The pharmaceutical sector in the MENA region is undergoing significant transformation fueled by the rising importance of both generic drugs and biologics. Generics are medications that match branded drugs in dosage, strength, and therapeutic effect but are sold at lower prices after patent expirations. Their role is vital in enhancing healthcare affordability and access across diverse economic groups. Biologics, on the other hand, are complex drugs developed from living cells and designed to treat serious illnesses such as cancer and autoimmune diseases. Biosimilars—cost-effective versions highly similar to original biologics—have become increasingly vital to healthcare systems. This dual approach of generics and biologics ensures broad access to essential medicines while addressing complex medical needs. These issues are prominently featured at the Pharma Conference Dubai.
The MENA pharmaceutical market has witnessed robust growth supported by healthcare reforms, expanding patient populations, and advances in drug manufacturing. Saudi Arabia and the UAE prioritize boosting domestic generics production to decrease reliance on imports and improve medicine accessibility. Saudi Arabia’s Vision 2030 actively encourages industry expansion through generic procurement and clinical trials, while Iran efficiently meets local demand with cost-effective generics. Jordan and Algeria similarly adopt generics to manage rising healthcare needs with budgeting constraints.
As for biologics and biosimilars, these are the fastest-growing segments in the region. The biologics market valued at $4.1 billion between 2015 and 2019, with Saudi Arabia leading at $1.8 billion in sales, followed by Egypt, UAE, and Algeria. Biosimilars are forecasted to grow at an annual rate close to 25% through 2026, propelled by increased healthcare spending and demand for novel treatments. Together, generics and biologics illustrate MENA’s commitment to accessible and innovative healthcare, positioning it as a pharmaceutical innovation center.
Regulatory frameworks across the region blend international standards from FDA and EMA with regional requirements. Agencies like the Saudi Food and Drug Authority (SFDA) administer stringent clinical and analytical checks for biologics and biosimilars, with Gulf Cooperation Council-specific guidelines fostering approval harmonization. However, inconsistencies in regulatory approaches between countries occasionally delay biosimilar introductions. Generics benefit from growing local production policies, with nations such as UAE and Jordan streamlining approvals. These regulatory themes are commonly discussed at the Pharma Exhibition in Dubai.
Manufacturing infrastructure has been expanding rapidly. The UAE’s pharmaceutical output grew from 4 facilities in 2010 to 23 in 2022. This surge is driven by oncology treatment needs, biosimilar approvals, specialty generics, and government investment. Initiatives like the Mubadala-G42 partnership in Abu Dhabi aim to form biopharmaceutical hubs focusing on vaccines and therapeutics. Mubadala’s 2024 acquisition of KELIX Bio further strengthens generics production in the UAE, supporting economic diversification. Leveraging patent expirations also allows the region to compete globally, with GCC countries leading in branded and generics output, and African regions emphasizing volume generics. You can explore deeper insights at the Dubai Pharma Expo 2026.
Government-backed initiatives fuel the rise of biologics and biosimilars. Vision 2030 in Saudi Arabia accelerates local biopharma innovation and production, while Abu Dhabi’s Mubadala Investment Company invests heavily in biosimilars and complex generics. Egypt prioritizes biosimilar safety and regulatory improvements. Despite ongoing challenges like regulatory fragmentation and heavy import reliance, public-private partnerships aligned with EMA and FDA guidelines foster ecosystem growth, a central topic at Pharmaceutical Events in Dubai.
Economically, generics play a critical role in lowering drug costs and enhancing access. Egypt’s health policies promoting generics have lowered medication prices and increased availability. Biosimilars offer additional savings with safety assured by SFDA regulatory frameworks that encourage healthy market competition. Pharmacy and Therapeutics Committees manage drug formularies and biosimilar monitoring in GCC states, supporting clinical and economic decision-making and often pairing biosimilars with brands for clarity. The UAE’s National Pharmaceutical Strategy aims to locally produce 50% of medicines by 2030, incorporating both generics and biosimilars, as highlighted at Upcoming Events in UAE.
Regional collaborations strengthen biosimilar and generic access. Oman builds sustainable biopharmaceutical ecosystems via public-private partnerships. Hikma’s alliance with Celltrion enhances essential medicine availability while educating healthcare providers. Biocon’s deal with Tabuk Pharmaceutical licenses diabetes and weight management drugs for MENA, advancing Saudi Vision 2030. WHO biosimilar guidelines are gradually adopted, particularly in Egypt, complemented by India’s role as the largest generics and biosimilars supplier. Collaboration was emphasized at the 2nd MENA Stakeholder Meeting on Biosimilars and at Upcoming Pharmacy Conferences in Dubai.
Country-specific highlights show Saudi Arabia’s leading biotech strategy with SFDA aligned to EMA and FDA standards, the UAE’s personalized medicine initiatives and streamlined biosimilar regulation, Egypt’s biosimilar leadership through robust regulation, and Jordan and Tunisia’s EMA-aligned practices that grow generics and biologics. These developments are spotlighted at Upcoming Pharmacy Conferences in Dubai.
The future of MENA pharma relies on ongoing innovation, collaboration, and regulatory refinement. Addressing regulatory inconsistencies and infrastructure limitations requires regional coordination and investment. Key regulators—SFDA, MOHAP, EDA—supported by GCC Health Council’s unified drug policies, are central to success. The region aims to become a world leader in delivering affordable, innovative healthcare, a theme promoted at Pharma Trade Shows in Dubai.
