£810 / $1295 / €985
The Islamic Republic of Iran forms the eastern border of the Middle East and is bordered by Iraq, Turkey, Pakistan, Afghanistan, Armenia, Azerbaijan and Turkmenistan. Iran had an estimated population of 74.8 million in 2011.
Government investment has resulted in an improved health sector, with modernised services and facilities being built annually. Ownership of hospitals is unevenly split between the public and private/charity sectors, and can be fragmented due to lack of co-ordination between agencies.
A series of Development Plans, spanning consecutive five-year periods from 1990, aimed to rejuvenate Iran’s health sector by raising hospital bed and personnel numbers, building primary healthcare facilities, improving family planning and immunisation rates, focusing on care of the elderly and prevention of non-communicable diseases, reforming the state medical insurance scheme and social welfare systems in addition to attracting foreign investment. However, there is no firm evidence of the success of these measures.
Iran’s medical device market is regulated by the Medical Equipment Department within the Ministry of Health and Medical Education. Regulatory requirements for medical devices are outlined in the Medical Cure and Medical Education Act; they are classified into four categories, depending upon their degree of risk. This classification structure is comparable to the one used in the EU. Post-approval, the General Department for Medical Equipment is charged with market vigilance. That said, Espicom recommends that overseas firms appoint a local agent with knowledge of relevant procedures.
Imports account for an estimated 88.1% of the market, despite the manufacture of basic consumable items such as syringes, needles & catheters, dental instruments & fittings and orthopaedic appliances. Imports were valued at US$785.3 million in 2011. A large proportion of imports (70.4%) were procured from suppliers from the European Union (EU-27), with the Netherlands and Germany being the leading suppliers. Consumables and diagnostic imaging apparatus were the most significant import sectors.
In May 2012, General Director of the Food and Medicine Organisation Saeed Shahmorandi claimed that Iran is self-sufficient in terms of production of disposable medical devices such as syringes, and the government claims that there are 294 domestic manufacturers of medical equipment in operation.
Tense international relations, particularly with the USA, and the internal political situation have affected, and will continue to affect, the market’s attractiveness in terms of foreign direct investment. October 2012 saw a tightening of existing sanctions. While pharmaceuticals and medical devices are supposedly exempt from sanctions, domestic media claim that these sanctions have led to shortages of essential drugs and equipment in the country. Medical device import growth has remained strong, mainly due to the country’s limited production capability. Collated monthly data to full year-ending September 2012 show that imports declined by 18.2% to reach US$632.5 million. This reflects the impact of trade sanctions.
In 2012, Iran’s medical device market is estimated to be worth US$919.5 million; however, the market size per capita is very low, at US$12. The market is projected to grow by a low CAGR of 2.8% in US dollar terms, taking the market to US$1,053 million by 2017. Per capita spending, however, is not expected to rise strongly over the same period.
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