United States Diagnostic Device Market Projected to Reach US$ 29.4 Billion by 2031, Driven by AI-Integrated Imaging, Chronic Disease Diagnostics, and Portable Device Innovations

Leander, Texas and TOKYO, Japan - Dec.12.2025 - "The Global Diagnostic Device Market reached US$ 47 billion in 2022 and is projected to grow to US$ 79.9 billion by 2030, exhibiting a CAGR of 6.9% during the forecast period 2024-2031."

The Diagnostic Device Market is driven by the escalating burden of chronic diseases such as cardiovascular conditions, cancer, and neurological disorders, alongside the proliferation of AI-integrated imaging technologies. Market growth is supported by an aging global population, increased healthcare expenditures, and expanding applications in oncology, cardiology, and neurology through innovations in portable ultrasound, CT scanners, and MRI systems.

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☛ Recent Industry Developments :
United States :
✅ December 2025:
GE Healthcare launched its AI-powered Revolution Apex CT scanner with enhanced dose reduction for cardiac imaging, targeting U.S. hospitals. The rollout includes a US$ 150 million investment in manufacturing expansions in Wisconsin, focusing on precision diagnostics for oncology and neurology.

✅ November 2025:
Siemens Healthineers expanded its Ultrasound portfolio with the Acuson Sequoia, featuring automated 3D/4D imaging for obstetrics. The company secured a US$ 120 million partnership with major U.S. diagnostic centers to integrate real-time AI analytics for faster workflows.

✅ October 2025:
Canon Medical Systems introduced the Vantage Galan 3T MRI with open-bore design for claustrophobic patients, following FDA clearance. This involves a US$ 90 million R&D commitment to enhance hybrid PET/MRI capabilities for cancer staging.

Global:
✅ December 2025:
Koninklijke Philips N.V. announced a supply agreement with a Chinese healthcare network for its EPIQ Elite ultrasound systems in cardiology applications. The joint venture commits US$ 110 million to localize production in Shanghai, addressing APAC's rising CVD diagnostics.

✅ November 2025:
Hologic, Inc. unveiled its global Genius AI Detection for mammography, improving breast cancer screening accuracy. The launch is backed by a US$ 85 million investment in European and Indian facilities for data processing centers.

✅ October 2025:
Medtronic Plc acquired a German startup specializing in portable X-ray devices for remote diagnostics, valued at US$ 70 million. This strengthens Medtronic's portfolio with AI-enabled planar scintigraphy for emergency and rural healthcare.

☛ Core Catalysts Behind Market Growth:
Surging incidence of chronic diseases and geriatric populations is intensifying demand for advanced diagnostic imaging to enable early detection and personalized treatment.

Integration of AI and machine learning in devices like CT and MRI is enhancing image interpretation accuracy, reducing diagnostic errors, and streamlining workflows in high-volume settings.

Technological advancements in portable and hybrid systems are improving accessibility, particularly in emerging markets with limited infrastructure.

Rising healthcare investments, supportive reimbursement policies, and global collaborations are propelling adoption across hospitals, imaging centers, and ambulatory facilities.

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☛ Market Segmentation :
By Product Type :
X-ray Imaging Systems lead the market with 32% share, driven by their widespread use in primary diagnostics, fracture assessment, dental imaging, and low cost deployment across hospitals and clinics. Computed Tomography (CT) Scanners hold 22% share, supported by rising demand for advanced cross sectional imaging in oncology, trauma care, and cardiovascular diagnostics. Ultrasound Systems account for 18% share, driven by increased usage in obstetrics, cardiology, and point of care diagnostics. MRI Systems hold 15% share, propelled by growing neurological, musculoskeletal, and spinal imaging requirements where high resolution soft tissue visualization is essential. Nuclear Imaging Systems contribute 9% share, used primarily for functional imaging in oncology and cardiology. Planar Scintigraphy Imaging Systems represent the remaining 4% share, with applications in organ specific imaging, bone scans, and metabolic disorder detection.

By Application :
Orthopedic applications lead with 24% share, fueled by rising bone disorders, sports injuries, and demand for accurate musculoskeletal imaging. Neurology holds 20% share, supported by increased detection of stroke, dementia, brain tumors, and neurological disorders requiring MRI and CT scans. Obstetrics/Gynecology accounts for 18% share, driven by the widespread use of ultrasound systems in pregnancy monitoring and reproductive health. Oncology applications capture 17% share, reflecting growing cancer incidence and adoption of CT, MRI, PET, and nuclear imaging for diagnosis and treatment planning. Cardiology represents 14% share, supported by increasing demand for CT angiography, echocardiography, and nuclear cardiology imaging. Dental imaging contributes 5% share, growing steadily with demand for digital X-rays and cone beam CT. Other applications hold 2% share, including urology, gastroenterology, and general preventive screening.

By End-User :
Hospitals dominate with 61% share, driven by high patient footfall, advanced imaging infrastructure, and large scale adoption of CT, MRI, X-ray, and nuclear imaging equipment. Diagnostic Imaging Centers account for 32% share, supported by the rise of independent imaging facilities offering specialized, cost effective scanning services with shorter wait times. Other end users contribute 7% share, including specialty clinics, ambulatory surgical centers, and mobile imaging units expanding access to diagnostic services across underserved regions.

☛ Competitive Landscape:
The global Diagnostic Device market is highly competitive, fueled by R&D in AI integration, strategic acquisitions, and regulatory approvals to address chronic disease diagnostics and efficiency gains.

GE Healthcare leads with an estimated 22% share, renowned for its broad imaging portfolio including Revolution CT and SIGNA MRI systems across global hospitals.

Siemens Healthineers holds approximately 20% market share, excelling in ultrasound and CT innovations like NAEOTOM Alpha for North America and Europe.

Koninklijke Philips N.V. captures around 18%, leveraging EPIQ ultrasound and Ingenia MRI for cardiology and oncology applications.

Canon Medical Systems commands nearly 15% share, dominating with Aquilion CT and Vantage MRI through advanced detector tech.

Hologic, Inc. maintains close to 12% market share, focusing on mammography and women's health imaging via Genius AI platforms.

Other Key Players:
Carestream Health, Inc., Allengers Medical Systems, SternMed, Neusoft Medical Systems, Medtronic Plc.

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☛ Regional Analysis :
North America :
North America accounts for 37%, driven by advanced infrastructure, high chronic disease rates, and leadership in mammography/CT adoption in the U.S. and Canada.

Europe :
Europe holds 25%, supported by EMA regulations, aging demographics, and strong MRI/ultrasound penetration in Germany, the UK, and France.

Asia-Pacific :
Asia-Pacific captures 22%, as the fastest growing region fueled by healthcare expansions, urbanization, and investments in China, India, and Japan.

Latin America :
Latin America represents 8%, with rising access to portable diagnostics in Brazil and Mexico amid public health initiatives.

Middle East & Africa :
Middle East & Africa account for 8%, propelled by infrastructure developments in GCC countries and South Africa for oncology imaging.

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