The Indian pharmaceutical giants are taking a halt in filing new drug applications, with new filings lowest in the past 19 years, says a latest report by Japanese brokerage firm, Nomura.
However, this is not concerning the report says, as the Indian pharmaceutical majors are going for quality over quantity. While the number of ANDA filings in Oct’23-Jun’24 declined to 521 versus 567 in the previous year. Filings classified as complex contributed 20 per cent and 16 per cent respectively in these periods. The industry is thus selective and targeting complex products, the brokerage report said.
The trend of first cycle approvals also seems healthy as in FY24 (Oct-23 to Jun-24) around 18 per cent of the approvals being first-cycle approvals, in line with the 6 year average of 16-18 per cent.
On the sales front; US generics overall sales increased 0.7 per cent quarter on quarter in June 2024 whereas excluding-Revlimid sales declined 0.2 per cent Q-o-Q, the report by Nomura noted.
Besides this, the regulatory challenge is also cooling, so far in FY24 (year ending Sept 2024), 112 inspections by USFDA in India have been classified. Only 7.1 per cent of the inspections are classified as OAI, which is the lowest in the past 11 years, Nomura report said.
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Baking in key approvals, filings, patent litigations and regulatory developments, Nomura highlighted Lupin as its only buying call in the report among Indian drugmakers.
According to the brokerage, Lupin is preparing the launch of PredForte, having a market of $200 million with 180 days competitive generic therapy (CGT) exclusivity in the near term. The company’s drug Spiriva has a stable market share of 30 per cent. In new launches, Myrbetriq (25mg) share was at 9.7 per cent. The company had launched Myrbetriq tablets recently. Lupin is also facing some setbacks, the report said, with its drugs such as Suprep and Albuterol declining in market share. Lupin also lost litigation in a district court recently for the birth control drug Slynd.
Meanwhile, growth in the specialty segment is slowing for India's biggest pharmaceutical company Sun Pharma, said the report, with Ilumya sales falling by $3 million quarter-on-quarter with a 9 per cent year-on-year increase. Its subsidiary Taro’s sales hit an eight-year low, down $3 million quarter-on-quarter.
On the positive side, Winlevi prescriptions grew by 12 per cent Y-o-Y and 14 per cent Q-o-Q. Generic volumes have also stabilised, with market share gains in Ciprodex at 22 per cent and Pentasa at 41 per cent. Nomura gave ‘Neutral' rating to the company.
Dr Reddy’s Laboratories, too, is facing decline in market share in key generics due to heightened competition: Ciprodex market share is at 8 per cent versus a peak of 44 per cent, Vascepa at 9 per cent against a peak of 15 per cent, with drugs such as Suboxone (23 per cent versus 27 per cent peak), and Toprol (28 per cent versus 38 per cent peak) falling in market share as well.
Other biggi’s such as Cipla and Zydus Lifesciences continue to log growth, Nomura noted. Cipla’s Albuterol drug’s market share rose to 18 per cent, while Lanreotide injection market share increased to 28 per cent in July 2024, with expectations to reach 40 per cent. However, the ongoing Goa site inspection remains a key focal point for Cipla, the brokerage said.
Ahmedabad based Zydus Lifesciences is also capturing market share in drugs like Myrbetriq and OrthoEvra. Zydus has a 17.2 per cent market share in Myrbetriq 25mg while having 21 per cent share in OrthoEvra. However, the company faces additional competition in gAsacol HD, which represents 8 per cent of its sales, according to IQVIA data for the three months ending July 2024. Both Cipla and Zydus were given a ‘Neutral’ rating by Nomura.