United States Clinical Oncology Next Generation Sequencing Market Segmented By Technology (Whole Genome Sequencing, Whole Exome Sequencing, Targeted Sequencing & Resequencing Centrifuges), By Workflow (NGS Pre-Sequencing, NGS Sequencing, NGS Data Analysis), By Application (Screening, Companion Diagnostics, Other Diagnostics), By End Use (Hospitals, Clinics, Laboratories) Region and Competition, Opportunity, and Forecast 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 154.67 Million
CAGR (2026-2031)	16.01%
Fastest Growing Segment	Targeted Sequencing & Resequencing Centrifuges
Largest Market	Midwest
Market Size (2031)	USD 377.03 Million

Market Overview

The United States Clinical Oncology Next Generation Sequencing Market will grow from USD 154.67 Million in 2025 to USD 377.03 Million by 2031 at a 16.01% CAGR. Clinical Oncology Next Generation Sequencing utilizes high-throughput genomic technologies to analyze DNA and RNA sequences for detecting cancer-associated genetic alterations. The market is primarily driven by the escalating demand for precision medicine and the critical need for companion diagnostics that guide targeted therapeutic interventions. This expansion is further supported by the rising prevalence of malignancy which necessitates robust diagnostic solutions. According to the American Cancer Society, in 2025, an estimated 2,041,910 new cancer cases were projected in the United States, highlighting the substantial addressable volume for genomic profiling services.

Despite these growth factors, the market faces a significant challenge regarding the inconsistent reimbursement landscape for comprehensive genomic profiling. Variable coverage policies across different payers and complex coding requirements frequently result in payment denials which restrict patient access to these essential tests. This financial uncertainty acts as a major barrier for clinical laboratories attempting to expand their sequencing capabilities and potentially impedes the broader adoption of these diagnostic tools within the healthcare system.

Key Market Drivers

Accelerating adoption of precision medicine and targeted therapies acts as a primary catalyst for the United States Clinical Oncology Next Generation Sequencing Market. As pharmaceutical developers increasingly prioritize treatments that target specific genetic alterations, the clinical necessity for high-throughput diagnostic tools has intensified. Next-generation sequencing (NGS) has become the standard of care for identifying patients eligible for these therapies, moving beyond single-gene tests to comprehensive panels that detect multiple actionable mutations simultaneously. This shift is structurally supported by the regulatory environment which continues to clear new biomarker-driven interventions. According to the FDA, October 2025, the Office of Oncologic Diseases approved 17 novel drugs for the treatment of various cancer types in 2024, many of which are linked to specific biomarkers requiring advanced molecular profiling.

Simultaneously, the proliferation of liquid biopsy for non-invasive cancer monitoring is reshaping the diagnostic landscape by enabling frequent, low-risk testing. Unlike traditional tissue biopsies, which are invasive and often limited by sample availability, liquid biopsy analyzes circulating tumor DNA from a simple blood draw, facilitating real-time detection of minimal residual disease and therapy response. This technological evolution has driven rapid uptake among clinicians who require longitudinal data to manage patient care effectively. Consequently, commercial volumes have surged; according to Natera, November 2025, the company performed approximately 211,000 oncology tests in the third quarter of 2025, a 53.9% increase compared to the prior year. Reflecting this broader commercial momentum, according to Guardant Health, October 2025, the company reported oncology revenue of $184.4 million for the third quarter of 2025, demonstrating the robust financial trajectory of the sector.

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Key Market Challenges

The inconsistent reimbursement landscape constitutes a critical impediment to the expansion of the United States Clinical Oncology Next Generation Sequencing Market. Clinical laboratories face substantial financial risk due to variable coverage policies and complex coding requirements that frequently lead to payment denials. This revenue uncertainty creates a hostile environment for market entrants and forces existing providers to absorb the costs of denied tests. As a result, laboratories are hesitant to invest in expanding their genomic profiling capabilities, which directly limits patient access to essential companion diagnostics required for targeted cancer therapies.

This challenge significantly distorts market dynamics by diverting resources away from technological advancement toward administrative management. According to the American Medical Association, in 2025, 31% of physicians reported that prior authorization requests were often or always denied, highlighting the severity of access barriers within the healthcare system. Such high denial rates reduce the commercial viability of offering comprehensive sequencing panels, particularly for smaller independent laboratories. Consequently, the growth of the United States Clinical Oncology Next Generation Sequencing Market is stifled, as the financial burden of uncompensated care prevents the widespread adoption of these vital diagnostic tools.

Key Market Trends

Integration of Artificial Intelligence for Enhanced Genomic Data Interpretation is fundamentally restructuring the value chain of the United States Clinical Oncology Next Generation Sequencing Market. AI algorithms are now indispensable for synthesizing genomic variants with clinical pathology to uncover biomarker patterns that manual bioinformatics cannot discern. This technological capability is driving a commercial evolution where providers monetize algorithmic insights and data licensing rather than just wet-lab processing. Validating this shift, according to TIKR.com, December 2025, in the 'Why Tempus AI Stock Is Up 87% In 2025' article, Tempus AI reported third-quarter revenue of $334.2 million, a surge driven largely by its AI-enabled genomics business which reached $252.9 million.

Simultaneously, the Emergence of NGS-Based Multi-Cancer Early Detection (MCED) Technologies is expanding the market's addressable population beyond diagnosed patients to asymptomatic individuals. Unlike the established liquid biopsy applications utilized for minimal residual disease monitoring in existing patients, MCED assays employ methylation profiling and fragmentomics to screen for malignancies before clinical symptoms manifest. This strategic pivot from disease management to preventative screening represents a massive new volume opportunity for clinical laboratories. Highlighting this rapid sector growth, according to Guardant Health, October 2025, in the 'Third Quarter 2025 Financial Results', the company's screening revenue reached $24.1 million, supported by a commercial volume of approximately 24,000 Shield tests.

Segmental Insights

Within the United States Clinical Oncology Next Generation Sequencing Market, the Targeted Sequencing & Resequencing Centrifuges segment is recognized as the fastest growing area. This rapid expansion is primarily driven by the method's superior cost-efficiency and optimized workflow speed, which are critical for routine clinical applications. Unlike broader genomic profiling, this approach allows for deep coverage of specific cancer-related genes, enabling the precise detection of low-frequency variants essential for personalized treatment. Furthermore, the increasing alignment of these focused panels with guidelines from regulatory bodies like the FDA continues to accelerate their adoption in diagnostic laboratories across the region.

Regional Insights

The Midwest US dominates the United States Clinical Oncology Next Generation Sequencing Market, primarily driven by a high concentration of premier healthcare institutions and reference laboratories. Market analysis indicates that this leadership is anchored by the presence of renowned centers such as the Mayo Clinic and Cleveland Clinic, which facilitate the accelerated adoption of genomic profiling in routine cancer care. These institutions foster robust clinical research and precision medicine initiatives, creating a fertile environment for sequencing advancements. Consequently, the region maintains a superior infrastructure for diagnostic integration, solidifying its position as the central hub for market expansion.

Recent Developments

• In October 2024, Thermo Fisher Scientific received approval from the U.S. Food and Drug Administration for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic for a newly approved brain cancer therapy. The regulatory clearance permits the use of the next-generation sequencing-based test to identify patients with Grade 2 IDH-mutant glioma who are eligible for treatment with vorasidenib. This approval expanded the clinical utility of the company's diagnostic platform, allowing healthcare providers to match patients with targeted therapies based on specific genomic alterations. The milestone reinforces the critical role of next-generation sequencing in guiding personalized treatment decisions for patients with solid tumors.
• In August 2024, Illumina launched an expanded oncology menu for its NovaSeq X Series sequencing systems, enhancing high-throughput comprehensive genomic profiling capabilities. The company introduced a new version of its flagship assay, TruSight Oncology 500, which allows laboratories to analyze hundreds of genes and immuno-oncology biomarkers from a single sample with greater efficiency. This product launch was designed to improve the economics and scalability of genomic testing, enabling clinical research laboratories to process larger batches of samples more rapidly. The advancement supports the growing demand for accessible and comprehensive genomic profiling in the United States clinical oncology sector.
• In July 2024, Guardant Health announced that the U.S. Food and Drug Administration (FDA) had approved its Shield blood test for colorectal cancer screening. This regulatory decision marked a significant development in the market, as the assay became the first blood-based test approved by the FDA as a primary screening option for average-risk adults. The test utilizes next-generation sequencing technology to detect colorectal cancer signals in the bloodstream, providing a non-invasive alternative to traditional screening methods. The company noted that this approval would facilitate Medicare reimbursement and support the broader adoption of blood-based screening tools in clinical oncology across the United States.
• In July 2024, Tempus AI entered into an expanded collaboration with Remix Therapeutics to advancing precision medicine in oncology. Under the terms of the agreement, the technology company agreed to provide next-generation sequencing support for a Phase I clinical trial of a novel small molecule therapy designed to target RNA processing. The partnership leverages the company's multimodal data platform and comprehensive genomic profiling assays to characterize specific patient cohorts and monitor therapeutic responses. This collaboration highlights the increasing integration of advanced genomic data and sequencing capabilities into the clinical development of new cancer therapies in the United States.

Key Market Players

• Illumina Inc
• Thermo Fisher Scientific Inc
• Roche Diagnostics
• BGI Group
• Exact Sciences Corporation
• Genomic Health
• Guardant Health Inc
• Invitae Corporation
• Qiagen N.V.
• Oxford Nanopore Technologies

By Technology	By Workflow	By Application	By End Use	By Region
Whole Genome Sequencing Whole Exome Sequencing Targeted Sequencing & Resequencing Centrifuges	NGS Pre-Sequencing NGS Sequencing NGS Data Analysis	Screening Companion Diagnostics Other Diagnostics	Hospitals Clinics Laboratories	Northeast Midwest South West

Report Scope:

In this report, the United States Clinical Oncology Next Generation Sequencing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Clinical Oncology Next Generation Sequencing Market, By Technology:

• Whole Genome Sequencing
• Whole Exome Sequencing
• Targeted Sequencing & Resequencing Centrifuges

• United States Clinical Oncology Next Generation Sequencing Market, By Workflow:

• NGS Pre-Sequencing
• NGS Sequencing
• NGS Data Analysis

• United States Clinical Oncology Next Generation Sequencing Market, By Application:

• Screening
• Companion Diagnostics
• Other Diagnostics

• United States Clinical Oncology Next Generation Sequencing Market, By End Use:

• Hospitals
• Clinics
• Laboratories

• United States Clinical Oncology Next Generation Sequencing Market, By Region:

• Northeast
• Midwest
• South
• West