Middle East Cell Gene Therapy Manufacturing Market Size, Share, Growth Drivers, Trends, Opportunities & Forecast 2025–2030

Middle East Cell Gene Therapy Manufacturing Market Overview

• The Middle East Cell Gene Therapy Manufacturing Market is valued at USD 55 million, based on a five-year historical analysis of the cell and gene therapy CDMO segment, which reflects the core manufacturing value chain in the region. This growth is primarily driven by advancements in biotechnology, the increasing prevalence of genetic and rare disorders, and rising investments in healthcare infrastructure and precision medicine. The market is further supported by the expansion of clinical research centers, the establishment of state-of-the-art manufacturing campuses, and the introduction of innovative therapies targeting previously untreatable conditions. Key trends include the localization of advanced therapy manufacturing, public-private partnerships, and the adoption of next-generation technologies such as CRISPR and viral vector platforms .
• Key players in this market include countries like Saudi Arabia, the United Arab Emirates, and Israel. These nations dominate the market due to robust healthcare systems, significant government funding for research and development, and a regulatory environment that actively supports innovation in gene therapy. Saudi Arabia leads with initiatives such as the National Biotechnology Strategy and Vision 2030, the UAE is investing in local CAR-T cell manufacturing and clinical research, and Israel continues to advance its biotech sector through strong academic-industry collaboration. The presence of leading biopharmaceutical companies and the development of regional biotech hubs further strengthen their market position .
• In 2023, the Saudi Food and Drug Authority (SFDA) issued the “Gene Therapy Products Regulatory Framework, 2023,” which mandates that all gene therapy products undergo a comprehensive review by the Advanced Therapy Medicinal Products (ATMP) Committee. This regulation requires detailed clinical and manufacturing data, GMP compliance, and post-market surveillance, ensuring safety and efficacy before market entry. The framework is designed to enhance patient access to innovative treatments while maintaining high safety standards .

Middle East Cell Gene Therapy Manufacturing Market Segmentation

By Type:The market is segmented into various types of therapies, including CAR-T Cell Therapy, TCR Therapy, Stem Cell Therapy, Gene Editing Therapy, and Others. Among these, CAR-T Cell Therapy is currently the leading sub-segment due to its effectiveness in treating certain types of cancers, particularly hematological malignancies. The increasing number of approvals for CAR-T therapies, successful clinical outcomes, and the establishment of local manufacturing facilities have significantly boosted their adoption in the region. TCR Therapy and Stem Cell Therapy are also gaining traction, driven by ongoing research, clinical trials, and expanding infrastructure for GMP-compliant manufacturing .

By End-User:The end-user segmentation includes Hospitals, Research Institutions, Biopharmaceutical Companies, and Others. Hospitals are the dominant end-user segment, primarily due to the increasing number of gene therapy treatments being administered in clinical settings. The growing collaboration between hospitals and biopharmaceutical companies for clinical trials and treatment protocols is also contributing to this trend. Research Institutions are significant as they drive innovation and development in gene therapies, while Biopharmaceutical Companies play a crucial role in manufacturing and distributing these therapies. The region is also witnessing increased outsourcing to contract development and manufacturing organizations (CDMOs) to accelerate clinical translation and commercialization .

Middle East Cell Gene Therapy Manufacturing Market Competitive Landscape

The Middle East Cell Gene Therapy Manufacturing Market is characterized by a dynamic mix of regional and international players. Leading participants such as Novartis AG, Gilead Sciences, Inc., Kite Pharma, Inc., Bluebird Bio, Inc., Spark Therapeutics, Inc., Bristol-Myers Squibb Company, Amgen Inc., Regeneron Pharmaceuticals, Inc., Cellectis S.A., CRISPR Therapeutics AG, Editas Medicine, Inc., Intellia Therapeutics, Inc., Sangamo Therapeutics, Inc., Orchard Therapeutics plc, Astellas Pharma Inc., King Faisal Specialist Hospital & Research Centre (Saudi Arabia), Burjeel Holdings (UAE), Lifera (Saudi Arabia), Cellenkos Inc. (USA, active in Saudi Arabia), Charles River Laboratories (GCC presence), ACROBiosystems (GCC presence), Caring Cross (UAE partnership), UAE University Stem Cells Research Centre (UAE), National Bank of Kuwait Hospital (Kuwait), Allogene Therapeutics (GCC expansion) contribute to innovation, geographic expansion, and service delivery in this space.

Middle East Cell Gene Therapy Manufacturing Market Industry Analysis

Growth Drivers

• Increasing Prevalence of Genetic Disorders:The Middle East has witnessed a significant rise in genetic disorders, with approximately 1 in 10 individuals affected by such conditions. According to the World Health Organization, the region reports over 1.5 million new cases of genetic disorders annually. This growing prevalence drives demand for innovative therapies, including cell gene therapies, as healthcare systems seek effective solutions to manage and treat these conditions, thereby expanding the market for gene therapy manufacturing.
• Advancements in Gene Editing Technologies:The rapid evolution of gene editing technologies, such as CRISPR-Cas9, has revolutionized the field of gene therapy. In future, investments in gene editing technologies are projected to exceed $5 billion globally, with a significant portion allocated to the Middle East. These advancements enhance the precision and efficacy of therapies, making them more attractive to healthcare providers and patients, thus propelling the growth of the cell gene therapy manufacturing market in the region.
• Rising Investment in Biopharmaceuticals:The biopharmaceutical sector in the Middle East is experiencing robust growth, with investments reaching approximately $3 billion in future. This surge is driven by both public and private sectors aiming to enhance healthcare infrastructure and develop innovative therapies. The increasing focus on biopharmaceuticals, particularly in gene therapy, is expected to create a favorable environment for manufacturing, leading to advancements in production capabilities and market expansion.

Market Challenges

• High Manufacturing Costs:The production of cell gene therapies involves complex processes and high-quality materials, leading to substantial manufacturing costs. In future, the average cost of producing a single gene therapy treatment is estimated to be around $500,000. These high costs pose a significant barrier to market entry and limit accessibility for patients, challenging the growth of the cell gene therapy manufacturing sector in the Middle East.
• Regulatory Hurdles:The regulatory landscape for gene therapies in the Middle East is evolving but remains complex. In future, it is anticipated that the average time for regulatory approval for new therapies will be approximately 18 months. This lengthy approval process can delay market entry and increase costs for manufacturers, creating challenges in navigating compliance while ensuring safety and efficacy standards are met.

Middle East Cell Gene Therapy Manufacturing Market Future Outlook

The future of the Middle East cell gene therapy manufacturing market appears promising, driven by technological advancements and increasing healthcare investments. As the region embraces innovative therapies, the integration of artificial intelligence in manufacturing processes is expected to enhance efficiency and reduce costs. Additionally, the growing focus on personalized medicine will likely lead to tailored therapies, further expanding market opportunities and fostering collaborations between industry players and academic institutions.

Market Opportunities

• Expansion of Research and Development Activities:The Middle East is witnessing a surge in R&D activities, with funding for biotechnology research projected to reach $1 billion in future. This investment will facilitate the development of innovative gene therapies, creating opportunities for manufacturers to collaborate with research institutions and enhance their product offerings in the market.
• Collaborations with Academic Institutions:Partnerships between biopharmaceutical companies and academic institutions are on the rise, with over 30 collaborations established in future. These collaborations aim to leverage academic research for developing cutting-edge therapies, providing manufacturers with access to novel technologies and expertise, thereby enhancing their competitive edge in the cell gene therapy market.