United States Diagnostic Device Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Global Diagnostic Device Market reached USD 47 billion in 2022 and is projected to witness lucrative growth by reaching up to USD 79.9 billion by 2030. The market is expected to exhibit a CAGR of 6.9% during the forecast period 2024-2031

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Key Development and Recent Mergers and Acquisitions:

United States: Recent Diagnostic Device Developments

✅ In December 2025, Femasys received U.S. FDA 510(k) clearance for its next‐generation FemVue Controlled diagnostic device designed for controlled contrast delivery during fallopian tube evaluation potentially improving fertility diagnostics.

✅ In December 2025, multiple AI/ML‐enabled diagnostic devices incorporating advanced software received FDA 510(k) clearances, marking continued momentum in AI integration for imaging and diagnostic workflows across specialties.

✅ In October 2025, the FDA's public record shows new biological device approvals including automated ORTHO VISION® Analyzer systems for immunohematology testing and other point‐of‐care diagnostic tools.

✅ In October 2025, GE HealthCare announced a $2.3 billion agreement to acquire Intelerad Medical Systems, strengthening its diagnostic imaging and workflow platform offerings in the U.S. market.

✅ In October 2025, private equity firms Blackstone and TPG agreed to acquire Hologic, Inc. a leading U.S. diagnostic device and women's health technology company in an $18.3 billion take‐private transaction, representing one of the largest medtech deals in decades and signaling strong investor interest in diagnostic platforms.

✅ In October 2025, Advanced Instruments announced its acquisition of Nova Biomedical, combining advanced analytical and clinical diagnostics technologies into a broader life‐science and patient testing solutions portfolio to expand its global diagnostics footprint.

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Japan: Recent Diagnostic Device Developments

✅ In December 2025, Japan's PMDA updated its list of approved companion diagnostics, reflecting ongoing evaluation and clearance activity for advanced in‐vitro tests.

✅ In October 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) approved Guardant360® CDx liquid biopsy as a companion diagnostic to detect ESR1 mutations in hormone receptor‐positive breast cancer patients, expanding precision cancer testing.

✅ In September 2025, Burning Rock's OncoGuideTM OncoScreenTM Plus CDx system was approved in Japan as a companion diagnostic for Capivasertib in breast cancer, advancing personalized oncology testing capabilities.

✅ In September 2025, Sysmex Corporation resolved to acquire the medical equipment business of JEOL Ltd, bringing the diagnostic device unit wholly under Sysmex's control in a strategic move to expand its diagnostic systems and integrated testing solutions globally.

✅ In the last 3 months, regulatory updates and reforms have continued to support AI/Software as a Medical Device (SaMD) diagnostic approvals and reviews, enabling broader market entry for digital diagnostic solutions in Japan.

Key Players:

=> GE Healthcare, Siemens Healthineers, Koninklijke Philips N.V, Canon Medical Systems Corporation, Carestream Health, Inc, Hologic, Inc, Allengers Medical Systems, SternMed, Neusoft Medical Systems, Medtronic Plc, among others.

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Key Segments:

By Product Type

X-ray Imaging Systems hold the largest share, estimated at 35%, driven by their affordability, accessibility, and wide use in general diagnostics and orthopedic assessments. Computed Tomography (CT) Scanners account for 25%, supported by high-resolution imaging, rapid scanning capabilities, and increasing adoption in emergency and oncology diagnostics. Ultrasound Systems represent 15%, fueled by portability, non-invasiveness, and applications across obstetrics, cardiology, and point-of-care settings. Magnetic Resonance Imaging (MRI) Systems hold 12%, benefiting from superior soft tissue contrast, expanding clinical applications, and technological advancements. Nuclear Imaging Systems account for 8%, primarily in cardiology and oncology diagnostics, while Planar Scintigraphy Imaging Systems represent 5%, used in targeted functional imaging and niche applications.

By Application

Orthopedic applications lead with 28% share, driven by rising musculoskeletal disorders and trauma cases. Neurology accounts for 20%, supported by increasing demand for neuroimaging in stroke, dementia, and brain injury diagnosis. Obstetrics/Gynecology represents 15%, fueled by rising prenatal care and maternal health programs. Oncology contributes 12%, driven by early cancer detection and treatment monitoring. Cardiology holds 10%, supported by non-invasive cardiac imaging adoption. Dental applications represent 8%, while Others account for 7%, including emergency care and research applications.

By End-User

Hospitals dominate the market with 55% share, due to high patient volume, advanced imaging infrastructure, and multi-specialty services. Diagnostic Imaging Centers account for 30%, driven by outpatient imaging demand, cost efficiency, and specialized imaging services. Others hold 15%, including academic institutions, research facilities, and mobile imaging units.

By Region

North America leads with 40% share, supported by high healthcare expenditure, advanced infrastructure, and rapid adoption of next-generation imaging technologies. Europe accounts for 25%, driven by established healthcare systems, government initiatives, and aging population. Asia Pacific represents 20%, fueled by rising healthcare access, increasing diagnostic facilities, and growing medical tourism. Latin America holds 10%, supported by healthcare modernization and private sector investment. Middle East & Africa contribute 5%, driven by rising awareness, infrastructure development, and increasing adoption of advanced imaging modalities.

Market Outlook (2024-2031)

The diagnostic imaging market is expected to witness robust growth through 2031, driven by rising prevalence of chronic diseases, technological advancements in imaging modalities, increasing healthcare investments, and growing demand for early and accurate diagnosis. Expansion of outpatient and specialty imaging centers, along with adoption of AI-assisted imaging solutions, presents significant growth opportunities across both developed and emerging markets.

FAQ

What is the current size of the Diagnostic Device Market?

A: In 2022, the Diagnostic Device Market was valued at USD 47 billion, reflecting its strong industry presence.

Q2: How large is the Diagnostic Device Market expected to be by 2030?

A: By 2030, industry forecasts suggest the Diagnostic Device Market will grow to around USD 79.9 billion , demonstrating significant expansion.

Q3: What is the growth rate of the Diagnostic Device Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 6.9% during the forecast period from 2024 to 2031.

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