Global HER2 Testing Market to Surpass USD 259.4 Million by 2031

Author : kaustubh Ravan | Published On : 12 May 2026

As of May 2026, the Human Epidermal Growth Factor Receptor 2 (HER2) Testing Market is undergoing a pivotal expansion. No longer confined to a binary "positive" or "negative" result, the industry is transitioning toward precision subtyping, including the identification of "HER2-low" populations. This shift is driven by the regulatory approval of advanced antibody-drug conjugates (ADCs) like Enhertu, which have redefined the therapeutic threshold for millions of patients. In 2026, the market is characterized by a move toward automated digital pathology and the integration of AI-driven scoring to reduce inter-observer variability in Immunohistochemistry (IHC) readings.

The global HER2 Testing Market was valued at USD 135.2 million in 2022 and is projected to surpass USD 259.4 million by the end of 2031. The market is expected to advance at a CAGR of 7.3% from 2023 to 2031, driven by the increasing prevalence of breast and gastric cancers, growing adoption of personalized medicine, and rising demand for advanced diagnostic testing technologies for accurate HER2 biomarker detection.

Increase in incidence of breast cancer is driving the demand for HER2 testing across the globe. Approval of new products with advanced technology by various companies contributes to the global HER2 testing market development. For instance, Roche reported that the U.S. FDA has granted approval for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. This antibody can be used to identify metastatic breast cancer patients who have low HER2 expression, and it helps determine whether Enhertu could be a suitable targeted treatment option for them.

Dive Deeper into Data: Get Your In-Depth Sample Now! https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=85621

Moreover, technological advancements, surge in healthcare spending, and growing awareness about the benefits of early detection and treatment are expected to be key growth drivers of the HER2 testing market. Additionally, increase in geriatric population and growing importance of personalized medicine are expected to further boost the HER2 testing market demand.

Key Findings of the Market Report

Breast Cancer Dominance: The breast cancer segment is anticipated to capture 40% of total revenue by 2035, driven by an aging global population and increased screening participation.
Technique Shift: While FISH (Fluorescence in Situ Hybridization) remains the gold standard for confirmatory analysis in equivocal cases, IHC (Immunohistochemistry) dominates initial screening with a 46% share due to its cost-effectiveness.
Hospital Concentration: By 2035, the Hospital segment is projected to hold 48% of the overall share, as health systems centralize molecular pathology to manage high-cost diagnostic equipment.
Precision Mandates: National oncology guidelines (NCCN and ASCO) are increasingly mandating standardized HER2 testing for not only breast and gastric cancers but also emerging indications in lung and colorectal cancers.

Global Market: Growth Drivers

Rise in Targeted Therapeutics: The launch of new ADCs and PROTACs (like the recently approved VEPPANU in May 2026) necessitates authorized companion diagnostic tests for patient selection.
Adoption of Digital Pathology: AI algorithms are now being used to provide more objective and reproducible IHC scoring, particularly for difficult "HER2-low" cases.
Gastric Cancer Prevalence in APAC: High rates of HER2-amplified gastric cancers in East Asia are driving massive regional investment in specialized diagnostic infrastructure.
Infrastructure Build-out: Global expansion of oncology centers and private diagnostic laboratories is improving access to molecular subtyping in emerging economies.

Global Market: Key Players

The market is characterized by high barriers to entry due to stringent regulatory requirements for companion diagnostics.

Roche Diagnostics (Leader in IHC with the Ventana platform)
Agilent Technologies (Dominant in FISH and Dako-branded assays)
Abbott Laboratories (Key player in molecular FISH probes)
Thermo Fisher Scientific (Focusing on NGS-based HER2 amplification detection)
Bio-Rad Laboratories
Illumina, Inc. (Leading the shift toward genomic-based HER2 assessment)
Myriad Genetics
Qiagen N.V.
Biocartis (Innovating in rapid, automated molecular testing)
Daiichi Sankyo / AstraZeneca (Directly influencing testing demand through their ADC portfolio)

Global Market: Segmentation

By Technique

Immunohistochemistry (IHC): The primary screening tool; valued for rapid results and lower cost.
In Situ Hybridization (FISH/CISH/SISH): Used to confirm gene amplification in cases where IHC results are "equivocal" (2+).
Next-Generation Sequencing (NGS): Gaining share for comprehensive genomic profiling of metastatic patients.

By Cancer Type

Breast Cancer: The largest and most established segment.
Gastric / Gastroesophageal Junction Cancer: Significant growth driver in Asian markets.
Non-Small Cell Lung Cancer (NSCLC): Emerging segment for HER2-mutant targeted therapies.

By End-User

Hospitals: Major hubs for integrated cancer care and inpatient diagnostics.
Diagnostic Laboratories: High-volume reference centers for outsourced specialized testing.
Research Institutes: Focused on clinical trials and biomarker discovery for next-gen HER2 inhibitors.

Buy this Premium Research Report: https://www.transparencymarketresearch.com/checkout.php?rep_id=85621&ltype=S

About Transparency Market Research

Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyses information.

Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

Contact:

Abhishek Budholiya
Transparency Market Research Inc.
State Tower, 90 State Street, Suite 700,
Albany NY - 12207, United States
Tel: +1-518-618-1030
USA – Canada Toll Free: 866-552-3453
Website: https://www.transparencymarketresearch.com
Sales Inquiries: sales@transparencymarketresearch.com
Media Inquiries: media@transparencymarketresearch.com