Ovarian Cancer Diagnostics Market By Diagnostic (Imaging Techniques {Ultrasound, CT Scan, MRI, PET Scan}, Biomarker Testing {CA-125, HE4, OVA1, ROMA}, Genetic Testing {BRCA1/BRCA2 and Others}, Biopsy, Laparoscopy, and Others), By Type (Epithelial Tumors, Germ Cell Tumors, and Stromal Tumors), By End-user (Hospitals, Clinics, Diagnostic Laboratories, and Cancer Research Institutes), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Ovarian Cancer Diagnostics market accounted for USD 2.85 Billion in 2024 and is expected to reach USD 7.13 Billion by 2035, growing at a CAGR of around 8.7% between 2025 and 2035.  The ovarian cancer diagnostics market involves the development and use of diagnostic tools and technologies to detect ovarian cancer at early stages. It encompasses a range of methods including imaging techniques (ultrasound, CT scans), blood tests (e.g., CA-125, HE4 markers), biopsy procedures, and genetic testing that identifies specific mutations linked with ovarian cancer.

Survivals due to improving early detection of ovarian cancer often go undetected until when the disease advances. Increasing market because of developing awareness, diagnostics technologies with growing interest toward personalized medicine increases. Improving healthcare costs and better structures also assist in growth within the healthcare market. 

Report Scope:

Market Dynamics

Rising Demand for Non-Invasive Screening Methods in Ovarian Cancer Diagnostics

The demand for ovarian cancer diagnostics is rising with the requirement for non-invasive screening procedures in the market as traditional invasive procedures are not liked by most patients and medical practitioners. Liquid biopsies and blood tests are picking up fast due to less invasiveness and safety associated with the risk in biomarkers for detecting cancer. According to the National Cancer Institute, ovarian cancer ranks fifth as the most common cause of death in the United States among women with about 19,710 new cases estimated in 2023.

Further, the American Cancer Society also notes that over 70% of ovarian cancer is diagnosed at late stages; if it could be diagnosed early using non-invasive techniques, this can considerably increase survival chances. This has been mainly followed due to emphasis on patient comfort, early diagnosis, and cost-effective solutions. Also, non-invasive techniques can provide regular screening and can thus give an early chance of detection, leading to improved outcomes, especially in at-risk populations.

Focus on Genetic Mutations for Early Detection Drives Personalized Ovarian Cancer Diagnostics

A recent driver in the ovarian cancer diagnostics market is focusing on genetic mutations for early detection. Advances in genetic research can create the scope for personalized diagnostic approaches, with specific mutations such as BRCA1 and BRCA2 being associated with a higher risk of ovarian cancer. Targeting these genetic markers could facilitate earlier detection.

According to the National Cancer Institute, women with mutations for BRCA have significantly a higher lifetime risk for developing ovarian cancer. The Centers for Disease Control and Prevention (CDC), asserts that such mutations cause at-risk individuals to become highly susceptible to ovarian cancer; therefore, genetic testing has become necessary for such a populace.

With the help of more available genetic testing, one can help to develop individualized screening strategies leading to higher success and increased effective treatment for patients. Such an increasing interest in genetic mutation helps support the rising trend toward personalized medicine in ovarian cancer diagnosis.

Complexity of Ovarian Cancer Diagnosis and Lack of Early Detection Hinder Market Growth

The complexity of diagnosis is considered a major driver in the market since the symptoms overlap with other common diseases and therefore lead to late detection. Symptoms such as bloating, abdominal pain, and changes in appetite can be mistaken for digestive disorders, leading to misdiagnosis or late-stage detection.

Early symptoms are very nonspecific, and most diagnoses rely on imaging or invasive procedures. This difficulty increases the need for even more accurate, non-invasive diagnostic tools to help determine ovarian cancer earlier in its stages, thereby increasing the chances of better patient outcomes and thus contributing to market growth.

As the demand for more reliable and efficient diagnostics grows, innovations in testing methods are important. However, the cost of advanced diagnostic technologies is high, and there are also issues of expertise needed to interpret results. Also, the lack of standardized protocols for early detection hampers the consistency and reliability of tests across healthcare settings.

Advancements in Biomarker Research Present Opportunities for Enhanced Ovarian Cancer Diagnostics

Biomarker research and development is a significant opportunity within ovarian cancer diagnostics. Such new avenues can be based on offering more accurate and cost-effective diagnostic testing strategies. Specific biomarkers are discovered in ovarian cancers in order to enable early diagnosis. Genetic mutations or the same protein markers in blood or tissues often improve the diagnosis quite evidently. Early-stage ovarian cancer is much more likely to survive than late-stage cancer, and innovations in biomarkers will be critical in the quest for early detection.

The progress in biomarker research could also minimize the requirement for costly imaging and invasive diagnostic procedures, making diagnostic testing more accessible. As this research advances, it will promise to develop tests that are reliable yet affordable, which will further open up screening options and help improve patient outcomes.

Liquid Biopsy Technologies Offer Promising Opportunity for Early Ovarian Cancer Detection

Liquid biopsy technology has a large potential in the ovarian cancer diagnostics market. They are not invasive and offer an immense capability to identify the presence of cancer-related biomarkers accurately. Liquid biopsy provides a tool through which genetic mutations are detected in the blood or other bodily fluids for early detection and monitoring. Since the results of further research have proved its efficiency, liquid biopsy is an alternative, which is more accessible and less invasive compared to traditional diagnostic methods like tissue biopsies, thus opening a possibility for larger screening and better patient outcomes.

Increasing interest in liquid biopsy will spur the growth of the market as it offers cost-effective, rapid, and repeatable testing and holds promise for earlier diagnosis and more personalized treatment strategies. Further, liquid biopsy allows for real-time monitoring of the response to treatment, which could improve long-term management and minimize the requirement for more invasive procedures.

Industry Experts Opinion

“Receiving a CPT code and CMS preliminary rate recommendation for our Avantect Ovarian Cancer Test represents the second time ClearNote Health has reached a critical commercial and reimbursement milestone for our organization in less than 12 months, and most importantly, expands patient access to the early detection for ovarian cancer.”

• Dave Mullarkey, CEO of ClearNote Health

"Ovarian cancer presents a significant challenge, especially for those with advanced or recurrent cases, where treatment options and prognosis are often limited. The encouraging Phase 1/2 data for Rina-S demonstrates the potential for future treatment options for patients. We are looking forward to additional data from tumor-specific dose expansion cohorts.”

• Elizabeth Lee, MD, a medical oncologist in the gynecologic oncology program at Dana-Farber

Segment Analysis

Based on the diagnostic, the Ovarian Cancer Diagnostics market has been classified into imaging techniques, biomarker testing, genetic testing, biopsy, laparoscopy, and others. The market is further segmented by imaging techniques types Ultrasound, CT scan, MRI, and PET scan. The biomarker testing segment is classified as CA-125, HE4, OVA1, and ROMA. The genetic testing segment is classified into BRCA1/BRCA2 and Others.

Biomarker testing leading in ovarian cancer diagnostics technique because it is non-invasive, cost-effective, and can detect the presence of cancer-related biomarkers much earlier. Tests such as CA-125, HE4, and ROMA have further enhanced the accuracy of diagnosis in distinguishing between benign and malignant conditions. It has been found that this has a lot to do with early detection and monitoring by using the most reliable and accessible technique in biomarker testing. 

Based on the type, the Ovarian Cancer Diagnostics market has been classified into Epithelial Tumors, Germ Cell Tumors, and Stromal Tumors. Epithelial tumors are the leading type in the ovarian cancer diagnostics market because they comprise around 90% of all ovarian cancer cases, making them the most common form of the disease. These tumors are well-studied, and most diagnostic tests, including CA-125, are designed primarily to identify them.

Regional Analysis

The ovarian cancer diagnostics market has the largest share in North America due to its highly advanced healthcare infrastructure, higher level of awareness regarding ovarian cancer, and a high tendency toward the use of innovative diagnostic technologies. There is an incidence of ovarian cancer in the United States with a very high rate combined with a structured program in screening for the government-supported early stages.

The widespread availability of diagnostic tools such as biomarker testing, imaging techniques, and genetic testing is also contributing to the market's dominance. Large-scale investments in research and development along with the presence of top health care companies are also boosting market growth in this region. High healthcare spending and an increased focus on personalized medicine in the region are also dominating the market.

The Asia-Pacific region is going to emerge as the largest growing market for ovarian cancer diagnostics due to increased awareness of cancer, better healthcare infrastructures, and a growth in disposable incomes. The incidence of ovarian cancer in countries like China, India, and Japan has also been growing, hence fueling the demand for sophisticated diagnostic tools.

The integration of early-stage cancer screening programs by governments and healthcare providers has increased to promote the adoption of diagnostic technologies. The rapid growth in the market can also be attributed to the ongoing advances in technology, rise in access to biomarker tests, and increase in research and development activities to enhance accuracy rates in diagnostics. Additionally, the rising number of hospitals along with health care investments within developing countries have led to its rapid growth within the region.  

Competitive Landscape

The competitive landscape of the ovarian cancer diagnostics market is led by major players such as Abbott Laboratories, Roche Diagnostics, Thermo Fisher Scientific, Illumina, and Myriad Genetics. They are investing massive amounts in research and development, thus upgrading diagnostic technologies such as biomarker tests, genetic testing, and liquid biopsy solutions. Recent innovations in this area include Guardant Health launching a liquid biopsy test for early detection, which would not be invasive. Further, companies such as Hologic and Siemens Healthineers are furthering imaging techniques and integrating state-of-the-art AI for higher diagnostic accuracy. With increased investment in innovative diagnostic tools, these players are nudging the market toward earlier and more accurate detection of ovarian cancer.

Ovarian Cancer Diagnostics Market, Company Shares Analysis, 2024

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Recent Developments:

• In September 2024, ClearNote Health, an early cancer detection company dedicated to empowering people at risk for high-mortality cancers to live longer, announced that the American Medical Association (AMA) has approved a new Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code for the Avantect Ovarian Cancer Test.
• In September 2024, Genmab A/S announced new data from the Phase 1/2 study of rinatabart sesutecan. The study showed a confirmed objective response rate (ORR) of 50.0% (95% CI) in ovarian cancer patients who received Rina-S 120 mg/m2 administered once every 3 weeks (Q3W), irrespective of FRα expression levels.

Report Coverage:

By Diagnostic

• Imaging Techniques
  • Ultrasound
  • CT Scan
  • MRI
  • PET Scan
• Biomarker Testing
  • CA-125
  • HE4
  • OVA1
  • ROMA
• Genetic Testing
  • BRCA1/BRCA2
  • Others
• Biopsy
• Laparoscopy
• Others

By Type

• Epithelial Tumors
• Germ Cell Tumors
• Stromal Tumors

By End-user

• Hospitals
• Clinics
• Diagnostic Laboratories
• Cancer Research Institutes

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Abbott Laboratories
• Roche Diagnostics
• Thermo Fisher Scientific
• BioMérieux
• Illumina, Inc.
• Qiagen N.V.
• Myriad Genetics
• Guardant Health
• Freenome
• Labcorp
• Medtronic
• Siemens Healthineers
• Hologic, Inc.
• Genomic Health
• OncoOne, Inc.

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