Cancer Biomarkers Market By Biomarker Type (Genetic Biomarkers, Protein Biomarkers, Metabolic Biomarkers, Epigenetic Biomarkers), By Cancer Type (Breast Cancer, Lung Cancer, Colorectal Cancer, Prostate Cancer, Melanoma, Blood Cancers, Others), By Technology (Omics Technologies, Imaging Technologies, Bioinformatics, Immunoassays, Next-Generation Sequencing, PCR-based Techniques), By Application (Diagnostics, Prognostics, Risk Assessment, Therapy Prediction/Monitoring, Companion Diagnostics), By End-user (Hospitals, Cancer Research Institutes, Diagnostic Laboratories, Biopharmaceutical and Biotechnology Companies, Others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

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Industry Outlook

The Cancer Biomarkers Market accounted for USD 30.80 Billion in 2024 and USD 34.77 Billion in 2025 is expected to reach USD 117 Billion by 2035, growing at a CAGR of around 12.9% between 2025 and 2035. The Cancer Biomarkers Market is the process in which biological molecules are developed, identified, and marketed to show the existence or spread of cancer. They are known as DNA, RNA, proteins, or metabolites as biomarkers and can be detected in blood, tissue, or other bodily fluids, assisting in early detection, diagnosis, prognosis, and monitoring treatment responses.

Due to the increased prevalence of cancer in the world, the need to have customized medicine and non-invasive diagnostic devices has been on the rise. The market potential is rising with the advancement of genomics, proteomics, and liquid biopsy technologies. Growth in the market is also expected because of declines in R&D, government subsidies, and partnerships related to biotech firms and diagnostic companies.

Industry Experts Opinion

"Cancer biomarkers are revolutionizing early detection and personalized therapy. For example, PD-L1 expression as a biomarker for immune checkpoint inhibitors has transformed treatment for non-small cell lung cancer. However, challenges remain in validation and standardization across labs."

• Dr. Elizabeth M. Jaffee, Deputy Director, Sidney Kimmel Comprehensive Cancer Center

Report Scope:

Market Dynamics

The rising global incidence of cancer demands early detection and targeted treatment solutions.

The Cancer Biomarkers Market is booming significantly because of the increasing incidence of cancer globally. According to the international health estimates, cancer is one of the major causes of death across the globe, hence the urgent need to develop an early and accurate diagnostic system. When they can be detected by biomarkers, early intervention can be done in most cases, even before the symptoms are exhibited, and the survival rates are tremendously high. The move to preventive care further boosted the need for biomarker-based screening devices. Medical practitioners and organizations are spending a lot on cancer monitoring systems using these biomarkers. Unemployment and high-cost treatment would spare the high budget requirement of early intervention based on biomarkers.

Moreover, innovation is being driven by the need for personalized treatment approaches. Such a tendency is particularly strong in countries with an aging population and prevalent cancer. Increased awareness by both clinicians and patients is assisting the Cancer Biomarkers Market. In the United States alone, an estimated 1,958,310 new cases of cancer will be diagnosed in 2023, and 609,820 people will die from the disease, which has driven greater reliance on biomarker testing for early detection and tailored treatment approaches.

Advancements in genomics, proteomics, and liquid biopsy technologies are driving diagnostic accuracy.

Innovation in molecular biology has made tremendous progress in the capacity of the Cancer Biomarkers Market. The same is true of sensitive detection of cancer-specific proteins and mutations in body fluids and tissues, which is now possible with genomic and proteomic technologies. These breakthroughs are revolutionizing conventional cancer diagnostics on accuracy, speed, and scope. A special mention is that of liquid biopsy, which has been growing in popularity due to its non-invasive property and the possibility of real-time monitoring. It can be used to detect circulating tumor DNA (ctDNA) that provides an insight into how the tumor is evolving and responds to treatment.

This kind of innovation reduces its invasiveness and requires tissue biopsies, hence motivating patients to comply. In addition, multi-omics platforms merge various information to give an overall picture of cancer. Such platforms are increasingly becoming the epicenter of specific cancer treatment plans. Biomarker data analysis was also enhanced through the use of enhanced computing, together with AI, to interpret such data more precisely. The marketplace of cancer Biomarkers is growing at a high rate as the labs and hospitals include these next-generation instruments.

The prohibitive cost of biomarker-based diagnostics is limiting accessibility in low-income regions.

The Cancer Biomarkers Market has enormous potential, but a significant setback to the market is that testing biomarkers is expensive. The latest technologies, such as next-generation sequencing (NGS) and multiplex assays, use high requirements in terms of equipment and qualified specialists. The latter limits its large-scale use, particularly in developing and underfunded healthcare environments. In most low and middle-income countries, traditional pathology remains the only option for cancer diagnosis because of financial limitations. Also, the reimbursement policies of bio-marker testing are remarkably diverse in different regions, which further complicates access.

In developed countries, newer tests or experimental tests might not necessarily be covered by the insurance. Another barrier to the biomarker testing process is the cost required to establish a biomarker testing facility, which is extremely expensive. Consequently, health disparities can increase, whereby the affluent get access to superior medicine, and the rest are left behind. This obstacle is an impediment to the fair development of the Cancer Biomarkers Market, even though it is very innovative. It is important to tackle the issue of affordability using public-private partnerships, policy reshaping, and inexpensive technologies.

Growing demand for personalized medicine and companion diagnostics in oncology care.

The evolving field of personalized medicine presents a significant opportunity for the Cancer Biomarkers Market. As oncology shifts from one-size-fits-all approaches to individualized treatment, biomarkers have become essential tools. They help identify patients most likely to benefit from specific therapies, minimizing unnecessary side effects and improving outcomes. Companion diagnostics, which are used alongside targeted drugs, rely heavily on biomarker validation.

Pharmaceutical companies increasingly collaborate with diagnostic firms to co-develop such tests. This trend is particularly strong in immuno-oncology and targeted therapy pipelines. The Cancer Biomarkers Market benefits from regulatory support as agencies promote precision medicine. For example, the FDA now encourages the use of companion diagnostics in drug approvals. Patient advocacy and clinical demand are also driving adoption. Healthcare systems recognize the clinical and economic value of personalized care. As more drugs require biomarker testing for eligibility, diagnostic uptake is rising.

Technological innovations in AI and big data analytics are enhancing biomarker discovery.

A combination of artificial intelligence (AI) and big data analytics is transforming the Cancer Biomarkers Market. New methods of bio-marker discovery led to huge datasets due to the sequencing of genomics, proteomics representations, and clinical studies. The processing of this information is faster and more accurate compared to the traditional approaches since AI algorithms can uncover novel biomarkers that have clinical significance. The technologies are especially useful in the study of heterogeneous tumor data at the population level of patients. It is also feasible to make predictions of how the patient will respond to treatment using machine learning models that make use of biomarker profiles as a predictive factor.

This predictive ability is transforming both cancer research and clinical ordering. Furthermore, there is ongoing simplification of the process of incorporating biomarkers into practice with the help of cloud platforms and digital health tools. Health-tech startups and AI-based companies are entering the Cancer Biomarkers Market, as well as healthcare companies are joining forces with diagnostic companies. Computational biology is the infrastructure solution valued by both hospitals and research centers. These modern technologies are reducing the cost of research and development, time to market, and accuracy of tests. Consequently, the implementation of AI-based diagnostics becomes a competitive differentiator in oncology care.

Segment Analysis

Based on the Biomarker Type, the Cancer Biomarkers Market is classified into Genetic Biomarkers, Protein Biomarkers, Metabolic Biomarkers, and Epigenetic Biomarkers. Genetic biomarkers dominate the market. This is because they are extremely specific and have been gaining ground in early detection of cancer, prognosis, and personal treatment planning. Such genetic biomarkers as gene mutations and gene alterations are the common features of advanced molecular diagnostic tools like next-generation sequencing (NGS).

Protein biomarkers also have a great proportion, especially in immunoassays and in ELISA-based diagnostic systems. In the meantime, metabolic and epigenetic biomarkers have become popular to a certain degree because of novel studies, and their clinical applications remain insufficient. Genetic biomarkers are also becoming increasingly popular in a variety of diagnostic uses, with their correlation with both genomics and bioinformatics.

Based on the Cancer Type, the Cancer Biomarkers Market is classified into Breast Cancer, Lung Cancer, Colorectal Cancer, Prostate Cancer, Melanoma, Blood Cancers, and Others. Breast cancer dominates the market because of its high prevalence rates in most parts of the world and the strong screening initiative. Many of these established biomarkers, HER2, BRCA1/2, and estrogen & progesterone receptors, are common in diagnosis and determining the treatment. Close follow-ups are lung and colorectal cancer, which are currently on the rise due to their incidence rates and the possibility of having validated biomarker panels.

Biomarkers of prostate cancer, including PSA, can be considered quite clinical but are under competitive threat because of the emergence of novel molecular diagnostics. Blood cancers and melanoma are some of the potential areas where active research is underway on the immunotherapy-related biomarkers. On the whole, increased awareness and drug-targeting therapy are driving biomarkers use in all cancer types.

Regional Analysis

North America Cancer Biomarkers Market has the highest share because of its well-developed health care infrastructure, predominance of cancer, and the dominance of major players in biotechnology/pharmaceuticals. The U.S., specifically, is at the forefront of biomarker-based research and development, clinical trials, and use of personalized medicine.

The market expansion is boosted by government programs, like the Cancer Moonshot and favorable FDA regulations. Moreover, biomarker testing, insurance coverage, and popularization of next-generation sequencing technologies additionally establish the region at a good point.  The dominance of the region is also inflated by strategic partnerships of diagnostic companies, universities, and even cancer care institutions.

Asia-Pacific Cancer Biomarkers Market is the fastest growing market, which is boosted by the death of cancer burden, augmenting investments in healthcare, and an increase in the use of molecular diagnosis. China, India, and Japan are some of the countries experiencing increased demand for early diagnosis and precision therapy products.

Principal drivers are governmental efforts to better cancer care and higher infrastructure for biotechnology. The innovation by local diagnostic companies is at a fast pace, and global firms are penetrating the market through joint ventures and alliances. The growing popularity of the personalized medicine concept and the increasing number of clinical studies also fuel the regional market development.

Competitive Landscape

The Cancer Biomarkers Market is characterized by high technological development speed, collaboration in the area of ensuring personalized medicines, and the focus on innovative strategies in the problem area. Major players in the industry are focusing on the creation of highly specialized and sensitive diagnosis tools or means such as next-generation sequencing (NGS), liquid biopsies, or AI-driven data analytics. Large market shares, along with comprehensive portfolios and worldwide presence, are occupied by companies such as Roche, Thermo Fisher Scientific, Illumina, QIAGEN, Bio-Rad Laboratories, and Abbott. Roche and Foundation Medicine have established a reputation as continually active players in the field of genomic profiling and companion diagnostics, whereas Illumina remains a harbinger of NGS-based platforms.

Guardant Health specializes in functional liquid biopsy, and Myriad Genetics specializes in hereditary cancer analysis, both providing real-time, non-invasive analysis. Such strategic partnerships as the co-development of targeted diagnostics by QIAGEN are boosting innovation. Acquisitions are also critical to fill the pipelines of molecular diagnostics. Thermo Fisher has acquired important genomics companies. In addition, firms have been increasingly venturing into high-growth markets such as Asia-Pacific to tap into emerging demand. On the whole, the industry is also extremely competitive due to the precision oncology momentum and rising clinical interest in biomarker-directed therapeutics.

Cancer Biomarkers Market, Company Shares Analysis, 2024

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Recent Developments:

• In April 2024, Freenome announced the success of PREEMPT CRC, a blood-based colorectal cancer screening test that demonstrated high sensitivity in early-stage detection. The test aims to improve compliance and early intervention through a non-invasive diagnostic approach.
• In March 2024, Roche (Ventana) received FDA approval for the VENTANA PD-L1 (SP142) Assay as a companion diagnostic for Tecentriq (atezolizumab) in treating triple-negative breast cancer. This approval supports more precise patient selection for immunotherapy, enhancing treatment outcomes.

Report Coverage:

By Biomarker Type

• Genetic Biomarkers
• Protein Biomarkers
• Metabolic Biomarkers
• Epigenetic Biomarkers

By Cancer Type

• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Prostate Cancer
• Melanoma
• Blood Cancer
• Others

By Technology

• Omics Technologies
• Imaging Technologies
• Bioinformatics
• Immunoassays
• Next-Generation Sequencing
• PCR-based Techniques

By Application

• Diagnostics
• Prognostics
• Risk Assessment
• Therapy Monitoring
• Companion Diagnostics
• Others

By End-user

• Hospitals
• Cancer Research Institutes
• Diagnostic Laboratories
• Biopharmaceutical and Biotechnology Companies
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• F. Hoffmann-La Roche Ltd.
• Thermo Fisher Scientific Inc.
• Illumina, Inc.
• QIAGEN N.V.
• Bio-Rad Laboratories, Inc.
• Abbott Laboratories
• Bristol Myers Squibb
• Agilent Technologies, Inc.
• Becton, Dickinson and Company (BD)
• Myriad Genetics, Inc.
• Sysmex Corporation
• Genomic Health
• PerkinElmer, Inc.
• Guardant Health, Inc.
• Foundation Medicine, Inc.

Frequently Asked Questions (FAQs)