Mitigating PATENT CLIFF Fallout

Monoclonal antibodies (mAbs) represent a $279.8 billion market, projected to reach $804 billion by 2033, according to a report from Dimension Market Research. With patents for many of these valuable drugs set to expire in the coming years, the industry faces significant challenges. In this story, we examine 11 blockbuster mAbs whose patents will expire between 2025 and 2030. These expirations, affecting some of pharma's biggest players, will have a major impact on the market and their revenue streams.

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2030, pharmaceutical companies are expected to lose over $236 billion in revenue due to the impending 'patent cliff,' as 190 drugs, including 69 blockbusters, lose exclusivity. This represents about 46 per cent of sales at risk for the top ten pharma companies over the next decade, according to a report by Deloitte.

This is currently what experts call 'wave 2' of patent expirations. The first wave (2010–2020) fueled the growth of the generics industry. Now, the second wave involves the expiration of key monoclonal antibody patents, such as Keytruda, presenting a massive multi-billion dollar opportunity for biosimilars.

To mitigate revenue loss from these blockbuster drugs, pharmaceutical companies are exploring various strategies, including partnerships, mergers and acquisitions, and patent thickets.

"Based on the current status of biosimilars in development, we will see more diversification of businesses (less pure players), more mergers, acquisitions and partnerships. For developers to continue to evaluate the investment required to launch future products in high-cost drug categories, there has to be a level of confidence that the market will support the lower cost biosimilars when they are approved years down the line," said Linda MacDonald, Executive Vice President and Commercial Division Lead at Samsung Bioepis.

Unlike generics, many biosimilars won't be interchangeable or directly substitutable. Also, because biosimilars are more expensive to develop and manufacture, their producers won't be able to reduce prices as significantly as generic drug makers do.