Cancer Diagnostics Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 114.87 Billion |
| Market Size (2030) | USD 169.72 Billion |
| Growth Rate (2025 - 2030) | 8.12% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
|
Cancer Diagnostics Market Analysis by Mordor Intelligence
The cancer diagnostics market is valued at USD 114.87 billion in 2025 and is projected to reach USD 169.72 billion by 2030, expanding to an 8.12% CAGR. Accelerated approvals of artificial-intelligence tools, broader Medicare coverage for blood-based screening, and rapid adoption of liquid biopsy platforms are reshaping early detection pathways. FDA breakthrough designations for multi-cancer blood tests and point-of-care imaging devices illustrate a regulatory climate that favors innovation while raising competitive intensity. Governments are scaling population screening most visibly through the Biden Cancer Moonshot and Australia’s new lung screening program, creating demand for decentralized solutions that fit within constrained public-health budgets. Strategic partnerships between imaging giants and AI specialists are driving productivity gains and shortening diagnostic turnaround times, while demographic shifts toward older populations sustain long-term test volume growth.[1]Food and Drug Administration, “Press Announcements: Shield Multi-Cancer Detection Test,” fda.gov
Key Report Takeaways
- By diagnostic type, Diagnostic Imaging Tests led with 46.2% revenue share in 2024; Genomic/Liquid Biopsy Tests are forecast to expand at an 18.4% CAGR through 2030
- By cancer type, breast cancer accounted for 24.4% of the cancer diagnostics market size in 2024, while Pancreatic Cancer is advancing at a 12.6% CAGR to 2030.
- By end user, hospitals held 52.6% of the cancer diagnostics market share in 2024; Point-of-Care Centers record the highest projected CAGR at 14.7% through 2030.
- By geography, North America commanded a 38.9% share in 2024, whereas Asia Pacific is set to grow at a 10.9% CAGR over the forecast period.
Global Cancer Diagnostics Market Trends and Insights
Drivers Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Increasing Government-Funded Screening Programs | +1.80% | Global, with early gains in North America, Europe, Australia | Medium term (2-4 years) |
| Rising Global Cancer Incidence & Aging Population | +2.10% | Global, with highest impact in Asia Pacific and Europe | Long term (≥ 4 years) |
| Rapid Adoption Of Liquid-Biopsy & ctDNA Tests | +1.50% | North America & EU core, spill-over to APAC | Short term (≤ 2 years) |
| Point-Of-Care Imaging & Diagnostics Expansion | +1.20% | APAC core, spill-over to MEA and Latin America | Medium term (2-4 years) |
| AI-Driven Multi-Omics Early Detection Platforms | +0.90% | North America & EU, with selective APAC adoption | Short term (≤ 2 years) |
| Value-Based Companion Diagnostics Reimbursement | +0.70% | North America & EU primarily | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
Increasing Government-Funded Screening Programs
Global health agencies are scaling population screening beyond breast and colorectal cancers. The ARPA-H POSEIDON initiative finances at-home multi-cancer tests, while Australia’s lung screening roll-out moves diagnostics closer to underserved groups. Europe now recommends lung, prostate, and gastric screening, prompting vendors to build high-throughput, cost-efficient platforms suitable for national programs. Political alignment is evident in the USD 650 million U.S. allocation to community cancer projects, which prioritizes accessible diagnostics that can run outside tertiary hospitals.[2]European Commission, “Cancer Screening Recommendations Update 2022,” ec.europa.eu
Rising Global Cancer Incidence & Aging Population
India forecasts 2 million annual cases by 2040, and Europe saw diagnoses climb from 2.1 million in 1995 to 3.2 million in 2022. These shifts pressure health systems to adopt both high-complexity genomics for precision therapy in older cohorts and low-cost rapid tests for populous markets. Vendors capable of scaling test menus across disparate infrastructures are well placed to capture outsized gains.[3]BMC Medicine, “Surface-Enhanced Raman Spectroscopy for Early Cancer Detection,” bmcmedicine.biomedcentral.com
Rapid Adoption of Liquid Biopsy & ctDNA Tests
The FDA’s 2024 approval of Guardant Shield for colorectal screening validated blood-based assays. Prospective trials such as SPOT-MAS delivered 70.8% sensitivity and 99.7% specificity in presymptomatic cohorts, demonstrating clinical readiness. Turnaround times of 3 days in community centers underscore operational benefits versus tissue biopsy waits, accelerating physician uptake.
Point-Of-Care Imaging & Diagnostics Expansion
AI-enabled handheld devices like DermaSensor achieve 96% sensitivity for skin cancer, reducing reliance on specialist dermatologists. Saliva-based biosensors provide breast-cancer triage in seconds, and inhalable nanoparticle sensors promise non-radiologic lung screening. Such technologies align with health equity goals and spur demand in low-resource regions.
Restraints Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| High Cost Of Advanced Molecular Diagnostics | -1.40% | Global, with highest impact in emerging markets | Medium term (2-4 years) |
| Limited Reimbursement In Low-Income Nations | -0.80% | APAC, MEA, Latin America primarily | Long term (≥ 4 years) |
| Shortage Of Trained Molecular Pathologists | -0.60% | Global, with acute impact in APAC and MEA | Long term (≥ 4 years) |
| Data-Privacy Concerns In AI Cloud Workflows | -0.40% | EU and North America primarily | Short term (≤ 2 years) |
| Source: Mordor Intelligence | |||
High Cost of Advanced Molecular Diagnostics
Median out-of-pocket charges for AI radiology exceed USD 1,000, deterring uptake where insurance lags. Although the AMA has drafted AI CPT codes, evidence hurdles delay broad coverage. Emerging economies face import duties and currency headwinds that elevate device prices well beyond local affordability, stalling the diffusion of genomics despite clinical value.
Limited Reimbursement in Low-Income Nations
Mortality-to-incidence ratios of 0.65 in South Asia highlight the care gap tied to diagnostic underuse. While India’s device market is growing, diagnostics trail overall health-tech spending. Many universal coverage schemes exclude laboratory services, compelling patients to travel abroad for testing, as seen with outbound flows from Sub-Saharan Africa to India.
Segment Analysis
By Diagnostic Type: Genomic Testing Drives Innovation
Genomic/Liquid Biopsy Tests are projected to log an 18.4% CAGR, the highest within the cancer diagnostics market, as pan-tumor companion diagnostics gain FDA clearance. The FDA green-lighted Illumina’s TruSight Oncology Comprehensive assay in 2024, supporting broad genomic profiling for solid tumors. Meanwhile, Diagnostic Imaging Tests preserved a 46.2% foothold in 2024 due to AI overlays that cut interpretation time and mitigate radiologist shortages. Biopsy & Cytology remain indispensable for histology confirmation, yet non-invasive blood tests inch closer to tissue accuracy, particularly when combined with multi-omic analytics. Tumor Biomarker panels see steady demand through their role in therapy selection. IVD Immunoassays thrive in decentralized sites where laboratory infrastructure is scarce, aligning with the push to expand basic oncology services in middle-income settings. Other platforms, such as surface-enhanced Raman spectroscopy, with 94.75% accuracy in large cohorts, signal future competitive threats.
Note: Segment shares of all individual segments available upon report purchase
By Cancer Type: Pancreatic Detection Advances
Breast Cancer retained 24.4% of revenue in 2024 as AI-guided risk tools gained regulatory traction. Clairity Breast’s FDA nod shows that screening algorithms can personalize pathways for younger women lacking classic risk factors. Pancreatic Cancer, historically hindered by late detection, is poised for a 12.6% CAGR thanks to high-sensitivity AI radiology like DAMO PANDA, which beats human readers by 34.1% in sensitivity on non-contrast CT. Lung Cancer volumes are set to climb as government-funded LDCT and liquid biopsy options broaden outreach. Colorectal screening expansion via Guardant Shield blood tests aims to lift compliance rates beyond traditional colonoscopy. Cervical triage technologies such as dual-stain assays promise to streamline colposcopy referrals, while prostate digital-pathology AI detects micro-carcinoma with 99.6% PPV. Multi-cancer early detection panels add incremental value by flagging malignancies that lack organized screening, pointing toward an integrated testing model.
By End User: POC Centers Gain Momentum
Hospitals captured 52.6% of testing revenue in 2024, leveraging integrated care pathways and capital-intensive modalities such as MRI and digital pathology. Yet, Point-of-Care Centers are forecast to grow 14.7% annually as saliva biosensors, handheld dermoscopy, and cartridge-based ctDNA assays bring oncology screening into retail clinics and community hubs. Diagnostic Laboratories retain relevance for complex NGS panels, but cloud-based analytics now allow smaller labs to run high-complexity assays without on-site bioinformaticians. Academic & Research Institutes underpin innovation pipelines through multi-center validation trials that feed regulatory submissions.
Note: Segment shares of all individual segments available upon report purchase
Geography Analysis
North America led revenue with a 38.9% share in 2024, supported by Medicare’s inclusion of blood-based colorectal tests in the 2025 fee schedule and frequent FDA breakthrough device designations. A mature payer system and widespread adoption of electronic health records ease integration of AI analytics, positioning the region as an early-adopter hub. U.S. academic networks are running multi-state trials that validate multi-cancer detection platforms, accelerating time-to-reimbursement once analytical validity is proven. Canada benefits from pan-provincial genomic initiatives that underwrite sequencing for therapy guidance, further buoying test volumes.
Europe holds the second-largest revenue pool. Updated EU screening guidelines now encompass lung, prostate, and gastric cancers, generating demand for both low-dose CT and liquid biopsy alternatives. The European Liquid Biopsy Society is standardizing sample handling, which should harmonize clinical adoption across member states. Reimbursement, however, varies widely: Germany’s DRG system promptly covers NGS panels, while southern Europe lags, creating a two-speed uptake environment. Data-privacy regulation under GDPR raises compliance costs for cloud-based AI vendors, but investment in in-country data centers is easing adoption.
Asia Pacific delivers the fastest expansion at a 10.9% CAGR. China’s NMPA approved 61 innovative devices in 2023, reflecting regulatory pragmatism that accelerates time to market for local innovators. Public–private partnerships are building molecular pathology labs across Tier-2 cities, expanding sample-processing capacity. India’s National Cancer Grid is rolling out digital pathology and tele-oncology, enabling rural facilities to access urban expertise. Japan’s fast-track approvals for pan-lung PCR panels exemplify how mature markets in the region continue to embrace precision diagnostics.
In Latin America, decentralized policies are nascent, but sequencing costs are declining, paving the way for targeted screening of high-incidence cancers like gastric and gallbladder. Middle East and Africa remain hampered by reimbursement gaps anda limited oncology workforce. Medical tourism underscores the deficit: more than 90% of Sub-Saharan oncologists report patients traveling abroad for diagnostics. International agencies are piloting portable imaging and point-of-care assays to bridge these inequities, but uptake hinges on sustainable funding models.
Competitive Landscape
The cancer diagnostics market features moderate fragmentation. Incumbents such as Roche, Abbott, and Siemens retain scale advantages in chemistry, reagents, and installed imaging bases. Startups specializing in methylation sequencing, AI histopathology, and breathomics supply disruptive technology that incumbents increasingly license or acquire. Quest Diagnostics’ purchase of PathAI Diagnostics in 2024 highlighted the strategic value of digital pathology intellectual property. M&A activity is likely to persist as payers reward tests with strong clinical-utility evidence, favoring firms that can embed algorithms into existing hardware.
Strategic alliances between imaging OEMs and AI vendors are proliferating. GE HealthCare’s link-up with RadNet to embed SmartMammo into mammography units shows the bid to boost throughput without expanding the workforce. Likewise, Illumina’s partnership with Tempus combines multi-modal clinical data with sequencing chemistry, aiming to shorten validation timelines for comprehensive genomic assays. Pharmaceutical–diagnostic codevelopment is intensifying under precision-therapy imperatives; the FDA approved multiple companion diagnostics for HER2-ultralow breast cancer and IDH-mutant glioma in 2024-2025, cementing the diagnostic role in therapeutic value chains.
Competitive differentiation is shifting from hardware to integrated workflows. Vendors able to pool imaging, genomics, and real-world evidence stand to build durable moats. Cloud-native platforms offer scalability but must navigate data-sovereignty constraints. Surface-enhanced Raman spectroscopy devices delivered 94.75% accuracy in extensive cohort studies, hinting at the next wave of modality convergence. The race is now to establish clinical-grade evidence across diverse populations, a prerequisite for payer coverage and guideline inclusion. Firms that align trial design with reimbursement metrics will outpace peers that focus only on analytical performance.
Cancer Diagnostics Industry Leaders
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F. Hoffmann-La Roche Ltd
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Thermo Fisher Scientific Inc.
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Abbott Laboratories Inc.
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Illumina Inc
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bioMérieux SA
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- June 2025: The FDA cleared Clairity Breast, the first AI tool to project 5-year breast-cancer risk from standard mammograms.
- June 2025: Guardant Health’s Shield multi-cancer detection assay received FDA breakthrough device designation after posting 98.6% specificity and 75% sensitivity.
- April 2025: Illumina and Tempus entered a strategic alliance to speed clinical adoption of NGS tests by integrating AI-driven evidence-generation capabilities.
- February 2025: Ibex Medical Analytics secured FDA 510(k) clearance for Prostate Detect, an AI digital-pathology tool with 99.6% PPV.
- January 2025: Roche received FDA approval for the PATHWAY HER2 (4B5) test, which identifies HER2-ultralow metastatic breast-cancer patients eligible for ENHERTU.
Research Methodology Framework and Report Scope
Market Definitions and Key Coverage
We define the cancer diagnostics market as all clinical tests, imaging procedures, and pathology services used to detect, characterize, and stage malignant tumors in humans, spanning in-vitro assays, radiological modalities, histology-based biopsies, and emerging liquid-biopsy platforms. Our study values revenue captured by manufacturers of instruments, reagents, and software alongside fees earned by hospitals and independent laboratories for performing the diagnostic service.
Scope exclusion: Screening pharmaceuticals, radiotherapy equipment, and any therapeutic procedure revenues are outside our lens.
Segmentation Overview
- By Diagnostic Type
- Diagnostic Imaging Tests
- Biopsy & Cytology Tests
- Tumor Biomarkers
- Genomic / Liquid-Biopsy Tests
- IVD Immunoassays
- Other Diagnostic Types
- By Cancer Type
- Breast Cancer
- Lung Cancer
- Colorectal Cancer
- Cervical Cancer
- Prostate Cancer
- Kidney Cancer
- Liver Cancer
- Pancreatic Cancer
- Ovarian Cancer
- Other Cancer Types
- By End User
- Hospitals
- Diagnostic Laboratories
- Academic & Research Institutes
- POC / Ambulatory Centres
- By Region
- North America
- United States
- Canada
- Mexico
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- South Korea
- Australia
- Rest of Asia Pacific
- Middle East and Africa
- GCC
- South Africa
- Rest of Middle East and Africa
- South America
- Brazil
- Argentina
- Rest of South America
- North America
Detailed Research Methodology and Data Validation
Primary Research
Structured interviews with oncologists, pathology lab directors, and procurement heads across North America, Germany, India, and Brazil helped validate average test utilization per patient, reimbursement shifts, and realistic price erosion curves, filling blind spots left by published material.
Desk Research
Analysts first assembled incidence and mortality series from tier-one public sources such as WHO-IARC GLOBOCAN, the US National Cancer Institute SEER, Eurostat's health database, and Japan's National Cancer Center. Trade group portals, including the Advanced Medical Technology Association and the Association of Molecular Pathology, supplied modality adoption ratios, while company 10-Ks and device registration logs clarified price brackets and installed bases. Select paid libraries, D&B Hoovers for laboratory financials and Dow Jones Factiva for deal flow, grounded revenue cross-checks. This list is illustrative; numerous other open datasets and journal archives supported data capture and clarification.
A second sweep parsed clinical-trial registries, patent families through Questel, and customs shipment tallies to spot volume inflections tied to innovative kits or scanners, ensuring alignment between reported sales and technological roll-outs.
Market-Sizing & Forecasting
A hybrid top-down model begins with national cancer incidence per type, multiplies by guideline-driven diagnostic pathways, then adjusts for screening coverage, repeat-test frequency, and public-private payer mix. Select bottom-up checks, laboratory revenue roll-ups and sampled ASP x instrument placements, reconcile totals. Key variables tracked include: 1) new cancer cases, 2) share of cases screened by imaging vs. molecular tests, 3) average selling price trajectory of IVD panels, 4) laboratory capacity additions, and 5) regulatory approvals that widen covered indications. Multivariate regression projects each driver to 2030, and scenario analysis layers in optimistic and conservative screening uptake to stress-test outcomes.
Data Validation & Update Cycle
Outputs pass anomaly and variance filters, peer review, and a senior sign-off. Reports refresh every twelve months, with interim revisions when guideline changes, major approvals, or macro currency swings move the baseline.
Why Our Cancer Diagnostics Baseline Earns Trust
Published estimates often diverge because firms slice the market differently, apply varied price curves, or freeze models for years before an update.
Key gap drivers here include the breadth of service revenues captured, the cadence at which test prices deflate, and whether liquid-biopsy revenues are counted or left out, all of which Mordor's disciplined refresh cycle captures more promptly than others.
Benchmark comparison
| Market Size | Anonymized source | Primary gap driver |
|---|---|---|
| USD 114.87 B (2025) | Mordor Intelligence | - |
| USD 109.61 B (2024) | Global Consultancy A | Excludes genomic screening assays; static ASP assumptions; biennial updates |
| USD 17.20 B (2021) | Trade Journal B | Counts only consumables and instruments for IVD; omits imaging and biopsy services; older base year |
Overall, buyers gain a baseline that links transparent variables to reproducible steps, giving decision-makers confidence that figures stay current and broad enough to mirror real-world cash flows.
Key Questions Answered in the Report
What is the current size of the cancer diagnostics market?
The market stands at USD 114.87 billion in 2025 and is forecast to reach USD 169.72 billion by 2030.
Which diagnostic segment is growing fastest?
Genomic and liquid biopsy platforms show the highest growth, with an 18.4% CAGR projected through 2030.
Why is Asia Pacific the fastest-growing region?
Regulatory reforms, increased healthcare spending, and rapid adoption of innovative devices push Asia Pacific toward a 10.9% CAGR.
How do liquid biopsies differ from traditional tissue biopsies?
Liquid biopsies use blood samples to analyze circulating tumor DNA, offering non-invasive, faster results that can complement or replace tissue procedures.
What is driving point-of-care expansion in cancer diagnostics?
Portable devices and AI interpretation allow testing in community settings, reducing turnaround times and expanding access where specialists are scarce.
How concentrated is the competitive landscape?
The market scores 6 on a 10-point scale, indicating moderate concentration as large incumbents coexist with nimble AI and liquid-biopsy innovators.
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