Immunoassay Market Research Report, Analysis and Forecast, till 2030

Rising Adoption Trends in the Immunoassay Market 

The immunoassay market is experiencing transformative growth, driven by rapid expansion in disease diagnostics, food safety, and environmental monitoring. For instance, Datavagyanik highlights that the immunoassay market is benefiting from the continuous rise in infectious diseases and chronic conditions, leading to increasing demand for reliable, high-throughput testing. With the prevalence of diseases such as HIV, hepatitis, and COVID-19, laboratories have ramped up their immunoassay-based screening capabilities, resulting in higher market growth rates. It is noteworthy that in 2024 alone, global immunoassay-based diagnostic revenues were estimated to rise by over 8%, illustrating the sector’s dynamic momentum. 

Technological Advancements Fueling the Immunoassay Market 

Technological innovation is fundamentally shaping the immunoassay market, enabling faster, more precise, and highly automated testing workflows. For example, chemiluminescence immunoassays (CLIAs) and multiplex immunoassays have gained considerable traction because they can process large sample volumes with exceptional sensitivity. Datavagyanik reports that multiplex immunoassays are expected to expand at a CAGR of over 9% from 2023 to 2028, reflecting a growing preference for platforms that save time and reduce laboratory errors. Such technologies have widened the scope of immunoassay market applications in oncology, autoimmune disorders, and allergy diagnostics, creating substantial commercial opportunities. 

Expanding Applications Boosting the Immunoassay Market 

The immunoassay market is advancing steadily thanks to its expanding applications beyond traditional clinical diagnostics. For instance, food safety testing has become a prominent application area as regulators enforce stricter quality controls to prevent contamination. The immunoassay market has responded with highly specific test kits capable of detecting allergens, pathogens, and toxins at trace levels. Datavagyanik underscores that demand for food safety immunoassays has grown at an annualized rate exceeding 7% since 2020, supporting the broader immunoassay market growth trajectory. Environmental testing, such as monitoring pesticide residues and industrial pollutants, is also accelerating adoption rates. 

Immunoassay Market Driven by Rising Chronic Disease Burden 

The immunoassay market is being significantly driven by the rising global burden of chronic diseases, including cancer, diabetes, and cardiovascular disorders. For instance, the World Health Organization projects that cancer cases will rise by over 47% by 2040, which directly amplifies the need for immunoassay-based biomarkers in oncology diagnostics and therapy monitoring. Datavagyanik identifies this trend as a central pillar supporting the immunoassay market’s robust expansion. With growing emphasis on early detection and preventive care, the immunoassay market is positioned as a cornerstone technology for modern diagnostic frameworks, sustaining long-term revenue opportunities. 

Automation and High-Throughput Systems Transforming the Immunoassay Market 

Automation has revolutionized laboratory workflows, and the immunoassay market is among the foremost beneficiaries of this technological shift. For instance, high-throughput immunoassay analyzers have slashed turnaround times while improving precision, enabling laboratories to process thousands of samples daily. Datavagyanik emphasizes that laboratories adopting fully automated immunoassay platforms have reported a productivity boost exceeding 30%, enabling them to meet rising testing volumes more efficiently. These high-performance systems have also reduced the risk of human error, a key factor in enhancing diagnostic quality across the immunoassay market landscape. 

Immunoassay Market Size Expanding Amid Personalized Medicine Growth 

The immunoassay market size is poised to expand significantly as personalized medicine becomes mainstream. For example, immunoassays are integral in tailoring treatment strategies based on individual biomarkers, supporting precision medicine initiatives in oncology and immunology. Datavagyanik estimates that over 60% of oncology treatment pathways now incorporate immunoassay-based companion diagnostics, underscoring their pivotal role. This deep integration with personalized medicine frameworks is a vital catalyst behind the immunoassay market size expansion projected through 2030. 

Immunoassay Market and Growing Point-of-Care Testing Demand 

The immunoassay market is responding rapidly to the global surge in point-of-care testing demand. Such technologies have become essential in remote and resource-limited settings, enabling real-time diagnosis and treatment. For instance, rapid immunoassay test kits are now widely deployed in emergency departments and rural clinics, addressing the need for decentralized testing infrastructure. Datavagyanik notes that the point-of-care segment within the immunoassay market is forecast to achieve double-digit growth through 2028, driven by the accessibility and simplicity of these testing platforms. 

Immunoassay Market Supporting Emerging Infectious Disease Preparedness 

Emerging infectious diseases remain a critical global health challenge, with the immunoassay market positioned as a frontline defense. For example, during recent outbreaks of diseases such as monkeypox and dengue, rapid immunoassay tests have enabled quick containment efforts. Datavagyanik points out that immunoassay systems capable of multiplex detection are proving especially valuable in outbreak settings, as they can simultaneously screen for multiple pathogens in a single run. Such capabilities are expected to bolster the immunoassay market’s future resilience and relevance in global health preparedness initiatives. 

Regulatory Developments and Quality Standards Shaping the Immunoassay Market 

The immunoassay market is also being shaped by evolving regulatory frameworks that demand higher quality and performance standards. For instance, the United States Food and Drug Administration and the European Medicines Agency have introduced more stringent requirements for immunoassay validation, pushing manufacturers to innovate and standardize their offerings. Datavagyanik underscores that regulatory harmonization across international markets is helping create consistent benchmarks, which boosts confidence in immunoassay market products. Consequently, these reforms are encouraging investments in advanced immunoassay technologies that adhere to global quality norms. 

Immunoassay Market Gaining Momentum with Biopharmaceutical R&D 

Biopharmaceutical research and development is driving major opportunities within the immunoassay market. For instance, immunoassays are fundamental tools in drug discovery, pharmacokinetics, and vaccine development. Datavagyanik reports that as biopharmaceutical pipelines continue to expand — with over 8,000 active molecules in clinical trials worldwide — the immunoassay market is positioned to supply critical testing solutions that streamline the development process. The growing need for highly sensitive, specific assays for drug monitoring and toxicity screening is further propelling the immunoassay market toward sustained growth. 

Immunoassay Market Responding to Increasing Cancer Biomarker Testing 

Cancer biomarker testing has emerged as one of the fastest-growing segments within the immunoassay market. For example, immunoassay-based methods are now widely applied to screen for tumor markers such as PSA, CEA, and CA-125, which support early cancer detection and monitoring. Datavagyanik projects that the oncology segment within the immunoassay market will record compound annual growth of over 9% through 2029, reflecting both rising cancer incidence and broader availability of targeted therapies. These applications are cementing the immunoassay market’s role in next-generation cancer management strategies. 

Immunoassay Market Trends in Veterinary and Agricultural Testing 

Beyond human health, the immunoassay market is gaining traction in veterinary diagnostics and agricultural safety testing. For instance, immunoassays are used to detect zoonotic diseases in livestock, ensuring healthier animal populations and protecting food chains. Datavagyanik observes that veterinary applications have grown consistently, with a market expansion rate of nearly 6% annually since 2021. In agriculture, immunoassays help monitor pesticide residues and crop diseases, contributing to safer agricultural practices. These non-human testing segments are critical contributors to the immunoassay market’s diversified growth outlook. 

Immunoassay Market and the Path Toward Sustainable Solutions 

Sustainability is emerging as a significant theme within the immunoassay market. For example, manufacturers are now prioritizing eco-friendly reagents and reducing hazardous waste from testing processes. Datavagyanik notes that environmentally conscious laboratory practices are being adopted widely, with over 40% of large laboratory networks implementing green protocols to limit their carbon footprint. Such efforts are not only addressing regulatory compliance but also elevating the reputation of companies active in the immunoassay market, promoting a culture of sustainable diagnostics. 

 

Regional Dynamics Fueling Immunoassay Market Growth 

The immunoassay market is witnessing differentiated regional demand patterns, shaped by variations in healthcare infrastructure, disease prevalence, and regulatory frameworks. For instance, North America commands a significant share of the immunoassay market thanks to advanced diagnostic laboratory networks, strong R&D investment, and high chronic disease burden. Datavagyanik points out that the United States alone accounted for over 35% of global immunoassay market revenues in 2024, supported by widespread adoption in oncology and infectious disease screening. 

In Europe, the immunoassay market continues to expand steadily, driven by growing emphasis on preventive health strategies and a rapidly aging population. For example, countries such as Germany, France, and the UK have seen immunoassay demand rise at an annualized rate of 6–7% since 2021, owing to strong public health initiatives and broad insurance coverage for diagnostics. 

Asia Pacific is emerging as the fastest-growing contributor to the immunoassay market, with Datavagyanik estimating CAGR levels exceeding 9% through 2030. For instance, rising awareness about early disease detection, coupled with growing healthcare investments in China and India, is accelerating immunoassay adoption across hospitals and diagnostic chains. In these economies, increasing middle-class spending and expanding medical insurance are reshaping immunoassay demand patterns, unlocking tremendous market potential. 

Immunoassay Market in Latin America and Middle East 

The immunoassay market is also making strong inroads across Latin America and the Middle East. For example, Brazil has experienced robust growth in immunoassay demand, driven by government investments in infectious disease surveillance programs. Datavagyanik highlights that Brazil’s immunoassay market has grown by over 5% annually since 2022, reflecting efforts to improve public health testing infrastructure. 

In the Middle East, the immunoassay market is supported by expanding private hospital networks and a rising incidence of lifestyle-related chronic illnesses such as diabetes and cardiovascular disease. Countries including Saudi Arabia and the UAE have prioritized health sector reforms, leading to higher immunoassay demand in laboratory and point-of-care settings. These trends suggest that emerging regions will continue to complement mature markets and collectively accelerate global immunoassay market growth. 

Immunoassay Market Segmentation by Technology 

Segmentation within the immunoassay market is increasingly defined by technological preference. For instance, enzyme-linked immunosorbent assays (ELISAs) continue to maintain a strong market share because of their cost-effectiveness, reliability, and ease of use. Datavagyanik estimates that ELISAs account for nearly 35% of immunoassay market revenues as of 2024, driven by their broad application in infectious disease detection and food safety testing. 

Meanwhile, chemiluminescence immunoassays are gaining significant momentum due to their superior sensitivity and high-throughput capabilities. Datavagyanik forecasts the chemiluminescence segment will grow at a CAGR of 9% between 2023 and 2028, supported by growing demand for automated platforms capable of handling large sample volumes. For instance, in oncology diagnostics, chemiluminescence assays are becoming the backbone of tumor marker screening, ensuring faster and more precise results. 

Lateral flow immunoassays are another dynamic segment, particularly relevant to point-of-care testing. Datavagyanik notes that lateral flow devices, widely adopted for rapid infectious disease screening, are expected to see double-digit growth through 2030 as demand rises for decentralized testing in rural and emergency care settings. 

Immunoassay Market Segmentation by Application 

Application-based segmentation is further transforming the immunoassay market. For instance, the infectious disease testing segment continues to dominate, supported by persistent viral outbreaks and public health screening initiatives. Datavagyanik projects that infectious disease testing will maintain over 40% share of the global immunoassay market through 2029, with HIV, hepatitis, and COVID-19 testing driving continued immunoassay demand. 

Oncology is another critical application area, where immunoassay-based biomarker detection supports targeted therapies and personalized medicine. For example, immunoassays for tumor markers such as CA-125, AFP, and PSA are seeing annual growth of over 8% as precision oncology expands worldwide. Datavagyanik emphasizes that the oncology segment within the immunoassay market is benefiting from increased global cancer incidence, which will keep driving demand for advanced diagnostic assays. 

Cardiology, autoimmune disorders, and allergy testing are also rapidly growing, creating broader market segmentation. For instance, autoimmune disease detection using immunoassays has seen consistent growth of 6–7% annually, supported by expanding research on autoimmune mechanisms. Datavagyanik highlights that this diverse range of applications safeguards the immunoassay market against volatility and supports a resilient long-term growth pattern. 

Immunoassay Market Price Trend and Cost Dynamics 

Pricing dynamics in the immunoassay market are evolving alongside technological sophistication and competition. For example, the average price of a standard ELISA kit has declined by around 10% over the last three years due to scale efficiencies and widespread manufacturer participation. Datavagyanik points out that competitive pricing strategies have enabled smaller labs in emerging regions to access high-quality immunoassay products, thereby expanding the customer base. 

In contrast, high-end chemiluminescence immunoassay platforms maintain premium pricing because of their advanced automation, reduced hands-on time, and enhanced accuracy. Datavagyanik estimates that chemiluminescence assay platforms can command pricing two to three times higher than traditional ELISA kits, justified by significant productivity and performance advantages. For example, a chemiluminescence analyzer capable of running 300 tests per hour can save labs nearly 20% on labor costs, offsetting the initial investment premium. 

Furthermore, lateral flow immunoassay devices, being single-use and disposable, maintain moderate pricing levels while capturing a fast-growing share of immunoassay demand. For instance, rapid antigen tests priced between USD 5 and 15 per unit have been widely adopted in both clinical and home settings. Datavagyanik expects prices in this segment to remain relatively stable as production scales up and governments continue to subsidize testing for public health emergencies. 

Immunoassay Market Growth Opportunities in Personalized Medicine 

The immunoassay market is seeing significant pricing resilience and growth opportunities within personalized medicine. For example, companion diagnostic immunoassays developed for targeted drug therapies command a premium because of their critical role in treatment decisions. Datavagyanik estimates that personalized immunoassays can be priced up to 30% higher than conventional tests, justified by their enhanced value in clinical pathways. 

This trend is expected to strengthen as personalized medicine frameworks expand to address oncology, rare diseases, and immunological disorders. For instance, immunoassay demand for biomarker-guided therapy selection is projected to grow by over 12% annually through 2030, cementing the immunoassay market’s position as an indispensable tool for next-generation precision healthcare. 

Immunoassay Market and Public Health Investments 

Public health initiatives remain critical drivers of regional immunoassay demand. For example, immunoassay-based HIV and hepatitis screening programs in Africa and Southeast Asia have scaled rapidly in the last five years, supported by government and NGO funding. Datavagyanik indicates that such initiatives have grown immunoassay market size by nearly 20% in these regions since 2020, illustrating how targeted investments can accelerate adoption. 

Similarly, vaccination programs rely heavily on immunoassay platforms to monitor antibody responses and ensure immunization coverage. For example, post-COVID vaccine antibody testing drove a surge in immunoassay demand, with volumes growing over 15% annually between 2021 and 2023. This robust growth pattern highlights the immunoassay market’s ability to adapt to emerging public health needs on short notice, strengthening its strategic role in global healthcare. 

Immunoassay Market Outlook for Food Safety and Environmental Testing 

The immunoassay market is also benefiting from sustained demand in food safety and environmental testing applications. For instance, immunoassays used to detect pesticide residues and mycotoxins have seen rising adoption in agricultural economies such as India, Brazil, and Vietnam. Datavagyanik estimates food safety applications to grow by 7–8% annually through 2029, supported by stricter international regulations on food exports. 

In environmental testing, immunoassays are applied to monitor contaminants in soil and water, providing a rapid and affordable solution to regulators. For example, pesticide residue testing using immunoassays has reduced test turnaround times by over 40% compared to traditional lab-based chromatography. Datavagyanik anticipates that environmental immunoassay demand will continue expanding at a healthy pace, reinforcing the market’s diversification beyond healthcare applications. 

Immunoassay Market Supply Chain and Logistics Factors 

The immunoassay market is also influenced by supply chain dynamics and logistics improvements. For instance, global distribution networks for immunoassay reagents and devices have become more robust since the COVID-19 pandemic, allowing manufacturers to reach remote geographies efficiently. Datavagyanik observes that cold chain infrastructure improvements have reduced spoilage rates of temperature-sensitive immunoassay kits by nearly 15%, ensuring better product availability worldwide. 

Additionally, regional production facilities in Asia and Latin America have helped balance supply chains by localizing manufacturing, reducing lead times, and cutting costs. This decentralization strategy is expected to stabilize pricing levels and support continuous immunoassay demand in high-growth markets. 

Immunoassay Market and Future Competitive Landscape 

Looking ahead, the competitive landscape of the immunoassay market is set to evolve as new entrants introduce niche, application-focused solutions. For instance, startups specializing in multiplex microfluidic immunoassays are gaining investor interest because of their promise to deliver faster, more compact testing platforms. Datavagyanik projects that these emerging technologies could capture up to 10% of the immunoassay market share within the next five years, challenging established players. 

Furthermore, partnerships between pharmaceutical firms and diagnostics manufacturers are accelerating innovation pipelines. For example, co-development agreements for companion diagnostics are shortening time-to-market for immunoassay kits, enhancing responsiveness to new medical needs. This partnership-driven innovation model will remain a defining force in shaping the future immunoassay market landscape. 

 

Leading Market Participants in the Immunoassay Market 

The immunoassay market is characterized by a concentrated landscape led by prominent multinational diagnostics companies. These organizations contribute to a significant portion of total global revenues, leveraging scalable platforms, deep product pipelines, and extensive geographic reach to maintain dominance. For instance, one key player controls approximately 18–20% of the immunoassay market through its broad portfolio of automated analyzers and reagents. Another major firm holds around 12–14% share, driven by its strong presence in both clinical laboratories and point-of-care segments within the immunoassay market ecosystem. 

Siemens Healthineers and Immunoassay Market Influence 

Among the top-ranked players, Siemens Healthineers stands out as a major contributor to the immunoassay market. Its ADVIA Centaur and Atellica immunoassay systems are widely implemented in large hospital networks and reference labs. For example, the Atellica IM Analyzer offers high-throughput processing of over 200 immunoassay tests per hour, providing comprehensive access to cardiac, thyroid, and tumor marker panels. This has helped Siemens maintain steady leadership in the immunoassay market, especially in North America and Europe. The firm’s strength in digital workflow integration further positions it as a consistent market influencer. 

Roche Diagnostics and Immunoassay Market Leadership 

Roche Diagnostics holds a top-tier position in the immunoassay market, with its cobas and Elecsys immunoassay lines contributing significant revenue. The Elecsys anti‑SARS‑CoV‑2 antibody test, launched during the COVID‑19 pandemic, reinforced Roche’s immunoassay market presence. With over 10 million test results processed globally by mid‑2021, the company expanded its reach in infectious disease surveillance using immunoassay technology. Additionally, Roche’s continuing innovation in oncology and cardiac markers maintains its strong foothold in the global immunoassay market. 

Abbott Laboratories’ Role in the Immunoassay Market 

Abbott Laboratories commands a leading position through its ARCHITECT and Alinity immunoassay platforms. ARCHITECT i2000SR and Alinity i models enable integrated testing of infectious disease, autoimmunity, and tumor markers. For example, the ARCHITECT progesterone immunoassay remains a top choice in reproductive health diagnostics, widely adopted by fertility clinics and women’s health providers. Abbott’s strategic investments in point-of-care immunoassay development, such as rapid SARS-CoV-2 antigen and antibody tests, have further diversified its share in the immunoassay market. 

Danaher Corporation in the Immunoassay Market 

Within the immunoassay market, Danaher Corporation plays a critical role through its Beckman Coulter and Cepheid divisions. The Access immunoassay systems by Beckman Coulter offer robust performance in endocrine, allergy, and cardiovascular testing. For instance, Access HBsAg and TSH assays are among the highest-selling immunoassays in clinical laboratories worldwide. Cepheid contributes to the immunoassay market primarily with its GeneXpert platform, integrating molecular and immunoassay testing workflows—particularly significant in infectious disease diagnostics across emerging markets. 

Thermo Fisher Scientific’s Presence in the Immunoassay Market 

Thermo Fisher Scientific has established a strong position in the immunoassay market through its Invitrogen and Fisher Healthcare divisions. Its SuperScript and Qubit immunoassays for protein quantification are widely used in research settings, underpinning translational immunoassay development. Meanwhile, the EliA family of autoimmune immunoassays continues to grow in prevalence among rheumatology labs and specialty diagnostic centers. Thermo Fisher’s broad reagent portfolio supports its growing influence in the immunoassay market. 

Bio-Rad Laboratories and Immunoassay Market Niche 

Bio-Rad Laboratories occupies a notable niche in the immunoassay market, especially within research and clinical immunology segments. Its BioPlex 2200 multiplex immunoassay system allows simultaneous measurement of autoantibodies and infectious disease markers, supporting efficient panel testing. The Vidas immunoassay line, co-branded with bioMérieux, also holds relevance in serology and allergen testing. Though smaller than top-tier players, Bio-Rad’s focused product innovation gives it a valuable immunoassay market position. 

Fujirebio’s Specialty Immunoassay Market Share 

Fujirebio is gaining traction in the immunoassay market, particularly through its Lumipulse line of chemiluminescence immunoassay analyzers. Specializing in neurological biomarkers, Lumipulse assays for amyloid-beta, tau proteins, and neurofilament light chain have become key components of neurodegenerative disease diagnostics. This positions Fujirebio as a strong player within the immunoassay market vertical focused on neurology and biomarker-driven testing. 

Ortho Clinical Diagnostics in the Immunoassay Market 

Ortho Clinical Diagnostics remains a significant participant in the global immunoassay market, with its VITROS immunodiagnostic systems widely used in chemistry, immunology, and serology testing. The VITROS XT 7600 system is particularly notable for its consolidated capability across multiple test types, enhancing throughput while reducing manual labor. Ortho’s strategic focus on integrated immunoassay and chemistry systems underscores its competitive strength in midsize to large laboratories. 

Recent Developments in the Immunoassay Market 

Several key developments in recent months have reshaped competitive positioning within the immunoassay market: 

• May 15, 2025 – A leading immunoassay company announced expanded global availability for its new high-sensitivity troponin assay. Leveraging improved sensitivity, the assay can detect cardiac events earlier, reinforcing the firm’s position in the immunoassay market and accelerating adoption in emergency care units. 

• April 3, 2025 – A multinational diagnostics provider launched a next-generation lateral flow immunoassay platform with digital connectivity. Featuring smartphone integration, the product establishes a new benchmark in point-of-care immunoassay market growth through enhanced patient data tracking. 

• March 28, 2025 – Bio‑Rad unveiled its new autoimmune disease multiplex immunoassay panel, expanding the immunoassay market’s range of specialty diagnostic options. Laboratories implementing the panel reported a 25% reduction in overall test turnaround time. 

• February 10, 2025 – Abbott received regulatory clearance for a highly sensitive C‑reactive protein immunoassay on its high-throughput system. This expansion augments Abbott’s immunoassay market share in chronic inflammation monitoring and cardiovascular risk management. 

• January 22, 2025 – Siemens Healthineers introduced the next version of its flagship immunoassay analyzer, featuring machine learning algorithms for real-time quality control, further reinforcing its leadership in the immunoassay market through innovation. 

 

Key Insights that the Immunoassay Market analysis report presents are:

• Immunoassay Market revenue and demand by countries
• Break-down of the Immunoassay Market in terms of application areas, target customers, and other potential market segments
• Areas that are relatively more potential and are faster growing
• Immunoassay Market competitive scenario, market share analysis
• Immunoassay Market business opportunity analysis

Global and Country-Wise Immunoassay Market Statistics

• Global and Country-Wise Immunoassay Market Size ($Million) and Forecast, till 2030
• Global and Country-Wise Immunoassay Market Trend Analysis
• Global and Country-Wise Immunoassay Market Business Opportunity Assessment