US Immunoassay Market (2025-2030)
The US Immunoassay Market was valued at $8757.09 Million in 2025 and projected to reach to $11474.68 Million by 2030, representing a compound annual growth rate of 5.6%. The US immunoassay market is poised for steady growth through 2030, driven by increasing prevalence of chronic diseases, rising demand for rapid diagnostic solutions, and continuous innovation in assay platforms.
US Immunoassay Market Trends and Insights
- The US market benefits from advanced healthcare infrastructure, high diagnostic spending, and widespread adoption of immunoassay technologies across clinical laboratories and point-of-care settings.
- Driven by increasing prevalence of chronic diseases, aging population demographics, and rising demand for rapid diagnostic solutions, the US immunoassay sector continues to expand steadily. In the US, immunoassay platforms are integral to disease detection, monitoring, and therapeutic drug management across hospitals, diagnostic centers, and research institutions.
- The US market is characterized by strong regulatory frameworks, significant investment in healthcare innovation, and the presence of leading diagnostic manufacturers.
- Between 2025 and 2030, the US immunoassay market will be propelled by technological advancements, automation in laboratory workflows, and growing emphasis on personalized medicine and early disease detection..
Key Market Statistics
- CAGR (2025-2030) 5.6% CAGR
- Market Size, 2025 ~USD 8757.09 Million
- Forecast, 2030 ~USD 11474.68 Million
- Country US
US Immunoassay Market Overview
Market Valuation :
The US immunoassay market is valued at $8,757.09 million in 2025, with projected growth to $11,474.68 million by 2030, reflecting strong demand across diagnostic sectors.
Growth Trajectory :
The US market demonstrates a CAGR of 5.6% through 2030, outpacing many developed markets due to robust healthcare spending and continuous technological advancement in diagnostic capabilities.
Healthcare Infrastructure :
Advanced clinical laboratory networks, extensive point-of-care testing adoption, and high diagnostic spending across US healthcare systems drive sustained immunoassay market expansion.
Technology Adoption :
Widespread integration of immunoassay technologies in hospitals, diagnostic centers, and physician offices positions the US as a leader in automated and high-throughput testing solutions.
US Immunoassay Market Dynamics
- Healthcare providers' focus on improving diagnostic accuracy and reducing turnaround times supports market expansion across clinical and point-of-care settings. Regulatory support, favorable reimbursement policies, and significant R&D investments by major diagnostic manufacturers strengthen the US market position.
- The shift toward personalized medicine and home-based testing further accelerates adoption, while consolidation among laboratory service providers creates opportunities for integrated immunoassay solutions..
Related Ecosystem
In Vitro Diagnostics
- Polymerase Chain Reaction (PCR)
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Dna Microarrays
- Assay Kits
- Microarrays
- ROCHE HOLDINGS AG
- Thermo Fisher Scientific Inc.
- Danaher Corporation
- Abbott Laboratories
- Biomerieux s.a.
Medical Devices
- Polymerase Chain Reaction (PCR)
- Magnetic Resonance Imaging (MRI)
- Disposable Autoinjectors
- Pulse Oximeters
- Blood Pressure Monitors
- Medtronic plc
- Abbott Laboratories
- Stryker Corporation
- Becton, Dickinson and Company
- JOHNSON & JOHNSON
Key Takeaways
- The US immunoassay market is valued at $8,757.09 million in 2025 and will reach $11,474.68 million by 2030.
- The US market is growing at a 5.6% CAGR, driven by chronic disease prevalence and aging demographics.
- The US benefits from advanced healthcare infrastructure and strong regulatory frameworks supporting diagnostic innovation.
- Automation, personalized medicine, and point-of-care testing are key growth drivers in the US immunoassay sector.
Immunoassay Market Report Scope
| Report Metric | Details |
|---|---|
| Base Year | 2025 |
| Fastest Growing Segment | CLIA (Technology) |
| Forecast Period | 2025–2030 |
| Growth Rate | CAGR of 6.1% from 2025 to 2030 |
| Largest Segment | REAGENTS & KITS (Product) |
| Market Size Base Year (Billions) | ~USD 35.48 (2025) |
| Revenue Forecast (Billions) | ~USD 47.7 (2030) |
| Segments Covered | Product, Type, Purchase Mode, Technology, Specimen, Application |
US Immunoassay Market Report Segmentation
6 segment dimensions are covered across the global market.
By Product
- Analyzers
- Reagents & Kits
By Type
- Clia Reagents & Kits
- Closed-Ended Systems
- Elisa Reagents & Kits
- Elispot Reagents & Kits
- Ifa Reagents & Kits
- Open-Ended Systems
- Other Reagents & Kits
- Rapid Test Reagents & Kits
- Western Blot Reagents & Kits
By Purchase Mode
- Outright Purchase
- Rental Purchase
By Technology
- Clia
- Elisa
- Elispot
- Ifa
- Other Technologies
- Rapid Tests
- Western Blotting
By Specimen
- Blood
- Other Specimens
- Saliva
- Urine
By Application
- Allergy Diagnostics
- Autoimmune Disorders
- Blood Screening
- Bone & Mineral Disorders
- Cardiology
- Drug Monitoring & Testing
- Endocrinology
- Infectious Diseases
- Newborn Screening
- Oncology
- Other Applications
Target Audience
- Diagnostic Equipment Manufacturers : Manufacturers need US-specific market data to benchmark product performance, identify market gaps, and develop targeted commercialization strategies for immunoassay platforms.
- Clinical Laboratory Operators : Laboratory managers require market insights to optimize test portfolios, evaluate technology investments, and understand competitive positioning within the US diagnostic market.
- Healthcare Investors & PE Firms : Investment professionals need comprehensive US market analysis to evaluate acquisition targets, assess growth potential, and make informed capital allocation decisions in diagnostics.
- Pharmaceutical & Biotech Companies : Companies developing companion diagnostics and biomarker assays need US market data to understand adoption rates, reimbursement landscapes, and commercialization timelines.
- Healthcare Consultants & Advisors : Consultants require detailed US market intelligence to advise clients on market entry strategies, competitive positioning, and growth opportunities in the immunoassay sector.
Key Companies in the US Immunoassay Market
| Company | HQ | Ownership | Strongest segments |
|---|---|---|---|
| PATHEON INC | Netherlands | Private Company | Drug Product Services (oral, sterile, packaging, lifecycle),Pharmaceutical Development Services (preclinical to clinical),Drug Substance Services (small-molecule and biologics APIs), |
| ALERE INC | United States | Private Company | Infectious disease diagnostics (rapid and serology, including ELISA and automated systems),Cardiometabolic and critical care point-of-care (blood gas, lipids, glucose, D-dimer, troponin, diabetes),Toxicology and workplace drug testing (devices, reagents, lab services, alcohol tests), |
| FLUOR CORPORATION | United States | Public Company | Energy Solutions (oil, gas, chemicals, LNG, power, energy transition),Urban Solutions (advanced technologies, life sciences, mining and metals, infrastructure, staffing, maintenance),Mission Solutions (government, nuclear remediation, nuclear security, logistics, mission-critical O&M), |
| CEPHEID INC. | United States | Private Company | Infectious disease & healthcare-associated infection assays (Xpert on GeneXpert),Virology assays (including emergency use authorization tests),Oncology and genetics assays, |
| IMMUCOR, INC. | United States | Private Company | Transfusion (serology instruments and reagents, including NEO, Echo, Capture),Transplant & Molecular (HLA, HPA assays, Array Imaging System, BASIS, platelet-focused products),Other / Services and Ancillary Products, |
| UNILABS | Switzerland | Private Company | Routine & Specialty Laboratory Testing,Medical Imaging,Pathology & Centres of Excellence (IVF, Fertility, Pregnancy, Targeted Diagnostics), |
| EIKEN CHEMICAL CO., LTD. | Japan | Public Company | Fecal immunochemical test (FIT) reagents and analyzers,Microbiological reagents and food/environmental microbiology,Urinalysis test strips and analyzers, |
| ABBOTT | United States | Public Company | Diagnostic Products,Medical Devices,Nutritional Products, |
| SIEMENS HEALTHINEERS AG | Germany | Public Company | Imaging,Diagnostics,Varian (Oncology), |
| DANAHER | United States | Public Company | Biotechnology (bioprocessing and related solutions),Life Sciences (analytical instruments, genomics, and lab automation),Diagnostics (clinical instruments and consumables), |
| THERMO FISHER SCIENTIFIC INC. | United States | Public Company | Life Sciences Solutions,Analytical Instruments,Specialty Diagnostics, |
| REVVITY | United States | Public Company | Diagnostics instruments and systems,Diagnostics reagents, assays, and consumables,Life science reagents and genomic workflow tools, |
| DIASORIN S.P.A. | Italy | Public Company | Immunodiagnostics – Infectious and Gastrointestinal Diseases,Immunodiagnostics – Endocrinology, Metabolic Disorders, Tumor Markers, Oncology,Molecular Diagnostics – Simplexa and Congenital CMV, |
| BIO-RAD LABORATORIES, INC. | United States | Public Company | Clinical Diagnostics,Life Science Research Tools,Other / Informatics & Software, |
| QUIDELORTHO CORPORATION | United States | Public Company | Labs (clinical chemistry and immunoassay),Transfusion Medicine,Point of Care, |
| BIOMÉRIEUX | France | Public Company | Clinical microbiology & AST (VITEK, CHROMID, ETEST, culture media, BACT/ALERT),Syndromic and molecular diagnostics (BIOFIRE, SPOTFIRE, ARGENE, EMAG/NUCLISENS),Immunoassays & biomarkers (VIDAS, Hybiome CLIA), |
| QIAGEN | Netherlands | Public Company | Sample technology consumables and instruments,Molecular diagnostics assays (TB, immune response, oncology, sexual and reproductive health),Research PCR and enzymes (qPCR, digital PCR, RT-PCR, configured solutions), |
| SYSMEX CORPORATION | Japan | Public Company | Hematology analyzers & reagents,Coagulation diagnostics,Urinalysis, blood gas, electrolyte, |
| AGILENT TECHNOLOGIES, INC. | United States | Public Company | Life Sciences and Diagnostics Markets,Agilent CrossLab,Applied Markets, |
| SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | China | Public Company | Patient monitoring and life support (monitoring, ventilators, defibrillation, AED, anesthesia),Ultrasound and medical imaging (ultrasound, radiology, endoscope camera system),In-vitro diagnostics (CLIA, chemistry, hematology, laboratory diagnostics), |
PATHEON INC
Patheon Inc. is a Netherlands-based pharmaceutical manufacturing company with 9,100 employees. Operating as a private company, it provides contract development and manufacturing services to the pharmaceutical industry.
ALERE INC
Alere Inc. is a United States-based diagnostics company founded in 1981 with 9,700 employees. Operating as a private company, it specializes in rapid diagnostic testing solutions for healthcare markets.
FLUOR CORPORATION
Fluor Corporation is a United States-based engineering and construction company founded in 1912 with 22,995 employees. As a public company, it provides design, engineering, procurement, and construction services across multiple industries.
CEPHEID INC.
Cepheid Inc. is a United States-based molecular diagnostics company founded in 1996 with 1,700 employees. Operating as a private company, it develops and manufactures automated molecular testing systems.
IMMUCOR, INC.
Immucor, Inc. is a United States-based immunohematology company founded in 1982 with 1,125 employees. As a private company, it specializes in blood bank and transfusion medicine diagnostic solutions.
UNILABS
Unilabs is a Switzerland-based clinical laboratory services company founded in 1987 with 1,897 employees. As a private company, it operates diagnostic laboratories across multiple European countries.
EIKEN CHEMICAL CO., LTD.
Eiken Chemical Co., Ltd. is a Japan-based diagnostics and pharmaceutical company founded in 1939 with 696 employees. As a public company, it manufactures in vitro diagnostic reagents and pharmaceutical products.
ABBOTT
Abbott is a United States-based healthcare company founded in 1888 with 115,000 employees. As a public company, it develops and manufactures diagnostics, medical devices, pharmaceuticals, and nutritional products.
SIEMENS HEALTHINEERS AG
Siemens Healthineers AG is a Germany-based medical technology company founded in 1896 with 72,369 employees. As a public company, it manufactures and distributes diagnostic imaging, laboratory diagnostics, and point-of-care testing systems.
DANAHER
Danaher is a United States-based conglomerate founded in 1969 with 59,000 employees. As a public company, it operates across multiple sectors including life sciences, diagnostics, and environmental solutions.
THERMO FISHER SCIENTIFIC INC.
Thermo Fisher Scientific Inc. is a United States-based life sciences company founded in 1956 with 125,000 employees. As a public company, it provides laboratory equipment, reagents, and analytical instruments globally.
REVVITY
Revvity is a United States-based life sciences and diagnostics company founded in 1937 with 11,000 employees. As a public company, it manufactures and distributes analytical instruments and reagents for research and diagnostics.
DIASORIN S.P.A.
DiaSorin S.p.A. is an Italy-based diagnostics company founded in 1968 with 3,242 employees. As a public company, it develops and manufactures in vitro diagnostic products for clinical laboratories.
BIO-RAD LABORATORIES, INC.
Bio-Rad Laboratories, Inc. is a United States-based life sciences company founded in 1952 with 7,450 employees. As a public company, it manufactures and distributes reagents, instruments, and quality control products for clinical and research laboratories.
QUIDELORTHO CORPORATION
QuidelOrtho Corporation is a United States-based diagnostics company founded in 1979 with 6,500 employees. As a public company, it develops and manufactures rapid diagnostic tests and laboratory instruments.
BIOMÉRIEUX
bioMérieux is a France-based diagnostics company founded in 1963 with 14,894 employees. As a public company, it specializes in in vitro diagnostics for infectious diseases, industrial microbiology, and clinical diagnostics.
QIAGEN
QIAGEN is a Netherlands-based molecular diagnostics company founded in 1984 with 5,500 employees. As a public company, it develops and manufactures sample preparation and molecular testing solutions.
SYSMEX CORPORATION
Sysmex Corporation is a Japan-based diagnostics company founded in 1968 with 10,861 employees. As a public company, it manufactures and distributes hematology, hemostasis, and clinical chemistry analyzers.
AGILENT TECHNOLOGIES, INC.
Agilent Technologies, Inc. is a United States-based life sciences and diagnostics company founded in 1999 with 18,000 employees. As a public company, it provides analytical instruments, software, and services for research and diagnostics.
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is a China-based medical device company founded in 1991 with 21,288 employees. As a public company, it manufactures and distributes diagnostic imaging, patient monitoring, and laboratory instruments globally.
Reasons to Buy this Report
- Market Size & Growth Data : Access precise US market valuations ($8.76B in 2025) and 5-year forecasts with detailed CAGR analysis to support strategic planning and investment decisions.
- Competitive Landscape Intelligence : Understand market dynamics specific to the US healthcare system, including key players, market share distribution, and competitive positioning within clinical and point-of-care segments.
- Segment & Application Insights : Identify high-growth immunoassay applications across US clinical laboratories, hospitals, and diagnostic centers to prioritize product development and market entry strategies.
- Regulatory & Reimbursement Analysis : Gain insights into US FDA regulations, reimbursement policies, and healthcare spending patterns that directly impact immunoassay adoption and market profitability.
- Strategic Growth Opportunities : Discover emerging trends in automation, home-based testing, and personalized diagnostics within the US market to identify partnerships, acquisitions, and expansion opportunities.
Frequently asked questions
What is the current size of the US immunoassay market?
The US immunoassay market is valued at $8,757.09 million in 2025.
What is the projected size of the US immunoassay market by 2030?
The US immunoassay market is projected to reach $11,474.68 million by 2030.
What is the growth rate of the US immunoassay market?
The US immunoassay market is growing at a compound annual growth rate (CAGR) of 5.6% from 2025 to 2030.
What factors are driving growth in the US immunoassay market?
Key drivers in the US include increasing chronic disease prevalence, aging population demographics, technological advancements, laboratory automation, and rising demand for rapid diagnostic solutions.
Why is the US immunoassay market significant?
The US market is significant due to advanced healthcare infrastructure, high diagnostic spending, strong regulatory frameworks, and the presence of leading diagnostic manufacturers supporting innovation and market expansion.
RESEARCH METHODOLOGY
This research study extensively used secondary sources, directories, and databases to identify and collect valuable information to analyze the global immunoassay market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative & quantitative information and assess the market's growth prospects. The global market size estimated through secondary research was then triangulated with inputs from primary research to arrive at the final market size.
Secondary Research
Secondary research was used primarily to identify & collect information for the extensive, technical, market-oriented, and commercial study. The secondary sources used for this study include annual reports, SEC filings, investor presentations, World Health Organization (WHO), United States Food and Drug Administration (US FDA), National Center for Biotechnology Information (NCBI), Health Canada, European Medicines Agency (EMA), and Centers for Disease Control and Prevention (CDC). These sources also obtained key information about major players, market classification, and segmentation according to industry trends, regional/country-level markets, market developments, and technology perspectives.
Primary Research
In-depth interviews were conducted with various primary respondents, including key industry players, subject-matter experts (SMEs), C-level executives of major market companies, and industry consultants, to gather and verify critical qualitative and quantitative information and evaluate the market prospects. Several primary sources from both the supply and demand sides of the market were interviewed to collect qualitative and quantitative data. The following is a breakdown of the primary respondents:
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
Both top-down and bottom-up approaches were employed to estimate and verify the total size of the immunoassay market. These methods were also widely used to determine the sizes of various subsegments within the market. The research methodology used to estimate the market size includes the following:
Data Triangulation
The total market was divided into several segments and subsegments after determining the overall market size from the estimation process. Where applicable, data triangulation and market breakdown techniques were used to complete the overall market analysis and obtain precise statistics for all segments and subsegments. The data was triangulated by examining various factors and trends from both the demand and supply perspectives.
Market Definition
An immunoassay is a test that uses biochemistry to detect the presence or level of an analyte, which is a large protein or antibody produced in response to an infection. These assays are highly versatile and can be adapted to many formats based on user needs. Immunoassays have become popular and well-established procedures in laboratories. They rapidly and easily provide precise and accurate results. This technique is mainly used in clinical diagnostics, drug monitoring, drug discovery, and food testing.
Stakeholders
- Manufacturers and vendors of immunoassay instruments and consumables
- Immunoassay product manufacturers
- Diagnostic associations
- Research associations involved in infectious and chronic disease research
- Various research and consulting firms
- Distributors of immunoassay instruments and consumables
- Contract research manufacturers of immunoassays
- Healthcare institutions
- Clinical laboratories
Report Objectives
- To define, describe, and forecast the global immunoassay market by product, technology, specimen, application, end user, and region
- To provide detailed information regarding the major factors influencing the growth of the market (such as drivers, restraints, challenges, and opportunities)
- To strategically analyze micromarkets with respect to individual growth trends, prospects, and contributions to the overall immunoassay market
- To analyze opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
- To forecast the size of the market segments with respect to five regions: North America, Europe, the Asia Pacific, Latin America, the Middle East & Africa
- To strategically profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies
- Track and analyze competitive developments such as acquisitions, product launches, expansions, agreements, partnerships, and R&D activities in the immunoassay market.
- To analyze and provide funding & investment activities, brand/product comparative analysis, and vendor valuation & financial metrics of the immunoassay market.
Customization Options
With the given market data, MarketsandMarkets offers customizations per the company’s specific needs. The following customization options are available for this report:
Portfolio Assessment
- Product Matrix gives a detailed comparison of the product portfolios of the top five companies.
Company Information
- • Detailed analysis and profiling of additional market players (up to five).
Geographical Analysis
- A further breakdown of the Rest of European immunoassay market into countries
- A further breakdown of the Rest of Asia Pacific immunoassay market into countries
- A further breakdown of the Rest of Latin American immunoassay market into countries
Get the Full Immunoassay Market Report
Full forecast, segment splits, and company analysis for all Immunoassay Market.
- Canada Immunoassay Market
- Germany Immunoassay Market
- France Immunoassay Market
- UK Immunoassay Market
- Spain Immunoassay Market
- Italy Immunoassay Market
- Russia Immunoassay Market
- China Immunoassay Market
- Japan Immunoassay Market
- India Immunoassay Market
- South Korea Immunoassay Market
- Australia Immunoassay Market
- Indonesia Immunoassay Market
- Brazil Immunoassay Market
- Mexico Immunoassay Market
- Rest Of Europe Immunoassay Market
- Rest Of Asia Pacific Immunoassay Market
Need a Tailored Report?
Customize this report to your needs
Get 10% FREE Customization
Customize This Report