The global imaging biomarkers market size was estimated at USD 13.95 billion in 2024 and is projected to reach USD 39.23 billion by 2033, growing at a CAGR of 12.62% from 2025 to 2033. The growth of the market can be attributed to the increasing burden of chronic diseases such as cancer, neurological disorders, and cardiovascular conditions.
The need for precise, non-invasive diagnostic methods and early disease detection has elevated the clinical relevance of imaging biomarkers. Furthermore, the growing emphasis on precision medicine and patient stratification has reinforced their role in therapeutic decision-making and clinical trial design. Supportive regulatory developments from agencies such as the U.S. FDA and EMA, which are advancing qualification pathways for imaging biomarkers, are enhancing industry confidence. Concurrently, public-private investments in translational imaging research are strengthening discovery, validation, and standardization initiatives across academic and industrial settings.
The current market dynamics emphasize upon an active period of innovation and consolidation. In 2025, Roche was granted FDA approval over its Elecsys PRO-C3 test to measure liver fibrosis and Thermo Fisher Scientific and Roche Diagnostics enlarged their biomarker cancer portfolios with companion diagnostic assays. Such strategic takeovers like the one of Eurofins Scientific to acquire the diagnostic activities of Synlab in Spain show a sense of move towards a networked biomarker services. Thermo Fisher has collaborated with UK Biobank in partnerships with technology developers to undertake massive validation and data integration of biomarkers and bioinformatics.
The market still continues to be redefined by technological advancement. Novel hybrid imaging systems (PET/CT, PET/MRI), novel high-specificity radiotracers, and artificial intelligence and radiomics are allowing quantitative imaging biomarkers (QIBs), which compose objective, reproducible measurements of disease states. Harmonized imaging protocols and cloud-based analytics platforms are enhancing cross-site reproducibility, which is a requirement to qualify regulation and multicenter trials.
The imaging biomarkers industry is growing in recent years due to the essential advances in molecular diagnostics. Cizzle Biotech introduced CIZ1B biomarker assay in March 2025, which is a non-invasive blood test to detect lung cancer at its early stage. This assay can be used to complement imaging-based diagnostic tests like CT and PET scans by identifying high-risk patients, allowing them to be intervened earlier and enhancing their diagnostic processes. The partnership with iGenomeDX will provide scalable accessibility in the U.S., improving its accessibility and supporting the combination of molecular and imaging biomarkers.
In August 2024, Hitachi High-Tech collaborated with Gencurix to create digital technology-based cancer molecular diagnostic tests with biomarker discovery. This project aids personalized medicine by connecting the molecular knowledge to the imaging data to allow the creation of a more specific diagnosis and treatment plan. These two developments point to the trend of combining molecular and imaging biomarkers which is fueling the growth of the market by enhancing diagnostic accuracy, speeding up the process of drug development and by facilitating earlier detection of the disease. All these developments lend strength to the trends toward the use of a more combined biomarker approach, a trend that ongoing future development has put the market squarely on the road to innovation, clinical integration, and a long-term growth trajectory.
As the issue of reimbursement and standardization continues, the integration of imaging with data science and molecular diagnostics is making imaging biomarkers a key component of the diagnostics, drug development, and personalized therapy. Further investment on AI-based quantification as well as approved imaging outcomes will support sustainable market expansion during the forecast period.
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The need for precise, non-invasive diagnostic methods and early disease detection has elevated the clinical relevance of imaging biomarkers. Furthermore, the growing emphasis on precision medicine and patient stratification has reinforced their role in therapeutic decision-making and clinical trial design. Supportive regulatory developments from agencies such as the U.S. FDA and EMA, which are advancing qualification pathways for imaging biomarkers, are enhancing industry confidence. Concurrently, public-private investments in translational imaging research are strengthening discovery, validation, and standardization initiatives across academic and industrial settings.
The current market dynamics emphasize upon an active period of innovation and consolidation. In 2025, Roche was granted FDA approval over its Elecsys PRO-C3 test to measure liver fibrosis and Thermo Fisher Scientific and Roche Diagnostics enlarged their biomarker cancer portfolios with companion diagnostic assays. Such strategic takeovers like the one of Eurofins Scientific to acquire the diagnostic activities of Synlab in Spain show a sense of move towards a networked biomarker services. Thermo Fisher has collaborated with UK Biobank in partnerships with technology developers to undertake massive validation and data integration of biomarkers and bioinformatics.
The market still continues to be redefined by technological advancement. Novel hybrid imaging systems (PET/CT, PET/MRI), novel high-specificity radiotracers, and artificial intelligence and radiomics are allowing quantitative imaging biomarkers (QIBs), which compose objective, reproducible measurements of disease states. Harmonized imaging protocols and cloud-based analytics platforms are enhancing cross-site reproducibility, which is a requirement to qualify regulation and multicenter trials.
The imaging biomarkers industry is growing in recent years due to the essential advances in molecular diagnostics. Cizzle Biotech introduced CIZ1B biomarker assay in March 2025, which is a non-invasive blood test to detect lung cancer at its early stage. This assay can be used to complement imaging-based diagnostic tests like CT and PET scans by identifying high-risk patients, allowing them to be intervened earlier and enhancing their diagnostic processes. The partnership with iGenomeDX will provide scalable accessibility in the U.S., improving its accessibility and supporting the combination of molecular and imaging biomarkers.
In August 2024, Hitachi High-Tech collaborated with Gencurix to create digital technology-based cancer molecular diagnostic tests with biomarker discovery. This project aids personalized medicine by connecting the molecular knowledge to the imaging data to allow the creation of a more specific diagnosis and treatment plan. These two developments point to the trend of combining molecular and imaging biomarkers which is fueling the growth of the market by enhancing diagnostic accuracy, speeding up the process of drug development and by facilitating earlier detection of the disease. All these developments lend strength to the trends toward the use of a more combined biomarker approach, a trend that ongoing future development has put the market squarely on the road to innovation, clinical integration, and a long-term growth trajectory.
As the issue of reimbursement and standardization continues, the integration of imaging with data science and molecular diagnostics is making imaging biomarkers a key component of the diagnostics, drug development, and personalized therapy. Further investment on AI-based quantification as well as approved imaging outcomes will support sustainable market expansion during the forecast period.
Global Imaging Biomarkers Market Report Segmentation
This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this report, the analyst has segmented the global imaging biomarkers market report based on biomarkers, imaging technology,application, end use, and region.Biomarkers Outlook (Revenue, USD Billion, 2021-2033)
- Anatomical biomarkers
- Functional biomarkers
- Molecular/Nuclear Biomarkers
- Quantitative Imaging Biomarkers
- Others
Imaging Technology Outlook (Revenue, USD Billion, 2021-2033)
- MRI
- CT
- PET
- SPECT
- Ultrasound
- Others
Application Outlook (Revenue, USD Billion, 2021-2033)
- Diagnostics
- Drug Discovery & Development
- Personalized Medicine
- Disease Risk Assessment
- Others
End Use Outlook (Revenue, USD Billion, 2021-2033)
- Hospitals
- Diagnostic/imaging centers
- Pharmaceutical and Biotech Companies
- Others
Regional Outlook (Revenue, USD Billion, 2021-2033)
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East and Africa (MEA)
Why You Should Buy This Report
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
Report Deliverables
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Market Variables, Trends, & Scope
Chapter 4. Imaging Biomarkers Market: Biomarkers Business Analysis
Chapter 5. Imaging Biomarkers Market: Imaging Technology Business Analysis
Chapter 6. Imaging Biomarkers Market: Application Business Analysis
Chapter 7. Imaging Biomarkers Market: End Use Business Analysis
Chapter 8. Imaging Biomarkers Market: Regional Estimates & Trend Analysis by Biomarkers, Imaging Technology, Application & End Use
Chapter 9. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The companies profiled in this Imaging Biomarkers market report include:- F. Hoffmann-La Roche AG
- Abbott Laboratories
- Thermo Fisher Scientific Inc.
- Siemens Healthineers AG
- Hologic
- QIAGEN
- Bio-Rad Laboratories, Inc.
- PerkinElmer Inc.
- Brainomix
- IXICO plc
- Median Technologies
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 120 |
| Published | October 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 13.95 Billion |
| Forecasted Market Value ( USD | $ 39.23 Billion |
| Compound Annual Growth Rate | 12.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 12 |
