Cancer Diagnostics Market Size and Share

Cancer Diagnostics Market (2026 - 2031)
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Cancer Diagnostics Market Analysis by Mordor Intelligence

The cancer diagnostics market size is expected to reach USD 124.1 billion in 2026 and is projected to climb to USD 183.5 billion by 2031, reflecting an 8.2% CAGR and underscoring the sector’s shift toward proactive, technology-enabled screening programs. Growing public funding for population-level screening, rapid commercialization of liquid-biopsy platforms that deliver molecular insights within 48 hours, and AI-driven image analytics that standardize interpretation are the primary engines of expansion. North America retained the largest share in 2025 as hospital networks continued to invest in central-laboratory automation, yet policy reforms across China and India are redirecting future momentum to Asia-Pacific. Hospitals still anchor procurement, but portable imaging systems and microfluidic cartridges are moving tests into community clinics, trimming the interval between suspicion and diagnosis from weeks to hours. Intensifying competition among integrated platform players and emerging liquid-biopsy firms is accelerating product cycles, while reimbursement wins for multi-cancer early-detection assays are widening the addressable patient pool. 

Key Report Takeaways

  • By diagnostic type, IVD immunoassays led with 53.2% revenue share in 2025, whereas genomic and liquid-biopsy tests are forecast to advance at a 9.2% CAGR through 2031. 
  • By cancer type, breast cancer generated 26.5% of demand in 2025, while lung cancer diagnostics are positioned to grow most quickly at a 9.9% CAGR to 2031. 
  • By end user, hospitals accounted for 53.1% of outlays in 2025, yet point-of-care and ambulatory centers are projected to expand at a 10.1% CAGR over the same horizon. 
  • By geography, North America captured 39.2% in 2025, whereas Asia-Pacific is set to rise at an 8.9% CAGR, the fastest regional pace. 

Note: Market size and forecast figures in this report are generated using Mordor Intelligence’s proprietary estimation framework, updated with the latest available data and insights as of January 2026.

Segment Analysis

By Diagnostic Type: Liquid Biopsies Gain While Immunoassays Anchor Revenue

IVD immunoassays contributed 53.2% to 2025 revenue, supported by high-throughput analyzers that process up to 400 samples an hour at unit costs below USD 5 [3]U.S. Food and Drug Administration, “Breakthrough Devices Program,” FDA.GOV. Genomic and liquid-biopsy platforms are projected to expand at 9.2% yearly through 2031 as coverage decisions proliferate and standard turnaround time drops to under 48 hours. Diagnostic imaging retains a mid-teens share and benefits from AI algorithms that reduce false positives by 22%, encouraging radiologist adoption. Biopsy and cytology test volumes are plateauing because oncologists now use blood-based assays for therapy selection, eliminating repeat tissue procedures. Tumor biomarker tests remain indispensable for ongoing monitoring but grow slower than the overall cancer diagnostics market. 

Margin profiles vary widely. Immunoassay vendors earn stable reagent revenue from broad installed bases, while genomic firms rely on intellectual-property-protected data analytics. Illumina’s NovaSeq X lowered sequencing cost per genome to USD 200, enabling laboratories to price comprehensive panels at USD 1,500 with 40% gross margins. Thermo Fisher Scientific’s sample-to-answer PCR unit delivers 28-gene detection in four hours without manual extraction, opening molecular testing to community hospitals lacking specialist staff. Regulators reinforce momentum; the FDA cleared 17 breakthrough oncology platforms in 2025, and the European Medicines Agency cut nine months off average review timelines for assays with strong clinical evidence. Consequently, immunoassays will continue anchoring revenue, but liquid biopsies will capture most incremental growth, reshaping the cancer diagnostics market by 2031.

Cancer Diagnostics Market: Market Share by Diagnostic Type
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By Cancer Type: Lung Cancer Diagnostics Accelerate on Screening Expansion

Breast cancer maintained 26.5% of 2025 revenue because long-standing screening guidelines guarantee steady mammography, ultrasound, and genomic panel volumes. Lung cancer diagnostics are positioned to grow fastest at 9.9% through 2031 on the back of expanded low-dose CT eligibility and emerging blood-based early-detection assays. The U.S. Preventive Services Task Force broadened criteria in 2024, adding 6.4 million eligible adults, while China mandated annual CT scans for 87 million smokers in 2025. Colorectal diagnostics gain from stool-DNA tests that deliver 92% sensitivity for advanced adenomas, pushing adherence among Medicare beneficiaries to 78%.

Prostate screening is under review, yet MRI-guided biopsies launched in 2024 cut overdiagnosis significantly, improving payer acceptance. Low-resource settings shift cervical screening to HPV DNA tests, as Roche processed 14 million samples across India and Sub-Saharan Africa in 2025. Liver and pancreatic diagnostics remain small but promising after liquid-biopsy methylation assays hit 83% sensitivity for early-stage pancreatic tumors in a 2025 trial. Ovarian screening still lacks high-specificity tools, and the USPSTF issued a grade D recommendation against population testing. Kidney and bladder detection hinges on incidental imaging and cystoscopy, keeping growth subdued. Segment momentum therefore pivots on technology readiness and policy alignment rather than incidence alone, propelling lung testing ahead within the cancer diagnostics market.  

By End User: Ambulatory Centers Gain as Testing Decentralizes

Hospitals absorbed 53.1% of spending in 2025 thanks to capital budgets for imaging suites and sequencing labs. Yet ambulatory and point-of-care sites are forecast to rise 10.1% annually, fueled by compact immunoassay analyzers and handheld imaging devices. Large commercial laboratories leverage scale; Quest Diagnostics processed 178 million oncology tests in 2025 at costs 40% below hospital peers, preserving mid-twenties market share. Academic centers such as Memorial Sloan Kettering convert proprietary assays into national standards, exemplified by the MSK-IMPACT panel’s ascent in U.S. oncology workflows. 

Payment policy accelerates decentralization. CMS trimmed 2026 outpatient rates for imaging and lab services by 3.8% while raising ambulatory-surgery-center rates, creating a USD 150 to USD 300 per-test advantage outside hospital walls. U.S. retail chains respond; Walgreens will install diagnostic kiosks in 1,500 stores by 2027, while CVS Health co-locates blood-draw stations in 800 MinuteClinics. In India, chains such as Dr. Lal PathLabs opened 340 collection centers in tier-2 and tier-3 cities during 2025, lifting volumes 28%. Rural U.S. facilities face consolidation pressure as 19 hospitals closed in 2025, outsourcing complex testing to regional hubs. Decentralization thus re-balances procurement, but hospitals remain indispensable for multidisciplinary cases that integrate imaging, pathology, and oncology boards.

Cancer Diagnostics Market: Market Share by End User
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Geography Analysis

North America generated 39.2% of sales in 2025, underpinned by USD 12,500 per-capita health spending and broad coverage for advanced diagnostics. The regional cancer diagnostics market will sustain mid-single-digit growth as Medicare coverage for multi-cancer early detection took effect in 2026, adding 41 million reimbursed lives. Europe faces budget tension, yet Germany approved ctDNA monitoring for colorectal and breast cancers in 2025 and France green-lit liquid biopsies for treatment selection, keeping the regional CAGR near 7.4%. The United Kingdom delayed national liquid-biopsy rollout because of a GBP 2.1 billion funding gap, signaling divergent adoption speeds inside Europe.

India’s Ayushman Bharat scheme covers 550 million citizens over 50. China’s domestic diagnostic chains now run 1,800 labs, driving local procurement and shortening installation cycles from 16 to six weeks. Japan’s shrinking population masks rising per-capita spending, which climbed 6.2% in 2025 after the government prioritized early detection to control late-stage therapy costs. South Korea’s screening program reached 76% participation in 2025, the highest globally, and newly reimbursed liquid-biopsy monitoring for colorectal survivors will support future test volumes. Australia expanded companion-diagnostic coverage in 2025, reinforcing a regional trend toward precision oncology reimbursement. 

The Middle East and Africa remain a low-single-digit share but show targeted investment. Saudi Arabia allocated USD 1.2 billion under Vision 2030 to install 45 PET-CT scanners and set up genomic labs in three major cities. The United Arab Emirates is establishing oncology centers that integrate AI pathology, aiming to serve medical tourists. South America presents mixed signals; Brazil’s national system added mammography and colonoscopy to coverage in 2024, yet equipment shortages persist in northern states. Overall, while North America and Europe still drive absolute revenue, Asia-Pacific will contribute most net new spending, reshaping competitive focus within the cancer diagnostics market.

Cancer Diagnostics Market CAGR (%), Growth Rate by Region
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Competitive Landscape

The five largest vendors, Roche, Abbott, Siemens Healthineers, Thermo Fisher Scientific, and Danaher, held about the majority of revenue share in 2025, indicating moderate concentration. Vertical integration defines strategy as platform makers acquire CLIA-certified laboratories to capture recurring per-test income alongside instrument sales. Illumina paved the way by absorbing GRAIL, followed by Exact Sciences’ USD 1.2 billion purchase of Genomic Health in 2025. Electronic-health-record integrations deepen moats; Exact Sciences embedded Cologuard ordering into 280 Epic-based systems, lifting volumes 19% within six months. 

Emerging players use artificial intelligence to attack workflow pain points. PathAI processed 2.3 million slides in 2025 with 94% concordance to human pathologists, allowing labs to expand throughput 40% without new hires. Freenome combined ctDNA, protein biomarkers, and machine-learning classifiers in a multi-cancer assay launched in 2025, differentiating itself from single-analyte competitors. Regulatory traction is a vital filter; only 8% of Breakthrough-Device applicants won FDA designation in 2025, steering advantage toward firms with robust trial management. Patent portfolios continue to matter; Myriad Genetics’ BRACAnalysis generated USD 312 million in 2025 under method claims valid until 2029. 

Regional challengers are advancing. Chinese and Indian manufacturers offer immunoassay analyzers priced up to 60% below Western equivalents, attracting cost-sensitive hospitals. Siemens Healthineers doubled Asia-Pacific manufacturing capacity with a new Shanghai plant that cut delivery lead times from 16 to six weeks. Guardant Health partnered with the U.K. National Health Service in 2025 to supply 50,000 liquid-biopsy tests annually, validating blood-based monitoring in publicly funded systems. The competitive field therefore balances scale economics against innovation speed, with data analytics and decentralized platforms opening fresh entry points across the cancer diagnostics market. 

Cancer Diagnostics Industry Leaders

  1. F. Hoffmann-La Roche Ltd

  2. Thermo Fisher Scientific Inc.

  3. Abbott Laboratories Inc.

  4. Siemens Healthineers

  5. Danaher Corporation

  6. *Disclaimer: Major Players sorted in no particular order
Cancer Diagnostics Market Concentration
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Recent Industry Developments

  • January 2026: Exelixis and Natera announced a collaboration on the Phase 3 STELLAR-316 pivotal trial for colorectal cancer treatment. The trial will use Natera's Signatera assay to identify and monitor patients with minimal residual disease (MRD).
  • November 2025: Abbott announced its definitive agreement to acquire Exact Sciences, a leader in cancer screening (like Cologuard) and precision oncology, for approximately $21 billion in cash.
  • June 2025: The FDA cleared Clairity Breast, the first AI tool to project 5-year breast-cancer risk from standard mammograms.

Table of Contents for Cancer Diagnostics Industry Report

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 Increasing Government-Funded Screening Programs
    • 4.2.2 Rising Global Cancer Incidence & Aging Population
    • 4.2.3 Rapid Adoption of Liquid-Biopsy & ctDNA Tests
    • 4.2.4 Expansion of Point-Of-Care Imaging & Diagnostics
    • 4.2.5 Ai-Driven Multi-Omics Early Detection Platforms
    • 4.2.6 Decentralized Microfluidic Sample-To-Answer Systems
  • 4.3 Market Restraints
    • 4.3.1 High Cost of Advanced Molecular Diagnostics
    • 4.3.2 Limited Reimbursement in Low-Income Nations
    • 4.3.3 Shortage Of Trained Molecular Pathologists
    • 4.3.4 Data-Privacy Concerns in AI Cloud Workflows
  • 4.4 Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter’s Five Forces
    • 4.7.1 Threat of New Entrants
    • 4.7.2 Bargaining Power of Buyers
    • 4.7.3 Bargaining Power of Suppliers
    • 4.7.4 Threat of Substitute Products
    • 4.7.5 Intensity of Competitive Rivalry

5. Market Size & Growth Forecasts (Value, USD)

  • 5.1 By Diagnostic Type
    • 5.1.1 Diagnostic Imaging Tests
    • 5.1.2 Biopsy & Cytology Tests
    • 5.1.3 Tumor Biomarkers
    • 5.1.4 Genomic / Liquid-Biopsy Tests
    • 5.1.5 IVD Immunoassays
    • 5.1.6 Other Diagnostic Types
  • 5.2 By Cancer Type
    • 5.2.1 Breast Cancer
    • 5.2.2 Lung Cancer
    • 5.2.3 Colorectal Cancer
    • 5.2.4 Cervical Cancer
    • 5.2.5 Prostate Cancer
    • 5.2.6 Kidney Cancer
    • 5.2.7 Liver Cancer
    • 5.2.8 Pancreatic Cancer
    • 5.2.9 Ovarian Cancer
    • 5.2.10 Other Cancer Types
  • 5.3 By End User
    • 5.3.1 Hospitals
    • 5.3.2 Diagnostic Laboratories
    • 5.3.3 Academic & Research Institutes
    • 5.3.4 POC / Ambulatory Centres
  • 5.4 By Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 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 as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
    • 6.3.1 Abbott Laboratories
    • 6.3.2 Agilent Technologies
    • 6.3.3 Becton, Dickinson and Company
    • 6.3.4 bioMérieux SA
    • 6.3.5 Bio-Rad Laboratories
    • 6.3.6 Danaher Corporation (Cepheid)
    • 6.3.7 Exact Sciences Corporation
    • 6.3.8 F. Hoffmann-La Roche Ltd
    • 6.3.9 Foundation Medicine
    • 6.3.10 GE HealthCare
    • 6.3.11 Guardant Health
    • 6.3.12 Hologic Inc.
    • 6.3.13 Illumina Inc.
    • 6.3.14 Myriad Genetics
    • 6.3.15 NanoString Technologies
    • 6.3.16 Natera Inc.
    • 6.3.17 NeoGenomics Inc.
    • 6.3.18 PerkinElmer
    • 6.3.19 Qiagen
    • 6.3.20 Siemens Healthineers
    • 6.3.21 Sysmex Corporation
    • 6.3.22 Thermo Fisher Scientific

7. Market Opportunities & Future Outlook

  • 7.1 White-Space & Unmet-Need Assessment
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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 Geography
    • 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 & Africa
      • GCC
      • South Africa
      • Rest of Middle East & Africa
    • South America
      • Brazil
      • Argentina
      • Rest of South 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 SizeAnonymized sourcePrimary gap driver
USD 114.87 B (2025) Mordor Intelligence-
USD 109.61 B (2024) Global Consultancy AExcludes genomic screening assays; static ASP assumptions; biennial updates
USD 17.20 B (2021) Trade Journal BCounts 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.

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Key Questions Answered in the Report

How large will be the cancer diagnostics market in 2026?

The cancer diagnostics market size reached USD 124.1 billion in 2026 and is set to grow at an 8.2% CAGR to 2031.

Which diagnostic type is expanding the fastest?

Genomic and liquid-biopsy platforms are projected to record the highest growth, advancing 9.2% annually through 2031.

Why is Asia-Pacific the fastest-growing region?

National screening mandates in China and India, combined with rising private insurance coverage, drive an 8.9% regional CAGR.

What restraints could slow future growth?

High per-test costs and limited reimbursement in low-income nations remain the main barriers to broader adoption.

Which companies dominate global revenue?

Roche, Abbott, Siemens Healthineers, Thermo Fisher Scientific, and Danaher collectively hold about significant share of revenue.

How are liquid biopsies changing the testing landscape?

Blood-based assays detect recurrence months earlier than imaging, secure expanding reimbursement, and cut reliance on invasive tissue biopsies

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Cancer Diagnostics Market Report Snapshots