Aurobindo Pharma Eyes 'Significant Portion' Of $7 Billion Osteoporosis Drug Market

Pharmaceutical giant Aurobindo Pharma is set to enter the global market for osteoporosis and cancer-related bone treatments with its version of Denosumab, a biosimilar drug.

Following the announcement of successful Phase 3 clinical study results, the company is preparing for regulatory filings in major Western markets and setting its sights on a significant portion of a global market currently valued at $7 billion, according to Satakarni Makkapati, CEO of the biologics, vaccines, and peptides businesses at Aurobindo Pharma. 

“So the drug has a market potential of around $7 billion globally, with entrants in biosimilars shaping the market probably from late 2025. We just announced a strong Phase 3 result for this biosimilar with regulatory filings planned for the US, EU and other key markets beginning from January 2026,” Makkapati said during a conversation with NDTV Profit.

He explained that the drug is meant to treat bone-related ailments. “Denosumab is a monoclonal antibody that is used primarily to treat conditions such as osteoporosis and bone metastasis from cancer.”

He expressed confidence in a swift approval process in Europe. “We are looking at around a 9- to 10-month window for approval in Europe with the UK and Health Canada. So I expect the product to be approved by the end of 2026,” he said.

The approval process in the US is expected to take slightly longer, with a target of 2027.

Dr Makkapati noted that the current market for the product in Europe is valued at $2.2 billion, while the US accounts for a substantial $5 billion.

“Starting from end-2025 to 2030, I expect biosimilars to take anywhere between 30% and 50% of the innovator market,” he said.

This could translate to biosimilar sales of $1.5-1.6 billion initially, potentially growing to $3-4 billion by 2030, shared among five to six key players.

 However, the CEO also cautioned about the competitive landscape and the “acceleration of the price erosion”. 

“But you need to understand that once biosimilars come in, the volumes will go up and there will be an acceleration of the price erosion,” he said.

Makkapati suggested that this intense competition could lead to some companies exiting the market over time. “We really need to see how many of these early entrants would be the last man standing,” he concluded.