Mammography Machine Market to hit US$ 4.1 billion by 2033, North America led 35.48% of global market share| Key Players:- GE HealthCare, Siemens Healthineers AG, Hologic, Inc.

The Global Mammography Machine Market reached US$ 2.6 billion in 2024 and is expected to reach US$ 4.1 billion by 2033, growing at a CAGR of 5.1% during the forecast period 2025-2033.

The demand for mammography machines has been increasing due to several factors, including the rise in breast cancer cases, advancements in technology and government health initiatives. The rising adoption of mammography machines for breast cancer screening, diagnosis and follow-ups is also a significant factor driving the market demand. FUJIFIM India Healthcare in collaboration with NM Medical Mumbai, launched its first Fujifilm Skill Lab for providing advanced training in FFDM (full-field digital mammography) technologies for radiologists and radiographers.

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Key Industry Development-
✅ January 2025: Vieworks received FDA 510(k) clearance for its VIVIX-M 1824S and VIVIX-M 2430S X-ray detectors for mammography expanding its digital mammography detector line into the U.S. market.

✅ April 2025: GE HealthCare announced at the 2025 Society of Breast Imaging Symposium the distribution of its new Pristina Via mammography system, designed to improve patient comfort and workflow efficiency with DBT (digital breast tomosynthesis) and AI-enabled tools.

✅ January 22, 2025: Siemens Healthineers marked the first U.S. installation of its new Mammomat B.brilliant mammography system at a clinic in Iowa a major new 3D-capable platform offering wide-angle tomosynthesis, improved detector performance and enhanced image reconstruction.

✅ April 2025: Canon Medical Systems launched the MAMMOREX U mammography system a new generation mammography platform featuring advanced tomosynthesis and AI-driven image analysis, now being deployed across major Japanese hospitals.

✅ March 2025: Shimadzu Corporation reportedly released a mammography-capable imaging solution (referenced in some 2025 media coverage as "Sonialvision G4 mammography system") offering improved image clarity and faster scanning times aimed at enhancing diagnostic imaging access across regional centers in Japan.

Recent FDA Approvals :-
→ November 2025 (Nov 26): GE HealthCare's Pristina Recon DL - a deep-learning powered 3D mammography image reconstruction technology - received FDA Premarket Authorization (PMA). This tool is designed to enhance 3D digital breast tomosynthesis (DBT) image quality, improving clarity and diagnostic confidence without increasing radiation dose.

→ August 2025 (Aug 22): Therapixel's MammoScreen BD software - an AI-powered tool for automatic analysis of mammography images (assessing breast density and aiding radiologists) - was granted FDA 510(k) clearance.

→ April 2025 (Apr 15): CureMetrix announced that its AI-based mammography software cmAngio received expanded FDA 510(k) clearance to support use on mammography imaging platforms from GE HealthCare (in addition to prior clearance for other platforms). The software is used for breast arterial calcification (BAC) detection on full-field digital mammography (FFDM) and DBT.

→ March 2025 (Mar 17 / Nov 24 notice): Hologic, Inc.'s ENVISION Mammography Platform was formally approved for commercial marketing by FDA; a regulatory-review-period determination notice was published on November 24, 2025, confirming the first permitted commercial marketing/use.

Report Objectives?
→ Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
→ Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
→ Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
→ Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
→ Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
→ Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
→ Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
→ The global mammography machine market report delivers a detailed analysis with 78 key tables, more than 70 visually impactful figures, and 168 pages of expert insights, providing a complete view of the market landscape.

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Market Segmenatation-

By Product Type (Systems)

→ Digital Systems: Dominated the market with a revenue share of over 59.82% (approx. USD 1.5 billion) and are expected to be the highest revenue-generating segment.
→ 3D Systems (Breast Tomosynthesis): This is the fastest-growing segment, projected for significant growth due to advantages in detecting cancer in dense breast tissue and reducing false positives.
→ Analog Systems: Accounted for a smaller share, with a general shift away from these film-based systems to digital alternatives.

By Technology
→ Digital Mammography (2D FFDM): Held the largest revenue share of over 65.94%.
→ Breast Tomosynthesis (3D Mammography): The fastest-growing technology segment, projected to experience a high CAGR as adoption increases in hospitals and clinics.
→ CAD (Computer-Aided Detection) Mammography: Often used as an AI-powered aid for radiologists.

By End-User
→ Hospitals: Dominated the market in 2024 with a revenue share of around 58%.
→ Diagnostic Centers: The fastest-growing end-user segment due to increased awareness and the expansion of outpatient screening services.
→ Specialty Clinics/Breast Care Centers: Held a significant share and are expanding rapidly.

Regional insights:-

➠ North America - 35.48% (USD 914.75 million)
Strongest regional market led by the U.S.; growth is driven by organized screening programs, broad DBT (3-D mammography) adoption, frequent device upgrades, and high penetration of AI-enabled image software. Regulatory and reimbursement frameworks support replacement of older systems with digital/DBT platforms.

➠ Europe - 27.30% (USD 703.85 million)
Mature market with major uptake in Western Europe; growth shaped by public screening initiatives, emphasis on dose reduction and image quality, and increasing DBT rollouts. Health-technology assessment and country-level reimbursement policies strongly influence procurement timing.

➠ Asia-Pacific - 20.86% (USD 537.81 million)
Fastest-growing region (rapid DBT and digital conversions in China, Japan, South Korea, India, Australia). Expansion driven by rising breast-cancer awareness, growing screening programs, rising hospital investments and replacement of legacy analog systems. High CAGR potential despite lower current penetration versus NA/EU.

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Market Players:-
→ GE HealthCare,
→ Siemens Healthineers AG,
→ Hologic, Inc.,
→ FUJIFILM Holdings Corporation,
→ PLANMED OY,
→ Koninklijke Philips N.V.,
→ Metaltronica S.p.A.,
→ Konica Minolta Healthcare Americas, Inc.,
→ Carestream Health,
→ CANON MEDICAL SYSTEMS ARGENTINA S.A.

Key Points:-

Digital Systems Dominate: 65.2% market share driven by superior image resolution and PACS integration.​

Breast Tomosynthesis Leads: 54.6% share due to 3D imaging reducing false positives and improving early detection.​

AI Integration Surge: Fujifilm's Amulet Sophinity (Feb 2024 launch, 2025 adoption) features AI-guided positioning and low-dose tomosynthesis.​

Portable Units Growth: Mobile mammography expands access in rural areas, boosting screening volumes.

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About DataM Intelligence
DataM Intelligence is a renowned provider of market research, delivering deep insightsthrough pricing analysis, market share breakdowns, and competitive intelligence. Thecompany specializes in strategic reports that guide businesses in high-growth sectors suchas nutraceuticals and AI-driven health innovations.
To find out more, visit https://www.datamintelligence.com/ or follow us on Twitter,LinkedIn and Facebook.

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