The prostate-specific antigen testing industry is valued at USD 7.9 billion in 2025. As per FMI's analysis, the industry will grow at a CAGR of 12.0% and reach USD 24.6 billion by 2035.
FMI analysis concluded that the industry of PSA testing experienced steady development in 2024 as a result of the accelerating adoption of newer diagnostic equipment and the growing application of screening across the globe.
North America led adoption, with doctors incorporating AI-driven PSA interpretation solutions for improved risk assessment. European regulatory authorities authorized new ultra-sensitive assays in sync, additionally accelerating test accuracy as well as the rate of early detection.
FMI believes 2025 will mark a turning point as healthcare policies increasingly prioritize early prostate cancer detection. Strategic partnerships among biotech companies and diagnostic labs will improve accessibility, especially in developing economies. More investments in point-of-care PSA testing will fuel demand, diminishing the dependency on centralized laboratory diagnostics.
Post-2025, developments in biomarker science are expected to narrow test specificity and reduce false negatives and positives. Increased reimbursement coverage in major industries, including the United States and Germany, will also facilitate high-scale adoption. Asia-Pacific will, however, experience strong growth due to increasing awareness and upgraded healthcare infrastructure.
Industry Forecast Table
| Metric | Value |
|---|---|
| Industry Size (2025E) | USD 7.9 billion |
| Industry Value (2035F) | USD 24.6 billion |
| CAGR (2025 to 2035) | 12.0% |
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The prostate-specific antigen (PSA) testing industry is poised for long-term growth, fueled by advances in diagnostic technology and greater focus on early detection of prostate cancer. FMI research found that doctors, testing labs, and biotech companies making accurate tests will benefit from the growing demand, while traditional lab tests might be challenged by fast, on-site testing developments.
FMI believes that as insurers and governments broaden screening coverage, access will increase, setting the stage for long-term steady growth in the industry.
Invest in AI-Driven Diagnostic Upgrades
Executive management must lead the incorporation of artificial intelligence within PSA testing to drive greater accuracy, eliminate false positives, and grow early detection rates. Collaboration with AI-specialty biotech companies will be integral to preserving competitiveness.
Increase Industry Access Through Policy and Price Realignment
Aligning with changing healthcare policies and broadening reimbursement coverage will be essential to penetration in the industry. Firms must collaborate with regulatory bodies and insurers to increase access and lower the cost of PSA testing.
Enhance distribution and strategic partnerships
FMI believes that partnership with hospitals, laboratory testing facilities, and telehealth providers will fuel growth in the industry. Spending on international distribution channels and point-of-care testing platforms will promote long-term industry leadership.
| Risk | Probability & Impact |
|---|---|
| Regulatory Delays in New Test Approvals | High Probability - High Impact |
| Competition from Emerging Non-PSA Biomarkers | Medium Probability - High Impact |
| Reimbursement Policy Uncertainty | High Probability - Medium Impact |
| Priority | Immediate Action |
|---|---|
| AI Integration in PSA Testing | Partner with AI-focused biotech firms to enhance diagnostic accuracy |
| Reimbursement Expansion | Engage with insurers and policymakers to secure broader test coverage |
| Point-of-Care Testing Growth | Develop and launch rapid PSA test kits for decentralized diagnostics |
To stay ahead, executives must accelerate investment in AI-powered PSA diagnostics and point-of-care testing to capitalize on shifting healthcare trends. FMI's analysis shows that changes in regulations and more funding options create a chance to increase use, but competition from other biomarkers could challenge long-term success.
FMI opines that aligning R&D with emerging precision medicine initiatives and forging strategic partnerships with insurers and healthcare providers will be critical to sustaining industry leadership.
Over the next 12 months, the roadmap should prioritize securing regulatory approvals for next-gen tests, expanding distribution in high-growth regions, and leveraging AI to enhance diagnostic accuracy, ensuring a competitive edge in the evolving PSA testing landscape.
Regional Variance
High Variance
Material Preferences
Regional Differences
Shared Challenges
89% reported higher operating costs with PSA testing from reagent price increases.
Regional Differences
Manufacturers
Hospitals & Labs
Worldwide Synergy
75% of PSA test manufacturers are investing in AI and multi-marker development.
Divergence
Keystone Variances
Strategic Insights
Leaders in this industry would be those that can localize PSA test pricing by region, embed technology, and maneuver through regulation.
| Countries | Regulatory Impact & Mandatory Certifications |
|---|---|
| United States | The FDA controls PSA tests using the Clinical Laboratory Improvement Amendments (CLIA) and a strict approval process for new tests, which makes it harder for them to enter the industry. Overall, CMS sets reimbursement policies that dictate whether tests can be afforded. |
| United Kingdom | In UKCA marking, PSA testing is regulated under MHRA; NICE sets the guidelines for screening, but no national screening program is currently present, restraining mass adoption. |
| France | PSA tests are governed by ANSM and European IVDR regulations, and national health insurance reimburses PSA screening only in selected conditions, generating access barriers. |
| Germany | As part of In-Vitro Diagnostic Regulation (IVDR), PSA testing is reimbursable only if certain medical conditions are reached, which limits the applicability of routine screenings. |
| Italy | The approval of PSA tests is also subject to the oversight of AIFA, while the differing reimbursement policies for the same test, based on regions, lead to discrepancies in the test being adopted by different healthcare facilities. |
| South Korea | PSA tests are regulated by the Ministry of Food and Drug Safety (MFDS). The government promotes early detection of cancer, but national screening coverage is very limited. |
| Japan | The Pharmaceuticals and Medical Devices Agency (PMDA) mandates stringent validation for PSA tests; no nationwide prostate cancer screening program exists. |
| China | In China, PSA diagnostics are regulated by the NMPA. Due to a focus on cost-effective solutions, government policies tend to restrict the adoption of high-end PSA tests. |
| Australia-NZ | Australian Therapeutic Goods Administration (TGA) and New Zealand Medsafe; PSA tests are available in both countries, but PSA screening is not included in routine government-funded screening programs. |
| India | PSA test approvals are regulated by the Central Drugs Standard Control Organization (CDSCO) in India, but there are currently no formalized national guidelines regarding the inclusion of PSA testing as part of routine screening, leading to varying accessibility of the tests. |
Based on test type, chemiluminescent immunoassays (CLIA) are anticipated to be the largest industry, fueled by the enhanced sensitivity of this method, suitability for automation, and rapid turnaround potentially reducing diagnostic delays and improving patient outcomes during 2025 to 2035.
With laboratories and diagnostic centers increasingly driving toward high-throughput methods, CLIA has become the gold standard for PSA testing due to its improved accuracy and reduced variability compared to traditional ELISA or lateral flow assays.
The analysis study indicates that the adoption rate will be driven by the increasing focus on early-stage detection of prostate cancer and constant developments in CLIA platforms in the years to come. In light of these propellers, the CLIA segment is anticipated to grow at a rate of approximately 13.1% during 2025 to 2035, which surpasses the overall industry CAGR of 12.0%.
Serum represents the most lucrative sample type segment in the global prostate cancer diagnostics industry in 2025 and 2035 owing to the familiar adoption of serum samples as the conventional sample source for PSA tests. As they are derived from serum, these tests are stable, consistent, and yield higher-quality results than tests based on whole blood or plasma.
Advancements in serum-based biomarker detection along with a higher preference for automated immunoassays will drive the segment growth, according to FMI analysis. Furthermore, the ongoing regulatory approvals of serum-based PSA tests only fortify the clinical utility of PSA. Considering these factors, the serum segment is expected to grow at a CAGR of 12.5% over the forecast period.
Diagnostic laboratories are expected to remain key intermediaries from 2025 to 2035 from 2025 to 2035 in terms of end-user segment, as patients increasingly favor lab-based tests over hospital-based tests, and investments in computerized PSA screening platforms will continue on an uptrend to support commercial-scale deployment.
According to FMI analysis, diagnostic labs outperform point-of-care settings in terms of test accuracy and scalability and are therefore the widely adopted option among oncologists and urologists.
Collaborations between labs and AI-powered diagnostic companies are improving test accuracy and decreasing turnaround times. Based on these motivating factors, the Diagnostic Laboratories segment is expected to be the fastest-growing segment at a CAGR of nearly 13.3% throughout the forecast period.
From 2025 to 2035, projections indicate a CAGR of 12.3% for the PSA testing industry in the United States. The United States: The country continues to be a major growth area owing to high adoption of AI-powered diagnostics, growing awareness about prostate cancer screening, and advanced healthcare infrastructure.
FDA certification begets rigorous validation of each test, but lengthy approval processes delay new technologies entering the industry.
Reimbursement policies have been found to impact accessibility, with expanded coverage correlating with increases in test volumes, according to FMI analysis of Medicare and private insurer reimbursement policies. FMI predicts partnerships with AI-based diagnostics companies are the key to industry penetration.
Estimates indicate that the PSA testing industry in the UK will grow at a CAGR of 11.1% between 2025 and 2035. Rising public awareness and healthcare investments drive the industry, but the absence of a national screening program restricts its widespread adoption. According to FMI analysis, the UKCA marking and MHRA oversight are in place to govern PSA testing, serving to assure quality standards.
FMI opines that alignment with the NHS's strategy and inclusion in more general cancer screening programs could drive growth. Incrementally improving test adoption will also help further transition the industry to biomarker-based prostate cancer. These qualities make this industry attractive to firms with a strong focus on innovation.
The PSA testing industry size in France is expected to grow at an annual rate of 10.5% between 2025 and 2035. Requirements such as ANSM and IVDR, which direct high-quality standard diagnostic assays, substantiate the industry. The national health insurance system partially covers PSA tests, but selective reimbursement policies prevent wider access, according to FMI analysis.
FMI sees expansion driven by increasing demand for early-stage cancer detection and biomarker-based diagnostics. With the new approvals for manufacturers in France following strict rules, companies in this field need to make sure they meet these approval standards, especially for accurate PSA (prostate-specific antigen) tests along with genetic risk profiling.
Forecasts indicate a CAGR of 11.8% for the PA industry in Germany from 2025 to 2035. The country has a compartmentalized cancer screening system, but the PSA test is reimbursed under strict conditions, meaning not all men are automatically tested.
IVDR compliance creates higher entry barriers for new PSA assays, according to a recent FMI analysis, but Germany is the leader in precision diagnostics. FMI predicts that multi-marker prostate cancer screening methods that factor in PSA along with genetic and molecular biomarkers will take off. Collaboration with hospitals and research institutes will be crucial in driving test accessibility and industry expansion.
From 2025 to 2035, the Italy PSA testing industry is estimated to grow at a compound annual growth rate (CAGR) of 10.2%. Italy’s PSA testing framework involves region-specific payer collaboration, with discrepancies in reimbursement policies and oversight by AIFA. Despite increasing early detection initiatives, inconsistent insurance coverage continues to limit access to PSA tests, according to FMI analysis.
The availability of tests will increase due to rising investments in healthcare and growing adoption of digital pathology (Source S64692). It is necessary for industry players to collaborate with regional healthcare authorities to make reimbursement policies more efficient and raise physician-patient awareness about advanced options for real-time diagnosis.
Projections indicate a CAGR of 11.5% for the PSA testing industry in South Korea from 2025 to 2035. Although the country's health system prioritizes preventive diagnostics, limited health insurance coverage hinders the widespread use of PSA testing.
MFDS regulations dominate the industry, with extensive clinical validation needed prior to acceptance of new tests, according to an FMI analysis. Both the increasing availability of point-of-care PSA testing and the inclusion of AI-powered diagnostics, according to FMI, are driving growing adoption. South Korea, meanwhile, will see a steady industry for companies that specialize in affordability and fast diagnostics.
In Japan, the PSA testing realm is anticipated to grow at a CAGR of 10.7% over the period of 2025 and 2035. Despite a highly advanced healthcare system, basic screening with PSA is not common and is not part of a national screening program for cultural reasons.
The FMI analysis revealed that PMDA regulations create a challenging pathway for the approval of new tests, resulting in a significant slowdown in industry access. According to FMI, an increasing interest in precision diagnostics and AI-based PSA testing will promote adoption. The industry in Japan will mainly benefit from strategic partnerships with research institutions and hospitals.
The PSA sector in China is projected to grow at a CAGR of 13.2% between 2025 and 2035, making it one of the world's fastest-growing industries. According to FMI analysis, high cancer prevalence, increasing healthcare expenditure, and large-scale diagnostic programs funded by the government will be supporting the industry growth.
In contrast, NMPA regulations favor cost-effective solutions that watch PSA test adoption with advanced AI. Localized manufacturing, pricing adjustments, and partnerships with state governments will remain key to success in this landscape, opines FMI. Increasing incorporation of PSA testing among rural healthcare platforms will boost industry penetration further.
Moreover, projections indicate a CAGR of 10.9% for the PSA testing industry in Australia and New Zealand between 2025 and 2035. This advantage stems from an established healthcare infrastructure industry, although it lacks government-funded routine PSA screening programs.
While TGA (Australia) and Medsafe (NZ) regulations guarantee high diagnostic quality in FMI analysis, assimilation is still physician-driven. FMI believes that coupling PSA tests with expanded men’s health programs and digital health platforms will drive growth. A focus on at-home and telehealth-based testing solutions represents an important cross-sell opportunity.
The PSA testing industry in India is projected to grow at a CAGR of 13.5% for the period extending from 2025 to 2035, highlighting the fast-paced growth in this industry. FMI's analysis also revealed that the absence of national screening guidelines and low awareness levels impede early detection efforts.
But demand is being driven by increased healthcare spending, urbanization, and rising incidence rates of cancer. PSA testing remains cost-sensitive, and industry expansion is being driven by government-funded early detection programs, according to FMI. This nascent industry has high potential; focusing on collaborative efforts with diagnostic laboratories and insurers for accessibility and affordability will be key.
Major players of the Prostate-Specific Antigen (PSA) Testing industry are fighting with pricing plans, technological development, strategic collaboration, and geographic expansion. Companies are investing intensely in AI-powered diagnostics, high-sensitivity immunoassays, and automation to improve the precision and speed of tests, according to FMI analysis.
Mergers and acquisitions are restructuring the competitive landscape as major companies acquire niche biotech startups to make their offerings robust. Moreover, hospital partnerships and diagnostic chain partnerships are creating an expanding industry size.
Pricing policies differ among firms; some offer cost-effective ELISA kits, while others focus on high-end chemiluminescence assays (CLIA) for high-throughput laboratories. Moves into emerging nations continue to remain a priority area.
Abbott Laboratories
Share: ~20-25%
A dominant leader in diagnostics, Abbott has an excellent position within PSA testing from its Alinity immunoassay systems to its worldwide network of distributors.
Roche Diagnostics
Share: ~18-22%
Roche is a strong industry leader with its Elecsys PSA tests, taking advantage of its automated cobas systems and emphasis on high-throughput laboratories.
Siemens Healthineers
Share: ~15-18%
Siemens is competitive with its Advia Centaur and Atellica PSA assays, highlighting accuracy and integration with lab automation.
Danaher Corporation (Beckman Coulter)
Share: ~12-15%
Beckman Coulter's Access PSA tests and DxI immunoassay systems play their role in maintaining its stable industry share, especially in Europe and North America.
Thermo Fisher Scientific
Share: ~8-12%
Thermo Fisher's Brahms PSA assays and ImmunoDiagnostics business target specialized laboratories, emphasizing precision and clinical utility.
Other Players (Bio-Rad, Fujirebio, etc.)
Share: ~10-15% combined
Smaller competitors such as Fujirebio (with its Lumipulse G PSA tests) and Bio-Rad focus on smaller niches, such as research and new industries.
Rising incidence of prostate cancer, heightened early detection awareness, improvements in high-sensitivity immunoassays, and are driving increased demand for PSA testing solutions.
The industry will see robust growth, underpinned by technological advancements, AI-driven diagnostic solutions, and rising laboratory uptake of chemiluminescent immunoassays (CLIA).
Major providers are Xiamen Biotime Biotechnology Co. Ltd, HWTAi, OptiBio Co., Ltd, Jiangsu MicroDiag Biomedicine Technology Co., Ltd, Beijing Hotgen Biotechn Co., Ltd, Humasis, Accuquik™ Test Kits, CTK Biotech, Inc, INTEC, XIAMEN BOSON BIOTECH CO., LTD, AccuBioTech Co., Ltd, Bio-Rad Laboratories, Inc, Accuquik Test Kits. It also includes OPKO Health, Inc, bioMérieux SA, Beckman Coulter, Inc, Abbott, Siemens Healthineers, DiaSorin, F. Hoffmann-La Roche Ltd, Mediwatch (LABORIE), BodiTech, Bristol-Myers Squibb Company, GE Healthcare, Endocare, GlaxoSmithKline, Anixa Biosciences, Ortho Clinical, Fujirebio, Roche Diagnostics, Danaher Corporation, Thermo Fisher Scientific.
Chemiluminescent immunoassays (CLIA) are anticipated to dominate driven by superior accuracy, automatization capabilities, and increased use in diagnostic laboratories.
The prostate-specific antigen (PSA) test industry is forecasted to reach USD 24.6 billion by the year 2035 due to increasing screening efforts and newer diagnostic technologies.
The industry is segmented into immunoassays, elisa kits, lateral flow assays, chemiluminescent immunoassays (clia), radioimmunoassay, point-of-care testing kits, cassette/cards, strips.
The industry is segmented into whole blood, serum, plasma.
The industry is segmented into hospitals, diagnostics laboratories, specialty clinics, research institutes, others.
The industry is studied across North America, Latin America, Europe, South Asia, East Asia, Oceania, Middle East and Africa (MEA)
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