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Global pharma is on the brink, driven by the looming ‘patent cliff’ in the United States. As a wave of blockbuster drugs lose their patent protection, the market will be flooded with generics and biosimilars, offering a cheaper alternative to branded medications. This opens up a highly competitive landscape, with established pharmaceutical giants facing increased pressure from more affordable options. This threatens the revenue streams of big pharma and provides an opportunity for smaller, agile players to disrupt the market.
The next few years will be critical as the industry navigates this transformation and adapts to the rising dominance of generics and biosimilars. With 750+ US FDA-approved plants, India is well primed to take advantage of this opportunity. Companies like Cipla and Sun Pharma are gearing up to unlock the next level of growth in this period by expanding their portfolios and de-risking their US supply chains by adopting multi-site manufacturing, said Dr. Purav Gandhi – CEO & founder, Healthark.
Now patent cliffs are not unusual, but the one currently underway is as steep as they get. Medicines worth $236 billion are expected to go off-patent in the next five years, a 65% rise over the previous five years. These are products that generate billions of dollars in sales annually. Hence, such a cliff is expected to deal a major blow to the revenues of some pharma companies, he added.
However, it is not all bad. This transition also creates valuable opportunities for the manufacturers of more affordable alternatives to push their drug. It will not only reshape the competition but impact pricing structures and availability of critical therapies worldwide, he said.
The current patent cliff, which will happen between 2025-2029, will impact nearly 70 drugs, with a $236 billion global pharma revenue at risk. Some of the major biologics losing exclusivity over the next five years include in 2025: Perjeta (Genentech) - HER2+ Breast Cancer, Benlysta (GSK) – Lupus, Elelyso (Pfizer) - Gaucher Disease, and Blincyto (Amgen) - Acute Lymphoblastic Leukemia. In 2026 it will be Kadcyla (Genentech) - HER2+ Breast Cancer, Lartruvo (Lilly) - Soft Tissue Sarcoma and Taltz (Lilly) for Psoriasis and Arthritis. Between 2027-2029, it will be Keytruda (Merck) and Opdivo (BMS) - Immuno-oncology, Darzalex (J&J) - Multiple Myeloma, Ocrevus (Genentech) - Multiple Sclerosis and Cosentix (Novartis) - Psoriasis and Psoriatic Arthritis.
We see oncology as a key affected segment, with top-selling drugs like Keytruda and Darzalex losing exclusivity by 2029. The patent cliff of 2025 is expected to result in a broad Loss of Exclusivity (LoE) opportunity across the US and EU. This will sharply drive up the launch of generic drugs and especially benefit Indian pharmaceutical companies that have growing US operations and expertise in complex generics, Dr Gandhi told Pharmabiz.
The patent cliff of 2025 brings with it a wave of change that will force the pharma companies to rethink revenue strategies, pipeline investments, and lifecycle management to safeguard long-term growth. This period not just demands strategic planning but also novel drug development. Innovators must accelerate new product development while biosimilar manufacturers must work to gain trust among healthcare providers, he said.
More than a threat, the patent cliff reminds of the inevitable evolution within pharma. It challenges old models while fostering competition that could ultimately lead to more accessible and sustainable healthcare solutions worldwide, pointed out Dr Gandhi.
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