The pharmaceutical industry in the Middle East and North Africa (MENA) region is rapidly evolving, driven by growing demand for both generics and biologics. Generics are medications equivalent in dosage, strength, and therapeutic effect to branded drugs but are offered at significantly lower prices after brand patents expire. These drugs are essential in making healthcare more affordable and accessible across different socioeconomic groups. On the other hand, biologics are complex medicines derived from living cells, aimed at treating serious diseases such as cancer and autoimmune disorders. Biosimilars—highly similar and less costly versions of biologics—are increasingly becoming important in the region’s healthcare landscape. The combined growth of generics and biologics underscores the dual approach MENA governments and healthcare systems take: generics enable widespread affordable care, while biologics address complex, high-need conditions. These themes are explored in depth at the Pharma Conference Dubai.

The MENA pharmaceutical market has seen remarkable growth fueled by reforms, rising health demands, and advances in pharmaceutical production. Generics have become a cornerstone of healthcare strategies in countries like Saudi Arabia and the UAE, where governments focus on boosting local drug manufacturing to reduce imports and enhance medicine availability. Saudi Arabia’s Vision 2030 contributes to sector expansion through generic drug procurement and clinical trials, while Iran is recognized for efficient and cost-effective generic production to meet domestic needs. Similarly, countries like Jordan and Algeria emphasize high-quality, affordable generics to cope with budget constraints amid growing healthcare demand.

Biologics and biosimilars constitute one of the fastest-growing segments in MENA’s market, reflecting global trends. The regional biologics market reached $4.1 billion between 2015 and 2019, with a strong annual growth rate of 14.5%. Saudi Arabia leads this segment, generating over $1.8 billion in sales, followed by Egypt, the UAE, and Algeria. Biosimilars are expected to grow at an impressive CAGR of nearly 25% between 2021 and 2026 due to rising healthcare investments and increasing demand for innovative treatments. Together, generics and biologics demonstrate the region’s commitment to accessible and innovative healthcare, positioning MENA as an emerging pharmaceutical hub.

Regulatory frameworks governing generics and biologics in MENA integrate international standards with regional adaptations. The approval of biologics requires stringent clinical and analytical evaluations, including pharmacovigilance measures, guided by agencies like the Saudi Food and Drug Authority (SFDA) and counterparts across MENA. These bodies align with FDA and EMA regulations while addressing regional healthcare priorities. For instance, the SFDA incorporates Gulf Cooperation Council-specific guidelines to harmonize biologics approval. Nonetheless, inconsistent regulatory pathways between countries sometimes delay biosimilar market entry and create challenges in establishing consistent efficacy and safety standards.

Generics benefit from intensifying local production policies, but regulatory bottlenecks occasionally slow their adoption in certain countries. While nations such as the UAE and Jordan facilitate straightforward generic approvals, others still face hurdles such as price controls and clinical trial requirements. Bridging these gaps requires harmonized regulations and collaboration with stakeholders. Discussions on these topics are often central to the Pharma Exhibition in Dubai.

Manufacturing capabilities for generics and biologics are expanding rapidly in the region. The UAE, for example, increased its pharmaceutical production facilities from 4 in 2010 to 23 in 2022. This expansion is driven by growing demand for affordable cancer treatments, advancements in biosimilar approvals, specialty generics, new product launches, and governmental support in healthcare research infrastructure. Innovations such as the Mubadala Investment Company’s partnership with G42 in Abu Dhabi aim to establish biopharmaceutical manufacturing hubs for vaccines and biologics. In 2024, Mubadala’s acquisition of KELIX Bio further bolstered UAE’s generics production and economic diversification goals. This evolution enables MENA to capitalize on expiring patents, enhancing its global competitiveness, with GCC countries focusing on branded and generic products, and African regions emphasizing cost-effective generics. More insights on this are available at the Dubai Pharma Expo 2026.

The rise of biologics and biosimilars in MENA is supported by government incentives and healthcare reforms. Saudi Arabia’s Vision 2030 prioritizes innovative biologics production and research collaborations. The UAE, leveraging the Mubadala Investment Company, is swiftly becoming a biopharmaceutical hub focusing on advanced generics and biosimilars. Egypt emphasizes improving biosimilar safety via regulatory enhancements and pharmacovigilance. Despite progress, challenges include regulatory discrepancies, limited large-scale manufacturing infrastructure, and dependence on imports. Collaborative public-private partnerships, alongside alignment with EMA and FDA guidelines, are paving the way for stronger regional ecosystems. Such topics are frequently addressed at Pharmaceutical Events in Dubai.

Economically, generics are vital for making essential medicines affordable. For instance, Egypt’s health policies promoting generic use lowered drug prices and enhanced patient access. Biosimilars also provide cost-saving options, with Saudi Arabia’s regulatory frameworks ensuring safety and encouraging competitive pricing to reduce biologics costs. Pharmacy and Therapeutics Committees (PTCs) in GCC countries assess drugs based on clinical, safety, ethical, and economic factors to optimize formularies. Policies for prescribing and monitoring biosimilars, including interchangeability decisions, help integrate these products safely. Local strategies like the UAE’s National Strategy for Pharmaceuticals aim to produce half of its medicines domestically by 2030, incorporating both generics and biosimilars. These strategies and collaborations are highlighted at Upcoming Events in UAE.

Strategic regional collaborations further bolster biosimilars and generics adoption. Oman’s public-private partnerships foster biopharmaceutical ecosystems, while Hikma Pharmaceuticals and Celltrion’s alliance enhances regional biosimilar access and education. In 2024, Biocon’s licensing with Tabuk Pharmaceuticals enabled marketing of diabetes management products in key MENA markets, supporting Saudi Vision 2030. Adoption of WHO biosimilar guidelines is progressing, led by Egypt, with India playing a pivotal role as the largest generic and biosimilar exporter to MENA. The 2nd MENA Stakeholder Meeting on Biosimilars emphasized regional cooperation for regulatory harmonization and market access, topics regularly featured at Upcoming Pharmacy Conferences in Dubai.

Key country insights reveal Saudi Arabia’s robust biotechnology strategy aligned with global regulatory standards and incentives fostering local production. The UAE’s personalized medicine initiatives and fast-tracked biosimilar approvals attract multinational investments, creating a bio-innovation hub. Egypt’s strengthened biosimilar regulations and pharmacovigilance programs have established it as a biosimilar leader, supported by government incentives. Jordan and Tunisia maintain stringent frameworks aligned with EMA guidelines, enhancing local pharmaceutical sectors. These advancements are often showcased at Upcoming Pharmacy Conferences in Dubai.

Looking forward, MENA’s pharmaceutical future is marked by innovation, collaboration, and regulatory progress. Addressing challenges like regulatory fragmentation and limited infrastructure requires regional harmonization and investment. Authorities such as SFDA, MOHAP, and EDA play critical roles, with the GCC Health Council advocating unified drug policies. With continued reforms, research funding, and partnerships, MENA is positioned to become a global leader in offering accessible, affordable, and innovative healthcare solutions. These transformative developments are central discussion points at Pharma Trade Shows in Dubai.