With sponsors and CROs still on the hunt for emerging markets rife with treatment-naive patients and good infrastructure, interest in the Middle East is increasing.
As of Oct. 11, 2011, 4,957 studies were underway in the 15 countries the FDA considers part of the region, according to ClinicalTrials.gov. That’s 4.3% of the 114,546 trials registered across the globe. But once you extract the very developed market of Israel from that equation, there are just 1,767 ongoing trials. That’s just 1.5% of all trials, still small yet up significantly from the 2006 to 2009 period, when there were just 400 trials in the region.
Vladimir Misik, Quintiles’ senior regional director for clinical operations in the Middle East, said the market there is growing despite volatility. Even with the crisis in Egypt surging this year, the region’s pharmaceutical industry reported 45% growth in sales over 2010.
Clinical research is another matter, though; while the pharma industry projects 4% of its sales will come from the region, only 0.4% of trial participants currently come from the Middle East, which has a population of 280 million.
“The Middle East has the size and potential of Eastern Europe, which contributes 15 to 20% of global patients,” said Misik.
According to ClinicalTrials.gov, after Israel where 3,190 trials are ongoing, Turkey has 874 trials, followed by Iran with 379, Saudi Arabia with 169 and Lebanon with 130. The countries with the least trial activity: Iraq, Oman and Yemen, which each has fewer than 10 studies currently.
Those in the region are making a concerted effort to grow these numbers. Recognizing that training more investigators is key, more groups have begun to hold conferences and summits over the last two years, said Misik. The next gathering, the Clinical Trials Partnership Middle East Summit, will be held Nov. 28-30 in Dubai, for those working in the field in the Middle East and North Africa, considered the MENA region.
“There has been an increase in clinical trials conducted in the MENA region in recent years, largely due to the prevalence of some chronic diseases such as diabetes, cancer and asthma,” explained event director Doaa Said. “Consequently, there is a growing need for training in order to conduct studies in the Middle East.”
The three-day summit will begin with interactive workshops on GCP guidelines as contrasted with regional guidelines. Sessions will focus on better recruiting, understanding new e-clinical technologies, partnering and improving timelines, all of which are pressing topics for those trying to grow the industry in the Middle East.
The volatile nature of the region is high on the agenda, too. Misik will speak on the topic of managing trials during political unrest, a concern some view as a red flag but which needn’t be, he said. “We have seen from the current crisis and previous crises that unless there’s a large-scale military involvement, local unrest or political disruption tends to have minimal impact on business,” said Misik. “There’s a deep understanding in the community of the importance of not letting disruptions get in the way of business.”
He said Quintiles had 15 trials ongoing during the political crisis in Egypt, and all continued uninterrupted. Quintiles, which has been in Turkey since 2002 and the Arabic Middle East since 2007, at this point has “road-tested strategies” for keeping trials running during unrest, he said.
Misik pointed to several upsides to the region that he said offset the volatility. The market is not yet saturated, so patients are plentiful. In addition there are some 600 rare genetic disorders found in the population, which is helpful to the increasing numbers of pharma companies interested in developing “niche blockbusters,” said Misik. Also, the region has the highest prevalence of hepatitis C in the world, which many pharma companies are now viewing as an area of interest, he said.
Timelines are improving across most of the region, especially in Turkey, which is embarking on aggressive efforts to speed up timelines that, if successful, could result in some of the best timelines in the world, said Misik. Also boosting confidence in the region is the fact that the FDA is now working to open an office in Jordan.
Other bright spots for the clinical research industry in the Middle East: The massive Dubai Biotechnology and Research Park (called DuBiotech), the Middle East’s first business park dedicated to the life sciences, was launched in 2005 to draw biotech R&D to the United Arab Emirates. It’s still under construction. Also, Saudi Arabia and Qatar are investing heavily in science parks.