(Albany, USA) DelveInsight’s Prostate Cancer Diagnostics Market Insights report provides the current and forecast market analysis, individual leading prostate cancer diagnostics companies’ market shares, challenges, prostate cancer diagnostics market drivers, barriers, trends, and key market prostate cancer diagnostics companies in the market.
The Prostate Cancer Diagnostics Market, segmented by test type (including imaging tests, biomarker tests, biopsy, immunohistochemistry, and others), end-user (such as hospitals & clinics, diagnostic centers, research & academic institutions, and others), and geography (North America, Europe, Asia-Pacific, and the Rest of the World), is projected to grow at a steady CAGR through 2030. This growth is primarily driven by the rising incidence of prostate cancer, along with increasing awareness and the expansion of screening programs worldwide.
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Key Takeaways from the Prostate Cancer Diagnostics Market Report
- As per DelveInsight estimates, North America is anticipated to dominate the global prostate cancer diagnostics market during the forecast period.
- In the test type segment of the prostate cancer diagnostics market, the imaging tests category had a significant revenue share in the prostate cancer diagnostics market in 2023.
- Notable prostate cancer diagnostics companies such as F. Hoffmann-La Roche Ltd, Myriad Genetics, Inc., Abbott., MDx Health, Siemens Healthcare, OPKO Health, Inc., Genomic Health, Inc., Agilent Technologies, Inc., BD., BIOCEPT, INC., Proteomedix, A3P Biomedical AB, GE HealthCare., Soteria Medical BV, Bio-Techne., Indica Labs, Inc., miR Scientific, MINOMIC®, ACON Laboratories, Inc., Hologic, Inc., and several others, are currently operating in the prostate cancer diagnostics market.
- In March 2025, Quibim announced that its QP-Prostate® CAD solution for prostate cancer lesion detection received FDA 510(k) clearance. This milestone advances Quibim’s mission to improve prostate cancer detection and treatment.
- In February 2025, Ibex Medical Analytics, a leader in AI-powered cancer diagnostics, received FDA 510(k) clearance for Ibex Prostate Detect. This in vitro diagnostic device uses AI to generate heatmaps that identify small and rare missed prostatic cancers, providing pathologists with a safety net to ensure accurate diagnoses.
- In January 2025, Clarity Pharmaceuticals announced that the FDA granted Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy.
- In September 2023, MDxHealth announced a research collaboration with the University of Oxford to investigate the correlation between the Genomic Prostate Score (GPS) test and prostate cancer progression following treatment for localized prostate cancer.
- In July 2023, Quest Diagnostics launched the novel prostate cancer biomarker test through its subspecialty pathology business, AmeriPath, in collaboration with Envision Sciences. Envision Sciences Pty Ltd. is an Australian-based clinical diagnostics company developing a pipeline of biomarker-based cancer diagnostic and prognostic tests in tissue and blood.
To read more about the latest highlights related to the prostate cancer diagnostics market, get a snapshot of the key highlights entailed in the Global Prostate Cancer Diagnostics Market Report
Prostate Cancer Diagnostics Overview
Prostate cancer diagnostics involve a combination of tests and procedures aimed at detecting the presence of cancerous cells in the prostate gland. The initial step typically includes a digital rectal examination (DRE), where a physician physically examines the prostate for abnormalities. However, the most definitive diagnostic tool is the prostate-specific antigen (PSA) blood test, which measures the level of PSA, a protein produced by the prostate. Elevated PSA levels can indicate prostate cancer, though they can also be due to other conditions such as benign prostatic hyperplasia (BPH) or prostatitis.
If initial tests suggest the possibility of cancer, further diagnostic procedures are often employed. A prostate biopsy, usually guided by transrectal ultrasound (TRUS), involves taking small tissue samples from the prostate to be examined microscopically for cancer cells. Imaging techniques, such as magnetic resonance imaging (MRI) and computed tomography (CT) scans, can provide detailed views of the prostate and surrounding tissues to assess the extent of the cancer and aid in staging. Together, these diagnostic tools help to accurately identify prostate cancer, determine its aggressiveness, and guide appropriate treatment strategies.
Prostate Cancer Diagnostics Market Insights
In 2023, North America held the largest share of the prostate cancer diagnostics market compared to other regions. This dominance is largely due to the high incidence of prostate cancer, the growing elderly population, and the region’s advanced diagnostic infrastructure. North America’s sophisticated healthcare system, featuring cutting-edge hospitals, diagnostic centers, and research facilities, facilitates accurate and timely prostate cancer diagnoses through state-of-the-art imaging technologies like multiparametric MRI (mpMRI) and advanced laboratory testing.
Additionally, North America’s public health initiatives, advocacy efforts, and healthcare policies bolster prostate cancer awareness and promote regular screening among at-risk individuals. These initiatives, including the Canadian Cancer Society’s Prostate Cancer Awareness Month in September, enhance early detection rates and diagnostic testing uptake. As a result, the increasing prevalence of prostate cancer and the region’s high-quality healthcare infrastructure, combined with growing government awareness efforts, are expected to significantly drive the prostate cancer diagnostics market in North America throughout the forecast period.
To know more about why North America is leading the market growth in the prostate cancer diagnostics market, get a snapshot of the Prostate Cancer Diagnostics Market Outlook
Prostate Cancer Diagnostics Market Dynamics
The prostate cancer diagnostics market is witnessing significant growth, driven by the increasing prevalence of prostate cancer and advancements in diagnostic technologies. As one of the most common cancers affecting men globally, the need for early and accurate diagnosis has spurred innovation. Traditional diagnostic methods, such as prostate-specific antigen (PSA) testing, have faced criticism for their lack of specificity, leading to false positives and unnecessary biopsies. This has created a demand for more reliable, non-invasive, and precise diagnostic tools, contributing to the expansion of this market.
Emerging diagnostic technologies, including liquid biopsies, genomic testing, and advanced imaging techniques, are gaining prominence. Liquid biopsies, for instance, offer a minimally invasive method to detect genetic mutations and monitor disease progression through blood samples. This approach is more patient-friendly and allows for continuous monitoring, unlike traditional biopsies. Genomic testing, on the other hand, enables personalized treatment strategies by identifying specific genetic markers linked to aggressive forms of prostate cancer. These innovations are helping clinicians make more informed decisions, thus improving patient outcomes and driving market growth.
The rise of artificial intelligence (AI) and machine learning in medical diagnostics is another key factor influencing the prostate cancer diagnostics market. AI-driven platforms are being developed to enhance the accuracy of imaging technologies such as magnetic resonance imaging (MRI) and positron emission tomography (PET) scans. These systems can analyze complex data more efficiently, helping radiologists detect early-stage cancer with greater precision. Moreover, AI can assist in interpreting results from genomic and biomarker tests, reducing human error and speeding up diagnosis. The integration of AI in prostate cancer diagnostics is expected to further propel market expansion.
However, despite these positive trends, the prostate cancer diagnostics market faces challenges. High costs associated with advanced diagnostic technologies, limited access to healthcare in certain regions, and the potential for overtreatment are key concerns. Nonetheless, ongoing research and development, coupled with growing collaborations between pharmaceutical companies and diagnostic tool developers, are likely to address these challenges and create lucrative opportunities for future growth in the market.
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Prostate Cancer Diagnostics Market Assessment
- Coverage: Global
- Study Period: 2021–2030
- Prostate Cancer Diagnostics Market CAGR: ~12%
- Key Prostate Cancer Diagnostics Companies: F. Hoffmann-La Roche Ltd (SWX: ROG), Myriad Genetics, Inc. (NASDAQ: MYGN), Abbott (NYSE: ABT), MDx Health (EBR: MDXH), Siemens Healthineers (XTRA: SHL), OPKO Health, Inc. (NASDAQ: OPK), Genomic Health, Inc. (formerly NASDAQ: GHDX, acquired by Exact Sciences), Agilent Technologies, Inc. (NYSE: A), Becton, Dickinson and Company (NYSE: BDX), BIOCEPT, INC. (OTC: BIOCQ), Proteomedix (Private), A3P Biomedical AB (Private), GE HealthCare (NASDAQ: GEHC), Soteria Medical BV (Private), Bio-Techne (NASDAQ: TECH), Indica Labs, Inc. (Private), miR Scientific (Private), MINOMIC® (Private), ACON Laboratories, Inc. (Private) and Hologic, Inc. (NASDAQ: HOLX) and others.
- Prostate Cancer Diagnostics Market Segmentation
- Prostate Cancer Diagnostics Market Segmentation By Test Type: Imaging Tests, Biomarker Tests, Biopsy, Immunohistochemistry, and Others
- Prostate Cancer Diagnostics Market Segmentation By End User: Hospitals & Clinics, Diagnostic Centers, Research & Academics, and Others
- Prostate Cancer Diagnostics Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World
- Porter’s Five Forces Analysis, Product Profiles, Case Studies, KOL’s Views, Analyst’s View
Which MedTech key players in the prostate cancer diagnostics market are set to emerge as the trendsetter explore @ Prostate Cancer Diagnostics Companies and Manufacturers
Table of Contents
1. Prostate Cancer Diagnostics Market Report Introduction
2. Prostate Cancer Diagnostics Market Executive Summary
3. Competitive Landscape
4. Regulatory Analysis
5. Prostate Cancer Diagnostics Market Key Factors Analysis
6. Prostate Cancer Diagnostics Market Porter’s Five Forces Analysis
7. Prostate Cancer Diagnostics Market Layout
8. Prostate Cancer Diagnostics Market Company and Product Profiles
9. KOL Views
10. Project Approach
11. About DelveInsight
12. Disclaimer & Contact Us
About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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