The global cancer biomarkers market size was USD 27.83 Billion in 2021, and is expected to register a revenue CAGR of 17.6% during the forecast period.
The global cancer biomarkers market size was USD 27.83 Billion in 2021, and is expected to register a revenue CAGR of 17.6% during the forecast period. Rapid implementation of advanced technologies for cancer biomarker detection and development, and rising investments towards Research & Development (R&D) activities for detection of various cancer biomarkers are major factors expected to drive the market revenue growth.
Early detection of cancer is important for effective and successful therapeutic interventions. Biomarkers are essential for anticancer drug research and clinical uses, such as determining prognosis and tracking treatment response. Conventional cancer screening procedures are expensive, time-consuming, and inconvenient for frequent screenings. Biomarker-based cancer diagnosis, on the other hand, is growing as one of the most promising approaches for early detection, monitoring of disease progression, and eventual treatment for cancer. Biological markers, often known as Cancer Biomarkers (CB) include help to identify genetic properties of malignant cells.
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Proteins, nucleic acids, antibodies, and peptides are some of the major examples of biomarkers. Cancer biomarkers also consist of a collection of gene expression, proteomic, and metabolic characteristics. With the development of clinical studies, a number of genes and protein-based cancer biomarkers are being used in patient care; including BCR-ABL (Chronic Myeloid Leukemia), AFP (Liver Cancer), CA-125 (Ovarian Cancer), CA19.9 (Pancreatic Cancer), EGFR (Non-small-cell lung carcinoma), HER-2 (Breast Cancer), KIT (Gastrointestinal stromal tumour), CEA (Colorectal Cancer), PSA (Prostate-Specific Antigen) (Prostate Cancer), and others. The ability to detect low quantities of specific target proteins in clinical specimens in a quick and low-cost manner is important for early cancer detection and diagnosis, which could help improve lifespan of cancer patients and ensure better health outcomes in such patients. Apart from early detection and diagnosis, biomarkers present physicians with actionable information and data regarding molecular pathway alterations in a specific cancer type that leads to evidence-based drug selection (predictive biomarkers), and enhanced and more accurate disease progression prognosis (prognostic biomarkers). These factors are expected to drive revenue growth of the market during the forecast period.
Testing the biomarker status of a patient preceding the administration of relevant co-dependent therapeutic treatments has become more common in clinical practice over the last decade. These biomarker-guided cancer therapeutic treatments have raised the prospect of personalized medicine, with correct treatment being prescribed to the right patient at the right time, all while avoiding costly ineffectual drugs and harmful drug effects.
Biomarker testing has been widely supported by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for development and usage of prescription medications, thus driving market revenue growth. According to the ClinicalTrials.gov database, more than 33,000 clinical trials employing biomarkers had been recorded in April 2020, with over 4,000 Phase III and IV trials conducted. The proportion of biomarker approvals is consistent between the EMA and FDA, with 69% and 59%, respectively. In recent years, there has been a minor increase in biomarker acceptability. The Norwegian Ministry of Health has devised a national strategy for integrating personalized medicine into healthcare services. Its goal is to make personalized medicine more accessible, ensuring that the right treatment is given to the right patient at the right time. As a result, these are major factors driving demand for biomarkers, which is expected to drive the market revenue growth.
Driver: Rapid implementation of advanced technologies for cancer biomarker detection and development
Advent of innovative and robust advanced technologies has resulted in substantial progress in the field of biomarker research. Implementation of novel, non-invasive, easier, and cheaper procedures and techniques in the detection of novel proteomic, genomic, or immunological biomarkers is driving revenue growth of this market. Development of strong proteomic and genomic technologies, combined with modern bioinformatics tools, has made it possible to analyze thousands of biological markers at the same time. Biomarkers are becoming more significant in the clinical diagnosis and management of cancer patients, owing to widespread availability of genomic and molecular profiling technologies. For instance, single gene, protein, or multi-gene-based signature assays have been developed to evaluate distinct molecular pathway alterations that support therapeutic decision-making. Genomic, metabolomics, proteomic, and microRNA profiling, Single Nucleotide Polymorphism (SNP) analysis, Comparative Genome Hybridization (CGH), High Throughput Screening (HTS), and Next-Generation Sequencing (NGS) are some of the major pre-clinical methodologies for cancer biomarker development. Other promising approaches include investigation of CSC-specific markers and cell-free circulating tumor DNA as well as the assessment of Circulating Tumor Cells (CTC). NGS can analyze a wide range of genomic changes at the same time, including Copy Number Variations (CNV), mutations, and translocations in multiple genes. As a result, NGS delivers a more efficient, and cost-effective tumor analysis in comparison to serial single-biomarker tests.
Modern techniques such as tissue microarrays, gene expression profiling, proteomics, mass spectrometry, machine learning, and other bioinformatics-based methodologies, help in identifying biomarkers that can help with drug development. These technologies also help in interpreting data and validate diagnostic, predictive, or prognostic value of cancer biomarkers, thus contributing to development of cancer biomarkers. Proteomics involves monitoring proteins of an organism or cellular system. Protein biomarkers are investigated conducting tests such as Fluorescent in Situ Hybridization (FISH), Enzyme-linked Immunosorbent Assay (ELISA), and western blot. Recently, there has been a lot of interest by healthcare professionals and physicians in developing biosensors to detect biomarkers and immunological checkpoints in liquid biopsies to evaluate and analyze cancer progression. Biosensors are linked with biomarker and point-of-care detection for high specificity and sensitivity, signal amplification, multi-analytical testing, rapid reaction time, cheap cost, and simplicity. A variety of biosensors, including electrochemical biosensors, have been recently created based on disease-specific biomarkers for early cancer diagnosis.
Restraint: Challenges regarding biomarker validation as well as lack of standardization are limiting market revenue growth
Integrating proteomics, genomes, and metabolomics technologies in biomarker detection and functional interpretation in conjunction with clinical data and epidemiology will be a significant challenge in discovery of cancer biomarkers. Lack of data reproducibility across various technological platforms, as well as problems of analytical validation, have hampered their application in clinical practice. Although, this type of technology has progressed at a slower rate than anticipated. The most difficult component of clinical proteomics is validation of newly found cancer biomarkers. The biomarker’s specificity, reproducibility, experimental study design, and adequate controls, such as clinical specimen and sample collection, handling, experimental design, and data processing, are all critical aspects that must be considered for the validation studies. Biomarker validation is divided into two parts: analytical validation and clinical validation. Use of prospectively acquired samples from target population before determining patient outcomes is a fundamental design aspect of all validation studies that reduce bias. Adoption of such technologies has unintentionally introduced a slew of new challenges to data validation and analysis, including complexities regarding identification of cancer driver alterations, cancer drug target classification, and selection of rational and practical treatment options for cancer patients. Furthermore, several candidate cancer biomarkers identified from preliminary studies fail validation in subsequent, more rigorous studies. Additionally, false discovery (defined as a discovery that was made by an error) occurs when an initial finding related to a new biomarker cannot be reproduced in independent sets of samples or by other laboratories. The main reasons for false discovery include study design and execution deficiencies/errors, including preanalytical, analytical, post-analytical, and bioinformatics shortcomings.
Absence of suitable economic incentives for pharmaceutical companies, variances in regulatory approval across different countries, complexities faced during research, and inaccuracy of biomarker prediction are other challenges impeding revenue growth of the cancer biomarkers market.
COVID-19 Analysis:
Cancer patients are particularly susceptible to the SARS-CoV-2 (COVID-19), as they are immunocompromised and thus at a higher risk of severe health complications and fatality from the virus. According to preliminary research, people with hematological and metastatic cancers are more likely to acquire severe COVID-19, which has a bad prognosis. Biomarkers such as C-reactive protein and interleukin-6 may be used to predict outcomes and are thus important in determining severity of COVID-19 in cancer patients. Some important biomarkers such as C-reactive protein (CRP), Interleukin-6 (IL-6), and others are being studied for prognostic and treatment course prediction in cancer patients with COVID-19. Studies conducted in 2020 and 2021, have reported that cancer biomarkers such as Carcinoembryonic Antigen (CEA), CA-125, and Human Epididymis protein 4 (HE4) are elevated in a variety of inflammatory pulmonary diseases. CEA levels were reported to be higher in smokers, while CA-125 levels were higher in people with Chronic Obstructive Pulmonary disease (COPD). In patients with severe or critically severe SARS-CoV-2 infection, serum CEA levels were shown to be higher. The initial levels of CEA biomarkers were linked to prognosis of COVID-19 patients, indicating that CEA could be used as a new COVID-19 prognostic biomarker.
Cancer Type Outlook:
Based on cancer type, the global cancer biomarkers market has been segmented into breast cancer, lung cancer, prostate cancer, colorectal cancer, and others. Breast cancer segment accounted for largest revenue share in 2021. According to the World Health Organization (WHO) and International Agency for Research on Cancer (IARC), 2.3 million women were diagnosed with breast cancer in 2020, involving 685,000 deaths worldwide. Breast cancer became the most frequently diagnosed cancer type in the world, as of the end of 2020, with 7.8 million women alive who had been diagnosed in the previous five years. Breast cancer is responsible for around 30% of female cancers worldwide, with a mortality-incidence ratio of 15%. Clinical biomarkers play a major role in diagnosis and treatment of breast cancer. Three molecular biomarkers for breast cancer provide prognostic data and predict response to a certain therapy, making them a cornerstone for better clinical management and decision-making. Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal growth factor Receptor 2 (HER-2) are some of these biomarkers. Biomarker status is normally characterized in current clinical practices by histological evaluation of Immunohistochemistry (IHC) stained tissue using independent IHC stains for every biomarker. In breast cancer, biomarker profiles have been associated with histologic characteristics. Estrogen Receptor (ER) and Progesterone Receptor (PgR) testing guidelines released by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) aim to improve the analytic efficiency and diagnostic performance of ER and PgR testing, as well as their clinical efficacy as biomarkers for management of primary breast cancer patients. These factors are expected to drive revenue growth of the market during the forecast period.
According to GLOBOCAN 2020 estimates produced by the International Agency for Research on Cancer, lung cancer was one of the leading causes of cancer death, with an estimated 1.8 million deaths (18%). Biomarkers are increasingly being used to diagnose lung cancer early. Biomarkers can play a variety of roles, ranging from risk categorization to classification of lesions discovered coincidently or through low-dose screening programs. There are several multianalyte biomarker panels in the market that have been demonstrated to be effective in classifying indeterminate pulmonary nodules. For instance, OncImmune’s EarlyCDT-Lung is a seven-autoantibody panel that has been extensively evaluated in seven different cohorts. This panel, which includes autoantibodies to p53, CAGE, NY-ESO-1 (CTAG1B), SOX2, GBU4–5, HuD, and MAGE-A4, performed well in identifying ambiguous pulmonary nodules, yielding useful information on whether the panel is positive or negative. Furthermore, Percepta Genomic Sequencing Classifier is an upgraded test based on next-generation RNA transcriptome sequencing that enables both up-and down-classification among patients who are at intermediate pre-test lung cancer risk, was introduced in 2019.
Type Outlook:
Based on type, the global cancer biomarkers market has been segmented into genomic, proteomic, epigenetic, and imaging biomarkers.
The epigenetics biomarkers segment is expected to register a rapid revenue growth rate during the forecast period. Promoter hypermethylation, chromatin remodeling, and histone modifications are examples of epigenetic biomarkers, which are changes in gene expression without a nucleotide change. Risk assessment, cancer diagnosis, and disease classification are all facilitated by the discovery of epigenetic biomarkers. Abnormal DNA methylation has been identified in several malignancies in recent years and is thought to play a major role in carcinogenesis. DNA methylation is a biological alteration carried out by DNA methyltransferases that are relatively stable. Methylation indicators can be found in serum, faeces, and plasma, indicating that it could be used as a noninvasive technique as a biomarker for cancer screening. SEPTIN9, NDRG4, and BMP3 are three DNA methylation biomarkers that have been included in FDA-approved cancer screening tests for early CRC detection. Epi proColon 2.0 CE and Colovantage are two tests that detect SEPTIN9 methylation in blood. Cologuard, the first FDA-approved stool DNA test for average-risk colorectal cancer screening, is a high-sensitivity multi-target stool DNA (mt-sDNA) test that analyses multiple molecular biomarkers, including N-Myc downstream-regulated Gene 4 Protein (NDRG4), Bone Morphogenetic Protein 3 (BMP3) methylation status, and KRAS mutation.
Proteomic biomarkers segment is expected to register a rapid revenue growth rate during the forecast period. Biomarkers identified employing technology capable of analyzing various proteins concurrently, such as protein microarray and Mass Spectrometry (MS), are referred to as proteomic biomarkers. Significantly improved resolution, depth of proteome coverage, and speed in focused proteomics applications such as MS analysis and Selective Reaction Monitoring or Multiple Reaction Monitoring (SRM/MRM) and multiplexed enzyme-linked immunosorbent have accelerated detection of protein biomarkers in serums and body fluids of the cancer patients, thus driving the revenue growth of the market. Although, abnormal protein expression in cancer has been recognized for decades, proteomic cancer biomarkers have only been discovered in the last 15 years, due to advancement of proteomic technologies. There are currently over 20 FDA-approved/cleared protein biomarkers for various malignancies. OVA1 is the first and only FDA-approved multivariate index test of proteome biomarkers in vitro. CA125, prealbumin, apolipoprotein A1, b2-microglobulin, and transferrin are the proteins tested. The other four proteins in this panel were found using SELDI-TOF-MS, with the exception of CA125.
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Application Outlook:
Based on application, the global cancer biomarkers market has been segmented into diagnostics, prognostics, drug discovery & development, and pharmacokinetics.
Drug discovery & development segment is expected to register a steady revenue growth rate during the forecast period. Biomarker-driven enrichment clinical trials have shown to be a crucial strategy in the area of clinical drug discovery and development, particularly for tailored anti-cancer treatments. More than 30 medications were developed in association with a biomarker test by the end of 2018, and a regulator-approved CDx assay had been associated with their use. These cancer drug therapies, on the other hand, have primarily been developed based on specific molecular biomarkers for a single-targeted cancer diagnosis, such as HER2-positive breast cancer and EGFR mutation-positive NSCLC. On 23 May 2017, Pembrolizumab (Keytruda, Merck & Co) received priority approval from the U.S. Food and Drug Administration for patients with metastatic, microsatellite instable-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors who have developed on prior existing therapy and did not have satisfactory alternative treatments. This was the first drug that was approved based on a molecular biomarker rather than a standard histopathologic diagnosis. These factors are expected to drive revenue growth of this segment.
Regional Insights:
Based on regional analysis, the cancer biomarkers market in North America is expected to account for largest revenue share during the forecast period. There is a rising demand for cancer biomarkers which is attributed to factors such as presence of pharma companies and research organizations in the U.S. and Canada, rise in government initiatives & programs related to cancer drug therapy and treatment options as well as global growth of the healthcare sector. The National Institutes of Health, the FNIH, and 12 major pharmaceutical companies formed the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration worth USD 220 million. PACT is working to identify, develop, and validate reliable biomarkers in order to progress innovative cancer medicines and treatments that use immune system to fight cancer. This is a major factor driving revenue growth of the market in this region. Furthermore, on 21 March 2022, the National Cancer Institute, which is part of the National Institutes of Health, began the Molecular Characterization Initiative for pediatric cancers in support of President Biden’s Cancer Moonshot goal of increasing clinical data exchange in cancer research. This program provides tumor molecular characterization and biomarker screening tests, to children, adolescents, and young adults with newly diagnosed Central Nervous System (CNS) cancers being treated at Children’s Oncology Group-affiliated hospitals (COG). These are major factors contributing to revenue growth of the market in this region.
Cancer biomarkers market in Asia-Pacific is expected to register a steady revenue CAGR during the forecast period. Some of the major factors include increased R&D funding by governments and private companies as well as technological advancements and innovations in the area of cancer biomarker detection and development in the region, which is expected to drive the market revenue growth. Furthermore, rising economy, improved healthcare framework, and rapid infrastructure development had a significant impact on the demand for cancer biomarkers among various upcoming pharmaceutical and biotechnological industries and startups, thus expected to drive revenue growth of the market in this region.
Europe is expected to register a rapid revenue growth rate during the forecast period. According to a study issued by the European Cancer Patient Coalition (ECPC), International Quality Network for Pathology (IQN Path), and the European Federation of Pharmaceutical Industries and Associations (EFPIA), biomarker testing is often successful in Northern and Western European countries, owing to their larger healthcare investment. Access to test facilities and financing tends to be more variable in Southern and Central European countries, as well as the Baltic states. Furthermore, The European Commission has unveiled Europe’s Beating Cancer Plan, which is a top priority for the von der Leyen Commission in the domain of health and a fundamental pillar of a robust European Health Union on 3 February 2022. The Cancer Plan lays out a new EU strategy for the prevention, and treatment of cancer, using new technology, research, and innovation. It is organized around four main action areas in which the EU has a huge impact: (1) prevention; (2) early detection; (3) cancer diagnosis; and (4) cancer patient’s quality of life. These rising initiatives by the governments are expected to drive the market revenue growth in this region.
Competitive Landscape
Competitive landscape of the global cancer biomarkers market is fragmented with several key players operating at global and regional levels. Key players are engaged in product development and strategic alliances to expand their respective product portfolios and gain a robust footing in the global market. Major companies in the market report include F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Inc., Illumina, Inc., QIAGEN N.V., Bio-Rad Laboratories, Inc., Abbott., Merck Millipore, bioMérieux SA, Eurofins Scientific, Inc., and Myraid Genetics, Inc.
- On 15 March 2022, Illumina, Inc. launched TruSight Oncology (TSO) Comprehensive, a single test that evaluates several tumor genes and biomarkers to identify an individual molecular profile of a patient’s cancer. In Vitro Diagnostic (IVD) kit will support precision medicine options for cancer patients across Europe, with its global debut taking place first in Europe.
- On 9 December 2021, the U.S. Food and Drug Administration permitted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) for the identification of non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor (EGFR) Exon20-insertion mutations for potential cancer treatment.
Segments Covered in the Report
This report offers historical data and forecasts revenue growth at global, regional, and country levels and provides analysis of market trends in each of the sub-segment from 2019 to 2030. For this study, Reports and Data has segmented the cancer biomarkers market based on cancer type, type, application, and region:
Segments Covered in the Report
This report offers historical data and forecasts revenue growth at a global, regional, and country level, and provides analysis of the market trends in each of the sub-segments from 2018 to 2030. For this study, Reports and Data has segmented the Cancer Biomarker Market based on biomolecule type, profiling technologies, services, diseases type, application, and region:
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Cancer Biomarkers Market Report Scope
Segments covered By Cancer Type Outlook, Type Outlook, Application Outlook, Regional Outlook
By Cancer Type Outlook
Breast Cancer
Lung Cancer
Prostate Cancer
Colorectal Cancer
Others
By Type Outlook
Genomic
Proteomic
Epigenetic
Imaging
By Application Outlook
Drug Discovery & Development
Diagnostics
Prognostics
Pharmacokinetics
Regional scope
North America
Europe
Asia Pacific
Latin America
Middle East & Africa
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