Middle East & Africa Biosimilars Market Outlook, 2030

MEA, particularly in the treatment of diseases such as cancer, diabetes, autoimmune disorders, and inflammatory conditions. The high cost of original biologic drugs, combined with budget constraints in many MEA countries, has fueled interest in biosimilars as cost-effective alternatives. Governments across the region are actively seeking to reduce healthcare spending while expanding patient access to life-saving treatments. This has resulted in a gradual yet steady increase in the adoption of biosimilars, with countries such as Saudi Arabia, the UAE, Egypt, and South Africa leading the way in terms of regulatory advancements and market penetration.

The MEA region remains heavily reliant on imports for both finished biosimilar products and raw materials used in their manufacturing. Most of the active pharmaceutical ingredients (APIs), excipients, and biotechnological inputs are imported from the EU, India, China, and the US. However, some countries - especially Saudi Arabia and South Africa - are investing in domestic pharmaceutical manufacturing capabilities to reduce this dependency and create a more sustainable supply chain. These nations are establishing biotechnology hubs and industrial clusters to promote local production, supported by favorable policies and public-private partnerships.

Raw material availability in the region is still a constraint, primarily due to the lack of local biotech infrastructure and specialized capabilities. Countries like Saudi Arabia and South Africa have relatively advanced regulatory frameworks modeled after the European Medicines Agency (EMA) and the US FDA, emphasizing rigorous clinical trials, comparability studies, and pharmacovigilance.

Meanwhile, in other parts of Africa and the Middle East, the regulatory landscape remains fragmented and underdeveloped, often leading to delays in biosimilar approvals and market entry. However, initiatives by regional bodies like the African Medicines Agency (AMA) aim to harmonize standards and streamline regulatory procedures across the continent.

According to the research report "Middle East and Africa Biosimilars Market Outlook, 2030," the Middle East and Africa Biosimilars market is anticipated to grow at more than 18.58% CAGR from 2025 to 2030. Companies like Biovac in South Africa and Julphar in the UAE are examples of local firms expanding into biologics and biosimilar segments. Moreover, multinational pharmaceutical companies are increasingly partnering with local manufacturers through technology transfer agreements and licensing deals to establish a production foothold in the region. These collaborations help in knowledge sharing and capacity building, crucial for ensuring quality and compliance with global standards.

Egypt, for example, has positioned itself as a regional manufacturing hub, with growing domestic production capacity aimed at serving both local and African markets. Saudi Arabia’s Vision 2030 reform agenda is also playing a pivotal role in reshaping the biosimilars landscape, with increased investment in pharmaceutical innovation and biotechnology as part of its broader goal of reducing reliance on imported drugs. Multinational pharmaceutical companies are forming strategic partnerships with regional players to facilitate technology transfer, local production, and regulatory alignment, which in turn are boosting investor confidence and market stability.

In 2024, the MEA biologics and biosimilars sector in the Middle East and Africa grew steadily. This growth happened because more approvals came from regulatory bodies, and the use of biosimilars increased in important sectors like Saudi Arabia, the UAE, and South Africa. The major factors for diabetes are obesity, unhealthy lifestyle, increased life expectancy, increased healthcare expenditures, and genetic susceptibility.

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.

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.

Saudi Arabia is leading the Middle East and Africa biosimilars industry due to its substantial government investment in healthcare infrastructure, strategic regulatory reforms, and strong commitment to local biopharmaceutical manufacturing and innovation.

Saudi Arabia’s emergence as the leader in the Middle East and Africa biosimilars industry can be attributed to its focused and strategic approach toward healthcare development and biopharmaceutical self-sufficiency. As one of the region’s wealthiest countries with vast natural resources, Saudi Arabia has been investing heavily in expanding and modernizing its healthcare infrastructure to meet the growing demand for advanced medical treatments, including biologics and biosimilars.

The Saudi government, through its Vision 2030 initiative, has prioritized the healthcare sector as a critical pillar for national development, emphasizing the reduction of dependence on imported pharmaceuticals and encouraging the growth of a local pharmaceutical industry. This vision includes significant funding for biotechnology research, manufacturing capacity expansion, and fostering public-private partnerships to cultivate a robust biosimilars ecosystem. Regulatory reforms have played a pivotal role in accelerating biosimilar adoption and development within the country.

The Saudi Food and Drug Authority (SFDA) has established comprehensive regulatory guidelines aligned with international standards, streamlining the approval process for biosimilars while maintaining stringent safety and efficacy requirements. These clear, science-based pathways have built industry confidence and encouraged both multinational and local companies to enter the biosimilar market. Saudi Arabia’s growing pharmaceutical manufacturing capabilities also contribute significantly to its leadership position.

With investments in state-of-the-art production facilities and technology transfer agreements, the country is strengthening its capacity to produce high-quality biosimilars domestically, which reduces reliance on imports and shortens supply chains. The presence of local manufacturing not only helps control costs but also aligns with the government’s objective of developing a knowledge-based economy.

Considered in this report

• Historic Year: 2019
• Base year: 2024
• Estimated year: 2025
• Forecast year: 2030

Aspects covered in this report

• Biosimilars Market with its value and forecast along with its segments
• Various drivers and challenges
• On-going trends and developments
• Top profiled companies
• Strategic recommendation

By Product

• Monoclonal Antibodies
• Insulin
• Erythropoietin
• Others (Includes recombinant glycosylated and non-glycosylated proteins)

By Application

• Oncology
• Chronic & Autoimmune Disorders
• Blood Disorders
• Growth Hormonal Deficiency
• Infectious Disease
• Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept)

By Manufacturer

• In-house
• Contract Research and Manufacturing Services

The approach of the report:

This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases.

After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources.

Intended audience

This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.