HER2 Breast Cancer Test Market: Introduction


According to the report, the global HER2 breast cancer test market was valued at US$ 313.4 Mn in 2020 and is projected to expand at a CAGR of 6.5% from 2021 to 2031. HER2 stands for human epidermal growth factor receptor 2. It is involved in normal cell growth. Women newly detected with invasive breast cancers should be tested for HER2. The purpose 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 usually 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.


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Increase in Incidence Breast Cancer Worldwide


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 major health burden globally. According to the World Health Organization (WHO), in 2020, there were 2.3 million women diagnosed with breast cancer, with 685,000 deaths globally. As 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. Treatment of breast cancer often consists of a combination of 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.


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Increase in Number of Immunohistochemistry (IHC) Tests


In terms of test type, the global HER2 breast cancer test market has been bifurcated into immunohistochemistry (IHC) and fluorescence/chromogenic in situ hybridization (FISH/CISH). The immunohistochemistry (IHC) segment was valued at US$ 210.6 Mn in 2020 and is projected to reach US$ 413.5 Mn by 2031, expanding at a CAGR of 6.3% from 2021 to 2031. Increase in number of immunohistochemistry (IHC) tests in emerging countries fuels the growth of the segment. Immunohistochemistry (IHC) is used in histology to detect the presence of a specific protein marker that can assist with accurate tumor classification and diagnosis.


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Rise in Early Detection Tests Available at Hospitals


In terms of end-user, the global HER2 breast cancer test market has been divided into hospitals and diagnostic laboratories. The hospitals segment accounted for 47.8% share of the market in 2020. The segment is likely to gain market share to reach US$ 523.9 Mn in 2031. Rise in prevalence of breast cancer and early detection tests available in hospitals are projected to propel the global HER2 breast cancer test market during the forecast period.


Increase in the number of cancer treatment hospitals and research institutes across the globe is anticipated to drive the global HER2 breast cancer test market in the near future.


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Europe to Lead HER2 Breast Cancer Test Market


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


Competition Landscape


The global HER2 breast cancer test market is fragmented due to the presence of a large number of leading players. Key players operating in the global market include Abbott Molecular Inc., Biogenex Laboratories, Inc., Leica Biosystems, Roche, Agilent Technologies, and Mylab, Discovery Solutions Pvt. Ltd.


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