimilar void," according to a new report from the IQVIA Institute analyzing upcoming biologic patent expirations. While biosimilars have historically played a critical role in reducing health care costs and increasing patient access to complex therapies, market challenges and the increasing complexity of biologics may hinder biosimilar development in the coming decade.

The report found that between 2025 and 2034, 118 biologic medicines will lose patent protection, representing a $232-billion opportunity for biosimilar competition. However, as of June 2024, only 12 of these molecules have biosimilars in development, leaving 106 biologics in a biosimilar void—a market segment where competition may not materialize, limiting potential savings.

Key Barriers to Biosimilar Development

The study identified multiple factors contributing to the biosimilar void, including:

• Market potential: Biosimilar developers prioritize biologics with high sales, but even some high-revenue drugs lack a biosimilar pipeline.
• Patent expiry timing: While patent expirations are accelerating—averaging 12 biologics per year compared to 5 per year in the previous decade—developers may struggle to keep pace.
• Therapeutic area and patient population: Biologics approved for rare (orphan) diseases (64% of upcoming expiries) present challenges due to small patient populations and complex clinical trials.
• Manufacturing and regulatory hurdles: High production costs, slow market adoption, regulatory burdens, and reimbursement challenges discourage biosimilar investment.

The Economic Impact of a Biosimilar Void

Biosimilar competition has historically generated significant savings for the US health care system, but this trend may not continue without targeted interventions. The report estimates that if biosimilar competition occurred for all 118 biologics facing patent expiration, the health care system could save an additional $189 billion beyond expected biosimilar-driven savings.

Solutions for a Sustainable Biosimilar Market

To prevent a widening biosimilar void and ensure continued cost savings, the report suggests several policy and market interventions, including:

• Regulatory streamlining to reduce the burden on biosimilar developers;
• Improving market conditions for biosimilars; and
• Collaborative efforts among stakeholders.

With biologic patent expirations accelerating, the next decade presents a major inflection point for biosimilar development. Without proactive measures, the US health care system may face higher costs and reduced access to life-changing therapies, according to the study.

Reference

Assessing the biosimilar void in the U.S.: achieving sustainable levels of biosimilar competition. The IQVIA Institute. Published February 3, 2025. Accessed February 13, 2025. https://www.iqvia.com/Insights/The-IQVIA-Institute/Reports-and-Publications/Reports/Assessing-the-Biosimilar-Void-in-the-US