A wave of blockbuster biologics is set to lose patent protection, creating a major inflection point for the biosimilars market in 2025 and beyond. While Europe remains the global leader in biosimilar adoption, South Korea is rapidly emerging as a powerhouse, leveraging strong government support and industry investment. However, a looming development gap threatens future competition—despite record losses of exclusivity, many biologics still lack biosimilar alternatives in the pipeline. As demand for cost-effective therapies grows, the industry must address barriers to development, regulatory challenges, and shifting market dynamics to sustain momentum.

 

Europe Leads in Uptake, but Global Competition Grows

Europe remains the undisputed leader in biosimilar adoption, accounting for over 50% of global use. With prices 15–35% lower than their reference biologics, biosimilars have become a key cost-saving tool for European healthcare systems, ensuring broader patient access while easing financial strain.

However, despite its strong adoption, biosimilar spending has slowed in recent years after a surge from 2018–2019 patent expirations. Today, biosimilars are available in six major therapeutic areas, contributing to 6.9 billion patient treatment days since the first EU approvals in 2006.

While Europe has long been dominated by homegrown biosimilar developers, foreign competition is gaining ground. Between 2022 and 2024, 11% of EMA-approved biosimilars came from India or South Korea, a 3% increase over the past three years. This trend is expected to accelerate as more non-European firms enter the space.

Beyond direct competition, global biosimilar firms are increasingly partnering with experienced European manufacturers to navigate the region’s complex regulatory landscape. Between 2014 and 2024, these strategic alliances accounted for 45% of all biosimilar approvals in Europe, reinforcing the market’s reliance on cross-border collaboration.

As Europe continues to lead in biosimilar adoption, its market dominance is being reshaped by increasing global participation and strategic partnerships, ensuring a more competitive and diversified industry in the years ahead.

 

Patent Expiry Boom, but a Biosimilar Gap Looms

A wave of biologic patent expirations is set to reshape the biosimilars landscape, opening unprecedented opportunities—but also exposing a worrying development gap.

Between now and 2030, 69 biologics in Europe and 118 in the U.S. will lose exclusivity, creating an opportunity eight times larger than the 2012–2014 period, according to Julie Maréchal-Jamil of Medicines for Europe. However, despite these record losses, only 29% of molecules nearing expiry in Europe have a biosimilar in development.

One major factor is commercial viability—many upcoming off-patent biologics are low-revenue drugs, generating under €500 million annually, making them less attractive for biosimilar developers. Unlike small-molecule generics, where competition is immediate, biosimilars require significant investment and are less likely to spur a highly competitive market.

Beyond financial concerns, pipeline concentration is another issue. 92% of biosimilar development is focused on oncology and immunology, leaving other therapeutic areas underserved. Meanwhile, orphan indications and complex biologics like antibody-drug conjugates (ADCs) and cell and gene therapies present additional scientific and regulatory hurdles, further limiting biosimilar expansion.

Despite the huge commercial potential, the biosimilars market remains selective, and unless development broadens beyond its current niche focus, many biologics may remain without competition—a growing concern for healthcare systems looking for cost-effective alternatives.

 

Regulatory Hurdles and Market Scepticism Slow Biosimilar Growth

Despite growing acceptance, regulatory barriers and market perception challenges continue to slow biosimilar adoption. While the EMA ruled in 2022 that biosimilars are interchangeable with their reference products, the FDA still requires costly switching studies to grant interchangeability status in the U.S.—a major hurdle for manufacturers.

In June 2024, the FDA proposed new draft guidance that could eliminate these additional switching studies, potentially easing market entry. However, until this guidance is formally adopted, biosimilar makers must continue absorbing massive development costs—ranging from $100 million to $300 million per product—a barrier that limits competition.

Biosimilars are gaining ground in the U.S. market, with new patient initiations rising from 1% in 2013 to 34% in 2022. However, persistent skepticism among both patients and physicians remains an obstacle, with some still viewing biosimilars as inferior to their branded counterparts.

For biosimilars to reach their full market potential, both regulatory alignment and broader education efforts will be essential in reducing uncertainty and increasing adoption.

 

South Korea: A Rising Star

South Korea is leading Asia’s biosimilars boom, and its global dominance is only set to grow. Fueled by strong government support and major industry investments, the country’s biosimilars market—valued at $177 million in 2021—is projected to expand at 20–30% annually in the coming years.

But South Korea’s influence extends far beyond its domestic market. 24 biosimilars developed by South Korean companies have already been approved worldwide, with another five in pre-registration, solidifying the country’s global footprint.

A total of 15 South Korean companies are actively developing biosimilars, but two firms stand out:

  • Samsung Bioepis leads with nine FDA and EMA-approved biosimilars, making it the most successful Korean player internationally.
  • Celltrion follows closely with eight approvals, continuing to expand its global reach.

With a fast-growing pipeline, global approvals, and sustained investment, South Korea is rapidly positioning itself as a top contender in the global biosimilars race, challenging traditional strongholds in Europe and India.