IMMUNOASSAY MARKETS. Strategies and Trends. Forecasts by Application, Technology, Product, User and by Country. With Executive and Consultant Guides. 2023 to 2027

The workhorse of the diagnostic industry is finding new legs. The pandemic has created a new demand for rapid easily available diagnostics. Immunoassay is stepping up. Advances in genetic knowledge are creating new markets for immunoassay. Multiplex is becoming table stakes. Rapid diagnostics, point of care, biomarkers and consumer markets are all areas of expansion while traditional immunoassay maintains a strong position in the growing market for clinical diagnostics. We profile over 60 companies, large and small, working in this area. Learn all about the pitfalls and opportunities in this extensive report.

All report data is available in Excel format on request.

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ABOUT THE LEAD AUTHOR:

Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years. Mr. Powell's education includes:

B.Sc. (Chemistry) University of BC
M.B.A. (Finance and Policy) University of BC
Market Research Seminar - Burke Institute
Finance for Senior Executives - Harvard Business School

1 Market Guides

1.1 Immunoassay Market - Strategic Situation Analysis
1.2 Guide for Executives, Marketing, Sales and Business Development Staff
1.3 Guide for Management Consultants and Investment Advisors

2 Introduction and Market Definition

2.1 Immunoassay Markets Definition In This Report
- 2.1.1 Enzyme Based
- 2.1.2 Immunofluorescence
- 2.1.3 Chemiluminescence
- 2.1.4 DNA/NAT
- 2.1.5 RIA & Other
- 2.1.6 Reagents/Kits, Analyzers, Software & Services
- 2.1.7 Infectious Disease
- 2.1.8 Auto Immune
- 2.1.9 Endocrinology
- 2.1.10 Oncology
- 2.1.11 Cardiology
- 2.1.12 Other Specialty
2.2 Market Definition
- 2.2.1 Market Sizes
- 2.2.2 Currency
- 2.2.3 Years
2.3 Methodology
- 2.3.1 Methodology
- 2.3.2 Sources
- 2.3.3 Authors
2.4 Perspective: Healthcare and the IVD Industry
- 2.4.1 Global Healthcare Spending
- 2.4.2 Spending on Diagnostics
- 2.4.3 Important Role of Insurance for Diagnostics

3 Industry Overview

3.1 Players in a Dynamic Market
- 3.1.1 Academic Research Lab
- 3.1.2 Diagnostic Test Developer
- 3.1.3 Instrumentation Supplier
- 3.1.4 Chemical/Reagent Supplier
- 3.1.5 Pathology Supplier
- 3.1.6 Independent Clinical Laboratory
- 3.1.7 Public National/regional Laboratory
- 3.1.8 Hospital Laboratory
- 3.1.9 Physicians Office Lab (POLS)
- 3.1.10 Audit Body
- 3.1.11 Certification Body
3.2 The Clinical Laboratory Market Segments
- 3.2.1 Traditional Market Segmentation
- 3.2.2 Laboratory Focus and Segmentation
- 3.2.3 Hospital Testing Share
- 3.2.4 Economies of Scale
- 3.2.5 Hospital vs. Central Lab
- 3.2.6 Physician Office Lab's
- 3.2.7 Physician's and POCT
3.3 Immunoassay -Markets and Discussion
- 3.3.1 Instruments - Genetics changes the picture
  - 3.3.1.1 RIA - A Technology Shows its Age
  - 3.3.1.2 Immunoassay vs. PCR vs. Sequencing - A See Saw Battle
  - 3.3.1.3 The Smart Shrinking Instrument - Serious Implications
  - 3.3.1.4 Research Funding and Capital Expense - Instrument Pooling
  - 3.3.1.5 Multiplex vs. POC - A Tradeoff Analysis
- 3.3.2 Reagents and Kits - Genetics changes the picture
  - 3.3.2.1 Bigger Test Menus a Boon for Kit Market
  - 3.3.2.2 Physician Office Labs - A New Frontier
- 3.3.3 Rapid and POCT to Threaten Instrument Markets
- 3.3.4 OTC and DTC - Huge Market Potential
- 3.3.5 Economies of Scale. Going Away?
- 3.3.6 Lower Barriers to Entry for Instruments/Analyzers
- 3.3.7 Miniturization and Technology Drive Acquisition

4 Market Trends

4.1 Factors Driving Growth
- 4.1.1 Diagnostic Factors
- 4.1.2 Changing Technologies Spur Early Instrument Retirement
- 4.1.3 Consumer Channels Open Wider
- 4.1.4 Immunity Technology Comes of Age
4.2 Factors Limiting Growth
- 4.2.1 Increased Competition Lowers Price
- 4.2.2 Threat from PCR Based Instruments
- 4.2.3 Lower Barriers to Entry
- 4.2.4 Wellness has a downside
4.3 Immunoassay Instrumentation
- 4.3.1 Instrumentation Tenacity
- 4.3.2 Declining Cost of Instruments Changes Industry Structure
- 4.3.3 LISTING of INSTRUMENT SPECIFICATIONS
- 4.3.4 Immunoassay - CRISPR Diagnostics

5 Immunoassay Recent Developments

5.1 Recent Developments - Importance and How to Use This Section
- 5.1.1 Importance of These Developments
- 5.1.2 How to Use This Section
5.2 EDP Biotech, New Day Diagnostics to Merge
5.3 Sorrento Therapeutics Nabs Contract for Dx Platform
5.4 Beckman Coulter Diagnostics DxI 9000 Access Immunoassay Analyzer
5.5 Qorvo Eyes Multiplex Immunoassay
5.6 BioMérieux Launches New Products
5.7 Senzo to Commercialize Infectious Disease Lateral Flow Tests
5.8 Nanomix Plans Instrument, Test Launches
5.9 Startup GLX Analytix Prepares for Commercialization
5.10 Nonagen Gets CE Mark for Bladder Cancer Immunoassay
5.11 Qualigen Acquires Majority Stake in NanoSynex
5.12 Saladax Biomedical Using Immunoassay Dx
5.13 Prolight Diagnostics to Acquire Psyros Diagnostics
5.14 Quidel to Acquire Ortho Clinical Diagnostics
5.15 FDA Grants EUA to Xtrava Health
5.16 Alamar Biosciences Develops Immuno-Sandwich Platform
5.17 FDA grants breakthrough device to multiplex immunoassay
5.18 Quidel, Beckman Settle Cardiac Immunoassay Dispute
5.19 BGI Americas, Advaite Form SARS-CoV-2 Testing Partnership
5.20 BioMérieux Gets CE Mark for Three Dengue Immunoassays
5.21 COVID-19 Portfolio to Accelerate At-Home Infectious Disease Testing
5.22 Roche Diagnostics Expanding Testing Portfolio in 2021
5.23 PerkinElmer Long-Term Outlook
5.24 Quidel Updates Outlook for C19 Testing
5.25 Dx Companies Look at Multiplex Tests for SARS-CoV-2, Influenza
5.26 Becton Dickinson and NAT Diagnostics Acquisition

6 Profiles of Key Companies

6.1 Abbott Laboratories
6.2 Abcam
6.3 Abionic
6.4 Accel Diagnostics
6.5 Applied BioCode
6.6 Arlington Scientific
6.7 Arrayit Corporation
6.8 Atomo Diagnostics
6.9 Aureum Diagnostics
6.10 Aurora Biomed
6.11 Autobio Diagnostics
6.12 AVIVA Systems Biology
6.13 Awareness Technology
6.14 Axis-Shield Diagnostics Ltd.
6.15 Beckman Coulter Diagnostics
6.16 Becton, Dickinson and Company
6.17 Biocartis
6.18 Biomatik
6.19 bioMérieux Diagnostics
6.20 Bioneer Corporation
6.21 Bio-Rad Laboratories, Inc.
6.22 BioTek Instruments
6.23 Boditech Med, Inc
6.24 Boster Biological Technology
6.25 Diamedix (Erba Diagnostics)
6.26 Diasorin S.p.A.
6.27 Dynex Technologies
6.28 Enzo Biochem
6.29 Eurofins Scientific
6.30 FUJIFILM Wako Diagnostics
6.31 Fujirebio
6.32 Gold Standard Diagnostics
6.33 Grifols
6.34 Hycor Biomedical
6.35 Immunodiagnostic Systems (IDS)
6.36 Immunodiagnostik AG
6.37 Inova Diagnostics
6.38 JR Biomedical
6.39 Luminex Corp
6.40 Maxim Biomedical
6.41 Mbio Diagnostics
6.42 Meso Scale Discovery
6.43 Millipore Sigma
6.44 Mindray
6.45 Molecular Devices
6.46 MP Biomedical
6.47 Operon
6.48 Ortho Clinical Diagnostics
6.49 Perkin Elmer
6.50 Qiagen
6.51 Quidel
6.52 R&D Systems
6.53 Randox Toxicology
6.54 Roche Molecular Diagnostics
6.55 SD Biosensor
6.56 Siemens Healthineers
6.57 Sysmex
6.58 Tecan
6.59 Thermo Fisher Scientific Inc.
6.60 TOSOH Bioscience
6.61 Veredus Laboratories
6.62 Vircell
6.63 YD Diagnostics
6.64 Zhejiang Orient Gene Biotech

7 The Global Market

7.1 Global Market by Country
- 7.1.1 Global Market by Country Table
- 7.1.2 Global Market by Country Chart
7.2 Global Market by Application
- 7.2.1 Global Market by Application Table
- 7.2.2 Global Market by Application Segment Growth Chart
- 7.2.3 Global Market by Application Segment Annual Chart
- 7.2.4 Global Market by Application Segment Base vs. Final
- 7.2.5 Global Market by Application Base Year
- 7.2.6 Global Market by Application Final Year
7.3 Global Market by Technology
- 7.3.1 Global Market by Technology Table
- 7.3.2 Global Market by Technology Segment Growth Chart
- 7.3.3 Global Market by Technology Segment Annual Chart
- 7.3.4 Global Market by Technology Segment Base vs. Final
- 7.3.5 Global Market by Technology Base Year
- 7.3.6 Global Market by Technology Final Year
7.4 Global Market by Product
- 7.4.1 Global Market by Product Table
- 7.4.2 Global Market by Product Segment Growth Chart
- 7.4.3 Global Market by Product Segment Annual Chart
- 7.4.4 Global Market by Product Segment Base vs. Final
- 7.4.5 Global Market by Product Base Year
- 7.4.6 Global Market by Product Final Year
7.5 Global Market by User
- 7.5.1 Global Market by User Table
- 7.5.2 Global Market by User Segment Growth Chart
- 7.5.3 Global Market by User Segment Annual Chart
- 7.5.4 Global Market by User Segment Base vs. Final
- 7.5.5 Global Market by User Base Year
- 7.5.6 Global Market by Application Final Year

8 Global Market by Application

8.1 Endocrinology Applications
- 8.1.1 Endocrinology Applications by Country Table
- 8.1.2 Endocrinology Applications Growth Chart
8.2 Immune Applications
- 8.2.1 Immune Applications by Country Table
- 8.2.2 Immune Applications Growth Chart
8.3 Oncology Applications
- 8.3.1 Oncology Applications by Country Table
- 8.3.2 Oncology Applications Growth Chart
8.4 Infectious Disease Applications
- 8.4.1 Infectious Disease Applications by Country Table
- 8.4.2 Infectious Disease Applications Growth Chart
8.5 Cardiology Applications
- 8.5.1 Cardiology Applications by Country Table
- 8.5.2 Cardiology Applications Growth Chart
8.6 Other Applications
- 8.6.1 Other Applications by Country Table
- 8.6.2 Other Applications Growth Chart

9 Immunoassay by Technology

9.1 Enzyme
- 9.1.1 Enzyme by Country Table
- 9.1.2 Enzyme Growth Chart
9.2 Flourescence
- 9.2.1 Flourescence by Country Table
- 9.2.2 Flourescence Growth Chart
9.3 Chemiluminescence
- 9.3.1 Chemiluminescence by Country Table
- 9.3.2 Chemiluminescence Growth Chart
9.4 Nucleic Acid
- 9.4.1 Nucleic Acid by Country Table
- 9.4.2 Nucleic Acid Growth Chart
9.5 Rapid/POC
- 9.5.1 Rapid/POC by Country Table
- 9.5.2 Rapid/POC Growth Chart
9.6 Other Technology
- 9.6.1 Other Technology by Country Table
- 9.6.2 Other Technology Growth Chart

10 Immunoassay by Product

10.1 Instrument
- 10.1.1 Instrument by Country Table
- 10.1.2 Instrument Growth Chart
10.2 Reagents
- 10.2.1 Reagents by Country Table
- 10.2.2 Reagents Growth Chart
10.3 Services
- 10.3.1 Services by Country Table
- 10.3.2 Services Growth Chart

11 Immunoassay by User

11.1 Hospital
- 11.1.1 Hospital by Country Table
- 11.1.2 Hospital Growth Chart
11.2 Outpatient Lab
- 11.2.1 Outpatient Lab by Country Table
- 11.2.2 Outpatient Lab Growth Chart
11.3 POC/Other
- 11.3.1 POC/Other by Country Table
- 11.3.2 POC/Other Growth Chart

12 Vision of the Future of Immunoassay

13 Appendices

13.1 United States Medicare System: Laboratory Fees Schedule
13.2 The Most Used IVD Assays
13.3 The Highest Grossing Assays

Table of Tables

Table 1 Market Players by Type
Table 2 Clinical Laboratory Departments and Segments
Table 3 Laboratory Management Focus - Different Approaches
Table 4 Key Segmentation Variables Going Forward
Table 5 The Different Markets for Immunoassay
Table 6 The Factors Driving Growth
Table 7 Factors Limiting Growth
Table 8 - Listing of Instrument Specifications
Table 9 The Global Immunoassay Market by Country
Table 10 Global Market by Application
Table 11 Global Market by Technology
Table 12 Global Market by Product
Table 13 Global Market by User
Table 14 Endocrinology Immunoassay by Country
Table 15 Immune Immunoassay by Country
Table 16 Oncology Immunoassay by Country
Table 17 Infectious Disease Immunoassay by Country
Table 18 Cardiology Immunoassay by Country
Table 19 Other Immunoassay by Country
Table 20 Enzyme Immunoassay by Country
Table 21 Flourescence Immunoassay by Country
Table 22 Chemiluminescence Immunoassay by Country
Table 23 Nucleic Acid Immunoassay by Country
Table 24 Rapid/POC Immunoassay by Country
Table 25 Other Technology Immunoassay by Country
Table 26 Instrument by Country
Table 27 Reagents by Country
Table 28 Services by Country
Table 29 Hospital Usrr by Country
Table 30 Outpatient Lab by Country
Table 31 POC/Other by Country
Table 32 Clinical Lab Fee Schedule
Table 33 The Most Common Assays
Table 34 Largest Revenue Assays

Table of Figures

Figure 1 Global Healthcare Spending
Figure 2 The Lab Test Pie
Figure 3 The Road to Diagnostics
Figure 4 Immunoassay - Country Sharea
Figure 5 Chart of Growth by Application
Figure 6 Chart of Segment by Year
Figure 7 Chart of Base vs. Final
Figure 8 Chart of Base Year by Application
Figure 9 Chart of Final Year by Application
Figure 10 Chart of Growth by Technology
Figure 11 Chart of Technology Segment by Year
Figure 12 Chart of Technology Base vs. Final
Figure 13 Chart of Base Year by Technology
Figure 14 Chart of Final Year by Technology
Figure 15 Chart of Growth by Product
Figure 16 Chart of Product Segment by Year
Figure 17 Chart of Product Base vs. Final
Figure 18 Chart of Base Year by Product
Figure 19 Chart of Final Year by Product
Figure 20 Chart of Growth by User
Figure 21 Chart of User Segment by Year
Figure 22 Chart of User Base vs. Final
Figure 23 Chart of Base Year by User
Figure 24 Chart of Final Year by User
Figure 25 Chart - Endocrine Segment vs Total Market Growth
Figure 26 Chart - Immune Growth vs. Total
Figure 27 Chart - Oncology vs Total
Figure 28 Chart - Infectious Disease Immunoassay vs Total
Figure 29 Chart - Cardiology Immunoassay vs total
Figure 30 Chart - Other Immunoassay vs Total
Figure 31 Chart - Enzyme Segment vs Total Market Growth
Figure 32 Chart - Flourescence Growth vs. Total
Figure 33 Chart - Chemiluminescence vs Total
Figure 34 Chart - Nucleic Acid Immunoassay vs Total
Figure 35 Chart - Rapid/POC Immunoassay vs total
Figure 36 Chart - Other Technology Immunoassay vs Total
Figure 37 Chart - Instrument Segment vs Total Market Growth
Figure 38 Chart - Reagents Growth vs. Total
Figure 39 Chart - Services vs Total
Figure 40 Chart - Hospital Segment vs Total Market Growth
Figure 41 Chart - Outpatient Lab Growth vs. Total
Figure 42 Chart - POC/Other vs Total