Next-Generation Breast Cancer Diagnostic and Screening Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (Real-Time PCR, Immunohistochemistry (IHC), Next-Generation Sequencing (NGS), Fluorescence In-Situ Hybridization (FISH), Others), By Biomarker (BRCA1/2, ER/PR Receptors, HER-2, Others), By Cancer Sub-Type (Luminal A, Luminal B, Triple Negative/Basal Like, Human Epidermal Growth Factor Receptor 2 (HER-2) Enriched), By Offering (Products, Services), By End User (Hospitals and Clinics, Diagnostic Centers and Reference Labs, Academic and Research Institutes), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 4.81 Billion
CAGR (2026-2031)	10.68%
Fastest Growing Segment	Products
Largest Market	North America
Market Size (2031)	USD 8.84 Billion

Market Overview

The Global Next-Generation Breast Cancer Diagnostic and Screening Market will grow from USD 4.81 Billion in 2025 to USD 8.84 Billion by 2031 at a 10.68% CAGR. The Global Next-Generation Breast Cancer Diagnostic and Screening Market consists of genomic profiling assays, liquid biopsy platforms, and artificial intelligence-enhanced imaging systems designed to detect malignancies with superior precision compared to traditional methods. Market growth is primarily propelled by the rising global prevalence of the disease and a paradigm shift toward personalized medicine that necessitates molecular-level tumor analysis for effective treatment planning. According to the American Cancer Society, in 2025, approximately 316,950 women were projected to be diagnosed with invasive breast cancer in the United States, highlighting the critical demand for these accurate detection capabilities.

However, market expansion faces a significant challenge regarding the high implementation costs associated with these advanced technologies. Consequently, restrictive reimbursement frameworks and substantial capital requirements for installation often limit accessibility in price-sensitive regions and smaller healthcare facilities. This financial barrier effectively restricts the widespread adoption of innovative screening solutions and impedes faster growth in markets where healthcare budgets remain constrained.

Key Market Drivers

The integration of Artificial Intelligence (AI) in diagnostic imaging is fundamentally reshaping screening protocols by enhancing sensitivity and optimizing radiologist workflows. AI algorithms are increasingly capable of identifying subtle malignancies and addressing false negatives in dense breast tissue, which significantly improves diagnostic accuracy. According to CancerNetwork, January 2025, in the article 'AI-Supported Mammography Screening Leads to Increased Breast Cancer Detection Rate', a real-world study demonstrated that AI-supported screening achieved a detection rate of 6.7 per 1,000 women, marking a 17.6% increase over standard methods. This proven clinical performance is driving the rapid uptake of AI-enhanced systems across healthcare facilities seeking to elevate care standards while managing high patient volumes.

Simultaneously, the growing adoption of liquid biopsy and non-invasive diagnostics is transforming personalized medicine and treatment monitoring. These genomic tools enable the detection of circulating tumor DNA, allowing clinicians to tailor therapies dynamically and detect recurrence earlier than traditional imaging. According to BioPharma APAC, June 2025, in the 'ASCO 2025 Showcases New Oncology Paradigms' report, the Phase III SERENA-6 trial showed that switching treatment based on liquid biopsy findings reduced the risk of disease progression or death by 56% in patients with specific mutations. This utility is vital as the global cancer burden escalates. According to UN News, in 2025, the International Agency for Research on Cancer projected that annual new breast cancer cases globally will rise to 3.2 million by 2050, underscoring the urgent necessity for these precise diagnostic innovations.

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Key Market Challenges

High implementation costs associated with advanced technologies significantly impede the expansion of the Global Next-Generation Breast Cancer Diagnostic and Screening Market. The integration of genomic profiling assays and artificial intelligence-driven imaging systems necessitates substantial capital investment and specialized infrastructure, creating a financial barrier that many healthcare facilities cannot overcome. This challenge is particularly acute in price-sensitive regions where healthcare budgets are already stretched thin, as the operational expenses for these advanced tools often exceed available funding. Furthermore, restrictive reimbursement frameworks frequently fail to cover the premium pricing of these innovative solutions, forcing providers to rely on traditional, less expensive methods despite the potential for enhanced detection accuracy.

The economic strain extends beyond equipment acquisition to the broader financial burden of disease management on national health systems. According to 'Breast Cancer Now', in '2025', the annual cost of breast cancer to the UK economy was projected to reach between £3.2 billion and £3.5 billion. Such immense financial pressure compels healthcare administrators to prioritize strict cost-containment measures over the procurement of premium diagnostic technologies. Consequently, this budgetary toxicity directly restricts the market's ability to scale operations and impedes the widespread adoption of next-generation screening solutions in resource-constrained environments.

Key Market Trends

The Implementation of Automated Breast Ultrasound (ABUS) for Dense Breast Tissue Screening is becoming a pivotal standard in diagnostic workflows, addressing the limitations of conventional mammography where dense tissue can obscure malignancies. By utilizing volumetric 3D ultrasound technology, this modality decouples image acquisition from operator skill, ensuring consistent and reproducible screening for women with fibroglandular breast architecture. This shift is critical for reducing false negatives and detecting interval cancers that standard X-ray systems often miss. According to ITN Online, April 2025, in the 'GE HealthCare to Highlight Latest Advancements in Breast Imaging' report, the Invenia ABUS Premium system was shown to detect 35.7% more cancers when paired with mammography compared to mammography alone, driving its increased integration into comprehensive screening strategies.

Simultaneously, the Rising Utilization of Contrast-Enhanced Mammography (CEM) is offering a highly sensitive, cost-effective alternative to Magnetic Resonance Imaging (MRI) for high-risk assessment and inconclusive diagnoses. This functional imaging technique employs iodinated contrast agents to visualize tumor neovascularization, providing superior clarity for lesion detection without the substantial operational costs or accessibility constraints associated with MRI protocols. This approach is proving particularly valuable for preoperative staging and clarifying complex cases in resource-limited settings. According to AuntMinnie, March 2025, in the article 'CEM improves breast cancer detection rate over low-energy mammography', a clinical study indicated that Contrast-Enhanced Mammography successfully depicted 90% of breast cancers, presenting a substantial improvement over the 10% detection rate observed with low-energy mammograms alone.

Segmental Insights

The Products segment represents the fastest-growing category in the Global Next-Generation Breast Cancer Diagnostic and Screening Market, driven by the escalating demand for platform-based technologies. This expansion is primarily attributed to the widespread adoption of Next-Generation Sequencing (NGS) and liquid biopsy systems, which require specialized reagent kits and instruments for comprehensive genomic profiling. As healthcare providers prioritize personalized medicine, the consumption of these precise diagnostic tools has surged. Furthermore, consistent approvals by the U.S. Food and Drug Administration (FDA) for novel companion diagnostics have reinforced market confidence, accelerating the commercial distribution of these essential testing solutions.

Regional Insights

North America leads the Global Next-Generation Breast Cancer Diagnostic and Screening Market due to the widespread implementation of advanced genomic profiling and liquid biopsy technologies. This dominance is anchored by a highly developed healthcare infrastructure that supports the rapid clinical adoption of these innovations. Additionally, the U.S. Food and Drug Administration (FDA) plays a critical role in fostering market growth through streamlined regulatory pathways for breakthrough devices and AI-enabled screening tools. Comprehensive reimbursement frameworks and strong public health initiatives further sustain high screening rates, solidifying the region's status as the primary hub for diagnostic advancements.

Recent Developments

• In March 2025, GE HealthCare launched the Invenia Automated Breast Ultrasound (ABUS) Premium, a three-dimensional ultrasound system integrated with artificial intelligence features. The device was engineered to provide supplemental screening specifically for women with dense breast tissue, where traditional mammography may have reduced sensitivity. The system incorporated Verisound AI tools, which included a scan quality assessment function to assist technologists in maintaining optimal image consistency and breast coverage. This development focused on streamlining the screening workflow and increasing diagnostic confidence by enabling the detection of small, invasive cancers that might otherwise remain obscured within dense tissue structures.
• In December 2024, Hologic introduced its Genius AI Detection PRO solution in the United States, coinciding with a presentation of clinical data at the Radiological Society of North America annual meeting. The newly launched software featured a deep-learning algorithm capable of analyzing both two-dimensional and three-dimensional mammography images while incorporating data from a patient’s prior exams to refine analysis. This approach was intended to enhance specificity and reduce false-positive findings in breast cancer screening. Concurrently, the company highlighted research results indicating that the performance of its AI detection technology remained consistent across diverse racial and ethnic patient cohorts, supporting equitable diagnostic accuracy.
• In September 2024, Siemens Healthineers received premarket approval from the US Food and Drug Administration for the three-dimensional imaging component of its Mammomat B.brilliant mammography platform. This regulatory milestone applied to the system's wide-angle tomosynthesis technology, which was designed to improve the visualization of lesions by separating overlapping breast tissue layers. The approval complemented the platform's previous clearance for two-dimensional imaging and biopsy features, establishing a comprehensive diagnostic suite. The system utilized new image acquisition and reconstruction methods to significantly reduce scan times, thereby enhancing patient comfort and improving operational efficiency for healthcare providers conducting breast cancer screenings.
• In May 2024, Lunit completed the acquisition of Volpara Health Technologies, a global provider of breast screening software, in a transaction valued at approximately $193 million. This strategic consolidation was executed to combine Lunit’s artificial intelligence-based cancer detection capabilities with Volpara’s extensive breast density assessment and workflow automation tools. The integration aimed to establish a robust presence in the United States market by leveraging Volpara’s installed base at numerous medical sites. The company planned to utilize the combined repository of mammography data to further train its deep-learning algorithms, ultimately striving to improve the accuracy and consistency of early-stage breast cancer diagnostics.

Key Market Players

• Exact Sciences Corporation
• F. Hoffmann‑La Roche Ltd.
• Abbott Laboratories, Inc.
• Thermo Fisher Scientific Inc.
• Hologic, Inc.
• Siemens Healthineers AG
• Danaher Corporation
• Becton, Dickinson and Company
• Agilent Technologies, Inc.
• Sysmex Corporation

By Technology	By Biomarker	By Cancer Sub-Type	By Offering	By End User	By Region
Real-Time PCR Immunohistochemistry (IHC) Next-Generation Sequencing (NGS) Fluorescence In-Situ Hybridization (FISH) Others	BRCA1/2 ER/PR Receptors HER-2 Others	Luminal A Luminal B Triple Negative/Basal Like Human Epidermal Growth Factor Receptor 2 (HER-2) Enriched	Products Services	Hospitals and Clinics Diagnostic Centers and Reference Labs Academic Research Institutes	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Next-Generation Breast Cancer Diagnostic and Screening Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Next-Generation Breast Cancer Diagnostic and Screening Market, By Technology:

• Real-Time PCR
• Immunohistochemistry (IHC)
• Next-Generation Sequencing (NGS)
• Fluorescence In-Situ Hybridization (FISH)
• Others

• Next-Generation Breast Cancer Diagnostic and Screening Market, By Biomarker:

• BRCA1/2
• ER/PR Receptors
• HER-2
• Others

• Next-Generation Breast Cancer Diagnostic and Screening Market, By Cancer Sub-Type:

• Luminal A
• Luminal B
• Triple Negative/Basal Like
• Human Epidermal Growth Factor Receptor 2 (HER-2) Enriched

• Next-Generation Breast Cancer Diagnostic and Screening Market, By Offering:

• Products
• Services

• Next-Generation Breast Cancer Diagnostic and Screening Market, By End User:

• Hospitals and Clinics
• Diagnostic Centers and Reference Labs
• Academic
• Research Institutes

• Next-Generation Breast Cancer Diagnostic and Screening Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE