Breast Cancer Diagnostics Market

The global Breast Cancer Diagnostics Market is valued at USD 19.43 Billion in 2024 and is projected to reach a value of USD 45.83 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 8.10% between 2025 and 2035.

Key Highlights

• North America led the market in 2024, with 46.4% of the total market share
• Asia Pacific is anticipated to register the fastest growth rate during the forecast period
• In 2024, the Imaging segment took the lead in the market, contributing 53.2% of considerable revenue share
• The Instrument-based Products segment captured a significant portion of the revenue in 2024, accounting for 72.5% of the total share
• The Diagnostic and Predictive segment greatly contributed to the markets growth in 2024, holding above 49.1% of the market share
• Based on End-use, the Hospitals & Clinics segment significantly contributed to the market’s expansion in 2024, over 51.5% of the market share
• AI algorithms are increasingly being integrated into diagnostic processes, assisting radiologists in interpreting images more accurately and quickly, potentially reducing error rates and improving outcomes

Regional Overview

In 2024, North America emerged as a dominant force in the Breast Cancer Diagnostics market, capturing a significant share of 46.4% in revenue. This stronghold can be attributed to the escalating prevalence of breast cancer and heightened governmental efforts to bolster screening and diagnostic rates. The American Cancer Society reported an estimated 287,850 new cases of invasive breast cancer among women in the U.S. in 2022, with 43,250 resulting in fatalities. Additionally, approximately 51,400 cases of Ductal carcinoma in situ (DCIS) were diagnosed among women, with a notable but smaller occurrence among men. Furthermore, over 4 million U.S. women with a history of invasive breast cancer were alive as of January 2022.

The Asia Pacific market is witnessing rapid market growth due to an uptick in breast cancer incidence and the adoption of advanced diagnostic methodologies, which are anticipated to propel market expansion. Moreover, improvements in healthcare infrastructure and diverse reimbursement mechanisms are bolstering the regional markets growth trajectory.

U.S. Market Overview

The surge in demand for Breast Cancer Diagnostics in the U.S. is primarily attributed to the escalating number of cases nationwide. Factors such as well-established diagnostic infrastructure, technological advancements, increased healthcare expenditure, and heightened awareness about breast cancer are pivotal in driving market expansion within the country.

Type Overview

• In 2024, the Imaging segment asserted its dominance in the Global market, commanding a significant 53.2% share of revenue. Within the global market, segments include Imaging, Biopsy, Genomic Tests, Blood Tests, and Others.
• The market experienced notable expansion fuelled by the widespread adoption of advanced imaging techniques such as mammography, ultrasound, & MRI. These modalities have emerged as pivotal tools for diagnosing breast cancer, while cutting-edge technologies like MBI, CT, 3D breast tomosynthesis, and PET hold promise for revolutionizing breast imaging capabilities.
• In April 2023, a groundbreaking collaboration between Myriad Genetics Inc., a leader in genetic testing and precision medicine, and SimonMed® Imaging, a leading independent outpatient medical imaging provider, was announced. They unveiled a pioneering hereditary cancer assessment program. This program combines diagnostic imaging, genetic risk assessment utilizing MyRisk® with RiskScore®, and patient education, facilitating accessible genetic testing and delivering personalized insights to millions of patients and families served at SimonMed.

Key Trends

1. Rapid advances in technology such as digital mammography, MRI, ultrasound and tomosynthesis have led to higher resolution images that are useful for early detection, which drives the Breast Cancer Diagnostics market growth.
2. Liquid biopsies, such as circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), offer less invasive methods for monitoring tumor progression and treatment response.
3. Theres a growing trend toward developing rapid, point-of-care diagnostic tests for breast cancer, enabling quicker diagnosis & treatment initiation, particularly in resource-limited settings, propelling the Breast Cancer Diagnostics market growth.
4. New indicators for breast cancer risk, prognosis and response to therapy are being discovered in the ongoing research on Biomarker as a means of improving diagnosis accuracy and personalized medicine approaches.
5. The aim to promote early detection & prevention measures, ultimately reducing the incidence of breast cancer mortality, through awareness raising, improved screening programs as well as education for both healthcare professionals and the general public. This boosts the Breast Cancer Diagnostics market development.

Major Developments and Innovations

• FDA Priority Review for Roches Inavolisib: Roches announcement in May 2024 revealed that the U.S. FDA had accepted their New Drug Application and granted Priority Review for inavolisib, an oral therapy. This drug, when combined with palbociclib (Ibrance®) and fulvestrant, was evaluated in adult patients with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer post-adjuvant endocrine treatment.
• Guideline Support for Germline Testing by Myriad Genetics: In January 2024, Myriad Genetics lauded the new ASCO-SSO guideline for germline testing in breast cancer patients. The guideline recommends BRCA1/2 testing for specific patient groups and emphasizes the importance of informed consent and counseling. Myriads MyRisk® Hereditary Cancer Test, analyzing 48 genes, aids in personalized treatment decisions and risk assessment.
• Impact of Hologics Breast Cancer Index (BCI) Test: March 2024 saw Hologic and Biotheranostics unveiling study results showing that their BCI test led to altered anti-estrogen treatment recommendations for 40% of early-stage HR+ breast cancer patients. The BCI test helps identify those who may benefit from longer anti-estrogen therapy, thus optimizing treatment duration.
• Partnership Between iCAD and CancerIQ: November 2023 marked a collaboration between iCAD and CancerIQ to develop a comprehensive breast health care solution. This partnership aims to enhance cancer risk identification, early detection, and patient adherence to personalized care plans.
• AI-Powered Breast Cancer Diagnosis by Paige: In June 2023, Paige launched its Enhanced Breast Suite, utilizing AI to assist pathologists in diagnosing breast cancer. This suite, comprising multiple AI tools, enhances diagnostic accuracy, efficiency, and confidence in breast cancer diagnosis.
• HALOs Pathway for Early Detection of Breast Cancer: February 2023 saw HALO Precision Diagnostics introducing HALO PathWay™, an ensemble approach combining advanced imaging, analytics, and genetic testing for early breast cancer detection. HALO aims to improve survival rates through precision diagnostics.
• Medicare Coverage for Epic Sciences' ctDNA Panel: April 2023 brought news that Epic Sciences' ctDNA panel for metastatic breast cancer is covered under Medicares MolDX program. This panel aids in genomic profiling and is crucial for patients where tissue-based profiling is infeasible.
• Hologics Statement on USPSTF Breast Cancer Screening Guidelines: September 2023 witnessed Hologics response to USPSTFs finalized breast cancer screening guidelines, emphasizing the importance of annual screenings from age 40. Hologic advocates for early detection through annual 3D mammograms to save lives.
• Stratipath and Proscia Partnership for AI-Based Precision Diagnostics: December 2023 marked a collaboration between Stratipath and Proscia to integrate AI-based decision support into routine diagnostic workflows for breast cancer. This partnership aims to improve treatment decision-making and patient outcomes through precision diagnostics.

Premium Insights

The primary risk factor for breast cancer is being female, with approximately 99% of breast cancer cases occurring in women, while only 0.5–1% occur in men. Treatment approaches for breast cancer in men are generally consistent with those for women. Various factors can elevate the risk of developing breast cancer, including advancing age, obesity, excessive alcohol consumption, a family history of the disease, exposure to radiation, reproductive factors (such as the age of menarche and age at first pregnancy), smoking, and postmenopausal hormone therapy.

Around half of breast cancer cases arise in women without any discernible risk factors apart from being female and aged over 40 years. While a family history of breast cancer can heighten the risk, most women diagnosed with breast cancer do not have such a history. Nevertheless, the absence of a known family history does not necessarily imply a reduced risk.

Certain inherited gene mutations, notably in BRCA1, BRCA2, and PALB-2, significantly increase the risk of breast cancer. Women with mutations in these genes may consider risk reduction measures such as prophylactic mastectomy or chemoprevention strategies. Early initiation and completion of breast cancer treatments lead to more effective outcomes and are generally better tolerated.

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Market Dynamics

Technological Advances Propel the Market Growth

The global Breast Cancer Diagnostics market is fuelled by the escalating prevalence of the disease. Government led emphasis on early detection and screening programs has resulted in increased diagnosis rates. The accuracy and efficiency of detection have improved with advances in diagnostics. Diagnostics have come a long way due to advances in technology such as Digital Mammography, Molecular Imaging Techniques and Breast MRI which led to the development of specific treatments. This personalized approach not only improves treatment efficacy and minimizes side effects but also amplifies revenue prospects in the market.

Public Health Initiatives Drive Early Detection in the Market

Through public health education initiatives like the WHO Global Breast Cancer Initiative (GBCI), awareness among women and their families regarding the signs and symptoms of breast cancer is being raised. The objective of GBCI is to reduce global breast cancer mortality by 2.5% annually, potentially averting 2.5 million deaths by 2040. The initiative focuses on health promotion for early detection, timely diagnosis, and comprehensive breast cancer management, aiming to prompt more women to seek medical consultation at the onset of suspected breast cancer, thus curbing advanced stages of the disease.

Competitive Landscape

• Major players in the global market maintain a formidable position in the industry, attributed to significant investments in research and development (R&D) resulting in pioneering advancements. These investments drive innovation within the sector.
• Philips, a renowned health technology leader, showcased its pivotal role in Scotlands National Health Service (NHS) breast cancer screening program amid the COVID-19 pandemic. Through its vendor-neutral Vue PACS (Picture Archiving and Communication System), Philips facilitated interoperability among Scotlands breast screening centers and mobile units, enhancing access to screening in rural areas, expanding patient options, and optimizing diagnostic and treatment workflows. This initiative underscores the companys commitment to advancing healthcare accessibility and efficiency.

Recent Market Developments

Exact Sciences Corp. Unveils Breakthrough Data on Oncotype DX Breast Recurrence Score® at ASCO® 2024 Annual Meeting

• In May 2024, Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, unveiled 10 abstracts showcasing the companys extensive screening and diagnostic portfolio at the American Society of Clinical Oncology® (ASCO®) Annual Meeting, held from May 31 to June 4, 2024, in Chicago, Ill. These presentations featured new data confirming the predictive and prognostic value of the Oncotype DX Breast Recurrence Score® test in racially and ethnically diverse patients.

Roche Receives CE Mark for Groundbreaking Companion Diagnostic for HER2-low Metastatic Breast Cancer

• In April 2024, Roche has been granted the CE Mark for the first companion diagnostic designed to identify patients with HER2-low metastatic breast cancer eligible for treatment with ENHERTU. The approval of the VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* by Roche enables the identification of metastatic breast cancer patients with low HER2 expression, for whom ENHERTU® (trastuzumab deruxtecan) may be considered as a targeted treatment. Branded as PATHWAY in the United States, this test had previously received approval from the US Food and Drug Administration (FDA) in October 2022. ENHERTU is a specially engineered antibody drug conjugate (ADC) directed towards HER2, developed and commercialized jointly by Daiichi Sankyo and AstraZeneca.

Hologic Inc. Announces Acquisition of Endomagnetics Ltd for $310 Million in April 2024

• In April 2024, Hologic Inc., a renowned player in womens health globally, has disclosed its agreement to purchase Endomagnetics Ltd (Endomag®), a privately owned company specializing in breast cancer surgery technologies. The acquisition is valued at around $310 million, with adjustments for working capital and other standard closing considerations.

BD Partners with Kenyan Government to Improve Cancer Diagnostics Access for Women

• In January 2024, BD, a leading global medical technology company, has announced a partnership with the Kenyan Government, facilitated by the National Cancer Institute-Kenya, to enhance access to essential cancer diagnostics for women in Kenya. This collaboration underscores BDs dedication to advancing health equity in underserved communities worldwide. The initiative aligns with the Ministry of Health Kenyas Cancer Control Strategy, which prioritizes early detection & screening for cancers such as cervical and breast cancer, along with facilitating access to care following diagnosis.

Pfizer and Thermo Fisher Forge Collaboration to Expand Cancer Genomic Testing Access Worldwide

• In May 2023, Pfizer and Thermo Fisher Scientific Inc. have forged a collaboration agreement aimed at expanding access to next-generation sequencing (NGS)-based testing for lung & breast cancer patients in over 30 countries across Latin America, Africa, the Middle East, and Asia. In regions where advanced genomic testing was previously limited or unavailable, this collaboration seeks to enhance local access.

The global Breast Cancer Diagnostics market can be categorized as Type, Product, Application, End-use, and Region.