The looming crisis in European drug markets
A quiet shift is underway in the pharmaceutical industry. For the past decade, biologic medicines reaching the end of their patent life triggered a predictable wave of lower-cost biosimilar competition. This process saved billions for European healthcare budgets. Now, those savings are no longer a certainty. Research firm IQVIA identifies this emerging problem as the biosimilar void.
Data indicates a stark decline in commercial interest for upcoming patent expiries. Approximately 110 biologic medicines will lose their protection over the next ten years. Despite this volume, the number of biosimilars in development for each molecule is projected to drop from 2.19 to 0.43 by 2027. This trend suggests that the competitive market that defined the last decade is shrinking. Without intervention, these therapies will lack the alternatives that previously kept drug costs manageable for patients.
The financial cost of market contraction
The financial stakes are significant. Researchers calculate a minimum of €15 billion in missed cost savings due to this void. The risk is even higher when analyzing total sales potential; a recent IQVIA assessment values the at-risk market—where pipelines currently lack competitors—at roughly $143 billion. This figure represents 55 percent of sales for drugs nearing their expiry dates.
Large-selling biologics are not immune to these pressures. Out of the 26 most successful biologics set to lose exclusivity by 2032, more than 25 percent lack any biosimilar in development. The situation for lower-selling drugs is even bleaker, with only 7 percent expected to see competitive entry. In specific sectors like oncology, the average count of developers per product is expected to fall from 4.3 down to 1.2 in the years after 2028.
Why current procurement methods fail
Experts point toward current purchasing strategies as a primary driver for this decline. European health systems often rely on single-winner tenders to secure the lowest possible price. While this strategy yields immediate budget relief, it creates long-term fragility. These tenders force smaller manufacturers out of the market, leaving supply chains vulnerable.
Adam Levysohn, who leads EU commercial strategy at Samsung Bioepis, notes that price erosion is accelerating due to a singular focus on short-term costs. He suggests that current systems ignore the value of long-term sustainability. International reference pricing further compounds the issue, as price drops in one nation often transmit automatically to others, effectively discouraging manufacturers from launching products in smaller markets.
Toward a sustainable competitive model
Not every country faces the same outlook. Italy and Sweden show higher stability than France and Belgium, where structural hurdles remain. The difference lies in how these nations manage their tenders. Regions that utilize multi-winner awards see better outcomes for supply security and market health.
Industry groups are now urging a revision of EU procurement rules. They argue for the adoption of criteria that weigh quality and supply reliability alongside price. The European Medicines Agency is also adjusting its guidelines to create a more direct path for development. Ultimately, the future of biologic affordability in Europe rests on policy decisions. Regulators have the opportunity to move away from rigid price-only models to ensure a stable supply of affordable medicine for the next generation of patients.