Ovarian Cancer Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Diagnosis Type (Diagnostic Imaging {Transvaginal Ultrasound, CT Scan, MRI Scan, PET Scan, Others}, Blood Test {CA-125, HER2, BRCA, KRAS Mutation, Others}, Biopsy {Image Guided Biopsy, Fine Needle Aspiration Biopsy, Others}, Others), By Cancer Type (Epithelial Tumor, Germ Cell Tumor, Stromal Cell Tumor, Others), By End User (Hospitals & Specialty Clinics, Ambulatory Care Centers, Others), By Region 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.21 Billion
CAGR (2026-2031)	5.34%
Fastest Growing Segment	CT Scan
Largest Market	North America
Market Size (2031)	USD 3.02 Billion

Market Overview

The Global Ovarian Cancer Diagnostics Market will grow from USD 2.21 Billion in 2025 to USD 3.02 Billion by 2031 at a 5.34% CAGR. Ovarian cancer diagnostics encompass medical procedures and laboratory assays designed to detect malignant neoplasms within the ovaries, fallopian tubes, and peritoneum, utilizing modalities such as transvaginal ultrasound, tumor biomarker testing, and genetic screening. The market is primarily driven by the increasing global incidence of gynecological malignancies and the expanding adoption of genetic testing for BRCA mutations among populations with elevated risk. According to the American Cancer Society, in 2025, approximately 20,890 women will receive a new diagnosis of ovarian cancer in the United States. This rising prevalence underscores the critical demand for accurate diagnostic tools to facilitate timely intervention and improve patient prognosis.

Despite these growth factors, the market faces significant impediments due to the high cost of genomic testing and the absence of a standardized and sensitive screening method for detection in the general population during the early phases of the disease. The frequent diagnosis of the condition at advanced stages limits the efficacy of current therapeutic interventions and consequently constrains the widespread implementation of routine diagnostic screening programs.

Key Market Drivers

Technological advancements in diagnostic imaging and biomarker analysis, particularly the emergence of non-invasive liquid biopsy and artificial intelligence (AI), represent the primary engine of growth for the market. Innovations in multi-omic platforms are enabling higher sensitivity in detecting early-stage malignancies, significantly overcoming the limitations of traditional CA-125 testing. The integration of machine learning algorithms allows for the precise identification of tumor-derived extracellular vesicles and circulating gangliosides, reducing false positives that historically hindered screening efforts. According to AOA Dx, April 2025, in the '2025 AACR Annual Meeting' presentation, their AI-powered liquid biopsy platform demonstrated an area under the curve (AUC) of over 90% across approximately 1,000 real-world patient samples. Such high accuracy in fluid-based diagnostics underscores a pivotal shift toward scalable, less invasive screening protocols that can facilitate intervention before metastasis occurs.

The expansion of public and private funding for cancer research acts as a critical catalyst, sustaining the development and commercialization of these next-generation diagnostic tools. Philanthropic organizations and government bodies are increasingly channeling capital into high-risk, high-reward studies focused on early detection and survivorship, thereby de-risking the R&D process for diagnostic developers. According to the Ovarian Cancer Research Alliance, January 2025, in the 'Ovarian Cancer Research Alliance Surpasses Year-End Fundraising Goals' press release, the organization funded more than $9.2 million in grants to leading researchers throughout the preceding year to advance treatment and detection capabilities. This influx of capital supports the broader adoption of personalized medicine, a trend further evidenced by industrial output; according to Roche, in 2025, there are currently more than 60 FDA-approved companion diagnostic tests available in oncology, reflecting the market's growing reliance on biomarker-driven precision medicine.

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Key Market Challenges

The absence of a standardized and sensitive screening method for detecting the disease in the general population serves as a primary impediment to the growth of the Global Ovarian Cancer Diagnostics Market. Unlike other oncological segments that benefit from established preventative screening protocols, ovarian cancer lacks a reliable, non-invasive test suitable for asymptomatic women. This technological deficiency confines the market largely to diagnostic confirmation in patients who already present with symptoms, rather than facilitating mass adoption for preventative care. Consequently, the total addressable market is significantly restricted, preventing manufacturers from accessing the high-volume revenue streams associated with routine population-based screening programs.

This limitation directly correlates with the prevalence of late-stage diagnoses, which undermines the perceived clinical utility and cost-effectiveness of current diagnostic tools for early intervention. According to the Ovarian Cancer Research Alliance, in 2024, only 16% of ovarian cancer cases were diagnosed in the early stages. This low rate of early detection emphasizes the inadequacy of existing modalities, such as transvaginal ultrasound and CA-125 testing, in identifying early-onset malignancies. As a result, healthcare payers and insurers are hesitant to support widespread reimbursement for these diagnostics in the general population, further constraining market penetration and commercial expansion.

Key Market Trends

The transition from single-marker testing to multi-parametric biomarker panels and index assays is reshaping clinical decision-making for adnexal mass evaluation. These Multivariate Index Assays (MIAs) utilize proprietary algorithms to analyze multiple proteins, such as transferrin and apolipoprotein A1 alongside CA-125, offering superior specificity for stratifying malignancy risk compared to traditional immunoassays. This technological evolution addresses the critical need for accurate pre-surgical triage, ensuring that high-risk patients are appropriately referred to gynecologic oncologists while reducing unnecessary procedures for benign conditions. According to Aspira Women's Health, March 2025, in the 'Aspira Women's Health Reports Fourth Quarter and Full Year 2024 Financial Results', the company's product revenue for the fourth quarter of 2024 increased 9.5% year-over-year, driven by the expanded adoption of its specialized gynecologic diagnostic portfolio.

Simultaneously, the adoption of Next-Generation Sequencing (NGS) for comprehensive genetic profiling is advancing standard care beyond limited BRCA testing. Clinicians are increasingly relying on genomic instability scores and Homologous Recombination Deficiency (HRD) status to guide the administration of poly (ADP-ribose) polymerase (PARP) inhibitors. This demand for broad molecular characterization drives the implementation of high-throughput sequencing platforms capable of analyzing somatic and germline mutations in a single workflow, essential for personalized therapeutic strategies. According to Myriad Genetics, February 2025, in the 'Fourth Quarter and Full-Year 2024 Financial Results', the company achieved an 11% year-over-year revenue increase for the full year 2024, reaching $838 million, a growth trajectory supported by the robust volume of its hereditary cancer and tumor profiling tests.

Segmental Insights

The Computed Tomography scan segment represents the fastest growing category in the Global Ovarian Cancer Diagnostics Market. This upward trend is driven by the indispensable capability of CT imaging to provide detailed preoperative staging and accurate detection of metastatic deposits, which are essential for determining surgical strategies. Guidelines from the National Comprehensive Cancer Network mandate these scans for initial evaluation and monitoring, thereby sustaining high demand. Additionally, technological progress in scanner resolution supports clearer anatomical visualization, allowing clinicians to manage disease progression effectively without immediate invasive intervention.

Regional Insights

North America dominates the Global Ovarian Cancer Diagnostics Market, driven by the high prevalence of the disease and a well-established healthcare infrastructure. The region benefits from significant research funding provided by organizations such as the National Cancer Institute, which supports the development of diagnostic solutions. Additionally, the presence of key industry participants and favorable reimbursement coverage from the Centers for Medicare & Medicaid Services facilitates widespread access to essential testing. These strategic advantages collectively secure North America’s position as the leading revenue contributor in the global market.

Recent Developments

• In April 2025, AOA Dx presented new clinical data at the American Association for Cancer Research Annual Meeting, demonstrating the high accuracy of its AI-powered liquid biopsy platform for ovarian cancer detection. The study analyzed approximately 1,000 patient samples and showed that the company's multi-omic platform outperformed traditional biomarkers in symptomatic women. The research, conducted in collaboration with the University of Colorado Anschutz Medical Campus and the University of Manchester, highlighted the potential of the test to aid clinicians in making faster, more accurate diagnostic decisions, thereby addressing the critical challenge of late-stage diagnosis in ovarian cancer.
• In November 2024, Roche announced the receipt of the CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. This approval marked the introduction of the first immunohistochemistry companion diagnostic test widely available in Europe to aid in the identification of epithelial ovarian cancer patients eligible for targeted treatment with a specific antibody-drug conjugate. The diagnostic assay detects the folate receptor 1 protein, which is over-expressed in the majority of ovarian cancers. This regulatory milestone followed an earlier exemption approval in Germany and Austria, highlighting the company's commitment to advancing personalized healthcare solutions and improving outcomes for women facing gynecological cancers.
• In November 2024, Aspira Women's Health Inc. disclosed the expansion of its co-marketing and distribution collaboration with BioReference Health, LLC, a subsidiary of OPKO Health Inc. Under the terms of this enhanced agreement, the companies agreed to jointly market Aspira's complete portfolio of gynecologic disease diagnostic tools, including the OvaWatch and Ova1Plus tests, to healthcare providers across New York and New Jersey. This strategic move followed the approval of OvaWatch by the New York State Department of Health, aiming to increase patient access to non-invasive ovarian cancer risk assessment tools in these key regional markets.
• In May 2024, Mercy BioAnalytics, Inc. received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Mercy Halo Ovarian Cancer Screening Test. This designation was granted for the test's use in asymptomatic, postmenopausal women, a population at high risk for the disease. The company's novel liquid biopsy platform utilizes extracellular vesicles to detect early-stage cancer with high sensitivity. The regulatory recognition was designed to accelerate the development and review of the test, addressing the significant unmet need for an effective screening method to detect ovarian cancer before it advances to a later, less treatable stage.

Key Market Players

• F. Hoffmann-La Roche AG
• Johnson & Johnson Services, Inc.
• GlaxoSmithKline Plc
• AstraZeneca Plc
• Siemens Healthineers GmbH
• Abbott Laboratories
• Thermo Fisher Scientific
• Bio-Rad Laboratories, Inc.
• Quest Diagnostics Incorporated
• Illumina, Inc.

By Diagnosis Type	By Cancer Type	By End User	By Region
Diagnostic Imaging {Transvaginal Ultrasound CT Scan MRI Scan PET Scan Others} Blood Test {CA-125 HER2 BRCA KRAS Mutation Others} Biopsy {Image Guided Biopsy Fine Needle Aspiration Biopsy Others} Others	Epithelial Tumor Germ Cell Tumor Stromal Cell Tumor Others	Hospitals & Specialty Clinics Ambulatory Care Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Ovarian Cancer Diagnostics Market, By Diagnosis Type:

• Diagnostic Imaging {Transvaginal Ultrasound
• CT Scan
• MRI Scan
• PET Scan
• Others}
• Blood Test {CA-125
• HER2
• BRCA
• KRAS Mutation
• Others}
• Biopsy {Image Guided Biopsy
• Fine Needle Aspiration Biopsy
• Others}
• Others

• Ovarian Cancer Diagnostics Market, By Cancer Type:

• Epithelial Tumor
• Germ Cell Tumor
• Stromal Cell Tumor
• Others

• Ovarian Cancer Diagnostics Market, By End User:

• Hospitals & Specialty Clinics
• Ambulatory Care Centers
• Others

• Ovarian Cancer Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE