The pharmaceutical sector in the MENA region is rapidly advancing due to increasing adoption of generics and biologics. Generics are economical drugs identical in formulation and effect to branded medicines but offered at lower prices following patent expiration, enhancing healthcare affordability across diverse populations. Biologics are innovative medicines made from living cells, treating complex conditions such as cancer. Biosimilars, which closely resemble original biologics yet cost less, are gaining traction. The regional healthcare strategy employs generics to ensure access and biologics to provide advanced treatments, a subject of focus at forums like the Pharma Conference Dubai.
The MENA pharmaceutical market has grown substantially due to policy reforms, increased healthcare demands, and manufacturing innovation. Nations like Saudi Arabia and the UAE emphasize localized generic production to cut reliance on imports and widen medicine access. Saudi Arabia’s Vision 2030 promotes expansion in generics with support for procurement and clinical trials. Iran is notable for efficient generic manufacturing for domestic consumption, and countries including Jordan and Algeria aim to address rising health expenses by encouraging affordable generics.
The biologics and biosimilars segments lead growth in MENA, with the former’s market reaching $4.1 billion from 2015-2019 and an annual growth rate of 14.5%. Saudi Arabia dominates biologics sales with $1.8 billion, followed by Egypt, UAE, and Algeria. Biosimilars are forecasted to grow nearly 25% annually through 2026, due to rising funding and demand for novel therapies, signifying the region’s pharmaceutical progress.
Regulatory frameworks are designed in line with international standards but adjusted for MENA-specific needs. Bodies like the SFDA conduct rigorous evaluations for biologics and biosimilars under Gulf Cooperation Council standards. While regulatory variations exist, slowing approvals, efforts to harmonize policies and foster stakeholder collaboration continue, with discussions frequently held at the Pharma Exhibition in Dubai.
Manufacturing infrastructure advances rapidly. The UAE expanded from four pharmaceutical manufacturing units in 2010 to 23 in 2022, driven by demand for cancer treatments, biosimilars, specialty generics, and government support. Partnerships like Mubadala and G42 in Abu Dhabi aim to create hubs focusing on vaccines and therapeutic agents, while Mubadala’s acquisition of KELIX Bio in 2024 bolsters generics production capacity. Patent expirations enable regional manufacturers to compete globally, with GCC focusing on branded and generics, and Africa emphasizing volumes via waived patents. Further details can be found at the Dubai Pharma Expo 2026.
Growth in biologics and biosimilars is supported by national programs. Saudi Arabia’s Vision 2030 directs resources toward biopharmaceutical innovation, UAE’s Mubadala invests heavily in biosimilars, and Egypt enhances regulatory oversight and pharmacovigilance. Challenges like fragmented regulations and import dependence are mitigated via collaborations aligned with international standards, a continual subject at Pharmaceutical Events in Dubai.
Generics play a major role in reducing drug costs and expanding access. Egypt’s generic drug policies have successfully lowered treatment prices. Biosimilars offer an additional financial benefit, backed by the SFDA’s strict regulations promoting safety and competition. Pharmacy and Therapeutics Committees manage drug formularies effectively, including biosimilar use and interchangeability in GCC states. The UAE aims for 50% local medicine production by 2030, including generics and biosimilars, regularly highlighted at Upcoming Events in UAE.
Collaborations like Oman’s partnerships, Hikma-Celltrion’s biosimilar agreements, Biocon and Tabuk’s licensing, and gradual WHO biosimilar guideline adoption (led by Egypt) advance the pharmaceutical landscape. India remains MENA’s chief generic and biosimilar exporter, supported by programs like Make in India. Regional cooperation, a priority at the 2nd MENA Stakeholder Meeting on Biosimilars, is frequently discussed at Upcoming Pharmacy Conferences in Dubai.
National highlights include Saudi Arabia’s biopharmaceutical leadership with SFDA’s EMA-FDA aligned regulations; UAE’s personalized medicine and streamlined biosimilar approvals; Egypt’s strong biosimilar regulatory framework; and Jordan and Tunisia’s EMA-compliant policies fostering generics and biologics sectors. These advancements are featured in Upcoming Pharmacy Conferences in Dubai.
The future outlook for MENA pharmaceuticals is promising yet complex, with emphasis on innovation, collaboration, and regulatory reform. Regional harmonization and infrastructure investment are necessary to overcome challenges. Agencies like SFDA, MOHAP, and EDA, supported by GCC Health Council’s unified approaches, are pivotal. These themes dominate discussions at Pharma Trade Shows in Dubai.
