Global AI-Powered Diagnostic Radiogenomics Devices Market Size, Share and Trends Analysis Report – Industry Overview and Forecast to 2032

AI-Powered Diagnostic Radiogenomics Devices Market Size

• The global AI-powered diagnostic radiogenomics devices market size was valued at USD 990 million in 2024 and is expected to reach USD 4,089.49 million by 2032, at a CAGR of 19.40% during the forecast period
• The market growth is largely fueled by the integration of artificial intelligence with advanced medical imaging and genomic profiling, enabling more precise, non-invasive, and personalized diagnostic solutions in oncology and other disease areas
• Furthermore, rising demand for precision medicine, early disease detection, and AI-driven decision support in hospitals and research centers is positioning radiogenomics as a transformative diagnostic technology. These converging factors are accelerating adoption across healthcare systems, thereby significantly boosting the industry’s growth

AI-Powered Diagnostic Radiogenomics Devices Market Analysis

• AI-powered diagnostic radiogenomics devices which combine advanced medical imaging with genomic data and AI are becoming essential in precision medicine due to their non-invasive biomarker prediction, improved diagnostic accuracy, and targeted therapy guidance across oncology and other key disease areas
• The rising demand for these technologies is primarily driven by the increasing adoption of precision oncology, heightened focus on early detection, and the integration of AI-based imaging analytics with genomic profiling, enabling more efficient and individualized treatment pathways
• North America dominated the AI-powered diagnostic radiogenomics devices market with the largest revenue share of 39.7% in 2024, supported by its advanced healthcare infrastructure, early AI-imaging adoption, and strong presence of radiogenomics technology providers, with the U.S. driving significant uptake in oncology-focused deployments across hospitals and research centers
• Asia-Pacific is expected to be the fastest-growing region in the AI-powered diagnostic radiogenomics devices market during the forecast period, fueled by increasing investments in AI-health technologies, rising cancer prevalence, and supportive regional health digitization initiatives
• The MRI modality segment dominated the AI-powered diagnostic radiogenomics devices market with a share of 45.1% in 2024, driven by its superior imaging resolution and established role in neuro-oncology and breast cancer applications, making it the preferred platform for radiogenomic integration

Report Scope and AI-Powered Diagnostic Radiogenomics Devices Market Segmentation 

AI-Powered Diagnostic Radiogenomics Devices Market Trends

Integration of AI with Multi-Modal Imaging and Genomics

• A significant and accelerating trend in the global AI-powered diagnostic radiogenomics devices market is the deeper integration of artificial intelligence with multi-modal imaging platforms such as MRI, CT, and PET alongside genomic datasets, enabling more comprehensive precision diagnostics
• For instance, in oncology, advanced AI models are increasingly applied to predict key mutations such as IDH or EGFR status directly from MRI or CT scans, reducing the need for invasive biopsies and streamlining patient selection for targeted therapies
• AI integration in radiogenomics enables features such as automated biomarker detection, prediction of treatment response, and enhanced risk stratification, supporting physicians in clinical decision-making and reducing diagnostic variability across sites
• The seamless integration of radiogenomics platforms with hospital PACS, EHR, and research databases facilitates centralized management of imaging-genomic data, enabling cross-institutional collaborations and large-scale clinical trials for precision oncology
• This trend toward more intelligent, multimodal, and interconnected diagnostic systems is reshaping oncology diagnostics, and companies are developing AI-radiogenomics solutions that combine imaging analytics with molecular insights to transform personalized healthcare delivery
• The demand for AI-radiogenomics devices that provide seamless integration of imaging and molecular data is rapidly growing across hospitals, research centers, and biotech collaborations, as stakeholders increasingly prioritize precision, efficiency, and individualized treatment outcomes

AI-Powered Diagnostic Radiogenomics Devices Market Dynamics

Driver

Growing Demand for Precision Medicine and Early Detection

• The increasing global burden of cancer and chronic diseases, coupled with the need for earlier and more accurate diagnostics, is a major driver for the rising adoption of AI-powered radiogenomics devices in clinical and research settings
• For instance, in March 2024, research groups announced advancements in AI-based radiogenomics pipelines that could predict mutation subtypes in lung cancer using CT scans, enabling more targeted treatment strategies without invasive procedures
• As healthcare systems place greater emphasis on personalized medicine, radiogenomics devices provide advanced features such as non-invasive biomarker discovery, real-time imaging-genomic correlation, and improved diagnostic confidence for clinicians
• Furthermore, the growing investment in AI-driven healthcare and the rising number of collaborations between hospitals, research institutes, and technology companies are accelerating the integration of radiogenomics into precision oncology workflows
• The ability of these devices to support treatment planning, patient monitoring, and clinical trial enrollment through AI-enhanced analytics is a key factor propelling their adoption across hospitals, imaging centers, and academic research programs
• The trend toward digitization of healthcare and increasing accessibility of AI-based imaging solutions are making radiogenomics an integral part of the precision medicine landscape, fueling long-term market expansion

Restraint/Challenge

Data Privacy Concerns and Regulatory Compliance Hurdle

• Concerns surrounding patient data privacy, security of genomic information, and interoperability issues across different healthcare systems pose significant challenges to broader adoption of AI-powered radiogenomics devices
• For instance, high-profile debates over AI-driven healthcare data sharing and patient consent have created caution among providers and regulators, slowing down large-scale clinical deployment of radiogenomics platforms
• Addressing these concerns through strict compliance with data protection regulations, encryption standards, and robust anonymization protocols is crucial to building trust among patients, clinicians, and health authorities
• Companies emphasize their adherence to HIPAA, GDPR, and FDA guidelines, but navigating the complex regulatory landscape for AI-based diagnostic devices remains a resource-intensive challenge for both startups and established firms
• The relatively high initial cost of deploying advanced AI-radiogenomics platforms, along with infrastructure needs for data storage and cloud integration, can also be a barrier to adoption for smaller hospitals and emerging markets
• While collaborations and funding initiatives are helping overcome cost hurdles, achieving regulatory clarity and establishing standardized validation frameworks will be vital for ensuring sustainable and widespread market growth

AI-Powered Diagnostic Radiogenomics Devices Market Scope

The market is segmented on the basis of imaging modality, genomic input, clinical application, and end user.

• By Imaging Modality

On the basis of imaging modality, the AI-powered diagnostic radiogenomics devices market is segmented into MRI, CT, PET, Ultrasound, X-ray / Mammography, and Multi-modal fusion. MRI segment dominated the market with the largest revenue share of 45.1% in 2024, driven by its superior resolution, versatility, and established role in neuro-oncology and breast cancer applications. MRI enables the extraction of high-dimensional radiomic features that correlate strongly with tumor genotypes such as IDH mutation in gliomas or BRCA status in breast cancers. Its widespread availability in hospitals and research centers further reinforces MRI as the preferred imaging modality for radiogenomics research and clinical validation. In addition, the growing development of AI algorithms specifically optimized for MRI datasets has accelerated its dominance, making it the gold standard for linking imaging phenotypes with genomic alterations.

Multi-modal fusion is anticipated to witness the fastest growth from 2025 to 2032, fueled by the growing need to integrate complementary imaging data such as PET-MRI or PET-CT with genomic information for a more comprehensive disease assessment. Fusion modalities enhance diagnostic confidence by combining functional and anatomical insights, which are critical for identifying complex tumor heterogeneity. The emergence of advanced AI frameworks capable of handling multimodal inputs further drives adoption. Growing oncology trials, particularly in lung and brain cancers, are increasingly leveraging fusion imaging with genomic biomarkers to refine patient stratification, positioning this segment for the highest CAGR.

• By Genomic Input

On the basis of genomic input, the AI-powered diagnostic radiogenomics devices market is segmented into DNA variants, RNA expression / transcriptomics, Epigenetics, Proteomics, and Liquid biopsy signals. DNA variants dominated the market in 2024, as mutation detection remains the most clinically validated application in radiogenomics. Predicting DNA mutations such as EGFR in lung cancer, IDH in gliomas, or KRAS in colorectal cancer through AI-imaging tools is increasingly used in precision oncology. The ability to bypass invasive biopsies and deliver non-invasive genotyping supports strong clinical adoption. DNA-based prediction also benefits from well-established reference datasets and ongoing FDA and CE clearances around AI-enabled biomarker prediction, further strengthening its market leadership.

Liquid biopsy signals are projected to be the fastest-growing genomic input segment during forecast period, driven by the convergence of non-invasive molecular diagnostics with imaging analytics. Combining AI-extracted imaging features with circulating tumor DNA (ctDNA) or exosomal markers enables real-time disease monitoring and dynamic prediction of treatment response. This hybrid approach is especially promising in monitoring metastatic cancers, where repeated biopsies are impractical. The growing focus on liquid biopsy adoption in oncology, supported by significant research investments, is expected to accelerate its growth rate over the forecast horizon.

• By Clinical Application

On the basis of clinical application, the AI-powered diagnostic radiogenomics devices market is segmented into mutation/biomarker status prediction, tumor detection, prognosis & survival risk stratification, therapy response prediction & monitoring, recurrence vs. treatment effect discrimination, and patient selection for trials. Mutation/biomarker status prediction dominated the market in 2024, as it represents the most immediate and impactful use case of AI-powered radiogenomics. Hospitals and research centers rely on these solutions to non-invasively predict clinically actionable mutations, reducing dependence on tissue biopsies. Predictive imaging biomarkers are increasingly integrated into oncology workflows, enabling faster and more personalized treatment planning. This segment also benefits from strong academic validation and increasing regulatory interest in AI-enabled companion diagnostics, reinforcing its leadership.

Therapy response prediction & monitoring is anticipated to be the fastest-growing application segment during forecast period, reflecting the urgent need for tools that track how patients respond to targeted therapies and immunotherapies. AI-powered radiogenomics can differentiate responders from non-responders earlier than traditional imaging, reducing unnecessary treatment costs and side effects. The ability to integrate serial imaging with evolving genomic data creates powerful models for dynamic treatment optimization. Growing use in clinical trials to evaluate novel cancer therapies further supports the rapid expansion of this segment.

• By End User

On the basis of end user, the AI-powered diagnostic radiogenomics devices market is segmented into hospitals & clinics, diagnostic imaging centers, academic/research institutes & biobanks, pharma/biotech & CROs, and government/public health programs. Hospitals & clinics dominated the market in 2024, as they are the primary settings for integrating AI-powered radiogenomics devices into patient care. Large cancer centers in North America and Europe are adopting these platforms to improve diagnostic confidence, personalize treatment pathways, and reduce reliance on invasive procedures. Hospitals benefit from integrating radiogenomics with existing PACS/EHR systems, which supports seamless clinical workflows. Growing emphasis on precision oncology tumor boards has further accelerated hospital adoption, making this segment the largest revenue contributor.

Pharma/biotech & CROs are expected to be the fastest-growing end user segment during forecast period, as drug developers increasingly incorporate AI-powered radiogenomics into clinical trials for patient stratification and response monitoring. Radiogenomics enables efficient identification of trial candidates with specific genetic profiles, reducing recruitment timelines and improving success rates. The ability to use non-invasive imaging biomarkers as surrogate endpoints is highly valuable in accelerating regulatory approvals. With rising global oncology R&D spending, collaborations between radiogenomics vendors and pharmaceutical companies are expected to expand rapidly, fueling strong growth in this segment.

AI-Powered Diagnostic Radiogenomics Devices Market Regional Analysis

• North America dominated the market with the largest revenue share of 39.7% in 2024, supported by its advanced healthcare infrastructure, early AI-imaging adoption, and strong presence of radiogenomics technology providers
• Hospitals and research institutes in the region are actively integrating radiogenomics into oncology workflows, leveraging AI for mutation prediction, therapy response monitoring, and personalized treatment planning
• The dominance is further reinforced by significant funding in precision medicine, favorable FDA initiatives for AI-enabled imaging solutions, and close collaborations between universities, biotech firms, and imaging technology providers

U.S. AI-Powered Diagnostic Radiogenomics Devices Market Insight

The U.S. AI-powered diagnostic radiogenomics devices market captured the largest revenue share of 80.4% in 2024 within North America, fueled by strong adoption of AI in precision oncology and widespread use of advanced imaging modalities such as MRI and PET. Leading cancer centers and research institutions are integrating radiogenomic platforms to link imaging features with genomic profiles for therapy planning. The FDA’s supportive regulatory frameworks and investments from both public and private sectors accelerate innovation in AI-enabled diagnostics. Furthermore, collaborations between tech giants and healthcare providers, alongside the U.S.’s dominance in clinical trial activity, significantly drive market growth.

Europe AI-Powered Diagnostic Radiogenomics Devices Market Insight

The Europe AI-powered diagnostic radiogenomics devices market is projected to expand at a substantial CAGR throughout the forecast period, primarily driven by government-backed precision medicine initiatives and strict healthcare standards. Rising cancer incidence across the continent, combined with robust genomic research infrastructure, is fostering adoption of AI-powered radiogenomics solutions. European hospitals are increasingly adopting imaging-genomics platforms for biomarker discovery, tumor detection, and personalized therapy design. The integration of these technologies in both academic and clinical settings is also supported by EU-wide collaborations, making Europe a critical growth hub for radiogenomics.

U.K. AI-Powered Diagnostic Radiogenomics Devices Market Insight

The U.K. AI-powered diagnostic radiogenomics devices market is anticipated to grow at a noteworthy CAGR during the forecast period, fueled by the NHS’s strong commitment to precision medicine and integration of AI tools in oncology care. The country’s genomics expertise, highlighted by initiatives such as Genomics England, supports the rapid uptake of radiogenomics for early cancer detection and biomarker identification. Rising concerns around cancer survival rates are encouraging healthcare providers to adopt AI-driven diagnostic imaging, particularly in breast and lung cancers. The U.K.’s advanced digital health ecosystem and investments in AI research further strengthen market momentum.

Germany AI-Powered Diagnostic Radiogenomics Devices Market Insight

The Germany AI-powered diagnostic radiogenomics devices market is expected to expand at a considerable CAGR, driven by its emphasis on innovation in healthcare technologies and robust oncology infrastructure. Germany’s strong clinical trial ecosystem and research partnerships with academic institutes foster the development of radiogenomics models integrating imaging with genomic profiling. The adoption of AI-powered diagnostic platforms is further supported by the country’s structured reimbursement frameworks and focus on improving precision oncology outcomes. In addition, Germany’s preference for data security and privacy ensures the demand for compliant, high-quality AI solutions in clinical practice.

Asia-Pacific AI-Powered Diagnostic Radiogenomics Devices Market Insight

The Asia-Pacific AI-powered diagnostic radiogenomics devices market is poised to grow at the fastest CAGR of 23.7% during 2025 to 2032, driven by rapid urbanization, rising cancer prevalence, and expanding healthcare digitization in countries such as China, Japan, and India. Governments in the region are investing in AI and genomics research to enhance cancer detection and treatment personalization. Increasing availability of affordable imaging systems and genomic sequencing is fueling adoption of radiogenomics in both clinical and research environments. Moreover, APAC’s strong base of AI startups and emerging biotech players makes it a fast-growing innovation hub.

Japan AI-Powered Diagnostic Radiogenomics Devices Market Insight

The Japan AI-powered diagnostic radiogenomics devices market is gaining momentum due to its advanced healthcare infrastructure, aging population, and high cancer burden. The country’s hospitals are increasingly deploying AI-integrated imaging systems that combine radiology and genomics to refine treatment strategies. Japanese researchers are at the forefront of developing multi-modal fusion approaches, aligning with the nation’s culture of high-tech innovation. Moreover, the government’s promotion of AI-driven healthcare and strong investment in oncology research accelerates adoption, particularly for therapy response monitoring and biomarker-based patient stratification.

India AI-Powered Diagnostic Radiogenomics Devices Market Insight

The India AI-powered diagnostic radiogenomics devices market accounted for the largest market revenue share in Asia Pacific in 2024, driven by the country’s expanding cancer patient base, rising research collaborations, and government-backed digital health programs. Indian oncology centers are increasingly adopting AI for tumor detection, biomarker prediction, and clinical trial enrollment. With the push toward smart healthcare infrastructure and the availability of cost-effective genomic testing, radiogenomics adoption is accelerating. Strong domestic AI startups and growing partnerships with international healthcare providers position India as a strategic growth market within APAC.

AI-Powered Diagnostic Radiogenomics Devices Market Share

The AI-powered diagnostic radiogenomics devices industry is primarily led by well-established companies, including:

• Quibim (Spain)
• Owkin, Inc (France)
• Aidoc (Israel)
• Lunit Inc. (South Korea)
• Ibex (Israel)
• Aidence (Netherlands)
• VUNO Inc (South Korea)
• RadLogics Inc. (U.S.)
• QMENTA (Spain)
• Imbio (U.S.)
• Perspectum (U.K.)
• Median Technologies (France)
• Tempus (U.S.)
• Synaptive Medical (Canada)
• Mirada Medical Ltd (U.K.)
• Ultromics Limited (U.K.)
• Seno Medical (U.S.)

What are the Recent Developments in Global AI-Powered Diagnostic Radiogenomics Devices Market?

• In June 2025, Dxcover, a UK-based company specializing in AI-powered multi-omic cancer detection, launched its U.S. headquarters in Nashville, Tennessee. This expansion supports clinical collaborations and commercialization of its PANAROMIC cancer test, which uses a cost-effective, non-invasive, high-throughput platform for early cancer detection
• In June 2025, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) unveiled the Global Radiopharmaceutical Trial Finder, an AI-enabled platform developed with Ancora.ai. This tool helps clinicians, researchers, and patients quickly identify relevant radiopharmaceutical clinical trials based on real-time global data, greatly enhancing trial accessibility and precision medicine efforts
• In March 2025, Quibim announced that its flagship QP-Prostate CAD solution including lesion detection and diagnostic capabilities received 510(k) FDA clearance in the United States, enabling its deployment in clinical settings and reinforcing its role in AI-powered prostate cancer diagnostics
• In October 2024, researchers demonstrated a cloud-based, end-to-end reproducible AI pipeline designed specifically for oncology imaging and radiogenomics. This infrastructure—from data retrieval to inference and reporting improves transparency, validation, and clinical translation of AI tools in diagnostic radiology
• In October 2023, Philips entered a multi-year collaboration with Quibim to integrate Quibim’s AI-based QP-Prostate software with Philips MRI systems, aiming to automate real-time prostate gland segmentation, enhance reporting, and elevate diagnostic precision for prostate cancer care

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