HER2 Testing Market Revenue to Exceed USD 259.4 Million by 2031 | Driven by Rising Breast Cancer Incidence, Technological Advancements, and the Shift Toward Personalized Medicine - Exclusive Report by Transparency Market Research, Inc.

HER2 testing is a critical diagnostic procedure used to evaluate the human epidermal growth factor receptor 2 (HER2) status in cancers, most notably in breast cancer. By determining the level of HER2 protein or gene amplification using methods such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), clinicians can identify patients who might benefit from targeted therapies. With the global HER2 testing market valued at US$ 135.2 million in 2022, it is set to exceed US$ 259.4 million by 2031, growing at a robust CAGR of 7.3% during the forecast period.

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The rising incidence of breast and gastric cancers has underscored the need for accurate and timely HER2 testing, a necessity further amplified by the growing emphasis on personalized medicine and early cancer detection.

Analysts' Viewpoint

Industry experts indicate that the global HER2 testing market is poised for significant growth due to an increased incidence of HER2-positive cancers and continuous advancements in diagnostic technologies. Regulatory approvals, such as the recent U.S. FDA clearance for advanced diagnostic antibodies and targeted treatment eligibility tools, are catalyzing market expansion. Additionally, growing healthcare expenditure and the strategic focus on personalized treatment approaches are expected to further propel market development, ensuring better patient outcomes through precise and early detection.

Market Drivers

Increase in Cancer Incidence

Breast and Gastric Cancers: With breast cancer being the most common cancer among women globally and gastric cancer ranking as a prevalent malignancy, the demand for HER2 testing is surging as more cases are accurately diagnosed and classified.

Early Detection and Treatment: Early and accurate HER2 status assessment allows for effective deployment of targeted therapies, which can significantly improve patient survival and quality of life.

Technological Advancements and Product Approvals

Innovative Diagnostic Tools: The introduction of advanced HER2 testing products-such as the FDA-approved PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody-has enhanced diagnostic precision and broadened treatment options for patients with low HER2 expression.

Enhanced Testing Techniques: Developments in molecular diagnostic techniques, including refined FISH methodologies, have significantly improved the sensitivity and specificity of HER2 detection.

Rise in Healthcare Spending and Personalized Medicine

Increased Expenditure: A surge in healthcare spending across various regions supports the adoption of state-of-the-art diagnostic tools.

Customized Treatment Regimens: The growing focus on personalized medicine, where treatments are tailored based on individual molecular profiles, further boosts the demand for accurate HER2 testing, ensuring that patients receive the most appropriate targeted therapies.

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Product Segmentation

By Technique

Fluorescence in situ hybridization (FISH), Dual-probe, Single-probe, Chromogenic in situ hybridization (CISH), Silver-enhanced in situ hybridization

By Cancer Type

Breast Cancer, Gastric Cancer

By End-user

Hospitals, Diagnostic Laboratories, Others

Regional Outlook

North America:
North America is projected to experience significant growth, driven by favorable reimbursement policies, advanced diagnostic infrastructures, and high awareness of breast cancer diagnostics. Favorable regulatory environments further encourage innovation and market expansion.

Asia Pacific:
Asia Pacific is emerging as the fastest growing market due to rapidly increasing breast cancer cases, rising healthcare expenditure, and improved access to modern diagnostic technologies. Countries such as China and India are expected to lead the regional market growth.

Other Regions:
Latin America, Europe, and the Middle East & Africa are also witnessing steady market growth, propelled by improved healthcare systems, enhanced diagnostic capabilities, and growing awareness of personalized cancer treatment.

Competitive Landscape

The global HER2 testing market is consolidated, with a few large companies dominating the space. Leading players such as Abbott, Hoffmann-La Roche Ltd, Agilent Technologies, Inc., Thermo Fisher Scientific, Inc., Leica Biosystems (Danaher Corporation), and others are actively investing in R&D to launch environment-friendly, high-accuracy diagnostic products. Strategic mergers, acquisitions, and collaborations are common strategies among these companies, aimed at expanding product portfolios and strengthening market presence.

Recent developments, including key product approvals and strategic alliances, highlight the dynamic nature of the market and its focus on improving patient care through advanced diagnostics.

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FAQs

Q1: What is HER2 testing?
A: HER2 testing is a diagnostic procedure used to assess the expression level of the HER2 protein or the amplification of the HER2 gene in cancers, primarily breast cancer, using techniques such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH).

Q2: What factors are driving the growth of the global HER2 testing market?
A: Key growth drivers include the rising incidence of breast and gastric cancers, regulatory approvals of advanced diagnostic tools, technological innovations in testing methods, increased healthcare spending, and the growing trend toward personalized medicine.

Q3: Which testing technique holds a major share in the market?
A: Fluorescence in situ hybridization (FISH) is a predominant technique in the HER2 testing market due to its high sensitivity and specificity in detecting HER2 gene amplification.

Q4: Who are the primary end-users of HER2 testing?
A: The primary end-users include hospitals and diagnostic laboratories, which are equipped with specialized instruments and advanced technologies required for HER2 testing.

Q5: Which regions are expected to drive market growth?
A: North America is expected to lead due to its advanced healthcare systems, while Asia Pacific is projected to be the fastest growing region, with steady growth also anticipated in Latin America, Europe, and the Middle East & Africa.

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