AI will be a useful tool in reducing R&D costs to help alleviate some of the pain pharma will feel by the imminent patent cliff.
Speaking at Arena International’s Clinical Data Management Innovation (CDMI) Europe 2025 in Barcelona, Spain, George El-Helou, strategic intelligence pharma analyst at GlobalData, said that patent expiries represent $236bn in revenue at risk between 2025 and 2030 in the US alone.
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While the industry has faced ‘patent cliffs’ in the past, most notably in 2010, the looming cliff is predicted to be one of the most significant the industry has experienced.
El-Helou explained: “The scale, composition, and financial impact of the 2025 to 2030 patent cliff makes it one of the most consequential patent expiries the industry has faced.”
He added that this comes at a time when the industry is seeing costs rising in the research space. This includes rising R&D costs, which stem from more specialised science, larger trial footprints, and greater operational demands.
Increased costs are also being seen in clinical trials due to increased complexity, narrow inclusion criteria, a higher number of endpoints, biomarker requirements, and more protocol adjustments. Companies are also facing a higher bar of regulatory expectations for evidence, data quality, and patient representation.
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By GlobalDataEl-Helou commented: “All of these pressures together are contributing to slowing R&D productivity. It’s taking longer, costing more, and requiring significantly more data to bring a new therapy to market, and this slowdown becomes even more concerning when you consider the patent cliff.”
AI could be the answer
This means that the sector is seeking solutions that can help alleviate some of these challenges, with El-Helou highlighting AI as a key tool.
“AI isn’t just a general trend but is becoming foundational to how companies discover and design drugs. Not only does it accelerate their identification and improve prediction accuracy, but it also helps to reduce the time and cost early in development, and this influence is already showing,” El-Helou explained.
While adoption is still in the early stages, there are already signals that the sector is open to using the technology. This includes its use in target identification, drug discovery, and efficiency.
There are already clinical trials of drugs which were discovered with the use of AI, however, many of these are either in very early stages or are preclinical. El-Helou states that this “reinforces the idea that AI is currently having its biggest impact at the front end of R&D”.
Pharma is also making significant deals in the AI space, with three significant agreements in the past three months. This includes Eli Lilly’s partnership with Nvidia, Roche’s partnership with Manifold, as well as Thermo Fisher Scientific’s acquisition of Clario.
El-Helou concludes: “As the industry faces rising complexity and looming patent cliffs, AI provides a clear path to greater efficiency, smarter decision making, and faster breakthroughs. The opportunity now is to adopt and scale these tools across the value chain.”
GlobalData is the parent company of Clinical Trials Arena.
