Luton, Bedfordshire, United Kingdom, May 21, 2025 (GLOBE NEWSWIRE) — Global Prostate Cancer Diagnostics Solution Market
The global prostate cancer diagnostics solution market is undergoing a significant transformation, propelled by technological advances, improved patient awareness, and increased healthcare spending. In 2024, the market size is valued at approximately USD 4.18 billion, and it is forecast to reach USD 10.84 billion by 2034, reflecting a strong CAGR of 10%. This growth is primarily fueled by the increasing incidence of prostate cancer globally, driven in part by an aging population, better screening coverage, and enhancements in molecular and imaging-based diagnostics.
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Prostate cancer remains one of the most prevalent malignancies among men, especially in North America and Europe. While early detection significantly improves prognosis, traditional diagnostic methods such as PSA screening and manual biopsies face criticism for low specificity and overdiagnosis. In response, the market is witnessing a shift toward precision diagnostics using biomarkers, genetic assays, and advanced imaging systems.
Market Growth Drivers The market is influenced by several factors. First, the growing awareness around early screening programs, especially in developed nations, has led to a significant uptick in test volumes. Public health campaigns and evolving guidelines from organizations like the American Urological Association (AUA) and European Association of Urology (EAU) encourage age-appropriate prostate screening. Secondly, technology has improved both the sensitivity and specificity of diagnostic tools. Multiparametric MRI, PSMA-based imaging, liquid biopsy, and AI-assisted pathology have reduced false positives and enabled targeted biopsies.
Healthcare providers are increasingly integrating prostate-specific biomarkers such as PCA3, 4Kscore, SelectMDx, and PHI (Prostate Health Index) into diagnostic workflows. Molecular diagnostics and genomic profiling are also gaining traction for risk stratification and treatment planning. For instance, gene expression panels help differentiate between indolent and aggressive tumors, enabling clinicians to tailor active surveillance or treatment strategies.
Emerging markets in Asia-Pacific, Latin America, and the Middle East are also contributing to market expansion. Improved healthcare infrastructure, greater access to insurance, and the establishment of private diagnostic centers have expanded access to prostate cancer testing beyond urban centers. Governments in countries like China, India, and Brazil are prioritizing cancer screening under national health plans, further accelerating adoption.
Challenges and Constraints Despite promising growth, the prostate cancer diagnostics market faces several challenges. Overdiagnosis and overtreatment remain concerns, particularly in cases where low-risk tumors are detected. Invasive diagnostic procedures, such as transrectal ultrasound (TRUS)-guided biopsies, are associated with discomfort, infection risk, and high costs. Moreover, the accessibility of advanced imaging and molecular testing remains limited in low-income regions.
Regulatory barriers also affect product adoption. Diagnostic test developers must navigate complex approval processes, such as FDA clearance and CE marking, which can delay commercialization. Furthermore, reimbursement coverage for newer tests varies significantly across markets, limiting patient access to cutting-edge solutions in some areas.
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Market Segmentation
By Product Type
Imaging continues to dominate the market owing to its role in tumor localization and staging. This includes multiparametric MRI and PSMA-PET, which are essential for visualizing high-risk tumors. Biomarkers, on the other hand, are rapidly gaining popularity, especially with non-invasive urine and blood-based tests that offer high specificity. Biopsy devices remain essential, particularly for confirmatory diagnosis.
The prostate cancer diagnostics market is segmented into imaging, biomarkers, and biopsy devices.
| Product Type | 2024 Market Share (%) | 2034 Market Value (USD Billion) | CAGR (2025–2034) |
| Imaging | 40% | 4.34 | 9.5% |
| Biomarkers | 35% | 3.79 | 10.2% |
| Biopsy Devices | 25% | 2.71 | 10.8% |
By Application
Screening forms the foundation of prostate cancer prevention strategies, accounting for the largest market share. Diagnosis is growing steadily with the adoption of precision-guided biopsy methods. Monitoring applications are increasingly important in active surveillance models and recurrence tracking.
Applications include screening, diagnosis, and monitoring.
| Application | 2024 Market Share (%) | 2034 Market Value (USD Billion) | CAGR (2025–2034) |
| Screening | 45% | 4.88 | 9.8% |
| Diagnosis | 35% | 3.79 | 10.1% |
| Monitoring | 20% | 2.17 | 10.5% |
By End User
Hospitals are the largest end users due to their integrated imaging, pathology, and urology departments. Diagnostic laboratories follow closely, with specialized labs offering advanced biomarker panels and gene sequencing. Research institutes contribute to market development through clinical trials and new test validation.
End users encompass hospitals, diagnostic laboratories, and research institutes.
| End User | 2024 Market Share (%) | 2034 Market Value (USD Billion) | CAGR (2025–2034) |
| Hospitals | 50% | 5.42 | 9.9% |
| Diagnostic Labs | 35% | 3.79 | 10.2% |
| Research Institutes | 15% | 1.63 | 10.4% |
By Technology
Immunohistochemistry techniques remain widely used due to their cost-effectiveness and accessibility. Molecular diagnostics are growing rapidly, especially with NGS and PCR-based tests enabling more accurate diagnosis. Imaging techniques continue to evolve, with AI-assisted MRI and PSMA scans reshaping early detection.
Technologies include immunohistochemistry, molecular diagnostics, and imaging techniques.
| Technology | 2024 Market Share (%) | 2034 Market Value (USD Billion) | CAGR (2025–2034) |
| Immunohistochemistry | 40% | 4.34 | 9.5% |
| Molecular Diagnostics | 35% | 3.79 | 10.2% |
| Imaging Techniques | 25% | 2.71 | 10.8% |
By Distribution Channel
Direct sales dominate the market as most products are sold directly to hospitals and diagnostic centers. Distributors play a key role in reaching secondary markets and mid-sized labs. Online sales are growing quickly, particularly for biomarker kits and reagent supplies, driven by digital procurement platforms.
Distribution channels comprise direct sales, distributors, and online sales.
| Distribution Channel | 2024 Market Share (%) | 2034 Market Value (USD Billion) | CAGR (2025–2034) |
| Direct Sales | 50% | 5.42 | 9.9% |
| Distributors | 30% | 3.25 | 10.3% |
| Online Sales | 20% | 2.17 | 10.5% |
Recent Developments
- EDX Medical Group has developed an AI-driven prostate cancer supertest that measures over 100 biomarkers using blood and urine samples, achieving 96% accuracy. This test is expected to revolutionize early detection and personalized treatment plans .
- Telix Pharmaceuticals received FDA approval for Gozellix, a prostate cancer screening agent designed for PET scanning of PSMA-positive lesions, offering a longer shelf life and enhanced clinical utility .
Key Players
- Abbott Laboratories
- Siemens Healthineers
- Roche Diagnostics
- Hologic, Inc.
- Myriad Genetics, Inc.
- OPKO Health, Inc.
- Genomic Health (Exact Sciences Corporation)
- MDxHealth
- Beckman Coulter, Inc.
- Thermo Fisher Scientific Inc.
Market Outlook In the next decade, the prostate cancer diagnostics market is expected to continue evolving toward non-invasive, high-accuracy, and personalized testing paradigms. AI integration will play a pivotal role in radiology and pathology, helping clinicians interpret results faster and more accurately. The convergence of imaging, molecular diagnostics, and clinical decision support tools is paving the way for comprehensive, data-driven diagnostic ecosystems.
Industry players are likely to invest in integrated diagnostic platforms, point-of-care testing innovations, and strategic collaborations with research institutions. Startups and biotech firms are actively exploring liquid biopsy techniques and next-generation sequencing (NGS) for early detection and risk profiling. At the same time, healthcare systems are adopting risk-based screening models to optimize resources and minimize overtreatment.
With increased emphasis on preventive care and patient-centered medicine, prostate cancer diagnostics are poised to become more accessible, reliable, and cost-effective worldwide. Stakeholders that prioritize innovation, regulatory agility, and affordability are expected to capture significant market share in this rapidly expanding field.
This report is also available in the following languages : Japanese (前立腺がん診断ソリューション市場), Korean (전립선암 진단 솔루션 시장), Chinese (前列腺癌诊断解决方案市场), French (Marché des solutions de diagnostic du cancer de la prostate), German (Markt für Prostatakrebsdiagnostiklösungen), and Italian (Mercato delle soluzioni diagnostiche per il cancro alla prostata), etc.
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