Immunoassay Markets. Strategies and Trends. Forecasts by Application, Technology, Product, User and by Country. With Executive and Consultant Guides. 2025 to 2029. Includes Impact of Artificial Intelligence.

Description

Report Overview:

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. Threats and opportunities abound. 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 affecting traditional immunoassay. We profile over 80 companies, 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.

Make investment decisions and valuations with confidence using the latest data.

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
1.4. Impact of Artificial Intelligence

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. 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. Beckman Coulter Dx Analyzer Gets FDA Clearance
5.3. Cubit Diagnostics Gets NIH Funding for Test on Multimodal Platform
5.4. Medix Biochemica Acquires Candor Bioscience
5.5. Siemens Healthineers Dx Business Poised for Growth
5.6. QuidelOrtho Stock Upgraded
5.7. AliveDx Gets CE Mark for Allergy Immunoassay
5.8. FDA Grants EAU for At-Home COVID, Flu Assay
5.9. Single-Molecule Detection Tech Shows Promise
5.10. QuidelOrtho Vitros Fentanyl Test
5.11. Labcorp: Plasma Phosphorylated-Tau 217
5.12. Renalytix Gets Immunoassay Medicare Coverage
5.13. Roche to Acquire LumiraDx POC Tech
5.14. Fujirebio, Sysmex to Collaborate on Immunoassay Development
5.15. EDP Biotech, New Day Diagnostics to Merge
5.16. Sorrento Therapeutics Nabs Contract for Dx Platform
5.17. Beckman Coulter Diagnostics DxI 9000 Access Immunoassay Analyzer
5.18. Qorvo Eyes Multiplex Immunoassay
5.19. BioMerieux Launches New Products
5.20. Senzo to Commercialize Infectious Disease Lateral Flow Tests
5.21. Nanomix Plans Instrument, Test Launches
5.22. Startup GLX Analytix Prepares for Commercialization
5.23. Nonagen Gets CE Mark for Bladder Cancer Immunoassay
5.24. Qualigen Acquires Majority Stake in NanoSynex
5.25. Saladax Biomedical Using Immunoassay Dx
5.26. Prolight Diagnostics to Acquire Psyros Diagnostics
5.27. Quidel to Acquire Ortho Clinical Diagnostics

6. Profiles of Key Companies

6.1. Abbott Laboratories
6.2. Abcam
6.3. Abionic
6.4. Accel Diagnostics
6.5. Agilent
6.6. Akonni Biosystems
6.7. Applied BioCode
6.8. Arlington Scientific
6.9. Arrayit Corporation
6.10. Atomo Diagnostics
6.11. Aureum Diagnostics
6.12. Aurora Biomed
6.13. Autobio Diagnostics
6.14. AVIVA Systems Biology
6.15. Awareness Technology
6.16. Axis-Shield Diagnostics Ltd.
6.17. Beckman Coulter Diagnostics (Danaher)
6.18. Becton, Dickinson and Company
6.19. Biocartis
6.20. Biomatik
6.21. bioMerieux Diagnostics
6.22. Bioneer Corporation
6.23. Bio-Rad Laboratories, Inc.
6.24. Bio-Synthesis
6.25. Bio-Techne
6.26. Boditech Med, Inc
6.27. Boster Biological Technology
6.28. Bruker
6.29. Cerstest Biotec
6.30. Chembio
6.31. CTK Biotech
6.32. Cue Health
6.33. Cytena
6.34. Diasorin S.p.A.
6.35. Dynex Technologies
6.36. Eiken Chemical
6.37. Enzo Biochem
6.38. Eurofins Scientific
6.39. Fluxion Biosciences (Cell Microsystems)
6.40. FUJIFILM Wako Diagnostics
6.41. Fujirebio
6.42. Global Access Diagnostics
6.43. Gold Standard Diagnostics
6.44. Greiner Bio-One
6.45. Grifols
6.46. Hycor Biomedical
6.47. Immunodiagnostic Systems (IDS)
6.48. Iollo
6.49. JR Biomedical
6.50. LightDeck Diagnostics
6.51. LumiraDx
6.52. Maxim Biomedical
6.53. Meso Scale Discovery
6.54. Millipore Sigma
6.55. Mindray
6.56. Molecular Devices
6.57. MP Biomedical
6.58. Operon
6.59. OraSure Technologies
6.60. Qiagen
6.61. QuidelOrtho
6.62. R&D Systems
6.63. Randox Toxicology
6.64. R-Biopharm AG
6.65. Response Biomedical
6.66. Revvity
6.67. Roche Diagnostics
6.68. SD Biosensor
6.69. Siemens Healthineers
6.70. Standard BioTools
6.71. Sysmex
6.72. Tecan
6.73. Thermo Fisher Scientific
6.74. TOSOH Bioscience
6.75. Uniogen
6.76. Veramarx
6.77. Veredus Laboratories
6.78. Vircell
6.79. Wantai Biopharm
6.80. Werfen
6.81. YD Diagnostics
6.82. 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. Growth of Approved IVD Test Menu
13.2. Growth of Approved Average IVD Test Fee
13.3. The Most Used IVD Assays
13.4. The Highest Grossing Assays
13.5. Laboratory Fees Schedule

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: The Global Immunoassay Market by Country
Table 9: Global Market by Application
Table 10: Global Market by Technology
Table 11: Global Market by Product
Table 12: Global Market by User
Table 13: Endocrinology Immunoassay by Country
Table 14: Immune Immunoassay by Country
Table 15: Oncology Immunoassay by Country
Table 16: Infectious Disease Immunoassay by Country
Table 17: Cardiology Immunoassay by Country
Table 18: Other Immunoassay by Country
Table 19: Enzyme Immunoassay by Country
Table 20: Flourescence Immunoassay by Country
Table 21: Chemiluminescence Immunoassay by Country
Table 22: Nucleic Acid Immunoassay by Country
Table 23: Rapid/POC Immunoassay by Country
Table 24: Other Technology Immunoassay by Country
Table 25: Instrument by Country
Table 26: Reagents by Country
Table 27: Services by Country
Table 28: Hospital Usrr by Country
Table 29: Outpatient Lab by Country
Table 30: POC/Other by Country
Table 31: The Most Common Assays
Table 32: Largest Revenue Assays
Table 33: Clinical Lab Fee Schedule

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
Figure 43: IVD Test Menu Growth
Figure 44: IVD Test Average Fees - A Ten Year View