Cancer Biomarkers Market

Cancer Biomarkers Market by Technology (Omics, Imaging, Immunoassay, and Others), Type (Protein, Genetic, and Others), Cancer Type (Breast, Lung, Colorectal, Prostate, and Others), Application (Diagnostics, Drug Delivery, Prognostics, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising prevalence of cancer worldwide, increase in the risk factors for cancer development, increasing research & development activities leading to new product launches and approvals in the cancer biomarkers arena across the globe.

The cancer biomarkers market is estimated to grow at a CAGR of 11.73% during the forecast period from 2025 to 2032. The global rise in cancer prevalence, driven by aging populations and environmental factors, is significantly increasing the demand for cancer biomarkers. Lifestyle changes, smoking, and exposure to carcinogens further elevate cancer risks, emphasizing the need for early detection and personalized treatments. Additionally, growing research and development efforts have led to the discovery of novel biomarkers and regulatory approvals for advanced diagnostic tools and companion diagnostics. These factors are expected to accelerate the adoption and market expansion of cancer biomarkers worldwide from 2025 to 2032.  

Cancer Biomarkers Market Dynamics:

According to recent data from GLOBOCAN (2024), the estimated number of new cancer cases worldwide was 20 million in 2022, with projections expected to rise to 32.6 million by 2045. Specifically, new cases of kidney cancer, breast cancer, and colorectal cancer were estimated at 435,000, 2.3 million, and 1.93 million, respectively, and are projected to increase to 693,000, 3.36 million, and 3.29 million by 2045. Additionally, the World Cancer Research Fund (2024) reported that global liver cancer cases exceeded 866,136 in 2022.  

With the rising incidence of cancer, there is an increasing demand for early detection, accurate diagnosis, and effective monitoring tools roles that cancer biomarkers fulfill. These biomarkers help identify specific cancer types, genetic mutations, and prognostic indicators, enabling personalized treatment strategies. This growing need has fueled investments in research and development, leading to innovative biomarker-based tests and therapies, thereby driving market growth.  

Recent advancements in omics technologies, including genomics, proteomics, and metabolomics, have revolutionized biomarker discovery and validation. The integration of big data analytics in cancer research has facilitated the analysis of vast genomic datasets to identify novel cancer-associated biomarkers. A notable trend is the increasing adoption of liquid biopsy techniques, which allow for non-invasive detection of circulating tumor DNA (ctDNA), offering real-time insights into tumor dynamics and treatment responses.  

Substantial public and private sector investments in R&D are accelerating biomarker innovation. For instance, government initiatives like the Cancer Moonshot program aim to advance cancer research and improve patient outcomes through enhanced biomarker discovery. Additionally, strategic industry activities are significantly boosting market expansion. In August 2024, Illumina, Inc., a leader in DNA sequencing technologies, received FDA approval for its in vitro diagnostic test, TruSight™ Oncology (TSO) Comprehensive. This test analyzes over 500 genes in solid tumors to identify immuno-oncology and actionable biomarkers, facilitating targeted therapy and clinical trial enrollment.  

These factors are expected to drive the global cancer biomarker market from 2025 to 2032. However, challenges such as high R&D costs, limited infrastructure, and the rigorous clinical validation and regulatory approval required for many biomarkers may hinder market growth to some extent.  

Cancer Biomarkers Market Segment Analysis:

Cancer Biomarkers Market by Technology (Omics, Imaging, Immunoassay, and Others), Type (Protein, Genetic, and Others), Cancer Type (Breast, Lung, Colorectal, Prostate, and Others), Application (Diagnostics, Drug Delivery, Prognostics, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the technology segment of the cancer biomarkers market, the immunoassay segment is expected to hold a significant share in 2024. Immunoassays play a crucial role in driving market growth by providing highly sensitive, specific, and cost-effective solutions for cancer detection and monitoring. These assays utilize antibodies to detect and quantify biomolecules, such as proteins, peptides, and other cancer-related biomarkers, making them essential tools in oncology diagnostics. Their ability to deliver rapid and accurate results has made them indispensable in clinical laboratories, particularly for early cancer detection, therapeutic monitoring, and prognostic assessments.  

Immunoassays are especially effective in identifying circulating tumor markers like carcinoembryonic antigen (CEA), prostate-specific antigen (PSA), and alpha-fetoprotein (AFP), which are widely used in diagnosing and monitoring various cancers. Advancements in technologies such as chemiluminescent immunoassays, enzyme-linked immunosorbent assays (ELISAs), and radioimmunoassays have further enhanced their precision, enabling the detection of low-abundance biomarkers with greater sensitivity. Additionally, the integration of automated platforms has streamlined the process, making these tests more accessible to healthcare providers.  

The rising global cancer burden and increasing awareness of early detection have significantly boosted the demand for immunoassay-based tests. Furthermore, the expansion of personalized medicine and targeted therapies has heightened the need for biomarker identification, where immunoassays remain a preferred method.  

Pharmaceutical companies and diagnostic manufacturers are heavily investing in R&D to develop innovative immunoassay kits and platforms, further expanding the market. Collaborations between biotech firms and healthcare institutions to validate and commercialize new biomarkers using immunoassay technologies have also fueled growth. For example, in April 2021, Roche launched the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. This test aids in diagnosing throat, bowel, and breast cancers when used alongside other diagnostic methods. The assay is now available in markets that accept the CE Mark.  

Overall, these factors are expected to drive the growth of the immunoassay segment, thereby contributing to the expansion of the global cancer biomarkers market.  

North America is expected to dominate the overall cancer biomarkers market:

North America is expected to dominate the cancer biomarkers market in 2024, driven by a high prevalence of cancer, particularly liver, kidney, breast, and lung cancers. The demand for advanced diagnostic solutions, coupled with a well-established healthcare infrastructure, a strong focus on precision medicine, and early disease detection, supports market growth. Additionally, technological advancements and the presence of key industry players further reinforce the region's leadership. Significant investments in research and development, along with strategic collaborations, continue to drive innovation and expand market accessibility.  

According to recent data from GLOBOCAN (2024), North America recorded an estimated 79,800 new cases of kidney cancer in 2022, projected to rise to 103,000 by 2045. Overall, the region saw 2.67 million new cancer cases in 2022, with projections reaching 3.83 million by 2045. Cancer biomarkers play a crucial role in identifying genetic, proteomic, and metabolic alterations associated with these cancers, enabling earlier diagnosis and improved patient outcomes.  

In lung cancer, biomarker advancements such as EGFR mutations, ALK rearrangements, and PD-L1 expression have paved the way for targeted therapies and immunotherapy, increasing the clinical utility and demand for these diagnostic tools. Similarly, in kidney cancer, biomarkers like VEGF, PDGF, and CAIX are proving instrumental in predicting prognosis, assessing therapeutic response, and monitoring disease progression—especially with the rise of targeted therapies such as tyrosine kinase inhibitors. The growing adoption of liquid biopsy and other non-invasive diagnostic methods further contributes to market expansion.  

Regulatory developments are also shaping the landscape. In June 2023, the FDA launched a pilot program aimed at mitigating risks associated with laboratory-developed tests (LDTs) used in cancer biomarker identification. This initiative underscores a shift toward ensuring the reliability, accuracy, and clinical validity of LDTs an essential aspect of precision oncology. By setting standardized evaluation criteria, the program enhances confidence among healthcare providers and patients, encourages innovation, and streamlines regulatory pathways for high-quality biomarker assays.  

Overall, these factors are expected to drive the growth of the cancer biomarkers market in North America, solidifying its position as the leading region in this sector.  

Cancer Biomarkers Market Key Players:

Some of the key market players operating in the cancer biomarkers market include F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Inc., QIAGEN N.V., Illumina, Inc., Bio-Rad Laboratories, Inc., Abbott Laboratories, bioMérieux SA, BD, Merck Millipore, Agilent Technologies, Myriad Genetics, Sysmex Corporation, Hologic, Inc., Quest Diagnostics, Centogene N.V., PerkinElmer, Inc., Siemens Healthineers, Exact Sciences, R&D Systems, Inc., BioVision, Inc., and others.

Recent Developmental Activities in the Cancer Biomarkers Market:

• In February 2022, OncoDNA, a genomic and theranostic company announced the launch of OncoDeep kit, integrating both reagents and quality control standards for the sequencing of over 600 cancer biomarkers, which provide powerful data analysis and support oncologists in the most effective and personalized treatments for cancer patients.
• In April 2021, Amgen launched Biomarker Assist™, a program to help more patients with non-small cell lung cancer gain access to biomarker testing.

Key Takeaways From the Cancer Biomarkers Market Report Study

• Market size analysis for current cancer biomarkers size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the cancer biomarkers market.
• Various opportunities available for the other competitors in the cancer biomarkers market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current cancer biomarkers market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for cancer biomarkers market growth in the coming future?

Target Audience Who Can be Benefited From This Cancer Biomarkers Market Report Study

• Cancer biomarkers product providers
• Research organizations and consulting companies 
• Cancer biomarkers -related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in cancer biomarkers 
• Various end-users who want to know more about the cancer biomarkers market and the latest technological developments in the cancer biomarkers market.  

Frequently Asked Questions for the Cancer Biomarkers Market:

1. What are cancer biomarkers?

• Cancer biomarkers are biological molecules that help in determining the presence of cancer in a patient. They are either produced by the cancer cells or by non-cancer cells in response to cancer onset and progression. They can be identified from serum and can be used for personalized daily care in screening, diagnosis, establishing prognosis, monitoring treatment, and detecting relapse.

2. What is the market for cancer biomarkers?

• The cancer biomarkers market is estimated to grow at a CAGR of 11.73% during the forecast period from 2025 to 2032. 

3. What are the drivers for the cancer biomarkers market?

• The rising prevalence of cancer worldwide, driven by factors such as aging populations and environmental influences, is significantly boosting the demand for cancer biomarkers. Increasing risk factors for cancer development, including lifestyle changes, smoking, and exposure to carcinogens, have heightened the need for early detection and personalized treatments. Additionally, the surge in research and development activities has led to the discovery and launch of novel biomarkers, alongside regulatory approvals for advanced diagnostic tools and companion diagnostics. Collectively, these factors are expected to strengthen the adoption and market penetration of cancer biomarkers worldwide during the forecast period from 2025 to 2032.

4. Who are the key players operating in the cancer biomarkers market?

• Some of the key market players operating in the cancer biomarkers are F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Inc., QIAGEN N.V., Illumina, Inc., Bio-Rad Laboratories, Inc., Abbott Laboratories, bioMérieux SA, BD, Merck Millipore, Agilent Technologies, Myriad Genetics, Sysmex Corporation, Hologic, Inc., Quest Diagnostics, Centogene N.V., PerkinElmer, Inc., Siemens Healthineers, Exact Sciences, R&D Systems, Inc., BioVision, Inc., and others.

5. Which region has the highest share in the global cancer biomarkers market?

• North America is expected to account for the highest proportion of the cancer biomarkers market in 2024, out of all regions. The region has a high prevalence of cancer, particularly liver, kidney, breast, and lung cancers, which drives the demand for advanced treatment options like Cancer Biomarkers. Additionally, the strong presence of established healthcare infrastructure, coupled with a strong focus on precision medicine and early disease detection, supports the market's growth. Technological advancements in cancer biomarkers along with the presence of key market players further contribute to the dominance of North America. Moreover, significant investment in research and development and collaborations among leading market players enhance product innovation and accessibility, solidifying the region's leadership in this sector.