Imaging Biomarkers Market, By Type, By Technology, By Application, By End User, By Country, and By Region – Global Industry Analysis, Market Size, Market Share & Forecast from 2025-2032

REPORT HIGHLIGHT

The Imaging Biomarkers Market size was valued at US$ 13,876.42 Million in 2024, expanding at a CAGR of 12.5% from 2025 to 2032.
The imaging biomarkers market is expanding rapidly, driven by advancements in quantitative imaging, AI-based analysis, and precision medicine. Imaging biomarkers enable the noninvasive assessment of physiological, molecular, and structural processes, improving disease diagnosis, prognosis, and therapy monitoring. Modalities such as MRI, CT, PET, and ultrasound are increasingly used to extract measurable imaging metrics that act as surrogate endpoints in clinical trials and personalised treatment plans. The rising demand for early disease detection, growth in clinical research, and the integration of radiomics and machine learning technologies further propel market growth. The market faces restraints such as high costs of imaging systems and biomarker validation, lack of standardised imaging protocols.

Imaging Biomarkers Market- Market Dynamics

Expansion of Clinical Research and Trials
Pharmaceutical and biotechnology companies increasingly rely on imaging biomarkers to accelerate patient recruitment, assess treatment safety, and evaluate drug efficacy in trials. Imaging biomarkers provide objective, quantitative measures of disease progression and therapeutic effects, which enhance the precision and reliability of trial outcomes compared to traditional endpoints. Additionally, imaging biomarkers provide non-invasive, reproducible measures of disease state or treatment effect (for example, tumour volume, metabolic uptake, tissue microstructure) and are rapidly being integrated into trial designs. For instance, the National Cancer Institute (NCI) notes that many trials now include imaging specifically to monitor response and progression, thereby accelerating decision-making. Moreover, broadening the scope and scale of clinical studies and trials drives demand for imaging biomarkers. According to the data published by the European Medicines Agency in September 2025, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission have set new goals for the next five years in the EU. They plan to approve about 500 more multinational clinical trials, which is roughly 100 extra trials each year.

Imaging Biomarkers Market- Segmentation Analysis:

The Global Imaging Biomarkers Market is segmented on the basis of Type, Technology, Application, End User, and Region.
The market is divided into five categories based on Type: Anatomical Biomarkers, Functional Biomarkers, Molecular/Nuclear Biomarkers, Quantitative Imaging Biomarkers, and Others. Anatomical biomarkers capture visible structural characteristics in medical images, such as organ dimensions, shape, tissue patterns, lesions, or other abnormalities. Functional imaging biomarkers, by contrast, assess dynamic physiological processes like blood flow, metabolic rates, neural connectivity, tissue perfusion, or overall organ performance beyond mere anatomy. Molecular/nuclear biomarkers involve molecular imaging techniques, especially nuclear medicine methods like PET and SPECT, which visualise processes at the molecular scale, such as protein expression, receptor interactions, and metabolic pathways. Recent ahead-of-print studies by the Bioengineer Organisation, highlighted in October 2025, innovative PET tracers like ¹⁸F-MeFAMP, which excels in distinguishing tumour responses to immune checkpoint inhibitor therapy from inflammation in preclinical models, outperform standard ¹⁸F-FDG scans due to low background uptake. Quantitative imaging biomarkers (QIBs) are objective, measurable features extracted from medical images that indicate normal biological processes, disease states, or responses to treatment.
The market is divided into six categories based on Technology: MRI, CT, PET, SPECT, Ultrasound, and Others. MRI offers high-resolution anatomical and functional biomarkers for soft tissues, brain connectivity, perfusion, and tumour microstructure. CT provides rapid, high-contrast anatomical biomarkers ideal for lung, bone, cardiovascular, and trauma imaging, often as an oncology baseline. PET visualises molecular biomarkers like metabolic activity, receptor expression, and therapy response via radiotracers, key in cancer, neurology, and cardiology. SPECT delivers cost-effective molecular biomarkers for cardiac perfusion, bone disorders, and neurodegeneration. Ultrasound yields real-time anatomical/functional biomarkers such as blood flow, elasticity, organ morphology, and fetal development, radiation-free. Other modalities like optical imaging, hybrid PET/MRI, and AI-enhanced radiomics integrate structural, functional, and molecular data for superior diagnosis and personalised treatment.

Imaging Biomarkers Market- Geographical Insights

The imaging biomarkers market exhibits significant geographical variation in growth and market share. Currently, North America holds the largest market share. This dominance is driven by well-established healthcare infrastructure, substantial investment in research and development, and early adoption of advanced imaging technologies. Europe also holds a substantial portion of the market, with countries like Germany, the United Kingdom, France, and Italy leading in adoption due to advanced healthcare systems and robust regulatory frameworks supporting imaging biomarker development. The Asia Pacific region is expected to witness the fastest growth during the forecast period. This rapid expansion is fueled by increasing healthcare access, rising disease burden, and growing investments in healthcare infrastructure and technology. Emerging markets in Latin America, the Middle East, and Africa are gradually gaining traction by improving healthcare infrastructure and increasing participation in clinical research.

Imaging Biomarkers Market- Country Insights

The U.S. holds a dominant position in the global Imaging Biomarkers market, driven by strong healthcare infrastructure, advanced imaging technology adoption, and extensive clinical research activity. The nation’s focus on precision medicine, especially in oncology and neurology, has accelerated the integration of imaging biomarkers into diagnosis and drug development. Supportive initiatives by agencies such as the National Institutes of Health (NIH) and the National Cancer Institute (NCI) fund biomarker discovery and validation programs. Additionally, collaborations between academic institutions, biotech firms, and imaging centres promote translational research. For instance, in November 2025, Washington University School of Medicine (WashU) launched the Centre for Computational and AI‑enabled Imaging Sciences, a new hub focused on creating AI-powered imaging tools. This centre unites experts from radiology, engineering, oncology, neurology, and other fields to fast-track innovations in diagnostics and precision treatment. Therefore, the growing demand for early disease detection, coupled with artificial intelligence integration in imaging analytics, further fuels U.S. market expansion.

Imaging Biomarkers Market- Competitive Landscape:

The competitive landscape of the imaging biomarkers market is marked by the presence of several established global companies and emerging innovators focusing on product innovation, strategic collaborations, and expanding geographical reach. Additionally, market players are leveraging comprehensive biomarker assay portfolios, advanced imaging platforms, and integration of artificial intelligence to enhance diagnostic accuracy and therapeutic monitoring. For instance, in June 2025, GE HealthCare renewed its long-standing research partnership with Stanford Medicine to advance the development of next-generation total body positron emission tomography/computed tomography (PET/CT) technology. This collaboration, which spans over three decades, focuses on leveraging ultra-high sensitivity total body PET/CT. Additionally, this competitive environment fosters continuous development in imaging biomarker technologies, improving precision medicine approaches and expanding applications in oncology, neurology, and other disease areas, ultimately fueling market growth and offering diversified solutions worldwide.

Recent Developments:

In April 2025, QIAGEN N.V. introduced new QIAseq panels designed for comprehensive genomic profiling (CGP), specifically targeting over 700 cancer-related genes to provide in-depth insights into cancer biology and biomarker identification.
In May 2025, Hologic, Inc. announced its Genius AI Detection PRO solution won the “Best New Imaging Technology Solution” award at the 2025 MedTech Breakthrough Awards.

SCOPE OF THE REPORT

The scope of this report covers the market by its major segments, which include as follows:

GLOBAL IMAGING BIOMARKERS MARKET KEY PLAYERS- DETAILED COMPETITIVE INSIGHTS

Siemens Healthineers
GE Healthcare
F. Hoffmann-La Roche AG
Hologic, Inc.
QIAGEN N.V.
Bio-Rad Laboratories, Inc.
BioClinica Inc.
IXICO plc
PerkinElmer Inc.
Bracco Imaging S.p.A.
Others

GLOBAL IMAGING BIOMARKERS MARKET, BY TYPE- MARKET ANALYSIS, 2019 - 2032

Anatomical Biomarkers
Functional Biomarkers
Molecular/Nuclear Biomarkers
Quantitative Imaging Biomarkers
Others

GLOBAL IMAGING BIOMARKERS MARKET, BY TECHNOLOGY- MARKET ANALYSIS, 2019 - 2032

MRI
CT
PET
SPECT
Ultrasound
Others

GLOBAL IMAGING BIOMARKERS MARKET, BY APPLICATION- MARKET ANALYSIS, 2019 - 2032

Diagnostics
Drug Discovery & Development
Personalized Medicine
Disease Risk Assessment
Others

GLOBAL IMAGING BIOMARKERS MARKET, BY END USER- MARKET ANALYSIS, 2019 - 2032

Hospitals
Pharmaceutical & Biotech Companies
Contract Research Organisations (CROs)
Research Institutes & Academic Centres
Others

GLOBAL IMAGING BIOMARKERS MARKET, BY REGION- MARKET ANALYSIS, 2019 - 2032

North America
U.S.
Canada
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Sweden
Russia
Poland
Rest of Europe
Asia Pacific
China
India
Japan
South Korea
Australia
Indonesia
Thailand
Philippines
Rest of APAC
Latin America
Brazil
Mexico
Argentina
Colombia
Rest of LATAM
The Middle East and Africa
Saudi Arabia
UAE
Israel
Turkey
Algeria
Egypt
Rest of MEA Show more