The U.S. biomarkers market was valued at USD 30.19 billion in 2024 and is projected to reach USD 124.49 billion by 2034, registering a CAGR of 15.22% from 2025 to 2034. The growing elderly demographic is more susceptible to chronic diseases, increasing the demand for early diagnostic tools, which has estimated to drive the growth of the U.S biomarkers market over the forecast period. Rising approval of biomarkers by the regulatory bodies has estimated to drive the growth of the U.S. biomarkers market.
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Technological breakthroughs in gene sequencing, proteomics, and bioinformatics enable the discovery of more precise biomarkers. Next-generation sequencing (NGS) and CRISPR-based gene editing enable the identification of novel genetic biomarkers linked to diseases like cancer, cardiovascular disorders, and neurological conditions. Mass spectrometry and protein microarrays allow deeper analysis of protein expression and post-translational modifications, leading to new protein biomarkers for disease progression and drug response.
• For instance, in October 2024, Illumina, Inc., leading DNA sequencing and array-based technology company revealed that it will give updates on a number of significant advancements in single-cell technology, proteomics, and whole-genome sequencing at the American Society of Human Genetics (ASHG) Annual Meeting in Denver the following week. In order to demonstrate the possible impact of Illumina's new developments, the most recent information will be provided alongside fresh data from influential figures in next-generation sequencing (NGS).
Growth in precision medicine has estimated to drive the growth of the U.S. biomarkers market in the near future. Precision medicine programs rely on biomarkers for targeted therapies, early disease detection, and personalized treatment plans. The push for personalized therapies in oncology, neurology, and autoimmune diseases fuels biomarker innovation. Precision medicine relies on biomarkers to identify patients most likely to benefit from specific treatments. This increases the need for companion diagnostic tests that use biomarkers to match patients with targeted therapies.
Government & private funding for developing biomarkers has estimated to drive the growth of the U.S. biomarkers market in the near future. Significant investments from the NIH, FDA, and private organizations support biomarker research and development. Government agencies like the National Institutes of Health (NIH), National Cancer Institute (NCI), and Biomedical Advanced Research and Development Authority (BARDA) provide grants and funding for biomarker discovery and validation. Programs like the Cancer Moonshot Initiative and All of Us Research Program accelerate biomarker research for precision medicine.
• For instance, in January 2025, according to the data published by the American Cancer Society, it was estimated that an estimated 2,041,910 new cases of cancer (5,600 each day) and 618,120 cancer-related deaths are predicted for the United States in 2025. AS researchers used incidence data from central cancer registries (through 2021) and mortality data from the National Center for Health Statistics (through 2022) to compile the most recent findings on population-based cancer occurrence and outcomes in addition to projecting the current cancer burden.
How is Artificial Intelligence is
Integrated in Biomarkers?
AI
algorithms, especially machine learning and deep learning, can
sift through massive datasets (genomic, proteomic, clinical) to identify novel
biomarkers much faster than traditional methods. AI can detect complex patterns
in biological data that humans might miss, enabling the identification of new
biomarkers associated with diseases like cancer, neurological disorders, and
autoimmune conditions. AI can analyze patient data (genomic, medical history,
and lifestyle factors) to identify which biomarkers will likely predict the
best response to specific treatments, enabling more personalized and targeted
therapies. AI can help design companion diagnostic tests that match patients
with the right drugs, optimizing treatment efficacy and minimizing side
effects.
U.S. Biomarkers Market Report Highlights:
• The safety segment accounted for the largest revenue share in 2024.
• The efficacy biomarkers segment is projected to witness the highest CAGR from 2025 to 2034.
• The consumables segment dominated the U.S. biomarkers market in 2024.
• The services segment is expected to register a CAGR over the forecast period.
• The diagnostics segment is anticipated to experience the fastest growth during the forecast period.
• The immunological disease segment is projected to achieve the highest CAGR during the forecast period.
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Market Trends
• Growth of Liquid Biopsy
Liquid biopsy is gaining popularity as a non-invasive method for detecting biomarkers in blood or other bodily fluids, replacing traditional tissue biopsies. Liquid biopsy allows for earlier detection of diseases, such as cancer, and facilitates real-time monitoring of disease progression and treatment response. Companies like Guardant Health and Foundation Medicine are leading the charge in developing liquid biopsy tests for early cancer detection.
• Personalized and Precision Medicine
Biomarkers are increasingly being used to tailor treatments to individual patients based on their genetic makeup, lifestyle, and environmental factors, leading to the rise of personalized medicine. The demand for targeted therapies and companion diagnostics (tests that identify patients likely to respond to specific treatments) is growing, especially in oncology, cardiology, and neurology. The success of HER2-positive breast cancer treatment (based on HER2 biomarkers) and BRCA gene testing for personalized cancer therapies.
• Integration of Artificial Intelligence (AI) and Machine Learning (ML)
AI and ML technologies are being integrated into the biomarker discovery process to analyze complex biological data, identify novel biomarkers, and optimize diagnostic and treatment methods. AI-driven models improve the speed and accuracy of biomarker identification, reduce time-to-market, and help in predicting patient outcomes based on biomarker data. AI-powered tools for predicting cancer treatment outcomes based on gene expression and other biomarker profiles.
• Focus on Multi-Omics and Biomarker Profiling
The use of multi-omics (genomics, proteomics, metabolomics, etc.) is gaining traction for a more comprehensive understanding of diseases and for identifying multiple biomarkers that contribute to disease. Multi-omics technologies allow for more accurate and holistic biomarker profiling, providing insights into complex diseases and improving personalized treatment strategies. The use of genomic sequencing alongside proteomic and metabolomic profiling to identify multiple biomarkers associated with cancer.
• Growing Demand for Non-Invasive Diagnostics
There is a rising demand for non-invasive diagnostics, particularly in cancer and cardiovascular diseases, where liquid biopsy and other non-invasive methods can detect biomarkers without the need for traditional tissue biopsy. This trend reduces patient discomfort, lowers healthcare costs, and improves the accessibility of diagnostics, especially in remote or underserved areas. Breath-based biomarkers for lung cancer detection and urinary biomarkers for kidney disease.
U.S. Biomarkers Market Report Scope
|
Report Highlights |
Details |
|
Market Size in 2024 |
USD 30.19 Billion |
|
Market Size in 2025 |
USD 34.78 Billion |
|
Market Size by 2034 |
USD 124.49 Billion |
|
Growth Rate from 2025 to 2034 |
CAGR of 15.22% |
|
Base Year |
2024 |
|
Segments Covered |
By Type, By Product, By Application, and By Disease |
Segment Insights
Type Insights
The safety segment held a dominant presence in the U.S. biomarkers market in 2024. The increased risk of adverse responses allows for the customization of patient therapy through the use of safety biomarkers. They have the ability to foresee or identify negative medication reactions or exposure effects. The market is expected to rise as safety biomarkers are used more often in medication discovery and development. Increases in the population at high risk of contracting diseases including cancer, heart disease, and kidney problems are also anticipated to have a favorable impact on the market. Biomarker-based medicines have been associated to reduced drug attrition rates and increased knowledge of the importance of routine health checkups, which are propelling the segment's growth.
The efficacy segment is expected to grow at the fastest rate in the U.S. biomarkers market during the forecast period of 2025 to 2034. Efficacy biomarkers help forecast how a patient will react to a particular medication. Numerous results about efficacy biomarkers have been published, despite the difficulties in the research. One biomarker for ovarian cancer detection is ATPase-copper Transporting B Polypeptide (ATP7B). Additionally, it is anticipated that cooperation between businesses and academic institutions would improve the identification of biomarkers. For example, the ComboMatch platform trial, which aids researchers in evaluating the effectiveness of treatment combinations, was announced by the National Cancer Institute in June 2023.
Product Insights
The consumables segment held a dominant presence in the U.S. biomarkers market in 2024. The demand for biomarkers to identify particular illness signs and adjust treatment regimens appropriately has increased as a result of the increased focus on personalized and precision medicine. Consumables utilized in biomarker discovery and validation are in high demand as a result. Additionally, as chronic conditions like cancer, heart disease, and neurological disorders become more common, people are consuming more consumables, which is propelling the market's expansion.
The services segment is projected to expand rapidly in the U.S. biomarkers market in the coming years. Clinical studies employ biomarkers to stratify patients, track treatment outcomes, and evaluate safety. In order to guarantee that biomarkers are efficiently used for drug development decision-making, biomarker services assist with the planning, execution, and analysis of clinical trials. Additionally, biomarker-based diagnostic testing services for a range of disorders are provided by clinical laboratories and diagnostic service providers. These services support early disease diagnosis and surveillance by assisting in the precise and trustworthy identification of biomarkers.
Application Insights
The drug discovery & development segment registered its dominance over the U.S. biomarkers market in 2024. Biomarkers play a crucial role in drug discovery and development because they provide valuable insights at various stages of the process, from preclinical testing to clinical trials and post-marketing surveillance. Biomarkers can help identify specific molecules or pathways that are involved in disease processes. This is essential for target discovery, which is the first step in the development of a new drug.
The diagnostics segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034. Biomarkers are widely used for diagnostic purposes because they offer valuable insights into disease presence, progression, and response to treatment. Their ability to provide objective, measurable data helps in accurate, early, and non-invasive diagnosis, making them indispensable in modern medicine. Biomarkers are revolutionizing diagnostic medicine by offering early detection, non-invasive testing, personalized treatment strategies, and more precise disease monitoring. They help reduce healthcare costs, improve patient outcomes, and enable faster, more accurate decision-making. Whether used for early diagnosis, personalized care, or predictive medicine, biomarkers are an essential tool in modern diagnostics.
Disease Insights
The cancer segment dominated the U.S. biomarkers market. Biomarkers are widely used in the treatment of cancer because they offer critical insights that help personalize treatment, monitor disease progression, and enhance the effectiveness of therapies. Biomarkers help identify specific molecular changes or mutations in cancer cells that are driving the disease. This allows for targeted therapies that attack only the cancer cells, leaving healthy cells unaffected. They provide the tools needed for targeted therapies, reducing the use of ineffective treatments, minimizing side effects, and offering precision medicine. Biomarkers are essential for improving outcomes, extending survival, and enhancing the quality of life for cancer patients.
The immunological diseases segment is anticipated to grow with the highest CAGR in the market during the studied years. The primary cause of this is the rise in research that has been facilitated by the increasing incidence of immunological disorders. For instance, in May 2023, Boston Children's Hospital reported that researchers had discovered immunological biomarkers that had aided in forecasting the severity of COVID-19 and were expected to be useful in pandemics to come.
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U.S. Biomarkers Market Top Players
• F. Hoffmann-La Roche AG
• Epigenomics AG
• Abbott
• Thermo Fisher Scientific Inc
• General Electric
• Eurofins Scientific
• Johnson & Johnson Services, Inc.
• QIAGEN
• Bio-Rad Laboratories, Inc.
• Siemens Healthineers AG
• Merck KGaA
• PerkinElmer Inc.
• Agilent Technologies, Inc.
Recent Developments:
• On January 2028, 2025, the US$50 million Series A investment for Quibim, a premier healthtech company that is leading the way in using imaging biomarkers for precision medicine, was closed today. Over the past year, the company has seen a notable increase in the number of patients evaluated by its devices.
• On Janury 12, 2025, Exagen Inc., a company focused on patient-focused and discovery-driven commercial-stage life sciences company, revealed the introduction of the company has received conditional approval from the New York State Department of Health for its latest rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) biomarker assays. The novel biomarkers TC4d, TigG, and TIgM are part of the T-cell lupus profile.
Segments Covered in Report:
By Type
• Safety Biomarkers
• Efficacy Biomarkers
• Predictive Biomarkers
• Surrogate Biomarkers
• Pharmacodynamic Biomarkers
• Prognostics Biomarkers
• Validation Biomarkers
By Product
• Consumable
• Services
• Software
By Application
• Diagnostics
• Drug Discovery & Development
• Personalized Medicine
• Disease Risk Assessment
• Others
By Disease
• Cancer
• Cardiovascular Diseases
• Neurological Diseases
• Immunological Diseases
• Others
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