This report values the global serology testing market at US$6.1 billion in 2025 and forecasts it to reach US$8.2 billion by 2030, a CAGR of 6.2% over 2026-2030. The market contracted from an estimated US$7.2 billion in 2021 (a historical CAGR of approximately -4.1% for 2021-2025) as pandemic-era SARS-CoV-2 antibody testing unwound, before returning to growth in 2024 and accelerating to an estimated 6.1% in 2025 as routine infectious-disease, autoimmune and allergy testing re-established the category’s structural trajectory. North America is the largest region at approximately 38% of 2025 revenue, anchored by the United States, while Asia Pacific is the fastest-growing region at approximately 7.8% CAGR, led by China’s laboratory modernization and India’s 11.5% national growth - the fastest of any major market covered in this report.
By test type, antibody testing leads with a 64% share, while antigen-antibody combination assays are the fastest-growing at approximately 7.4% CAGR. Chemiluminescence immunoassay (CLIA) is the leading technology at 38% (52% including electrochemiluminescence), and multiplex immunoassays are the fastest-growing at approximately 9.5%. Infectious disease testing accounts for 56% of demand and autoimmune testing is the fastest-growing application at approximately 7.6%; correspondingly, viral infections form the largest disease/condition group at 41% and autoimmune diseases the fastest-growing. Serum is the dominant sample type at 58%, with capillary blood the fastest-growing at approximately 8.6%, while hospitals are the largest end user at 41% and point-of-care settings the fastest-growing at approximately 9.5%.
Growth is underpinned by the persistent burden of HIV, viral hepatitis, syphilis and vector-borne infections, mandatory blood-donor and antenatal screening, rising diagnosis of autoimmune and allergic disease, and expanding laboratory infrastructure in emerging markets. Key trends include consolidation onto fully automated, high-throughput chemiluminescence platforms, multiplex autoantibody and allergen panels, AI-assisted immunofluorescence interpretation, LIS-connected digital workflows and decentralized rapid serology. Principal challenges include China’s volume-based procurement pricing reforms, reagent and capital costs, cross-reactivity and assay-standardization limitations, regulatory and quality-control burden under frameworks such as the EU IVDR, and uneven testing infrastructure in low-income settings.
The competitive landscape is moderately concentrated around diversified in-vitro diagnostics leaders - Roche Diagnostics, Abbott, Siemens Healthineers and Danaher’s Beckman Coulter - whose installed bases of automated immunoassay analyzers generate recurring reagent revenue, alongside specialty leaders such as DiaSorin, bioMérieux, Thermo Fisher Scientific and QuidelOrtho. With COVID-related volatility largely absorbed, the market enters 2026 on a steady, menu- and automation-led growth path, with emerging-market adoption, autoimmune and allergy specialty testing, and multiplex and point-of-care formats offering the strongest incremental opportunities through 2030.
By test type, antibody testing leads with a 64% share, while antigen-antibody combination assays are the fastest-growing at approximately 7.4% CAGR. Chemiluminescence immunoassay (CLIA) is the leading technology at 38% (52% including electrochemiluminescence), and multiplex immunoassays are the fastest-growing at approximately 9.5%. Infectious disease testing accounts for 56% of demand and autoimmune testing is the fastest-growing application at approximately 7.6%; correspondingly, viral infections form the largest disease/condition group at 41% and autoimmune diseases the fastest-growing. Serum is the dominant sample type at 58%, with capillary blood the fastest-growing at approximately 8.6%, while hospitals are the largest end user at 41% and point-of-care settings the fastest-growing at approximately 9.5%.
Growth is underpinned by the persistent burden of HIV, viral hepatitis, syphilis and vector-borne infections, mandatory blood-donor and antenatal screening, rising diagnosis of autoimmune and allergic disease, and expanding laboratory infrastructure in emerging markets. Key trends include consolidation onto fully automated, high-throughput chemiluminescence platforms, multiplex autoantibody and allergen panels, AI-assisted immunofluorescence interpretation, LIS-connected digital workflows and decentralized rapid serology. Principal challenges include China’s volume-based procurement pricing reforms, reagent and capital costs, cross-reactivity and assay-standardization limitations, regulatory and quality-control burden under frameworks such as the EU IVDR, and uneven testing infrastructure in low-income settings.
The competitive landscape is moderately concentrated around diversified in-vitro diagnostics leaders - Roche Diagnostics, Abbott, Siemens Healthineers and Danaher’s Beckman Coulter - whose installed bases of automated immunoassay analyzers generate recurring reagent revenue, alongside specialty leaders such as DiaSorin, bioMérieux, Thermo Fisher Scientific and QuidelOrtho. With COVID-related volatility largely absorbed, the market enters 2026 on a steady, menu- and automation-led growth path, with emerging-market adoption, autoimmune and allergy specialty testing, and multiplex and point-of-care formats offering the strongest incremental opportunities through 2030.
Table of Contents
1. Introduction
2. Market Size and Growth
3. Market Segmentation
4. Regional and Country Analysis
5. Technology, Applications and Diagnostic Insights
6. Competitive Landscape
7. Company Profiles
8. Strategic Insights and Outlook
List of Tables and Figures
Companies Mentioned
- Roche Diagnostics
- Abbott Laboratories
- Siemens Healthineers
- Danaher (Beckman Coulter Diagnostics)
- Thermo Fisher Scientific
- bioMérieux
- DiaSorin
- QuidelOrtho
