Alira Health Releases Global Report on Trends and Competitive Dynamics in the Biosimilar Market

2024 Global Biosimilars Report. The report provides a comprehensive analysis of global biosimilar trends, with a focus on competitive dynamics in the US and Europe. It highlights key players, their biosimilar-related licensing and M&A activities, and examines the legal and regulatory landscape influencing market growth.

Key insights from the report include:

• Biosimilar launches have become increasingly successful, with recent products achieving nearly 70% market share by volume within two years of launch.
• The US and EU, supported by biosimilar-friendly regulations such as the US Inflation Reduction Act and interchangeability guidelines, dominate the global market, accounting for over 80% of market share.
• Strategic partnerships and M&A have significantly shaped the biosimilar industry, with deal activity peaking in 2021 and 2022. Generic pharmaceutical companies are playing a larger role, signaling their growing interest in biosimilars.
• The global biosimilars market is expanding rapidly, driven by patent expirations of major biologics and the increasing need for cost-effective alternatives. Notably, 15 of the top marketed biologics without approved biosimilars—accounting for about $150 billion in global sales in 2023—are set to lose patent protection by 2033, creating a sizeable market opportunity for biosimilars.

“The global biosimilar market has matured significantly in recent years, with the US and EU leading this expansion,” said Alexandra Wollersheim, Partner at Alira Health. “Regulatory advances, such as the IRA and updated FDA guidance on biosimilar interchangeability, are driving this growth. With patent expirations and increasing biosimilar approvals, the market is on track to surpass $64 billion by 2028. This represents a significant shift in healthcare, delivering the benefits of biologics at reduced costs and expanding patient access while alleviating financial pressures on health systems.”

About Alira Health

Alira Health is a global advisory and clinical research firm whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, Alira Health complements the expertise of its Pharma, Biotech, and Medtech clients with a full spectrum of services across their entire solutions lifecycle. Learn more at AliraHealth.com.

Contact: John McLaughlin [email protected]