With an enabling regulatory environment, advanced healthcare systems, and promising commercial potential, the Middle East North Africa (MENA) region represents an attractive opportunity for orphan drug development
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Ranging from Morocco in the west to Iran in the east, the Middle East North Africa (MENA) region comprises 6% of the world’s
population, including an extraordinary high concentration of patients living with rare and genetic disorders and related Non-Communicable Disease (NCDs). Given low clinical trial density in the MENA region, this high level of unmet patient needs represents an opportunity for orphan drug development.
More broadly, rapid transition from rural to urban economic development in the MENA region has shifted the focus in healthcare from infectious diseases to rare diseases, genetic disorders and related non-communicable diseases (NCDs). By improving time to market and expanding patient access in the commercially attractive and rapidly growing MENA region, inclusion of the MENA region in global multi-center clinical trials may speed up development and commercialization of important new diagnostic and therapeutic interventions to address global unmet patient needs.
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Genetic Disorders in the MENA Region
The MENA region is noted for the increased prevalence of genetic diseases due to high levels of the traditional practice of consanguinity (marriage between blood relatives ie, first and second cousins). Overall it is estimated that 40-50% of marriages in the Arab world are consanguineous. The prevalence of consanguinity ranges from about 25% in Beirut to 60% in Saudi Arabia and 90% in some Bedouin communities in Kuwait and Saudi Arabia. Arabs consider consanguineous marriages as a way to maintain the unity of family assets, ease of premarital negotiations and a way to enforce the couples’ stability due to higher compatibility between husband and wife who share the same social relationships after marriage as before marriage, as well as the compatibility between the couple and other family members. Frequent consanguineous marriage increases the incidence of autosomal recessive disorders by 5 to 10 times at the population level. Other factors such as large family size, advanced maternal and paternal age are also associated with the occurrence of these diseases.
The most prevalent genetic disorders in MENA are as follows:
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Blood disorders
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Inborn Errors of Metabolism
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Cancer
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Other Rare genetic diseases