Smart In-Vitro Diagnostics Market 2025-2029 - Artificial Intelligence for IVD Markets by Application, Technology and User, with Executive and Consultant Guides

Artificial Intelligence is Bringing Diagnostics into a Mainstream Role in Healthcare - Will it Replace the Physician?

Will Smart Diagnostics replace the physician? Will the power of Artificial Intelligence provide better diagnostics? The market is moving out of a research mode into the clinic. The market is exploding as physicians use all the information they can get to battle disease. While Pharmaceutical Companies see the potential to make nearly any therapy viable. Find out how this new approach to diagnostics will change medical care forever.

Learn all about how players are jockeying for position in a market that is being created from scratch - and some players are pulling way out in front and expanding globally. It is a dynamic market situation with enormous opportunity where the right diagnostic with the right support can command premium pricing - and the science is developing at the same time creating new opportunities with regularity - and the cost of many diagnostics continues to fall.

This report provides data that analysts and planners can use. Hundreds of pages of information including a complete list of United States Medicare Fee Payment Schedules to help understand the new pricing for nucleic acid-based tests. Forecast demand for new testing regimes or technologies. Make research investment decisions. Assistance in providing specific growth and market size estimates for new technology tests is provided without additional charges. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities growth.

The report includes detailed breakouts for 18 countries and 4 regions. A detailed breakout for any country in the world is available to purchasers of the report.

1 Market Guides

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

2 Introduction and Market Definition

2.1 What are Smart Diagnostics?
2.2 Market Definition
2.2.1 Revenue Market Size
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 Market 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 Understanding Artificial Intelligence
3.2.1 Artificial intelligence
3.2.2 Machine learning
3.2.3 Deep learning
3.2.4 Convolutional neural networks
3.2.5 Generative adversarial networks
3.2.6 Limitations
3.3 AI Applications in IVD
3.3.1 Infectious Disease
3.3.1.1 Known vs. Unknown
3.3.1.2 TMI
3.3.1.3 Disease surveillance
3.3.1.4 Outbreak detection
3.3.1.5 Contact tracing
3.3.1.6 Forecasting
3.3.1.7 Drug discovery
3.3.1.8 Resource allocation
3.3.2 Oncology
3.3.2.1 Electronic health records
3.3.2.2 Genomic analysis
3.3.2.3 Treatment planning
3.3.2.4 Clinical trial matching
3.3.3 Anatomic Pathology
3.3.3.1 Image analysis
3.3.3.2 Tumor segmentation
3.3.3.3 Disease classification
3.3.3.4 Predictive modeling
3.3.3.5 Quality control
3.3.3.6 Digital pathology
3.3.4 Cardiology
3.3.4.1 Electrocardiogram analysis
3.3.4.2 Electronic health records
3.3.4.3 Genomic analysis
3.3.4.4 Treatment planning
3.3.4.5 Prediction of outcomes
3.3.5 Diabetes
3.3.5.1 Diagnosis
3.3.5.2 Blood glucose monitoring
3.3.5.3 Personalized treatment plans
3.3.5.4 Medication management
3.3.5.5 Diabetes education
3.3.5.6 Predictive analytics
3.3.6 General Medicine
3.3.6.1 Diagnosis
3.3.6.2 Predictive Analytics
3.3.6.3 Personalized Treatment Plans
3.3.6.4 Medication Management
3.3.6.5 Disease Monitoring
3.3.6.6 Telemedicine

4 Market Trends

4.1 Factors Driving Growth
4.1.1 Outcome Improvement
4.1.2 The Aging Effect
4.1.3 Cost Containment
4.1.4 Physician Impact
4.1.5 Cost of Intelligence
4.2 Factors Limiting Growth
4.2.1 State of knowledge
4.2.2 Genetic Blizzard
4.2.3 Protocol Resistance
4.2.4 Regulation and coverage
4.3 Instrumentation, Automation and Diagnostic Trends
4.3.1 Traditional Automation and Centralization
4.3.2 The New Automation, Decentralization and Point Of Care
4.3.3 Instruments Key to Market Share
4.3.4 Bioinformatics Plays a Role
4.3.5 PCR Takes Command
4.3.6 Next Generation Sequencing Fuels a Revolution
4.3.7 NGS Impact on Pricing
4.3.8 Whole Genome Sequencing, A Brave New World
4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment
4.3.10 Shifting Role of Diagnostics

5 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 Ataraxis AI Launches AI Cancer Dx
5.3 Tempus Immuno-Oncology Portfolio AI-enabled
5.4 AI enables precision diagnosis of cervical cancer
5.5 UK to Rollout Digital Pathology Across NHS
5.6 AI Based Next-Generation Colorectal Cancer Test
5.7 Evident, Corista, Sakura Finetek, Visiopharm Form Digital Pathology Alliance
5.8 Viome Life Sciences Raises $86.5M in Oversubscribed Series C Round
5.9 Becton Dickinson Gets Clearance for AI-Based Bacterial Imaging
5.10 Paige, Leica Biosystems Expand Digital Pathology Partnership
5.11 Clarapath Acquires Digital Pathology Company Crosscope
5.12 CanSense to Develop Colorectal Cancer Test
5.13 Owkin-led Machine Learning Study IDs Cancer Treatment Biomarkers
5.14 Guardant Health to Integrate Lunit's AI PD-L1 Algorithm
5.15 Vésale Bioscience to Develop AI Phage Therapy Diagnostic Platform
5.16 Caris Life Sciences To Use AI and Machine Learning
5.17 Numares Health To Develop AI for “Metabolite Constellations”
5.18 Sepsis Testing Startup DeepUll to Use AI for Medical Decisions
5.19 Viome Life Sciences Raises $67M in Series C Financing For AI Cancer Dx
5.20 ADM Diagnostics Wins Grant for Brain Injury Test Development
5.21 Paige to Develop New AI-based Pathology Test
5.22 Aiforia Gains CE-IVD Mark for AI-Powered Histopathology
5.23 Genetic Profiling May Identify Patients Who Do Not Need Radiation Therapy
5.24 Thermo Fisher Introduces Homologous Score for Cancer Profiling
5.25 Genomic Test IDs Cancer Cells Early

6 Profiles of Key Players

6.1 Adaptive Biotechnologies
6.2 Aidoc
6.3 Anumana
6.4 ARUP Laboratories
6.5 Atomwise
6.6 Bayesian Health
6.7 Behold.ai
6.8 BGI Genomics Co. Ltd
6.9 bioMérieux Diagnostics
6.10 Bio-Rad Laboratories, Inc
6.11 Cambridge Cognition
6.12 Cardiologs (Phillips)
6.13 CareDx
6.14 Caris Molecular Diagnostics
6.15 Cleerly
6.16 ClosedLoop AI
6.17 CloudMedX Health
6.18 Deepcell
6.19 Digital Diagnostics
6.20 EKF Diagnostics Holdings
6.21 Freenome
6.22 GE Healthcare
6.23 Glooko
6.24 Idoven
6.25 Illumina
6.26 Infohealth
6.27 Jade
6.28 K Health
6.29 Lunit
6.30 MaxCyte
6.31 Mayo Clinic Laboratories
6.32 Medtronic
6.33 Merative
6.34 Nanox
6.35 NIOX Group
6.36 Niramai Health Analytix
6.37 NVIDIA
6.38 Oncohost
6.39 OraLiva
6.40 Owkin
6.41 Oxford Nanopore Technologies
6.42 Pacific Biosciences
6.43 Paige.AI
6.44 PathAI
6.45 Perthera
6.46 Philips Healthcare
6.47 Prognos
6.48 Qiagen
6.49 Qure.ai
6.50 Renalytix
6.51 Seegene
6.52 Siemens Healthineers
6.53 Sophia Genetics
6.54 Sysmex
6.55 Viz.ai

7 The Global Market for Smart Diagnostics

7.1 Global Market Overview by Country
7.1.1 Table - Global Market by Country
7.1.2 Chart - Global Market by Country
7.2 Global Market by Application - Overview
7.2.1 Table - Global Market by Application
7.2.2 Chart - Global Market by Application - Base/Final Year Comparison
7.2.3 Chart - Global Market by Application - Base Year
7.2.4 Chart - Global Market by Application - Final Year
7.2.5 Chart - Global Market by Application - Share by Year
7.2.6 Chart - Global Market by Application - Segment Growth
7.3 Global Market by Technology - Overview
7.3.1 Table - Global Market by Technology
7.3.2 Chart - Global Market by Technology - Base/Final Year Comparison
7.3.3 Chart - Global Market by Technology - Base Year
7.3.4 Chart - Global Market by Technology - Final Year
7.3.5 Chart - Global Market by Technology - Share by Year
7.3.6 Chart - Global Market by Technology - Segment Growth
7.4 Global Market by Place - Overview
7.4.1 Table - Global Market by Place
7.4.2 Chart - Global Market by Place - Base/Final Year Comparison
7.4.3 Chart - Global Market by Place - Base Year
7.4.4 Chart - Global Market by Place - Final Year
7.4.5 Chart - Global Market by Place - Share by Year
7.4.6 Chart - Global Market by Place - Segment Growth

8 Global Markets - By Application

8.1 Cancer
8.1.1 Table Cancer Testing - by Country
8.1.2 Chart - Cancer Testing Growth
8.2 Infectious Disease Testing
8.2.1 Table Infectious Disease Testing - by Country
8.2.2 Chart - Infectious Disease Testing Growth
8.3 Metabolic Testing
8.3.1 Table Metabolic Testing - by Country
8.3.2 Chart - Metabolic Testing Growth
8.4 Cardiac Testing
8.4.1 Table Cardiac Testing - by Country
8.4.2 Chart - Cardiac Testing Growth
8.5 Diabetes Testing
8.5.1 Table Diabetes Testing - by Country
8.5.2 Chart - Diabetes Testing Growth
8.6 Other Disease Testing
8.6.1 Table Other Disease Testing - by Country
8.6.2 Chart - Other Disease Testing Growth

9 Global Markets - By Technology

9.1 NGS Technology
9.1.1 Table NGS Technology - by Country
9.1.2 Chart - NGS Technology Growth
9.2 PCR Technology
9.2.1 Table PCR Technology - by Country
9.2.2 Chart - PCR Technology Growth
9.3 Chemistry/IA Technology
9.3.1 Table Chemistry/IA Technology - by Country
9.3.2 Chart - Chemistry/IA Technology Growth
9.4 Pathology Technology
9.4.1 Table Pathology Technology - by Country
9.4.2 Chart - Pathology Technology Growth
9.5 Other Technology
9.5.1 Table Other Technology - by Country
9.5.2 Chart - Other Technology Growth

10 Global Markets - By Place

10.1 Research
10.1.1 Table Research - by Country
10.1.2 Chart - Research Growth
10.2 Pharmaceutical Research
10.2.1 Table Pharmaceutical Research - by Country
10.2.2 Chart - Pharmaceutical Research Growth
10.3 Clinical
10.3.1 Table Clinical - by Country
10.3.2 Chart - Clinical Growth
10.4 Other Place
10.4.1 Table Other Place - by Country
10.4.2 Chart - Other Place Growth

11 Appendices

11.1 United States Clinical Laboratory Fees Schedule
11.1.1 Laboratory Fees Schedule
11.1.2 The Most Used IVD Assays
11.1.3 The Highest Grossing Assays

List of Tables

Table 1 Market Players by Type
Table 2 Factors Driving Growth
Table 3 Four Factors Limiting Growth
Table 4 Seven Key Diagnostic Laboratory Technology Trends
Table 5 Global Market by Region
Table 6 Global Market by Application
Table 7 Global Market by Technology
Table 8 Global Market by Place
Table 9 Cancer Testing by Country
Table 10 Infectious Disease Testing by Country
Table 11 Metabolic Testing by Country
Table 12 Cardiac Testing by Country
Table 13 Diabetes Testing by Country
Table 14 Other Disease Testing by Country
Table 15 NGS Technology by Country
Table 16 PCR Technology by Country
Table 17 Chemistry/IA Technology by Country
Table 18 Pathology Technology by Country
Table 19 Other Technology by Country
Table 20 Research by Country
Table 21 Pharmaceutical Research by Country
Table 22 Clinical by Country
Table 23 Other Place by Country
Table 24 Laboratory Fee Schedule
Table 25 The Most Common Assays
Table 26 Largest Revenue Assays

List of Figures

Figure 1 Global Healthcare Spending
Figure 2 The Lab Test Pie
Figure 3 The Road to Diagnostics
Figure 4 AI and Learning Methods
Figure 5 The Changing Age of The World’s Population
Figure 6 Health Care Consumption by Age
Figure 7 Cancer Incidence - Age at Diagnosis
Figure 8 Centralized vs. Decentralized Laboratory Service
Figure 9 A Highly Multiplexed Syndromic Testing Unit
Figure 10 The Real Cost to Sequence the Human Genome
Figure 11 The Codevelopment Process
Figure 12 Comparing MDx Diagnostic and Traditional Testing
Figure 13 Base Year Country Global Share
Figure 14 Global Market by Application - Base vs. Final Year
Figure 15 Market by Application Base Year
Figure 16 Market by Application Final Year
Figure 17 Application Share by Year
Figure 18 Application Segment Growth
Figure 19 Global Market by Technology - Base vs. Final Year
Figure 20 Market by Technology Base Year
Figure 21 Market by Technology Final Year
Figure 22 Market by Technology Share by Year
Figure 23 Market by Technology Segment Growth
Figure 24 Market by Place - Base vs. Final Year
Figure 25 Market by Place Base Year
Figure 26 Market by Place Final Year
Figure 27 Market by Place Share by Year
Figure 28 Market by Place Segment Growth
Figure 29 Cancer Testing Growth
Figure 30 Infectious Disease Testing Growth
Figure 31 Metabolic Testing Growth
Figure 32 Cardiac Testing Growth
Figure 33 Diabetes Testing Growth
Figure 34 Other Disease Testing Growth
Figure 35 NGS Technology Growth
Figure 36 PCR Technology Growth
Figure 37 Chemistry/IA Technology Growth
Figure 38 Pathology Technology Growth
Figure 39 Other Technology Growth
Figure 40 Research Growth
Figure 41 Pharmaceutical Research Growth
Figure 42 Clinical Growth
Figure 43 Other Place Growth

Companies Mentioned

Ataraxis AI
Tempus
Evident
Corista
Sakura Finetek
Visiopharm
Viome Life Sciences
Becton Dickinson
Paige
Leica Biosystems
Clarapath
Crosscope
CanSense
Owkin
Guardant Health
Lunit
Vésale Bioscience
Caris Life Sciences
Numares Health
DeepUll
ADM Diagnostics
Aiforia
Thermo Fisher
Adaptive Biotechnologies
Aidoc
Anumana
ARUP Laboratories
Atomwise
Bayesian Health
Behold.ai
BGI Genomics Co. Ltd
bioMérieux Diagnostics
Bio-Rad Laboratories, Inc
Cambridge Cognition
Cardiologs (Phillips)
CareDx
Caris Molecular Diagnostics
Cleerly
ClosedLoop AI
CloudMedX Health
Deepcell
Digital Diagnostics
EKF Diagnostics Holdings
Freenome
GE Healthcare
Glooko
Idoven
Illumina
Infohealth
Jade
K Health
MaxCyte
Mayo Clinic Laboratories
Medtronic
Merative
Nanox
NIOX Group
Niramai Health Analytix
NVIDIA
Oncohost
OraLiva
Oxford Nanopore Technologies
Pacific Biosciences
PathAI
Perthera
Philips Healthcare
Prognos
Qiagen
Qure.ai
Renalytix
Seegene
Siemens Healthineers
Sophia Genetics
Sysmex
Viz.ai

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