What factors are driving the market for biomarkers?
In Biomarkers Market Report, The increasing prevalence of chronic diseases, advancements in the techniques used for the development of biomarker-based diagnostics, and the growing geriatric population are factors that are anticipated to significantly boost the biomarkers market over the forecast period.
Impact of COVID-19 on the Global Biomarkers Market
COVID-19 is an infectious disease caused by the newest novel coronavirus to be discovered. Prior to the December 2019 outbreak in Wuhan, China, COVID-19 was largely unknown and has now evolved from a regional crisis to a global pandemic. The World Health Organization (WHO) declared the COVID-19 outbreak to be a pandemic.
According to a study conducted by Diaceutics PLC (UK) on tracking the diagnosis and biomarker testing rates for specific cancer types, the volume of newly diagnosed metastatic non-small cell lung cancer patients in the United States decreased by over 30 percent between February 2020 and March 2020. This drastic decline in a single month also affected the rates of KRAS, BRAF, and EGFR testing, which are essential biomarkers for the selection of precision medicine therapies that are beneficial to specific patients.
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In particular, nearly 4,000 fewer EGFR tests were conducted during the month in which the majority of the nation implemented strict “stay-at-home” orders, representing a 13 percent decrease from the previous month. Also declining were the incidences of colorectal cancer (14% lower), acute myeloid leukaemia (14% lower), breast cancer (8.4% lower), and ovarian cancer (8.6 percent lower).
In contrast, numerous biomarkers play an important role in the diagnosis of COVID-19. C-reactive protein, serum amyloid A, interleukin-6, lactate dehydrogenase, neutrophil-to-lymphocyte ratio, D-dimer, cardiac troponin, renal biomarkers, lymphocytes, and platelet count are examples of biomarkers.
These markers were significantly elevated in patients with severe complications of COVID-19 infection compared to those without such complications. The number of lymphocytes and platelets was significantly lower in severe patients than in less severe patients.
In addition, the market’s leading companies have developed a variety of tests and assay kits to support COVID-19 research.
Chugai Pharmaceutical Co., Ltd. (Japan) and Thermo Fisher Scientific, Inc. are collaborating (U.S.)
The company signed a companion diagnostic agreement with Chugai Pharmaceutical to expand the use of the Oncomine Dx Target Test and expedite local biomarker testing of non-small cell lung cancer (NSCLC) patients eligible for treatment with ROZLYTREK (entrectinib) in Japan.
QIAGEN N.V. (Netherlands) and BioNTech S.E. are collaborating (Germany)
The company collaborated with BioNTech to develop and commercialise a tissue-based companion diagnostic (CDx) for use with the investigational cancer treatment BNT113. The CDx identifies patients with human papillomavirus (HPV)-associated squamous cell carcinoma of the head and neck (SCCHN). In addition, the company intends to expand the panel’s application to HPV-driven cancers such as cervical cancer and other cancers in order to provide their pharmaceutical partners with a universal HPV CDx.
High capital expenditures and lengthy development schedules for biomarker
Validating biomarkers is a time-consuming process due to its inconsistent performance in disease diagnosis. Due to this, the validation process becomes costly and time-consuming (approximately 15 years, including the time required for FDA approval). Different categories of biomarkers tend to share common development and validation process phases; consequently, the process and timeline to develop and validate biomarkers are, with a few exceptions, comparable across biomarker categories. In contrast to predictive and safety biomarkers, the clinical validation and utility phase for prognostic biomarkers and surrogate endpoints takes significantly longer. In clinical trials, development and validation of surrogate endpoints are the most expensive due to the extensive clinical validation required.
Personalized medicine represents an opportunity.
Applications of biomarkers in personalised medicine include diagnosis, prognosis, and the selection of targeted therapies. Due to the numerous limitations of conventional diagnostic and treatment procedures, personalised medicine has gained popularity over time. Numerous branches of medicine, including oncology and immunology, are moving toward patient-specific treatment based on their genetic signatures and clinical characteristics. Personalized medicine is used to determine the optimal course of treatment for each individual patient.
In certain facets of personalised medicine, the utilisation of biomarkers plays a crucial role. The consumables utilised in biomarker testing allow for the detection of these diseases. Several investigational therapies employ biomarker diagnostic products as companion diagnostics.
In addition, advances in genomics have led to a better understanding of certain types of cancer, enabling the development of precision therapies based on a specific gene mutation or molecular target, thereby providing patients with more treatment options.
For women with breast cancer, biopharmaceutical researchers have focused on identifying biomarkers, such as the HER2 positive gene mutation. These mutations can predict a patient’s risk of developing certain cancers and can be passed from generation to generation. By customising treatments based on biomarkers, medical professionals can provide patients with the greatest possible benefit.
Problem: difficulties associated with biomarker validation
Evaluation of assays or measurements of performance characteristics such as sensitivity, specificity, and reproducibility are components of the biomarker validation process. Validation is essential for establishing biomarkers as reliable decision-making tools for biopharma development, medical care, and investment. However, the high costs associated with biomarker validation are a major concern for businesses, particularly smaller ones.
In addition, the biomarker validation process is complicated by factors such as the inherent variability of biomarker concentrations and molecular heterogeneity. Due to the time required for assay development, the ability to develop assays lags behind the ability to generate biomarkers.
The use of biomarker-based tests in clinical settings requires proof of the clinical validity and utility of the biomarker. This is crucial not only for assisting physicians with decision-making within the practise of evidence-based medicine, but also for obtaining regulatory approvals and appropriate reimbursements for the test.
Nonetheless, collecting the necessary data to demonstrate clinical validity and utility may be a time-consuming and costly process that is further complicated by the absence of standards. There are also concerns regarding data sharing, security, and analysis. All of these elements may pose a formidable obstacle for the biomarkers market.
Integrating Artificial Intelligence (AI) Into Biomarker Technology
Since more than three decades ago, oncology has made greater use of biomarkers than any other field. Biomarkers have been utilised beyond the research laboratory for monitoring disease status, disease diagnosis, and treatment efficacy. Consequently, the intensifying circumstances of cancer are likely to propel the global market growth of biomarker tests.
According to the Product
The consumables segment was reported to have the highest biomarker market share, thereby contributing to the expansion of the biomarker diagnostics market as a whole.
In 2019, the safety biomarkers segment generated the most revenue, while the efficacy biomarkers segment recorded the highest CAGR over the forecast period. The technological advances in sequence profiling tools, the multiplex biomarkers platform, and the increasing need to interpret DNA sequences, proteins, and nucleic acids will increase biomarker-based testing.
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