If pharmaceutical drug patents are an hourglass turned over on the day of approval – with the approaching loss of exclusivity known in the industry as the “patent cliff” – then Big Pharma is currently watching the final grains of sand slipping through the neck of the glass.
At the bottom of the hourglass awaits an unforgiving world of generic and biosimilar competition. Between 2025 and 2030, the patent cliff is set to be one of the biggest since 2010 by revenue at risk, according to analysts.
Gone will be the exclusivity that underpinned years of research budgets, dividends and acquisitions, replaced by a market in which hungry rivals arrive at a discount and pricing power drains fast.
And the patent cliff is not the only headwind. US drug makers are also operating in a tougher political environment as Washington takes a harder line on Chinese life sciences and supply chains.
The Biosecure Act, awaiting final passage in the US Senate and US President Donald Trump’s signature to become law, has added uncertainty to an industry that is simultaneously trying to refill pipelines at speed.
For US drug makers, all of these shifts are approaching like icebergs shearing off a glacier: slowly at first, then all at once.
Morgan Stanley estimates US$171 billion of 2025 revenue at large-cap biopharma companies will go off-patent by the end of 2030, forcing the industry into a race to replace ageing blockbusters.
