Smaller Indian drugmakers are eating into the share of their local big brothers in the U.S. market. And if brokerage firm Jefferies is to be believed, their troubles are only going to get bigger in coming years.
Data compiled by the research house showed that the market share of top 20 players slipped to 77 percent from 91 percent in past six years.
The trend is reflected in the filing of abbreviated new drug application approvals by the American regulator. An ANDA contains data which is submitted to the regulator for the review and potential approval of a generic drug product.
New and smaller players account for half the ANDA clearances by the Food and Drug Administration, said a report by Jefferies. The year 2016-17 saw 26 companies getting approval for the first time.
The regulator clears nearly 70 applications a month. “The share of Indian companies in the total approvals stable is riding strong at 37 percent currently,” the brokerage said. In the 11 months starting October last year, the Indian pharmaceutical sector saw 1,090 filings, with 855 approvals.
“We expect these trends to continue as filings in U.S. continue unabated and multiple new players are planning to enter the market,” Jefferies said.
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