Written by The global HER2 breast cancer test market is witnessing steady development as healthcare systems adapt to disruptions caused by the coronavirus outbreak. The pandemic affected breast cancer screening, diagnosis, treatment, and follow-up care, with concerns about infection exposure prompting some patients to postpone appointments and procedures. Against this backdrop, telehealth platforms, virtual consultations, and mobile healthcare applications are emerging as valuable tools for maintaining communication between patients and healthcare providers and reducing avoidable delays in care. As healthcare systems restore routine services and expand access to essential oncology services, demand for accurate HER2 testing is expected to remain closely linked to improvements in breast cancer diagnosis and treatment pathways. HER2, or human epidermal growth factor receptor 2, testing helps determine whether breast cancer cells contain elevated levels of the HER2 protein or HER2 gene amplification, information that can influence treatment decisions.
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Market Size and Growth
The HER2 breast cancer test market is projected to reach US$627.7 Mn by 2031, expanding at a 6.5% CAGR during the forecast period. The rising global burden of breast cancer remains a major growth factor, alongside increasing emphasis on early diagnosis, personalized treatment, and improved pathological evaluation. According to the World Health Organization, approximately 2.3 million women were diagnosed with breast cancer in 2020, while 685,000 deaths were reported globally. The growing adoption of targeted therapies has also increased the importance of reliable HER2 status determination. However, inconsistent interpretation of immunohistochemistry (IHC) results across laboratories remains a market challenge. Healthcare providers and diagnostic laboratories are therefore emphasizing standardized testing procedures, quality control, and additional review of ambiguous results.
Market Segmentation
Based on test type, the HER2 breast cancer test market is segmented into immunohistochemistry (IHC) and fluorescence/chromogenic in situ hybridization (FISH/CISH). IHC remains widely used because it assesses HER2 protein expression and is comparatively accessible in routine pathology settings. FISH evaluates HER2 gene amplification and is frequently used when IHC results are equivocal. Chromogenic in situ hybridization is also gaining attention because it can enable tumor evaluation using conventional microscopy and offers permanent signals for archival purposes. By end user, the market is divided into hospitals and diagnostic laboratories, with both segments benefiting from increasing breast cancer testing volumes and the broader adoption of standardized diagnostic protocols.
Regional Analysis
Europe represents a significant regional market for HER2 breast cancer testing. The European market was valued at approximately US$106.1 Mn in 2020 and is projected to reach US$207.2 Mn by 2031, representing a CAGR of 6.3% during 2021–2031. The region’s growth is supported by the substantial incidence of breast cancer, established healthcare infrastructure, and increasing focus on accurate cancer diagnosis. North America is also expected to remain an important market due to advanced pathology capabilities, oncology research, and the adoption of precision-medicine approaches. Meanwhile, Asia Pacific offers considerable expansion opportunities as healthcare infrastructure improves, awareness of cancer screening increases, and diagnostic services become more accessible.
Competitive Landscape
The competitive landscape includes diagnostic technology companies and laboratory-solution providers developing and supplying HER2 testing technologies, reagents, instruments, and pathology solutions. Prominent companies identified in the market include Abbott Molecular, Inc., Biogenex Laboratories, Inc., Leica Biosystems, Roche, Agilent Technologies, and Mylab Discovery Solutions Pvt. Ltd. Competition is increasingly centered on test accuracy, workflow efficiency, automation, reproducibility, and the ability to support standardized pathology practices. Companies can also pursue opportunities through technology development, laboratory partnerships, and expanded access to diagnostic services in emerging markets.
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