A significant opportunity lies ahead for the Indian pharmaceuticals industry in 2025-26. During this period, the patents of 20-25 high-revenue drugs will expire-a situation known as the patent cliff-presenting a big chance for Indian firms to introduce more affordable alternatives, adding to their already impressive supply of over 20% of the world’s generic drugs. "India already has a strong position in the global generic drugs market. The patent cliff will further enhance this role," says Rashmi Chaturvedi Upadhyay, Senior Pharma Consultant at Dialectica, an information services firm.
In 2025-26, the patents for key drugs such as Keytruda (developed by US pharma major Merck for cancer immunotherapy) and Ozempic (produced by Danish firm Novo Nordisk and used for diabetes and anti-obesity treatment) will expire. Keytruda alone generated over $25 billion in sales in 2024. Other significant drugs, such as Bristol-Myers Squibb’s blood thinner Eliquis and Novartis’ immunology drug Cosentyx, will face a similar situation this year, opening more opportunity for generics.
In the coming years, several more patents will expire. Between 2023 and 2029, patents for more than 100 critical drugs used in treating cancer, diabetes, cardiovascular diseases, and autoimmune disorders will expire. These drugs collectively account for a significant portion of the global pharmaceutical market, with total annual sales exceeding $300 billion. This, Upadhyay says, will create additional market space for manufacturers of generics and biosimilars.
According to European Pharmaceutical Review, global demand for generics is projected to grow at a CAGR of over 7%, primarily driven by these patent expirations. Indian firms such as Sun Pharma, Dr. Reddy’s, Laboratories and Biocon are set to gain from this.
Beyond generics, biosimilars present another growth avenue. "The upcoming patent expirations will open up new markets, but ensuring compliance and scalability will be essential to remaining competitive," says Kiran Mazumdar-Shaw, Executive Chairperson of Biocon.
Indian firms are advancing in biosimilars. However, they encounter competition from low-cost generics manufacturers, especially those based in China. “Innovator companies may also attempt to delay the entry of generics and biosimilars, leading to potential legal challenges. Pricing pressures in markets like the US, along with demands for significant discounts from pharmacy benefit managers, could impact profit margins,” says Upadhyay.
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