Global Immunoassay Market: Trends, Technologies, and Growth Opportunities, 2025

Kalorama Information’s new report, Global Immunoassay Market: Trends, Technologies, and Growth Opportunities, 2025, provides an in-depth analysis of one of the most pivotal segments of the in vitro diagnostics (IVD) industry with market estimates and forecasts spanning 2024-2029. Immunoassays—diagnostic tests that detect target analytes via antibody-antigen interactions—are foundational tools in clinical laboratories and point-of-care (POC) settings, enabling the detection of proteins, hormones, drugs, and infectious agents.

The global immunoassay market continues to expand, driven by advances in automation, miniaturization, multiplexing, and biomarker discovery. Despite being a mature technology, immunoassays are evolving rapidly to meet modern healthcare needs—from central labs to self-testing applications.

Market Segmentation

By Setting

• Centralized Lab-Based Immunoassays:
• Used in core labs for diagnostics, monitoring, and screening.
• Market Sales: Major contributors include infectious diseases, cardiac markers, and tumor markers.
• Top segments covered:
• Infectious Disease
• Cardiac Markers
• Metabolic Disorders & Hormones
• Tumor Markers
• Autoimmune & Allergy Testing
• Point-of-Care (POC) Immunoassays:
• Includes lateral flow and other rapid tests in hospitals, clinics, retail settings, and self-testing.
• Rapidly growing due to ease of use and decentralized access.
• Top segments covered:
• Infectious Disease
• Hormone/Fertility
• Cardiac Markers
• Oncology & FOBT
• Toxicology

Breakout By Disease Category

• Infectious Disease: Largest and most diverse segment; includes tests for HIV, hepatitis, MRSA, STDs, COVID-19, and TORCH.
• Cardiac Markers: Strong growth from heart failure and acute care testing.
• Hormones & Fertility: High usage in both labs and POC; includes reproductive and thyroid hormones.
• Oncology/Tumor Markers: Focus on PSA, CEA, CA-125, AFP with lab-based dominance.
• Toxicology & Drug Monitoring: Used in pain management, emergency medicine, and substance abuse programs.
• Autoimmune & Allergy: Emerging targets and expanded panels for systemic diseases.
• Genetic Testing: Includes prenatal screening and gene expression profiling via immunoassay platforms.
• Other Emerging Areas: Alzheimer’s disease, gastrointestinal disorders, transplant medicine, and women’s health (e.g., preeclampsia).

Analysis of Geographic Trends

• Developed Markets:
• North America and Western Europe dominate due to high healthcare infrastructure and adoption of advanced diagnostics.
• Developed Asia Pacific also plays a key role.
• Emerging Markets:
• Immunoassays are key to expanding access in Latin America, Eastern Europe, Southeast Asia, and Africa, where centralized diagnostics are limited.
• Lateral flow and self-testing are critical tools in resource-limited settings.

Scope and Methodology

This report presents the global immunoassay market in U.S. dollars, covering the years 2024 through 2029. It analyzes a wide range of immunoassay technologies, from high-throughput lab instruments to manual point-of-care (POC) tests, including rapid immunochromatographic or lateral flow formats.

The primary focus is on developed regions—North America, Western Europe, and developed Asia-Pacific—while also recognizing the importance of POC testing in expanding diagnostic access in underserved areas.

Market data reflects manufacturer revenue rather than retail prices or reimbursements. Segment values generally align with test volumes, as instrument costs are often bundled into per-test pricing.

A blend of primary and secondary research underpins the report's findings. Secondary sources included public and proprietary databases, industry reports, regulatory filings, company publications, and peer-reviewed journals. These sources provided context, competitor identification, and strategic insights.

To validate and deepen the research, Kalorama conducted over 30 interviews with industry experts such as executives, product and marketing leaders, consultants, healthcare professionals, and government representatives. These interviews provided qualitative insights into market dynamics and trends.

Additional outreach to companies yielded specific figures on revenue, market share, and product performance. All data were verified against multiple sources and, when possible, triangulated using public disclosures, proprietary insights, and expert feedback.

Market sizing and forecasts are based on 2024 as the base year, with projections through 2029 supported by historical trends, demographic shifts, technological advances, and global market expansion. Competitive analysis reflects the landscape in 2024, with forward-looking trends identified for subsequent years. Show more