ESR1 Mutation Metastatic Breast Cancer Diagnostics Market
Market Overview
The global ESR1 Mutation Metastatic Breast Cancer Diagnostics Market generated a Market Value of US$58.70 Million in 2022 and is expected to accumulate a Market Value of US$185 Million by registering a CAGR of 11% during the forecast period 2023 to 2030. Growth of the ESR1 mutation metastatic breast cancer diagnostics market can be attributed to the increasing prevalence of breast cancer and growing need for personalized treatment options for patients with genetic mutations specific. The ESR1 mutation metastatic breast cancer diagnostics market registered a CAGR of 6.9% during the historical period from 2018 to 2022.
ESR1 is a gene that codes for estrogen receptor alpha protein, which plays a crucial role in regulating the growth and development of breast tissue. Mutations in this gene are found in about 30-40% of patients with metastatic breast cancer and can lead to resistance to hormone therapy, a common treatment for breast cancer.
imaging tests to monitor disease progression and other biomarker tests to aid in the diagnosis and treatment of metastatic breast cancer with an ESR1 mutation.
Demand Analysis for ESR1 Mutated Metastatic Breast Cancer Diagnostics from 2018 to 2022 vs. Forecast from 2023 to 2030
According to market research and competitive intelligence provider Pharmanucleus, the ESR1 mutation metastatic breast cancer diagnostics market represented a value of 6.9% during the historical period, from 2018 to 2022.
During this time, there have been several advances in diagnostic tools and treatment options for patients with metastatic breast cancer with an ESR1 mutation. In 2018, the FDA granted accelerated approval for a diagnostic test to identify patients with ESR1 mutations who may benefit from specific treatment. In 2019, the American Society of Clinical Oncology released updated guidelines for the treatment of advanced breast cancer, highlighting the importance of genomic testing to identify patients with ESR1 mutations.
In addition, several key market players have contributed significantly to the development and commercialization of diagnostic tests for metastatic breast cancer with ESR1 mutation. These included Myriad Genetics, Foundation Medicine and Guardant Health.
Overall, the ESR1 metastatic breast cancer diagnostics market has shown significant growth potential during the period between 2018 and 2021, with advancements in diagnostic tools and treatment options, but has also made face challenges related to pricing and regulatory issues.
Thus, the ESR1 mutation metastatic breast cancer diagnostics market is expected to register a CAGR of 11% during the forecast period 2023 to 2030.
Which Market Factors Are the Most Important for ESR1 Mutated Metastatic Breast Cancer Diagnostics?
Breast cancer prevalence is rising, which is good for market expansion.
Breast cancer is one of the most commonly diagnosed cancers in women worldwide, and the incidence of breast cancer is increasing globally. Accordingly, there is a growing need for personalized treatment options for patients with specific genetic mutations such as ESR1 mutations.
There have been significant advances in diagnostic technologies, including genetic testing, imaging and biomarker analysis, which have allowed more accurate and rapid identification of ESR1 mutations in patients with a breast cancer. The trend towards personalized medicine is growing and there is a need for diagnostic tests that can identify specific genetic mutations in cancer patients in order to provide personalized treatment options tailored to each patient's individual needs.
There has been a significant increase in investment in research and development in the area of ??breast cancer diagnostics, including the development of new technologies and treatments for patients with metastatic breast cancer with an ESR1 mutation. . Regulatory approvals for diagnostic tests capable of identifying ESR1 mutations in breast cancer patients have increased, which has helped drive the market growth.
The diagnostics market for ESR1-mutated metastatic breast cancer is being shaped by the availability of diagnostic technologies.
Genetic testing: Genetic testing can be used to identify ESR1 gene mutations in breast cancer patients. These tests can be performed on tumor tissue or blood samples.
Imaging tests: Imaging tests such as computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET) can be used to monitor disease progression in patients with breast cancer with ESR1 mutations.
Biomarker tests: Biomarker tests such as circulating tumor DNA (ctDNA) analysis can be used to monitor disease progression and response to treatment in breast cancer patients with mutations ESR1.
Hormone receptor test: The hormone receptor test can be used to determine if a breast cancer patient has hormone receptor positive breast cancer, which is a type of breast cancer often treated with hormone therapy .
Pathology tests: Pathology tests can be used to examine tissue samples from a breast cancer biopsy to determine the type and stage of breast cancer and to identify ESR1 mutations.
What problems does the market for diagnosing ESR1-mutated metastatic breast cancer face?
Regulational issues and limited availability to diagnostic testing are impeding market expansion.
The high cost of diagnostic tests and limited insurance coverage may limit patient access to these tests. Many healthcare providers may not be aware of the importance of genetic testing and other diagnostic tests to identify ESR1 mutations in breast cancer patients.
There are currently limited targeted therapies available for the treatment of metastatic breast cancer with ESR1 mutation, which may limit the impact of diagnostic tests. Regulatory hurdles can slow the approval and adoption of new diagnostic tests and targeted therapies.
Technical challenges associated with genetic testing, including the complexity of the testing process and the need for specialized expertise and equipment, may limit the widespread adoption of these tests. Genetic testing raises ethical concerns, such as questions related to the confidentiality of genetic information and the potential for genetic discrimination. Thus, all the aforementioned factors are derailing the growth of the ESR1 Mutation Metastatic Breast Cancer Diagnostics Market.
Regional Perspectives
For the North American ESR1 Mutated Metastatic Breast Cancer Diagnostics Market, is a strong regulatory environment creating profitable opportunities?
The expansion of the market in North America is being driven by improvements in diagnostic technology.
Breast cancer is one of the most commonly diagnosed cancers in North America, and the incidence of breast cancer is increasing in the region. There have been significant advances in diagnostic technologies, including genetic testing, imaging and biomarker analysis, which have allowed more accurate and rapid identification of ESR1 mutations in patients with a breast cancer.
The trend towards personalized medicine is growing in North America, and there is a need for diagnostic tests capable of identifying specific genetic mutations in cancer patients in order to offer personalized treatment options tailored to each patient's individual needs. patient.
The regulatory framework for diagnostic testing in North America is strong, and new diagnostic tests are subject to scrutiny, helping to ensure their safety and effectiveness. North America has one of the highest levels of healthcare expenditure in the world, which has helped the market grow. Thus, North America is expected to own 45% market share for the ESR1 mutated metastatic breast cancer diagnostic market in 2023.
ESR1 Mutated Metastatic Breast Cancer Diagnostics Market Growth Favoured in Europe by Rising Healthcare Spending?
Growing focus on individualised medicine propels market expansion in Europe
Breast cancer is one of the most common types of cancer in Europe, with approximately 562,500 new cases diagnosed in 2020 alone. As breast cancer continues to be a major public health problem, demand of advanced diagnostic tools such as the diagnosis of metastatic breast cancer with ESR1 mutation is expected to increase.
As medical research continues to uncover new information about breast cancer mutations, more healthcare providers are realizing the importance of the ESR1 test. This increased awareness has led to increased demand for diagnostics for metastatic breast cancer with an ESR1 mutation, as well as increased funding for research and development in this area.
Precision medicine aims to tailor treatment plans to each patient based on their unique genetic makeup. As more healthcare professionals adopt this approach, the demand for advanced diagnostic tools like the diagnosis of metastatic breast cancer with ESR1 mutation is expected to increase.
Early detection and prevention are essential in the treatment of breast cancer. Diagnostics for metastatic breast cancer with an ESR1 mutation can play a key role in identifying mutations at an early stage, leading to more effective treatment and better patient outcomes.
Thus, Europe is expected to own 40% market share for the ESR1 mutated metastatic breast cancer diagnostic market in 2023.
Industry-Specific Insights
Comprehensive Testing: The Go-To Option for ESR1 Mutated Metastatic Breast Cancer Testing at Diagnostic Centres?
Dependence on ESR1 Mutated Metastatic Breast Cancer Testing is caused by the assurance of quality in diagnostic facilities.
Diagnostic centers often have a team of highly trained and specialized medical professionals who have extensive experience in the diagnosis and treatment of cancer, including breast cancer. Diagnostic centers usually have access to the latest imaging and diagnostic equipment, which can help more accurately and quickly identify ESR1 mutations in breast cancer patients.
Diagnostic centers typically offer a full range of tests and procedures, including genetic testing, imaging, and biomarker analysis, which can help identify ESR1 mutations in breast cancer patients and to guide personalized treatment options.
Diagnostic centers often work closely with other health care providers, including oncologists, surgeons, and radiation therapists, to develop personalized treatment plans for breast cancer patients based on their specific needs.
Diagnostic centers often have strict quality assurance protocols in place to ensure that all tests and procedures are performed accurately and safely. Thus, diagnostic centers are expected to hold 47% market share for the ESR1 mutated metastatic breast cancer diagnostic market in 2023.
Market Competition
Key players in the ESR1 mutated metastatic breast cancer diagnostics are Berlin-Chemie, Pfizer, Sanofi, G1 Therapeutics, Inc., Sun Pharma Advanced Research Company, Zenopharm, Arvinas, Sermonix Pharmaceuticals, Roche, AstraZeneca, Novartis, Zentalis Pharmaceuticals, Olema Pharmaceuticals
- Berlin-Chemie has developed a diagnostic test called OnkoSelect ESR1 Mutation Test, which is used to identify ESR1 mutations in breast cancer patients. The OnkoSelect ESR1 Mutation Test is a PCR-based diagnostic test that detects the most common ESR1 mutations in breast cancer patients. The test is designed to be highly sensitive and specific, and it can be used with a range of different tissue samples, including formalin-fixed paraffin-embedded (FFPE) tissue samples.
- Pfizer has developed a targeted therapy called palbociclib (brand name: Ibrance), which is used to treat advanced breast cancer, including ESR1 mutated metastatic breast cancer. Palbociclib is a first-in-class cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that works by blocking the activity of proteins that promote cell division, thereby slowing or stopping the growth of cancer cells. The drug was approved by the US FDA in 2015 for the treatment of advanced breast cancer and has since been approved in several other countries around the world.
Key Segments Profiled in the ESR1 Mutated Metastatic Breast Cancer Diagnostics Industry Survey
Hormonal therapy:
- Tamoxifen
- Aromatase inhibitors
- Ovarian suppression
- Fulvestrant
- Elacestrant
Chemotherapy:
- Capecitabine
- Carboplatin
- Cisplatin
- Cyclophosphamide
- Docetaxel
- Others
Targeted therapy:
- Monoclonal antibodies
- Small molecule inhibitors
- Tumor-agnostic treatments
- Immunotherapy
- Pembrolizumab
- Dostarlimab
End User:
- Hospitals
- Clinics
- Research and Academic Institutes
- Diagnostic Centres
Region:
- North America
- Latin America
- Europe
- South Asia
- East Asia
- Oceania
- Middle East & Africa