HER2 Testing Market Analysis

  • Report ID: 5626
  • Published Date: Nov 27, 2025
  • Report Format: PDF, PPT

HER2 Testing Market Segmentation:

Cancer Type Segment Analysis

Based on cancer type, the breast cancer segment in the HER2 testing market is anticipated to hold the largest revenue share of about 40% during the forecast period. Throughout the projection period, breast cancer is anticipated to have the greatest growth rate in the HER 2 testing market. The risk factors that raise the incidence of breast cancer include aging, genetic mutations, reproductive history, having thick breasts, having a personal or family history of the disease, and drug exposure. HER3 genes change and produce additional copies of themselves in breast cancer. The purpose of HER2 testing is to determine whether the cancer is HER-2 positive and to determine whether the malignancy is responding to treatment or coming back after it has been stopped. In 2020, 685,000 people died worldwide from breast cancer, accounting for 2.3 million new diagnoses. Breast cancer is the most common cancer worldwide, with 7.8 million people surviving as of the end of 2020 who received a diagnosis within the previous five years.

End Users Segment Analysis

Based on end users, the hospital segment in the HER2 testing market is attributed to hold the largest revenue share of about 48% during the forecast period. This test was primarily used by clinicians in hospitals to identify tumors with higher-than-normal amounts of the HER2 protein or cancer cells with an excessive number of HER2 gene copies. Hospital laboratories examine a sample of breast cancer tissue retrieved during surgery or biopsy for HER2 levels in invasive breast tumors. Rather than diagnostic labs, the hospitals are equipped with state-of-the-art medical technology. Hospitals may readily obtain Fluorescence in Situ Hybridization (FISH) devices, which are a prerequisite for the HER 2 test. Therefore, the market for HER 2 testing is dominated by hospitals.

Our in-depth analysis of the global HER2 testing market includes the following segments:

     Technique

  • Immunohistochemistry (IHC) Test
  • Fluorescence in Situ Hybridization
  • Chromogenic in Situ Hybridization
  • Silver-Enhanced in Situ Hybridization

     Cancer Type

  • Breast Cancer
  • Gastric Cancer
  • Bladder Cancer
  • Ovarian Cancer

     End Users

  • Hospital
  • Diagnostic Centers
  • Specialty Clinics

Browse key industry insights with market data tables & charts from the report:

Frequently Asked Questions (FAQ)

In the year 2026, the industry size of HER2 testing is evaluated at USD 177.12 million.

The global HER2 testing market size was worth over USD 166.34 million in 2025 and is poised to grow at a CAGR of around 7.2%, reaching USD 333.38 million revenue by 2035.

North America is expected to capture a 44% share of the HER2 testing market by 2035, supported by its strong product adoption and substantial need for HER2 diagnostics owing to rising breast cancer incidence.

Key players in the market include Thermo Fisher Scientific, Roche, Empire Genomics Inc., Abnova Corporation, Eli Lilly and Company, Oxford Gene Technology IP Limited, Genetech, Genemed Technologies Inc., PERKINELMER Inc.
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