Trade & Channel Strategies 2025: The $405 Billion Patent Cliff Demands Partnership and Adaptive Market Access Strategies

BioCare's Ryan Cort outlines the pharmaceutical industry's "unprecedented sea change," driven by over $400 billion in anticipated revenue loss from generics and biosimilars losing exclusivity.

The industry would agree that the life sciences landscape is continuing to change as more generics and biosimilars come into the fold, especially following loss of exclusivity (LOE) of branded drugs.

At Trade & Channel Strategies, Ryan Cort, BioCare’s senior director of generics & biosimilars trade relations, shared his insight in a session revolving around “Winning in the Age of Generics and Biosimilars—Strategies for Market Access and Growth.”

His presentation aimed to:

  • Offer a lay of the land in terms of innovator products approaching the end of their lifecycle that will be undergoing changes, due to the latest intro of generics and biosimilars
  • Describe how over the next five years, industry will undergo an “unprecedented sea change” relating to intermediaries, including their market position
  • Share how macros event will make this next wave different from previous patent cliffs
  • Detail how stakeholders’ great knowledge, access to data, and expanded capabilities to access prescribes and patients will converge. “We'll see greater levels of innovation in terms of go-to market models and diversification strategy on the manufacturing side of the business. It'll give us all an opportunity to really partner differently and expand the pie for those willing to join in on that innovation practice,” Cort explained.

The generics and biosimilars landscape: Quantifying the LOE wave

Generics now make up 90% of prescriptions in the US, with an attributed $3.1 trillion in savings for the healthcare system between 2014 and 2023. Also, over the past seven to 10 years, manufacturers lived though what he called a “deflationary environment,” pushing them to diversify their portfolios and diversify into more complex products, and encouraging them to boost their presence outside of the core competency of retail into hospital and specialty.

“These manufacturers are more efficient, smarter, and create value around that supply security. They're ready to tackle the next complex set of issues in this upcoming LOE way,” he noted, as over the next five years, $180 billion of market revenue is anticipated to be affected by LOEs to generics.

Biosimilars on the other hand are reshaping markets and payor formularies, as the first decade started off slowly and garnered momentum, with both the Medicare Part D and Part B markets innovating. Education within the provider space—along with access and competitive market pressure—are demonstrating signs of maturation. Over the next half decade, approximately $225 billion of market revenue is predicted to be impacted by LOE to biosimilars.

Over the years, history has shown that generic drug adoption has welcomed healthy penetration, as players have understood their role in the ecosystem. However, looking ahead to the next five years, at least 13 drugs are expected to lose exclusivity, with two of those headliners being Eliquis (BMS and Pfizer) and Amgen’s Otezla.

Knowing that biosimilars are only 10 years old, their adoption is growing, but is following a more nuanced path compared to generics. Its global market is predicted to reach a CAGR of 18% over the next decade, although uptake speed is highly dependent on the market. For instance, oncology biosimilars (think trastuzumab or bevacizumab) have experienced rapid growth.

Of course, a delay in adoption can also be related to rebate schemes and patent litigation, along with HCP and patient education.

It’s important to note that nearly 50 biologics are losing exclusivity over through 2030, including Opdivo and Keytruda in 2028.

The path to growth: Pillars of collaborative market access

Given the facts that Cort presented, it was a bit of shock when he noted that opportunity doesn’t lie in competition, but partnership. The generics/biosimilars category will rely on collaboration, specifically in the form of transparency, reliability, and shared insights that will help push adoption and loyalty to the forefront.

It begins with education. Are patient support assets not only available, but accessible? This is coupled with providers understanding any new protocols, while being aligned by payor rules.

Then, there’s economics. With GTN strategies having shifted over the years, learning from prior experiences is valuable, and so are having plans that are easy to follow.

The final piece is the channel itself. Can one’s channel partners be considered real partners, and do performance incentives align to strategies? Your partner should also be included in education efforts (material, etc.), which “provide significant areas of opportunity,” according to Cort.

Reference

Cort R. Winning in the Age of Generics and Biosimilars—Strategies for Market Access and Growth. December 10, 2025. Trade & Channel Strategies, Philadelphia. https://informaconnect.com/trade-channel/