Executive Summary of the 2024 Global Biosimilars Report

In the last 20 years, groundbreaking innovations in biologics have transformed patient care across several indications, most notably in oncology and immunology. However, the cost of treatment with biologics remains extremely high, rendering them inaccessible to a significant number of patients and adding a considerable financial burden to health systems around the world. 

With loss of exclusivity for the first blockbuster biologics—patent-protected drugs that reached billion-dollar sales—the industry witnessed the emergence of biosimilars, which are highly similar versions of already approved biologics. The introduction of biosimilars marks a significant evolution in healthcare, offering comparable therapeutic benefits at lower costs. This promise of expanded patient access and reduced financial burden on health systems is already manifesting. We have seen substantial growth in the global biosimilars market over the last five years: in 2023, the global biosimilars market reached $26.7 billion, growing at a compound annual growth rate (CAGR) of 21% since 2019.

Global Biosimilars Regulatory Environment

Biosimilars follow a condensed regulatory pathway from development to launch, supported by increasingly favorable regulations led by the Food & Drug Administration (FDA) and the European Medicines Agency. This allows biosimilars to enter the market more quickly and at lower costs, making them an attractive opportunity for major players in the drug development space.

Biosimilars Market Maturity

The global biosimilars market has greatly matured and expanded in the last few years, with the European Union and the United States (US) leading this growth. The US biosimilars market grew at a CAGR of 21% during this time, from $4.5 billion in 2019 to $9.3 billion in 2023, fueled by regulatory advancements, including the Inflation Reduction Act and updated FDA guidance on biosimilar interchangeability. As the first region to establish a biosimilar regulatory framework, Europe remains a leader in the global market, growing at 17% each year from a market size of $7 billion in 2019 to $13 billion in 2023. The region’s supportive regulatory environment and extensive experience with biosimilar approvals have allowed it to maintain a dominant market position. Emerging biosimilar markets in Latin America and the Middle East and Africa have exhibited strong growth potential at a CAGR of over 40% from 2019 to 2023. Like many other markets, this growth is driven by the need to reduce healthcare costs and improve access to biologics treatments.

Biosimilars Market Leaders and Activity

The biosimilars market is dominated by large pharmaceutical companies such as Sandoz, Pfizer, and Amgen, which together control 50% of the global market. These companies leverage their extensive research and development capabilities and global reach to maintain a competitive edge. Significant deal activity, including mergers and acquisitions as well as licensing agreements, has also shaped the market, allowing companies to expand their biosimilar portfolios and accelerate time to market.

Global Biosimilars Market Growth

The biosimilars market is poised for continued growth, projected to exceed $64 billion by 2028, driven by patent expirations, favorable regulatory environments, and an increasing number of biosimilar approvals. The entry of new players, particularly generics companies, will influence the market’s evolution because they may employ different business models to compete with established pharmaceutical firms. As the market matures even further, these dynamics will play a crucial role in determining the future landscape of biosimilars.