전립선암 진단 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the prostate cancer diagnostics market size was valued at USD 8.78 billion in 2025 and is estimated to grow from USD 9.42 billion in 2026 to reach USD 13.86 billion by 2031, at a CAGR of 8.03% during the forecast period (2026-2031).

This report is Segmented by Diagnostic Technology (PSA/Biomarker Testing, MRI/MpMRI, Biopsy, Molecular/Genomic Testing, PSMA PET/CT), Sample Type (Blood, Tissue, Urine, Saliva), Cancer Type, Stage, End User (Hospital Urology, Oncology Labs, Imaging Centers, Urology Clinics, Research), and Geography (North America, Europe, Asia-Pacific, MEA, South America). The Market Forecasts are Provided in Value (USD).

Global Prostate Cancer Diagnostics Market Trends and Insights

Rising Prostate Cancer Screening Volume

The prostate cancer diagnostics market is gaining from a broader rise in organized and semi-organized screening activity across several countries. Prostate cancer is now the most commonly diagnosed cancer in men in 118 of 185 countries, which supports the need for more routine testing pathways in both mature and under-screened health systems. Japan's 2025 clinical practice guidelines introduced the first weak recommendation in favor of PSA screening for middle-aged men, which marked a clear shift from the long period of uncertain official guidance. In the United States, the prostate cancer death rate fell by 50% between 1993 and 2022, which keeps the case for earlier detection central to screening decisions. Lombardy's multilevel screening pilot enrolled 8,558 men by June 2025 and recorded a 15.9% referral rate without evidence of overdiagnosis, which gives the prostate cancer diagnostics market a practical model for urban screening scale-up. Higher screening volume supports repeat demand for PSA reagents, follow-on biomarker work, imaging, and biopsy across the wider prostate cancer diagnostics market.

Expanding Reimbursement for Advanced Biomarker and Imaging Tests

The prostate cancer diagnostics market is also being lifted by coverage decisions that reduce ordering uncertainty for clinicians and laboratories. CMS updated its Local Coverage Determination for the Decipher Prostate Cancer Classifier Assay, effective July 3, 2025, and that decision covered use in localized prostate cancer patients with at least 10 years of life expectancy under NCCN-aligned criteria. Once a molecular test gains reimbursement, it becomes easier for similar tools to frame their own value in terms that payers already recognize. The same pattern matters for advanced imaging, because reimbursement changes shape referral behavior, budget planning, and vendor investment decisions across the prostate cancer diagnostics market. The direct effect is stronger in systems where coverage policy quickly translates into everyday clinical pathways, especially in the United States and other reimbursement-led markets. Over time, this creates a more stable commercial floor for the prostate cancer diagnostics market than clinical enthusiasm alone could provide.

High Out-of-Pocket Cost for Advanced Diagnostics

The prostate cancer diagnostics market still faces a clear affordability barrier in advanced testing categories. ASCO's 2025 guideline noted that ctDNA liquid biopsy tests are priced at USD 1,000 to USD 3,000 per test, and genomic classifiers often fall into a similar range. Those price levels can suppress both physician ordering and patient uptake outside strong reimbursement frameworks. Access differences are not only financial, because a 2025 Medicare claims study in Cancer Imaging found materially lower PSMA PET use among rural patients and the sharpest gap among Black patients in rural settings. This means advanced testing volume remains concentrated in insured, urban, and academically linked populations. That concentration limits how fully the prostate cancer diagnostics market can reflect the true epidemiological burden of disease across broader populations.

Other drivers and restraints analyzed in the detailed report include:

1. Liquid Biopsy and Genomic Testing Uptake
2. Variable Clinical Utility and PSA Overdiagnosis Concerns

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

PSA and biomarker testing held 46.31% of the prostate cancer diagnostics market share in 2025, while PSMA PET and CT imaging is projected to grow at an 8.68% CAGR through 2031. PSA-based testing remains the broad volume base of the prostate cancer diagnostics market because it is scalable, low-cost, and widely embedded in primary care and referral pathways. PSMA PET has moved into a different position because its role is now tied more closely to staging quality and downstream treatment selection. Journal of Nuclear Medicine data showed that PSMA PET use among high-risk and very-high-risk patients in the VA system had risen to 70% by mid-2023 after guideline support strengthened. MRI and mpMRI continue to gain value as pre-biopsy triage tools, especially in health systems that want to reduce unnecessary biopsy volume while preserving detection of clinically significant disease.

Biopsy and histopathology still remain central to definitive diagnosis, grading, and subtype assessment across the prostate cancer diagnostics market. The more important change is that imaging now has stronger clinical authority before biopsy and around therapy decisions, rather than only after pathology. PSMA PET carries added relevance because it links diagnosis with theranostic pathways, which raises its importance beyond a single imaging event. This makes the prostate cancer diagnostics industry more dependent on vendors that can align clinical evidence, tracer supply, reimbursement, and physician education at the same time. At the same time, PSA and related biomarker tests are likely to remain the largest technology category because no other platform matches their population-level reach and repeat-testing frequency.

Blood-based samples represented 46.68% of the prostate cancer diagnostics market size in 2025, while tissue is the fastest-growing sample type with a 10.12% CAGR through 2031. Blood remains dominant because PSA testing still drives the highest routine volume in the prostate cancer diagnostics market, and ctDNA has widened the role of blood in advanced disease management. Tissue is growing faster because treatment selection increasingly depends on immunohistochemistry and genomic profiling that cannot always be replaced by liquid biopsy. This shifts tissue from a traditional confirmation role toward a recurring precision-oncology role in selected patients. Urine-based diagnostics are also drawing interest at the decentralized end of the pathway because they can fit low-friction collection models and may help refine pre-biopsy risk selection.

The sample mix now reflects a more layered clinical pathway inside the prostate cancer diagnostics market rather than a single dominant specimen logic. Blood remains the main entry point for screening and routine monitoring. Tissue becomes more important when physicians need deeper characterization for therapy planning or for higher-confidence disease classification. Urine fits best where providers want a noninvasive step between PSA signal and invasive workup, while saliva and other biospecimens remain early-stage options with limited routine use. This mix favors companies that can operate across more than one sample type and support both broad-volume testing and high-specificity downstream decisions in the prostate cancer diagnostics industry.

Complete Report Scope:

• By Diagnostic Technology
  • PSA and Biomarker Testing
  • MRI and mpMRI Imaging
  • Biopsy and Histopathology
  • Molecular and Genomic Testing
  • PSMA PET and CT Imaging
• By Sample Type
  • Blood
  • Tissue
  • Urine
  • Saliva and Other Biospecimens
• By Cancer Type
  • Prostatic Adenocarcinoma
  • Small Cell Carcinoma
  • Interstitial Cell Carcinoma
  • Other Prostate Cancer Types
• By Stage
  • Localized Prostate Cancer
  • Recurrent and Advanced Prostate Cancer
  • Castration-Resistant Prostate Cancer
• By End User
  • Hospital Urology Departments
  • Oncology Reference Laboratories
  • Diagnostic Imaging Centers
  • Urology Clinics
  • Research and Academic Institutes
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America accounted for 43.64% of the prostate cancer diagnostics market share in 2025, which made it the leading regional contributor by value. The region benefits from high PSA testing penetration, strong specialist infrastructure, and a reimbursement environment that is gradually expanding support for genomic classifiers and advanced imaging. The United States alone is expected to record 333,830 new prostate cancer cases in 2026, which sustains a very large testing base across screening, staging, and follow-up. CMS coverage for selected genomic tools and strong uptake of PSMA PET in higher-risk patients strengthen North America's leadership in the prostate cancer diagnostics market. Canada benefits from coordinated provincial cancer programs but still shows less advanced imaging depth outside major academic centers, while Mexico remains more PSA-centric with advanced imaging concentrated in private networks.

Europe remains clinically sophisticated, but the prostate cancer diagnostics market is more uneven there because screening policy, reimbursement depth, and implementation speed vary widely by country. Germany's high-risk staging pathways and the wider EU regulatory environment favor established vendors with validated assay portfolios. The United Kingdom's MRI-first approach before prostate biopsy has become a recognized model for limiting unnecessary procedures while preserving diagnostic quality. Sweden is also building evidence through region-based organized prostate cancer testing programs with standardized risk-stratified protocols. France, Spain, and Italy are expanding structured PSA access, and Lombardy's pilot results show that large urban screening models can scale without obvious overdiagnosis in early implementation.

Asia-Pacific is the fastest-growing region, and the prostate cancer diagnostics market size there is projected to rise at a 9.96% CAGR through 2031 as screening and diagnostic infrastructure catch up with disease burden. More than 60% of prostate cancer patients in China are diagnosed at advanced stages, while the United States diagnoses around 70% at localized or regional stages, which highlights the scale of under-screening and under-staging in the region. Japan's 2025 guideline shift toward individual PSA screening and Chinese evidence supporting the Prostate Health Index both support stronger test adoption in the region. India, South Korea, and Australia add further growth potential, while the Middle East and Africa and South America continue to expand from smaller bases with uptake led by private networks, targeted partnerships, and selective investment in advanced imaging and molecular testing.

1. Abbott Laboratories
2. Agilent Technologies
3. Beckton Dickinson
4. bioMerieux
5. Danaher
6. DiaSorin
7. Exact Sciences
8. Roche
9. GE HealthCare Technologies Inc.
10. Hologic
11. Illumina
12. LabCorp
13. Lantheus Holdings, Inc.
14. MDxHealth SA
15. Myriad Genetics
16. Opko Health
17. Proteomedix AG
18. QIAGEN
19. Quest Diagnostics
20. Siemens Healthineers
21. Thermo Fisher Scientific
22. Veracyte, Inc.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Prostate Cancer Screening Volume
  • 4.2.2 Shift Toward Multimodal Diagnostic Pathways
  • 4.2.3 Expanding Reimbursement for Advanced Biomarker and Imaging Tests
  • 4.2.4 Decentralization of Testing to Outpatient and Ambulatory Settings
  • 4.2.5 AI-Enabled Imaging and Risk Stratification Adoption
  • 4.2.6 Liquid Biopsy and Genomic Testing Uptake
• 4.3 Market Restraints
  • 4.3.1 High Out-of-Pocket Cost for Advanced Diagnostics
  • 4.3.2 Variable Clinical Utility and PSA Overdiagnosis Concerns
  • 4.3.3 Limited Access to Advanced Diagnostics in Price-Sensitive Markets
  • 4.3.4 Workflow and Integration Complexity Across Legacy Care Settings
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Diagnostic Technology
  • 5.1.1 PSA and Biomarker Testing
  • 5.1.2 MRI and mpMRI Imaging
  • 5.1.3 Biopsy and Histopathology
  • 5.1.4 Molecular and Genomic Testing
  • 5.1.5 PSMA PET and CT Imaging
• 5.2 By Sample Type
  • 5.2.1 Blood
  • 5.2.2 Tissue
  • 5.2.3 Urine
  • 5.2.4 Saliva and Other Biospecimens
• 5.3 By Cancer Type
  • 5.3.1 Prostatic Adenocarcinoma
  • 5.3.2 Small Cell Carcinoma
  • 5.3.3 Interstitial Cell Carcinoma
  • 5.3.4 Other Prostate Cancer Types
• 5.4 By Stage
  • 5.4.1 Localized Prostate Cancer
  • 5.4.2 Recurrent and Advanced Prostate Cancer
  • 5.4.3 Castration-Resistant Prostate Cancer
• 5.5 By End User
  • 5.5.1 Hospital Urology Departments
  • 5.5.2 Oncology Reference Laboratories
  • 5.5.3 Diagnostic Imaging Centers
  • 5.5.4 Urology Clinics
  • 5.5.5 Research and Academic Institutes
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Agilent Technologies, Inc.
  • 6.3.3 Becton, Dickinson and Company
  • 6.3.4 bioMerieux SA
  • 6.3.5 Danaher Corporation
  • 6.3.6 DiaSorin S.p.A.
  • 6.3.7 Exact Sciences Corporation
  • 6.3.8 F. Hoffmann-La Roche AG
  • 6.3.9 GE HealthCare Technologies Inc.
  • 6.3.10 Hologic, Inc.
  • 6.3.11 Illumina, Inc.
  • 6.3.12 Laboratory Corporation of America Holdings
  • 6.3.13 Lantheus Holdings, Inc.
  • 6.3.14 MDxHealth SA
  • 6.3.15 Myriad Genetics, Inc.
  • 6.3.16 OPKO Health, Inc.
  • 6.3.17 Proteomedix AG
  • 6.3.18 QIAGEN N.V.
  • 6.3.19 Quest Diagnostics Incorporated
  • 6.3.20 Siemens Healthineers AG
  • 6.3.21 Thermo Fisher Scientific Inc.
  • 6.3.22 Veracyte, Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment