This is perhaps one of the first ever gynaecology therapies in recent years to break into the select group, which has been mostly dominated by medication for long-lasting diseases or chronic conditions. Typically, the highest selling drugs in the domestic pharma retail market are mostly treatments for lifestyle ailments like blood pressure, diabetes, anti-infectives and antibiotics. The massive growth is also a grim reminder of the rise in gynaecology issues in women, including menstrual disorders, miscarriages and infertility, according to experts.
“The huge demand for the widely used molecule Dydrogesterone — possibly more superior than Progesterone — was not being fully met for years. Its manufacturing process is complex, the API (active pharmaceutical ingredient) is imported by most players and it has thin margins. Mankind’s launch in early 2020 as the first generic to develop this drug opened the gates for a host of other companies — including Emcure, Alkem, Torrent and Eris — to follow suit over the last two years,” an industry expert told TOI. The expert added that the market is expected to grow further with entry of more players and affordable options.
Till three years ago, Abbott’s legacy brand Duphaston was the only drug available, netting annual sales of Rs 350 crore. “Over the last five years, we have continued experiencing strong demand for the brand, with double-digit growth (IQVIA MAT December’ 2021). It is manufactured in the Netherlands with a rigorous manufacturing process that is proprietary to Abbott. Dydrogesterone is approved for prescription as a convenient oral medicine for eleven indications, and is widely prescribed to support pregnancies, as part of infertility treatments, and in gynaecological indications such as endometriosis,” an Abbott spokesperson said.
Sales of branded generics Dydrogesterone, excluding ‘Duphaston’, shot up to Rs 250 crore over a two-year timeframe, analysts say, with a rapid volume expansion (50% YoY in FY22) on account of new players. Since the route of administration is oral, patient compliance is very high, leading to higher acceptance in this category. “Currently, according to AWACS, we reflect a revenue of Rs 58.6 crore (July MAT), with Dydrogest being among the top five brands,” a Zydus Cadila executive said.
Eris Life Sciences COO & ED Krishnakumar V said, “With several companies launching Dydrogesterone, the product penetration, availability and affordability has significantly improved, making it a preferred option for patients.”
The natural Progesterone market was pegged at around Rs 700 crore in FY22. But offtake was impacted in FY21, largely due to the pandemic. The offtake normalised with an 11% YoY volume growth in FY22. However, Dydrogesterone volumes increased 48% YoY in FY22, indicating a considerable shift in doctor’s prescription from progesterone, a note from Motilal Oswal said.