With global pharmaceutical companies heading into a major patent expiry cycle over the next decade, pharma major Lupin is increasing its focus on complex generics, biosimilars and specialty medicines as it expands its portfolio in regulated markets.

The Mumbai-based drugmaker, which has strengthened its profitability and balance sheet over the past two years, is positioning itself to tap opportunities emerging from rising demand for lower-cost alternatives in markets such as the US. The company is also expanding its presence in emerging markets and investing in respiratory therapies, injectables and ophthalmology products.

Lupin’s FY26 results indicate the financial flexibility it now has to invest more aggressively in differentiated products. The company reported revenue growth of 23.9% and a 62% rise in annual profit, while EBITDA margins expanded to 33.6%. Lupin ended the year with net cash of over Rs 4,600 crore.

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The US business, which contributes 42% of global sales, remains central to the company’s strategy. Lupin continues to build its pipeline in complex therapies where competition is relatively lower and margins are relatively better.

“America continued to do very well because of the products that we introduced in recent times, which include Tolvaptan and Mirabegron, and before that Spiriva and Albuterol,” Ramesh Swaminathan, Executive Director, CFO, Lupin told Business Today.

Lupin’s India business also reported growth across cardiovascular, diabetes and respiratory therapies. “In the last quarter, we grew by 14.5%, much above the industry growth rates,” Swaminathan said.

The company currently has 52 first-to-file filings in the US, including 22 exclusive opportunities that could support future launches. Lupin also maintained investments in research and development, spending over Rs 2,000 crore during FY26.

“In recent times, we have pivoted to more complex products. The bulk of our turnover in the future would potentially come from respiratory products. Biosimilars are going to be a fairly significant contributor to our results. Injectables and complex injectables would also be very important,” Swaminathan said.

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Industry experts expect complex generics, inhalation therapies and specialty medicines to become increasingly important for Indian pharmaceutical companies as pricing pressure persists in conventional oral generics in the US market. Patent expiries in several therapies are also expected to open up opportunities for biosimilars and differentiated products over the next decade.

Swaminathan said the company sees biosimilars not only as a US opportunity but also as a platform for expansion across other global markets.

Alongside the US, Lupin is expanding its presence across emerging markets, where sales grew over 35% during FY26. Brazil, Mexico, South Africa and the Philippines are becoming important markets for the company. Swaminathan said Dapagliflozin performed well in Brazil, supporting both revenue and profitability.

The company is also building its specialty portfolio following the acquisition of Visu Pharma in Europe and plans to expand its ophthalmology business further across global markets.

Managing Director Nilesh Gupta said the company would continue investing in technology, operational efficiencies and execution to sustain growth momentum.

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However, challenges remain. Lupin’s API business declined nearly 18% during FY26 amid pricing pressure and continued dependence on Chinese supplies across the sector. The company also flagged concerns around rising raw material and logistics costs.

“Raw materials, KSMs and solvent prices have gone up, and sometimes even the availability of certain chemicals has become difficult,” Swaminathan said. “Air freight and ocean freight have also gone up in recent times because of geopolitical tensions.”

He added that the company has been working on alternate vendor development and reducing dependence on single suppliers to mitigate supply chain risks.

Lupin also acknowledged that sustaining margins at current levels could become more challenging as competition intensifies globally and pricing pressure continues in the generics market.

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“The nature of the industry is a huge upside on launch and thereafter a continuous decline. It is a bit like running on a treadmill, so you need to continuously replenish the portfolio with newer products,” Swaminathan said.

Looking ahead, the company expects differentiated and specialty therapies to contribute a larger share of growth. “A fair chunk of our portfolio would potentially come from biosimilars, complex injectables and respiratory products,” he said.