The U.S. next generation cancer diagnostics market was valued at USD 5,119 million in 2024 and is projected to reach USD 11,052 million by 2034, registering a CAGR of 8 % from 2025 to 2034. Rising prevalence of cancer has estimated to drive the growth of the next generation cancer diagnostics market in the near future. The key players operating in the market are focused on adopting inorganic growth strategies like partnership to develop next generation cancer diagnostics, which has observed to drive the growth of the market.
Elevate your business strategy with market-driven insights—purchase the report today (Price@ USD 1550) https://www.statifacts.com/order-report/7900
Advancements in Genomic Technologies: An Overview to NextGen Diagnostics Industry
A non-invasive method that detects circulating tumor DNA (ctDNA), exosomes, and circulating tumor cells (CTCs) in the blood. The advancement in next generation cancer diagnostics enables comprehensive cancer genome profiling for early detection and targeted therapy selection. Advancements in genomics and molecular technologies are transforming next-generation cancer diagnostics by making detection more precise, personalized, and accessible.
For instance, in January 2025, Illumina, Inc., global leader in array-based technologies and DNA sequencing, announced a number of upgrades to its NovaSeq X Series, including new kits and a state-of-the-art software upgrade in addition to the NovaSeq X single-flow-cell system. The single-flow-cell NovaSeqX Sequencing System, which is now available for purchase for the first time, provides the same high-quality flow cells and speed as the NovaSeq X Plus Sequencing System, which is Illumina's most widely used and quickly adopted high-throughput sequencing platform to date, but at a lower cost for smaller labs.
Growth Factors:
• Growing Adoption of Personalized Medicine
Biomarker-Based Diagnostics: Helps identify genetic mutations and predict response to specific therapies. Companion diagnostics is essential for matching cancer patients with targeted therapies (e.g., HER2 testing for Herceptin).
• Point-of-Care & At-Home Testing Growth
Development of portable, rapid cancer diagnostics for early-stage detection has estimated the growth of the U.S. next generation cancer diagnostics market in the near future. Increasing demand for low-cost, decentralized testing solutions, has estimated to drive the growth of the next generation cancer diagnostics market.
• Regulatory Support & Approvals
Faster FDA approvals for breakthrough diagnostic tests. Streamlined regulatory pathways for AI-based cancer diagnostics.
• Rising Demand for Early Cancer Screening
Governments pushing nationwide screening programs for high-risk populations. Increasing patient awareness about the benefits of early detection.
How is AI integration Helping Cancer Diagnosis?
AI can analyze radiology images (MRI, CT, mammograms) to detect cancer at earlier stages with high precision, reducing false positives and negatives. AI can analyze radiology images (MRI, CT, mammograms) to detect cancer at earlier stages with high precision, reducing false positives and negatives. AI can analyze large genomic datasets to identify cancer-associated mutations and predict patient responses to treatments. Machine learning (ML) models can assess patient risk factors to predict cancer likelihood and progression. AI models can screen millions of compounds to identify potential cancer therapies faster than traditional methods. AI helps match patients with the most effective treatments based on their genetic profile and tumor characteristics.
AI reduces manual workloads by assisting pathologists and radiologists, leading to faster diagnoses. AI provides second opinions, minimizing human oversight and enhancing reliability. AI-driven cancer diagnostics can revolutionize the industry by enhancing precision, reducing costs, and making advanced care accessible to more patients. The next step is integrating AI with regulatory frameworks to ensure safety and reliability.
U.S. Next Generation Cancer Diagnostics Market Trends
• Technological Advancements
Liquid Biopsies: Blood-based tests, known as liquid biopsies, are emerging as non-invasive methods for early cancer detection. Companies like Guardant Health have received FDA approval for tests such as Shield, designed for colorectal cancer screening. AI is enhancing diagnostic accuracy and efficiency. For instance, the UK's National Health Service is trialing "Edith," an AI platform aimed at improving breast cancer screening speeds.
• Strategic Collaborations and Investments
Companies like Owkin have formed alliances with major pharmaceutical firms, including Sanofi and Bristol-Myers Squibb, to leverage AI in oncology research and clinical trials. Siemens Healthineers' acquisition of Novartis' Advanced Accelerator Applications segment for over €200 million aims to bolster cancer imaging capabilities, particularly in PET scans.
• Emphasis on Early Detection and Personalized Medicine
Genetic Testing Initiatives: Pfizer is promoting testing for specific genetic mutations, such as BRAF V600E in lung cancer, to tailor treatments and expand the market for targeted therapies like Braftovi. Consumer Health Engagement: There's a growing trend of private companies offering comprehensive health scans directly to consumers, facilitating early diagnosis and personalized care plans.
U.S. Next Generation Cancer Diagnostics Market Report Highlights:
• By technology, next-generation sequencing (NGS) technology segment held the largest revenue share of 28.55% in 2024 and is expected to expand at fastest CAGR of 10.5% over the forecast period.
• By cancer type, the other cancer segment accounted highest revenue share of 34.28% in 2024.
• By cancer type, the breast cancer segment is expanding at a CAGR of 10.6% over the forecast period.
• By function, the therapeutic monitoring segment accounted highest revenue share of 18.05% in 2024.
• The prognostic diagnostics segment is projected to grow at the fastest CAGR of 10.2% over the forecast period.
• Based on application, the biomarker development segment with the highest market share of 33.68% in 2024.
Elevate your business strategy with Statifacts. Improve efficiency and achieve better outcomes—schedule a consultation today! https://www.statifacts.com/schedule-meeting
Market Report Scope
|
Report Coverage |
Details |
|
Market Size in 2024 |
USD 5,119 Million |
|
Market Size in 2025 |
USD 5,529 Million |
|
Market Size by 2034 |
USD 11,052 Million |
|
Growth Rate from 2025 to 2034 |
CAGR of 8% |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
By Technology, By Application, By Cancer Type, and By Function |
Segment Insights
Technology Insights
The next-generation sequencing (NGS) technology segment led the U.S. next generation cancer diagnostics market. This technology makes it possible to analyze multiple genes or genetic changes at once, giving a thorough picture of the genomic landscape and assisting in the identification of different types of genetic changes, such as gene mutations, amplifications, deletions, and rearrangements, all of which are essential for precise diagnosis and individualized treatment planning.
The qPCR & multiplexing segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034. qPCR (Quantitative Polymerase Chain Reaction) can detect even low-abundance tumor DNA, making it highly effective for early cancer detection. Multiplexing allows for simultaneous detection of multiple genetic mutations, reducing false positives and improving diagnostic accuracy.
Cancer Type Insights
The lung cancer segment accounted for a considerable share of the U.S. next generation cancer diagnostics market in 2024. Lung cancer is the leading cause of cancer-related deaths worldwide, with a high mortality rate due to late-stage diagnosis. Next-generation diagnostics enable early and accurate detection, significantly improving survival rates. Liquid biopsies (blood-based tests) detect circulating tumor DNA (ctDNA) and other biomarkers, allowing non-invasive monitoring. Unlike traditional biopsies, liquid biopsies reduce patient discomfort and procedure-related risks.
The breast cancer segment is anticipated to grow with the highest CAGR in the U.S. next generation cancer diagnostics market during the studied years. The segment's higher growth can be attributed to the rising incidence of breast cancer as well as increased awareness and screening initiatives. Breast cancer detection and early diagnosis have improved as a result of advancements in screening techniques and diagnostic technologies. Better patient outcomes, more efficient therapy, and prompt action are made possible by this early diagnosis. The efficiency and accuracy of diagnosing breast cancer have increased with the use of sophisticated imaging methods like mammography, ultrasound, and MRI as well as the creation of biomarker-based assays.
Function Insights
The therapeutic monitoring segment dominated the U.S. next generation cancer diagnostics market in 2024. Effective therapeutic monitoring is now more important than ever as targeted treatments and immunotherapies are being used more often to treat cancer. Close observation is frequently necessary to assess the effects of these cutting-edge treatment techniques on the tumor and guarantee the best possible outcomes for the patient. Real-time monitoring of the effectiveness of treatment is made possible by next-generation cancer diagnostics, which can identify particular genetic changes or indicators linked to the response to targeted therapy.
The prognostic diagnostics segment is anticipated to grow with the highest CAGR in the market during the studied years. Prognostic diagnostics help predict disease progression, guiding oncologists in treatment selection and patient management. With the rise of precision medicine, there is a growing need for tests that provide insights into tumor aggressiveness, recurrence risk, and survival rates.
Application Insights
The biomarker development segment registered its dominance over the U.S. next generation cancer diagnostics market in 2024. Due to high accuracy levels discovered by biomarker tests, reaching up to 90% in investigational research studies, and their ability to improve sensitivity in tumor screening. The market is also expanding as a result of the introduction of cutting-edge technologies to satisfy the growing need for oncology diagnosis. For example, Quest Diagnostics and Envision Sciences announced the release of a revolutionary prostate biomarker test in July 2023, which contributes to increased accuracy.
The genetic analysis segment is expected to grow at the fastest rate in the U.S. next generation cancer diagnostics market during the forecast period of 2025 to 2034. The increasing prevalence of cancer, particularly those with known genetic links (e.g., breast, lung, and colorectal cancers), is driving demand for genetic testing. Precision oncology relies on genetic analysis to tailor treatments to a patient’s specific cancer mutations, making this segment essential.
Significant funding from government initiatives like the Cancer Moonshot, as well as venture capital investments, are accelerating development in this area. Increased awareness of genetic testing benefits among patients and healthcare providers is driving demand for early detection and personalized treatment strategies. The use of artificial intelligence to analyze genetic data is improving diagnostic accuracy and enabling faster clinical decision-making.
Related Reports:
• U.S. Ovarian Cancer Diagnostics Market: https://www.statifacts.com/outlook/us-ovarian-cancer-diagnostics-market
• U.S. Lung Cancer Diagnostics Market: https://www.statifacts.com/outlook/us-lung-cancer-diagnostics-market
•
U.S. Cancer Diagnostics Market: https://www.statifacts.com/outlook/us-cancer-diagnostics-market
• U.S. Skin Cancer Diagnostics Market: https://www.statifacts.com/outlook/us-skin-cancer-diagnostics-market
• U.S. Breast Cancer Diagnostics Market: https://www.statifacts.com/outlook/us-breast-cancer-diagnostics-market
• U.S. Blood Cancer Diagnostics Market: https://www.statifacts.com/outlook/us-blood-cancer-diagnostics-market
U.S. Next Generation Cancer Diagnostics Market Players
• Johnson & Johnson
• Illumina Inc
• Novartis AG ADR
• Roche
• Koninklijke Philips NV
• Qiagen NV
• Agilent Technologies Inc
• Abbott Laboratories
• Thermo Fisher Scientific Inc
• GE HealthCare Technologies Inc Common Stock
Recent Developments:
• In January 2025, A multi-year exclusive strategic commercial partnership between NeoGenomics, Inc., a leading provider of oncology testing services, and Adaptive Biotechnologies Corporation, a commercial stage biotechnology company that seeks to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, will advance minimal residual disease (MRD) monitoring options for patients with specific blood cancers. The first and only FDA-approved in vitro diagnostic (IVD) test for identifying MD in lymphoid malignancies is Adaptive's clonoSEQ, which is based on next-generation sequencing (NGS). A unique multi-modal testing method is provided for each patient by NeoGenomics' COMPASS and CHART series of comprehensive and individualized assessment services for complex blood malignancies.
• In October 2024, Owkin, the first end-to-end Al-biotech company, has unveiled MSintuit CRCv21, a next-generation Al solution that unlocks precision drug discovery, development, and diagnostics using state-of-the-art causal Al. In the US, MSIntuit CRC v2 will first be released as an RUO version on Roche's navify Digital Pathology enterprise software with the goal of revolutionizing colorectal cancer (CRC) detection and treatment.
Segments Covered in Report:
By Technology
• Next-generation Sequencing
• qPCR & Multiplexing
• Lab-on-a-chip (LOAC) & Reverse Transcriptase-PCR (RT-PCR)
• Protein Microarrays
• DNA Microarrays
By Application
• Biomarker Development
• CTC Analysis
• Proteomic Analysis
• Epigenetic Analysis
• Genetic Analysis
By Cancer Type
• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Cervical Cancer
• Others
By Function
• Therapeutic Monitoring
• Companion Diagnostics
• Prognostics
• Cancer Screening
• Risk Analysis
Immediate Delivery Available | Buy This Premium Research: https://www.statifacts.com/order-report/7900
Statifacts offers subscription services for data and analytics insights. This page provides options to explore and purchase a subscription tailored to your needs, granting access to valuable statistical resources and tools. Access here - https://www.statifacts.com/get-a-subscription
Connect with Us
- Ballindamm 22, 20095 Hamburg, Germany
Web: https://www.statifacts.com/
Browse our Brand-New Journals:
Precedence Research | Towards Packaging | Towards Automotive | Towards Dental | Towards EV Solutions | Nova One Advisor | Healthcare Webwire | Packaging Webwire | Automotive Webwire
