Immunoassays Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

Global Immunoassays Market Trends and Insights

Rising Prevalence of Chronic & Infectious Diseases

Escalating cancer, cardiovascular, and infectious-disease burdens continue to redefine testing volumes worldwide. Multi-parameter panels that combine circulating tumor DNA with traditional protein biomarkers are improving early diagnosis and therapy selection, as evidenced by research identifying CA724, ferritin, and β2-microglobulin as thoracic cancer indicators. Cardiometabolic care has embraced advanced lipoprotein(a) assays, with Roche’s Tina-quant test delivering the first molar-based Lp(a) measurement cleared by the FDA. Communicable-disease surveillance, supported by WHO quality-assurance networks, further accelerates reagent consumption and instrument installations.^{[1]World Health Organization, “Laboratory Network Strengthening for Disease Surveillance,” who.int}

Rapid Technological Advances in High-Throughput Analyzers

Automation and machine learning now underpin daily laboratory workflows. The Mayo Clinic’s AI model for kidney-stone spectral analysis cut per-sample review time while preserving accuracy. CLIA platforms from Revvity deliver 60 tests per hour with 48-minute turnaround and monoclonal antibody specificity, a combination essential for precision oncology and endocrinology. Microfluidic biosensors integrate fluid control and optical detection on a single chip, shrinking assay footprints and permitting true walk-away operation.

Expansion of Point-of-Care/Home-Based Rapid Tests

Demand for decentralized diagnostics is reshaping procurement budgets and reimbursement structures. Global POC revenues are slated to eclipse USD 35 billion by 2027, buoyed by diabetes and respiratory-virus screening needs. LOCA-PRAM algorithms now reduce false positives in handheld readers, while optofluidic immunoassays deliver COVID-19 antibody results from 1 µL blood in 40 minutes. Shelf-stable bioluminescence reagents achieve 2.1 pg/mL IL-6 detection, removing cold-chain dependencies for field deployment.

Government-Funded Global Surveillance & Immunization Programs

National and multilateral initiatives continue to build diagnostic capacity. The US CDC’s Global Health Protection division has trained local laboratorians in more than 80 countries. India’s serosurveillance projects guide immunization policy by pinpointing immunity gaps, while Australia’s National Serosurveillance Program has generated 26 peer-reviewed outputs that inform vaccine schedules. WHO’s integrated VPD framework, first deployed in Costa Rica, illustrates how harmonized testing can streamline pathogen tracking.

Stringent Multi-Jurisdictional Regulatory Approvals

Developers face divergent evidence expectations across the FDA, European IVDR, and multiple Asian frameworks, inflating timelines and budgets. Companion diagnostics add layers of inter-agency coordination, while guidance for AI-enabled or multiplex assays remains fragmented. Lack of global harmonization compels parallel validation studies and onsite audits, draining resources from R&D pipelines and product launches.

High Capital Cost of Multiplex & Automated Systems

Instrument price tags, ongoing reagent contracts, and facility retrofits deter smaller labs. Protein A resin and automated analyzers command premium pricing that pushes total cost of ownership beyond many public-sector budgets. Contract manufacturing can offset scale constraints but introduces supply-chain dependencies and potential quality lapses.

Segment Analysis

By Products & Services: Reagents Sustain Market Foundation

Reagents and kits generated USD 22.9 billion in revenue in 2024, translating into the single largest slice of the immunoassays market and providing predictable, recurring income streams for suppliers. Volume growth comes from routine infectious-disease panels, chronic-disease monitoring, and expanding global surveillance programs that require validated, lot-consistent consumables. Reagent interoperability across multiple analyzer platforms is increasingly important, prompting manufacturers to invest in universal chemistries and CE-marked bulk packs that support lean-lab initiatives.

Analyzers and instruments, the fastest-expanding category at a 5.34% CAGR, reflect laboratory moves toward full automation and high-throughput operations. AI-enabled scheduling modules now optimize run order and maintenance cycles, easing technician shortages. Meanwhile, middleware connects immunoassay data with LIS and hospital EHRs, driving integrated clinical decision support. As a result, the immunoassays market size for instruments is projected to rise from USD 7.6 billion in 2025 to USD 9.9 billion in 2030.

Note: Segment shares of all individual segments available upon report purchase

By Technology: ELISA Dominance Faces CLIA Challenge

ELISA occupied 55.34% revenue share in 2024, anchored by standardized protocols, low consumable cost, and decades of accumulated performance evidence. Academic and community laboratories alike continue to rely on ELISA for cytokine panels, endocrine markers, and autoimmune screening, sustaining strong base demand. Yet sensitivity ceilings and relatively long incubation times limit ELISA’s suitability for emerging ultra-low-analyte applications.

Chemiluminescence immunoassays, growing at a 5.41% CAGR, offer higher analytical sensitivity and wider dynamic range, making them the method of choice for therapeutic drug monitoring and tumor-marker quantification. Multiplex microarray platforms add throughput by simultaneously detecting dozens of analytes, a capability now indispensable in translational oncology programs. Consequently, the immunoassays market share commanded by CLIA is forecast to climb toward 30% by decade-end, even as ELISA retains a sizeable installed base.

By Application: Infectious Diseases Lead, Oncology Surges

Infectious-disease testing represented 35.45% of 2024 revenues, supported by surveillance mandates, global vaccine programs, and continuing SARS-CoV-2 variant tracking. WHO-aligned procurement schemes ensure reagent standardization and funding continuity, making this application a durable volume driver. Simultaneously, new multiplex respiratory panels incorporate antigen and antibody targets, extending menu breadth per cartridge and boosting ASPs.

Oncology assays, meanwhile, are projected to register 5.51% CAGR through 2030, the fastest among applications. Liquid-biopsy panels that combine ctDNA and protein markers are gaining reimbursement endorsements, and personalized immunotherapy regimens depend on longitudinal monitoring of checkpoint inhibitor biomarkers. Consequently, the immunoassays market size for oncology is set to rise from USD 6.9 billion in 2025 to USD 9.1 billion by 2030, supported by big-pharma companion-diagnostic partnerships.

By Specimen Type: Blood Dominance, Saliva Innovation

Blood and serum samples comprised 51.23% of 2024 revenues thanks to clinical familiarity, broad analyte coverage, and robust reference ranges. Venipuncture remains the gold standard for high-throughput central-lab workflows, and dried-blood-spot cards now extend cold-chain-free logistics to resource-limited settings.

Saliva testing, advancing at a 5.23% CAGR, benefits from painless collection suited to pediatrics and telehealth. Validation studies have confirmed salivary cortisol, HIV antibodies, and SARS-CoV-2 antigens as reliable targets, with microfluidic devices requiring under 200 µL of sample for multiplex panels. As acceptance grows, the immunoassays market size for saliva-based tests is expected to double between 2025 and 2030, capturing hospital, home, and employer-screening demand.

Note: Segment shares of all individual segments available upon report purchase

By End User: Hospitals Lead, POC Transforms Care

Hospitals accounted for 36.45% of revenue in 2024, leveraging integrated LIS systems, reimbursement coverage, and multidisciplinary care pathways that demand rapid diagnostics. Bundle-payment models and clinical-decision-support integration push hospitals toward analyzers that combine immunoassays with chemistry and hematology on a single track, improving throughput and reagent utilization.

Point-of-care and home settings will see 5.53% CAGR through 2030, propelled by patient preference, remote-care policy incentives, and miniaturized analyzer launches. Wearable patches that incorporate microfluidic immunoassay cartridges for cytokine monitoring are entering early clinical trials, signaling future expansion beyond episodic tests. Under these trends, the immunoassays market share of POC users is positioned to exceed 15% by 2030, up from 11% in 2024.

Geography Analysis

North America maintained 41.12% revenue share in 2024, supported by strong reimbursement frameworks, NIH funding, and rapid FDA review pathways for breakthrough diagnostics. Recent clearances such as Roche’s B-cell lymphoma assay illustrate the region’s innovation cadence. Collaboration between Biogen, Beckman Coulter, and Fujirebio on Alzheimer’s markers further demonstrates the value placed on immunoassay-based companion diagnostics^{[2]Beckman Coulter, “Partnership Advances Alzheimer’s Disease Biomarkers,” beckmancoulter.com}. The United States continues to replace aging analyzers with fully automated lines integrating sample prep, while Canada emphasizes universal access and Mexico channels public-sector tenders toward high-sensitivity infectious-disease platforms.

Asia-Pacific is the fastest-growing region at 5.54% CAGR through 2030. China’s Made-in-China 2025 plan accelerates diagnostic self-sufficiency, with Chemclin’s automated systems moving from pilot to national rollout^{[3]Yicai Global, “Chemclin Diagnostics Unveils Fully Automated Immunodetection System,” yicaiglobal.com}. India’s organized diagnostics sector is expanding beyond metropolitan hubs into tier-3 and tier-4 cities, aided by wellness packages and price transparency. Japan incentivizes regenerative-medicine and oncology companion tests via fast-track approval programs, while South Korea supports start-ups through tax credits and hospital test beds. Southeast Asian nations benefit from multilateral funding aimed at tuberculosis and dengue surveillance, creating first-time buyer opportunities for bench-top platforms.

Europe remains a major revenue contributor, although IVDR transition challenges extend launch timelines. Germany and France anchor centralized testing demand, the United Kingdom prioritizes early cancer detection via NHS funding, and Spain expands point-of-care programs in primary-care clinics. Meanwhile, the Middle East and Africa, though smaller today, show double-digit test-volume growth thanks to Gulf state hospital construction and African CDC procurement initiatives. South America leverages Brazil’s unified health-service upgrades to expand neonatal and prenatal screening, while Argentina pushes for local reagent production amid import restrictions.