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Prostate Cancer Diagnostics Market Size & Share 2026-2035

Report ID: GMI6107
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Published Date: October 2026
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Prostate Cancer Diagnostics Market Size

The global prostate cancer diagnostics market was valued at USD 5.06 billion in 2025 and is projected to reach USD 5.50 billion in 2026, advancing at a CAGR of 8.7% from 2026 to 2035 to reach USD 11.67 billion by 2035.

Prostate Cancer Diagnostics Market Key Takeaways

2025 Market Size
$ 5.06 Billion
2026 Market Size
$ 5.50 Billion
2035 Forecast Market Size
$ 11.67 Billion
CAGR (2026–2035)
8.7%
Regional Dominance
Largest Market
North America
Fastest Growing Region
Asia Pacific
Key Players

  • Market Leader: Roche Holding AG led with over 14% market share in 2025.

  • Leading Players: Top 5 players in this market include Roche Holding AG, Siemens Healthineers AG, Abbott Laboratories, GE HealthCare, Lantheus Holdings Inc., which collectively held a market share of 47% in 2025.

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The prostate cancer diagnostics market is expanding as a larger pool of men enters screening, surveillance, staging, treatment-selection, and recurrence-monitoring pathways. Demand is shifting toward care models that combine laboratory testing, imaging, pathology, and risk classification rather than relying on a single diagnostic event. More than 3.5 million men in the U.S. with a prior prostate cancer diagnosis remain alive, sustaining demand for serial monitoring and post-treatment assessment across the care continuum [1].

GMI Analyst View

Based on our proprietary demand-side assessment of manufacturer revenues across the historic review period, the prostate cancer diagnostics market expanded at a CAGR of 9.6% from 2022 to 2025 - a pace that exceeded our 2026-2035 forecast growth rate - driven by accelerating adoption of advanced PSA variant assays, PSMA PET/CT radiopharmaceuticals, and reimbursement-fueled genomic testing. This historic momentum establishes a well-primed commercial base that underpins our outlook for the forecast decade.

Prostate Cancer Diagnostics Market Trends, Growth Drivers & GMI Forecast Outlook

Clinical pathways are moving toward a more risk-stratified diagnostic model, where PSA testing increasingly serves as an entry point to imaging, and molecular decision support. Revenue growth depends not only on incidence, but also on reimbursement breadth, specialist capacity, and health systems' ability to deploy advanced modalities beyond academic centers.

Key Drivers

Driver Evidence signal Market-demand implication GMI forecast condition
Sustained and rising prostate cancer incidence generating high-volume clinical demand 333,830 new prostate cancer cases estimated in the U.S. for 2026, the leading cancer diagnosis among American men [1] Persistent high-volume clinical entry into PSA testing, biopsy, and precision diagnostics; elevated incidence in men 65 and older sustains active surveillance and biochemical recurrence monitoring demand Diagnostic procedure volumes maintain a stable growth floor throughout the forecast period; incidence-driven PSA and biopsy demand supports baseline laboratory segment revenue
Growing global cancer burden creating a long-duration diagnostic demand pipeline GLOBOCAN 2024 data recorded 1,546,112 new prostate cancer cases worldwide - the highest annual incidence of any male cancer globally [2] High and rising global burden drives diagnostic scale requirements; geographic distribution of case growth toward Asia, Latin America, and MEA shapes technology adoption mix and infrastructure investment pace Demand pipeline for both conventional and advanced diagnostics is sustained globally; volume distribution favors PSA and CT in lower-income markets pending infrastructure development
PSMA PET/CT regulatory approvals and reimbursement formalization broadening clinical access FDA approved multiple PSMA-targeted PET agents including 68Ga-gozetotide (Gozellix, HCPCS code A9616); CMS granted Transitional Pass-Through reimbursement effective October 1, 2025 [3] PSMA PET/CT addressable patient population expands as Medicare access barriers are reduced; adoption extends into staging and biochemical recurrence monitoring applications across both community and academic settings Continued PSMA PET/CT revenue growth as TPT coverage matures; commercial payer alignment with CMS reimbursement framework is the critical determinant of mid-decade demand acceleration
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Evidence anchors use cited external data; demand implications and forecast conditions represent GMI analysis.

Incidence creates a durable baseline for diagnostic utilization, but the commercial value of each patient pathway is changing. In established health systems, a suspicious PSA result is increasingly followed by multiparametric MRI, targeted biopsy, pathology review, and, for selected patients, genomic classification or PSMA imaging. This sequencing raises diagnostic intensity per patient and gives manufacturers exposure to both routine laboratory volumes and higher-acuity procedures.

PSMA PET/CT is particularly consequential because it extends molecular imaging into staging and biochemical recurrence workflows where conventional imaging can be less informative. The expanding availability of approved agents and transitional reimbursement support improves the operating case for hospital nuclear medicine departments, while payer alignment will determine how quickly use broadens across community settings [3]. The forecast assumes that provider capacity and coverage policies advance in tandem rather than leaving newly eligible patients without local access.

Key Restraints

Restraint Evidence signal Market-demand implication GMI forecast condition
PSA screening false-positive burden driving guideline variability and selective program adoption More than 15% of men undergoing PSA-based screening experienced at least one false-positive test result over 10 years in clinical trial evidence reviewed by the USPSTF [4] Guideline-driven caution suppresses population-wide PSA screening programs; false positives generate downstream biopsy volume but create clinical hesitancy that limits net screening frequency per capita PSA test volume growth is moderated by shared-decision-making frameworks in the U.S. and equivalent guideline bodies in Europe; population-level screening expansion is not the dominant demand driver
High out-of-pocket cost burden for molecular and genomic classifiers constraining real-world adoption U.S. insurance claims data show a median claim payment of USD 3,001 per patient for genomic classifiers in localized prostate cancer [5] Cost-access barriers restrict adoption of Decipher, Prolaris, and GPS mdx outside Medicare and favorable commercial plan populations; physician ordering is influenced by anticipated patient financial exposure Molecular & Genomic Testing segment CAGR is moderated by coverage gaps; meaningful acceleration requires Medicaid expansion and broader commercial payer alignment beyond the current Medicare base
Infrastructure constraints for advanced PSMA PET/CT and mpMRI across lower-income and emerging markets PSMA PET/CT requires cyclotron- or generator-supplied short-half-life radiopharmaceuticals and trained nuclear medicine staff; mpMRI depends on advanced scanner density and radiologist specialization - capabilities concentrated in academic and metropolitan centers Infrastructure gaps restrict diagnostic revenue generation from markets where cancer burden is growing fastest, particularly across rural India, Southeast Asia, and sub-Saharan Africa Emerging-market imaging segment growth is contingent on public health infrastructure investment; PSA testing and CT staging remain primary revenue contributors outside established urban centers absent that investment

Evidence anchors use cited external data; demand implications and forecast conditions represent GMI analysis.

Screening policy remains an enduring constraint because clinical benefits must be balanced against overdiagnosis, unnecessary follow-up, and treatment-related consequences. The USPSTF notes that a meaningful portion of screen-detected cases may represent cancers that would not have become symptomatic, supporting the continued use of shared decision-making rather than uniform population-wide testing programs [4]. This preserves a large clinical role for PSA testing while limiting the likelihood of a screening-led step change in volumes.

Cost and infrastructure barriers compound one another outside well-funded specialist networks. Genomic classifiers can be difficult to integrate where coverage is narrow or patient exposure is material, while PSMA PET/CT and multiparametric MRI require specialized supply chains, equipment, interpretation expertise, and referral coordination. As a result, rising case burden in emerging markets does not automatically translate into rapid adoption of premium diagnostic modalities.

GMI Analyst View

We see the market's central tension as a shift from broad laboratory-led testing toward a more selective, multimodal precision pathway. Advanced imaging and molecular diagnostics have stronger revenue leverage per encounter, but their uptake remains governed by reimbursement discipline, specialist availability, and practical patient access rather than clinical promise alone.

Prostate Cancer Diagnostics Market Segment Analysis

By Test Type

Laboratory & Biomarker Tests

Laboratory & biomarker tests accounted for a 65.0% revenue share of the prostate cancer diagnostics market in 2025 and are projected to generate USD 6.42 billion by 2035. Their scale reflects the enduring role of PSA-based assessment, pathology consumables, and biomarker-led risk stratification throughout screening, surveillance, recurrence detection, and treatment planning. The category remains commercially resilient because it is embedded across virtually every care setting, even as higher-acuity imaging takes a larger role in complex decision pathways.

Global Prostate Cancer Diagnostics Market Size, by Test Type, 2025 & 2035 (USD Million)

To get key market trends
PSA Testing

PSA testing generated USD 2.02 billion in 2025 and is projected to retain a 35.0% global revenue share by 2035. Its clinical importance rests on repeat use in active surveillance, biochemical recurrence monitoring, and treatment-response assessment. Demand is becoming more clinically selective, but the transition toward PSA variants and multi-marker panels supports value expansion in patients requiring more precise risk discrimination.

Prostate Biopsy

Prostate biopsy held a 10.0% revenue share in 2025 and is projected to generate USD 934 million by 2035. MRI-guided cognitive-fusion and in-bore approaches are changing the procedural mix toward higher-value kits, needles, and workflow tools. Biopsy remains a necessary bridge between abnormal screening or imaging findings and pathological confirmation, preserving demand even as diagnostic algorithms become more discriminating upstream.

Molecular & Genomic Testing

Molecular & genomic testing generated USD 607 million in 2025 and is advancing at a CAGR of 6.8% from 2026 to 2035. Tissue classifiers, urine biomarkers, and emerging liquid-biopsy approaches can refine decisions between active surveillance and intervention, but commercial adoption remains uneven across payer types and care settings. MDxHealth's acquisition of Exosome Diagnostics consolidates SelectMDx and ExoDx Prostate capabilities within a more focused precision-urology platform, strengthening the commercial proposition for community-urology workflows [6].

Imaging Tests

Imaging tests are projected to account for a 45.0% revenue share by 2035 and are advancing at a CAGR of 12.8% from 2026 to 2035. Their faster growth reflects the greater clinical use of multiparametric MRI in biopsy planning and the expanding role of PSMA PET/CT in staging and recurrence evaluation. Imaging demand is increasingly shaped by the availability of radiopharmaceutical supply, scanner access, trained interpreters, and reimbursement rather than by incidence alone.

Multiparametric MRI

Multiparametric MRI generated USD 759 million in 2025 and is projected to account for a 17.0% revenue share by 2035. Its role in lesion localization, biopsy targeting, local staging, and surveillance makes it a central component of contemporary prostate care pathways. AI-enabled segmentation and lesion-assessment tools also broaden the revenue opportunity beyond scanner utilization by improving reading consistency and workflow efficiency.

PSMA PET/CT

PSMA PET/CT is projected to generate USD 2.10 billion by 2035 and is advancing at a CAGR of 13.2% from 2026 to 2035. This growth reflects its expanding relevance in identifying metastatic disease and biochemical recurrence, supported by a growing portfolio of radiopharmaceutical options. Commercial execution will depend on whether radiopharmacy networks, hospital nuclear medicine operations, and payer coverage can expand together.

CT Scan

CT scan diagnostics held a 5.0% revenue share in 2025 and are projected to generate USD 700 million by 2035. CT retains a practical role in distant-metastasis staging, lymph-node assessment, and treatment monitoring, particularly where more advanced molecular imaging is unavailable. Its accessibility supports continued use in resource-constrained systems even as sensitivity-driven substitution accelerates in higher-income markets.

By Cancer Type

Prostatic Adenocarcinoma

Prostatic adenocarcinoma accounted for a 90.0% revenue share in 2025 and is projected to generate USD 10.50 billion by 2035. This concentration reflects the alignment of PSA assays, PSMA-targeted imaging, genomic classifiers, and established pathology workflows with the dominant histological form of prostate cancer. Multi-year active-surveillance protocols create recurring diagnostic demand as patients move through serial testing and reassessment.

Small Cell Carcinoma

Small cell carcinoma held a 5.0% revenue share in 2025 and is projected to generate USD 584 million by 2035. Its diagnostic pathway differs from mainstream adenocarcinoma because PSMA expression may be limited, increasing the relevance of pathology, neuroendocrine-marker staining, conventional imaging, and specialized staging approaches. The segment remains clinically distinct despite its smaller commercial footprint.

By End Use

Hospitals & Health Systems

Hospitals & health systems held a 45.0% global revenue share in 2025 and are projected to generate USD 4.90 billion by 2035. Their leadership is tied to concentration of advanced imaging, MRI-guided biopsy, multidisciplinary tumor boards, and institutional molecular-testing programs. Integrated systems can coordinate referrals and procurement across laboratory, radiology, pathology, and oncology services, making them an important channel for high-acuity diagnostic adoption.

Global Prostate Cancer Diagnostics Market Share, by End Use, 2025

Urology Clinics

Urology clinics held a 20.0% global revenue share in 2025 and are projected to generate USD 2.10 billion by 2035. These settings remain the principal point of interpretation for PSA results, surveillance decisions, biopsy referrals, and follow-up management. Their importance rises as office-based workflows connect patients to external molecular laboratories and imaging providers without requiring every diagnostic capability to be housed on site.

Diagnostic Imaging Centers

Diagnostic imaging centers generated USD 759 million in 2025 and are advancing at a CAGR of 10.7% from 2026 to 2035. Their growth reflects decentralization of multiparametric MRI and, increasingly, molecular imaging capacity from tertiary centers into community radiology networks. Greater local availability can reduce travel and scheduling barriers, although access to nuclear medicine infrastructure remains uneven.

Oncology & Pathology Laboratories

Oncology & pathology laboratories are projected to account for a 13.0% global revenue share by 2035 and are advancing at a CAGR of 9.6% from 2026 to 2035. These laboratories are positioned to capture more value as genomic classifier ordering, digital pathology, biomarker processing, and companion-diagnostic workflows become more commercially integrated. Their growth depends on the ability to demonstrate actionable clinical value to ordering physicians and payers.

Cancer Research & Academic Institutes

Cancer research & academic institutes held a 5.0% revenue share in 2025 and are projected to generate USD 584 million by 2035. These organizations function as early-adoption settings for investigational tracers, liquid-biopsy platforms, and AI-enabled pathology tools before broader clinical adoption. Their influence extends beyond direct purchasing because evidence development and specialist practice patterns often originate in academic networks.

Other End Use

Other end-use settings are advancing at a CAGR of 11.9% from 2026 to 2035 and are projected to generate USD 469 million by 2035. Primary care, decentralized laboratory services, and telehealth-enabled referral models can extend access to initial testing and follow-up interpretation. Their expansion is most relevant where specialist capacity is constrained but laboratory logistics and digital care coordination are improving.

GMI Analyst View

We interpret segment performance as a reallocation of diagnostic value rather than a simple rise in procedure counts. Imaging is increasing the economic intensity of complex encounters, while molecular testing remains an access-sensitive opportunity whose adoption could change materially if evidence, payment policy, and community-urology workflows become more closely aligned.

Prostate Cancer Diagnostics Market Regional Analysis

Global Prostate Cancer Diagnostics Market Share, by Region, 2025 & 2035

Learn more about the key segments shaping this market

North America Prostate Cancer Diagnostics Market Analysis

The prostate cancer diagnostics market in North America held a 47.0% global revenue share in 2025 and is projected to generate USD 4.70 billion by 2035. The region combines established screening and surveillance practices with dense academic-urology, laboratory, and nuclear-medicine infrastructure. Broad reimbursement capabilities support earlier uptake of advanced diagnostics, although expansion is increasingly determined by access beyond large tertiary systems.

U.S.

The U.S. accounted for a 39.9% global revenue share in 2025 and is projected to generate USD 4.00 billion by 2035. Its scale rests on a deep installed base of PSA testing, specialty laboratory services, imaging capacity, and reimbursement pathways for advanced diagnostics. Continued growth is expected to center on broader integration of PSMA PET/CT, surveillance programs, and more targeted molecular testing.

Canada

Canada generated USD 357 million in 2025 and is projected to generate USD 700 million by 2035. Provincial health-system pathways support PSA testing and MRI-guided biopsy adoption, while advanced imaging capacity is developing through major academic oncology centers. Regional variation in reimbursement and access will continue to shape how quickly sophisticated modalities move beyond concentrated specialist hubs.

Europe Prostate Cancer Diagnostics Market Analysis

The prostate cancer diagnostics market in Europe generated USD 1.32 billion in 2025 and is advancing at a CAGR of 7.5% from 2026 to 2035. Mature healthcare infrastructure and established PSA uptake provide a stable diagnostic base, while mpMRI-first biopsy practices and PSMA PET/CT access drive incremental value growth. Centralized health technology assessment processes can lengthen the commercial pathway for newer modalities relative to more fragmented reimbursement environments.

Germany

Germany generated USD 342 million in 2025 and is projected to generate USD 701 million by 2035. Strong university-hospital networks, high biomarker familiarity, and early nuclear-medicine experience position the country as a key European market for advanced prostate diagnostic workflows. Its clinical infrastructure supports sustained uptake of PSMA imaging alongside established laboratory testing.

U.K.

The U.K. generated USD 289 million in 2025 and is projected to generate USD 593 million by 2035. The continued integration of mpMRI before biopsy supports imaging demand, while digital pathology investment can improve capacity for more consistent histopathology workflows. Adoption will remain influenced by NHS commissioning priorities and service-delivery capacity.

France

France held a 4.7% global revenue share in 2025 and is projected to generate USD 475 million by 2035. Its relatively proactive PSA-use culture and hospital-based nuclear-medicine capabilities support demand for both routine testing and advanced staging. Reimbursement formalization for radiopharmaceuticals will shape how broadly PSMA PET/CT becomes available outside leading centers.

Italy

Italy held a 3.4% global revenue share in 2025 and is projected to generate USD 342 million by 2035. Major academic hospitals are driving genomic risk-stratification and MRI-guided biopsy adoption, while uneven healthcare capacity between regions constrains national consistency. The market's trajectory depends on translating specialist-center practices into broader regional access.

Spain

Spain generated USD 132 million in 2025 and is projected to generate USD 264 million by 2035. Increasing PSMA PET/CT activity in oncology hospitals and investment in MRI-guided biopsy capacity are broadening the diagnostic mix. Public and private system differences will continue to influence the pace at which biomarker testing reaches routine use.

Netherlands

The Netherlands generated USD 66 million in 2025 and is projected to generate USD 132 million by 2035. Strong healthcare spending, established PSA uptake, and early alignment with mpMRI-guided biopsy pathways support adoption of advanced diagnostics relative to the country's market size. Its experience illustrates how coordinated clinical protocols can support technology uptake without relying solely on volume growth.

Asia Pacific Prostate Cancer Diagnostics Market Analysis

The prostate cancer diagnostics market in Asia Pacific is advancing at a CAGR of 13.0% from 2026 to 2035 and is projected to account for a 26.5% global revenue share by 2035. Aging populations, improving diagnostic awareness, and investments in oncology infrastructure are widening the addressable patient pool. The pace of revenue conversion will vary sharply between metropolitan centers able to deploy advanced imaging and broader markets where PSA testing and conventional staging remain the predominant options.

China

China is projected to generate USD 1.20 billion by 2035 and is advancing at a CAGR of 14.2% from 2026 to 2035. Urban cancer centers, rising screening awareness, and investment in precision-oncology infrastructure are expanding access to advanced diagnostics. However, adoption remains uneven between leading cities and lower-tier markets, making domestic supply development and referral connectivity important determinants of growth.

Japan

Japan generated USD 200 million in 2025 and is projected to generate USD 565 million by 2035. Its aging population and mature university-hospital network provide a durable basis for testing and surveillance demand. Regulatory progress and institutional readiness will govern the pace at which PSMA PET/CT becomes more widely embedded in clinical pathways.

India

India is advancing at a CAGR of 14.3% from 2026 to 2035 and is projected to generate USD 620 million by 2035. Private diagnostic chains, rising health awareness, and expanding cancer-detection initiatives are increasing access to initial testing. Advanced imaging and genomic diagnostics remain concentrated in metropolitan private systems, leaving infrastructure investment and specimen-referral networks central to wider adoption.

South Korea

South Korea held a 1.8% global revenue share in 2025 and is advancing at a CAGR of 11.9% from 2026 to 2035. Universal coverage and a sophisticated specialist-hospital base provide a strong foundation for diagnostic volume growth. The transition toward more advanced imaging will depend on regulatory approvals and national reimbursement decisions.

Australia

Australia generated USD 63 million in 2025 and is projected to generate USD 175 million by 2035. Established PSA testing and expanding access to specialized cancer centers support a well-developed diagnostic pathway. The country's high prostate cancer burden and clinical infrastructure make it a relevant market for further PSMA PET/CT integration.

Latin America Prostate Cancer Diagnostics Market Analysis

The prostate cancer diagnostics market in Latin America generated USD 253 million in 2025 and is advancing at a CAGR of 9.4% from 2026 to 2035. Growth is led by rising clinical demand and private-sector investment, but access to multiparametric MRI, PSMA PET/CT, and genomic classifiers remains concentrated in major metropolitan markets. Standard laboratory testing and histopathology therefore remain the principal commercial channels across much of the region.

Brazil

Brazil generated USD 114 million in 2025 and is advancing at a CAGR of 9.7% from 2026 to 2035. Its large private health-insurance market supports demand for PSA testing, biopsy, and selective premium diagnostics, while public-sector pathways remain more concentrated in conventional testing. Investment in advanced imaging is centered in leading private oncology networks.

Mexico

Mexico held a 1.4% global revenue share in 2025 and is projected to generate USD 173 million by 2035. Private oncology capacity in major cities is expanding the availability of advanced diagnostics, while public-sector access remains more heavily weighted toward PSA testing and standard pathology. Awareness initiatives may expand the diagnostic funnel, but affordability will remain a constraint on technology mix.

Argentina

Argentina held a 0.6% global revenue share in 2025 and is projected to generate USD 74 million by 2035. Economic constraints restrict broad adoption of premium modalities in the public system, leaving private oncology facilities as the primary access point for biomarker testing and MRI-guided procedures. The market will remain sensitive to equipment availability and imported diagnostic supply.

Middle East & Africa Prostate Cancer Diagnostics Market Analysis

The prostate cancer diagnostics market in Middle East & Africa held a 4.0% global revenue share in 2025 and is projected to generate USD 555 million by 2035. The region includes highly funded Gulf healthcare markets alongside systems where diagnostic infrastructure remains limited. This divide shapes the product mix, with advanced imaging concentrated in select centers and PSA testing and histopathology accounting for most routine demand elsewhere.

Saudi Arabia

Saudi Arabia generated USD 61 million in 2025 and is advancing at a CAGR of 11.0% from 2026 to 2035. Healthcare-expansion initiatives and investment in oncology-center capacity are strengthening the foundation for cancer screening, staging, and monitoring. Advanced diagnostics are likely to grow first through major hospital networks before becoming more broadly distributed.

UAE

The UAE held a 0.9% global revenue share in 2025 and is projected to generate USD 125 million by 2035. Internationally accredited oncology hospitals and high-income patient populations support demand for multiparametric MRI, PSMA PET/CT, and genomic classifiers. Medical-tourism ambitions further reinforce investment in diagnostic technology and specialist service capability.

South Africa

South Africa held a 0.7% global revenue share in 2025 and is advancing at a CAGR of 10.1% from 2026 to 2035. Public-health attention to prostate cancer is increasing, but advanced diagnostics remain concentrated in private hospital groups and major urban areas. Broader growth will depend on improving earlier detection and extending diagnostic capacity beyond specialist centers.

GMI Analyst View

We expect geographic growth to be shaped less by the incidence curve than by the speed at which countries translate clinical need into reimbursed diagnostic capacity. North America remains the revenue anchor, while Asia Pacific carries the clearest structural upside as healthcare investment, specialist training, and access to advanced imaging broaden.

Prostate Cancer Diagnostics Market Share & Competitive Landscape

The prostate cancer diagnostics market share structure is moderately concentrated, with Roche Holding AG, Siemens Healthineers AG, Abbott Laboratories, GE HealthCare, and Lantheus Holdings Inc. collectively holding approximately 47% of global revenue in 2025. Competitive advantage differs by modality: large in vitro diagnostics suppliers benefit from installed analyzer bases and reagent relationships, while imaging and radiopharmaceutical participants compete on equipment access, distribution reach, regulatory execution, and reimbursement positioning.

Roche Holding AG

Roche Holding AG held a 14% revenue share in 2025. Its position is supported by Elecsys and cobas PSA assay platforms and by entrenched laboratory relationships across hospital networks. The ability to support total PSA, free PSA, and related risk-stratification workflows creates meaningful switching costs in high-throughput laboratory accounts.

Siemens Healthineers AG

Siemens Healthineers AG held an 11% revenue share in 2025. Its portfolio spans PSA immunoassays, MRI systems, and nuclear-medicine imaging infrastructure, creating an advantage in health systems seeking to consolidate diagnostic procurement. This multimodality presence supports commercial relevance as prostate care moves toward more coordinated laboratory and imaging pathways.

Abbott Laboratories

Abbott Laboratories held a 9% revenue share in 2025. Its ARCHITECT and Alinity platforms provide broad immunoassay reach across central laboratories, including markets where accessible installed infrastructure is especially important. Cross-portfolio relationships can reinforce its position as customers evaluate routine assay continuity alongside more specialized diagnostic needs.

GE HealthCare

GE HealthCare participates primarily through MRI and PET/CT systems used in multiparametric MRI, staging, and recurrence workflows. Its radiology and nuclear-medicine installed base positions the company to benefit as imaging-based prostate diagnostics expand, particularly where institutions are upgrading workflow capability rather than building wholly new service lines.

Lantheus Holdings Inc.

Lantheus Holdings Inc. is a significant participant in PSMA PET/CT through PYLARIFY and its radiopharmacy distribution capabilities. Its commercial position reflects the importance of reliable tracer supply and established relationships with nuclear-medicine departments. As multi-agent competition intensifies, distribution execution, site activation, and reimbursement support will remain important differentiators.

Recent Industry Developments

MDxHealth SA closed its acquisition of Exosome Diagnostics, Inc. from Bio-Techne Corporation on September 15, 2025, adding the ExoDx Prostate urine biomarker test, a CLIA-certified laboratory, and related assets to its portfolio [6]. The transaction brings SelectMDx and ExoDx Prostate under one commercial organization, strengthening the company's position in pre-biopsy risk assessment and active-surveillance workflows.

Telix Pharmaceuticals received U.S. FDA approval for Gozellix in March 2025, followed by CMS Transitional Pass-Through payment status effective October 1, 2025 [3]. The regulatory and reimbursement sequence supports access to PSMA PET imaging in hospital outpatient settings and strengthens the commercial case for generator- and cyclotron-compatible tracer distribution.

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Authors:  Monali Tayade, Sampada Kulkarni

Frequently Asked Questions (FAQs):

The prostate cancer diagnostics market size was estimated at USD 5.06 billion in 2025 and is expected to reach USD 5.50 billion in 2026.
The market is projected to reach USD 11.67 billion by 2035, growing at a CAGR of 8.7% from 2026 to 2035.
North America currently holds the largest share of the prostate cancer diagnostics market in 2025.
Asia Pacific is projected to be the fastest-growing region during the forecast period.
Some of the major players in prostate cancer diagnostics market include Roche Holding AG, Siemens Healthineers AG, Abbott Laboratories, GE HealthCare, Lantheus Holdings Inc..

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Authors:  Monali Tayade, Sampada Kulkarni
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