U.S. Oncology Molecular Diagnostics Market to Capture USD 2570.17 Mn by 2034

The U.S. oncology molecular diagnostics market size is calculated at USD 909.14 million in 2025 and is expected to reach around USD 2570.17 million by 2034, growing at a CAGR of 12.24% for the forecasted period.

Ottawa, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The U.S. oncology molecular diagnostics market size was valued at USD 810 million in 2024 and is predicted to hit around USD 2570.17 million by 2034, rising at a 12.24% CAGR, a study published by Towards Healthcare a sister firm of Precedence Research.

Around the US, a rise in demand for tailored medicines and technological breakthroughs is fueling the respective market growth.

The Complete Study is Now Available for Immediate Access | Download the Sample Pages of this Report @ https://www.towardshealthcare.com/download-sample/5468

Key Takeaways

By type, the breast cancer segment dominated the market in 2024.
By type, the liver cancer segment is expected to grow at a notable CAGR during 2025-2034.
By product, the reagents segment led the U.S. oncology molecular diagnostics market in 2024 and is expected to grow significantly in the studied years.
By technology, the PCR segment held the largest share of the global market in 2024.
By technology, the sequencing segment is expected to grow significantly in the predicted timeframe.

What is the U.S. Oncology Molecular Diagnostics?

Primarily, the widespread application of oncology molecular diagnostics comprises the analysis of a tumor's genetic makeup to customize cancer treatment, accelerate diagnosis, select targeted therapies, and monitor for minimal residual disease. The U.S. oncology molecular diagnostics market is currently shifting from single-gene tests to comprehensive Next-Generation Sequencing (NGS) panels. Alongside, putting efforts into ultra-sensitive digital PCR (dPCR) and cell-free DNA (cfDNA) assays for early detection and monitoring, and rapid, cartridge-based systems for rapid results.

What are the Key Growth Drivers Involved in the Expansion of the Market?

Mainly, the growing burden of cancer cases in the US is boosting innovations in the oncology sector. Along with this, the US is advancing minimally invasive liquid biopsy and cell-free DNA (ctDNA) testing to enable prior detection and real-time disease monitoring. Expanded government investment in cancer research, infrastructure, and funding for molecular diagnostics is stimulating innovation and the U.S. oncology molecular diagnostics market expansion. The emergence of targeted and immunotherapies depends on molecular diagnostics for the detection of specific biomarkers for patient stratification and to monitor treatment response.

You can place an order or ask any questions, please feel free to contact us at sales@towardshealthcare.com

What are the Significant Trends Involved in the Market?

The U.S. oncology molecular diagnostics market is fostering innovations in diverse oncology testing and liquid biopsy by collaborating with leading players.

In September 2025, OmniPathology, a U.S.-based advanced molecular diagnostics laboratory, collaborated with Delta Medical Laboratories, a leading clinical laboratory provider in Saudi Arabia, to accelerate access to proprietary oropharyngeal HPV swab testing.
In June 2025, Oxford Cancer Biomarkers Ltd (OCB), a company in molecular precision cancer diagnostic tests, partnered with Mira Precision Health Inc to advance OCB's proprietary ToxNav test in the USA.
In April 2025, Guardant Health, Inc., a leading precision oncology company, entered into a strategic collaboration with Pfizer, Inc., to assist the development and commercialization of Pfizer’s oncology portfolio using the Guardant Infinity smart liquid biopsy platform.

What is the Major Challenge in the Market?

The U.S. oncology molecular diagnostics market is facing a few limitations, such as the need for advanced bioinformatics and specialized professionals for the analysis of the large volume of genetic data. Also, the protection of sensitive patient genetic information is crucial, with stringent measures like HIPAA in the U.S. required to prevent data theft and maintain patient trust.

Regional Analysis

A significant growth in cancer cases is boosting a wide range of innovations in oncology diagnostics, like the promising development of liquid biopsies for ctDNA and circulating tumor cells (CTCs) for cancer detection and tracking. Although the U.S. oncology molecular diagnostics market encompasses the transformation of next-generation sequencing (NGS) technologies for complete genomic profiling of tumors, the enhanced application of biomarker testing for targeted therapy selection and treatment response. Also, the market is widely involved in the enhancements in the integration of artificial intelligence (AI) to expand diagnostic precision and find innovative biomarkers.

For instance,

In January 2025, C the Signs, the developer of an Artificial Intelligence (AI)-based platform, secured $8 million in funding from Khosla Ventures to advance AI-driven early cancer detection.

Global Oncology Molecular Diagnostics Market Growth

The global oncology molecular diagnostics market size is calculated at USD 3.11 billion in 2024, grew to USD 3.48 billion in 2025, and is projected to reach around USD 9.76 billion by 2034. The market is expanding at a CAGR of 12.13% between 2025 and 2034.

Access the global oncology molecular diagnostics market size, trends and regional analysis report @ https://www.towardshealthcare.com/price/5465

Segmental Insights

By type analysis

Why did the Breast Cancer Segment Lead the Market in 2024?

The breast cancer segment captured a major revenue share of the U.S. oncology molecular diagnostics market in 2024. Around the US, a rise in various health issues, growing awareness, fostering higher screening, with raised demand for tailored treatment strategies on molecular subtyping and targeted therapies. Inclusion of companion tests, like immunohistochemistry (IHC) for PD-L1, is contributing a vital role in the determination whether patients with specific types of breast cancer (e.g., TNBC) are candidates for immunotherapy. The emergence of ctDNA assays is supporting the analysis of tumor DNA in blood, to offer a non-invasive method for monitoring disease progression, identification of recurrence, and characterizing tumor heterogeneity without a tissue biopsy.

And, the liver cancer segment is predicted to expand notably during 2025-2034. A prominent driver in the development of liver cancer is a growth in the incidence of chronic hepatitis B and C, alcohol-related liver disease, and obesity and non-alcoholic fatty liver disease (NAFLD). In these conditions, a novel molecular imaging agent, used to target GPC3 (68Ga-aGPC3-scFv) that represented greater sensitivity and specificity in a pilot study for detecting liver tumors. Other breakthroughs, including AI-enabled pathomics, are applying deep learning models to revolutionize liver cancer management by decoding histopathological patterns to find prognostic features and immune biomarkers.

By product analysis

How did the Reagents Segment Dominate the Market in 2024?

The reagents segment registered dominance in the U.S. oncology molecular diagnostics market in 2024 and will expand significantly. Reagents mainly comprise DNA/RNA extraction kits, PCR reagents, sequencing reagents, probes, and enzymes. Also, ongoing innovation in molecular biology and biotechnology is supporting more accurate, efficient, and sensitive reagent kits for early disease detection and monitoring.

Phenomenal approaches in multiplexing reagents, used in the identification of multiple targets simultaneously, and the development of CRISPR-based reagents for accurate genetic analysis. The widespread adoption of automated, high-throughput platforms and the requirement for more stable and effective formulations for application in both clinical and resource-limited settings is also impacting a broader demand for various reagents.

Become a valued research partner with us - https://www.towardshealthcare.com/schedule-meeting

By technology analysis

What Made the PCR Segment Dominant in the Market in 2024?

The PCR segment accounted for a major share of the U.S. oncology molecular diagnostics market in 2024. Advantages of PCR include its greater sensitivity, affordability, speed, and versatility are assisting in the development of real-time (qPCR) and digital PCR (dPCR) that boost accuracy and quantification. These developing PCR techniques are vital in the detection of tiny amounts of remaining cancer cells (MRD), which enables the prediction of relapse, particularly in blood cancers like leukemia and lymphoma. Integration of RT-PCR with NGS facilitates detailed insights into a tumor's genetic profile, resulting in better-informed treatment decisions and a more customized solution to oncology.

On the other hand, the sequencing segment is anticipated to witness notable expansion. This technology possesses long-read sequencing technologies, which are employed in finding complex structural variations, and nanopore sequencing, known for its speed in real-time analysis. The emerging applications of single-cell analysis examine each cell within a tumor, leveraging heterogeneity and several cell populations that are involved in cancer development and progression. Alongside, whole-genome bisulfite sequencing (WGBS) is coupled with NGS for the further detection of DNA methylation patterns, a vital epigenetic alteration that impacts gene expression in cancer.

Recent Developments

In September 2025, Exact Sciences Corp., a company in cancer diagnostics, launched the Cancerguard test, a new multi-cancer early detection (MCED) blood test that is now available as a laboratory-developed test (LDT) in the United States.
In July 2025, Gnosis, a Southern California-based diagnostic lab advancing women's health through molecular innovation, unveiled EdenDx, the first commercially available non-invasive liquid-based cytology test in the United States for early-stage endometrial cancer detection.
In April 2025, Predicta Biosciences, a precision oncology company, launched its first Laboratory Developed Test (LDT), GenoPredicta for bone marrow or blood, to improve the prognosis of multiple myeloma.

U.S. Oncology Molecular Diagnostics Market Key Players List

Abbott Laboratories
Adaptive Biotechnologies Corporation
Ataraxis AI
BioGenex Laboratories
Illumina, Inc.
Danaher Corporation
DELFI Diagnostics
Invivoscribe Technologies, Inc.
LabGenomics USA
Myriad Genetics, Inc.
Naveris, Inc.
Nucleix
Pillar Biosciences, Inc.
Thermo Fisher Scientific
Ventana Medical Systems, Inc.

Browse More Insights of Towards Healthcare:

The global diagnostic testing market was valued at USD 203.3 billion in 2024 and is projected to grow to USD 209.48 billion in 2025. By 2034, the market is expected to reach approximately USD 274.53 billion, expanding at a CAGR of 3.04%.

The global allergy diagnostics market stood at USD 5.79 billion in 2024, increasing to USD 6.42 billion in 2025, and is forecasted to hit around USD 16.45 billion by 2034, growing at a CAGR of 10.96% between 2025 and 2034.

The global point-of-care molecular diagnostics market generated USD 4.05 billion in 2024, rose to USD 4.48 billion in 2025, and is expected to climb to nearly USD 11.03 billion by 2034, registering a CAGR of 10.45% during 2025–2034.

The global infectious disease diagnostics market was valued at USD 25.01 billion in 2024 and is projected to reach USD 27.43 billion in 2025. By 2034, it is anticipated to touch about USD 62.95 billion, advancing at a CAGR of 9.67%.

The global veterinary infectious disease diagnostics market stood at USD 2.68 billion in 2024, rose to USD 2.89 billion in 2025, and is forecasted to achieve around USD 5.76 billion by 2034, growing at a CAGR of 7.95% between 2025 and 2034.

The global precision diagnostics and medicine market reached USD 146.88 billion in 2024, expanded to USD 162.88 billion in 2025, and is projected to surge to USD 412.95 billion by 2034, reflecting a CAGR of 10.89% over the forecast period.

The rapid genomic diagnostics market is witnessing notable growth worldwide, with revenues expected to scale into the hundreds of millions of dollars by 2034.

The LC-MS/MS-based diagnostics market is also gaining momentum, with forecasts indicating revenues in the hundreds of millions between 2025 and 2034.

The global autoimmune disease diagnostics market was valued at USD 5.75 billion in 2024, grew to USD 6.11 billion in 2025, and is projected to reach around USD 10.5 billion by 2034, expanding at a CAGR of 6.22%.

The global thyroid cancer diagnostics market was valued at USD 3.1 billion in 2024, rose to USD 3.27 billion in 2025, and is expected to hit approximately USD 5.22 billion by 2034, advancing at a CAGR of 5.34% between 2025 and 2034.

Segments Covered in The Report

By Type

Breast Cancer
Prostate Cancer
Colorectal Cancer
Cervical Cancer
Liver Cancer
Lung Cancer
Blood Cancer
Kidney Cancer
Others

By Product

Instruments
Reagents
Others

By Technology

PCR
In-situ Hybridization
INAAT
Chips & Microarrays
Mass Spectrometry
Sequencing
TMA
Others

Immediate Delivery Available | Buy This Premium Research @ https://www.towardshealthcare.com/price/5468

Access our exclusive, data-rich dashboard dedicated to the healthcare market - built specifically for decision-makers, strategists, and industry leaders. The dashboard features comprehensive statistical data, segment-wise market breakdowns, regional performance shares, detailed company profiles, annual updates, and much more. From market sizing to competitive intelligence, this powerful tool is one-stop solution to your gateway.

Access the Dashboard: https://www.towardshealthcare.com/access-dashboard

About Us

Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics, with a strong emphasis on life science research. Dedicated to advancing innovation in the life sciences sector, we build strategic partnerships that generate actionable insights and transformative breakthroughs. As a global strategy consulting firm, we empower life science leaders to gain a competitive edge, drive research excellence, and accelerate sustainable growth.

You can place an order or ask any questions, please feel free to contact us at sales@towardshealthcare.com

Europe Region: +44 778 256 0738

North America Region: +1 8044 4193 44

APAC Region: +91 9356 9282 04

Web: https://www.towardshealthcare.com

Our Trusted Data Partners

Find us on social platforms: LinkedIn | Twitter | Instagram | Medium | Pinterest

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.