ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Size, Share, Industry, Forecast and Outlook (2024-2031)

Global ESR1 Mutated Metastatic Breast Cancer Diagnostics Market is segmented By Test Type (NGS Based, PCR Based) By Sample Type (Tissue, Plasma) By End User (Oncology Centers, Diagnostic Centers, Cancer Research Institutes) and By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Market Overview

Global ESR1 Mutated Metastatic Breast Cancer Diagnostics Market reached US$ YY billion in 2022 and is expected to reach US$ YY million by 2031 growing at a CAGR of YY% during the forecast period 2024-2031.

ESR1 mutated metastatic breast cancer refers to a subtype of breast cancer characterized by mutations in the ESR1 gene. ESR1 encodes the estrogen receptor alpha (ERα), a protein that plays a crucial role in estrogen signaling pathways.

ESR1 mutations can arise during breast cancer treatment, especially in the metastatic setting. These mutations are associated with acquired resistance to hormonal therapies, such as tamoxifen or aromatase inhibitors, which are commonly used to block estrogen receptor signaling.

Market Scope

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Market Dynamics

Increasing prevalence of metastatic breast cancers

The increasing prevalence of metastatic breast cancers acts as a significant driver for market growth. Metastatic breast cancer is cancer that is spread from the breast to other areas of the body. Metastatic breast cancer can spread to other parts of the body like lungs, liver, bones, and brain.

For instance, according to the American Society of Clinical Oncology (ASCO), breast cancer is the second most common cause of death from cancer in women in the United States. It is estimated that 43,700 people (43,170 women and 530 men) deaths will occur in the United States in 2023. In the United States, 6% of women have metastatic breast cancer when they are first diagnosed.

Additionally, according to the National Institute of Health Report, about 279,000 new cases of breast cancer are diagnosed in China each year, which is an increase over previous years. Also, according to the Canadian Cancer Society, 29,400 Canadian women were diagnosed with metastatic breast cancer which represents 26% of all new cancer cases in women in 2023. 5,400 Canadian women will die from breast cancer.

Furthermore, significant growth drivers such as the rising development of assay testing kits, and technological advancements in diagnostic devices are expected to drive the market in the forecast period.

High costs associated with Next-generation sequencing (NGS) technologies that are used for diagnosis

NGS technologies are sophisticated and often expensive, limiting widespread adoption, especially in resource-constrained healthcare settings. The high cost can hinder accessibility for both healthcare providers and patients. Next-generation sequencing (NGS) technologies and equipment can be also expensive to acquire and maintain. Thus, the above factors are expected to hamper the market growth.

Segment Analysis

The global ESR1 mutated metastatic breast cancer diagnostics market is segmented based on test type, sample type, end-user and region.

The NGS-based segment accounted for approximately 45.6% of the market share 

The NGS-based segment is expected to hold the largest market share over the period forecast due to the increasing number of product approvals. Next-generation sequencing (NGS) plays a crucial role in the diagnostics and management of metastatic breast cancer, particularly in cases involving mutations in the ESR1 gene.

Estrogen receptor 1 (ESR1) is a gene that encodes the estrogen receptor alpha, a protein involved in hormone signaling pathways. Mutations in the ESR1 gene can lead to resistance to endocrine therapies commonly used in breast cancer treatment. NGS allows for comprehensive analysis of the entire genomic landscape of cancer cells. Comprehensive genomic profiling involves sequencing the DNA of cancer cells to identify mutations in ESR1. 

Next genome sequencing is also used in liquid biopsy samples, such as circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), or cell-free DNA (cfDNA). Liquid biopsies provide a minimally invasive method for monitoring the genomic changes in real-time, allowing for the detection of ESR1 mutations and other alterations. Thus, due to the above factors, the segment is expected to hold the largest market share.

Geographical Analysis

North America is expected to hold a significant position in the global ESR1 mutated metastatic breast cancer diagnostics market share

The global ESR1 mutated metastatic breast cancer diagnostics market is segmented into North America, Europe, Asia Pacific, South America, Middle East, and Africa. 

North America has maintained a significant market proportion due to factors such as the rising prevalence of mutated metastatic breast cancer, increasing product approvals, and increasing healthcare expenditure, this trend is anticipated to continue throughout the forecast period.

For instance, in January 2023, Guardant Health received FDA approval for Guardant360 CDx as a companion diagnostic for Menarini Group’s ORSERDU for the treatment of patients with ESR1 mutations in ER, HER2 advanced or metastatic breast cancer.

COVID-19 Impact Analysis 

The COVID-19 pandemic has had a significant impact on the global ESR1 mutated metastatic breast cancer diagnostics market. The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular diagnoses, and consultations worldwide. With the outbreak of the pandemic, many clinical diagnostic centers faced labor shortages and were unable to travel to work due to lockdown restrictions. Therefore, owing to the above factors, the ESR1 mutated metastatic breast cancer diagnostics market was moderately affected over the forecast period.

Competitive Landscape

The major global players in the market include Illumina Inc., Guardant Health Inc., APIS Assay Technologies Ltd., Gencurix Inc., RainSure Scientific, NeoGenomics Inc., Sysmex Corporation, Asuragen Inc., CUSABIO TECHNOLOGY LLC and Cayman Chemical Company among others.

Key Developments

• In September 2023, Lunit signed a distribution agreement with Guardant Health which is a U.S.-based company specializing in precision oncology to distribute the latter’s cancer diagnostic products in Korea.
• In November 2023, Biocartis expanded its product portfolio with the launch of the Idylla PIK3CA-AKT1 Mutation Assay (RUO1). PIK3CA is an important biomarker in the treatment of advanced breast cancer.

Why Purchase the Report?

• To visualize the global ESR1 mutated metastatic breast cancer diagnostics market segmentation based on test type, sample type, end user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of global ESR1 mutated metastatic breast cancer diagnostics market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global ESR1 mutated metastatic breast cancer diagnostics market report would provide approximately 61 tables, 56 figures, and 185 Pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies