Companion Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Partnering Opportunities, 2027-2031 (6th Edition)

Companion diagnostics (CDx) are tests that decide whether a patient should receive a particular drug. They range from immunohistochemistry (IHC) stains on a tumour slide to sequencing panels that test hundreds of genes, and blood tests repeated during treatment. Regulators such as the U.S. FDA and the EU under the IVDR treat them as essential to the safe and effective use of the matched therapy.

The past year has brought several firsts: the first companion diagnostic based on minimal residual disease (MRD) testing, Natera’s Signatera CDx; the first liquid biopsy CDx approved for repeat testing during treatment; and a Phase 3 trial that selects patients with an AI-scored pathology test. The FDA renamed its list of companion diagnostics to cover every regulatory route, and the EU’s IVDR reached its main deadline for companion diagnostics in May 2026.

Market Size and Growth Outlook:

This report estimates the global companion diagnostics market at $9.5 billion in 2026, growing at 12.4% a year to $17.1 billion in 2031. Values are at the manufacturer level in constant 2026 U.S. dollars.

Market Size 2026: USD $9.5B Market Size 2031: USD $17.1B CAGR: 12.4%

Key Market Drivers

Comprehensive Panels Replace Single Tests:

Sequencing takes most of the growth. NGS-based companion diagnostics grow 17.5% a year, from $3.3 billion to $7.4 billion, and account for 54% of the $7.6 billion of new spending. Comprehensive panels such as FoundationOne CDx, Guardant360, TruSight Oncology Comprehensive, Oncomine and PGDx elio collect claims across many drugs.

This changes the economics from one test per drug to platforms that serve many drugs. Platform owners with large evidence bases and many claims are best placed, and smaller developers increasingly win by partnering with them or by owning a hard-to-copy biomarker.

Blood Joins Tissue:

Blood-based companion diagnostics grow 19.4% a year, from $2.4 billion to $5.9 billion, and their share rises from 26% to 35%. Companion diagnostics are moving from a single test at diagnosis to monitoring.

The forecast covers the main technologies:

Next-generation sequencing (NGS)
PCR and digital PCR
Immunohistochemistry (IHC)
In situ hybridization (ISH/FISH)
Digital pathology and AI

The September 2026 approval of Guardant360 CDx for camizestrant, with repeat testing every three months, and Signatera CDx for adjuvant immunotherapy show where the market is heading. Tissue remains the largest sample type at $10.5 billion in 2031, but its share falls from 71% to 61%.

Antibody-Drug Conjugates Revive Tissue Testing:

Antibodies and antibody-drug conjugates (ADCs) grow 15.1% a year to $4.7 billion and supply 31% of the growth. HER2-low and HER2-ultralow, CLDN18.2, c-Met and TROP2 all need protein tests on tissue, so IHC is again a growth area after years in the shadow of sequencing.

AI is becoming part of the test. Roche’s AI-scored TROP2 test is selecting patients in the TROPION-Lung17 Phase 3 trial, Tempus bought Paige, and PathAI works with Roche on AI-scored companion diagnostics. Digital pathology and AI is the fastest-growing technology, rising from $190 million to $599 million at 25.7% a year.

Regulation Diverges

The FDA’s list of authorised companion diagnostics passed 170 entries in 2026 and was renamed in July 2026 to cover 510(k), De Novo and humanitarian routes as well as premarket approval. In Europe, companion diagnostics are Class C devices under the IVDR and need a notified body certificate after consultation with a medicines regulator.

In the U.S., a court set aside the FDA’s rule on laboratory-developed tests in 2025, so laboratories can still offer therapy-selection tests without FDA review. Most drugs in late-stage oncology development now have a diagnostic partner, because a test that predicts treatment success can turn a “failed” drug into a success.

Market Segmentation

The report forecasts the market by disease area, therapy class, technology, sample type, product & service and country.

By Technology:

NGS grows from 35% to 43% of the market. PCR grows 9.2% a year to $3.8 billion and IHC 9.1% a year to $3.7 billion, while digital pathology and AI is small but the fastest-growing technology.

By Disease Area:

Lung cancer is the largest disease area, growing from $2.6 billion to $4.1 billion, followed by other solid tumours, breast cancer and blood cancers.

The fastest

growth is outside oncology:

Neurology, growing 33.2% a year as amyloid blood tests select patients for Alzheimer’s drugs

Gene therapy and rare disease, growing 20.7% a year

Cell and gene therapy companion diagnostics, growing 21.0% a year

By therapy class, targeted small molecules remain the largest group at $6.8 billion in 2031, while immunotherapy tests grow 13.4% a year to $4.0 billion.

By Product & Service:

Product and service categories include:

Central laboratory services

Kits & reagents and instruments

Pharma development services

Software & AI

Central laboratory services are the largest category, growing 14.4% a year to $7.2 billion. Kits and reagents grow 9.8% a year to $5.4 billion, pharma development services 14.9% a year to $2.5 billion, and software and AI 26.5% a year to $770 million.

Geographic Trends:

The United States accounts for 43% of global revenue, reaching $7.4 billion in 2031. Europe accounts for about a quarter and grows a little more slowly as the IVDR raises the cost of keeping tests on the market. China is the fastest-growing major market, at 15.1% a year, as its drug industry produces more targeted therapies and antibody-drug conjugates.

Competitive Landscape

Roche, through Roche Tissue Diagnostics and Foundation Medicine, is the largest participant, followed by Agilent, Thermo Fisher Scientific, Illumina, QIAGEN, Guardant Health, Labcorp, Myriad Genetics and Abbott. The report profiles 102 companies.

The industry is reorganising around platforms and data. Tempus bought the AI pathology company Paige, SOPHiA GENETICS signed two decentralised CDx programmes with AstraZeneca, and Leica Biosystems expanded its CDx partnerships to compete with Roche and Agilent in tissue testing. Success depends on pharma relationships, regulatory capability and reach into laboratories and hospitals.

Future Outlook

In the long term, the largest opportunities are in monitoring and in new therapy classes. Repeat blood testing during treatment, AI-scored tissue tests for antibody-drug conjugates and companion diagnostics for gene and cell therapies all expand the market beyond the original one-time test at diagnosis.

Testing is also moving closer to the patient. Distributable kits with fast turnaround, such as Thermo Fisher’s 24-hour Oncomine Dx Express Test and Labcorp’s PGDx elio, and decentralised CDx programmes let hospitals keep samples and data in house.

The main risks are the failure or delay of partners’ drugs, price pressure on comprehensive panels as distributable kits spread, the cost and capacity of IVDR certification in Europe, and uncertainty over how regulators will treat AI-based tests.

Product Code: CANCOMDx 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 Companion Diagnostics

3.1 What are Companion Diagnostics?
3.2 The Personalized Medicine Revolution
3.3 Personalized Medicine and Companion Diagnostics
3.4 Chromosomes, Genes and Epigenetics
3.5 Cancer Genes

4. The Global Market for Companion Diagnostics

4.1 Global Market Overview by Country
4.2 Global Market by Disease Area – Overview
4.3 Global Market by Therapy Class – Overview
4.4 Global Market by Technology – Overview
4.5 Global Market by Sample Type – Overview
4.6 Global Market by Product & Service – Overview

5. Approved Companion Diagnostic Landscape

5.1 FDA-Authorized Companion Diagnostics
5.2 Companion Diagnostic Approvals in 2026
5.3 Companion Diagnostics by Technology
5.4 Leading Laboratory Therapy-Selection Tests
5.5 Companion Diagnostics Outside Oncology

6. Clinical Evidence & Biomarker Pipeline

6.1 The Co-Development Process
6.2 Biomarkers in Development
6.3 From Single Tests to Panels
6.4 Immunotherapy Biomarkers

7. Technology Landscape

7.1 Immunohistochemistry and In Situ Hybridisation
7.2 PCR and Digital PCR
7.3 Next-Generation Sequencing
7.4 Digital Pathology and Artificial Intelligence
7.5 Liquid Biopsy
7.6 Instrumentation and Automation
7.7 Bioinformatics

8. Pharma Partnerships & Business Models

8.1 How Companion Diagnostic Deals Work
8.2 Who Partners with Whom
8.3 Commercial and Biological Rationale

9. Regulatory & Reimbursement Landscape

9.1 United States: FDA and Laboratory-Developed Tests
9.2 Europe: The In Vitro Diagnostic Regulation
9.3 China, Japan and Other Markets
9.4 Reimbursement

10. Intellectual Property, Litigation & Pricing

10.1 Patent Landscape
10.2 Litigation
10.3 Pricing

11. China Companion Diagnostics Ecosystem

11.1 Market Overview
11.2 Key Companies
11.3 Regulation and Market Access
11.4 Why China Matters to Global Companies

12. Deal-Making & M&A Analysis

12.1 Deal Database
12.2 Deal Themes
12.3 Valuation Trends

13. Recent Developments

13.1 Recent Developments – Importance and How to Use This Section
13.2 FDA Approves Guardant360 CDx for Repeat Testing with Camizestrant in Breast Cancer
13.3 Labcorp's PGDx elio Tissue Complete CDx Approved for BRAF Melanoma
13.4 SOPHiA GENETICS and AstraZeneca Agree Two Decentralised CDx Programmes
13.5 FDA Renames Its Companion Diagnostics List
13.6 Agilent PD-L1 Tests Gain New Gastrointestinal Indications
13.7 Roche's VENTANA PTEN Assay Approved with Truqap in Prostate Cancer
13.8 Signatera CDx Becomes the First FDA-Approved MRD Companion Diagnostic
13.9 Leica Biosystems Expands Its CDx Development Partnerships
13.10 Phase 3 Trial Selects Patients with an AI-Scored TROP2 Test
13.11 EU IVDR Deadline for Companion Diagnostics

14. Laboratory Operations & Supply Chain

14.1 Central Laboratories vs. Hospital Laboratories
14.2 Decentralisation of Companion Diagnostics
14.3 Physician Offices and Point of Care
14.4 Instrument and Reagent Supply

15. Competitive Landscape

15.1 Market Structure
15.2 Healthcare and the IVD Industry
15.3 Leading Companies
15.4 Emerging Players
15.5 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

18. Market Forecast by Disease Area, 2026–2031

18.1 Lung
18.2 Breast
18.3 Colorectal
18.4 Blood Cancers
18.5 Other Solid Tumours
18.6 Gene Therapy & Rare Disease
18.7 Neurology
18.8 Other

19. Market Forecast by Therapy Class, 2026–2031

19.1 Targeted Small Molecules
19.2 Antibodies & ADCs
19.3 Immunotherapy
19.4 Cell & Gene Therapy
19.5 Other Therapy

20. Market Forecast by Technology, 2026–2031

20.1 NGS
20.2 PCR & Digital PCR
20.3 IHC
20.4 ISH/FISH
20.5 Digital Pathology & AI
20.6 Other Technology

21. Market Forecast by Sample Type, 2026–2031

21.1 Tissue
21.2 Blood (Liquid Biopsy)
21.3 Other Sample

22. Market Forecast by Product & Service, 2026–2031

22.1 Central Lab Services
22.2 Kits & Reagents
22.3 Instruments
22.4 Pharma Development Services
22.5 Software & AI

23. Company Profiles

23.1 Abbott Laboratories
23.2 AccuraGen
23.3 AcuamarkDx
23.4 Adaptive Biotechnologies
23.5 Admera Health
23.6 Agilent Technologies
23.7 Amoy Diagnostics (AmoyDx)
23.8 AnchorDx (Kindstar Globalgene)
23.9 ANGLE plc
23.10 ARUP Laboratories
23.11 Beckman Coulter (Danaher)
23.12 Becton, Dickinson and Company (BD)
23.13 BGI Genomics
23.14 BillionToOne
23.15 Bioarray Genetics
23.16 Biocartis
23.17 Biodesix
23.18 BioFluidica
23.19 BioGenex
23.20 Biolidics
23.21 bioMerieux
23.22 Bioneer
23.23 Bio-Rad Laboratories
23.24 Bio-Techne
23.25 BioView
23.26 Bristol Myers Squibb
23.27 Burning Rock Biotech
23.28 Caris Life Sciences
23.29 Castle Biosciences
23.30 CellCarta
23.31 CellMax Life
23.32 Cepheid (Danaher)
23.33 Charles River Laboratories
23.34 Circulogene
23.35 Cizzle Biotechnology
23.36 Clinical Genomics
23.37 Datar Cancer Genetics
23.38 Diaceutics
23.39 Dxcover
23.40 Element Biosciences
23.41 Epic Sciences
23.42 Eurofins Scientific
23.43 Exact Sciences (Abbott)
23.44 Fluxion Biosciences
23.45 Foundation Medicine (Roche)
23.46 Freenome
23.47 Fujirebio
23.48 FYR Diagnostics (FYR Bio)
23.49 GeneFirst
23.50 Genetron Health
23.51 GenomOncology
23.52 Guardant Health
23.53 HansaBioMed Life Sciences (Lonza)
23.54 HLB Panagene
23.55 Ibex Medical Analytics
23.56 iCellate Medical
23.57 ICON plc
23.58 Illumina
23.59 INOVIQ
23.60 Invivoscribe
23.61 Johnson & Johnson Innovative Medicine
23.62 Labcorp
23.63 Leica Biosystems (Danaher)
23.64 Lucence
23.65 MDxHealth
23.66 Menarini Silicon Biosystems
23.67 MilliporeSigma (Merck KGaA)
23.68 Miltenyi Biotec
23.69 miR Scientific
23.70 Myriad Genetics
23.71 Natera
23.72 NeoGenomics
23.73 NGeneBio
23.74 Novogene
23.75 Oncocyte
23.76 OncoDNA
23.77 OncoHost
23.78 Oxford Nanopore Technologies
23.79 PathAI
23.80 Personalis (Tempus AI)
23.81 Pillar Biosciences
23.82 Precipio
23.83 Predicine
23.84 Promega
23.85 Qiagen
23.86 Quest Diagnostics
23.87 Rarecells Diagnostics
23.88 RareCyte
23.89 Revvity
23.90 Roche Diagnostics
23.91 ScreenCell
23.92 Singlera Genomics
23.93 SkylineDx
23.94 SOPHiA GENETICS
23.95 Standard BioTools
23.96 Sysmex (Sysmex Inostics)
23.97 Tempus AI
23.98 Thermo Fisher Scientific
23.99 Ultima Genomics
23.100 Veracyte
23.101 Visiopharm
23.102 VolitionRx

24. Appendix

24.1 Abbreviations
24.2 Report Limitations Restated
24.3 Developments Archive
24.4 IVD Test Menu and Fee Data

Product Code: CANCOMDx 1026

List of Tables

Table 1 Leading Companion Diagnostic Tests and Platforms
Table 2 Forecast Segments
Table 3 The Base Pairs
Table 4 Global Market by Country
Table 5 Global Market by Disease Area
Table 6 Global Market by Therapy Class
Table 7 Global Market by Technology
Table 8 Global Market by Sample Type
Table 9 Global Market by Product & Service
Table 10 FDA Approved Companion Dx
Table 11 Selected Companion Diagnostic Approvals, 2026
Table 12 Companion Diagnostics by Technology
Table 13 Leading Laboratory Therapy-Selection Tests
Table 14 Selected Biomarkers in Development
Table 15 Selected Companion Diagnostic Partnerships
Table 16 Selected Companies in China
Table 17 Selected Companion Diagnostic Deals
Table 18 Market Players by Type
Table 19 Factors Driving Growth
Table 20 Factors Limiting Growth
Table 21 Lung by Country
Table 22 Breast by Country
Table 23 Colorectal by Country
Table 24 Blood Cancers by Country
Table 25 Other Solid Tumours by Country
Table 26 Gene Therapy & Rare Disease by Country
Table 27 Neurology by Country
Table 28 Other by Country
Table 29 Targeted Small Molecules by Country
Table 30 Antibodies & ADCs by Country
Table 31 Immunotherapy by Country
Table 32 Cell & Gene Therapy by Country
Table 33 Other Therapy by Country
Table 34 NGS by Country
Table 35 PCR & Digital PCR by Country
Table 36 IHC by Country
Table 37 ISH/FISH by Country
Table 38 Digital Pathology & AI by Country
Table 39 Other Technology by Country
Table 40 Tissue by Country
Table 41 Blood (Liquid Biopsy) by Country
Table 42 Other Sample by Country
Table 43 Central Lab Services by Country
Table 44 Kits & Reagents by Country
Table 45 Instruments by Country
Table 46 Pharma Development Services by Country
Table 47 Software & AI by Country
Table 48 Clinical Laboratory Fee Schedule
Table 49 The Most Common Assays
Table 50 Largest Revenue Assays

List of Figures

Figure 1 Key Graphic – Blood Joins Tissue: Companion Diagnostics Market by Sample Type, 2026 vs 2031
Figure 1 DNA Strands and Chromosomes
Figure 2 Karyogram of Human Chromosomes
Figure 3 Size of Various Genomes
Figure 4 Germline vs Somatic Mutations
Figure 5 Global Market Pareto Chart
Figure 6 Global Market by Disease Area - Base vs. Final
Figure 7 Global Market by Disease Area Base Year
Figure 8 Global Market by Disease Area End Year
Figure 9 Disease Area Share by Year
Figure 10 Disease Area Segments Growth
Figure 11 Global Market by Therapy Class - Base vs. Final
Figure 12 Global Market by Therapy Class Base Year
Figure 13 Global Market by Therapy Class End Year
Figure 14 Therapy Class Share by Year
Figure 15 Therapy Class Segments Growth
Figure 16 Global Market by Technology - Base vs. Final
Figure 17 Global Market by Technology Base Year
Figure 18 Global Market by Technology End Year
Figure 19 Technology Share by Year
Figure 20 Technology Segments Growth
Figure 21 Global Market by Sample Type - Base vs. Final
Figure 22 Global Market by Sample Type Base Year
Figure 23 Global Market by Sample Type End Year
Figure 24 Sample Type Share by Year
Figure 25 Sample Type Segments Growth
Figure 26 Global Market by Product & Service - Base vs. Final
Figure 27 Global Market by Product & Service Base Year
Figure 28 Global Market by Product & Service End Year
Figure 29 Product & Service Share by Year
Figure 30 Product & Service Segments Growth
Figure 31 The Codevelopment Process
Figure 32 The Real Cost to Sequence the Human Genome
Figure 33 Centralized vs. Decentralized Laboratory Service
Figure 34 Global Healthcare Spending
Figure 35 The Changing Age of The World’s Population
Figure 36 Lung Growth
Figure 37 Breast Growth
Figure 38 Colorectal Growth
Figure 39 Blood Cancers Growth
Figure 40 Other Solid Tumours Growth
Figure 41 Gene Therapy & Rare Disease Growth
Figure 42 Neurology Growth
Figure 43 Other Growth
Figure 44 Targeted Small Molecules Growth
Figure 45 Antibodies & ADCs Growth
Figure 46 Immunotherapy Growth
Figure 47 Cell & Gene Therapy Growth
Figure 48 Other Therapy Growth
Figure 49 NGS Growth
Figure 50 PCR & Digital PCR Growth
Figure 51 IHC Growth
Figure 52 ISH/FISH Growth
Figure 53 Digital Pathology & AI Growth
Figure 54 Other Technology Growth
Figure 55 Tissue Growth
Figure 56 Blood (Liquid Biopsy) Growth
Figure 57 Other Sample Growth
Figure 58 Central Lab Services Growth
Figure 59 Kits & Reagents Growth
Figure 60 Instruments Growth
Figure 61 Pharma Development Services Growth
Figure 62 Software & AI Growth

Companion Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Partnering Opportunities, 2027-2031 (6th Edition)

Description

Table of Contents

List of Tables

Market Overview:

Market Size and Growth Outlook:

Key Market Drivers

Blood Joins Tissue:

Antibody-Drug Conjugates Revive Tissue Testing:

Market Segmentation

Geographic Trends:

Competitive Landscape

Future Outlook

Table of Contents

List of Tables

List of Figures

1. Executive Summary

2. Research Methodology & Scope

3. Introduction to Companion Diagnostics

4. The Global Market for Companion Diagnostics

5. Approved Companion Diagnostic Landscape

6. Clinical Evidence & Biomarker Pipeline

7. Technology Landscape

8. Pharma Partnerships & Business Models

9. Regulatory & Reimbursement Landscape

10. Intellectual Property, Litigation & Pricing

11. China Companion 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 Disease Area, 2026–2031

19. Market Forecast by Therapy Class, 2026–2031

20. Market Forecast by Technology, 2026–2031

21. Market Forecast by Sample Type, 2026–2031

22. Market Forecast by Product & Service, 2026–2031

23. Company Profiles

24. Appendix

List of Tables

List of Figures