Contract manufacturing driving Indian bulk drugs market

pharmafile | December 13, 2010 | News story | Manufacturing and Production |  Cygnus, Drug Master Files, India, Indian pharmaceutical industry, contract manufacturing 

The Indian bulk drug industry is expected to expand at an annual growth rate of 21% to reach $16.91 billion by 2014, according to a new report by market research firm Cygnus.

In 2009-10, the country’s bulk drug producers – which operate more than 100 manufacturing facilities – mustered total sales of around $11.54 billion, of which exports contributed about $7.5 billion or 65% of the total.

India ranks third in terms of volume among the top 15 drug manufacturing countries,” according to the report, which notes that contract manufacturing has been driving the bulk drugs exports in the last few years.

All told, the Indian contract manufacturing market stood at $986 million in 2009 and is expected to grow at more than 41% a year to reach $5.63 billion by 2014. Contract chemistry and biology research and clinical trials were also $1 billion sectors last year.

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“Global pharmaceutical companies have been outsourcing contract manufacturing to Indian companies to cut costs,” notes Cygnus.

India has also submitted the most Drug Master Files (DMFs) of all competing economies, the report notes. DMFs are dossiers submitted to regulatory authorities and contain confidential, detailed information about the facilities and processes used in the manufacturing of a bulk ingredient.

Once filed, a company which wishes to use the ingredient in its pharmaceutical product need only cite the DMF, rather than filing this information separately.

From 2000-2009 India had more than 1,614 DMF filings, three times higher than its closest competitor China and a long way ahead of other countries such as Italy, Spain, Mexico and Brazil.

The share of DMFs made by Indian firms has increased considerably from 14% in 2000 to 50% in 2009, the Cygnus report noted.

Phil Taylor

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