Cancer Molecular Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Partnering Opportunities, 2027-2031

Cancer molecular diagnostics are growing at every stage of the cancer journey. This report estimates the global market at $10.56 billion in 2026, growing 11.9% a year to $18.5 billion in 2031, adding $7.94 billion of new annual spending. 96 companies are profiled.

The trends driving growth include:

blood-based colorectal and multi-cancer screening, with new FDA approvals and a Medicare coverage pathway
universal germline testing for colorectal, endometrial and gastric cancer patients under NCCN 2026 guidelines
MRD and monitoring, the fastest-growing application at 20.6% a year
NGS replacing PCR, rising from 39.5% to 48.0% of the market and taking 59% of new spending
at-home sample collection for HPV and colorectal screening
consolidation, led by Abbott's $21 billion acquisition of Exact Sciences and the Hologic take-private

Screening & Early Detection grows 13.5% a year to $4,070 million and MRD & Monitoring 20.6% a year to $2,960 million; together they take 47% of new spending. Therapy Selection & CDx remains the largest application at $3,010 million in 2026, and Lung is the largest cancer type, while Prostate grows fastest at 15.2% a year.

Reagents & Kits are the largest product category at $5,544 million, while Software & Services grow fastest at 16.0% a year. Clinical Laboratories account for 74.5% of spending by 2031. The United States holds 43.3% of the market, and China is the fastest-growing country at 14.3% a year.

"Cancer Molecular Diagnostics Markets" provides data that analysts and planners can use: approved test landscapes, clinical evidence and the test pipeline, technology and pricing, regulation and reimbursement, a China chapter, a deal database, 10 market-moving developments, SWOT and strategic recommendations. Make facilities planning decisions, forecast demand for new tests and technologies, and make research investment decisions.

Assistance in providing specific growth and market size estimates for new technologies or segments is available to purchasers.

The report includes detailed breakouts for 14 countries and regions. A detailed breakout for any country in the world is available to purchasers of the report.

Product Code: CANMDx 1026

List of Tables

List of Figures

1. Executive Summary

1.1 Situation Analysis
1.2 Market Snapshot
1.3 Key Findings
1.4 Investment & Strategic Thesis

2. Research Methodology & Scope

2.1 Forecast Approach
2.2 Data Sources
2.3 Scope & Definitions
2.4 Limitations
2.5 Authors

3. Introduction to Cancer Molecular Diagnostics

3.1 What are Cancer Molecular Diagnostics?
3.2 The Diagnostics Revolution
3.3 The Patient Journey
3.4 Cancer Types and Their Molecular Testing
3.5 Technologies Primer
3.6 How the Market Works
3.7 Perspective: Healthcare Spending
3.8 Industry Structure

4. The Global Market for Cancer Molecular Diagnostics

4.1 Global Market Overview by Country
4.2 Global Market by Cancer Type – Overview
4.3 Global Market by Application – Overview
4.4 Global Market by Technology – Overview
4.5 Global Market by Product – Overview
4.6 Global Market by Customer – Overview

5. Approved Test Landscape

5.1 Routes to Market
5.2 Screening & Early Detection
5.3 Hereditary Risk & Germline
5.4 Diagnosis & Subtyping
5.5 Therapy Selection & Companion Diagnostics
5.6 MRD & Monitoring
5.7 The LDT Landscape
5.8 Key Approvals and Coverage Decisions, 2025–2026

6. Clinical Evidence & Test Pipeline

6.1 Evidence and Market Growth
6.2 Hereditary Risk & Germline
6.3 Screening & Early Detection
6.4 Diagnosis & Subtyping
6.5 Therapy Selection & CDx
6.6 MRD & Monitoring
6.7 Pipeline to Watch, 2027 to 2031

7. Technology Landscape

7.1 Overview
7.2 PCR & Digital PCR
7.3 NGS
7.4 ISH/FISH
7.5 Gene Expression & Microarray
7.6 Isothermal & Other
7.7 Product: Instruments, Reagents & Kits, Software & Services
7.8 Automation, Instruments and Informatics

8. Pharma Partnerships & Business Models

8.1 Pharma as a Customer
8.2 Business Models
8.3 Selected Partnerships
8.4 Economics and Risks

9. Regulatory & Reimbursement Landscape

9.1 United States: FDA
9.2 Europe: The In Vitro Diagnostic Regulation
9.3 China
9.4 Japan
9.5 United States: Reimbursement
9.6 Europe and Other Markets: Reimbursement

10. Intellectual Property, Litigation & Pricing

10.1 Intellectual Property
10.2 Litigation
10.3 Pricing

11. China Cancer Molecular Diagnostics Ecosystem

11.1 Market Overview
11.2 Cancer Burden and Testing Demand
11.3 Domestic Test Makers
11.4 Regulation, Pricing and Market Access
11.5 Illumina, Domestic Sequencers and Geopolitics
11.6 Screening Programmes
11.7 Why China Matters to Global Companies

12. Deal-Making & M&A Analysis

12.1 Deal Database
12.2 Deal Themes
12.3 Valuation Trends
12.4 Outlook for Deal-Making

13. Recent Developments

13.1 Recent Developments – Importance and How to Use This Section
13.2 Abbott Completes $21 Billion Acquisition of Exact Sciences
13.3 FDA Advisory Panel Backs GRAIL's Galleri Multi-Cancer Test
13.4 Medicare MCED Screening Coverage Act Becomes Law
13.5 FDA Approves Freenome SimpleScreen CRC Blood Test; Abbott to Commercialise
13.6 Blood-Based Colorectal Screening Goes Mainstream
13.7 FDA Clears At-Home HPV Self-Collection with Onclarity
13.8 NCCN Recommends Germline Panel Testing for All Colorectal, Endometrial and Gastric Cancer Patients
13.9 FDA Approves Next-Generation Guardant360 Liquid CDx
13.10 Medicare Sets Payment for Illumina TruSight Oncology Comprehensive
13.11 Myriad Expands Precise MRD to Breast, Colorectal and Kidney Cancer

14. Laboratory Operations & Supply Chain

14.1 Where Cancer Molecular Testing Is Done
14.2 Central Laboratories
14.3 Hospital Laboratories and NGS Decentralisation
14.4 Sample Collection: Central, Hospital and Home
14.5 Instrument and Reagent Supply
14.6 Automation and Informatics
14.7 Workforce

15. Competitive Landscape

15.1 Market Structure
15.2 Industry Structure: Players in a Dynamic Market
15.3 Leading Companies by Application and Technology
15.4 Leading Companies
15.5 Emerging Players
15.6 Outlook

16. SWOT, Porter's Five Forces & Investment Risk Analysis

16.1 Factors Driving Growth
16.2 Factors Limiting Growth
16.3 SWOT Analysis
16.4 Porter's Five Forces
16.5 Key Investment Risks

17. Strategic Recommendations

17.1 Guidance for Executives, Marketing, Sales and Business Development
17.2 White-Space Opportunities
17.3 Partnering Strategy Guidance
17.4 Guide for Management Consultants and Investment Advisors

18. Market Forecast by Cancer Type, 2026–2031

18.1 Breast
18.2 Colorectal
18.3 Cervical
18.4 Lung
18.5 Prostate
18.6 Blood Cancers
18.7 Melanoma & Skin
18.8 Other Cancers

19. Market Forecast by Application, 2026–2031

19.1 Hereditary Risk & Germline
19.2 Screening & Early Detection
19.3 Diagnosis & Subtyping
19.4 Therapy Selection & CDx
19.5 MRD & Monitoring

20. Market Forecast by Technology, 2026–2031

20.1 PCR & Digital PCR
20.2 NGS
20.3 ISH/FISH
20.4 Gene Expression & Microarray
20.5 Isothermal & Other

21. Market Forecast by Product, 2026–2031

21.1 Instruments
21.2 Reagents & Kits
21.3 Software & Services

22. Market Forecast by Customer, 2026–2031

22.1 Clinical Laboratories
22.2 Pharma & CRO
22.3 Research

23. Company Profiles

23.1 Abbott (Exact Sciences)
23.2 Agendia
23.3 Agilent Technologies
23.4 Ambry Genetics (Tempus)
23.5 Amoy Diagnostics (AmoyDx)
23.6 ARUP Laboratories
23.7 Aspira Women's Health
23.8 Asuragen (Bio-Techne)
23.9 Berry Oncology
23.10 BGI Genomics
23.11 BillionToOne
23.12 Biocartis
23.13 Biodesix
23.14 Biofidelity
23.15 bioMerieux
23.16 Bio-Rad Laboratories
23.17 Bio-Techne
23.18 Burning Rock Biotech
23.19 CareDx
23.20 Caris Life Sciences
23.21 Castle Biosciences
23.22 Cepheid (Danaher)
23.23 Datar Cancer Genetics
23.24 DELFI Diagnostics
23.25 Diaceutics
23.26 Element Biosciences
23.27 Epic Sciences
23.28 Eurofins Scientific
23.29 Foundation Medicine (Roche)
23.30 Freenome
23.31 Fulgent Genetics
23.32 GeneDx
23.33 Geneoscopy
23.34 Geneplus-Beijing
23.35 Genetron Health
23.36 GRAIL
23.37 Guardant Health
23.38 Harbinger Health
23.39 Hologic
23.40 H.U. Group
23.41 Illumina
23.42 Integrated DNA Technologies (Danaher)
23.43 Interpace Biosciences
23.44 Invivoscribe
23.45 Labcorp
23.46 LetsGetChecked
23.47 Lucence
23.48 Lucid Diagnostics
23.49 Mainz Biomed
23.50 Mayo Clinic Laboratories
23.51 MDxHealth
23.52 Menarini Silicon Biosystems
23.53 Mirxes
23.54 Myriad Genetics
23.55 Natera
23.56 NeoGenomics
23.57 NGeneBio
23.58 Nonacus
23.59 Novogene
23.60 Nucleix
23.61 Oncocyte
23.62 OncoDNA
23.63 OneCell Diagnostics
23.64 Ophiomics
23.65 Oxford Nanopore Technologies
23.66 Pacific Biosciences
23.67 Personalis (Tempus AI)
23.68 Pillar Biosciences
23.69 Precipio
23.70 Predicine
23.71 Promega
23.72 Qiagen
23.73 Quest Diagnostics
23.74 QuidelOrtho
23.75 Revvity
23.76 Roche Diagnostics
23.77 Sansure Biotech
23.78 Seegene
23.79 Siemens Healthineers
23.80 Singlera Genomics
23.81 Sonic Healthcare
23.82 SOPHiA GENETICS
23.83 Synlab
23.84 Sysmex (Sysmex Inostics)
23.85 Takara Bio
23.86 Teal Health
23.87 Tempus AI
23.88 Thermo Fisher Scientific
23.89 Twist Bioscience
23.90 Ultima Genomics
23.91 Unilabs
23.92 Universal DX
23.93 Veracyte
23.94 VolitionRx
23.95 Watchmaker Genomics
23.96 Waters Corporation

24. Appendix

24.1 Abbreviations
24.2 Developments Archive
24.3 Report Limitations Restated

Product Code: CANMDx 1026

List of Tables

Table 1 Leading Cancer Molecular Diagnostic Tests and Platforms
Table 2 Forecast Segments
Table 3 The Cancer Patient Journey and Molecular Testing
Table 4 Cancer Types and Their Main Molecular Tests
Table 5 Global Market by Country
Table 6 Global Market by Cancer Type
Table 7 Global Market by Application
Table 8 Global Market by Technology
Table 9 Global Market by Product
Table 10 Global Market by Customer
Table 11 FDA-Approved Molecular Colorectal Cancer Screening Tests, October 2026
Table 12 Leading FDA-Approved HPV Tests
Table 13 Leading Multi-Cancer Early Detection Tests
Table 14 Selected Hereditary Cancer Tests
Table 15 Leading Gene Expression and Prognostic Tests
Table 16 Selected FDA-Authorised Molecular Tests in Blood Cancers
Table 17 Selected FDA-Approved Therapy Selection and Companion Diagnostic Tests
Table 18 Leading MRD Tests
Table 19 The LDT Landscape by Application
Table 20 Selected Cancer Molecular Diagnostic Approvals and Coverage Decisions, 2025–2026
Table 21 Application Lines: Market Size and Evidence Status
Table 22 Molecular and Comparator CRC Screening Tests: Reported Performance
Table 23 Tumour-Informed and Tumour-Naive MRD Tests
Table 24 Selected Cancer Molecular Diagnostics Pipeline Items, 2027–2031
Table 25 Cancer Molecular Diagnostics by Technology, 2026 and 2031
Table 26 Cancer Molecular Diagnostics by Product, 2026 and 2031
Table 27 Cancer Molecular Diagnostics by Customer, 2026 and 2031
Table 28 Selected Cancer Molecular Diagnostics Partnerships
Table 29 Selected Cancer Molecular Diagnostics Litigation
Table 30 Indicative Prices for Cancer Molecular Diagnostics
Table 31 China Compared with Other Markets, Cancer Molecular Diagnostics
Table 32 Selected Companies in China's Cancer Molecular Diagnostics Market
Table 33 Selected Deals in Cancer Molecular Diagnostics, 2023–2026
Table 34 Cancer Molecular Diagnostics Market by Customer
Table 35 Leading Companies by Application and Technology
Table 36 Factors Driving Growth
Table 37 Factors Limiting Growth
Table 38 Breast by Country
Table 39 Colorectal by Country
Table 40 Cervical by Country
Table 41 Lung by Country
Table 42 Prostate by Country
Table 43 Blood Cancers by Country
Table 44 Melanoma & Skin by Country
Table 45 Other Cancers by Country
Table 46 Hereditary Risk & Germline by Country
Table 47 Screening & Early Detection by Country
Table 48 Diagnosis & Subtyping by Country
Table 49 Therapy Selection & CDx by Country
Table 50 MRD & Monitoring by Country
Table 51 PCR & Digital PCR by Country
Table 52 NGS by Country
Table 53 ISH/FISH by Country
Table 54 Gene Expression & Microarray by Country
Table 55 Isothermal & Other by Country
Table 56 Instruments by Country
Table 57 Reagents & Kits by Country
Table 58 Software & Services by Country
Table 59 Clinical Laboratories by Country
Table 60 Pharma & CRO by Country
Table 61 Research by Country

List of Figures

Figure 1 Key Graphic – Screening and Monitoring Lead: Cancer Molecular Diagnostics Market by Application, 2026 vs 2031
Figure 2 Global Market Pareto Chart
Figure 3 Global Market by Cancer Type - Base vs. Final
Figure 4 Global Market by Cancer Type Base Year
Figure 5 Global Market by Cancer Type End Year
Figure 6 Cancer Type Share by Year
Figure 7 Cancer Type Segments Growth
Figure 8 Global Market by Application - Base vs. Final
Figure 9 Global Market by Application Base Year
Figure 10 Global Market by Application End Year
Figure 11 Application Share by Year
Figure 12 Application Segments Growth
Figure 13 Global Market by Technology - Base vs. Final
Figure 14 Global Market by Technology Base Year
Figure 15 Global Market by Technology End Year
Figure 16 Technology Share by Year
Figure 17 Technology Segments Growth
Figure 18 Global Market by Product - Base vs. Final
Figure 19 Global Market by Product Base Year
Figure 20 Global Market by Product End Year
Figure 21 Product Share by Year
Figure 22 Product Segments Growth
Figure 23 Global Market by Customer - Base vs. Final
Figure 24 Global Market by Customer Base Year
Figure 25 Global Market by Customer End Year
Figure 26 Customer Share by Year
Figure 27 Customer Segments Growth
Figure 28 Health Care Consumption by Age
Figure 29 Cancer Incidence - Age at Diagnosis
Figure 30 Breast Growth
Figure 31 Colorectal Growth
Figure 32 Cervical Growth
Figure 33 Lung Growth
Figure 34 Prostate Growth
Figure 35 Blood Cancers Growth
Figure 36 Melanoma & Skin Growth
Figure 37 Other Cancers Growth
Figure 38 Hereditary Risk & Germline Growth
Figure 39 Screening & Early Detection Growth
Figure 40 Diagnosis & Subtyping Growth
Figure 41 Therapy Selection & CDx Growth
Figure 42 MRD & Monitoring Growth
Figure 43 PCR & Digital PCR Growth
Figure 44 NGS Growth
Figure 45 ISH/FISH Growth
Figure 46 Gene Expression & Microarray Growth
Figure 47 Isothermal & Other Growth
Figure 48 Instruments Growth
Figure 49 Reagents & Kits Growth
Figure 50 Software & Services Growth
Figure 51 Clinical Laboratories Growth
Figure 52 Pharma & CRO Growth
Figure 53 Research Growth

Cancer Molecular Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Partnering Opportunities, 2027-2031

Description

Table of Contents

List of Tables

Report Overview:

Table of Contents

List of Tables

List of Figures

1. Executive Summary

2. Research Methodology & Scope

3. Introduction to Cancer Molecular Diagnostics

4. The Global Market for Cancer Molecular Diagnostics

5. Approved Test Landscape

6. Clinical Evidence & Test Pipeline

7. Technology Landscape

8. Pharma Partnerships & Business Models

9. Regulatory & Reimbursement Landscape

10. Intellectual Property, Litigation & Pricing

11. China Cancer Molecular Diagnostics Ecosystem

12. Deal-Making & M&A Analysis

13. Recent Developments

14. Laboratory Operations & Supply Chain

15. Competitive Landscape

16. SWOT, Porter's Five Forces & Investment Risk Analysis

17. Strategic Recommendations

18. Market Forecast by Cancer Type, 2026–2031

19. Market Forecast by Application, 2026–2031

20. Market Forecast by Technology, 2026–2031

21. Market Forecast by Product, 2026–2031

22. Market Forecast by Customer, 2026–2031

23. Company Profiles

24. Appendix

List of Tables

List of Figures