United States Ovarian Cancer Diagnostics Market, By Diagnosis Type, By Cancer Type, By End Use, Region and Competition, Opportunity, and Forecast, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 734.56 Million
CAGR (2026-2031)	5.78%
Fastest Growing Segment	Imaging
Largest Market	Midwest
Market Size (2031)	USD 1029.08 Million

Market Overview

The United States Ovarian Cancer Diagnostics Market will grow from USD 734.56 Million in 2025 to USD 1029.08 Million by 2031 at a 5.78% CAGR. Ovarian cancer diagnostics include medical examinations and clinical tests, such as transvaginal ultrasound and biomarker analysis, used to identify malignant tumors within the ovaries. Market growth is primarily driven by the aging female population and the increasing adoption of genetic screening for individuals with elevated risk factors. According to the American Cancer Society, in 2025, an estimated 20,890 new cases of ovarian cancer will be diagnosed in the United States. This substantial incidence rate highlights the critical demand for reliable detection modalities that can enable timely and effective therapeutic interventions.

A significant challenge hindering market expansion is the absence of a sensitive early screening method for the general population which frequently leads to diagnosis at advanced stages. This limitation significantly restricts the ability to improve survival outcomes and complicates patient management protocols. According to the American Cancer Society, in 2025, approximately 12,730 women will die from ovarian cancer in the United States, a figure that emphasizes the urgent need for improved diagnostic solutions capable of reducing disease lethality.

Key Market Drivers

Robust federal funding and favorable regulatory support for oncology research are fundamental in accelerating the development of diagnostic tools within the United States. This financial ecosystem mitigates the high risks associated with R&D, encouraging the entry of novel screening modalities and ensuring sustained progress in biomarker discovery. According to the Department of Defense, April 2024, in the 'Ovarian Cancer Research Program Anticipated Funding Opportunities', the program secured a fiscal year 2024 appropriation of $45 million to support high-impact research focused on preventing and detecting the disease. This federal commitment is heavily complemented by private and non-profit initiatives that sustain the innovation pipeline. According to the Ovarian Cancer Research Alliance, January 2025, in the '2025 Research Investment Announcement', the organization invested more than $10.8 million toward scientific research, underscoring the robust collaborative effort required to enhance detection capabilities across the market.

The rapid emergence of non-invasive liquid biopsy and multi-omic technologies is simultaneously transforming the clinical approach to early detection and patient monitoring. Unlike traditional tissue biopsies, these advanced methods analyze circulating biomarkers, such as extracellular vesicles, offering a tangible solution to the sensitivity limitations of current screening protocols. According to the Association for Diagnostics & Laboratory Medicine, September 2024, in the '2024 Disruptive Technology Award' report, a newly recognized blood-based test demonstrated the capacity to detect 100,000 tumor-derived extracellular vesicles in a single milliliter of blood, significantly outperforming circulating tumor DNA in early-stage abundance. This technological shift towards high-sensitivity, non-invasive profiling enables more frequent monitoring and earlier intervention, directly addressing the critical market need for reducing the lethality associated with late-stage diagnosis.

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Key Market Challenges

The lack of a sensitive early screening method for the general population significantly impedes the United States Ovarian Cancer Diagnostics Market. Because current diagnostic tools generally lack the specificity required for asymptomatic screening, their usage is largely confined to confirming diagnoses in women who are already presenting symptoms. This operational reality limits the total addressable market to a reactive patient pool rather than enabling the implementation of high-volume, proactive screening programs. Consequently, the commercial potential of diagnostic technologies remains capped by their inability to serve the broader demographic of average-risk women.

This diagnostic gap directly influences adoption rates by healthcare providers. Late-stage detection renders many diagnostic interventions less effective in altering disease trajectories, which complicates the value proposition for payers. According to the American Cancer Society, in 2024, the 5-year relative survival rate for ovarian cancer patients diagnosed at a distant stage was 31 percent. This statistic highlights that current diagnostics often identify the disease too late to ensure favorable survival rates, thereby reducing the perceived clinical utility and economic incentive for widespread market adoption.

Key Market Trends

The Integration of Artificial Intelligence in Diagnostic Imaging is revolutionizing the accuracy of transvaginal ultrasounds, directly addressing the difficulty of distinguishing between benign cysts and malignant tumors. By leveraging deep learning algorithms, clinicians can now significantly reduce false positives and minimize the rate of unnecessary surgical interventions that often result from subjective human interpretation. This capability is vital for optimizing hospital resources and improving patient triage in complex clinical settings. According to The ASCO Post, January 2025, in the 'AI May Improve Ovarian Cancer Diagnoses' article, a newly validated neural network model demonstrated a diagnostic accuracy rate of 86.3 percent in identifying ovarian cancer from ultrasound images, surpassing the 82.6 percent accuracy achieved by expert examiners.

Simultaneously, the Expansion of Multi-Biomarker Assay Panels is reshaping the market by providing sophisticated risk stratification tools for women who present with indeterminate adnexal masses. Unlike traditional single-biomarker tests that often lack the necessary specificity for surgical decision-making, these multivariate index assays combine quantifications of multiple serum proteins with proprietary algorithms to assess the likelihood of malignancy. The commercial uptake of these solutions has accelerated as healthcare providers increasingly rely on them to guide patient management protocols and avoid missed diagnoses. According to Aspira Women's Health, August 2024, in the 'Second Quarter 2024 Financial Results', the commercial test volume for the OvaWatch ovarian cancer risk assessment product increased by 48 percent year-over-year.

Segmental Insights

The Imaging segment currently stands as the fastest-growing division within the United States Ovarian Cancer Diagnostics Market. This expansion is primarily fueled by advancements in Magnetic Resonance Imaging and Computed Tomography, which offer enhanced resolution for precise tumor staging. Additionally, the integration of artificial intelligence tools is streamlining diagnostic workflows, reducing error rates in lesion detection. The rising clinical preference for these non-invasive modalities, driven by the critical need for early and accurate diagnosis to improve patient outcomes, continues to stimulate substantial investment and adoption across the American healthcare sector.

Regional Insights

The Midwest dominates the United States Ovarian Cancer Diagnostics Market, driven by a robust ecosystem of premier medical research institutions and a strong diagnostic manufacturing base. This region is home to world-renowned facilities such as the Mayo Clinic and Cleveland Clinic, which lead the nation in clinical trials and the adoption of advanced screening protocols. Furthermore, the presence of major industry players like Abbott Laboratories in Illinois fosters a collaborative environment that accelerates the development of innovative detection technologies. This combination of academic excellence and corporate infrastructure firmly establishes the Midwest as the primary hub for advancements in ovarian cancer diagnostics.

Recent Developments

• In October 2025, AOA Dx published peer-reviewed clinical evidence validating the performance of its multi-omic blood test for the detection of ovarian cancer in symptomatic women. The study demonstrated that the diagnostic platform, which analyzes tumor-marker gangliosides alongside other biomarkers, achieved high levels of accuracy in identifying the disease even at early stages. This research breakthrough was significant for the United States ovarian cancer diagnostics market, as it offered a promising solution for the large population of women who often face delays in diagnosis due to non-specific symptoms. The validated data supported the company's ongoing efforts to commercialize a non-invasive liquid biopsy test.
• In August 2025, Cleo Diagnostics Limited announced the engagement of EntityRisk and Norstella to execute a comprehensive health economic analysis and market assessment for its ovarian cancer pre-surgical test in the United States. The collaboration focused on modeling the economic value of the test to support future reimbursement strategies and commercial market entry. By utilizing extensive data on physician behaviors and insurance claims, the company aimed to define high-value launch territories and establish a strong evidence base for payers. This development marked a critical step in the company’s strategy to introduce its biomarker-based diagnostic solution to the American healthcare system.
• In June 2025, Aspira Women’s Health Inc. entered into a strategic partnership with Dorsata to launch a clinical decision support module designed for the management of adnexal masses. This collaboration integrated the company’s non-invasive ovarian cancer risk assessment tests directly into a maternity management platform utilized by hundreds of women's health practices. The initiative aimed to streamline the ordering and documentation process for healthcare providers, potentially expanding access to these diagnostic tools for over 1.5 million patients in the United States. By embedding the tests into clinical workflows, the company sought to improve the timely identification of ovarian malignancy risk.
• In September 2024, Exact Sciences Corporation presented new performance data for its blood-based multi-cancer early detection test at the European Society for Medical Oncology Congress. The study involved a simulation of a screening population in the United States and analyzed approximately 3,000 prospectively collected blood samples. The findings revealed that the test achieved a sensitivity of 63.7% for six aggressive cancers with typically short survival rates, specifically including ovarian cancer. This research underscored the clinical potential of the multi-marker approach to identify malignancies that currently lack standard screening guidelines, thereby addressing a significant unmet need in the diagnostics sector.

Key Market Players

• Abbott Laboratories Inc.
• F. Hoffmann-La Roche Ltd.
• GlaxoSmithKline plc
• Johnson & Johnson
• AstraZeneca plc
• Siemens Healthcare GmbH
• Quest Diagnostics Incorporated
• Thermo Fisher Scientific Inc
• Bio-Rad Technologies Inc
• Eli Lily and Company

By Region

Northeast Midwest South West

Report Scope:

In this report, the United States Ovarian Cancer Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Ovarian Cancer Diagnostics Market, By Region:

• Northeast
• Midwest
• South
• West