Breast Cancer Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Imaging, Biopsy, Genomic Tests, Blood Tests, Others), By Product (Platform-based Products (Next-generation Sequencing, Microarrays, PCR, Others), Instrument-based Products (Imaging, Biopsy)), By Application (Screening, Diagnostic and Predictive, Prognostic, Research, Others), By End-use (Hospitals & Clinics, Diagnostic Centers and Medical Laboratories, Others), By Region, and By Competition, 2020-2030F

Market Overview

The Global Breast Cancer Diagnostics Market, valued at USD 62.98 Billion in 2024, is projected to experience a CAGR of 11.21% to reach USD 119.14 Billion by 2030. The Global Breast Cancer Diagnostics Market encompasses an array of specialized tests, imaging modalities, and biopsy procedures engineered to detect, characterize, and monitor breast cancer. Market growth is primarily driven by the escalating global incidence of breast cancer, augmented public health awareness campaigns, and governmental initiatives promoting early detection and screening programs. Additionally, continuous technological advancements in imaging techniques, such as mammography and advanced molecular diagnostics, further stimulate market expansion. According to the World Health Organization, in 2022, an estimated 2.3 million new cases of breast cancer were diagnosed globally, underpinning the consistent demand for diagnostic solutions.

However, a significant challenge impeding market expansion remains the substantial cost associated with advanced diagnostic technologies. These high costs can limit accessibility, particularly in developing economies, and constrain healthcare budgets, thereby impacting the widespread adoption of comprehensive diagnostic screening protocols.

Key Market Drivers

The increasing global incidence of breast cancer serves as a fundamental driver for the breast cancer diagnostics market. A rising number of new cases necessitates expanded screening and diagnostic capabilities worldwide to facilitate early detection and improve patient outcomes. This persistent disease burden creates consistent demand for diverse diagnostic solutions, from initial screening to definitive diagnosis and staging. For example, according to the American Cancer Society's Breast Cancer Facts & Figures 2024, an estimated 310,720 new cases of invasive breast cancer were expected to be diagnosed in the United States in 2024, underpinning the critical need for effective diagnostic tools. This widespread health challenge reinforces the market’s expansion, with breast cancer being the most common cancer in women in 157 countries out of 185 in 2022, as reported by the World Health Organization in February 2024.

Technological advancements in diagnostic modalities are another significant factor, enhancing the accuracy, efficiency, and accessibility of breast cancer detection. Innovations encompass improved imaging techniques, including enhanced mammography systems and the integration of artificial intelligence, alongside sophisticated molecular diagnostics. These developments enable earlier, more precise identification of cancerous lesions and provide crucial information for personalized treatment strategies. A recent milestone occurred in June 2025, when Clairity, Inc. received U. S. Food and Drug Administration De Novo authorization for CLAIRITY BREAST, an AI-driven platform predicting five-year breast cancer risk from routine screening mammograms, demonstrating the integration of advanced analytics into diagnostic pathways. This continuous progress not only refines diagnostic capabilities but also drives further innovation across the entire diagnostic spectrum.

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Key Market Challenges

The substantial cost associated with advanced diagnostic technologies represents a significant challenging factor impeding the growth of the Global Breast Cancer Diagnostics Market. These high expenses restrict accessibility to crucial screening and diagnostic procedures, particularly within developing economies where healthcare budgets are often constrained. This financial barrier limits the widespread adoption of comprehensive diagnostic screening protocols across various regions.

The direct financial burden on patients frequently results in delayed or foregone necessary medical examinations. According to the American Cancer Society Cancer Action Network (ACS CAN), over 70% of commercially-insured patients encountered out-of-pocket expenses for follow-up breast cancer diagnostic tests in 2023. Furthermore, the ACS CAN estimated that in 2024, more than 1 million women aged 40 to 75 were likely to experience a delay in follow-up testing and imaging due to associated costs. Such delays and reduced uptake of diagnostic services directly decrease the volume of procedures performed, consequently hampering overall market expansion for these essential solutions.

Key Market Trends

The growing adoption of liquid biopsy for early detection and monitoring represents a pivotal shift in breast cancer diagnostics. This non-invasive technique, which analyzes circulating tumor DNA or cells from a blood sample, offers a less burdensome alternative to traditional tissue biopsies, facilitating earlier detection and ongoing disease surveillance. Its utility is becoming increasingly recognized as research progresses, with clinical applications expanding beyond advanced disease. According to the American Society of Clinical Oncology, in January 2024, five liquid biopsy companion diagnostic assays were approved by the U. S. Food and Drug Administration for their clinical application in the diagnosis of cancer. The ease of repeat testing also enables more dynamic monitoring of treatment response and detection of minimal residual disease. Guardant Health, Inc. received U. S. Food and Drug Administration approval in January 2023 for its Guardant360 CDx liquid biopsy test, serving as a companion diagnostic for patients with ER-positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations. This advancement underscores the increasing clinical validation and commercialization of liquid biopsy solutions, driving market expansion.

The expansion of genomic and molecular profiling for personalized treatment is another significant trend transforming the breast cancer diagnostics market. These advanced tests delve into the specific genetic and molecular characteristics of a tumor, enabling oncologists to tailor treatment strategies to an individual patient's unique disease profile. This approach moves beyond broad treatment regimens, aiming for more effective therapies and reduced adverse effects. According to the American Society of Clinical Oncology, in its 2024 guidelines, it was recommended that BRCA1/2 testing be offered to all patients newly diagnosed with breast cancer under 65 years of age, with consideration for selected patients over 65, indicating a movement towards broader genetic screening. The increasing complexity of targeted therapies necessitates comprehensive genomic insights for optimal patient stratification. Thermo Fisher Scientific announced agreements with Takeda Pharmaceuticals and Daiichi Sankyo to expand the clinical utility of its FDA-approved Oncomine Dx Target Test for their clinical trials and drug development programs, reflecting ongoing efforts to integrate comprehensive genomic insights into therapeutic strategies. Such collaborations are vital for developing and validating companion diagnostics that link specific genetic alterations to responsive treatments, thereby enhancing the market for specialized molecular profiling services.

Segmental Insights

In the Global Breast Cancer Diagnostics Market, the Imaging segment is experiencing rapid growth due to continuous technological advancements and increasing emphasis on early detection. Modern modalities such as digital breast tomosynthesis and artificial intelligence (AI)-powered analysis significantly enhance diagnostic accuracy and efficiency, improving the ability to detect breast cancer at earlier stages. Furthermore, the rising global incidence of breast cancer, coupled with a growing awareness of the benefits of timely screening and proactive government initiatives supporting widespread screening programs, further fuels the demand for advanced imaging solutions. These factors collectively contribute to Imaging becoming a pivotal and expanding segment within breast cancer diagnostics.

Regional Insights

North America dominates the global breast cancer diagnostics market due to several distinct advantages. The region benefits from highly developed healthcare infrastructure and widespread integration of advanced diagnostic technologies, including sophisticated imaging modalities. High levels of patient awareness, supported by extensive public screening programs, significantly contribute to early detection rates. Moreover, favorable reimbursement policies from institutions such as Medicare and private insurance providers encourage widespread diagnostic testing, improving accessibility. The presence of major industry players, coupled with a robust regulatory framework overseen by bodies like the U. S. Food and Drug Administration through the Mammography Quality Standards Act, further fosters innovation and ensures quality standards in breast cancer diagnosis.

Recent Developments

• In October 2025, Aiforia Technologies' AI-driven solutions for breast cancer diagnostics were implemented at Fimlab Laboratories, Finland's largest healthcare laboratory company. This marked a significant advancement in enhancing diagnostic workflows and improving the quality and consistency of pathology examinations. The deployment included Aiforia's comprehensive suite of breast cancer diagnostic solutions, covering both grading and biomarker panels with multiple AI models, as the initial phase of a multi-year framework agreement. These solutions are now actively supporting routine diagnostic processes at Fimlab, aiming to address the increasing volume of samples and specialist shortages.

• In October 2025, Lunit, a company specializing in AI-based technologies for cancer prevention and early detection, acquired Prognosia. This innovative biotech startup, founded by researchers from Washington University School of Medicine in St. Louis, developed software utilizing artificial intelligence to analyze mammograms. The software, Prognosia Breast, accurately predicts a woman's five-year risk of developing breast cancer and had received Breakthrough Device Designation from the Food and Drug Administration earlier in the year. Lunit's acquisition aims to accelerate the integration of this technology into clinical practice.

• In November 2024, Hologic, Inc. introduced its next-generation Genius AI® Detection PRO solution for use in the United States, alongside the Envision™ Mammography Platform. These new product launches in the breast cancer diagnostics market were showcased at the Radiological Society of North America (RSNA) Annual Meeting. The Genius AI® Detection PRO solution enhances cancer screening by leveraging deep learning to analyze both 2D and 3D mammograms, improving accuracy and efficiency for radiologists. The Envision™ platform provides a high-speed 3D mammogram with an improved patient experience.

• In October 2024, Oncocyte Corp. announced a significant breakthrough in breast cancer diagnostics with the publication of a study validating its DetermaIO™ test. The peer-reviewed journal *Clinical Cancer Research* featured findings demonstrating the test's effectiveness in identifying triple-negative breast cancer patients who could benefit from the immunotherapy drug atezolizumab. This research focused on the predictive capability of DetermaIO™ among established biomarkers in patients with this aggressive form of breast cancer. The company emphasized its commitment to broadening access to molecular diagnostic testing.

Key Market Players

• Baxter Pharmaceuticals India Private Limited.
• Bristol-Myers Squibb India Private Limited.
• Cipla Ltd.
• Roche Products (India) Private Limited.
• Glenmark Pharmaceuticals Ltd.
• Lupin Ltd
• Abbott India Laboratories Limited
• BIO-RAD LABORATORIES (INDIA) PRIVATE LIMITED.
• Siemens Healthcare Private Limited.
• Thermo Fisher Scientific India Private Limited.

Report Scope:

In this report, the Global Breast Cancer Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Breast Cancer Diagnostics Market, By Type:

o   Imaging

o   Biopsy

o   Genomic Tests

o   Blood Tests

o   Others

• Breast Cancer Diagnostics Market, By Product:

o   Platform-based Products

o   Instrument-based Products

• Breast Cancer Diagnostics Market, By Application:

o   Screening

o   Diagnostic and Predictive

o   Prognostic

o   Research

o   Others

• Breast Cancer Diagnostics Market, By End-use:

o   Hospitals & Clinics

o   Diagnostic Centers and Medical Laboratories

o   Others

• Breast Cancer Diagnostics Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Breast Cancer Diagnostics Market.

Available Customizations:

Global Breast Cancer Diagnostics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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