HER2 Testing Market Size & Share, by 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) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2024-2036

  • Report ID: 5626
  • Published Date: Feb 12, 2024
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2024-2036

HER2 Testing Market size is expected to cross USD 408 Million by the end of 2036, growing at a CAGR of 8% during the forecast period, i.e., 2024-2036. In the year 2023, the industry size of HER2 testing was over USD 150 Million. The market for HER2 testing is slated to grow at a rate that is proportionate to research and development in cancer diagnostic technologies, which will lead to more sophisticated applications for HER2 testing and cancer screening. The United States alone has a sizable patient pool for breast cancer, with around 62800 occurrences of in situ breast cancer, 1980 of which are in men, and approximately 15% of cases dying from rising rates of breast cancer, according to data from the American Society of Clinical Oncology (ASCO).

In addition to these, the popularity of HER2 testing for breast cancer screening is predicted to soar due to the expanding support from both public and private organizations, as well as reimbursement policies for breast biopsy and diagnosis. It is predicted that the combination of the Inform HER2 Dual ISH test and the SPoT-Light HER2 CISH test will provide an accurate and affordable solution for breast HER2 testing.

HER2 testing Market
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HER2 Testing Market: Key Insights

Base Year


Forecast Year



~ 8%

Base Year Market Size (2023)

 ~ USD 150 Million

Forecast Year Market Size (2036)

 ~ USD 408 Million

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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HER2 Testing Market: Growth Drivers and Challenges


Growth Drivers

  • Technology developments in the HER 2 testing to support market expansion- Imaging technology developments enhance screening and early detection. Modern testing technologies are available for use in clinical practices with HER2 testing, which targets trastuzumab treatment for patients with breast cancer. Trastuzumab treatment is very successful for 20–30% of patients with breast tumors that overexpress the HER2 gene, according to HER2 testing that has been developed. One effective test that has been utilized in clinical practice to focus on cancer treatment is HER2 testing. Patients with metastatic HER2-positive breast cancer are seeing higher odds of survival after using anti-HER2 therapy than those with HER2-negative disease. During the patient's first line of treatment, the double HER2 blockage using a combination of trastuzumab and pertuzumab along with a taxane achieved an exceptional survival rate. The HER2 testing market is growing because of all the technological developments in HER2 testing.
  • Rising Breast Cancer Prevalence- The most prevalent malignancy in women to be diagnosed is breast cancer. Breast cancer is primarily caused by menopause, early childbirth, and later marriage ages. The late age of marriage and delivery, increased exposure to non-estrogen-producing mutagens, and the genotoxicity of estrogen are the causes of the lack of breast tissue differentiation. After menopause, there is a longer period of exposure to estrogen. Breast cancer risk is increased by specific hereditary high penetrance gene mutations. Women discovered that various abnormalities in these main genes, including BRCA1, BRCA2, and PALB-2, have been leading to risk reduction techniques, such as surgically removing both breasts.
  • Increasing the Gastric Cancer Prevalence will accelerate HER2 testing market expansion- Helicobacter pylori infection and autoimmune gastritis, which arises when the body's immune system targets the stomach lining, are the main causes of gastric cancer. Radiation, obesity, and tobacco usage are further reasons which cause. Globally, males have a 1.87 percent chance of developing stomach cancer from birth to age 74, while females have a 0.79 percent chance. The most frequent cause of cancer-related death was gastric cancer. Male gastric cancer is the most lethal type of the disease, with 783,000 deaths annually.


  • Exorbitant price for HER 2 testing- Due to the high expense of the HER 2 test, neither the middle class nor the lower class can afford it. Trastuzumab, an advanced HER 2 test, is quite expensive. For each patient treated in an adjuvant or metastatic breast cancer context, trastuzumab costs USD 49,915 and USD 28,350, respectively. Globally, the high cost of trastuzumab therapies places a heavy financial strain on local health budgets.
  • Throughout the projection period, the expansion of the worldwide HER2 testing market could be restricted by a lack of skilled specialists who are unaware of the best ways to treat this illness.
  • Several pharmaceuticals' expiring patents are impeding the growth of the HER2 testing market.  The market's growth is being hampered by the main brands' patent expirations, especially Perjeta, Herceptin, and Kadcyla, which accounted for the majority of sales.

HER2 Testing Segmentation

Cancer Type (Breast Cancer, Gastric Cancer, Bladder Cancer, Ovarian Cancer)

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 (Hospital, Diagnostic Centers, Specialty Clinics)

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:


  • 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

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HER2 Testing Industry - Regional Synopsis

North American Market Forecast

HER2 testing market in North America is expected to hold the largest revenue share of about 34% during the forecast period.  Because of its high acceptance rate and greater product penetration, North America is expected to be the leading regional market for HER2 testing. A significant need for HER2 testing exists in the area as well. The United States leads the market in North America as a result of the nation's rising breast cancer incidence rate. Growing rates of cancer, including stomach, breast, and other cancers, a well-established healthcare system, and rising healthcare spending are the main factors driving the regional HER2 testing market. According to projections from the American Cancer Society, 310,720 new instances of invasive breast cancer will be identified in women in the US by 2024. There will be roughly 56,500 new diagnoses of ductal carcinoma in situ (DCIS).

APAC Market Statistics

HER2 testing market in the Asia Pacific region is projected to hold the second largest revenue share of about 27% during the forecast period. In terms of the ongoing adoption of new technologies and research from businesses in the field of HER2 testing research, China and India are predicted to expand quickly. HER2 testing is in high demand in the Asia Pacific due to high occurrences of gastric and gastroesophageal junction cancer. Patients with advanced HER2-positive disease have a better quality of life owing to HER2-targeted therapy, which also makes high-quality testing methods more important to determine whether patients have responded to the treatment.

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HER2 testing Market Size
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Companies Dominating the HER2 Testing Market

    • Agilent Technologies, Inc.
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Thermo Fisher Scientific
    • Roche
    • Empire Genomics Inc.
    • Abnova Corporation
    • Eli Lilly and Company
    • Oxford Gene Technology IP Limited
    • Genetech
    • Genemed Technologies Inc.


In The News

  • Roche announced that the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody has received approval from the U.S. FDA. When a patient has low HER2 expression, this antibody can be used to identify them and assist assess whether Enhertu is a good targeted treatment choice for them.
  • Eli Lilly and Company declared that the expanded use of Verzenio (abemaciclib) in conjunction with endocrine therapy (ET) has received approval from the U.S. FDA. Adjuvant treatment for adult patients with hormone receptor-positive (HR+), HER2-negative, node-positive early breast cancer (EBC) who are at high risk of recurrence is now permitted with this approval.

Author Credits:  Radhika Gupta, Shivam Bhutani

  • Report ID: 5626
  • Published Date: Feb 12, 2024
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

Increasing research and development in cancer diagnostic technologies and the popularity of HER2 testing for breast cancer screening are the major factors driving the growth of the HER2 testing market.

The market size of HER2 testing is anticipated to attain a CAGR of 8% over the forecast period, i.e., 2024-2036.

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

The breast cancer segment is anticipated to garner the largest market size by the end of 2036 and display significant growth opportunities.

The market in the North American region is projected to hold the largest market share by the end of 2036 and provide more business opportunities in the future.
HER2 testing Market Report Scope

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