Molecular Breast Imaging Market Size to Reach US$ 1.15 Billion by 2035 as Dense-Breast Imaging Adoption Expands

According to DataM Intelligence, the global molecular breast imaging market size was valued at US$ 612 million in 2025 and is projected to reach US$ 1.15 billion by 2035, registering a CAGR of 6.5% during 2026-2035. Demand is supported by the need for supplementary breast imaging in women with dense breast tissue, growing use of functional imaging and advances in low-dose detector technologies.

Molecular breast imaging uses radiotracers such as technetium-99m sestamibi and dedicated gamma cameras to identify areas of increased tracer uptake. Its role remains primarily supplementary to mammography, with applications in diagnostic evaluation and selected dense-breast imaging pathways. Recent clinical research continues to examine its incremental cancer-detection value when combined with digital breast tomosynthesis.

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Recent Developments in the Molecular Breast Imaging Market

United States

✓ In March 2026, the FDA approved Perimeter Medical Imaging AI's Claire OCT System, an AI-enabled 3D breast-imaging technology for adjunctive detection of cancer during lumpectomy procedures.

✓ In September 2026, the FDA reported 9,128 certified mammography facilities and 13,575 accredited digital breast tomosynthesis units, reflecting continued investment in advanced breast-imaging infrastructure.

Japan

✓ In April 2026, the Japanese Society of Nuclear Medicine updated its PET imaging facility certification and standardized imaging protocols, supporting greater standardization of molecular imaging in Japan.

✓ In February 2026, the Japanese Society of Nuclear Medicine updated its GMP standards for in-house PET radiopharmaceutical production, supporting quality-controlled molecular imaging applications.

Mergers and Acquisitions

✓ GE HealthCare & DeepHealth - 2026: The companies expanded their collaboration around AI-powered breast-imaging solutions, supporting broader integration of intelligent tools into mammography and breast-care workflows.

✓ SmartBreast & FoxSemicon - Earlier strategic development: SmartBreast established a manufacturing partnership with FoxSemicon for MBI systems based on the GE HealthCare Discovery NM 750b and Dilon D6800 platforms, rebranded as the EVE Clear Scan e750 and e680.

Molecular Breast Imaging Market Trends

Growing Focus on Dense-Breast Imaging

Dense breast tissue can reduce mammographic sensitivity, supporting interest in supplementary imaging technologies. The Density MATTERS trial found that adding MBI to digital breast tomosynthesis increased cancer detection in women with dense breasts, although recall rates also increased.

Advances in Functional and AI-Assisted Imaging

The market is moving toward improved detector sensitivity, lower-dose protocols and software-assisted interpretation. AI-based risk assessment is also being evaluated alongside MBI, creating opportunities for more targeted patient selection.

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Market Segmentation

By Design Type

Radioactive tracer-based systems accounted for the largest share, reflecting the central role of radiotracer uptake in functional breast imaging. Special gamma cameras provide the dedicated hardware required to detect tracer distribution within breast tissue.

By Modality

Dual-head gamma cameras led with an estimated 61% share, supported by opposing detector geometry, improved count collection and close breast positioning. Single-head systems remain relevant where portability and lower capital requirements are priorities.

By Application

Breast diagnosis accounted for approximately 58% of the market, supported by use following abnormal mammography or palpable findings. Breast screening represented the remaining share, with adoption influenced by radiation exposure, clinical guidelines and reimbursement.

Regional Analysis

North America generated approximately 40.3% of global revenue, supported by established nuclear-medicine infrastructure, breast-imaging expertise and the presence of specialized imaging companies.

Asia Pacific accounted for approximately 24% of revenue and is expected to register the fastest regional growth through 2035, supported by expanding cancer-care infrastructure and increasing availability of advanced imaging technologies.

Key Players in the Molecular Breast Imaging Market

Major companies include SmartBreast Corporation, CMR Naviscan Corporation, Dilon Technologies, Inc., Curium Pharma, GE HealthCare Technologies Inc., and Digirad Corporation, among others.

Company Profiles

SmartBreast Corporation develops dedicated MBI systems, including the EVE Clear Scan e750 and e680, targeting functional breast imaging and improved access to dedicated gamma-camera technology.

Curium Pharma supplies radiopharmaceutical products including technetium-99m-based products used in nuclear medicine, supporting the tracer infrastructure required for MBI procedures.

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Conclusion

The molecular breast imaging market is developing around the need for supplementary functional imaging, particularly in dense-breast and diagnostically challenging cases. Dedicated gamma-camera technology, radiotracer availability, lower-dose approaches and improved clinical evidence remain central to adoption.

Continued research into MBI combined with tomosynthesis and AI-based patient-risk assessment could broaden its role in selected breast-imaging pathways. At the same time, competition from ultrasound, MRI and contrast-enhanced mammography will continue to influence clinical adoption and purchasing decisions.

FAQs

Q: What is the projected molecular breast imaging market size by 2035?

A: The market is projected to reach US$ 1.15 billion by 2035, expanding at a 6.5% CAGR from 2026 to 2035.

Q: What is molecular breast imaging used for?

A: MBI is primarily used as supplementary functional breast imaging for diagnostic evaluation and selected dense-breast imaging applications.

Q: Which region leads the molecular breast imaging market?

A: North America leads with approximately 40.3% of global revenue.

Q: Who are the key players in the market?

A: Major players include SmartBreast Corporation, CMR Naviscan Corporation, Dilon Technologies, Curium Pharma, GE HealthCare and Digirad Corporation.

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