CANCER BIOMARKERS MARKET ANALYSIS

Cancer Biomarkers Market Size and Trends

Global cancer biomarkers market is estimated to be valued at USD 25.60 Bn in 2024 and is expected to reach USD 59.01 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 12.7% from 2024 to 2031.

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Advancements in precision medicine and personalized cancer treatment boosts demand for cancer biomarkers. The ability of biomarkers to detect cancer at its earliest stages, guide therapeutic options, and monitor the effectiveness of treatment is boosting its adoption across the healthcare industry. Biomarker tools that improve diagnosis and help clinicians develop targeted therapies tailored to an individual patient's tumor characteristics are most widely used in clinical practice. This shift towards precision medicine and individualized care based on a patient's molecular profile is propelling the cancer biomarkers market growth.

High prevalence and incidence of cancer

Rising prevalence of cancer is expected to drive the market growth over the forecast period. Breast cancer is the second most common type of cancer in the U.S., after skin cancer. Breast cancer can occur both, in men and women. However, it is mostly found among females and the male occurrence of breast cancer is very rare. For instance, according to the data provided by the Breastcancer.org in March 2022, an estimated 287,850 new cases of invasive breast cancer were diagnosed in women in the U.S., along with 51,400 new cases of non-invasive (in situ) breast cancer in 2022.

Market Concentration and Competitive Landscape

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Technology is revolutionizing the field of cancer research and precision oncology at a rapid pace. Advanced techniques like next generation sequencing, multiplex assays, machine learning and artificial intelligence are enabling discovery of novel biomarkers and robust biomarker panels. These breakthrough innovations allow detection of cancer mutations, gene fusions, copy number variations and biomolecules with higher sensitivity and specificity. Development of techniques like liquid biopsy makes it possible to non-invasively monitor cancer evolution and response to treatment in real time by analyzing biomarkers in blood or other biofluids. At the same time, miniaturization and digitization is driving the development of portable, affordable detection platforms suitable for point-of-care application. This includes tools like smartphone-based readers and microfluidic chips. Widespread adoption of such technologies in clinical practice would significantly improve accessibility of timely and repeated biomarker tests. Given the fast pace of scientific progress, many more innovative biomarkers and companion diagnostics are in product development pipeline.

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The major factors that hinder growth of the global cancer biomarkers market include high treatment cost and unfavorable reimbursement policies. For instance, according to the data updated by ClinicSpots, an online platform for users/patients to interact and discuss symptoms and cure for their ailment, on June 2, 2022, on average, the cost of cancer treatment in India is around INR 500,000 (US$ 6,437) with a minimum expense of INR 90,000 (US$ 1,158) and a maximum cost of INR 2,750,000 (US$ 35,403). Moreover, the cost varies in different countries and treatment of cancer in India costs 60-80% less than in countries like the U.S., the U.K., Singapore, and others.

Market Opportunities: Demand for innovative diagnostics tools

As the population continues to age, projections indicate a substantial increase in cancer incidence rates, thereby generating a heightened demand for innovative diagnostic and monitoring tools in the healthcare sector. Personalized medicine and companion diagnostics are expanding the applications of biomarkers. Biopharma companies are increasingly collaborating with diagnostic firms to co-develop drugs and biomarkers. New technologies such as genomics and proteomics are enabling discovery of novel biomarkers from biofluids and tissues.

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Biomarker type segment is sub-segmented into CA 125, HER2, EGFR, CD20, BRAF, calcitonin, and others. HER2 segment is anticipated to hold 26.8% of the market share in 2024. HER2 protein overexpression or gene amplification is a key biomarker for breast cancer, detected in approximately 20% of breast cancer cases. The development of immunohistochemistry assays and in-situ hybridization tests has enabled accurate detection of HER2 status to determine treatment with HER2-targeted therapies such as trastuzumab. Continuous technological improvements have made these diagnostic tests more robust and affordable. Inclusion of HER2 testing in breast cancer treatment guidelines globally has promoted its widespread usage. Further clinical validations have expanded assessment of HER2 biomarkers beyond breast cancer to other tumor types such as gastric and colorectal cancers. Increased understanding of HER2's relevance in tumor biology and advances in companion diagnostics have consolidated its leadership position in the cancer biomarkers landscape.

Insights, By Cancer Type: Rise in the number of Awareness Campaign for Breast Cancer

Cancer type segment is sub-segmented into breast cancer, lung cancer, prostate cancer, kidney cancer, liver cancer, head & neck cancer, non-small cell lung cancer, and other cancers. Breast cancer segment contributes the highest share of the cancer biomarkers market and is projected to hold 28.8% of the market share in 2024. Breast cancer is the most common cancer among women worldwide, with over 2 million new cases diagnosed each year. Extensive campaigns by women's health organizations have raised awareness about risks and importance of early detection. This has increased participation in mammography screening programs across populations. Further, development of novel imaging technologies like tomosynthesis and contrast-enhanced spectral mammography have improved diagnostic capabilities of screening. Such screening enables detection of tumors at localized stages amenable to effective treatment and monitoring. This has boosted demand for diagnostic biomarkers to personalize therapeutic approaches in breast cancer management. Clinical adoption of multi-parametric biomarker panels and liquid biopsy tests also allow non-invasive, longitudinal monitoring of patients. Collectively, these efforts in creating awareness and diagnostic advancements promote the dominance of breast cancer segment.

Insights, By End User: Growing number of Diagnostic Laboratories

End User segment is sub-segmented into hospitals, specialty clinics, diagnostic laboratories, academic & research institutes, and others. Diagnostic laboratories contribute the highest share of the cancer biomarkers market and is projected to hold 29.2% of the market share in 2024. Diagnostic laboratories possess the necessary infrastructure, trained personnel and regulatory approvals to perform complex biomarker assays on a large scale. These work closely with pathologists to provide critical information for clinical decision making. Tests conducted by diagnostic labs are directly reimbursed under healthcare programs unlike those by other end users. This ensures a steady stream of revenue. Diagnostic labs also have capabilities to develop and validate novel multiplex biomarker tests. Their expertise enables translation of research insights into clinically useful tools. Moreover, centralization of testing in large diagnostic laboratories offers advantages of standardized, high-quality results with faster turnaround times. This sustains their primacy in fulfilling the bulk of demand for cancer biomarkers from hospitals and physicians. Continuous technologization of labs will further expand their diagnostic portfolio and market share over time. 

Regional Insights

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North America has established itself as the dominant region in the global cancer biomarkers market over the years, and is anticipated to hold 45.8% of the market share in 2024. The presence of leading biotechnology and pharmaceutical companies has propelled significant investments in cancer biomarker research and development activities. Furthermore, the region has higher prevalence of cancer types such as lung, prostate and breast cancer as compared to other parts of the world. This has sustained demand for newer diagnostic and treatment methods, driving the uptake of cancer biomarkers. Regulatory approvals are also quicker in the U.S., allowing new biomarkers to be commercialized at a faster pace.

Asia Pacific has emerged as the fastest growing regional market for cancer biomarkers. The growth can be attributed to improving healthcare standards and increasing disposable income levels in major Asian countries. Governments are allocating higher budgets for modernization of healthcare facilities. This along with expanding medical insurance will enhance the affordability of high-end diagnostic technologies. Moreover, countries like China and India offer low-cost operations and a large patient population for clinical trials, attracting several global research firms to set up regional centers. The prevalence of certain cancers is rising due to environmental factors and changing lifestyle habits in Asia. This growing cancer burden coupled with industry friendly business environment makes the region an attractive long-term investment destination for leading biomarker companies. Collaborations between international pharmaceutical players and domestic diagnostic labs are also propelling the adoption of advanced cancer screening approaches.

Market Report Scope

Cancer Biomarkers Industry News

• On March 04, 2024, Synexa Life Sciences, a global clinical laboratory services supplier for the biopharma sector, announced the addition of the Olink Target immunoassays and the Olink Signature Q100 instrument to its comprehensive suite of biomarker discovery platforms
• On January 23, 2024, Cleveland Diagnostics, Inc., a clinical-stage biotechnology firm developing next-generation diagnostic tools for cancer detection, announced the closure of USD 75 million in growth capital investment. The financing was spearheaded by Novo Holdings, a renowned global life sciences investor that manages the Novo Nordisk Foundation's assets, with participation from existing investors and a credit facility from Symbiotic Capital.
• In June 2023, Invivoscribe, an industry leader in precision diagnostics, announced a collaboration with Complete Genomics, a life sciences business, to develop and market biomarker assays using Complete Genomics' NGS systems. Under the terms of the agreement, Invivoscribe will be in charge of developing biomarker assays, including test controls and supporting bioinformatics tools.
• On June 16, 2022, Nonagen Bioscience, a cancer diagnostics company, announced that it had received CE marking for its Oncuria immunoassay for bladder cancer. Oncuria is the first-of-its-kind multiplex urine test for the quantitative detection of 10 biomarkers in urine that are associated with the presence of bladder cancer.
• On June 3, 2022, Tempus, a leader in artificial intelligence and precision medicine, announced the expansion of its comprehensive genomic profiling offerings with xF+, a new non-invasive, liquid biopsy panel of 523 genes, focused on pathogenic mutations in cell-free DNA (cfDNA). It can measure blood-based tumor mutational burden (bTMB) and microsatellite instability (MSI), predictive biomarkers for response to various cancer immunotherapies.

*Definition: Global cancer biomarkers market involves the discovery, development, and commercialization of biomolecules found in blood, tissue, urine or other body fluids that can be indicators of normal biological processes, pathogenic processes, or pharmacological responses to therapeutic interventions for cancer. Cancer biomarkers are used for early detection of cancer, screening for cancer risk, deciding treatment options, monitoring treatment response, and recurrence of cancer after treatment. Global cancer biomarkers market offers tests for protein, genetic and epigenetic biomarkers to aid accurate diagnosis and effective treatment.

Market Segmentation

• Biomarker Type Insights (Revenue, USD BN, 2019 - 2031)
• • CA 125
  • HER2
  • EGFR
  • CD20
  • BRAF
  • Calcitonin
  • Others
•  Cancer Type Insights (Revenue, USD BN, 2019 - 2031)
• • Breast Cancer
  • Lung Cancer
  • Prostate Cancer
  • Kidney Cancer
  • Liver Cancer
  • Head & neck Cancer
  • Non-small Cell Lung Cancer
  • Other Cancers
•  Profiling Technology Insights (Revenue, USD BN, 2019 - 2031)
• • OMICS Technology
  • Imaging Technology
  • Immunoassays
  • Cytogenetics
  • Others
•  End User Insights (Revenue, USD BN, 2019 - 2031)
• • Hospitals
  • Specialty Clinics
  • Diagnostic Laboratories
  • Academic & Research Institutes
  • Others
• Regional Insights (Revenue, USD BN, 2019 - 2031)
• • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • bioMérieux Inc.
  • INOVIQ
  • Bio-Rad Laboratories Inc.
  • Abbott
  • Becton Dickinson and Company
  • Merck KgaA
  • QIAGEN N.V.
  • Thermo Fisher Scientific Inc.
  • CENTOGENE N.V.
  • PerkinElmer Inc.
  • Siemens Healthineers
  • F. Hoffmann-la Roche Ltd
  • Agilent Technologies, Inc
  • Invitae Corporation
  • Myriad Genetics
  • Guardant Health
  • Illumina
  • FOUNDATION MEDICINE, INC.