HER2 Breast Cancer Test Market is expected to reach US$ 627.7 Mn by 2022-2030

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.

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Inaccurate HER2 Test Results with IHC Affect Market Growth

The HER2 breast cancer test market is expected to reach US$ 627.7 Mn by 2031. 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.

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The HER2 breast cancer test market is expected to register a CAGR of 6.5% 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.

Analysts’ Viewpoint

Virtual medical appointments hold potentials in increasing healthcare utilization post the COVID-19 period. Since HER2 testing is associated with inaccuracy in results, healthcare providers, and labs in the HER2 breast cancer test market should adhere to the guidelines issued by the CAP (College of American Pathologists) to address a wide range of pre-analytic, analytic, and post-analytic variables. Apart from testing, companies in the HER2 breast cancer test market should unlock growth opportunities in increasing the availability of treatments such as enhertu, Herceptin, and kadcyla to improve patient outcomes. IHC test and FISH test remain the gold standard for efficient diagnosis of HER2 breast cancer.

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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 2020, with 685,000 deaths globally. As of end of 2020, there were 7.8 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.

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 2021 to 2031, considering 2020 as the base year. The compound annual growth rate (percentage CAGR) has been provided for each segment and market from 2021 to 2031 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$ 106.1 Mn in 2020 and is projected to reach US$ 207.2 Mn by 2031, expanding at a CAGR of 6.3% from 2021 to 2031

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 2018, breast cancer was the most common cancer among women, with incidence of 29.2% of all cancers in the European Union (EU-28).

Major Players

The HER2 breast cancer test market report concludes with the company profiles section, which includes key information about major players in the global HER2 breast cancer test market

Leading players analyzed in the report include

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

Each of these players has been profiled in the HER2 breast cancer test market report based on parameters such as company overview, financial overview, business strategies, application portfolio, business segments, and recent developments

Key Questions Answered in HER2 Breast Cancer Test Market Report

  • What is the sales/revenue generated by HER2 breast cancer test procedure across all regions during the forecast period?
  • What are the opportunities in the global HER2 breast cancer test market?
  • What are the major drivers, restraints, opportunities, and threats in the market?
  • Which regional market is set to expand at the fastest CAGR during the forecast period?
  • Which segment is expected to generate the highest revenue globally in 2031?
  • Which segment is projected to expand at the highest CAGR during the forecast period?
  • What are the market positions of different companies operating in the global market?

HER2 Breast Cancer Test Market – Segmentation

Test Type

  • Immunohistochemistry (IHC)
  • Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH)

End-user

  • Hospitals
  • Diagnostic Laboratories

Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

TABLE OF CONTENT

1. Preface

1.1. Report Scope and Market Segmentation

1.2. Research Highlights

2. Assumptions and Research Methodology

2.1. Assumptions and Acronyms Used

2.2. Research Methodology

3. Executive Summary

4. Market Overview

4.1. Introduction

4.2. Global HER2 Breast Cancer Test Market Forecast

4.3. Global HER2 Breast Cancer Test Market Outlook

4.3.1. Drivers

4.3.2. Restraints

4.3.3. Opportunity

5. Key Insights

5.1. Revenue Model

5.2. Pricing Analysis

5.3. COVID-19 Impact Analysis

6. Global HER2 Breast Cancer Test Market Analysis, by Test Type

6.1. Introduction

6.2. Global HER2 Breast Cancer Test Market Value Share Analysis, by Test Type

6.3. Global HER2 Breast Cancer Test Market Forecast, by Test Type

6.3.1. Immunohistochemistry (IHC)

6.3.2. Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH)

6.4. Global HER2 Breast Cancer Test Market Analysis, by Test Type

6.5. Global HER2 Breast Cancer Test Market Attractiveness Analysis, by Test Type

7. Global HER2 Breast Cancer Test Market Analysis, by End-user

7.1. Introduction

7.2. Global HER2 Breast Cancer Test Market Value Share Analysis, by End-user

7.3. Global HER2 Breast Cancer Test Market Forecast, by End-user

7.3.1. Hospitals

7.3.2. Diagnostic Laboratories

7.4. Global HER2 Breast Cancer Test Market Analysis, by End-user

7.5. Global HER2 Breast Cancer Test Market Attractiveness Analysis, by End-user

8. Global HER2 Breast Cancer Test Market Analysis, by Region

8.1. Introduction

8.2. Global HER2 Breast Cancer Test Market Value Share Analysis, by Region

8.3. Global HER2 Breast Cancer Test Market Forecast, by Region

8.3.1. North America

8.3.2. Europe

8.3.3. Asia Pacific

8.3.4. Latin America

8.3.5. Middle East & Africa

9. North America HER2 Breast Cancer Test Market Analysis

9.1. North America HER2 Breast Cancer Test Market Overview

9.2. North America HER2 Breast Cancer Test Market Value Share and Attractiveness Analysis, by Country

9.2.1. U.S.

9.2.2. Canada

9.3. North America HER2 Breast Cancer Test Market Value Share and Attractiveness analysis, by Test Type

9.4. North America HER2 Breast Cancer Test Market Forecast, by Test Type

9.4.1. Immunohistochemistry (IHC)

9.4.2. Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH)

9.5. North America HER2 Breast Cancer Test Market Value Share and Attractiveness Analysis, by End-user

9.6. North America HER2 Breast Cancer Test Market Forecast, by End-user

9.6.1. Hospitals

9.6.2. Diagnostic Laboratories

10. Europe HER2 Breast Cancer Test Market Analysis

10.1. Europe HER2 Breast Cancer Test Market Overview

10.2. Europe HER2 Breast Cancer Test Market Value Share and Attractiveness analysis, by Country/Sub-region

10.2.1. Germany

10.2.2. U.K.

10.2.3. France

10.2.4. Italy

10.2.5. Spain

10.2.6. Rest of Europe

10.3. Europe HER2 Breast Cancer Test Market Value Share and Attractiveness Analysis, by Test Type

10.4. Europe HER2 Breast Cancer Test Market Forecast, by Test Type

10.4.1. Immunohistochemistry (IHC)

10.4.2. Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH)

10.5. Europe HER2 Breast Cancer Test Market Value Share and Attractiveness Analysis, by End-user

10.6. Europe HER2 Breast Cancer Test Market Forecast, by End-user

10.6.1. Hospitals

10.6.2. Diagnostic Laboratories

11. Asia Pacific HER2 Breast Cancer Test Market Analysis

11.1. Asia Pacific HER2 Breast Cancer Test Market Overview

11.2. Asia Pacific HER2 Breast Cancer Test Market Value Share and Attractiveness Analysis, by Country/Sub-region

11.2.1. China

11.2.2. Japan

11.2.3. India

11.2.4. Australia & New Zealand

11.2.5. Rest of Asia Pacific

11.3. Asia Pacific HER2 Breast Cancer Test Market Value Share and Attractiveness analysis, by Test Type

11.4. Asia Pacific HER2 Breast Cancer Test Market Forecast, by Test Type

11.4.1. Immunohistochemistry (IHC)

11.4.2. Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH)

11.5. Asia Pacific HER2 Breast Cancer Test Market Value Share and Attractiveness analysis, by End-user

11.6. Asia Pacific HER2 Breast Cancer Test Market Forecast, by End-user

11.6.1. Hospitals

11.6.2. Diagnostic Laboratories

12. Latin America HER2 Breast Cancer Test Market Analysis

12.1. Latin America HER2 Breast Cancer Test Market Overview

12.2. Latin America HER2 Breast Cancer Test Market Value Share and Attractiveness analysis, by Country/Sub-region

12.2.1. Brazil

12.2.2. Mexico

12.2.3. Rest of Latin America

12.3. Latin America HER2 Breast Cancer Test Market Value Share and Attractiveness analysis, by Test Type

12.4. Latin America HER2 Breast Cancer Test Market Forecast, by Test Type

12.4.1. Immunohistochemistry (IHC)

12.4.2. Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH)

12.5. Latin America HER2 Breast Cancer Test Market Value Share and Attractiveness analysis, by End-user

12.6. Latin America HER2 Breast Cancer Test Market Forecast, by End-user

12.6.1. Hospitals

12.6.2. Diagnostic Laboratories

13. Middle East & Africa HER2 Breast Cancer Test Market Analysis

13.1. Middle East & Africa HER2 Breast Cancer Test Market Overview

13.2. Middle East & Africa HER2 Breast Cancer Test Market Value Share and Attractiveness Analysis, by Country/Sub-region

13.2.1. GCC Countries

13.2.2. South Africa

13.2.3. Rest of Middle East & Africa

13.3. Middle East & Africa HER2 Breast Cancer Test Market Value Share and Attractiveness Analysis, by Test Type

13.4. Middle East & Africa HER2 Breast Cancer Test Market Forecast, by Test Type

13.4.1. Immunohistochemistry (IHC)

13.4.2. Fluorescence/Chromogenic In Situ Hybridization (FISH/CISH)

13.5. Middle East & Africa HER2 Breast Cancer Test Market Value Share and Attractiveness Analysis, by End-user

13.6. Middle East & Africa HER2 Breast Cancer Test Market Forecast, by End-user

13.6.1. Hospitals

14. Competition Landscape

14.1. Market Player – Competition Matrix (by tier and size of companies)

14.2. Market Share Analysis, by Company, 2019

14.3. Company Profiles

14.3.1. Abbott Laboratories

14.3.1.1. Company Overview (HQ, Business Segments, Employee Strength)

14.3.1.2. Product Portfolio

14.3.1.3. SWOT Analysis

14.3.1.4. Strategic Overview

14.3.2. BioGenex

14.3.2.1. Company Overview (HQ, Business Segments, Employee Strength)

14.3.2.2. Product Portfolio

14.3.2.3. SWOT Analysis

14.3.2.4. Strategic Overview

14.3.3. Agilent Technologies, Inc.

14.3.3.1. Company Overview (HQ, Business Segments, Employee Strength)

14.3.3.2. Product Portfolio

14.3.3.3. SWOT Analysis

14.3.3.4. Strategic Overview

14.3.4. Leica Biosystems

14.3.4.1. Company Overview (HQ, Business Segments, Employee Strength)

14.3.4.2. Product Portfolio

14.3.4.3. SWOT Analysis

14.3.4.4. Strategic Overview

14.3.5. Roche

14.3.5.1. Company Overview (HQ, Business Segments, Employee Strength)

14.3.5.2. Product Portfolio

14.3.5.3. SWOT Analysis

14.3.5.4. Strategic Overview

14.3.6. Mylab Discovery Solutions Pvt. Ltd.

14.3.6.1. Company Overview (HQ, Business Segments, Employee Strength)

14.3.6.2. Product Portfolio

14.3.6.3. SWOT Analysis

14.3.6.4. Strategic Overview

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