Breast cancer is still one of the leading causes of death in women, but over the last decades, there has been a sustained decline in mortality rates. With the discovery of specific prognostic and predictive biomarkers enabling the application of more individualized therapies to different molecular subgroups, breast cancer treatment has experienced several progressions in the past decades.
Biomarkers predict therapies that will be efficacious for breast cancer to be evaluated in tissue samples obtained from biopsy or surgery. In contrast, breast cancer assessing therapy response in the neoadjuvant and metastatic settings has usually been based on tumor size.
The use of biomarkers in basic and clinical research as well as in clinical practice has become so commonplace that their presence as primary endpoints in clinical trials is now accepted almost without question.
What are biomarkers?
The term biomarker refers to a broad subcategory of medical signs, that is, objective indications of medical state observed from outside the patient, which can be measured accurately and reproducibly.
Some examples of protein markers are prostate-specific antigens that are used for the detection of prostate cancer and genomic markers and epidermal growth factor receptor (EGFR) kinase mutations in non–small cell lung cancer, which predict response to EGFR kinase inhibitors.
Biomarkers are crucial to the rational development of medical therapeutics and are used for in-vitro diagnostics purposes, particularly in the fields of chronic disease and nutrition.
Breast cancer is the most frequent tumor growth in women, and its incidence has experienced innovation in systematic screening. The increasing incidence of breast cancer has led to an increase in the demand for its diagnosis and treatment.
Clinical biomarkers have been extensively preferred in the field of clinical medicine to offer individualized treatment options to patients.
Clinical Role of Imaging-Based Biomarkers
Tissue-based biomarkers, including estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2), are used in the treatment of breast cancer to determine the status of the treatment.
However, these biomarkers cannot capture the spatial heterogeneity of breast cancer that has been described at the intratumoral, intrametastatic, and intermetastatic levels. These factors have created the need for imaging-based biomarkers.
Molecular imaging studies can complement tissue-based biomarkers since they allow noninvasive assessment of disease throughout the body at single or multiple times.
This has raised intense interest in the elucidation of prognostic, predictive, and pharmacodynamic biomarkers.
A prognostic biomarker provides information about the patient’s overall cancer outcome, regardless of therapy, while a predictive biomarker gives information about the effect of a therapeutic intervention.
A predictive biomarker can be a target for therapy. Amongst the genes that have proven to be of relevance are well-known markers such as ER, PgR, and HER2 in breast cancer.
A pharmacodynamic biomarker is a response biomarker that indicates the biological activity of a medical product without necessarily drawing conclusions about efficacy or disease outcome.
The growth in the global clinical biomarkers market is expected to be driven by the increasing demand for clinical biomarker products, increasing key player initiatives, and the increasing prevalence of infectious diseases and various types of cancer globally.
According to a research report by BIS Research, in 2021, the global clinical biomarkers market was valued at $21.30billion, and it is expected to reach $54.29billion by 2032, growing at a CAGR of 8.73% during the forecast period 2022–2032.
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Breast Cancer Clinical Biomarkers and their Recent Advancements
According to the World Health Organization (WHO), there are 21 histological types of breast cancer that differ in risk factors, presentation, response to treatment, and outcomes, based on histomorphology and growth patterns alone.
The increasing demand for clinical biomarkers products is anticipated to support the growth of the global clinical biomarkers market during the forecast period 2022–2032.
The market is expected to grow at a significant growth rate due to opportunities such as the expansion of biomarker discovery and increased research funding for executing research and development activities.
One of the most important roles of cancer biomarkers is in the widespread screening of asymptomatic individuals so that the disease can be detected at a very early stage.
Several reported cancer biomarkers have been found to have low sensitivity in that they are found only in a small subset of patients with a particular type of cancer. One such biomarker is CA-125 which is also elevated in endometriosis and some other benign conditions, failing to identify more than 50% of the early cancers; thus, it is not recommended for use in general screening.
Recent advancements in biomarker development using gene arrays, in addition to proteomic technologies, including two-dimensional electrophoresis (2-DE) and mass spectrometry, have facilitated the discovery of several new biomarkers.
Companies such as Illumina, Inc., F. Hoffmann-La Roche Ltd, Agilent Technologies, Inc., and Myriad Genetics, Inc., are launching products, majorly focusing on indications for infectious diseases and cancer types such as breast cancer, ovarian cancer, lung cancer, and cervical cancer.
Several companies, such as Thermo Fisher Scientific Inc., QIAGEN N.V., Neo Genomics Laboratories, and CENTOGENE N.V., are collaborating and partnering with the stakeholders to develop and expand technological expertise to offer potential products in the global clinical biomarkers market.
Since clinical biomarkers are useful for predicting several outcomes during the course of the disease, including early detection and detection of disease recurrence, the future of cancer management is expected to be profoundly dependent upon the use of biomarkers that will guide physicians at every step of disease management.
Furthermore, the clinical biomarkers market is expected to grow at a significant growth rate due to opportunities for expansion of biomarker discovery and increased research funding for executing research and development activities.
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