| REPORT ATTRIBUTE |
DETAILS |
| Historical Period |
2019-2022 |
| Base Year |
2023 |
| Forecast Period |
2024-2032 |
| MEA Biologics and Biosimilars Market Size 2024 |
USD 537.6 million |
| MEA Biologics and Biosimilars Market, CAGR |
5.9% |
| MEA Biologics and Biosimilars Market Size 2032 |
USD 850.4 million |
Market Overview
The MEA Biologics and Biosimilars market is projected to grow from USD 537.6 million in 2024 to USD 850.4 million by 2032, at a compound annual growth rate (CAGR) of 5.9% during the forecast period.
The MEA Biologics and Biosimilars market is driven by the growing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders, which increases the demand for advanced therapeutic options. Biologics offer targeted and effective treatment, while biosimilars provide cost-efficient alternatives, addressing affordability concerns in the region. Government initiatives and regulatory frameworks promoting the adoption of biosimilars further fuel market growth. Rising healthcare expenditure and expanding access to medical facilities, especially in emerging economies within the region, bolster the market. Technological advancements in biologics manufacturing and ongoing investments in research and development enhance product innovation and availability. Additionally, collaborations between pharmaceutical companies and healthcare providers contribute to greater awareness and accessibility of biologics and biosimilars. However, challenges such as limited awareness among patients and clinicians, coupled with concerns about biosimilar interchangeability, remain key hurdles. Overall, the MEA market is poised for steady growth, supported by evolving healthcare infrastructure and increased adoption.
The MEA Biologics and Biosimilars market is geographically dominated by the Middle East, contributing approximately 60% of the regional revenue, with Saudi Arabia and the UAE being the key players due to advanced healthcare infrastructure and supportive government policies. Africa accounts for the remaining 40%, with South Africa and Egypt leading growth, driven by improving healthcare systems and rising pharmaceutical investments. Key players driving the market include AbbVie Inc., Pfizer Inc., Johnson & Johnson, and Amgen, alongside emerging regional manufacturers like Hikma Pharmaceuticals and Zydus Cadila. These companies are expanding their presence through partnerships and local production facilities, addressing affordability and accessibility challenges. The region’s demand for biologics and biosimilars is propelled by a high prevalence of chronic diseases and increasing investments in healthcare modernization.
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Market Drivers:
Growing Prevalence of Chronic Diseases:
The increasing prevalence of chronic diseases, such as cancer, diabetes, and autoimmune disorders, is a significant driver of the MEA Biologics and Biosimilar market. These conditions often require advanced therapeutic solutions that biologics provide through their targeted mechanisms of action. For instance, Roche’s biologic drug Herceptin has shown a 50% reduction in the risk of cancer recurrence in HER2-positive breast cancer patients. Biosimilars, as cost-effective alternatives to biologics, are gaining traction in the region, making treatment accessible to a larger patient population. The rising incidence of these diseases is creating sustained demand for biologics and biosimilars, fueling market growth.
Government Support and Regulatory Frameworks:
Supportive government policies and regulatory frameworks in the MEA region are accelerating the adoption of biologics and biosimilars. Many countries are focusing on improving healthcare access and affordability, with biosimilars playing a key role in reducing healthcare costs. For instance, the Saudi Food and Drug Authority (SFDA) has implemented expedited approval processes for biosimilars, reducing the approval time by 30%. Regulatory agencies are actively working to streamline the approval processes for biosimilars, ensuring their safety and efficacy, which encourages their acceptance among healthcare providers and patients. The Egyptian Drug Authority (EDA) has also introduced guidelines to ensure the quality and safety of biosimilars, promoting their use in the healthcare system.
Expanding Healthcare Infrastructure:
The rapid development of healthcare infrastructure across the MEA region is significantly boosting the market for biologics and biosimilars. Emerging economies in the region are investing heavily in healthcare facilities, enabling broader access to advanced medical treatments. For instance, the UAE has invested over $2 billion in healthcare infrastructure projects, including new hospitals and clinics equipped with state-of-the-art technology. Improved distribution networks and enhanced hospital capabilities support the availability and administration of biologics and biosimilars. This trend, coupled with rising healthcare spending, is creating a favorable environment for market expansion.
Advancements in Research and Development:
Technological advancements and increasing investments in research and development are key drivers of innovation in the MEA Biologics and Biosimilar market. Pharmaceutical companies are leveraging cutting-edge technologies to improve the efficiency, efficacy, and safety of biologics and biosimilars. For example, Pfizer’s advanced cell line development technology has reduced production time by 40%, enhancing the efficiency of biologic manufacturing. Collaborations between research institutions and private firms are fostering innovation and driving the development of new products, catering to the evolving healthcare needs of the region. These advancements are enhancing product availability and creating growth opportunities for market players.
Market Trends:
Rising Adoption of Biosimilars:
A prominent trend in the MEA Biologics and Biosimilars market is the increasing adoption of biosimilars as cost-effective alternatives to biologics. Biosimilars offer comparable efficacy and safety to their reference biologics at a reduced price, making them more accessible in cost-sensitive markets. For instance, Biocon’s biosimilar Trastuzumab has demonstrated comparable efficacy to the reference product, with a 95% confidence interval in clinical trials. Another example is Celltrion’s Remsima, a biosimilar for infliximab, which has been widely adopted in the region due to its affordability and proven effectiveness in treating autoimmune diseases. Governments and healthcare providers in the region are actively promoting the use of biosimilars to optimize healthcare budgets while ensuring treatment accessibility for chronic and life-threatening conditions such as cancer and autoimmune diseases.
Technological Advancements in Biologics Manufacturing:
Advancements in biologics manufacturing technologies are transforming the MEA market landscape. Innovations such as improved cell culture systems, efficient downstream processing, and advanced bioengineering techniques are enhancing the production efficiency and quality of biologics. For example, Samsung Biologics has developed a continuous manufacturing process that increases production yield by 30%, ensuring a more consistent supply of biologics. The integration of AI and machine learning is also streamlining drug discovery and development processes.
Growth in Local Production Capabilities:
There is a notable shift towards establishing local production facilities for biologics and biosimilars in the MEA region. Governments and private enterprises are investing in local manufacturing to reduce dependency on imports and enhance supply chain resilience. For instance, Egypt has launched a national initiative to produce biosimilars locally, aiming to cover 70% of the domestic demand by 2025. This trend not only addresses cost and logistical challenges but also aligns with the region’s broader objective of achieving healthcare self-sufficiency.
Increasing Focus on Awareness and Education:
Efforts to increase awareness and education about biologics and biosimilars among healthcare professionals and patients are gaining momentum. Pharmaceutical companies and healthcare organizations are collaborating to provide training and information on the safety, efficacy, and interchangeability of biosimilars. For instance, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has partnered with local health ministries to conduct workshops and seminars, educating over 5,000 healthcare workers on the benefits and usage of biosimilars. These initiatives aim to overcome skepticism and foster greater acceptance of biosimilars, driving their adoption across the region and supporting the market’s growth trajectory.
Market Challenges Analysis:
Limited Awareness and Acceptance:
One of the significant challenges facing the MEA Biologics and Biosimilars market is the limited awareness and acceptance of biosimilars among healthcare providers and patients. Concerns regarding the safety, efficacy, and interchangeability of biosimilars often lead to hesitation in their adoption. Many healthcare practitioners are reluctant to switch patients from biologics to biosimilars due to uncertainties about potential immunogenic reactions or variations in therapeutic outcomes. Similarly, patients often perceive biosimilars as inferior to their biologic counterparts, stemming from a lack of proper education and understanding. Additionally, cultural and market-specific factors in the region exacerbate these concerns, slowing the pace of adoption. Overcoming these misconceptions requires comprehensive awareness campaigns, targeted education initiatives, and collaborative efforts from governments, healthcare organizations, and pharmaceutical companies to build confidence in the safety and effectiveness of biosimilars.
High Development Costs and Regulatory Hurdles:
The high costs associated with developing biologics and biosimilars pose another critical challenge in the MEA market. Biologics require sophisticated manufacturing processes, extensive clinical trials, and rigorous quality assurance measures, leading to significant investment requirements. For biosimilar manufacturers, navigating complex regulatory pathways adds to the financial burden. Although regulatory agencies in the MEA region are making efforts to streamline approval processes, inconsistencies and varying standards across countries create obstacles for market players. The need for region-specific trials and compliance with local guidelines further complicates entry for global manufacturers. These challenges not only delay product launches but also increase the cost of bringing biosimilars to market, potentially limiting their accessibility and affordability for patients. Addressing these issues requires a concerted effort to harmonize regulations, incentivize local production, and support cost-effective manufacturing solutions, ensuring sustainable growth in the market.
Market Segmentation Analysis:
By Drug Class
The drug class segment includes monoclonal antibodies, insulin, growth hormones, and others. Monoclonal antibodies dominate this segment due to their extensive use in treating chronic and life-threatening diseases such as cancer, rheumatoid arthritis, and autoimmune disorders. Insulin biosimilars are witnessing rapid growth, driven by the rising prevalence of diabetes across the MEA region. Growth hormones also hold a significant share, supported by their application in addressing growth deficiencies and hormone-related conditions. As healthcare access improves in emerging economies, the demand for a diverse range of biosimilars across drug classes is expected to rise.
By Dosage Form
The dosage form segment is categorized into injectables, tablets, and others. Injectables represent the largest share in this segment due to the predominance of biologics and biosimilars that require parenteral administration for optimal efficacy. Tablets and other forms are less common but are gaining attention as advancements in drug delivery technology explore new possibilities. The preference for injectables is supported by their higher bioavailability and faster therapeutic effects, making them essential for critical conditions like cancer and autoimmune diseases. Improved distribution infrastructure and availability of cold chain logistics further enhance the accessibility of injectable biologics and biosimilars in the MEA market.
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Segments:
Based on Drug:
- Adalimumab
- Bevacizumab
- Trastuzumab
- Ustekinumab
- Golimumab
- Eculizumab
- Rituximab
Based on Drug Class:
- Antirheumatics
- TNF Alfa Inhibitors
- VEGF/VEGFR Inhibitors
- HER2 Inhibitors
- Selective Immunosuppressant’s
- Interleukin Inhibitors
Based on Dosage Form:
Based on Indication:
-
- Rheumatoid
- Psoriatic
- Others
-
- Plaque-Type Psoriasis
- Hidradenitis Suppurativa
- Inflammatory Bowel Disease (IBD)
-
- Crohn’s Disease
- Ulcerative Colitis
Based on Distribution Channel:
-
- Specialty Clinics
- Cancer Research Centers
- Retail Sales
- Retail Pharmacies
- Mail Order Pharmacies /Online Sales
Region:
- UAE
- Bahrain
- Iraq
- Jordan
- Kuwait
- Lebanon
- Oman
- Qatar
- KSA
- Iran
- Palestine
Regional Analysis:
Middle East
The Middle East dominates the MEA Biologics and Biosimilars market, accounting for 60% of the regional revenue in 2024. Key countries like Saudi Arabia, the UAE, and Qatar are leading due to their advanced healthcare infrastructure and government-backed initiatives to expand access to innovative treatments. Saudi Arabia contributes nearly 35% of the Middle East’s market share, driven by its Vision 2030 plan, which includes significant investments in healthcare modernization and support for cost-effective biosimilar adoption. The UAE, holding a significant portion of the market, benefits from its well-established medical tourism sector, attracting patients from across the region for advanced biologic therapies. Regulatory bodies in the Middle East are working towards harmonized approval frameworks to encourage the introduction of biosimilars, fostering confidence among healthcare providers and patients. Additionally, the high prevalence of chronic diseases such as diabetes, cancer, and autoimmune disorders has intensified the demand for biologics, while biosimilars are emerging as an economical solution, particularly for low- and middle-income populations. Strong supply chain networks, improved cold chain logistics, and growing partnerships between global pharmaceutical companies and local entities are further accelerating market growth in the region.
Africa
Africa accounts for around 40% of the MEA Biologics and Biosimilars market, with South Africa, Egypt, and Kenya driving significant growth. South Africa leads this segment, contributing approximately 18% of the regional market share due to its expanding middle class, improving healthcare infrastructure, and rising awareness of biologics’ therapeutic benefits. Egypt, leveraging its strategic position and growing pharmaceutical sector, has become a hub for local biosimilar production and exports to neighboring countries. However, Africa faces several challenges, including uneven healthcare infrastructure, limited access in rural areas, and affordability constraints for biologics. Despite these hurdles, governments and non-governmental organizations (NGOs) are collaborating to improve healthcare access and affordability. Global pharmaceutical companies are also investing in localized production and distribution to address these challenges, particularly for biosimilars. Moreover, initiatives to increase healthcare education and awareness are driving acceptance among healthcare providers and patients. With rising incidences of chronic diseases and a growing focus on public health, Africa presents a significant growth opportunity for biologics and biosimilars. Continued investment in healthcare infrastructure and regulatory frameworks is expected to unlock the market’s potential further, positioning Africa as a key contributor to regional growth.
Key Player Analysis:
- Johnson & Johnson
- Pfizer Inc.
- AbbVie Inc.
- Amgen
- F. Hoffmann–La Roche Ltd (Genentech, Inc.)
- Celltrion, Inc.
- Eisai Co Ltd
- Zydus Cadila (Cadila Healthcare)
- Coherus BioSciences, Inc.
- Hikma Pharmaceuticals plc.
Competitive Analysis:
The MEA Biologics and Biosimilars market is marked by intense competition among leading global and regional players, including AbbVie Inc., Pfizer Inc., Johnson & Johnson, Amgen, Hikma Pharmaceuticals, F. Hoffmann–La Roche Ltd (Genentech, Inc.), Celltrion, Inc., Zydus Cadila, Eisai Co Ltd, and Coherus BioSciences, Inc. These companies compete on the basis of innovation, product portfolio, and strategic collaborations to expand their market presence. For instance, AbbVie Inc. has leveraged its advanced R&D capabilities to develop high-quality biologics, such as the recent advancements in their precision medicine and genomics research. Additionally, Johnson & Johnson has been recognized for its innovative supply chain technologies, earning multiple Lighthouse designations for excellence in manufacturing innovation. Global players leverage their advanced R&D capabilities to develop high-quality biologics and biosimilars, while regional firms focus on cost-effective manufacturing and local distribution to meet the demand for affordable treatments. Increasing investments in local production facilities and partnerships with healthcare organizations have intensified competition.
Recent Developments:
- In January 2024, Gilead Sciences and Arcus Biosciences announced an amended collaboration agreement along with a separate equity investment. Gilead invested US$ 320 billion in Arcus common stock at US$ 21 per share. This strategic move aims to accelerate the growth of both companies through enhanced collaboration and increased financial support.
- In June 2023, the Public Investment Fund (PIF), Saudi Arabia’s global investment organization, announced that it had launched Lifera, a commercial-scale contract development and manufacturing organization (CDMO). The CDMO will enable the growth of the local bio/pharmaceutical industry, strengthen national resilience, and support Saudi Arabia’s position as a global pharmaceutical manufacturing destination.
- In February 2023, Saudi Pharmaceutical Industries & Medical Appliances Corporation announced the details of its revamped 5-year strategy. The strategy focused on building the National Champion in the Saudi pharma industry by capitalizing on long-term opportunities offered by the conducive market outlook, while aiming at improving the wellbeing of patients and benefiting all groups of the Company’s stakeholders in the long-term.
- In November 2023, mAbxience and MS Pharma signed a partnership to develop a denosumab biosimilar in select MEA countries, aiming to expand their biosimilar market presence.
Market Concentration & Characteristics:
The MEA Biologics and Biosimilars market exhibits a moderately fragmented nature, with a mix of global giants and regional players driving competition. Leading companies like AbbVie Inc., Pfizer Inc., Johnson & Johnson, Amgen, and F. Hoffmann–La Roche Ltd (Genentech, Inc.) hold significant market shares due to their extensive product portfolios and advanced R&D capabilities. Regional players such as Hikma Pharmaceuticals and Zydus Cadila contribute by offering cost-effective solutions tailored to local market needs. The market is characterized by high entry barriers, including the complex regulatory approval process and substantial investment requirements for biologics and biosimilars production. Despite these barriers, increasing government support and streamlined regulations are fostering new entrants. Innovation, affordability, and access to advanced healthcare infrastructure are key competitive factors. Overall, the market concentration reflects a balanced blend of established firms and emerging players shaping the competitive landscape in the MEA region.
Report Coverage:
The research report offers an in-depth analysis based on Drug, Drug Class, Dosage Form, Indication, Distribution Channel and country. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.
Future Outlook:
- The MEA Biologics and Biosimilars market is expected to witness steady growth driven by the rising prevalence of chronic diseases.
- Increasing adoption of biosimilars is likely to reduce healthcare costs and improve access to advanced treatments.
- Investments in local manufacturing facilities are anticipated to strengthen regional production capabilities.
- Regulatory frameworks are expected to become more streamlined, supporting faster approvals of biosimilars.
- Technological advancements in biologics manufacturing will enhance efficiency and product innovation.
- Expansion of healthcare infrastructure in emerging economies will boost market accessibility and growth.
- Collaborations between global pharmaceutical companies and regional players are expected to accelerate market penetration.
- Awareness campaigns and education initiatives will improve the acceptance of biosimilars among patients and healthcare providers.
- The growing middle-class population in the region is likely to drive demand for cost-effective biosimilar solutions.
- Government support for affordable healthcare solutions will continue to create favorable conditions for market expansion.
