New Delhi: The Indian drug industry would make huge gains as over $70 billion worth of drugs are expected to go off patent in the US, the world’s largest pharma market, in the next three years, according to a report.
In the past five years, drugs worth around $50 billion went off-patent in the US, which, along with a doubling of generic alternatives in the market, has led to a rise in the generic share by volume to 68%, said a report by Noble, the UK investment bank.
“The Indian generic industry is well positioned to benefit from the structural and macro-economic changes affecting the healthcare industry globally...,” the report on the Indian generic industry said.
Indian pharma companies have earned the reputation of being the most competitive generic firms globally with a large FDA approved product pipeline, coupled with a strong research and development foundation.
Indian companies have filed more than 900 abbreviated new drug applications (ANDA) which is the first stage approval for launching the drugs with US health regulator in 2008 alone and has got around 300 approvals in the last year.
According to industry experts, Indian firms account for the largest number of FDA approvals gained in 2008 and the number is set to rise in future also as there is huge backlog of pending approvals.
The Indian industry is benefiting from the drying pipeline of future products of innovating companies as the US regulator has shown its reluctance in granting approvals to new patented medicines, the report said.
In 2008, only 21 new molecules and four new biologics medicines were approved by US health regulator, Food and Drug Administration (FDA) - an improvement over 2007, which saw only 14 new molecules and two biologicals were approved for marketing by the regulator.
The report said US FDA is adopting a “safety first approach after several drug safety scandals” that have caused a shift in public opinion against the pharma industry and resulted in increasing political pressure on regulators.