Table of Content

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines


2. EXECUTIVE SUMMARY


3. INTRODUCTION
3.1. Chapter Overview
3.2. Evolution of Personalized Medicines
3.3. Overview of Companion Diagnostics
3.3.1. Development of Companion Diagnostics
3.3.2. Analytical Techniques Used in Companion Diagnostic Tests
3.3.2.1. Immunohistochemistry
3.3.2.2. In situ Hybridization
3.3.2.3. Polymerase Chain Reaction (PCR)
3.3.2.4. DNA Sequencing / Next Generation Sequencing
3.3.2.5. Liquid Biopsy
3.3.2.6. Flow Cytometry
3.3.3. Advantages of Companion Diagnostics
3.4. Applications of Companion Diagnostics across Different Therapeutic Areas
3.4.1. Oncology
3.4.2. Infectious Diseases
3.4.3. Neurological Disorders
3.5. Regulatory Review and Approval Process for Companion Diagnostics
3.6. Existing Challenges
3.7. Key Guidelines for Selecting a Contract Diagnostics Organization (CDO)
3.8. Future Perspectives


4. COMPANION DIAGNOSTICS SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Companion Diagnostics Service Providers: List of Players
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Company Ownership
4.2.4. Analysis by Location of Headquarters
4.2.5. Analysis by Type of Service Offered
4.2.6. Analysis by Other Affiliated Services Offered
4.2.7. Analysis by Type of Analytical Technique Used
4.2.8. Analysis by Therapeutic Area
4.2.9. Grid Representation: Analysis by Company Size, Location of Headquarters and Type of Service Offered
4.2.10. Grid Representation: Analysis by Company Size, Location of Headquarters and Type of Analytical Technique Used
4.2.11. Analysis by Regulatory Accreditation / Certification


5. COMPANION DIAGNOSTICS SERVICE PROVIDERS: COMPANY COMPETITIVENESS ANALYSIS
5.1 Chapter Overview
5.2 Methodology
5.3 Assumptions / Key Parameters
5.4 Competitiveness Analysis: Companion Diagnostics Service Providers
5.4.1 Companion Diagnostics Service Providers based in North America
5.4.2 Companion Diagnostics Service Providers based in Europe
5.4.3 Companion Diagnostics Service Providers based in Asia-Pacific and Rest of the World
5.5. Summary of Key Players


6. COMPANION DIAGNOSTICS SERVICE PROVIDERS: COMPANY PROFILES
6.1. Chapter Overview
6.2. Key Players in North America
6.2.1. Geneuity Clinical Research Services
6.2.1.1. Company Overview
6.2.1.2. Service Portfolio
6.2.1.3. Recent Developments and Future Outlook
6.2.2. Interpace Biosciences
6.2.2.1. Company Overview
6.2.2.2. Service Portfolio
6.2.2.3. Financial Information
6.2.2.4. Recent Developments and Future Outlook
6.2.3. Labcorp (formerly known as Covance)
6.2.3.1. Company Overview
6.2.3.2. Service Portfolio
6.2.3.3. Financial Information
6.2.3.4. Recent Developments and Future Outlook
6.2.4. Quest Diagnostics
6.2.4.1. Company Overview
6.2.4.2. Service Portfolio
6.2.4.3. Financial Information
6.2.4.4. Recent Developments and Future Outlook
6.2.5. Q? Solutions
6.2.5.1. Company Overview
6.2.5.2. Service Portfolio
6.2.5.3. Financial Information
6.2.5.4. Recent Developments and Future Outlook
6.2.6. ResearchDx
6.2.6.1. Company Overview
6.2.6.2. Service Portfolio
6.2.6.3. Recent Developments and Future Outlook
6.3. Key Players in Europe
6.3.1. Almac Diagnostic Services
6.3.1.1. Company Overview
6.3.1.2. Service Portfolio
6.3.1.3. Financial Information
6.3.1.4. Recent Developments and Future Outlook
6.3.2. Biocartis
6.3.2.1. Company Overview
6.3.2.2. Service Portfolio
6.3.2.3. Financial Information
6.3.2.4. Recent Developments and Future Outlook
6.3.3. Cerba Research
6.3.3.1. Company Overview
6.3.3.2. Service Portfolio
6.3.3.3. Recent Developments and Future Outlook
6.3.4. Eurofins
6.3.4.1. Company Overview
6.3.4.2. Service Portfolio
6.3.4.3. Financial Information
6.3.4.4. Recent Developments and Future Outlook
6.3.5. MLM Medical Labs
6.3.5.1. Company Overview
6.3.5.2. Service Portfolio
6.3.5.3. Recent Developments and Future Outlook
6.3.6. QIAGEN
6.3.6.1. Company Overview
6.3.6.2. Service Portfolio
6.3.6.3. Financial Information
6.3.6.4. Recent Developments and Future Outlook
6.4. Key Players in Asia-Pacific and Rest of the World
6.4.1. BGI Genomics
6.4.1.1. Company Overview
6.4.1.2. Service Portfolio
6.4.1.3. Recent Developments and Future Outlook
6.4.2. MEDx (Suzhou) Translational Medicine (formerly known as QIAGEN (Suzhou) Translational Medicine)
6.4.2.1. Company Overview
6.4.2.2. Service Portfolio
6.4.2.3. Recent Developments and Future Outlook
6.4.3. MEDICAL & BIOLOGICAL LABORATORIES (MBL)
6.4.3.1. Company Overview
6.4.3.2. Service Portfolio
6.4.3.3. Recent Developments and Future Outlook
6.4.4. Novogene
6.4.4.1. Company Overview
6.4.4.2. Service Portfolio
6.4.4.3. Recent Developments and Future Outlook


7. COMPANION DIAGNOSTICS: MARKET LANDSCAPE
7.1. Chapter Overview
7.2. Companion Diagnostics: List of Marketed Products / Investigational Programs
7.2.1. Analysis by Assay Technique Used
7.2.2. Analysis by Target Disease Indication
7.2.3. Analysis by Therapeutic Area
7.2.4. Analysis by Type of Biomarker Detected
7.2.5. Analysis by Chemical Nature of Biomarker
7.2.6. Analysis by Type of Sample Used
7.2.7. Analysis by Commercial Availability and Therapeutic Area
7.2.8. Investigational Programs: Analysis by Year of Initiation of Development
7.2.9. Marketed Products: Analysis by Year of Approval
7.2.10. Marketed Products: Analysis by Regulatory Authority Involved
7.2.11. Marketed Products: Analysis by Year of Approval and Regulatory Authority Involved
7.2.12. Marketed Products: Analysis by Expediated Review Designation and Type of Biomarker
7.2.13. Heat Map Representation: Analysis by Target Disease Indication and Assay Technique Used
7.3. Companion Diagnostic Devices: List of Developers
7.3.1. Analysis by Year of Establishment
7.3.2. Analysis by Company Size
7.3.3. Analysis by Company Ownership
7.3.4. Analysis by Location of Headquarters
7.3.5. Most Active Players: Analysis by Number of Marketed Products and Investigational Programs
7.3.6. Most Active Players: Analysis by Number of Marketed Products
7.3.7. Most Active Players: Analysis by Number of Target Disease Indications


8. PARTNERSHIPS AND COLLABORATIONS
8.1. Chapter Overview
8.2. Partnership Models
8.3. List of Partnerships and Collaborations
8.3.1. Analysis by Year of Partnership
8.3.2. Analysis by Type of Partnership
8.3.3. Analysis by Type of Partner
8.3.4. Analysis by Year of Partnership and Type of Partner
8.3.5. Analysis by Type of Partnership and Type of Partner
8.3.6. Analysis by Therapeutic Area
8.3.7. Most Active Players: Analysis by Number of Partnerships
8.3.8. Regional Analysis
8.3.9. Intercontinental and Intracontinental Agreements
9. LIKELY PARTNER ANALYSIS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Scoring Criteria and Key Assumptions
9.4. Likely Partners for Companion Diagnostics Service Providers: Alzheimer?s Disease
9.4.1. Potential Strategic Partners for Initiatives on Amyloid Beta Biomarker
9.4.1.1. Companies Working on the Amyloid Beta Biomarker
9.4.1.2. World Map Representation: Amyloid Beta Biomarker Focused Clinical Trials
9.4.2. Potential Strategic Partners for Initiatives on Tau Biomarker
9.4.2.1. Companies Working on the Tau Biomarker
9.4.2.2. World Map Representation: Tau Biomarker Focused Clinical Trials
9.5. Likely Partners for Companion Diagnostics Service Providers: Breast Cancer
9.5.1. Potential Strategic Partners for Initiatives on BRCA Biomarker
9.5.1.1. Companies Working on the BRCA Biomarker
9.5.1.2. World Map Representation: BRCA Biomarker Focused Clinical Trials
9.5.2. Potential Strategic Partners for Initiatives on HER Biomarker
9.5.2.1. Companies Working on the HER Biomarker
9.5.2.2. World Map Representation: HER Biomarker Focused Clinical Trials
9.5.3. Potential Strategic Partners for Initiatives on HR Biomarker
9.5.3.1. Companies Working on the HR Biomarker
9.5.3.2. World Map Representation: HR Biomarker Focused Clinical Trials
9.5.4. Potential Strategic Partners for Initiatives on PD-L1 Biomarker
9.5.4.1. Companies Working on the PD-L1 Biomarker
9.5.4.2. World Map Representation: PD-L1 Biomarker Focused Clinical Trials
9.6. Likely Partners for Companion Diagnostics Service Providers: Colorectal Cancer
9.6.1. Potential Strategic Partners for Initiatives on BRAF Biomarker
9.6.1.1. Companies Working on the BRAF Biomarker
9.6.1.2. World Map Representation: BRAF Biomarker Focused Clinical Trials
9.6.2. Potential Strategic Partners for Initiatives on EGFR Biomarker
9.6.2.1. Companies Working on the EGFR Biomarker
9.6.2.2. World Map Representation: EGFR Biomarker Focused Clinical Trials
9.6.3. Potential Strategic Partners for Initiatives on KRAS Biomarker
9.6.3.1. Companies Working on the KRAS Biomarker
9.6.3.2. World Map Representation: KRAS Biomarker Focused Clinical Trials
9.6.4. Potential Strategic Partners for Initiatives on MSI Biomarker
9.6.4.1. Companies Working on the MSI Biomarker
9.6.4.2. World Map Representation: MSI Biomarker Focused Clinical Trials
9.6.5. Potential Strategic Partners for Initiatives on NRAS Biomarker
9.6.5.1. Companies Working on the NRAS Biomarker
9.6.5.2. World Map Representation: NRAS Biomarker Focused Clinical Trials
9.7. Likely Partners for Companion Diagnostic Service Providers: HIV
9.7.1. Potential Strategic Partners for Initiatives on CCR5 Biomarker
9.7.1.1. Companies Working on the CCR5 Biomarker
9.7.1.2. World Map Representation: CCR5 Biomarker Focused Clinical Trials
9.8. Likely Partners for Companion Diagnostics Service Providers: Lung Cancer
9.8.1. Potential Strategic Partners for Initiatives on ALK Biomarker
9.8.1.1. Companies Working on the ALK Biomarker
9.8.1.2. World Map Representation: ALK Biomarker Focused Clinical Trials
9.8.2. Potential Strategic Partners for Initiatives on EGFR Biomarker
9.8.2.1. Companies Working on the EGFR Biomarker
9.8.2.2. World Map Representation: EGFR Biomarker Focused Clinical Trials
9.8.3. Potential Strategic Partners for Initiatives on PD-L1 Biomarker
9.8.3.1. Companies Working on the PD-L1 Biomarker
9.8.3.2. World Map Representation: PD-L1 Biomarker Focused Clinical Trials
9.8.4. Potential Strategic Partners for Initiatives on RET Biomarker
9.8.4.1. Companies Working on the RET Biomarker
9.8.4.2. World Map Representation: RET Biomarker Focused Clinical Trials
9.8.5. Potential Strategic Partners for Initiatives on ROS Biomarker
9.8.5.1. Companies Working on the ROS Biomarker
9.8.5.2. World Map Representation: ROS Biomarker Focused Clinical Trials
9.9. Likely Partners for Companion Diagnostics Service Providers: NASH / NAFLD
9.9.1. Potential Strategic Partners for Initiatives on AST Biomarker
9.9.1.1. Companies Working on the AST Biomarker
9.9.1.2. World Map Representation: AST Biomarker Focused Clinical Trials
9.10. Likely Partners for Companion Diagnostics Service Providers: Ovarian Cancer
9.10.1. Potential Strategic Partners for Initiatives on BRCA Biomarker
9.10.1.1. Companies Working on the BRCA Biomarker
9.10.1.2. World Map Representation: BRCA Biomarker Focused Clinical Trials
9.10.2. Potential Strategic Partners for Initiatives on CA-125 Biomarker
9.10.2.1. Companies Working on the CA-125 Biomarker
9.10.2.2. World Map Representation: CA-125 Biomarker Focused Clinical Trials
9.11. Likely Partners for Companion Diagnostics Service Providers: Prostate Cancer
9.11.1. Potential Strategic Partners for Initiatives on AR-V7 Biomarker
9.11.1.1. Companies Working on the AR-V7 Biomarker
9.11.1.2. World Map Representation: AR-V7 Biomarker Focused Clinical Trials


10. MERGERS AND ACQUISITONS
10.1. Chapter Overview
10.2. Merger and Acquisition Models
10.3. List of Mergers and Acquisitions
10.3.1. Analysis by Type of Deal
10.3.2. Analysis by Year of Deal
10.3.3. Regional Analysis
10.3.3.1. Continent-wise Distribution
10.3.3.2. Intercontinental and Intracontinental Deals
10.3.3.3. Country-wise Distribution
10.3.4. Analysis by Company Size
10.3.5. Ownership Change Matrix
10.3.6. Analysis by Key Value Drivers
10.3.7. Valuation Analysis: Acquisition Deal Multiples
10.3.8. Key Players: Analysis by Number of Deals


11. STAKEHOLDER NEEDS ANALYSIS
11.1. Chapter Overview
11.2. Companion Diagnostics: Needs of Different Stakeholders
11.3. Comparison of Needs of Various Stakeholders
11.3.1. Needs of Drug Developers
11.3.2. Needs of Companion Diagnostics Developers
11.3.3. Needs of Regulatory Authorities
11.3.4. Needs of Testing Laboratories
11.3.5. Needs of Payers / Insurance Providers
11.3.6. Needs of Physicians
11.3.7. Needs of Patients


12. VALUE CHAIN ANALYSIS
12.1. Chapter Overview
12.2. Companion Diagnostics Value Chain: Cost Distribution
12.2.1. Research and Product Development
12.2.2. Manufacturing and Assembly
12.2.3. Clinical Trials, FDA Approval and Other Administrative Tasks
12.2.4. Payer Negotiation and KOL Engagement
12.2.5. Marketing and Sales
12.3. Companion Diagnostics Development Operations: Key Cost Contributors
12.4. Companion Diagnostics Co-Development Operations: Key Cost Contributors


13. CLINICAL RESEARCH ON CANCER BIOMARKERS: BIG PHARMA PERSPECTIVE
13.1. Chapter Overview
13.2. Methodology
13.3. Big Pharma Sponsored Biomarker Focused Clinical Trials: List of Likely Drug Candidates for IVD Developers
13.4. Clinical Trial Analysis
13.4.1. Analysis of Trials by Trial Registration Year
13.4.2. Analysis of Trials by Phase of Development
13.4.3. Analysis of Trials by Sponsor
13.4.4. Analysis of Trials by Recruitment Status
13.4.5. Analysis of Trials by Therapy Design
13.4.6. Analysis of Trials by Geography
13.4.7. Analysis of Trials by Enrolled Patient Population
13.4.8. Analysis of Trials by Popularity of Biomarkers
13.4.8.1. Most Popular Biomarkers
13.4.8.2. Moderately Popular Biomarkers
13.4.8.3. Less Popular / Preliminary Stage Biomarkers
13.4.8.4. Other Emerging Biomarkers: Word Cloud
13.4.8.5. Analysis of Trials of Most Popular Biomarkers by Trial Registration Year
13.4.8.6. Analysis of Trials of Moderately Popular Biomarkers by Trial Registration Year
13.4.8.7. Analysis of Trials of Less Popular Biomarkers by Trial Registration Year
13.4.8.8. Analysis of Trials of Most Popular Biomarkers by Phase of Development
13.4.8.9. Analysis of Trials of Moderately Popular Biomarkers by Phase of Development
13.4.8.10. Analysis of Trials of Less Popular and Other Biomarkers by Phase of Development
13.4.8.11. Analysis of Trials of Most Popular Biomarkers by Sponsors
13.4.8.12. Analysis of Trials of Moderately Popular Biomarkers by Sponsors
13.4.8.13. Analysis of Trials of Less Popular and Other Biomarkers by Sponsors
13.4.9. Analysis of Trials by Popularity of Indications
13.4.9.1. Most Popular Indications
13.4.9.2. Moderately Popular Indications
13.4.9.3 Less Popular and Other Indications
13.4.9.4. Other Emerging Indications: Word Cloud
13.4.9.5. Analysis of Trials of Most Popular Indications by Trial Registration Year
13.4.9.6. Analysis of Trials of Moderately Popular Indications by Trial Registration Year
13.4.9.7. Analysis of Trials of Less Popular / Preliminary Stage Indications by Trial Registration Year
13.4.9.8. Analysis of Trials of Most Popular Indications by Phase of Development
13.4.9.9. Analysis of Trials of Moderately Popular Indications by Phase of Development
13.4.9.10. Analysis of Trials of Less Popular / Preliminary Stage Indications by Phase of Development
13.4.9.11. Analysis of Trials of Less Popular / Preliminary Stage Indications by Trial Registration Year
13.4.9.12. Analysis of Trials of Most Popular Indications by Sponsor
13.4.9.13. Analysis of Trials of Moderately Popular Indications by Sponsor
13.4.9.14. Analysis of Trials of Less Popular / Preliminary Stage Indications by Sponsor
13.5. Clinical Trials Summary

14. CASE STUDY ON BIOMARKER-DRIVEN TARGETED THERAPIES IN USE WITH COMPANION DIAGNOSTICS
14.1. Chapter Overview
14.2. Biomarker-Driven Targeted Therapies: Pipeline Review
14.2.1. Analysis by Commercial Availability
14.2.2. Analysis by Type of Molecule
14.2.3. Analysis by Commercial Availability and Type of Molecule
14.2.4. Analysis by Route of Administration
14.2.5. Leading Biomarker-Driven Targeted Therapies: Analysis by Number of Companion Diagnostic Products / Programs
14.3. Biomarker-Driven Targeted Therapies: Developer Landscape
14.3.1. Analysis by Year of Establishment
14.3.2. Analysis by Company Size
14.3.3. Analysis by Company Ownership
14.3.4. Analysis by Location of Headquarters
14.3.5. Leading Players: Analysis by Number of Drugs
14.4. Heat Map Representation: Analysis by Company Size, Location of Headquarters and Commercial Availability of Drug


15. CASE STUDY ON PRECISION MEDICINE SOFTWARE SOLUTIONS
15.1. Chapter Overview
15.2. Precision Medicine Software Solutions: List of Products
15.2.1. Analysis by Type of Platform
15.2.2. Analysis by Purpose of Software Applications
15.2.3. Analysis by Type of Data Handled
15.2.4. Analysis by Therapeutic Area
15.2.5. Analysis by Type of End User
15.3. Precision Medicine Software Solutions: List of Developers
15.3.1. Analysis by Year of Establishment
15.3.2. Analysis by Company Size
15.3.3. Analysis by Location of Headquarters


16. COMPANION DIAGNOSTICS SERVICE PROVIDERS: MARKET FORECAST AND OPPORTUNITY ANALYSIS
16.1 Chapter Overview
16.2. Key Assumptions and Forecast Methodology
16.3. Global Companion Diagnostics Services Market, 2022-2035
16.3.1. Global Companion Diagnostics Services Market: Distribution by Type of Service Offered, 2022-2035
16.3.2. Global Companion Diagnostics Services Market: Distribution by Type of Analytical Technique Used, 2022-2035
16.3.3. Global Companion Diagnostics Services Market: Distribution by Therapeutic Area, 2022-2035
16.3.4. Global Companion Diagnostics Services Market: Distribution by Region, 2022-2035
16.4. Companion Diagnostics Services Market in North America, 2022-2035
16.4.1. Companion Diagnostics Services Market in North America: Distribution by Type of Service Offered, 2022-2035
16.4.2. Companion Diagnostics Services Market in North America: Distribution by Type of Analytical Technique Used, 2022-2035
16.4.3. Companion Diagnostics Services Market in North America: Distribution by Therapeutic Area, 2022-2035
16.5. Companion Diagnostics Services Market in Europe, 2022-2035
16.5.1. Companion Diagnostics Services Market in Europe: Distribution by Type of Service Offered, 2022-2035
16.5.2. Companion Diagnostics Services Market in Europe: Distribution by Type of Analytical Technique Used, 2022-2035
16.5.3. Companion Diagnostics Services Market in Europe: Distribution by Therapeutic Area, 2022-2035
16.6. Companion Diagnostics Services Market in Asia-Pacific and Rest of the World, 2022-2035
16.6.1. Companion Diagnostics Services Market in Asia-Pacific and Rest of the World: Distribution by Type of Service Offered, 2022-2035
16.6.2. Companion Diagnostics Services Market in Asia-Pacific and Rest of the World: Distribution by Type of Analytical Technique Used, 2022-2035
16.6.3. Companion Diagnostics Services Market in Asia-Pacific and Rest of the World: Distribution by Therapeutic Area, 2022-2035


17. EXECUTIVE INSIGHTS
17.1. Chapter Overview
17.2. Genomenon
17.2.1. Company Snapshot
17.2.2. Interview Transcript: Mike Klein, Chief Executive Officer; Mark Kiel, Founder and Chief Scientific Officer; and Candace Chapman, Vice President of Marketing
17.3. Tymora Analytical Operations
17.3.1. Company Snapshot
17.3.2. Interview Transcript: Anton Iliuk, President and Chief Technology Officer
17.4. Novodiax
17.4.1. Company Snapshot
17.4.2. Interview Transcript: Paul Kortschak, Former Senior Vice President
17.5. OWL Metabolomics
17.5.1. Company Snapshot
17.5.2. Interview Transcript: Pablo Ortiz, Chief Executive Officer
17.6. NeoGenomics Laboratories
17.6.1. Company Snapshot
17.6.2. Interview Transcript: Lawrence M. Weiss, Former Chief Scientific Officer

18. CONCLUDING REMARKS
18.1. Chapter Overview
18.2. Key Takeaways

19. APPENDIX 1: TABULATED DATA

20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS