Global Immunoassay Market Strategies & Trends Report 2023-2027: From Clinical to Consumer – Immunoassay’s Expanding Footprint in Diagnostics

The “Immunoassay Markets. Strategies and Trends. Forecasts by Application, Technology, Product, User and by Country. With Executive Guides, Customized Forecasting and Analysis. 2023 to 2027”report has been added to’s offering.


In the ever-evolving landscape of the diagnostic industry, immunoassay is emerging as a steadfast workhorse, finding new relevance driven by the demands of the ongoing pandemic. The need for rapid, easily accessible diagnostics has propelled immunoassay to the forefront, as it adapts and advances in response to shifting market dynamics.

Advancements in genetic knowledge are opening up new avenues for immunoassay technologies, with multiplex capabilities becoming the standard. This transformation extends to rapid diagnostics, point-of-care solutions, biomarker exploration, and the expanding consumer market, while traditional immunoassay methods continue to hold a strong position within the growing realm of clinical diagnostics.

Within the realm of immunoassay instrumentation, multiple factors are fueling growth, including ongoing diagnostic breakthroughs, the retirement of older instruments driven by evolving technologies, wider consumer adoption, and the maturation of immunity-related technology.

However, these opportunities are not without their challenges. Heightened competition is exerting downward pressure on prices, while the threat from PCR-based instruments looms. Lower barriers to entry and potential drawbacks associated with wellness trends also present limitations to growth.

This dynamic landscape is characterized by enduring instruments, industry structures in flux due to declining instrument costs, and meticulous instrument specifications, which play a pivotal role in shaping the field. Innovations like CRISPR diagnostics further contribute to the evolving immunoassay landscape.

With profiles of over 60 companies, spanning both large and small players in this field, this comprehensive report offers invaluable insights into the pitfalls and opportunities that define the immunoassay industry. It equips stakeholders to make informed investment decisions and valuations, providing the latest data to navigate this ever-changing landscape with confidence.

Key Topics Covered:

Industry Overview 

Players in a Dynamic Market

  • Academic Research Lab
  • Diagnostic Test Developer
  • Instrumentation Supplier
  • Chemical/Reagent Supplier
  • Pathology Supplier
  • Independent Clinical Laboratory
  • Public National/regional Laboratory
  • Hospital Laboratory
  • Physicians Office Lab (POLS)
  • Audit Body
  • Certification Body

The Clinical Laboratory Market Segments

  • Traditional Market Segmentation
  • Laboratory Focus and Segmentation
  • Hospital Testing Share
  • Economies of Scale
  • Hospital vs. Central Lab
  • Physician Office Lab’s
  • Physician’s and POCT

Immunoassay – Markets and Discussion

  • Instruments – Genetics changes the picture
  • RIA – A Technology Shows its Age
  • Immunoassay vs. PCR vs. Sequencing – A See Saw Battle
  • The Smart Shrinking Instrument – Serious Implications
  • Research Funding and Capital Expense – Instrument Pooling
  • Multiplex vs. POC – A Tradeoff Analysis
  • Reagents and Kits – Genetics changes the picture
  • Bigger Test Menus a Boon for Kit Market
  • Physician Office Labs – A New Frontier
  • Rapid and POCT to Threaten Instrument Markets
  • OTC and DTC – Huge Market Potential
  • Economies of Scale. Going Away?
  • Lower Barriers to Entry for Instruments/Analyzers
  • Miniturization and Technology Drive Acquisition

Immunoassay Recent Developments

  • Recent Developments – Importance and How to Use This Section
  • EDP Biotech, New Day Diagnostics to Merge
  • Sorrento Therapeutics Nabs Contract for Dx Platform
  • Beckman Coulter Diagnostics DxI 9000 Access Immunoassay Analyzer
  • Qorvo Eyes Multiplex Immunoassay
  • BioMerieux Launches New Products
  • Senzo to Commercialize Infectious Disease Lateral Flow Tests
  • Nanomix Plans Instrument, Test Launches
  • Startup GLX Analytix Prepares for Commercialization
  • Nonagen Gets CE Mark for Bladder Cancer Immunoassay
  • Qualigen Acquires Majority Stake in NanoSynex
  • Saladax Biomedical Using Immunoassay Dx
  • Prolight Diagnostics to Acquire Psyros Diagnostics
  • Quidel to Acquire Ortho Clinical Diagnostics
  • FDA Grants EUA to Xtrava Health
  • Alamar Biosciences Develops Immuno-Sandwich Platform
  • FDA grants breakthrough device to multiplex immunoassay
  • Quidel, Beckman Settle Cardiac Immunoassay Dispute
  • BGI Americas, Advaite Form SARS-CoV-2 Testing Partnership
  • BioMerieux Gets CE Mark for Three Dengue Immunoassays
  • COVID-19 Portfolio to Accelerate At-Home Infectious Disease Testing
  • Roche Diagnostics Expanding Testing Portfolio in 2021
  • PerkinElmer Long-Term Outlook
  • Quidel Updates Outlook for C19 Testing
  • Dx Companies Look at Multiplex Tests for SARS-CoV-2, Influenza
  • Becton Dickinson and NAT Diagnostics Acquisition

Market Trends

Factors Driving Growth

  • Diagnostic Factors
  • Changing Technologies Spur Early Instrument Retirement
  • Consumer Channels Open Wider
  • Immunity Technology Comes of Age

Factors Limiting Growth

  • Increased Competition Lowers Price
  • Threat from PCR Based Instruments
  • Lower Barriers to Entry
  • Wellness has a downside
  • Immunoassay Instrumentation
  • Instrumentation Tenacity
  • Declining Cost of Instruments Changes Industry Structure


  • Immunoassay – CRISPR Diagnostics

Market Guides

  • Immunoassay Market – Strategic Situation Analysis
  • Guide for Executives, Marketing, Sales and Business Development Staff
  • Guide for Management Consultants and Investment Advisors

Market Definition

Immunoassay Markets Definition In This Report

  • Enzyme Based
  • Immunofluorescence
  • Chemiluminescence
  • RIA & Other
  • Reagents/Kits, Analyzers, Software & Services
  • Infectious Disease
  • Auto Immune
  • Endocrinology
  • Oncology
  • Cardiology
  • Other Specialty

Market Definition

  • Methodology
  • Perspective: Healthcare and the IVD Industry
  • Global Healthcare Spending
  • Spending on Diagnostics
  • Important Role of Insurance for Diagnostics


  • United States Medicare System: Laboratory Fees Schedule
  • The Most Used IVD Assays
  • The Highest Grossing Assays

Profiles of Key Companies

  • Abbott Laboratories
  • Abcam
  • Abionic
  • Accel Diagnostics
  • Applied BioCode
  • Arlington Scientific
  • Arrayit Corporation
  • Atomo Diagnostics
  • Aureum Diagnostics
  • Aurora Biomed
  • Autobio Diagnostics
  • AVIVA Systems Biology
  • Awareness Technology
  • Axis-Shield Diagnostics Ltd.
  • Beckman Coulter Diagnostics
  • Becton, Dickinson and Company
  • Biocartis
  • Biomatik
  • bioMerieux Diagnostics
  • Bioneer Corporation
  • Bio-Rad Laboratories, Inc.
  • BioTek Instruments
  • Boditech Med, Inc
  • Boster Biological Technology
  • Diamedix (Erba Diagnostics)
  • Diasorin S.p.A.
  • Dynex Technologies
  • Enzo Biochem
  • Eurofins Scientific
  • FUJIFILM Wako Diagnostics
  • Fujirebio
  • Gold Standard Diagnostics
  • Grifols
  • Hycor Biomedical
  • Immunodiagnostic Systems (IDS)
  • Immunodiagnostik AG
  • Inova Diagnostics
  • JR Biomedical
  • Luminex Corp
  • Maxim Biomedical
  • Mbio Diagnostics
  • Meso Scale Discovery
  • Millipore Sigma
  • Mindray
  • Molecular Devices
  • MP Biomedical
  • Operon
  • Ortho Clinical Diagnostics
  • Perkin Elmer
  • Qiagen
  • Quidel
  • R&D Systems
  • Randox Toxicology
  • Roche Molecular Diagnostics
  • SD Biosensor
  • Siemens Healthineers
  • Sysmex
  • Tecan
  • Thermo Fisher Scientific Inc.
  • TOSOH Bioscience
  • Veredus Laboratories
  • Vircell
  • YD Diagnostics
  • Zhejiang Orient Gene Biotech

Scope of the Report

Global Market by Application

  • Endocrinology Applications
  • Immune Applications
  • Oncology Applications
  • Infectious Disease Applications
  • Cardiology Applications
  • Other Applications

Immunoassay by Technology

  • Enzyme
  • Flourescence
  • Chemiluminescence
  • Nucleic Acid
  • Rapid/POC
  • Other Technology

Immunoassay by Product

  • Instrument
  • Reagents
  • Services

Immunoassay by User

  • Hospital
  • Outpatient Lab
  • POC/Other

12 Vision of the Future of Immunoassay 

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