HER2 Breast Cancer Test Market (Test Type: Immunohistochemistry [IHC] and Fluorescence/Chromogenic In Situ Hybridization [FISH/CISH]; and End-user: Hospitals and Diagnostic Laboratories) - Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2022-2030

The global HER2 Breast Cancer Test market size was estimated at USD 320.4 Million in 2021 and is expected to surpass around USD 628.1 Million by 2030 and poised to grow at a compound annual growth rate (CAGR) of 6.9% during the forecast period 2022 to 2030.

HER2 Breast Cancer Test Market: Overview

• HER2 stands for human epidermal growth factor receptor 2. It is involved in normal cell growth. Women newly detected with invasive breast cancer should be tested for HER2. The application of HER2 testing is to define whether cancer cells have too many copies of the HER2 gene or cancer cells are in developed stage. Cancers with higher-than-normal levels of HER2 are called HER2-positive. Cancers with normal HER2 levels are called HER2-negative.
• HER2 status is primarily determined using immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). IHC assesses the expression of the HER2 protein in cell membranes and FISH assesses HER2 gene amplification.
• Immunohistochemistry (IHC) is the common application of immunostaining. It includes the process of selectively isolating antigens (proteins) in cells of a tissue section by using the principle of antibodies binding specifically to antigens in biological tissues. Fluorescence in situ hybridization (FISH) is a laboratory technique to identify and locate a specific DNA sequence on a chromosome.

HER2 Breast Cancer Test Market: Key Drivers

• Rise in prevalence of breast cancer across the globe is projected to drive the global HER2 breast cancer test market during the forecast period. Breast cancer in women is a primary health burden globally. According to the World Health Organization (WHO), 2.3 million women were diagnosed with breast cancer in 2021, with 686,000 deaths globally. As of end of 2021, there were 8.1 million women alive who were diagnosed with breast cancer in the past five years, making it the world’s most prevalent cancer. Significant disability-adjusted life years (DALYs) are lost by women to breast cancer globally than any other type of cancer.
• Breast cancer management can be highly effective, particularly when the disease is identified early. Key players in the cancer treatment market are increasing research and development activities for early detection and cure of cancer. This factor is anticipated to drive the global HER2 breast cancer test market during the forecast period.
• Treatment of breast cancer often comprises surgical removal, radiation therapy, and medication (hormonal therapy, chemotherapy, and/or targeted biological therapy) to treat microscopic cancer that has spread from the breast tumor through the blood. The treatment inhibits cancer growth and spread.

Report Scope of the HER2 Breast Cancer Test Market

Telehealth Helps Avoid Delay in Breast Cancer Treatment amid Coronavirus Outbreak

The coronavirus outbreak has affected screening, diagnosis, treatment, and follow-up care for breast cancer. This is why the HER2 breast cancer test market is expanding in a staggered manner during the ongoing pandemic. Many individuals are fearing the contraction of the novel infection, leading to postponement and cancellation of treatments and screening. Nevertheless, telehealth services and mobile apps hold promising potentials to avoid delay in treatment of potential patients.

Since many countries have lifted their stay-at-home orders and allowed businesses to re-open, revenue flow is anticipated to grow in the HER2 breast cancer test market. Healthcare providers are extending their arms to provide essential and critical services to improve the patient quality of life during the ongoing pandemic.

Inaccurate HER2 Test Results with IHC Affect Market Growth

The HER2 breast cancer test market is expected to reach US$ 628.1 Mn by 2030. Immunohistochemistry (IHC) is being publicized as the gold standard for HER2 breast cancer testing. However, it has been found that some HER2 test results may be inaccurate, as different labs have different rules for classifying positive and negative HER2 status. Such findings are anticipated to affect market growth.

Inaccurate HER2 test results may deprive women diagnosed with breast cancer of proper care and treatment. Hence, healthcare providers in the HER2 breast cancer test market are increasing awareness about multiple reviewing of HER2 test results from more than one pathologist to attain certainty in outcomes.

FISH Test V/S IHC Test: Which is Better?

The FISH (Fluorescence In Situ Hybridization) test is not as widely available as compared to IHC. However, it has been found that FISH test in more accurate and reliable than IHC. In many cases, a lab will do the IHC test first and order FISH test only if the IHC results do not clearly show whether the cells are HER2-positive or negative.

The HER2 breast cancer test market is expected to register a CAGR of 6.9% during the forecast period. The growing popularity of FISH test helps to map the genetic material in a person’s cells. This test is used to visualize specific genes or portions of genes.

HER2 Testing Becoming Routine Practice for Newly Diagnosed Breast Cancer

IHC and FISH tests are gaining popularity for proper diagnosis, treatment, and follow-up care for HER2 breast cancer. HER2 testing is becoming a routine practice for newly diagnosed breast cancer in pathology. Bright-field in situ hybridization such as chromogenic in situ hybridization (CISH) has an advantage, since it allows histologic evaluation of tumors, utilizes ordinary microscope, can be fully automated, and leaves permanent signals for archival storage.

The CISH test is emerging as a suitable alternative to FISH test. Such trends are contributing to the growth of the HER2 breast cancer test market. For uniformity in accuracy and reproducibility of HER2 testing in breast cancer, the ASCO (American Society of Clinical Oncology) has released guidelines for the interpretation of HER2 status.  

Market Segmentation: HER2 Breast Cancer Test Market

• In terms of type, the global HER2 breast cancer test market has been classified into immunohistochemistry (IHC) and fluorescence/chromogenic in situ hybridization (FISH/CISH)
• Based on end-user, the global HER2 breast cancer test market has been divided into hospitals and diagnostic laboratories
• Each of the segments has been analyzed in detail for market trends, recent trends, and developments, drivers, restraints, opportunities, and useful insights. The HER2 breast cancer test market report provides current and expected revenue (US$ Mn) for each of these segments from 2022 to 2030, considering 2021 as the base year. The compound annual growth rate (percentage CAGR) has been provided for each segment and market from 2021 to 2030 along with market size estimations.

Regional Overview: HER2 Breast Cancer Test Market

• In terms of region, the global HER2 breast cancer test market has been segmented into North America, Europe, Latin America, Asia Pacific, and Middle East & Africa
• The HER2 breast cancer test market in Europe was valued at US$ 106.9 Mn in 2021 and is projected to reach US$ 207.0 Mn by 2030, expanding at a CAGR of 6.2% from 2021 to 2030
• The HER2 breast cancer test market in Europe is driven by increase in incidence of breast cancer. According to the European Cancer Information System (ECIS), in 2019, breast cancer was the most common cancer among women, with incidence of 29.4% of all cancers in the European Union (EU-28).

Some of the prominent players in the HER2 Breast Cancer Test Market include:

• Abbott Molecular, Inc.
• Biogenex Laboratories, Inc.
• Leica Biosystems
• Roche
• Agilent Technologies
• Mylab Discovery Solutions Pvt. Ltd.

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global HER2 Breast Cancer Test market

• Test Type
• Immunohistochemistry (IHC)
• Fluorescence/chromogenic in situ hybridization (FISH/CISH)
• End-user
• Hospitals
• Diagnostic Laboratories

By Geography

North America

• U.S.
• Canada

Europe

• Germany
• France
• United Kingdom
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Southeast Asia
• Rest of Asia Pacific

Latin America

• Brazil
• Rest of Latin America

Middle East & Africa (MEA)

• GCC
• North Africa
• South Africa
• Rest of Middle East & Africa

Key Points Covered in HER2 Breast Cancer Test Market Study:

• Growth of HER2 Breast Cancer Test in 2022
• Market Estimates and Forecasts (2017-2030)
•  Brand Share and Market Share Analysis
•  Key Drivers and Restraints Shaping Market Growth
•  Segment-wise, Country-wise, and Region-wise Analysis
•  Competition Mapping and Benchmarking
•  Recommendation on Key Winning Strategies
•  COVID-19 Impact on Demand for HER2 Breast Cancer Test and How to Navigate
•  Key Product Innovations and Regulatory Climate
•  HER2 Breast Cancer Test Consumption Analysis
•  HER2 Breast Cancer Test Production Analysis
•  HER2 Breast Cancer Test and Management