Clinical Trials in Egypt and the MENA Region

Pharma IQ

Biopharmaceutical companies looking for cost-effective ways for conducting clinical trials are looking towards the emerging markets in the Middle East and North Africa (MENA) region.

Currently just five percent of clinical trials take place in the area, but this figure is only likely to increase. The outsourcing of clinical research practices to the MENA region is expected to increase 20 percent in the coming years.

Those looking for long-standing expertise within the clinical research field, and biopharmaceuticals industry are likely to turn to Egypt - a country which holds the regulatory and cost advantages of the MENA, with the added benefit of an existing infrastructure. Egypt continues to attract large bio-pharma providing a high standard of research at a lower cost.

As Frank Mueller, R&D manager at Egyptian-based Minapharm, told ContractPharma: "Egypt has a very robust and solid pharmaceutical background and tradition."

Clinical Trials Outsourcing in Egypt

Since 2007, Egypt has been a base for what is believed to be the largest contract research organisations in the world, Quintiles.

Although the company does not produce public financial statements, a Business Insights report names it as the largest CRO, with a 16.9 percent market share in 2007.The bulk of its services in Egypt centre around clinical monitoring and site management of clinical trials.

Quintiles also recently reaffirmed its commitment to the Egyptian market with the creation of a joint venture with Health Kare Pharma International (HKPI), and Ramco Import and Export to provide a contract sales force and promotion marketing in the country.

"The alliance brings together deep local market knowledge with global commercialisation expertise, along with existing stakeholder relationships and a network of regional contacts," Hossam Kamel, managing director of HKPI, commented.

There are clear reasons why such large companies would chose to have operations in Egypt.

Sherif Hanala, senior consultant at Global BioFocus LLC, told Contract Pharma: "[Egypt's] established manufacturing capability is the largest in the region and is a basis for pharmaceutical services development. However, this capability is yet to reach its full potential, as a source of services."

IMS Health also named Egypt as one of its pharmemerging markets, which is expected to contribute $1 to 5 billion in annual sales growth leading up to 2013. Merck Serono as also had a presence in the country since 1965 and  is now one of the leading companies in the Egyptian market.

Changes in the MENA region

Lower costs and fewer regulatory hurdles are two of the key reasons why pharmaceutical companies choose to conduct R&D activities within the MENA region.

This is now being compounded by the building of new state-of-the-art hospitals and healthcare facilities further improving the infrastructure for clinical trials. Many of these hospitals have now received Joint Commission International accreditation.

Lifestyle changes have also brought new problems with World Health Organisation (WHO) reporting the region having the highest rate of diabetes in the world.

"Increased prevalence of diabetes, cardiovascular disease, gastrointestinal disorders and cancer in the region has fuelled a lot of the clinical trial activity," Dr. Umakanta Sahoo, managing director of Chiltern India told Contract Pharma.

However, in line with this comes the imperative to attract or train higher numbers of professionals in clinical research.

Dr. Rabinder Buttar, president and chief executive officer of ClinTec International, explained: "There is a growing need to educate, train and develop more clinical researchers who are certified to international standards in clinical research."

Other experts suggested those operating in the region should make an partnership with established organisations in the region, such as Quintiles, which have the expertise to ensure trials are conducted in accordance with good clinical practice guidelines.