Breast Cancer Diagnostics Market Size, Share, and Trends 2025 to 2034

Breast Cancer Diagnostics Market Size and Forecast 2025 to 2034

The global breast cancer diagnostics market size was estimated at USD 18.63 billion in 2024 and is anticipated to reach around USD 40.71 billion by 2034, expanding at a CAGR of 8.13% from 2025 to 2034. The market growth is attributed to the increasing demand for early and accurate breast cancer diagnosis and technological advancements in diagnostic tools.

Breast Cancer Diagnostics Market Key Takeaways

• North America dominated the global market with the largest market share of 45.77% in 2024.
• Asia Pacific is projected to expand at the fastest CAGR during the forecast period.
• By type, the Imaging segment contributed the highest market share of 53% in 2024.
• By type, The blood tests segment is fastest growing during the forecast period.
• By application, the diagnostics and predictive segment captured the biggest market share of 49% in 2024.
• By application, The prognostic segment is predicted to grow with CAGR of 8.4% during the forecast period
• By End-user, the hospitals and clinics segment has held the largest market share of 51% in 2024.

Impact of Artificial Intelligence on the Breast Cancer Diagnostics Market

AI is an invigorating tool to boost the accuracy and efficiency of breast cancer diagnostics. Integrating AI algorithms in radiograms and other diagnostic tools helps spot patterns that might reflect malignancies. They can assess huge amounts of data like genetic and medical histories, which help doctors design personalized treatment plans for patients. Moreover, AI automates workflows, allowing radiologists to focus on more complex cases and improve overall productivity in diagnostic centers.

U.S. Breast Cancer Diagnostics Market Size and Growth 2025 to 2034

The U.S. breast cancer diagnostics market size was evaluated at USD 7.25 billion in 2024 and is predicted to be worth around USD 15.94 billion by 2034, rising at a CAGR of 8.20% from 2025 to 2034.

North America dominated the breast cancer diagnostics market  with the largest market share of 45.77% in 2024. The presence of large players, well-established diagnostic and screening infrastructure, technological breakthroughs, strong patient awareness, and attractive reimbursement policies are all elements that contribute to the region’s dominance. 

Asia-Pacific, on the other hand, is expected to develop at the fastest rate during the forecast period, as a result of the rising incidence of breast cancer and the use of better diagnostic procedures. Furthermore, the breast cancer diagnostics market expansion is likely to be supported by increasing reimbursement guidelines and expanding healthcare infrastructure.

Market Overview

In the breast's glandular tissue, breast cancer develops in the living cells of the ducts or lobules. The malignant development is initially restricted to the duct or lobule, which usually causes no symptoms and has a low risk of spreading. The treatment for breast cancer can be quite effective, especially if the disease is detected early. Microscopic cancer that has spread from the breast tumor through the blood is generally treated with a combination of surgical removal, medication, and radiation therapy. This type of treatment, which can stop cancer from spreading and growing, saves lives.

Breast cancer is the most difficult to diagnose and cure because it is usually discovered after it has progressed to an advanced stage. People are looking for more efficient diagnostic options to deal with the condition effectively; hence, demand for early diagnosis of breast cancer is on the rise. Imaging and screening, in addition to other tests for detecting breast cancer, have gained immense popularity.

Breast Cancer Diagnostics Market Growth Factors

• Rising awareness about early detection and prevention of breast cancer drives the demand for diagnostic services, thus boosting the market.
• Technological advancements in molecular imaging and biomarker discovery enable more precise detection methods.
• Increased insurance coverage for cancer screenings encourages higher participation in diagnostic programs.
• Government initiatives and cancer registries provide funding and data, supporting diagnostic tool development.
• Expanding telemedicine networks makes diagnostic services more accessible, especially in rural areas.
• Innovations in breast cancer screening technologies lead to early and more reliable detection across diverse populations.
• Growing emphasis on reducing breast cancer mortality rates boosts investments in research and diagnostics.

Market Scope

Market Dynamics

Driver

Increasing Prevalence of Breast Cancer 

The increasing prevalence of breast cancer is a major factor boosting the growth of the market. With the increasing incidences, majorly due to factors such as aging populations, hormonal changes, and lifestyle changes, the need for improved screening and detection methods is rising worldwide. According to the Breast Cancer Research Foundation, breast cancer is the most common cancer in women worldwide. In 2022, about 2.3 million women were diagnosed with breast cancer worldwide, and 670,000 died. Every 14 seconds, somewhere in the world, a woman is diagnosed with breast cancer, highlighting the need for improved diagnostics technologies to reduce this burden.  

Restraint

High costs of Advanced Diagnostic Technologies

Although there is a high need for advanced diagnostic technologies, their high costs are expected to hamper market growth. Various technologies, including 3D mammography, molecular imaging, and AI-driven diagnostic tools, are costly, and hence, they are not widely utilized, especially in low- and middle-income countries. Moreover, advanced diagnostic tools require substantial maintenance and operation costs, which further discourages small healthcare organizations from adopting them. Furthermore, the lack of insurance covering the screening and diagnoses hinders the market growth. 

Opportunity

Rising Investments in Cancer Research

Increasing investments in cancer research by governments and healthcare organizations create lucrative growth opportunities in the market. In regions such as Asia Pacific, Latin America, and the Middle East, governments are heavily investing in cancer research to develop tailored therapeutics. Moreover, governments are implementing screening programs to reduce the overall burden of breast cancer, contributing to the growth of the market.

Product Insights

The instrument-based products had the highest revenue share in 2024. For widespread population-based screening of breast cancer patients, imaging is the first approach. All women with breast cancer undergoes a biopsy to confirm their diagnosis of the treatment.

The platform-based products segment is fastest growing segment of the breast cancer diagnostics market in 2024. Due to the increased demand of such products for targeted therapy, the platform-based products segment is expected to develop at the quickest rate throughout the projection period. The next generation sequencing, polymerase chain reaction, and other technologies are used to diagnose breast cancer. 

Type Insights

The Imaging segment contributed the highest market share of 53% in 2024. The segment is expected to be driven by factors such as ease of access, high number of operations, and increased effectiveness. The ultrasounds, mammograms, and magnetic resonance imaging are the most common imaging methods used for screening and diagnosis.

The blood tests segment is fastest growing segment of the breast cancer diagnostics market in 2024, as a result of a number of research projects being conducted globally by research groups and key players. The liquid biopsy tests’ excellent efficacy is predicted to propel the blood testing segment growth.

Application Insights

The diagnostics and predictive segment captured the biggest market share of 49% in 2024. The rising popularity of genetic testing may contribute to the expansion of the segment.

The prognostic segment, on the other hand, is predicted to develop at a rapid rate over the projection period. As these tests are used to match patients with medicines, they are booming increasingly significant. As a result, the patient’s chances of survival improve dramatically. 

End Use Insights

The hospitals and clinics segment has held the largest market share of 51% in 2024. The segment’s expansion is likely to be fueled by rising patient hospitalizations and the growing burden of disease. The patients undergo biopsies for confirmation testing in hospitals after the screening test.

The diagnostic centers and medical laboratories segment, on the other hand, is predicted to develop at the quickest rate in the future years, as a result of an increase in the number of government programs to provide various services, such as diagnostic test reimbursement.

To strengthen their product portfolio, the major market players use organic and inorganic expansion tactics. To stay competitive in the global breast cancer diagnostics market, these companies have used methods such as geographic growth, collaborations, acquisitions, investment in research and development, and manufacturing of novel breast cancer diagnostic tools in the market.

Breast Cancer Diagnostics Market Companies

• Genomic Health
• NanoString Technologies Inc.
• Paragon Biosciences LLC
• Devicor Medical Products Inc.
• AstraZeneca
• Quest Diagnostics Incorporated
• Koninklijke Philips N.V.
• Siemens AG
• Biocept Inc.
• Epigenomics Inc.

Latest Announcement by Industry Leader

• In September 2024, Roche announced the expansion of its digital pathology open environment with the integration of over 20 advanced artificial intelligence (AI) algorithms, including algorithms for breast biomarkers, from eight new collaborators. These strategic partnerships are designed to enhance the support available to pathologists and scientists in cancer research and diagnosis by utilizing advanced AI technology. Jill German, Head of Pathology Lab for Roche Diagnostics, said that these cutting-edge AI solutions will revolutionize cancer research, diagnostics, and treatment, ultimately enabling clinicians to improve patient outcomes globally.

Recent Developments

• In November 2024, BioMark Diagnostics Inc., a leader in liquid biopsy tests for early cancer detection, announced significant advancements in its breast cancer program. The company’s liquid biopsy platform, which combines metabolomics and machine learning, promises early detection of breast cancer, particularly lobular breast cancer (LBC).
• In August 2024, Izotropic Corporation revealed plans to pursue a regulatory strategy in the U.S. and EU to launch IzoView as a diagnostic tool for patients with dense breast tissue, a condition that is linked to an increased risk of developing breast cancer.

Segments Covered in the Report

By Type

• Imaging
• Biopsy
• Genomic Tests
• Blood Tests
• Others

By Product

• Platform-based Products
• Instrument-based Products

By Application

• Screening
• Diagnostic and Predictive
• Prognostic
• Others

By End Use

• Hospitals & Clinics
• Diagnostic Centers & Medical Laboratories
• Others

By Geography

• North America
  • U.S.
  • Canada
• Europe
  • U.K.
  • Germany
  • France
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Malaysia
  • Philippines
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC
  • North Africa
  • South Africa
  • Rest of the Middle East & Africa