گزارش تحلیلی بیزینس مانیتور- صنعت داروسازی ایران - سه ماهه اول 2010

For the Q110 update of the Iran Pharmaceuticals & Healthcare Report, BMI’s proprietary forecasts for patented products, generic drugs and over-the-counter (OTC) medicine sales have been extended through to 2019. The key finding is that overall pharmaceutical sales will post a compound annual growth rate (CAGR) of 11.1% over the next decade. However, due to high inflation, the market’s nominal rate of expansion is much lower, diminishing the attractiveness of Iran to drugmakers.

Throughout 2009, BMI received several anecdotal reports that Iran’s pharmaceutical regulatory environment was becoming increasingly opaque. A major development was the Q209 change to the medicine law. In addition to other subjects, the legislation stated that: drug licences would be valid for 4 years; medicines sold in Iran must be produced to current Good Manufacturing Practice (cGMP) standards; pharmaceutical dossiers would be assessed within 180 days; medicine prices would be calculated using reference levels in Spain, Greece, Turkey and the country of origin; and also confirmed exactly what constituted a biosimilar.

In BMI’s Middle East and Africa Pharmaceutical Business Environment Ratings for Q110, Iran has fallen one place to 11th, behind Morocco and ahead of Israel. The cause of this decline is a drop in its Pharmaceutical Rating from 44.9 to 41.8, which itself is due to a downward calculation of the value of the country’s US$2.3bn pharmaceutical market. Nevertheless, compared with its regional neighbours, Iran scores well for Pharmaceutical Market, but is let down by Market Risks and Country Risks.

The standard of Iran’s biomedical R&D sector is fairly good for the Middle East, but far below that seen in developed countries. In November 2009, the Health Ministry ordered 2mn doses of H1N1 swine flu vaccine from undisclosed Chinese and European countries. Delivery was expected in February or March 2010. The government had set aside US$20mn for the purchase, but was willing to contribute another US$10mn if necessary. Because there were three Iranian biomedical institutions were already researching an indigenous swine flu vaccine, self sufficiency was expected in May 2010.

Because Iran’s economy is dominated by oil, government spending fluctuates according to the price of a barrel of crude oil. The 2008 price spike meant that the state over-spent on certain services and this has resulted in debts during 2009. A senior government official revealed in October 2009 that state-run hospitals and clinics had accrued debts totalling IRR3,322bn (US$335mn) to local pharmaceutical companies, thereby threatening their commercial viability due to a lack of liquidity.