Next-Generation Breast Cancer Diagnostic and Screening Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (Real-Time PCR, Immunohistochemistry (IHC), Next-Generation Sequencing (NGS), Fluorescence In-Situ Hybridization (FISH), Others), By Biomarker (BRCA1/2, ER/PR Receptors, HER-2, Others), By Cancer Sub-Type (Luminal A, Luminal B, Triple Negative/Basal Like, Human Epidermal Growth Factor Receptor 2 (HER-2) Enriched), By Offering (Products, Services), By End User (Hospitals and Clinics, Diagnostic Centers and Reference Labs, Academic and Research Institutes), By Region and Competition, 2020-2030F

Market Overview

Global Next-Generation Breast Cancer Diagnostic and Screening Market was valued at USD 4.65 Billion in 2024 and is expected to reach USD 8.53 Billion in the forecast period with a CAGR of 10.61% through 2030. Next-generation breast cancer diagnostic and screening methods refer to advanced and innovative approaches to detecting and diagnosing breast cancer. These methods incorporate cutting-edge technologies, molecular insights, and personalized approaches to improve the accuracy and effectiveness of breast cancer detection, diagnosis, and risk assessment. Next-generation methods enable the molecular subtyping of breast cancer based on specific genetic markers. This subtyping provides insights into the tumor's behavior and helps determine the most appropriate treatment strategy. Common subtypes include hormone receptor-positive, HER2-positive, and triple-negative breast cancer. The increasing incidence of breast cancer worldwide has been a significant driver. As breast cancer rates continue to rise, the demand for advanced diagnostic and screening methods to detect the disease at an early stage has also increased.

Ongoing technological advancements in breast imaging, genetic testing, and molecular diagnostics have improved the accuracy and early detection of breast cancer, driving demand for these technologies. The shift toward personalized medicine has led to an increased demand for diagnostic tests that provide individualized information about a patient's breast cancer subtype and genetic profile. This information guides treatment decisions. Breast cancer awareness campaigns and initiatives promoting early detection have encouraged more women to undergo regular breast cancer screening, contributing to market growth. Next-generation sequencing (NGS) and genomic profiling have expanded their applications in breast cancer diagnosis, allowing for a more comprehensive assessment of the disease's genetic characteristics. Growing awareness of hereditary factors contributing to breast cancer risk has led to an increased demand for genetic testing, including BRCA1/2 mutation testing, among individuals with a family history of the disease.

Key Market Drivers

Advancements in Technology

​Digital mammography has largely supplanted traditional film mammography, offering enhanced image quality, streamlined storage and retrieval, and the capability to manipulate images for improved visualization of breast tissue. As of June 2023, the U.S. Food and Drug Administration reported that 87% of mammography facilities in the United States have adopted 3D mammography systems, also known as breast tomosynthesis, which capture multiple X-ray images from different angles to create a three-dimensional representation of the breast. This technology has been shown to reduce false positives and improve cancer detection, particularly in women with dense breast tissue.​

Breast Magnetic Resonance Imaging (MRI) utilizes powerful magnets and radio waves to generate detailed images of breast tissue, proving especially useful for assessing disease extent and detecting tumors in high-risk women. Advanced ultrasound technologies, including elastography and contrast-enhanced ultrasound, offer additional insights into breast lesions, aiding in distinguishing between benign and malignant tumors. Genetic testing has advanced with next-generation sequencing, allowing simultaneous analysis of multiple genes to comprehensively assess mutations associated with breast cancer.​

Liquid biopsy techniques, which analyze biomarkers such as circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) in blood samples, provide real-time information on cancer status and treatment response. In England, the National Health Service has implemented liquid biopsies to detect tumor DNA, benefiting approximately 1,100 women annually by enabling access to targeted treatments like elacestrant for specific mutations. Artificial intelligence (AI) algorithms are being developed to analyze mammograms and other medical images for signs of breast cancer, enhancing diagnostic accuracy and efficiency. A study involving 461,818 women screened between July 2021 and February 2023 found that AI-assisted radiologists achieved a 17.6% higher cancer detection rate without increasing false positives. ​

Technologies like gene expression profiling and proteomics are employed to characterize breast cancer at the molecular level, informing treatment options and predicting patient outcomes. The integration of telemedicine and remote monitoring facilitates breast cancer screening and follow-up care without necessitating in-person visits, thereby improving access to diagnostic services. Digital pathology enables remote viewing and analysis of tissue samples, enhancing efficiency and collaboration among experts for more accurate diagnoses. Advanced computational models assess individual breast cancer risk based on factors including genetics, family history, and lifestyle. Emerging imaging techniques like positron emission tomography (PET) and single-photon emission computed tomography (SPECT) are being explored for their potential in breast cancer diagnosis and staging. Refinements in immunohistochemistry (IHC) techniques provide more accurate characterization of breast cancer subtypes and biomarkers, guiding treatment decisions.​

These advancements collectively contribute to the development of the Global Next-Generation Breast Cancer Diagnostic and Screening Market.

Expanding Applications of Genomic Sequencing

Genomic sequencing, the process of determining an organism's complete DNA sequence, has significantly expanded its applications across diverse fields, particularly in healthcare and genetics. In oncology, genomic sequencing is used to characterize genetic mutations in cancer cells, thereby guiding oncologists in selecting the most appropriate targeted therapies for individual patients. According to the National Cancer Institute (NCI), genomic sequencing contributed to the management of approximately 35% of new cancer cases in the U.S. in 2022, underscoring its critical role in precision medicine. Liquid biopsies, which involve sequencing cell-free DNA in blood samples, are gaining prominence for real-time monitoring of tumor dynamics and treatment responses. Furthermore, genomic sequencing enables the identification of genetic variations that influence patient responses to medications, forming the basis of pharmacogenomics to optimize drug efficacy and safety.

Whole exome sequencing (WES) and whole genome sequencing (WGS) are indispensable for diagnosing rare genetic disorders when conventional methods fail. Genomic sequencing also finds application in non-invasive prenatal testing (NIPT), where cell-free fetal DNA in maternal blood is analyzed to screen for chromosomal abnormalities. The Centers for Disease Control and Prevention (CDC) reported that over 10 million SARS-CoV-2 sequences were generated between 2020 and 2022, highlighting the transformative impact of sequencing in public health. Beyond healthcare, genomic sequencing is used in agriculture to enhance crop breeding and in environmental studies to assess biodiversity. These advancements, supported by robust bioinformatics tools to manage large-scale data, continue to drive the demand for next-generation diagnostic technologies, a factor that will pace up the Global Next-Generation Breast Cancer Diagnostic and Screening Market.

Rising Awareness and Early Detection Campaigns

Awareness campaigns provide essential information about breast cancer risk factors, signs, symptoms, and the benefits of early detection. This education empowers individuals to make informed decisions about their health and screening options. Awareness initiatives often promote adherence to recommended breast cancer screening guidelines, which may include mammography, genetic testing, clinical breast exams, and self-breast exams. Encouraging adherence to these guidelines drives demand for screening services. Breast cancer awareness campaigns help reduce the stigma associated with cancer and dispel fears related to screening procedures. When individuals are more informed and less fearful, they are more likely to undergo recommended screenings. Early detection of breast cancer is associated with better treatment outcomes and improved survival rates. Awareness campaigns emphasize the importance of detecting cancer at an early, more treatable stage, motivating individuals to seek screening services. Many awareness campaigns target specific populations, including women of certain age groups, ethnic backgrounds, or those with known risk factors. Targeted outreach efforts increase awareness and screening rates within these populations.

Awareness campaigns often include information about where and how to access breast cancer screening services. This information makes it easier for individuals to schedule screenings and seek care. Awareness campaigns often advocate for funding and support for breast cancer research. This research leads to advancements in screening technologies and diagnostic methods, increasing the availability of next-generation tools. These campaigns emphasize the importance of individual agency in healthcare decisions. Empowered patients are more likely to engage in preventive healthcare measures like screening. Many breast cancer awareness campaigns involve local communities, healthcare providers, and advocacy organizations. These collaborations foster a sense of community support and encourage individuals to prioritize their health. Sharing the stories of breast cancer survivors who benefited from early detection and treatment can inspire others to prioritize screening and early intervention. Awareness campaigns have a global impact by raising awareness about breast cancer in regions with limited access to healthcare. These campaigns contribute to international efforts to combat breast cancer. Awareness campaigns can influence healthcare policies and regulations, advocating for improved access to screening services, insurance coverage, and research funding. This factor will accelerate the demand of Global Next-Generation Breast Cancer Diagnostic and Screening Market.

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Key Market Challenges

Ethical and Legal Issues

As next-generation diagnostic and screening methods generate large volumes of sensitive patient data, ensuring privacy and data security becomes paramount. Ethical concerns arise regarding the storage, sharing, and protection of patient genetic and medical information. Patients must provide informed consent before undergoing genetic testing or other screening procedures. Ensuring that patients fully understand the implications of the tests, including potential psychological and medical consequences, is an ethical imperative. Concerns about genetic discrimination in employment, insurance, and other areas may deter individuals from undergoing genetic testing. Legal protections against such discrimination are essential to address these concerns. Ethical and legal questions arise about who owns the genetic and medical data generated through screening. This includes issues related to data access, sharing, and commercialization. Next-generation screening technologies must adhere to regulatory standards to ensure safety, accuracy, and efficacy. Navigating the complex regulatory landscape can be a challenge for companies and healthcare providers. Ethical issues related to healthcare equity and access arise when next-generation screening technologies are not equally available to all populations. Disparities in access can lead to unequal health outcomes.

Cost and Accessibility

Many next-generation breast cancer screening and diagnostic methods, such as genetic testing, molecular profiling, and advanced imaging techniques, can be expensive. The cost of equipment, laboratory testing, and data analysis can be a barrier to access for both patients and healthcare providers. Socioeconomic disparities can affect access to advanced breast cancer screening. Low-income individuals and underserved populations may face difficulties in accessing these services due to financial constraints and limited healthcare resources. The availability and extent of insurance coverage for next-generation breast cancer screening and diagnostics vary by region and healthcare system. Lack of adequate insurance coverage can limit access for many patients, making these services financially out of reach. Access to advanced diagnostic centers, specialized expertise, and next-generation technologies may be limited in rural or remote areas. Geographic barriers can hinder individuals from undergoing timely screenings and diagnostics. In some regions, a lack of healthcare infrastructure and resources can limit access to advanced screening and diagnostic services. This includes the availability of trained healthcare professionals and specialized facilities. The high cost of next-generation technologies can be particularly challenging for healthcare systems in developing countries, where resources are limited. This can result in disparities in breast cancer detection and care on a global scale.

Key Market Trends

Integration of Multi-Omics Data

Multi-omics approaches enable healthcare providers to obtain a detailed profile of breast cancer at the molecular level. This includes information on genetic mutations, gene expression patterns, protein activity, metabolite levels, and epigenetic modifications. Integration of multi-omics data allows for precise molecular subtyping of breast cancer, which helps tailor treatment strategies based on the unique characteristics of each patient's tumor. This approach enhances the effectiveness of targeted therapies and minimizes unnecessary treatments. Multi-omics data analysis can identify biomarkers associated with early-stage breast cancer and risk prediction. This aids in early detection and risk assessment, enabling healthcare providers to intervene at an earlier, more treatable stage. Multi-omics analysis identifies specific molecular targets within breast cancer cells that can be exploited for treatment. This leads to the development of targeted therapies and more effective treatment options. Multi-omics data can be used to monitor a patient's response to treatment over time. Changes in gene expression, protein activity, or metabolite levels can indicate treatment efficacy or the need for therapeutic adjustments.

Segmental Insights

Biomarker Insights

Based on the Biomarker, BRCA1/2 emerged as the dominant segment in the Global Next-Generation Breast Cancer Diagnostic and Screening Market in 2024. This is due to its well-established role in hereditary breast cancer risk assessment. Mutations in the BRCA1 and BRCA2 genes are among the most significant genetic markers associated with an increased risk of developing breast and ovarian cancers. Individuals carrying these mutations have a considerably higher lifetime risk of cancer, making BRCA1/2 testing critical for early diagnosis, risk management, and preventive strategies. As awareness of hereditary breast cancer increases, there has been a surge in demand for genetic testing, particularly among individuals with a family history of cancer. The clinical utility of BRCA1/2 testing has also expanded with the integration of precision medicine into oncology. These biomarkers not only assist in early detection and risk assessment but also play a key role in guiding treatment decisions, especially the use of PARP inhibitors, which are particularly effective in BRCA-mutated cancers.

Cancer Sub-Type Insights

Based on the Cancer Sub-Type, Luminal A emerged as the dominant segment in the Global Next-Generation Breast Cancer Diagnostic and Screening Market in 2024. This is due to its high prevalence and relatively favorable prognosis compared to other breast cancer sub-types. Luminal A tumors are typically estrogen receptor-positive (ER+), progesterone receptor-positive (PR+), and HER2-negative, with low levels of the Ki-67 protein, indicating slower growth. This sub-type represents the most common form of breast cancer, especially among postmenopausal women, making it a major focus for diagnostic and screening efforts worldwide. Next-generation diagnostic tools, including multi-gene panels and molecular profiling techniques, have significantly improved the identification and classification of Luminal A tumors, enabling more precise treatment strategies. The dominance of Luminal A is also supported by clinical guidelines that emphasize hormone receptor testing as a first-line diagnostic step in breast cancer management. As this sub-type typically responds well to hormonal therapies such as tamoxifen or aromatase inhibitors, early and accurate identification through advanced diagnostics plays a vital role in improving patient outcomes.

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Regional Insights

North America emerged as the dominant region in the Global Next-Generation Breast Cancer Diagnostic and Screening Market in 2024. This is due to a combination of advanced healthcare infrastructure, high awareness levels, and strong government initiatives supporting early cancer detection. The region has seen rapid adoption of next-generation diagnostic tools, such as digital breast tomosynthesis (DBT), molecular breast imaging (MBI), and genomic testing, which offer greater accuracy and sensitivity in identifying breast cancer at earlier stages. Moreover, significant investments in research and development by both public institutions and private entities have facilitated continuous innovation in diagnostic technologies. The presence of major market players and diagnostic companies in the United States and Canada has further supported market expansion, with strategic collaborations and product launches aimed at improving screening outcomes.

Asia-Pacific emerged as the fastest growing region in the Global Next-Generation Breast Cancer Diagnostic and Screening Market during the forecast period. This is due to increasing awareness and proactive government initiatives focused on early cancer detection. Various national screening programs and public health campaigns in countries like China, India, Japan, and South Korea have helped boost early-stage breast cancer detection rates. Governments across the region are collaborating with healthcare organizations to deploy advanced diagnostic technologies, including molecular testing and imaging systems, in public hospitals and diagnostic centers. In addition, rising educational efforts aimed at reducing social stigma and improving knowledge about breast cancer among women have significantly increased screening uptake. The region has also seen growing partnerships between public and private players, further supporting investment in diagnostic infrastructure and access to innovative technologies.

Recent Developments

• In December 2024, Hologic, Inc. showcased new data on its Genius AI Detection 2.0 software at the Radiological Society of North America’s 110th Annual Meeting. The study highlighted the AI tool’s effectiveness in supporting breast cancer detection across diverse patient populations. Hologic emphasized the importance of using racially and ethnically representative datasets in training AI algorithms to reduce bias and ensure accurate results for all demographic groups.
• In November 2024, Caris Life Sciences announced that the U.S. FDA approved its MI Cancer Seek test as a companion diagnostic (CDx) to identify patients eligible for targeted cancer therapies. This marks the first FDA-approved test to combine Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) for pan-cancer and five tumor-specific indications. The assay is approved for use in both adults and pediatric patients aged 1 to 22.
• In October 2024, Foundation Medicine received FDA approval for its liquid biopsy test, FoundationOneLiquid CDx, as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant. This combination therapy, developed by Genentech (Roche Group), was also FDA-approved for treating PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant advanced breast cancer in adults. The test helps identify patients eligible for this targeted treatment.
• In June 2024, DELFI Diagnostics, Inc. announced the publication of pivotal data in Cancer Discovery from its L101 study, validating the performance of its FirstLook Lung test, a blood-based, AI-driven assay for early lung cancer detection. The study highlights the test’s clinical potential, marking a major step forward in non-invasive cancer diagnostics.
• In June 2024, Thermo Fisher Scientific, National University Hospital (NUH) Singapore, and RNA technology firm Mirxes signed an MoU to expand access to affordable, advanced genomic testing for early cancer detection in Singapore. The collaboration aims to co-develop and clinically validate next-generation sequencing (NGS) solutions tailored to the Southeast Asian population, supporting cancer research and early diagnosis efforts in the region.
• In January 2024, Cleveland Diagnostics, Inc., a clinical-stage biotech firm specializing in early cancer detection, secured over USD 75 million in growth capital. The round was led by Novo Holdings, with participation from existing investors and a credit facility from Symbiotic Capital. The funding will support the company’s commercial expansion and corporate development initiatives.

Key Market Players

• Abbott Laboratories
• Agendia Inc.
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• Genomics Co., Ltd.
• CENTOGENE N.V
• Danaher Corporation
• Exact Sciences Corporation
• Hoffmann-La Roche Ltd.
• Illumina, Inc.
• Thermo Fisher Scientific Inc.
• Lucence Diagnostics Pte Ltd.

Report Scope:

In this report, the Global Next-Generation Breast Cancer Diagnostic and Screening Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

•  Next-Generation Breast Cancer Diagnostic and Screening Market, By Technology:

o    Real-Time PCR

o    Immunohistochemistry (IHC)

o    Next-Generation Sequencing (NGS)

o    Fluorescence In-Situ Hybridization (FISH)

o    Others

•  Next-Generation Breast Cancer Diagnostic and Screening Market, By Biomarker:

o    BRCA1/2

o    ER/PR Receptors

o    HER-2

o    Others

•  Next-Generation Breast Cancer Diagnostic and Screening Market, By Cancer Sub-Type:

o    Luminal A

o    Luminal B

o    Triple Negative/Basal Like

o    Human Epidermal Growth Factor Receptor 2 (HER-2) Enriched

• Next-Generation Breast Cancer Diagnostic and Screening Market, By Offering:

o    Products

o    Services

• Next-Generation Breast Cancer Diagnostic and Screening Market, By End User:

o    Hospitals and Clinics

o    Diagnostic Centers, and Reference Labs

o    Academic and Research Institutes

• Next-Generation Breast Cancer Diagnostic and Screening Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

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 present in the Global Next-Generation Breast Cancer Diagnostic and Screening Market.

Available Customizations:

Global Next-Generation Breast Cancer Diagnostic and Screening 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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