Breast Cancer Diagnostics Market By Diagnostic Type (Imaging {Mammography, Ultrasound, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), Others} Genetic Test, Blood Tests, Biopsy {Fine Needle Aspiration (FNA), Vacuum-Assisted Biopsy, Incisional Biopsy, Others} Others), By Cancer Type (Invasive Ductal Carcinoma (IDC), Invasive Lobular Carcinoma (ILC), Ductal Carcinoma In Situ (DCIS), Inflammatory Breast Cancer (IBC), Triple-Negative Breast Cancer (TNBC), Others), By End-User (Hospitals and Clinics, Cancer Diagnostic Centers, Cancer Research Institutes, Ambulatory Surgical Centers), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Breast Cancer Diagnostics market accounted for USD 4.92 Billion in 2024 and is expected to reach USD 10.9 Billion by 2035, growing at a CAGR of around 7.5% between 2025 and 2035.  The Breast Cancer Diagnostics Market refers to the industry involved in developing, manufacturing, and distributing diagnostic tools and technologies used to detect breast cancer in its early stages. Such diagnostics include imaging methods such as mammography, ultrasound, MRI, and advanced techniques like biopsy and genetic testing. It has been driven by increasing prevalence, more awareness about early detection, and advancement in medical technology.

Furthermore, it is influenced by the growing demand for non-invasive and more accurate diagnostic means. Due to innovations in artificial intelligence, personalized medicines, and the increase of home-based kits for screening purposes, innovations the growth of this market is notable. It comprises makers of diagnostic equipment, practitioners of healthcare, and research scientists. Precision medicine is being emphasized, and it will continue gaining significant growth around the world.

Report Scope:

Market Dynamics

Rising Incidences of Breast Cancer as a Key Driver of the Growing Diagnostics Market

The Rising incidences of breast cancer are one such major contributor to the expanding global market of breast cancer diagnostics. Breast cancer is noted to be the most diagnosed cancer across the globe as per WHO statistics, In 2020 over 2.3 million new diagnoses were registered during that time. Factors contributing to this increase are an aging population, in whom the risk of breast cancer increases with age, and lifestyle factors such as unhealthy diets, lack of physical activity, and alcoholism.

In addition, some women have inherited genetic changes that predispose them to breast cancer; notably women who carry mutations in BRCA1 and BRCA2 genes. Incidence is sure to escalate with the advancing population age, meaning more demand for early detection and diagnosing services. Therefore, governments and health departments implement initiatives to enhance screening programs and awareness campaigns to help contain the growing health problem.

Increasing Awareness and Screening Programs Driving Growth in Breast Cancer Diagnostics

Increasing awareness and implementing screening programs are significant factors in the growth of the breast cancer diagnostics market. Governments and health organizations across the globe have been investing in public awareness campaigns to enlighten people about early detection. For example, the U.S. CDC is actively promoting such activities as the National Breast and Cervical Cancer Early Detection Program for free or low-cost mammography to those women belonging to the vulnerable group.

The National Health Service in the UK delivers consistent breast cancer screening for the entire population in the age bracket 50-70 years. More adoption of diagnostic techniques helped in the earlier detection process as well as survival percentages so this is supporting and driving the market growth. With increased access to screening services, the number of breast cancer cases reported is likely to rise and force the demand for more sophisticated methods of diagnosis.

High Costs of Diagnostic Procedures Limiting Access to Breast Cancer Diagnostics

The high price of advanced diagnostic procedures puts a significant restraint on the implementation of breast cancer diagnostic devices worldwide, especially in lower-income regions. Technologies like MRI, PET scans, and genetic tests are highly effective but sometimes expensive. For example, an MRI costs a few hundred to thousands of dollars and genetic testing for BRCA1 and BRCA2 mutations is equally costly and hence out of reach for most, especially in the developing world.

This economic burden limits early detection and diagnosis, especially among populations from these regions, thereby usually giving diagnoses that have reached the late stages, which offer limited treatment options. High costs will also affect healthcare systems in low-resource settings, preventing the implementation of mass screening programs. In turn, there is an immense disparity in accessing breast cancer diagnostics, which may postpone market expansion and enhance the outcomes of these regions.

Opportunity in Biomarker Discovery for Improved Breast Cancer Detection

This is a very important finding that will lead to enhanced accuracy in the diagnosis of breast cancer and early detection. Research, which the government agency U.S. National Cancer Institute (NCI) funds, focuses on specific biomarkers that can make breast cancer tests more sensitive. It has invested heavily in projects such as the "Cancer Biomarkers Research Group," which researches new biomarkers capable of detecting breast cancer at the earliest stages when the chances for cure and treatment are still excellent.

As reported by the American Cancer Society, early detection with sensitive tests based on biomarkers increases the 5-year survival rate to nearly 99%. Advances in biomarker discovery may result in the development of less invasive, more cost-effective blood tests or liquid biopsy technologies capable of detecting cancer in its earliest, most treatable stages. This will be a great opportunity to improve diagnostic techniques and grow the breast cancer diagnostics market.

Personalized Screening Opportunity for Breast Cancer Based on Genetic Risk

The enhancing early detection of breast cancer with the optimized utility of diagnostic resources in developing and applying individualized screening strategies based on genetic risk. So, for BRCA1 and BRCA2 carrier families, with a given genetic mutation, there exists the possibility of developing relevant screening strategies, which further enables earlier and more often conducted screenings in those exposed to higher risks.

The U.S. Centers for Disease Control and Prevention (CDC) supports personalized approaches through initiatives like genetic counseling and testing, aiming to reduce cancer risk in high-risk populations. According to the U.S. National Cancer Institute (NCI), women with BRCA1 or BRCA2 mutations have up to an 85% lifetime risk of developing breast cancer, which emphasizes the importance of personalized screening.

Focus on high-risk individuals will improve the early detection rate, reduce healthcare costs, and ensure efficient utilization of diagnostic tools, both improving patient outcomes and driving market growth.

Industry Experts Opinion

"We are very encouraged by the predictive data presented at the Miami Breast Cancer Conference. We look forward to the launch of AidaBreast™ to initially assist with radiation treatment decisions, and soon after to help answer additional therapeutic questions, so that we can significantly increase our clinical impact in the broader breast cancer market,"

• Dan Forche, President and CEO of PreludeDx. 

Segment Analysis

Based on diagnostic type, the Breast Cancer Diagnostics market is classified into imaging, genetic tests, blood tests, and biopsy methods. The imaging segment is further segmented into mammography, ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and others. The genetic test segment includes various molecular diagnostics. The blood tests segment encompasses liquid biopsy and other blood-based tests. The biopsy segment is further divided into fine needle aspiration (FNA), vacuum-assisted biopsy, incisional biopsy, and other biopsy methods.

Based on cancer type, the Breast Cancer Diagnostics market includes invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), inflammatory breast cancer (IBC), triple-negative breast cancer (TNBC), and others. IDC is the leading cancer type, as it represents the majority of breast cancer cases, driving diagnostic and treatment advancements.

Regional Analysis

The largest market is for breast cancer diagnostics in North America, mainly driven by advanced healthcare infrastructure, high levels of awareness, and governmental support for screening programs against cancers. In the United States, for example, it has an established health system with a wide range of access to diagnostic tools including mammography, MRI, and genetic testing.

More programs including the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) have further boosted rates of early detection and driven market growth. Increased prevalence of breast cancer among more mature women and increased penetration of advanced diagnostic technologies will also strengthen the dominance in the region. Major healthcare companies and research institutions are also there, which promotes innovation and the introduction of new diagnostic solutions in the region.

The Asia-Pacific market is the fastest-growing location for breast cancer diagnostics on account of rapid urbanization, improving access to health care, and increasing awareness relating to breast cancer. Changing lifestyles and an aging population have fueled the growth of the region, particularly in the BRIC countries like China and India.

Governments are more significantly investing in healthcare infrastructure as well as screening programs while devising plans to spread general awareness about early detection and treatment. Other drivers of the market in the region include the growing demand for advanced diagnostic tools and rising disposable incomes in emerging economies. The large population base and rising healthcare investments in the region create significant opportunities for market expansion, especially in countries with a high burden of breast cancer.

Competitive Landscape

This highly dynamic competitive landscape is set for its market share as the leaders here continuously work on improving the technology to stay ahead. Major players include Roche Diagnostics, Siemens Healthineers, Hologic, GE Healthcare, and Philips Healthcare, which hold front-row seats in providing advanced imaging systems, genetic testing, and biopsy solutions. Recent advancements like Caris Life Sciences gaining approval of its MI Cancer Seek™ test in November 2024 as a companion diagnostic and Roche CE Mark approval for its HER2-low metastatic breast cancer diagnostic in April 2024, showing the personalized diagnostics trend.

Moreover, companies like Hologic and GE Healthcare are expanding their solutions for breast cancer imaging with more accurate and cost-effective technologies that will fuel growth in the market. The strategic acquisition Lunit did in acquiring Volpara Health Technologies shows ongoing effort toward the integration of AI and other software innovations into breast cancer diagnostics to improve early detection and treatment outcomes.

Breast Cancer Diagnostics Market, Company Shares Analysis, 2024

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Recent Developments:

• In November 2024, Caris Life Sciences received FDA approval for MI Cancer Seek™ as a companion diagnostic for targeted therapies. It is the first FDA-approved assay combining WES and WTS for solid tumor profiling.
• In May 2024, Lunit completed its acquisition of Volpara Health Technologies, a leader in breast cancer screening software. This move enhances Lunit's mission to advance cancer diagnostics through AI.
• In April 2024, Roche obtained the CE Mark for its companion diagnostic to identify HER2-low metastatic breast cancer patients eligible for ENHERTU.
• In March 2024, PreludeDx™ introduced a test to predict radiation therapy benefits and recurrence risk in early-stage invasive breast cancer patients.

Report Coverage:

By Diagnostic Type

• Imaging
  • Mammography
  • Ultrasound
  • Magnetic Resonance Imaging (MRI)
  • Positron Emission Tomography (PET)
  • Others
• Genetic Test
• Blood Tests
• Biopsy
  • Fine Needle Aspiration (FNA)
  • Vacuum-Assisted Biopsy
  • Incisional Biopsy
  • Others
• Others

By Cancer Type

• Invasive Ductal Carcinoma (IDC)
• Invasive Lobular Carcinoma (ILC)
• Ductal Carcinoma In Situ (DCIS)
• Inflammatory Breast Cancer (IBC)
• Triple-Negative Breast Cancer (TNBC)
• Others

By End-User

• Hospitals and Clinics
• Cancer Diagnostic Centers
• Cancer Research Institutes
• Ambulatory Surgical Centers

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Roche Diagnostics
• Siemens Healthineers
• GE Healthcare
• Philips Healthcare
• Hologic, Inc.
• Abbott Laboratories
• Agilent Technologies
• Bio-Rad Laboratories
• Thermo Fisher Scientific
• Caris Life Sciences
• Medtronic
• Illumina, Inc.
• F. Hoffmann-La Roche Ltd.
• Beckman Coulter
• Mammotome

Frequently Asked Questions (FAQs)