The Impact of Biosimilar Competition in Europe 2023
Introduction
The 'Impact of Biosimilar Competition in Europe' report, conducted by IQVIA, provides an overview of the effects of biosimilar introduction on the pharmaceutical market in Europe. This 9th iteration highlights the evolution of biosimilar competition, its impact on pricing, volume, and market share, and the role of biosimilars in healthcare systems. Biosimilars, though representing a small portion of total pharmaceutical expenditure (4%), offer substantial benefits in cost savings, innovation headroom, and patient access.
Biologics in the EU Pharmaceutical Market
Biologics account for 40% of total pharmaceutical spending in the EU, a significant increase from 28% ten years prior. Their growth is attributed to advancements in treatment options for complex conditions, despite downward pressures from biosimilar competition, discounts, and rebates. Biosimilars, contributing approximately €9 billion in 2022, play a critical role in maintaining the sustainability of biologic medicines.
Biologic vs. Non-Biologic Spending Dynamics
Biologic medicines show higher growth rates (9.9%) compared to non-biologics (5.5%) over the past period. Biologics dominate in four of the top-10 major therapy classes, indicating their importance in healthcare. The biologic market encompasses both originator biologics and biosimilars, reflecting the dynamic nature of the sector.
The Role of Biosimilars
Biosimilars contribute significantly to the accessible biologic market, accounting for 20% of treatment volume. They drive savings through reduced list and net prices, impacting both the referenced and non-referenced markets. Biosimilars influence pricing strategies and reduce the non-accessible market volume upon loss of exclusivity.
Challenges and Future Outlook
The biosimilar landscape faces challenges, particularly in orphan drug development and disparities in access across European countries. However, the report's ongoing analysis adapts to include new therapy areas, enhancing its relevance. With the addition of pipeline activities, the report continues to provide insights into the evolving biologic and biosimilar market.
Methodology and Data Sources
IQVIA compiles this report, incorporating data and analyses from key stakeholders such as EFPIA, Medicines for Europe, and EuropaBio. The methodologies employed focus on tracking key performance indicators (KPIs) and monitoring the impact of biosimilars in 23 European markets. The report underscores the importance of the European Medicines Agency (EMA) in biosimilar regulation, including submission standards, approval processes, and post-market surveillance.
Acknowledgements
IQVIA expresses gratitude for the support received from contributors over the years, including Marco Travaglio, Vibhu Tewary, Michael Kleinrock, Urvashi Porwal, Kirstie Scott, Mohit Agarwal, among others, in developing this comprehensive series.
Conclusion
The 'Impact of Biosimilar Competition in Europe' report offers a detailed analysis of the biosimilar market's evolution, emphasizing its role in managing costs, driving innovation, and enhancing patient access within the European healthcare landscape. As the market continues to evolve, the report serves as a valuable resource for policymakers, industry professionals, and healthcare stakeholders.
