Breast Cancer Diagnostics Market Size, Share & Trends Analysis Report By Cancer Type (Invasive lobular breast cancer, Ductal carcinoma in situ (DCIS), Triple-negative breast cancer, Inflammatory breast cancer, Others), By Test Type (Clinical Breast Exam, Blood Tests, Imaging Tests, Biopsies, Others), By Stage (Stage I, Stage II, Stage III, Stage IV), By End-User (Hospitals and Clinics, Cancer Diagnostic Centers, Cancer Research Institutes, Ambulatory Surgical Centers, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Breast Cancer Diagnostics Market Size

The global breast cancer diagnostics market size is estimated to be worth USD 4.96 billion in 2024 and is projected to reach from USD 5.30 billion in 2025 to USD 9.65 billion by 2033, growing at a CAGR of 7.62% during the forecast period (2025-2033).

Breast cancer diagnostics involves a range of tests and procedures designed to detect the presence of breast cancer at its earliest stages, offering a critical opportunity for effective treatment and improved survival rates. This process includes self-exams, clinical check-ups, imaging tests like mammograms, and advanced diagnostic tools such as biopsies and genetic screening. Early detection is key to managing this growing global health concern.

Breast cancer has increasingly become a critical health issue worldwide, affecting women of all ages and lifestyles. According to data from the World Health Organization (WHO) published in February 2024, breast cancer cases are projected to rise sharply from 2.3 million in 2020 to over 3 million by 2040. Low- and middle-income countries are expected to bear the brunt of this surge, with around one million deaths annually by 2040. These alarming statistics underscore the urgent need for proactive health measures.

Regular self-exams, clinical screenings, and mammograms are essential for early detection, which significantly improves treatment outcomes and enhances survival rates. As the prevalence of breast cancer continues to rise, it is critical for healthcare systems and individuals alike to prioritize screening practices and early intervention to combat this growing global health crisis.

The table below displays the global breast cancer incidence and rates for women in 2022. France reported the highest breast cancer incidence rate:

Source: Straits Research Analysis

The above data highlights the need for effective screening processes for detecting breast cancer early. Recent technological advancements have significantly broadened diagnostic options, enhancing the effectiveness of early detection strategies. For instance, the development of digital mammography has improved image clarity, resolution, and contrast, especially for dense breast tissue and small tumors.

• In December 2023, RadNet, Inc., a national leader in providing outpatient diagnostic imaging services, introduced MammogramNow, an innovative screening service that uses DeepHealth AI-powered digital mammography technology. This service offers women enhanced breast cancer detection during routine visits without extending appointment times.

Breast Cancer Diagnostics Market Trends

Growing Breast Cancer Early-Detection Programs

The increasing focus on breast cancer early-detection programs is emerging as a major trend in the global market. Given that breast cancer remains one of the leading causes of cancer-related deaths among women, early diagnosis is essential for improving survival rates. These programs, which emphasize the importance of early screening, such as mammography, have proven effective in significantly reducing breast cancer mortality.

• For example, in November 2023, FUJIFILM launched the "Find It Early, Fight It Early" campaign in India, partnering with 35 diagnostic centers equipped with their Amulet digital mammography solution. This initiative aims to provide free breast cancer screenings to over 90,000 women annually, particularly focusing on urban slums and lower-income communities where access to healthcare is limited.

By increasing accessibility to early detection tools, such programs are driving the breast cancer diagnostics market growth and reinforcing the critical role of early intervention in saving lives. The expansion of such initiatives globally is expected to continue, further advancing the market and reducing breast cancer mortality in underserved populations.

Breast Cancer Diagnostics Market Growth Factors

Global Support for Breast Cancer Management in Fragile Health Systems

The global initiative to support breast cancer management in countries with fragile or underdeveloped healthcare systems is a key driver of market. These nations, often unable to manage the rising incidence of breast cancer, face immense pressure on individuals, families, economies, and healthcare infrastructures. Recognizing this, healthcare ministers and governments worldwide are taking proactive measures to ensure that breast cancer diagnostics and treatment options are made available in low- and middle-income countries.

For example, in February 2023, the World Health Organization (WHO) launched a comprehensive roadmap aimed at enhancing breast cancer management in over 70 countries, particularly those with limited resources. This initiative focuses on improving early detection, speeding up diagnosis, and enhancing the quality of treatment to provide women in low- and middle-income nations with better access to life-saving care. By addressing these critical gaps, the WHO's roadmap is poised to reduce breast cancer mortality rates and alleviate the strain on fragile health systems.

Global collaborations of this nature are vital in expanding the reach of breast cancer diagnostics, particularly in underserved regions, and ensuring that all individuals, regardless of location, have the opportunity for timely and effective treatment.

Market Restraints

Fragmented Healthcare System Reveals Disparities in Breast Cancer Diagnosis

The fragmented nature of healthcare systems reveals significant disparities in breast cancer diagnosis, which hampers the overall market growth. Unequal access to healthcare services leads to varying health outcomes within the same country, particularly between private and public sectors.

• For instance, data from the AMAZONA-III trial in Brazil (March 2022) demonstrated that over 80% of privately insured patients were diagnosed with early-stage breast cancer (I-II). In contrast, only 40% of those covered by the public healthcare system were diagnosed early.

Most public system patients were diagnosed at later, more advanced stages (III-IV), when treatment options are more limited and outcomes are poorer. This disparity underscores the gap in access to advanced imaging technologies and timely diagnosis, particularly for underprivileged populations, limiting the widespread adoption of breast cancer diagnostics. Addressing these inequities is crucial for ensuring equal access to early detection and improving overall breast cancer survival rates.

Market Opportunity

Rising Integration of AI Platforms to Improve the Diagnosis

The integration of Artificial Intelligence (AI) platforms is emerging as a key opportunity in the breast cancer diagnostics industry, revolutionizing early detection and diagnostic accuracy. A notable example is the recent launch of iOncology.ai by the All-India Institute of Medical Sciences (AIIMS) Delhi in collaboration with the Centre for Development of Advanced Computing, Pune. This AI-driven platform is designed to detect breast and ovarian cancers at early stages by utilizing advanced algorithms that analyze patient data more efficiently.

AI platforms in cancer diagnostics are increasingly prevalent due to their ability to deliver faster and more precise assessments, helping identify abnormalities that may be missed by traditional methods. AI not only improves diagnostic accuracy but also eases the burden on healthcare professionals, enabling them to focus on treatment strategies. As AI technologies continue to evolve, their integration into breast cancer diagnostics is set to expand, offering significant potential for improving patient outcomes and streamlining diagnostic processes across healthcare systems globally.

Regional Insights

North America: Dominant Region with 45.8% market share

North America holds a dominant position in the breast cancer diagnostics industry, commanding a substantial 45.8% market share. This dominance is attributed to its advanced healthcare infrastructure and the widespread adoption of cutting-edge diagnostic technologies, such as digital mammography and MRI. The region benefits from significant investments in research and development, which enhance early detection methods and improve treatment options.

• For example, in 2023, the American College of Radiology expanded its Imaging Network, focusing on integrating artificial intelligence to improve mammogram interpretation accuracy.

Moreover, widespread public awareness campaigns and extensive screening programs, such as National Breast Cancer Awareness Month, have significantly contributed to early diagnosis rates. These factors combined foster a robust environment for the growth of breast cancer diagnostics, ultimately improving survival outcomes and patient care in the region.

Asia Pacific: Fastest growing region

The Asia Pacific region is poised for remarkable growth in the breast cancer diagnostics market. This growth is driven by healthcare reforms aimed at improving access to diagnostic services and the rising incidence of breast cancer, often attributed to lifestyle and dietary changes. Countries like India and China are significantly increasing investments in research and development, with initiatives such as the Indian government’s National Cancer Control Program focusing on early detection and treatment.

Furthermore, advancements in breast imaging technologies, including the use of AI in mammography, are enhancing diagnostic accuracy. Collaborative efforts among industry players, such as partnerships between local hospitals and biotech firms, are accelerating innovation. Moreover, the growing emphasis on breast cancer biomarkers and personalized treatment options is further enhancing the region's market potential, positioning it as a vital area for future growth in breast cancer diagnostics.

Countrywise Insights

The market dynamics in major key countries reflect a global trend towards improved diagnostic methods and increased emphasis on early detection and treatment. Below are a few countries that illustrate the diverse contributions and advancements in the breast cancer diagnostics market.

• United States- The U.S. remains a leader in metastatic breast cancer research, contributing significantly to understanding and treating the disease. For instance, in 2022, the Breast Cancer Research Foundation in New York invested USD 47.5 million to fund breast cancer research, supporting 250 scientists globally.
• India- India is witnessing increasing demand for enhanced diagnostic and treatment strategies due to the rising cases of cancers. For instance, in 2022, according to the Global Cancer Observatory, India has the highest estimated breast cancer deaths among females, with 98,337 cases reported in 2022. Moreover, India provides a cost-effective option for breast cancer treatment, maintaining high standards of quality. The country is recognized for its skilled oncologists and state-of-the-art medical facilities.
• Japan- Japan's healthcare system is renowned for its efficiency and advanced technology, providing top-tier breast cancer treatments. The country emphasizes minimally invasive techniques and a patient-centered approach to care.
• China- In China, the government is implementing supportive policies and investments in cancer screening programs and initiatives such as Cervical Cancer and Breast Cancer Screening Programmes. This program aims to increase screening coverage to 70% by 2030.
• South Korea- South Korea's medical tourism industry is thriving, with the government aiming to attract 700,000 foreign patients by 2027. The country is highly competitive in different cancer treatments, including breast cancer, using advanced technologies like PET-CT and CyberKnife and offering affordable, high-quality care.
• Germany- Germany is renowned for its precision in medical treatment and exceptional healthcare system. The country offers top-quality breast cancer care, emphasizing personalized treatment plans tailored to each patient's unique needs. Germany is a leader in advanced breast cancer treatment, with about 80% of oncology research conducted there.The country’s innovative therapies, including chemoembolization and immunotherapy, are highly effective for stage 4 breast cancer, achieving significant tumor reduction and improved patient outcomes.
• Italy- As per NCBI, 2022, in Italy, 6.4% of breast cancer cases are metastatic at diagnosis, with lower rates in the north (5.1%) compared to the center (7.4%) and south (7.8%). These mentioned rates of breast cancer highlight the need for targeted diagnostic and screening strategies, especially in regions with higher metastatic rates.

Breast Cancer Diagnostics Market Segmentation Analysis

By Cancer Type

The global market is bifurcated into invasive lobular breast cancer, ductal carcinoma in situ (DCIS), triple-negative breast cancer, inflammatory breast cancer, and others. The ductal carcinoma in situ (DCIS) segment leads the market due to its non-invasive nature and potential to progress to invasive ductal carcinoma (IDC). Diagnosing DCIS is critical, as untreated cases may become life-threatening. Early detection, primarily through routine mammography, has significantly increased demand for DCIS-specific diagnostic tools.

• For instance, the American Cancer Society projected that 55,720 new DCIS cases will be diagnosed in 2024, emphasizing its growing importance. This surge in early detection, along with advancements in imaging technologies, has driven revenue for DCIS-related diagnostics.

By Test Type

The global market is bifurcated into clinical breast exams, blood tests, imaging tests, biopsies, and others. The imaging test segment, particularly mammography, dominates the market, accounting for the majority of screenings. Mammograms are widely recommended for early detection, identifying approximately 85% of breast cancers in women.

• In September 2023, Siemens Healthineers launched the Mammomat B.brilliant, offering the fastest wide-angle tomosynthesis on the market, which delivers high-quality 3D images in just five seconds. Such technological advancements, coupled with the widespread use of mammograms for routine screenings, particularly in women over 40, have cemented imaging tests as the leading diagnostic method in the market.

By Stage

The global market is bifurcated into stage I, stage II, stage III, and stage IV. The stage I segment holds the dominant share in the market due to its early-stage, localized nature, which makes it highly treatable. Early detection at stage I requires advanced diagnostic tools that can identify small, non-invasive tumors. For example, as of June 2024, the Susan G. Komen Foundation reported a five-year relative survival rate of 98-100% for stage I breast cancer when treated promptly. This strong survival rate highlights the importance of diagnosing breast cancer at this early stage, boosting demand for accurate and reliable diagnostic technologies in the market.

By End-User

The global market is bifurcated into hospitals and clinics, cancer diagnostic centers, cancer research institutes, ambulatory surgical centers, and others. Hospitals and clinics are the dominant end-users in the market due to the large volume of patients requiring diagnostic tests each month. Hospitals serve as the primary point of contact for breast cancer diagnostics, offering a wide range of imaging tests, biopsies, and other diagnostic services. For example, in October 2023, Apollo Hospitals revealed that 25% of breast cancer cases in India involved women under the age of 40, highlighting the importance of hospital-based screenings. The availability of advanced technologies and specialized care at hospitals makes them the leading segment for breast cancer diagnostics.

Company Market Share

Key players in the breast cancer diagnostics market, including Siemens Healthineers AG, Kheiron Medical Technologies, Bio-Rad Laboratories, and Hologic, Inc., among others, hold highest market revenue and are actively working to strengthen their market presence and enhance their offerings through strategic partnerships, acquisitions, and ongoing innovations.

By expanding their product portfolios and integrating advanced technologies, these companies aim to meet the growing demand for breast diagnostic technologies, offering deeper market insights.

Hologic, Inc.: An emerging player in the breast cancer diagnostics market

Hologic, Inc. is an emerging leader in medical technology specializing in women's health, including breast cancer diagnostics and imaging solutions. The company is renowned for its innovative products, such as the Hologic Genius AI Detection solution. The platform searches every slice of the tomosynthesis image set to identify lesions likely indicative of breast cancer. With a high sensitivity of 94%, it highlights suspicious areas at radiologists' workstations, facilitating smart and precise interpretation.

Recent developments at Hologic, Inc. include:

• In April 2024, Hologic endorsed the new breast cancer screening guidelines from the U.S. Preventive Services Task Force, highlighting the critical role of regular mammography in reducing mortality rates.

Recent Developments

• April 2024- Bio-Rad Laboratories announced the launch of ddPLEX ESR1 Mutation Detection Kit, a highly sensitive multiplexed digital PCR assay for breast cancer research.
• September 2024- RadNet introduced its Enhanced Breast Cancer Detection (EBCD) service, powered by AI technology Saige-Dx, offering improved accuracy in breast cancer detection and personalized risk assessments for women in New York and New Jersey.

Analyst Opinion

As per our analyst, significant progress has been made in breast cancer diagnostics with advanced imaging techniques like digital mammography, ultrasound, and MRI, which improve early detection. Genetic testing and biomarker profiling further personalize treatment. However, more work is needed to improve accessibility and patient education to ensure these advancements reach a wider population.