Middle East and Africa Immunoassay Reagents and Devices Market Size, Share and Trends Analysis Report – Industry Overview and Forecast to 2033

Middle East and Africa Immunoassay Reagents and Devices Market Size

• The Middle East and Africa immunoassay reagents and devices market size was valued at USD 784.59 million in 2025 and is expected to reach USD 1,049.24 million by 2033, at a CAGR of 3.7% during the forecast period
• The market growth is primarily driven by increasing healthcare expenditure, rising prevalence of chronic and infectious diseases, and growing demand for advanced diagnostic tools including immunoassay‑based reagents, kits, and devices across clinical laboratories, hospitals, and research institutes in the region
• Furthermore, technological advancements in immunoassay platforms and expanding applications in disease detection, personalized medicine, and clinical diagnostics are fueling uptake of immunoassay solutions, thereby significantly accelerating market expansion throughout the forecast period

Middle East and Africa Immunoassay Reagents and Devices Market Analysis

• Immunoassay reagents and devices, offering highly sensitive and specific detection of biomarkers, are increasingly vital components of modern clinical diagnostics, research laboratories, and healthcare monitoring systems across both hospitals and diagnostic centers due to their rapid results, high accuracy, and adaptability to automated platforms
• The escalating demand for immunoassay reagents and devices is primarily fueled by the rising prevalence of chronic and infectious diseases, growing healthcare expenditure, and increasing adoption of advanced diagnostic tools for early disease detection and personalized treatment
• Saudi Arabia dominated the market with the largest revenue share of 30.9% in 2025, characterized by improved healthcare infrastructure, government initiatives to enhance diagnostics, and a strong presence of key industry players, with substantial growth in immunoassay adoption across hospitals, laboratories, and research centers
• South Africa is expected to be the fastest growing country in the market during the forecast period due to increasing awareness of early diagnosis, rising investments in healthcare infrastructure, and expanding access to modern diagnostic facilities
• Enzyme-linked immunosorbent assay (ELISA) segment dominated the market with a market share of 42.8% in 2025, driven by its established reliability, high sensitivity, and broad application across clinical, research, and point-of-care diagnostics

Report Scope and Middle East and Africa Immunoassay Reagents and Devices Market Segmentation       

Middle East and Africa Immunoassay Reagents and Devices Market Trends

Advancements in Automated and High-Throughput Immunoassays

• A significant and accelerating trend in the MEA immunoassay market is the adoption of automated and high-throughput immunoassay platforms that enhance testing efficiency, reduce human error, and support large-scale diagnostic needs across hospitals, laboratories, and research centers
  • For instance, fully automated ELISA analyzers and multiplex immunoassay platforms are being implemented in major Saudi Arabian and UAE hospitals, enabling simultaneous testing of multiple biomarkers and faster result turnaround
• Integration with laboratory information systems (LIS) and digital reporting software enables intelligent sample tracking, automated data analysis, and real-time reporting, improving workflow efficiency and diagnostic accuracy. For instance, some Cobas and Bio-Rad platforms provide predictive insights by analyzing trends in patient biomarkers and alerting clinicians to potential anomalies
• The seamless integration of advanced immunoassay systems with centralized hospital and laboratory data platforms facilitates improved patient management, research capabilities, and disease surveillance
• This trend toward more automated, high-throughput, and interconnected immunoassay solutions is fundamentally reshaping expectations for diagnostic speed and accuracy. For instance, Siemens Healthineers and Abbott are developing platforms that combine automated sample handling with real-time analytics for faster clinical decision-making
• The demand for advanced, efficient, and integrated immunoassay systems is growing rapidly across both clinical and research settings, as healthcare providers prioritize accuracy, speed, and the ability to manage high sample volumes effectively

Middle East and Africa Immunoassay Reagents and Devices Market Dynamics

Driver

Rising Demand Due to Growing Disease Burden and Healthcare Investment

• The increasing prevalence of chronic and infectious diseases, coupled with rising healthcare expenditure in MEA countries, is a significant driver of immunoassay reagent and device adoption
  • For instance, Saudi Arabia and UAE governments are investing in diagnostic infrastructure and expanding laboratory networks to improve early disease detection, supporting market growth
• Growing awareness among healthcare providers and patients about the importance of early diagnosis and personalized treatment is increasing demand for sensitive and rapid immunoassay-based diagnostics
• Furthermore, expanding clinical and research applications, including biomarker discovery and monitoring of disease progression, are making immunoassays indispensable in modern healthcare and laboratory workflows
• The ability of immunoassays to deliver accurate, reproducible, and timely results for a variety of applications, including infectious disease screening and chronic disease management, is propelling their adoption across hospitals, diagnostic labs, and research institutions
  • For instance, automated ELISA and multiplex immunoassay systems are enabling faster diagnosis, reducing manual workload, and supporting large-scale health initiatives, particularly in high-burden countries such as South Africa
• Technological innovations such as multiplex assays and high-sensitivity detection kits are enhancing the scope of disease monitoring, particularly for emerging infectious diseases in MEA countries

Restraint/Challenge

High Cost and Regulatory Compliance Complexity

• The relatively high cost of advanced immunoassay platforms and reagents compared to conventional diagnostic methods poses a challenge to adoption, particularly in budget-constrained healthcare facilities
  • For instance, premium multiplex immunoassay systems with automated data analytics are often unaffordable for smaller clinics and laboratories in developing MEA countries
• Regulatory compliance and approval processes across multiple countries in MEA can be complex and time-consuming, creating delays in product launches and adoption. For instance, meeting both Gulf Cooperation Council (GCC) and South African regulatory requirements can extend time-to-market
• Addressing these challenges requires cost optimization of immunoassay kits, streamlined regulatory pathways, and increased local manufacturing capabilities to make solutions more accessible
• While prices of some reagents and kits are gradually decreasing, the high upfront investment for automated platforms continues to be a barrier for smaller labs or research centers
  • For instance, some hospitals in Egypt and Nigeria still rely on manual or semi-automated immunoassay methods due to affordability and regulatory barriers, limiting the adoption of advanced technologies
• Limited technical expertise and shortage of trained laboratory personnel in certain MEA countries can hinder optimal utilization of advanced immunoassay systems, affecting their adoption rate
• Inconsistent supply chains and import dependencies for reagents and devices may cause delays and price fluctuations, restricting the expansion of immunoassay services in some regional markets

Middle East and Africa Immunoassay Reagents and Devices Market Scope

The market is segmented on the basis of product, platform, technique, specimen type, application, and end user.

• By Product

On the basis of product, the MEA immunoassay market is segmented into reagents & kits and analyzers. The reagents & kits segment dominated the market with the largest revenue share in 2025, driven by their essential role in routine diagnostic testing and research applications. Reagents and kits are widely used across hospitals, clinical laboratories, and research centers for detecting biomarkers of infectious diseases, oncology, endocrinology, and other conditions. The segment’s dominance is also supported by the continuous launch of disease-specific and multiplex kits tailored for regional disease profiles. High adoption is seen in Saudi Arabia, UAE, and South Africa, where advanced diagnostics are increasingly integrated into healthcare workflows. Consistency, accuracy, and relative affordability compared to automated analyzers make reagents and kits the backbone of immunoassay diagnostics. Moreover, collaborations between manufacturers and local distributors ensure widespread availability and accessibility of kits in both urban and semi-urban regions.

The analyzers segment is expected to witness the fastest growth during forecast period, fueled by the increasing adoption of automated and high-throughput immunoassay systems in hospitals and large diagnostic laboratories. Advanced analyzers enable faster testing, reduced manual errors, and integration with laboratory information systems, making them attractive for high-volume settings. Countries such as Saudi Arabia, UAE, and South Africa are investing in automated platforms to support early disease detection and large-scale health screening programs. The rising demand for multiplex analyzers that can handle multiple biomarkers simultaneously further accelerates market growth. Manufacturers focusing on compact, user-friendly, and AI-integrated analyzers are also driving adoption in emerging MEA markets.

• By Platform

On the basis of platform, the market is segmented into chemiluminescence immunoassays (CLIA), fluorescence immunoassays (FIA), enzyme immunoassays (EIA), radioimmunoassays (RIA), and others. The enzyme immunoassay (EIA) segment dominated the market in 2025 due to its long-standing reliability, sensitivity, and broad application across infectious disease, oncology, and hormonal disorder testing. EIAs are widely implemented in hospitals and reference laboratories throughout MEA countries, with strong uptake in Saudi Arabia, UAE, and Egypt. Their compatibility with semi-automated and automated platforms ensures scalability and faster result turnaround, enhancing workflow efficiency. EIAs are preferred for routine diagnostics and clinical research due to reproducibility and cost-effectiveness. The availability of multiplex EIA kits further supports high-volume testing in laboratories conducting epidemiological and clinical studies. The segment’s established reputation and regulatory approvals in major MEA countries contribute to sustained demand.

The chemiluminescence immunoassay (CLIA) segment is expected to witness the fastest growth during forecast period, driven by superior sensitivity, automation compatibility, and growing adoption in hospital-based laboratories. CLIA platforms are particularly suited for early disease detection, oncology biomarker screening, and high-throughput testing. Countries investing in advanced diagnostic infrastructure, such as Saudi Arabia and UAE, are increasingly implementing CLIA-based systems. Integration with digital laboratory management systems further enhances efficiency and adoption. The segment is also benefiting from technological innovations such as miniaturized CLIA analyzers suitable for medium-sized labs.

• By Technique

On the basis of technique, the market is segmented into enzyme-linked immunosorbent assays (ELISA), rapid tests, enzyme-linked immunospot (ELISPOT), western blotting, immuno-PCR, and others. The ELISA segment dominated the market in 2025 with a market share of 42.8% due to its widespread clinical acceptance, high reproducibility, and applicability across infectious disease testing, oncology, and endocrine disorder diagnostics. ELISA kits and systems are commonly used in hospitals, clinical laboratories, and research institutions throughout MEA countries. The segment benefits from affordability, ease of use, and integration with semi-automated and automated platforms. ELISA’s long-standing presence and regulatory approvals make it a trusted diagnostic technique for clinicians and laboratory technicians. Continuous introduction of disease-specific ELISA kits tailored to regional disease prevalence strengthens its dominance. Training and technical support from manufacturers also enhance adoption rates across both urban and rural laboratories.

The rapid tests segment is expected to witness the fastest growth during forecast period, propelled by demand for point-of-care diagnostics, especially in remote and under-resourced regions of Africa. Rapid immunoassays enable timely disease detection without centralized laboratories, making them vital for infectious disease screening and epidemic management. Increasing public health initiatives and mobile testing programs in MEA countries are driving growth. Technological improvements such as higher sensitivity, multiplexing capability, and easy-to-read results are accelerating adoption. Rapid tests are particularly favored in South Africa, Nigeria, and Egypt for mass screening campaigns and emergency diagnostics.

• By Specimen Type

On the basis of specimen type, the market is segmented into saliva, urine, blood, and others. The blood segment dominated the market in 2025 due to its universal application in detecting a wide range of biomarkers across infectious diseases, oncology, hematology, and endocrinology. Blood samples provide high accuracy and reproducibility, making them the preferred specimen in hospitals, diagnostic laboratories, and research centers in MEA countries. The segment benefits from well-established collection, handling, and testing protocols. Availability of automated analyzers and ELISA kits for blood testing further supports widespread adoption. Strong clinical validation and regulatory approvals in Saudi Arabia, UAE, and South Africa enhance confidence among healthcare providers. High demand in large-scale screening and research programs ensures consistent market dominance.

The saliva segment is expected to witness the fastest growth during forecast period, driven by increasing adoption of non-invasive, patient-friendly diagnostic methods. Saliva-based immunoassays are gaining traction in infectious disease screening, hormonal testing, and point-of-care applications. Growing awareness of non-invasive diagnostics and easier sample collection make it suitable for schools, workplaces, and remote clinics. Advances in saliva-based immunoassay kits and portable analyzers are enabling wider adoption in MEA countries. The segment benefits from rising demand for rapid and convenient testing solutions in outpatient and community health settings.

• By Application

On the basis of application, the market is segmented into infectious diseases, oncology and endocrinology, bone & mineral disorders, cardiology, hematology & blood screening, autoimmune disorders, toxicology, neonatal screening, and others. The infectious diseases segment dominated the market in 2025 due to high prevalence of viral, bacterial, and parasitic infections in MEA countries. Immunoassays for infectious diseases are critical for early detection, outbreak management, and monitoring of public health initiatives. Hospitals, laboratories, and government health programs in Saudi Arabia, UAE, South Africa, and Egypt extensively utilize these tests. Multiplex assays and rapid tests for infectious agents contribute to higher testing volumes. Ongoing government-supported screening campaigns for diseases such as hepatitis, HIV, and tuberculosis strengthen market dominance. High sensitivity, accuracy, and regulatory approvals for infectious disease kits further support sustained adoption.

The oncology and endocrinology segment is expected to witness the fastest growth during forecast period, driven by rising cancer prevalence and hormonal disorders in MEA countries. Immunoassay-based biomarker detection and hormone profiling are increasingly integrated into personalized medicine and preventive care programs. Expansion of diagnostic infrastructure, adoption of advanced analyzers, and public awareness campaigns are fueling growth. Countries such as Saudi Arabia and UAE are investing in early cancer detection programs. Multiplex immunoassays enable simultaneous detection of multiple cancer or endocrine biomarkers, enhancing efficiency and adoption.

• By End User

On the basis of end user, the market is segmented into hospitals, clinical laboratories, pharmaceutical and biotechnology companies, blood banks, research & academic laboratories, and others. The hospitals segment dominated the market in 2025 due to their role as primary diagnostic centers for patient care, high testing volumes, and availability of advanced laboratory facilities. Hospitals in Saudi Arabia, UAE, and South Africa are increasingly investing in automated immunoassay analyzers and multiplex kits. Integration with electronic medical records and laboratory information systems enhances workflow and reporting efficiency. Hospitals conduct testing for infectious diseases, oncology, endocrinology, and other conditions, contributing to high demand. Strong budgets, regulatory approvals, and technical expertise further reinforce the segment’s dominance. Government-funded hospitals also support large-scale screening programs, sustaining market growth.

The clinical laboratories segment is expected to witness the fastest growth during forecast period, driven by increasing outsourcing of diagnostic tests, high-volume testing needs, and expansion of private laboratory chains in MEA countries. Laboratories adopt automated and high-throughput analyzers to manage multiple sample types efficiently. Growth is particularly strong in urban centers with high patient inflow and research collaborations. Rising demand for specialized immunoassays and integration with LIS platforms accelerate adoption. Expansion of accredited clinical laboratories in South Africa, UAE, and Egypt supports rapid market growth.

Middle East and Africa Immunoassay Reagents and Devices Market Regional Analysis

• Saudi Arabia dominated the market with the largest revenue share of 30.9% in 2025, characterized by improved healthcare infrastructure, government initiatives to enhance diagnostics, and a strong presence of key industry players, with substantial growth in immunoassay adoption across hospitals, laboratories, and research centers
• Healthcare providers in the country highly value the accuracy, reliability, and rapid turnaround of immunoassay testing, which is widely used for infectious disease screening, oncology, endocrinology, and chronic disease management
• This strong adoption is further supported by government initiatives promoting early diagnosis, private sector investments in diagnostic laboratories, and the presence of key global and regional immunoassay manufacturers. The focus on modernizing healthcare systems and improving diagnostic capabilities establishes immunoassay solutions as a preferred choice across hospitals, clinical laboratories, and research centers in Saudi Arabia

The Saudi Arabia Immunoassay Reagents and Devices Market Insight

The Saudi Arabia immunoassay reagents and devices market captured the largest revenue share in the MEA region in 2025, fueled by substantial investments in healthcare infrastructure and expansion of hospital and laboratory networks. Healthcare providers are increasingly prioritizing early disease detection through advanced immunoassay solutions, particularly for infectious diseases, oncology, and endocrinology. The growing adoption of automated and multiplex platforms, along with integration with laboratory information systems, further propels market growth. Government initiatives and public health programs supporting large-scale disease screening are driving the demand for high-throughput and accurate immunoassay systems. In addition, the presence of key global and regional manufacturers ensures the availability of advanced reagents and analyzers across hospitals and clinical laboratories.

UAE Immunoassay Reagents and Devices Market Insight

The UAE immunoassay market is expected to grow at a notable CAGR during the forecast period, driven by rapid modernization of healthcare infrastructure and rising awareness about early diagnostics. Hospitals, diagnostic laboratories, and research centers are increasingly adopting automated immunoassay analyzers and multiplex kits for rapid and accurate testing. The integration of immunoassay systems with electronic medical records and digital reporting platforms enhances workflow efficiency and clinical decision-making. Strong government support for healthcare innovation and private sector investments in advanced diagnostics further boost market expansion. The UAE’s focus on healthcare tourism and cutting-edge clinical research fosters demand for state-of-the-art immunoassay solutions.

South Africa Immunoassay Reagents and Devices Market Insight

The South Africa immunoassay market is poised to register the fastest growth in the MEA region due to a rising disease burden and increasing adoption of advanced diagnostic technologies. The country is witnessing high demand for point-of-care rapid tests and automated immunoassay analyzers in both urban and semi-urban healthcare settings. Public health initiatives targeting infectious diseases, along with growing investments in private and public laboratories, are driving the market. The use of multiplex assays for efficient detection of multiple biomarkers simultaneously is gaining traction. In addition, collaborations between immunoassay manufacturers and local healthcare providers are facilitating wider accessibility of advanced diagnostic kits and systems. The market growth is further supported by increasing awareness of personalized medicine and early detection programs.

Egypt Immunoassay Reagents and Devices Market Insight

The Egypt immunoassay market is expected to expand at a considerable CAGR during the forecast period, driven by rising healthcare expenditure and adoption of modern diagnostic technologies. Hospitals, clinical laboratories, and research institutions are increasingly implementing immunoassay solutions for infectious disease screening, oncology, endocrinology, and blood screening. Government initiatives and public health campaigns are promoting early diagnosis and large-scale testing programs, increasing the need for rapid, reliable, and automated systems. The market also benefits from international collaborations and technology transfer initiatives, enabling local laboratories to access high-quality reagents and analyzers. In addition, awareness programs highlighting the importance of early detection and preventive healthcare support market expansion.

Middle East and Africa Immunoassay Reagents and Devices Market Share

The Middle East and Africa Immunoassay Reagents and Devices industry is primarily led by well-established companies, including:

• Abbott (U.S.)
• BIOMÉRIEUX (France)
• DiaSorin S.p.A. (Italy)
• Bio Rad Laboratories, Inc. (U.S.)
• Siemens Healthineers AG (Germany)
• Thermo Fisher Scientific Inc. (U.S.)
• BD (U.S.)
• Quidel Corporation (U.S.)
• Ortho Clinical Diagnostics (U.S.)
• Sysmex Corporation (Japan)
• PerkinElmer Inc. (U.S.)
• Agilent Technologies Inc. (U.S.)
• QIAGEN (Netherlands)
• Mindray Bio Medical Electronics Co., Ltd. (China)
• Autobio Diagnostics Co., Ltd. (China)
• Werfen (Spain)
• Luminex Corporation (U.S.)
• Hologic, Inc. (U.S.)
• Randox Laboratories Ltd. (U.K.)
• Tosoh Bioscience (Japan)

What are the Recent Developments in Middle East and Africa Immunoassay Reagents and Devices Market?

• In September 2025, the Saudi Food and Drug Authority (SFDA) approved a first‑of‑its‑kind biotech blood test for early Alzheimer’s detection that uses plasma biomarkers to yield results in under 20 minutes, marking a significant immunoassay‑related diagnostic advancement in the Kingdom
• In August 2025, MS Pharma inaugurated the Middle East’s first Saudi‑approved biologics manufacturing facility with in‑house bioanalytical labs for monoclonal antibodies and peptides, strengthening local capabilities for complex immunoassay‑related biologics and testing reagents production
• In January 2025, Anbio Biotechnology announced it will showcase cutting‑edge immunoassay and POCT diagnostic solutions— including dry chemiluminescence immunoassay and immunofluorescence systems—at the 2025 Medlab Middle East trade show in Dubai, reinforcing the introduction of advanced in‑vitro diagnostic products in the MEA region
• In November 2024, Integrated Diagnostics Holdings (IDH), a leading diagnostics services provider with operations in Egypt, Sudan, Nigeria, and Saudi Arabia, expanded its footprint by purchasing an additional 49% stake in Biolab KSA, hinting at broader network growth that supports immunoassay testing services across the region
• In September 2023, Anbio Biotechnology made a successful presence at Medic East Africa 2023, presenting fluorescence immunoassay (FIA) and lateral flow solutions and portable analyzers, marking the company’s formal introduction of high‑sensitivity IVD products across African clinical settings
• https://www.prnewswire.com/news-releases/anbio-biotechnology-to-showcase-cutting-edge-diagnostic-solutions-at-2025-medlab-middle-east-302356934.html
• https://www.healthcaremea.com/saudi-fda-approves-first-biotech-blood-test-for-early-alzheimers-detection/?u
• https://biopharmaapac.com/news/33/6799/ms-pharma-inaugurates-middle-easts-first-sfda-approved-biologics-manufacturing-facility-in-saudi-arabia.html?u
• https://www.prnewswire.com/news-releases/anbio-biotechnology-made-a-successful-presence-at-medic-east-africa-2023-301929645.html?ut
• https://idhcorp.com/media/press-releases/?

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