EU Biologics Patent Expirations Expose Major Biosimilar Opportunity Gap

Industry Insights from Next Move Strategy Consulting

A significant wave of biologic drug patent expirations across Europe is poised to reshape the pharmaceutical landscape through 2032. However, a large portion of these therapies approaching loss of exclusivity currently lack biosimilar competition, signaling both structural challenges and substantial untapped market potential.

According to a report released by the Korea Biomedicine Industry Association (KoBIA), citing IQVIA and related market data, nearly 100 biologics are expected to lose patent protection in Europe by 2032. Of these, approximately 79% do not have biosimilars under development, raising concerns about delayed competitive entry and unrealized cost-saving opportunities.

Limited Pipeline Readiness Ahead of Patent Expiry

The findings indicate that only about 10% of biologics nearing exclusivity loss have biosimilar pipelines scheduled for entry into the European market. An additional 11% remain uncertain regarding European commercialization timelines.

Development progress has been notably slower for lower-revenue products and therapies targeting rare diseases. This uneven pipeline readiness underscores a growing mismatch between patent expirations and biosimilar availability.

In ophthalmology, for instance, ranibizumab — recognized as the first biosimilar entrant in the field — captured approximately 40% market share six quarters after launch. This lags behind the 50–60% or higher adoption levels typically observed in other therapeutic categories, reflecting distinct market dynamics and adoption barriers.

$143 Billion in Potential Opportunity at Risk

The report estimates that the biosimilar development gap could translate into approximately $143 billion in opportunity losses within the European market. This figure represents nearly 55% of total sales generated by biologics approaching loss of exclusivity.

Importantly, the report emphasizes that pricing alone does not guarantee biosimilar uptake. Real-world adoption is influenced by additional factors including formulation convenience, physician familiarity, and established clinical practice patterns.

Strategic Implications for South Korea

KoBIA highlighted that the structural issues observed in Europe’s biosimilar ecosystem offer strategic lessons for South Korea’s biopharmaceutical industry.

The association recommends that Korean biosimilar manufacturers prioritize blockbuster-focused strategies while expanding into emerging therapeutic areas such as ophthalmology and dermatology. Enhancing development efficiency through formulation differentiation and leveraging global regulatory streamlining were also identified as key competitive levers.

Further, companies are encouraged to secure next-generation pipelines, including antibody-drug conjugates (ADCs), by building on accumulated manufacturing capabilities. Diversification into emerging markets was also suggested to reinforce long-term growth foundations.

The report stressed the importance of continuous monitoring of biologics nearing patent expiry at both domestic and global levels. Coordinated collaboration among industry, academia, research institutions, and government stakeholders was identified as essential to proactively address anticipated development gaps and strengthen global competitiveness.

Korean Presence in the European Biosimilar Market

South Korean firms have been actively expanding their footprint in Europe’s biosimilar segment. In 2024, 12 of the 28 biosimilars that received marketing authorization recommendations from the European Medicines Agency (EMA) were developed by Korean companies — representing the highest share by country.

Companies such as Samsung Bioepis and Celltrion continue to strengthen their presence in the European biosimilar market. However, momentum showed variability, as only one of 41 recommended products in the prior year originated from South Korea.

According to Next Move Strategy Consulting

According to Next Move Strategy Consulting, the widening biosimilar pipeline gap ahead of Europe’s biologics patent cliff is likely to reshape investment priorities within the global biologics market. Companies that proactively align development pipelines with upcoming exclusivity losses may capture significant commercial upside, while delayed entrants risk forfeiting high-value opportunities.

The evolving landscape underscores the growing importance of strategic portfolio planning, regulatory agility, and therapeutic diversification in sustaining long-term competitiveness within the biologics market.

Source: pulse.mk

Prepared by: Next Move Strategy Consulting