Exports by Indian producers of Active Pharmaceutical Ingredients (APIs) are forecast to reach a value of $12.75 billion in 2012, more than trebling the level of $3.75 billion which they reached in fiscal 2007, according to a new report.

“The share of API exports to innovator companies in regulated markets is expected to increase from 7% of total exports in FY 2007 to 15% by FY 2012,” says the study, which is published by the Tata Strategic Management Group.

The biggest area of growth for the sector is forecast to be in sales to research-based drugmakers situated in the regulated markets of the USA, Europe and Japan. The concerns which customers, regulators and manufacturers in these markets have about the quality standards of bulk drugs, intermediates and excipients are giving India’s API producers the edge over firms in other parts of Asia, comments the report, and it adds that the stronger patent safeguards being adopted by India and the international industry’s growing confidence in the country’s regulatory framework will also provide a boost.

During the last financial year, Indian API producers exported 45% of their output to customers in the regulated markets and 54% to the semi-regulated markets, but by 2012 almost 65% of exports will be to the regulated markets and 35% to the semi-regulated sector, according to the report. It notes that this trend is evident from the growing number of regulatory approvals granted by the US Food and Drug Administration (FDA) and the European Union (EU) to Indian manufacturing plants.

The national API sector’s overall production was worth $4.1 billion during fiscal 2007, and 90% of this total, worth $3.75 billion, was exported, with 39% of overseas sales going to generics manufacturers. The large numbers of top-selling drugs which are due to come off-patent over the next five years will provide the sector with a further significant boost, the Tata report adds.

- Meantime, the CPhI Worldwide convention on pharmaceutical ingredients and intermediates, the International Contract Services Exhibition (ICSE) and the Pharmaceutical Machinery and Equipment Convention (P-MEC), which were to take place concurrently in Mumbai from 27-30 November, have been postponed until 2009 following the terrorist attacks in the city.