The pharmaceutical industry in the Middle East and North Africa (MENA) region is witnessing dynamic growth, driven by rising healthcare demands, regulatory reforms, and advancements in pharmaceutical manufacturing. Generics and biologics are central to this transformation, each playing vital roles in improving healthcare access, affordability, and treatment options. Generics are drugs that offer equivalent dosage, strength, and therapeutic effect as branded medications but are available at significantly lower costs after patent expiration, enabling broader access among diverse socioeconomic groups. Biologics, complex drugs derived from living cells, target serious conditions such as cancer and autoimmune diseases, with biosimilars—cost-effective and highly similar versions of biologics—gaining traction as a promising therapeutic alternative. This comprehensive evolution underscores the balancing act between delivering affordable care through generics and innovative treatments via biologics, themes extensively discussed at leading industry events including the Pharma Conference Dubai.
The MENA pharmaceutical market is poised for strong expansion. The generic drug market alone is expected to grow at a compound annual growth rate (CAGR) of roughly 6.8% between 2025 and 2033, reaching a valuation exceeding USD 34 billion by 2033, up from about USD 19 billion in 2024. This growth is propelled by factors such as improved healthcare infrastructure, increasing prevalence of chronic conditions like diabetes and cardiovascular diseases, and supportive government policies that encourage generics adoption and local manufacturing. For instance, Saudi Arabia’s Vision 2030 includes initiatives that strengthen pharmaceutical production capabilities and streamline regulatory pathways for generics, while countries such as Iran and Jordan serve as models of effective, cost-efficient generic drug manufacturing. Moreover, the UAE has witnessed a surge in pharmaceutical manufacturing facilities, growing from only four in 2010 to 23 in 2022, reflecting robust industrial momentum backed by government investment and strategic partnerships such as those involving Mubadala Investment Company.
Biologics and biosimilars represent the fastest-growing segments of the MENA pharmaceutical market. The regional biologics market reached approximately USD 4.1 billion between 2015 and 2019 and has experienced an annual growth rate of around 14.5%. Saudi Arabia leads in biologics sales with revenues surpassing USD 1.8 billion, followed by key markets including Egypt, the UAE, and Algeria. The biosimilars sector is projected to grow at a CAGR of nearly 25% between 2021 and 2026, driven by rising healthcare expenditures and increasing demand for innovative therapies that tackle complex diseases. Efforts by regulatory bodies like the Saudi Food and Drug Authority (SFDA)—which actively works to align local regulatory frameworks with international standards such as the FDA and EMA—are streamlining the approval process for biosimilars, improving market access and patient availability. These initiatives, including regulatory harmonization across Gulf Cooperation Council (GCC) nations, are regularly highlighted at events like the Pharma Exhibition in Dubai.
The MENA region’s pharmaceutical manufacturing landscape is rapidly evolving. The expansion of generics manufacturing capabilities is a strategic priority supported by government incentives, partnerships between local and international companies, and investments in production infrastructure. Advanced manufacturing technologies, including automation and quality control innovations, are enhancing efficiency and output. Notable projects, such as Mubadala’s collaboration with G42 in Abu Dhabi to develop biopharmaceutical hubs focused on vaccines and therapeutic products, emphasize the region’s commitment to becoming a pharmaceutical manufacturing powerhouse. Mubadala’s acquisition of KELIX Bio in March 2024 further illustrates the ambition to boost generics production capacity and drive life sciences sector growth. This evolving manufacturing prowess enables the MENA region to capitalize on expiring patents and compete effectively in global pharmaceutical markets, balancing high-value branded products predominantly in GCC countries with cost-effective generic medicines, especially in parts of Africa with waived patent protections. Insights into these advancements feature prominently at the Dubai Pharma Expo 2026.
Economically, generics are fundamental in reducing healthcare expenses while expanding access to essential medicines. For example, Egypt’s Ministry of Health policies promoting generics have led to substantial reductions in drug prices and improved patient reach. Biosimilars also play a critical role by offering more affordable alternatives to originator biologics. The SFDA’s regulatory frameworks ensure biosimilars meet stringent safety and efficacy standards while fostering market competition to drive prices down. Pharmacy and Therapeutics Committees (PTCs) across GCC countries evaluate medications for formularies with a balanced approach considering clinical benefits, safety, ethical factors, and cost-effectiveness. These committees guide prescribing, dispensing, and monitoring of biosimilars, including policies on switching and interchangeability, often pairing biosimilars with brand names and batch numbers to optimize procurement and reimbursement processes. National strategies, such as the UAE’s National Strategy for Pharmaceuticals aiming to locally produce 50% of its medicines by 2030, encompass both generics and biosimilars to enhance self-sufficiency and healthcare sustainability. Many of these policy and economic developments are addressed in forums like Upcoming Events in UAE.
Collaborations and partnerships are pivotal in accelerating pharmaceutical access and innovation in the MENA region. Oman’s public-private partnerships seek to build a sustainable biopharmaceutical ecosystem by attracting international expertise and investment to expand biosimilars production and exports. The partnership between Hikma Pharmaceuticals and Celltrion combines commercial reach with biosimilar manufacturing expertise to enhance availability and healthcare provider education across MENA. Similarly, Biocon’s 2024 licensing and supply agreement with Tabuk Pharmaceuticals focuses on commercializing treatments for diabetes and chronic weight management, supporting local market authorization and distribution in key countries aligned with Saudi Vision 2030 objectives. The World Health Organization’s revised biosimilar guidelines are gradually adopted across MENA, led by Egypt, though some hesitancy remains in certain countries. India’s role as the largest generic and biosimilar exporter to MENA, supported by initiatives like the Make in India campaign, further strengthens regional pharmaceutical supply chains. Collaborations to unify regulatory approaches and improve market access were the focus of the 2nd MENA Stakeholder Meeting on Biosimilars and remain central topics at Upcoming Pharmacy Conferences in Dubai.
Country-specific case studies illustrate diverse approaches and strengths. Saudi Arabia continues to advance its National Biotechnology Strategy, enhancing local biosimilar production and regulatory alignment with EMA and FDA standards. The UAE champions personalized medicine through initiatives like the Emirati Genome Programme and facilitates biosimilar approvals via fast-track regulatory processes, positioning itself as a regional biopharmaceutical innovation hub. Egypt’s regulatory framework fosters biosimilar growth through updated guidelines and strengthened pharmacovigilance. Jordan and Tunisia provide examples of strong pharmaceutical sectors supported by robust generics and biologics regulation aligned with EMA norms. These success stories are prominently featured at Upcoming Pharmacy Conferences in Dubai.
Looking ahead, the MENA pharmaceutical industry’s prospects are promising but require continued focus on harmonizing regulatory frameworks, strengthening manufacturing infrastructure, and fostering innovation and partnerships. Agencies such as the SFDA, UAE Ministry of Health and Prevention (MOHAP), and Egyptian Drug Authority (EDA) are essential to maintaining strict safety and efficacy standards. The GCC Health Council’s efforts toward unified pharmaceutical policies emphasize regional collaboration’s importance. Through sustained reforms, investment in research and development, and enhanced stakeholder collaboration, the MENA region is well-positioned to become a global leader in delivering affordable, innovative healthcare solutions. These transformative trends and opportunities are regularly discussed at Pharma Trade Shows in Dubai.
