The global breast cancer diagnostics market was valued at USD 4.49 billion in 2023 and is expected to reach over USD 9.00 billion by 2033, poised to grow at a noteworthy CAGR of 7.2% from 2024 to 2033 North America dominated the market with a revenue share of 46.00% in terms of revenue in 2023.
The global breast cancer diagnostics market was valued at USD 4.49 billion in 2023 and is expected to reach over USD 9.00 billion by 2033, poised to grow at a noteworthy CAGR of 7.2% from 2024 to 2033 North America dominated the market with a revenue share of 46.00% in terms of revenue in 2023.
The breast cancer market is seeing significant growth due to various factors contributing to increased detection and treatment options. Screening recommendations and advancements in diagnostic imaging, such as digital breast tomosynthesis, have led to the identification of smaller tumours with lower metastatic potential.
This, in turn, has fuelled demand for surgical interventions and radiation treatments, as well as systemic options like chemotherapy and targeted therapies. The ability to detect tumours earlier and with greater accuracy has not only improved patient outcomes but also expanded the market for breast cancer-related products and services. As a result, the breast cancer market is experiencing a surge in growth driven by advancements in screening technology and comprehensive treatment approaches.
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Breast Cancer Diagnostics Market Overview
The breast cancer diagnostic market is experiencing rapid growth driven by advancements in diagnosis and treatment. Diagnosis typically involves exams, discussions of symptoms, and imaging tests like mammograms, ultrasounds, and MRIs. Tissue samples are often taken through biopsy to confirm cancer presence. Breast cancer stages range from 0 to 4, with lower stages indicating less advancement and higher chances of cure. Early detection through screening is crucial as many cases are asymptomatic initially. The shift towards personalized medicine is reshaping breast cancer management, with sophisticated diagnostics like molecular imaging and genomic profiling improving tumor characterization. This, coupled with innovative surgical and radiation techniques, supports a multidisciplinary approach aimed at minimizing recurrence and treatment-related complications. Breast cancer remains a significant cause of morbidity and mortality globally among women. Early diagnosis and effective treatment are paramount for favorable outcomes. Theranostics, an emerging paradigm, integrates diagnosis, imaging, and treatment, offering personalized therapy opportunities. Nanotheranostics, incorporating targeted moieties and agents within single formulations, holds promise for enhanced treatment efficacy.
- In January 2024, GE Healthcare announced an agreement to acquire MIM Software.
- In March 2024, QT Imaging Holdings announced the completion of its business combination with GigCapital5.
Breast Cancer Diagnostics Market Size in the U.S. 2023 to 2032
The U.S. Breast Cancer Diagnostics market size was valued at USD 1.51 billion in 2023 and is anticipated to reach around USD 3 billion by 2033, growing at a CAGR of 7.1% from 2024 to 2033.
North America dominated the market with a revenue share of 46.00% in terms of revenue in 2023, According to U.S. Cancer Statistics, breast cancer is the most frequently diagnosed cancer among American women, excluding nonmelanoma skin cancers. It ranks as the second leading cause of cancer-related deaths among women overall, with lung cancer being the only one surpassing it. However, among Black and Hispanic women, breast cancer stands as the primary cause of cancer-related mortality.
- In 2022, an estimated 287,850 new cases of invasive breast cancer and 51,400 cases of DCIS are projected, resulting in approximately 43,250 deaths. The disease predominantly affects women aged 50 and older, emphasizing the importance of advanced diagnostic and treatment approaches in this region.
- In November 2023, Truqap (capivasertib) plus Faslane was approved in the US for patients with advanced HR-positive breast cancer.
In the Asia-Pacific region, rapid growth is anticipated in the breast cancer diagnostics market. There’s a notable focus on leveraging breast cancer biomarkers for enhanced screening, prognosis, and personalized treatment. Collaborative efforts and partnerships among industry players are driving technological advancements and screening methodologies. Age is a significant risk factor for breast cancer, with incidence rates varying based on population demographics. Despite the availability of preventive healthcare services, high-income countries in the region are underutilizing national breast screening programs.
Breast Cancer Diagnostics Market top trends
- Advancements in Imaging Technologies: Innovations in imaging techniques such as mammography, MRI, ultrasound, and molecular breast imaging are enhancing early detection capabilities and accuracy in diagnosing breast cancer.
- Rise of Liquid Biopsies: Liquid biopsy methods, which involve analyzing blood or other bodily fluids for tumor markers, circulating tumor cells (CTCs), or cell-free DNA (cfDNA), are gaining traction for their non-invasive nature and potential for real-time monitoring of disease progression.
- Precision Medicine and Personalized Treatment: With the increasing understanding of the molecular and genetic factors underlying breast cancer, there’s a growing emphasis on personalized treatment approaches tailored to the specific characteristics of individual tumors. This trend is driving the demand for molecular diagnostic tests and targeted therapies.
- Integration of Artificial Intelligence (AI) and Machine Learning: AI algorithms are being deployed to analyze medical imaging data and pathology slides, aiding radiologists and pathologists in detecting subtle signs of breast cancer and improving diagnostic accuracy.
- Point-of-Care Testing (POCT): The development of rapid and portable diagnostic devices for breast cancer detection is facilitating early diagnosis and treatment initiation, particularly in resource-limited settings or remote areas where access to healthcare infrastructure is limited.
- Expanding Role of Biomarkers: Biomarkers play a crucial role in early detection, prognosis, and treatment selection for breast cancer patients. Ongoing research is identifying novel biomarkers with potential applications in screening, diagnosis, and monitoring of treatment response.
- Telemedicine and Remote Monitoring: Telemedicine platforms are enabling remote consultations, second opinions, and follow-up care for breast cancer patients, improving access to specialized healthcare services and reducing the burden of in-person visits, especially during the COVID-19 pandemic.
- Patient-Centric Approaches: There’s a growing recognition of the importance of patient preferences, experiences, and outcomes in shaping breast cancer diagnostics and treatment decisions. Patient-centered care models
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Market Dynamics
Driver
Rising Prevalence of Breast Cancer
In 2022, breast cancer emerged as a significant global health challenge, impacting 2.3 million women and claiming 670,000 lives worldwide. Notably, stark disparities in disease burden were observed, particularly in very high Human Development Index (HDI) countries, where 1 in 12 women faced diagnosis and 1 in 71 succumbed to the disease. Guided by biological subtyping, medical treatments encompassed both neoadjuvant and adjuvant approaches. The imperative for fundamental health system strengthening extends beyond breast cancer to encompass other cancers and non-malignant noncommunicable diseases (NCDs), thus driving growth in the breast cancer market.
- In January 2023, the FDA approved lacustrine for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
Restraint
Financial Barriers
Breast cancer treatment in the United States poses a substantial financial burden, even for insured individuals, due to high treatment costs and lost income from time off work. As treatment expenses escalate, some patients struggle to afford recommended therapies, leading to delayed or skipped treatments. Breast cancer ranks among the most costly cancer types to treat, with rising treatment prices placing a heavier financial burden on patients. A 2022 Breastcancer.org survey of 1,437 US residents diagnosed with breast cancer in the past decade revealed that 47% considered their out-of-pocket costs significant or catastrophic, with 37% cutting spending on essential items to cover treatment expenses. These financial constraints limit the growth potential of the breast cancer market.
Opportunity
Integration with Digital Mammography and CAD Systems
The integration of computer-aided detection (CAD) systems with digital mammograms offers a significant opportunity in the breast cancer market. CAD systems utilize advanced computer algorithms to identify patterns in images indicative of malignancies, assisting radiologists in detecting suspicious areas for further examination. This technology can be applied directly to digital mammograms or conventional films converted to digital format. Numerous studies suggest that CAD can enhance radiologists’ ability to detect and classify breast abnormalities, thereby improving diagnostic accuracy. The recent FDA approval of a CAD detection system for breast cancer screening further underscores the potential growth prospects in the breast cancer market.
- In October 2023, Densities and Interleaf formed a strategic partnership to advance breast cancer screening with innovative AI technology.
- In November 2023, GE Healthcare introduced a new AI platform for breast cancer imaging.
By Product
On the basis of product, the market is segmented into platform-based products and instruments-based products. The instrument-based products segment dominated the overall market with a revenue share of 72.18% in 2023. Biopsy procedures, crucial for definitive cancer diagnosis, vary based on cancer type and location. Mammography is key for breast cancer screening in most women of screening age.
The platform-based products segment is the fastest-growing in the breast cancer diagnostics market. Web-based Medical Imaging Platforms offer efficient analysis through web browsers and Internet access, saving time and providing access to vast computing resources and expert insights shared online. Cloud computing, a key technology, enables network access to shared computing resources that can be quickly provisioned and managed with minimal effort.
By Type
On the basis of type, the market is segmented into imaging, biopsy, genomic tests, blood tests, and others. The imaging segment dominated the overall market with a revenue share of 53.74% in 2023. These tests capture internal body images crucial for cancer detection, diagnosis, treatment monitoring, and assessing recurrence. The transition to digital file storage enhances accessibility and efficiency. Among the most common imaging tests is Breast MRI, leveraging magnets and radio waves to generate detailed cross-sectional breast images.
The blood tests segment is the fastest-growing in the breast cancer diagnostics market. Blood testing is integral for cancer diagnosis and management, offering insights into overall health, organ function, and potential disease presence. Examples include complete blood count and tumor markers. While results are valuable, they should be evaluated alongside other factors and tests for comprehensive assessment.
By Application
On the basis of application, the market is segmented into screening, diagnostic & predictive, prognostic, and research. The diagnostic & predictive segment dominated the overall market with a revenue share of 49.4% in 2023. Imaging tests like X-ray, Bone, CT, MRI, and PET scans, along with lab tests, play a crucial role in diagnosing breast cancer and improving patient survival outcomes. However, one critical challenge is detecting metastatic spread, which significantly impacts survival rates. Detecting breast cancer metastasis remains a key focus area for enhancing diagnostic accuracy and improving patient outcomes in the market.
The prognostic segment is expected to experience rapid growth in the breast cancer diagnostics market. Biomarkers, crucial for functional characterization, prognostication, and therapeutic prediction, are essential for clinical management. Traditional clinicopathological parameters are supplemented by genetic and molecular markers, enhancing patient characterization, particularly in luminal breast cancer cases. This advancement underscores the importance of biomarkers in guiding treatment decisions and improving patient outcomes in the market.
By End Use
On the basis of end-use, the market is segmented into hospitals & clinics, diagnostics centers & medical laboratories, and others. The hospitals & clinics segment dominated the overall market with a revenue share of 51.00% in 2023. Additional tests are commonly employed by doctors for breast cancer detection and diagnosis, often leading to referrals to specialists or surgeons. However, such referrals do not necessarily indicate a cancer diagnosis or the need for surgery. This highlights the crucial role of hospitals and clinics in facilitating comprehensive diagnostic pathways and patient care in the market.
Diagnostic centres and medical laboratories are poised for rapid growth in the breast cancer diagnostics market. These facilities play a crucial role in diagnosing breast cancer through various biopsy techniques such as fine-needle aspiration, core needle biopsy, MRI-guided biopsy, or surgical biopsy. Specialists analyse tumour samples and genetic profiles in laboratories. Hormone receptor and HER2/neu tests are common lab procedures. These centres facilitate accurate diagnosis and personalized treatment planning for patients, driving growth in the market.
Recent Developments
- In April 2023, Epic Sciences announced Medicare coverage for its breast-cancer-focused ctDNA gene panel.
- In September 2023, Detumomab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial.
- In December 2023, Pfizer completed the acquisition of Seage.
- In December 2023, Strati path and Proscia announced a partnership, paving the way to bring relapse risk prediction to more breast cancer patients.
- In January 2024, Siemens Healthiness expanded its partnership with City Cancer Challenge.
- In November 2023, iCAD and CancerIQ announced a partnership to integrate AI-enabled technology with a best-in-class risk assessment and care management platform, offering a comprehensive breast health care solution.
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Some of the prominent players in the global breast cancer diagnostics market include:
- Genomic Health (Exact Sciences Corporation)
- BD
- Danaher
- Koninklijke Philips N.V.
- QIAGEN
- Thermo Fisher Scientific Inc.
- Myriad Genetics, Inc.
- Argon Medical Devices, Inc.
- F. Hoffmann-La Roche Ltd.
- Hologic Inc.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Breast Cancer Diagnostics market.
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
By End-use
- Hospitals & Clinics
- Diagnostic Centers and Medical Laboratories
- Others
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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