Global HER2 Breast Cancer Tests Market to Reach US$529.5 Million by 2030

The global market for HER2 Breast Cancer Tests estimated at US$394.4 Million in the year 2024, is expected to reach US$529.5 Million by 2030, growing at a CAGR of 5.0% over the analysis period 2024-2030. Immunohistochemistry Test, one of the segments analyzed in the report, is expected to record a 4.0% CAGR and reach US$331.3 Million by the end of the analysis period. Growth in the Fluorescence / Chromogenic In-Situ Hybridization Test segment is estimated at 6.8% CAGR over the analysis period.

The U.S. Market is Estimated at US$107.4 Million While China is Forecast to Grow at 7.8% CAGR

The HER2 Breast Cancer Tests market in the U.S. is estimated at US$107.4 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$104.1 Million by the year 2030 trailing a CAGR of 7.8% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 2.5% and 5.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 3.2% CAGR.

Global HER2 Breast Cancer Tests Market - Key Trends & Drivers Summarized

Why Are HER2 Breast Cancer Tests Essential in Modern Oncology?

HER2 (Human Epidermal Growth Factor Receptor 2) breast cancer tests are diagnostic procedures used to determine the overexpression or amplification of the HER2 gene in breast cancer tissue. These tests are critical in guiding treatment decisions, as HER2-positive cancers typically grow faster and respond differently to targeted therapies. Accurate identification allows for the selection of therapies such as trastuzumab or pertuzumab, which specifically inhibit HER2 activity and improve survival outcomes.

Testing is typically performed using immunohistochemistry (IHC) or in situ hybridization (ISH) techniques on biopsy or surgical tissue samples. In recent years, advanced assays, digital pathology solutions, and companion diagnostics have emerged to improve diagnostic precision. HER2 testing is now a routine part of breast cancer diagnosis in oncology centers, contributing to the growing demand for high-quality and reliable diagnostic platforms.

What Diagnostic Innovations Are Influencing Test Accuracy and Adoption?

Technological advancements have improved HER2 test sensitivity, reproducibility, and interpretability. IHC tests have evolved with enhanced antibodies, automated staining systems, and standardized scoring algorithms. Dual-probe ISH tests provide confirmation in ambiguous cases, helping resolve borderline HER2 expressions. Fluorescence ISH (FISH) and chromogenic ISH (CISH) remain widely used for confirming gene amplification at the cellular level.

Emerging platforms are integrating digital imaging, AI-assisted pathology, and multiplex testing capabilities to enhance diagnostic workflows. Some HER2 assays are now being developed as part of broader genomic profiling tests that assess multiple biomarkers simultaneously. Companion diagnostic tests co-developed with targeted drugs are also gaining traction, especially as HER2-targeted treatments expand into other tumor types like gastric and colorectal cancers.

Where Is Testing Volume Increasing, and Which Institutions Are Driving Uptake?

Testing volumes are rising globally due to increasing breast cancer incidence and the growing adoption of personalized medicine in oncology. Hospitals, cancer specialty centers, and reference laboratories are key testing sites. In high-income countries, HER2 testing is a standard part of breast cancer workups, while in middle-income regions, uptake is increasing with improvements in pathology infrastructure and treatment access.

North America and Europe are mature markets with well-established diagnostic guidelines and reimbursement systems. Asia Pacific is witnessing rapid growth due to rising breast cancer awareness, expanding access to targeted therapies, and government initiatives supporting oncology diagnostics. The development of public-private partnerships and national cancer screening programs is further accelerating testing penetration.

What Is Driving Growth in the HER2 Breast Cancer Tests Market?

Growth in the HER2 breast cancer tests market is driven by several factors including rising global breast cancer incidence, increased use of HER2-targeted therapies, and ongoing improvements in diagnostic precision. Advances in staining reagents, automation systems, and AI-powered pathology tools are making HER2 testing more accurate and scalable.

End-use expansion in oncology hospitals, pathology labs, and companion diagnostics for new HER2-targeted drugs is boosting market relevance. Regulatory approvals for HER2 testing in tumor types beyond breast cancer and increased adoption of multiplex biomarker panels are broadening application scope. As precision medicine becomes central to oncology care, demand for reliable, high-throughput HER2 testing solutions is expected to grow steadily.