Middle East & Africa Biosimilars Market Research Report, 2030

Market Dynamic

Market Drivers • Rising Disease Burden and Demand for Cost-effective Treatments: The Middle East and Africa face a growing burden of chronic diseases such as cancer, diabetes, and autoimmune disorders. At the same time, healthcare budgets in many MEA countries are constrained, making access to expensive biologics difficult for both patients and governments. Biosimilars present a highly attractive solution: they offer similar clinical benefits at significantly lower costs. This is especially important in low- and middle-income countries across Africa and parts of the Middle East, where the affordability of life-saving treatments is a major concern. • Government Support and Favorable Import Policies: Several countries in the MEA region, particularly in the Gulf Cooperation Council (GCC) countries such as Saudi Arabia, the UAE, and Qatar, are taking proactive steps to encourage biosimilar adoption. Regulatory agencies are accelerating approval processes, and health ministries are including biosimilars in public tenders to reduce costs. Countries with limited biologic production capacity often rely on biosimilar imports from Europe, India, and South Korea, making favorable import policies a key driver of growth. Market Challenges • Weak Local Manufacturing and R&D Infrastructure: One of the major challenges in the MEA biosimilars market is the limited local manufacturing capacity, especially in Sub-Saharan Africa. Producing biosimilars is technologically complex and capital-intensive, requiring significant infrastructure and skilled labor, which are often lacking in the region. As a result, many MEA countries are dependent on imports, which can face delays, supply chain disruptions, and fluctuating pricing. Without local production capabilities or strong R&D ecosystems, the region remains vulnerable to global market dynamics and may struggle to ensure consistent access to biosimilars. • Regulatory Gaps and Lack of Harmonization: The regulatory landscape for biosimilars in the MEA region is fragmented and underdeveloped in many countries. While some nations like Saudi Arabia and South Africa have created relatively robust regulatory frameworks aligned with WHO and EMA standards, many others lack clear biosimilar guidelines. The absence of harmonized standards complicates market entry for biosimilar developers and increases the cost and complexity of obtaining approvals across multiple jurisdictions. In addition, regulatory agencies may lack technical expertise or resources to evaluate biosimilar submissions efficiently, causing delays and uncertainty. Market Trends • Increased Biosimilar Adoption in Public Healthcare Systems: As awareness grows and governments aim to reduce pharmaceutical expenditures, public healthcare systems in the MEA region are increasingly incorporating biosimilars into formularies and procurement programs. In countries like Egypt, Algeria, and South Africa, public tenders are starting to favor biosimilars over originator biologics due to their cost advantages. This trend is expected to accelerate as successful case studies from other regions (such as Europe or Latin America) are used to support biosimilar integration in national treatment guidelines. • Regional Collaborations and Technology Transfers: To address the lack of local production, several countries in the Middle East and North Africa are entering technology transfer agreements and establishing joint ventures with international biosimilar manufacturers. These collaborations aim to build domestic manufacturing capacity, enhance technical expertise, and reduce dependency on imports. Examples include partnerships between GCC countries and companies from South Korea and India. These initiatives are part of broader strategies to develop the local pharmaceutical industry and improve healthcare self-reliance in the long term.