Global HER2 Breast Cancer Test Market Report

The forecast for the global HER2 Breast Cancer Test market predicts substantial growth, with market size projected to soar to USD 732.34 Million by 2033, a significant increase from the USD 406.48 Million recorded in 2024. This expansion reflects an impressive compound annual growth rate (CAGR) of 6.76% anticipated between 2025 and 2033.

HER2 Breast Cancer Test Market Size and Forecast 2025 to 2033

The HER2 breast cancer test market is experiencing substantial growth driven by the rising global incidence of breast cancer, particularly the HER2-positive subtype. The World Health Organization reported that in 2022, there were 2.3 million women diagnosed with breast cancer globally. This increasing disease burden directly fuels the demand for accurate and timely HER2 testing, which is crucial for determining appropriate targeted therapies. Advances in diagnostic technologies, such as improved immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) techniques, are enhancing the precision and efficiency of HER2 assessment, thereby contributing to market expansion. Moreover, growing awareness among healthcare professionals and patients about the importance of HER2 status in personalized medicine is further boosting market opportunities. The continuous development of novel HER2-targeted therapies also necessitates robust diagnostic tools, creating a symbiotic relationship that propels market growth.

Market Dynamics

HER2 Breast Cancer Test Market Drivers

• Increasing Breast Cancer Incidence and Mortality Rates: The escalating global incidence and mortality rates associated with breast cancer are significant drivers for the HER2 breast cancer test market. According to the World Health Organization, breast cancer remains the most common cancer globally, with millions of new cases diagnosed annually. The American Cancer Society highlights that while incidence rates have stabilized in recent years, breast cancer still accounts for a substantial number of cancer-related deaths. This persistent burden of the disease necessitates widespread and accurate diagnostic tools like HER2 tests to guide effective treatment strategies and improve patient outcomes worldwide
• Advancements in Personalized Medicine: The paradigm shift towards personalized medicine in oncology is profoundly impacting the HER2 breast cancer test market. This approach emphasizes tailoring treatments based on an individual's genetic and molecular profile. HER2 testing is a cornerstone of this strategy for breast cancer, enabling clinicians to identify patients who will benefit from HER2-targeted therapies. The increasing adoption of precision oncology models by healthcare systems globally, as reported by the National Cancer Institute, underscores the growing demand for highly specific diagnostic tools like HER2 tests.
• Development of Targeted Therapies: The continuous innovation and introduction of new HER2-targeted therapies are driving the demand for corresponding diagnostic tests. These therapies, such as antibody-drug conjugates, require precise identification of HER2 status to ensure efficacy and minimize adverse effects. For instance, the approval of novel HER2-directed drugs necessitates accurate and reliable companion diagnostics, as highlighted by various medical regulatory bodies. This co-evolution of therapeutics and diagnostics creates a sustained need for advanced HER2 testing.
• Growing Awareness and Screening Programs: Enhanced awareness among both healthcare providers and the general public regarding breast cancer screening and the importance of HER2 testing is propelling market growth. Public health initiatives and campaigns promoting early detection contribute to a higher rate of diagnosis. Increased understanding that HER2 status dictates specific treatment pathways, as emphasized by the Centers for Disease Control and Prevention, encourages broader adoption of these tests in clinical practice, leading to better management of the disease.

HER2 Breast Cancer Test Market Opportunities

• Emergence of HER2-low Subtype Testing: The recent identification and therapeutic targeting of the HER2-low breast cancer subtype present a substantial market opportunity. This new classification expands the patient population eligible for HER2-directed therapies, necessitating the development and widespread adoption of more sensitive and quantitative testing methods. As research continues to elucidate the clinical implications of HER2-low expression, the demand for precise diagnostic tools capable of distinguishing this subtype will grow significantly, fostering innovation in assay development.
• Integration of Liquid Biopsy in HER2 Testing: The increasing adoption of liquid biopsy as a less invasive alternative to tissue biopsy offers a significant opportunity for market expansion. Liquid biopsy allows for real-time monitoring of tumor evolution and HER2 status, which is particularly valuable in cases where tissue biopsy is challenging or repeated assessments are needed. As this technology matures and its clinical utility for HER2 testing becomes more established, its integration into routine practice will create new avenues for diagnostic companies, improving patient convenience and enabling dynamic treatment adjustments.
• Expansion into Emerging Economies: Developing regions present immense untapped market potential due to improving healthcare infrastructure, rising disposable incomes, and increasing awareness of breast cancer. Many emerging economies are witnessing a growing burden of non-communicable diseases, including cancer. Investment in healthcare infrastructure and increased access to advanced diagnostics in countries across Asia-Pacific and Latin America, as noted by various development agencies, will drive the demand for HER2 breast cancer tests, offering significant growth opportunities for market players.
• Technological Advancements in Automation and Digital Pathology: The ongoing advancements in automation and digital pathology are creating opportunities to enhance the efficiency and accuracy of HER2 testing. Automated staining platforms and digital image analysis systems reduce human error, improve turnaround times, and facilitate remote pathology consultations. These technologies streamline laboratory workflows and enable more standardized and reproducible results. The adoption of artificial intelligence and machine learning in analyzing HER2 test images further contributes to more precise and consistent diagnoses, representing a key area for future market development.

HER2 Breast Cancer Test Market Restrain & Challenges

• High Cost of HER2 Testing: The considerable cost associated with advanced HER2 breast cancer tests, particularly molecular assays, presents a significant restraint on market growth. While these tests offer invaluable diagnostic information, their expense can limit accessibility, especially in healthcare systems with budget constraints or for uninsured patients. The economic burden of comprehensive testing, including the specialized equipment and trained personnel required for sophisticated techniques, can deter widespread adoption, impacting patient access to crucial diagnostic information.
• Complexity and Standardization Challenges in Testing: The inherent complexity of HER2 testing methodologies, involving multiple steps from sample collection to interpretation, poses a challenge to standardization and reproducibility. Variations in pre-analytical factors, such as tissue fixation, and analytical factors, like antibody clones or scoring criteria, can lead to discrepancies in results. This variability necessitates stringent quality control and proficiency testing programs, and as highlighted by the College of American Pathologists, achieving consistent inter-laboratory and intra-laboratory concordance remains an ongoing challenge, potentially affecting treatment decisions.
• Lack of Skilled Professionals and Infrastructure in Developing Regions: A significant challenge, particularly in low and middle-income countries, is the dearth of adequately trained healthcare professionals and the absence of robust laboratory infrastructure required for accurate HER2 testing. Performing and interpreting complex tests like FISH or quantitative IHC demands specialized expertise. Without sufficient skilled pathologists, laboratory technicians, and state-of-the-art equipment, the widespread adoption of advanced HER2 testing remains hindered, limiting equitable access to precise diagnostics globally.
• Reimbursement Policy Limitations: Inadequate or restrictive reimbursement policies for HER2 breast cancer tests can significantly impede market growth. In many healthcare systems, diagnostic tests must meet specific criteria to be eligible for reimbursement, and delays or insufficient coverage can create financial barriers for patients and healthcare providers. The complexity of securing reimbursement for newer, more advanced HER2 testing modalities can discourage their adoption, even when they offer superior diagnostic accuracy and clinical utility, thereby slowing market penetration.

Current Trends in the HER2 Breast Cancer Test Market

• Shift Towards Quantitative HER2 Assessment: A notable trend in the HER2 breast cancer test market is the increasing focus on quantitative assessment methods, moving beyond traditional semi-quantitative approaches. This shift is driven by the emergence of HER2-low breast cancer, which requires more precise measurement of protein expression. Technologies such as digital image analysis and quantitative immunofluorescence are gaining traction, allowing for more objective and reproducible results, which is crucial for stratifying patients into appropriate treatment categories and optimizing therapeutic outcomes, as detailed by recent research in precision oncology.
• Growing Adoption of Next-Generation Sequencing (NGS) for Comprehensive Genomic Profiling: The integration of Next-Generation Sequencing (NGS) into breast cancer diagnostics is a significant trend. While not solely focused on HER2, NGS allows for comprehensive genomic profiling, including HER2 gene amplification and mutations, alongside other actionable biomarkers. This holistic approach provides a more complete picture of the tumor's molecular landscape, guiding more personalized treatment strategies. The National Cancer Institute emphasizes the increasing role of broad molecular testing panels in oncology, reflecting this trend towards comprehensive genomic assessment.
• Development of Minimally Invasive or Non-Invasive Testing Methods: There is a strong trend towards developing and adopting less invasive methods for HER2 testing, such as liquid biopsies. These approaches, utilizing circulating tumor DNA (ctDNA) or circulating tumor cells (CTCs) from blood samples, offer several advantages, including reduced patient discomfort, the ability to monitor disease progression in real-time, and overcome limitations of tissue availability. Research institutions are actively exploring the clinical utility of these non-invasive techniques for initial HER2 assessment and monitoring treatment response, promising a future of more accessible and dynamic testing.
• Artificial Intelligence (AI) and Machine Learning in Image Analysis: The application of artificial intelligence and machine learning algorithms in the analysis of HER2 immunohistochemistry and FISH slides is a rapidly evolving trend. AI-powered tools can automate and standardize the interpretation process, reducing inter-observer variability and improving diagnostic accuracy and efficiency. These technologies can objectively quantify HER2 protein expression and gene amplification, assisting pathologists in making more consistent and reliable diagnoses, a development highlighted by advances in computational pathology aiming to enhance diagnostic precision.

Segmentation Insights

HER2 Breast Cancer Test market Analysis, By Test Type

By Test Type, the market is categorized into Immunohistochemistry (IHC), Fluorescence /Chromogenic In Situ Hybridization (FISH/CISH)

• Within the HER2 breast cancer test market, Immunohistochemistry (IHC) currently holds the largest share. This dominance can be attributed to several factors. IHC is widely adopted due to its relatively lower cost compared to other methods, making it more accessible to a broader range of healthcare facilities globally. Furthermore, IHC is a relatively rapid technique that can be performed using standard laboratory equipment, allowing for quicker turnaround times. Its ability to visually assess protein expression directly on tissue morphology provides pathologists with valuable contextual information, which aids in diagnosis and classification. The widespread availability of IHC reagents and established protocols also contributes significantly to its leading position in the market.

• Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH) is the fastest-growing segment in the HER2 breast cancer test market. This rapid growth is driven by the increasing need for highly accurate and quantitative assessment of HER2 gene amplification, especially with the emerging understanding of HER2-low breast cancer. While IHC identifies protein overexpression, FISH/CISH directly measures gene amplification, providing a more definitive diagnosis in equivocal IHC cases. The superior sensitivity and specificity of FISH/CISH, coupled with the rising demand for precision diagnostics to guide targeted therapies, are propelling its adoption. Technological advancements leading to improved automation and workflow for these techniques further contribute to their accelerated growth.

HER2 Breast Cancer Test market Analysis, By End-user

By End-user, the market is categorized into Hospitals and Diagnostic Laboratories.

• Hospitals represent the largest segment in the HER2 breast cancer test market by end-user. This leading position is primarily due to hospitals being the primary point of care for cancer diagnosis and treatment. They house comprehensive pathology departments equipped with the necessary infrastructure, advanced instruments, and highly skilled personnel to perform a wide array of cancer diagnostic tests, including HER2 assessment. The integrated nature of hospital settings allows for seamless coordination between diagnostic testing and subsequent treatment planning, making them central to the patient care pathway. The high volume of breast cancer cases managed within hospitals naturally contributes to their dominant market share.
• Diagnostic Laboratories are currently the fastest-growing segment in the HER2 breast cancer test market by end-user. This accelerated growth can be attributed to several factors, including the increasing trend towards outsourcing specialized diagnostic tests by smaller hospitals and clinics. These laboratories often offer a broad spectrum of advanced testing services, including molecular assays for HER2, with specialized expertise and economies of scale that can be more efficient than in-house hospital labs for certain tests. The focus of diagnostic laboratories on rapid turnaround times and high-quality results also appeals to healthcare providers. The rising demand for second opinions and confirmatory testing further drives the growth of these specialized facilities.

HER2 Breast Cancer Test Market Regional Insights

The market has been geographically analysed across five regions, Europe, North America, Asia Pacific, Latin America, and the Middle East & Africa.

• North America holds the largest share in the HER2 Breast Cancer Test market. This dominance is primarily attributable to several factors, including the region's highly developed healthcare infrastructure, which facilitates widespread access to advanced diagnostic technologies. Furthermore, North America benefits from significant research and development investments in cancer diagnostics, leading to early adoption of innovative testing methods. The presence of a large patient population with breast cancer and high awareness among healthcare professionals about the importance of HER2 testing for guiding targeted therapies also contribute to the region's leading position. Favorable reimbursement policies for these tests further bolster market growth.
• Asia-Pacific is the fastest-growing region in the HER2 Breast Cancer Test market. This rapid expansion is driven by the increasing incidence of breast cancer across several countries in the region, coupled with improving healthcare infrastructure and rising healthcare expenditure. Governments and private organizations are investing in modernizing diagnostic facilities and increasing access to advanced cancer care. Moreover, growing awareness about personalized medicine and the crucial role of HER2 testing in treatment selection among oncologists and patients is propelling demand. The large and aging population, alongside a significant unmet medical need, makes Asia-Pacific a lucrative market for HER2 breast cancer testing.

HER2 Breast Cancer Test Market Competitive Overview

The competitive landscape of the HER2 Breast Cancer Test market is characterized by intense innovation and strategic collaborations aimed at enhancing diagnostic accuracy and expanding market reach. Leading players are focusing on developing comprehensive portfolios that include both immunohistochemistry and in situ hybridization assays, catering to diverse clinical needs and laboratory capabilities. The market is witnessing a trend towards more automated and digital solutions to improve workflow efficiency and reduce manual errors. Companies are also investing significantly in research and development to introduce next-generation testing platforms, including those capable of analyzing HER2-low expression, and exploring the utility of liquid biopsy for less invasive assessment. Strategic partnerships with pharmaceutical companies developing HER2-targeted therapies are also prevalent, ensuring the availability of companion diagnostics alongside new drug approvals.

Leading Market Players in the HER2 Breast Cancer Test Market

• Abbott Molecular, Inc.: Abbott Molecular, Inc. is a prominent player in the HER2 breast cancer test market, renowned for its contributions to molecular diagnostics. The company offers a portfolio of advanced testing solutions, including fluorescence in situ hybridization (FISH) probes that are crucial for determining HER2 gene amplification. Their diagnostic tools are widely used in laboratories globally, providing essential information for guiding treatment decisions in HER2-positive breast cancer. Abbott Molecular focuses on delivering high-quality, reliable, and standardized assays that assist pathologists and oncologists in accurately assessing HER2 status. The company is committed to innovation, continually developing new technologies to enhance the precision and efficiency of cancer diagnostics, supporting the evolving needs of personalized medicine and contributing to improved patient outcomes through accurate molecular profiling.
• Roche: Roche holds a significant and influential position in the HER2 breast cancer test market, distinguished by its comprehensive diagnostic and therapeutic offerings. The company is a pioneer in HER2 testing, with its immunohistochemistry (IHC) assays and fluorescence in situ hybridization (FISH) tests being widely adopted as gold standards in clinical practice. Roche's PATHWAY HER2 (4B5) test is particularly notable for its role as a companion diagnostic, enabling the identification of patients who will benefit from HER2-targeted therapies. Roche's integrated approach, spanning diagnostics to therapeutics, allows for a synergistic development process, ensuring that diagnostic tools are precisely calibrated to identify eligible patients for their innovative targeted treatments. The company also continually invests in research and development to refine existing tests and develop novel solutions for emerging HER2 subtypes, like HER2-ultralow breast cancer.
• Agilent Technologies: Agilent Technologies is a key participant in the HER2 breast cancer test market, primarily through its Dako brand, which is recognized for its high-quality pathology solutions. Agilent offers a range of immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) assays specifically designed for HER2 testing. Their products are valued for their reliability, sensitivity, and specificity, providing crucial diagnostic information for breast cancer patients. Agilent's focus extends to delivering integrated workflow solutions that streamline laboratory processes, from sample preparation to analysis, enhancing efficiency and accuracy in diagnostic settings. The company is dedicated to advancing precision medicine by providing robust and reproducible diagnostic tools that empower pathologists to make confident diagnoses and support targeted therapeutic interventions, contributing to improved patient management and clinical outcomes in HER2-positive breast cancer.

Top Strategies Followed by Players

• Strategic Collaborations and Partnerships: A key strategy adopted by market players is forming strategic collaborations and partnerships with other companies, research institutions, and pharmaceutical firms. These alliances facilitate the co-development of companion diagnostics for new HER2-targeted therapies, ensuring that diagnostic tests are available concurrently with drug approvals. For instance, partnerships between diagnostic companies and pharmaceutical giants accelerate the market entry of novel integrated solutions, streamlining the path from diagnosis to treatment. This approach also allows for sharing of expertise and resources, enhancing the robustness and clinical utility of HER2 testing platforms, and ultimately benefiting patient access to advanced therapies.
• Investment in Research and Development for Novel Assays: Leading companies in the HER2 breast cancer test market are significantly investing in research and development to innovate and introduce novel diagnostic assays. This includes developing more sensitive and quantitative methods to detect various levels of HER2 expression, such as the recently recognized HER2-low subtype. Investments are also channeled into exploring alternative testing modalities, like liquid biopsy, which offer less invasive options for diagnosis and monitoring. This continuous commitment to R&D ensures that market players remain at the forefront of technological advancements, providing cutting-edge solutions that address evolving clinical needs and improve diagnostic accuracy.
• Geographic Expansion and Market Penetration in Emerging Economies: A prevalent strategy is to expand geographic presence and penetrate emerging economies. These regions often represent significant untapped markets due to improving healthcare infrastructure, rising awareness of cancer, and increasing access to advanced medical technologies. Companies are focusing on establishing distribution networks, local partnerships, and training programs to make HER2 tests more accessible in these areas. This strategy not only broadens the customer base but also contributes to global efforts in improving cancer diagnostics and personalized treatment options in underserved populations, driving overall market growth and reach.

List of Companies Profiled in the Report are:

• Abbott Molecular Inc.
• Biogenex Laboratories Inc.
• Leica Biosystems
• Roche
• Agilent Technologies
• Mylab Discovery Solutions Pvt. Ltd.
• Jiangsu HengRui Medicine Co., Ltd.
• Shanghai Henlius Biotech
• Merus N.V.
• GeneQuantum

Global HER2 Breast Cancer Test Market Report: Scope

List of Segments Covered

This section of the HER2 Breast Cancer Test market report provides detailed data on the segments at country and regional level, thereby assisting the strategist in identifying the target demographics for the respective product or services with the upcoming opportunities.

By Test Type

• Immunohistochemistry (IHC)
• Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH)

By End-user

• Hospitals
• Diagnostic Laboratories
• Others