Roots Analysis has done a detailed report on Companion Diagnostics Development Services Market covering key aspects of the industry and identifying future growth opportunities.

Key Market Insights
• Over 180 companies from different regions across the globe presently claim to provide services for the development of companion diagnostic tests
• Currently, a variety of services are available across the entire diagnostics development supply chain, including assays based on a wide range of analytical techniques, especially in the developed geographies
• Numerous pharmaceutical players are actively seeking to enter into partnership with companion diagnostics service providers, in order to leverage the latter’s expertise in this field
• The rise in interest in this field is reflected in the number of partnerships established in the recent past, involving both international and indigenous stakeholders, and focused on a variety of end objectives
• In order to achieve an edge over the contemporary competition, companies engaged in this domain are increasingly focusing on the integration of advanced service offerings in their respective portfolios
• The value chain involves drug and diagnostics developers, service providers, along with other important stakeholders, each having a discrete set of priorities and requirements
• Given the growing demand for precision medicine, the companion diagnostics services market is expected to witness a double digit growth; the opportunity is likely to be distributed across different regions and techniques
• In the long-term, growth in the market is anticipated to be driven by the clinical studies based on novel tumor markers, which have been identified as promising biological targets for development of companion diagnostics

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Table of Contents
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Evolution of Personalized Medicine
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
3.3.2.4. DNA Sequencing / Next Generation Sequencing
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. Future Roadmap

4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Companion Diagnostics Service Providers: Overall Market Landscape
4.2.1 Analysis by Type of Service Offered
4.2.2. Analysis by Type of Analytical Technique
4.2.3. Analysis by Regulatory Accreditation / Certification
4.3. Companion Diagnostics Service Providers: Developer Landscape
4.3.1 Analysis by Year of Establishment
4.3.2 Analysis by Company Size
4.3.3 Analysis by Geographical Location
4.3.4 Grid Representation: Analysis by Type of Service Offered, Company Size, and Geographical Location
4.3.5 World Map Representation: Analysis by Geography

5. COMPANY PROFILES
5.1. Chapter Overview
5.2. Key Players in North America
5.2.1. Asuragen
5.2.1.1. Recent Developments and Future Outlook
5.2.2. Covance
5.2.2.1. Recent Developments and Future Outlook
5.2.3. Geneuity
5.2.3.1. Recent Developments and Future Outlook
5.2.4. MD Biosciences
5.2.4.1. Recent Developments and Future Outlook
5.2.5. ResearchDx
5.2.5.1. Recent Developments and Future Outlook
5.3. Players in Europe
5.3.1. Almac Diagnostic Services
5.3.1.1. Recent Developments and Future Outlook
5.3.2. Leica Biosystems
5.3.2.1. Recent Developments and Future Outlook
5.3.3. R-Biopharm
5.3.3.1. Recent Developments and Future Outlook
5.3.4. Tepnel Pharma Services
5.3.4.1. Recent Developments and Future Outlook
5.4. Key Players in Asia-Pacific
5.4.1. BARD1 Life Sciences
5.4.1.1. Recent Developments and Future Outlook
5.4.2. BioMarCare Technologies
5.4.2.1. Recent Developments and Future Outlook
5.4.3. Gencurix
5.4.3.1. Recent Developments and Future Outlook
5.4.4. Macrogen
5.4.4.1. Recent Developments and Future Outlook

6. PARTNERSHIPS AND COLLABORATIONS
6.1 Chapter Overview
6.2 Partnership Models
6.3 List of Partnerships and Collaborations
6.3.1 Analysis by Year of Partnership
6.3.2 Analysis by Type of Partnership
6.3.3 Analysis by Type of Analytical Technique
6.3.4 Analysis by Type of Therapeutic Area
6.3.5 Analysis by Year of Partnership and Type of Partner
6.3.6 Analysis by Type of Partnership and Type of Partner
6.3.7 Most Active Players: Analysis by Number of Partnerships
6.3.8 Popular Analytical Techniques: Analysis by Number of Partnerships
6.3.9 Regional Analysis
6.3.10 Intercontinental and Intracontinental Agreements

7. LIKELY PARTNER ANALYSIS
7.1. Chapter Overview
7.2. Scope and Methodology
7.3. Scoring Criteria and Key Assumptions
7.4. Likely Partners for Companion Diagnostics Service Providers: Alzheimer’s Disease
7.4.1. Companies Working on the Amyloid Beta Biomarker
7.4.1.1. World Map Representation: Amyloid Beta Biomarker Focused Clinical Trials
7.4.2. Companies Working on the Tau Biomarker
7.4.2.1. World Map Representation: Tau Biomarker Focused Clinical Trials
7.5. Likely Partners for Companion Diagnostics Service Providers: Breast Cancer
7.5.1. Companies Working on the BRCA Biomarker
7.5.1.1. World Map Representation: BRCA Biomarker Focused Clinical Trials
7.5.2. Companies Working on the HER Biomarker
7.5.2.1. World Map Representation: HER Biomarker Focused Clinical Trials
7.5.3. Companies Working on the HR Biomarker
7.5.3.1. World Map Representation: HR Biomarker Focused Clinical Trials
7.5.4. Companies Working on the PD-L1 Biomarker
7.5.4.1. World Map Representation: PD-L1 Biomarker Focused Clinical Trials
7.6. Likely Partners for Companion Diagnostics Service Providers: Colorectal Cancer
7.6.1. Companies Working on the BRAF Biomarker
7.6.1.1. World Map Representation: BRAF Biomarker Focused Clinical Trials
7.6.2. Companies Working on the EGFR Biomarker
7.6.2.1. World Map Representation: EGFR Biomarker Focused Clinical Trials
7.6.3. Companies Working on the KRAS Biomarker
7.6.3.1. World Map Representation: KRAS Biomarker Focused Clinical Trials
7.6.4. Companies Working on the MSI Biomarker
7.6.4.1. World Map Representation: MSI Biomarker Focused Clinical Trials
7.6.5. Companies Working on the NRAS Biomarker
7.6.5.1. World Map Representation: NRAS Biomarker Focused Clinical Trials
7.7. Likely Partners for Companion Diagnostic Service Providers: HIV
7.7.1. Companies Working on the CCR5 Biomarker
7.7.1.1. World Map Representation: CCR5 Biomarker Focused Clinical Trials
7.8. Likely Partners for Companion Diagnostics Service Providers: Lung Cancer
7.8.1. Companies Working on the ALK Biomarker
7.8.1.1. World Map Representation: ALK Biomarker Focused Clinical Trials
7.8.2. Companies Working on the EGFR Biomarker
7.8.2.1. World Map Representation: EGFR Biomarker Focused Clinical Trials
7.8.3. Companies Working on the PD-L1 Biomarker
7.8.3.1. World Map Representation: PD-L1 Biomarker Focused Clinical Trials
7.8.4. Companies Working on the ROS Biomarker
7.8.4.1. World Map Representation: ROS Biomarker Focused Clinical Trials
7.9. Likely Partners for Companion Diagnostics Service Providers: NASH / NAFLD
7.9.1. Companies Working on the AST Biomarker
7.9.1.1. World Map Representation: AST Biomarker Focused Clinical Trials
7.10. Likely Partners for Companion Diagnostics Service Providers: Ovarian Cancer
7.10.1. Companies Working on the BRCA Biomarker
7.10.1.1. World Map Representation: BRCA Biomarker Focused Clinical Trials
7.10.2. Companies Working on the CA-125 Biomarker
7.10.2.1. World Map Representation: CA-125 Biomarker Focused Clinical Trials
7.11. Likely Partners for Companion Diagnostics Service Providers: Prostate Cancer
7.11.1. Companies Working on the PTEN Biomarker
7.11.1.1. World Map Representation: PTEN Biomarker Focused Clinical Trials

8. COMPANY COMPETITIVENESS ANALYSIS
8.1 Chapter Overview
8.2 Methodology
8.3 Assumptions and Key Parameters
8.4 Company Competitiveness Analysis
8.4.1 Companion Diagnostics Service Providers based in North America
8.4.2 Companion Diagnostics Service Providers based in Europe
8.4.3 Companion Diagnostics Service Providers based in Asia Pacific / RoW

9. STAKEHOLDER NEEDS ANALYSIS
9.1. Chapter Overview
9.2. Companion Diagnostics: Needs of Different Stakeholders
9.3. Comparison of Needs of Various Stakeholders
9.3.1. Needs of Drug Developers
9.3.2. Needs of Companion Diagnostics Developers
9.3.3. Needs of Regulatory Authorities
9.3.4. Needs of Testing Laboratories
9.3.5. Needs of Payers / Insurance Providers
9.3.6. Needs of Physicians
9.3.7. Needs of Patients

10. VALUE CHAIN ANALYSIS
10.1. Chapter Overview
10.2. Companion Diagnostics Value Chain: Cost Distribution
10.2.1. Research and Product Development
10.2.2. Manufacturing and Assembly
10.2.3. Clinical Trials, FDA Approval and Other Administrative Tasks
10.2.4. Payer Negotiation and KOL Engagement
10.2.5. Marketing and Sales
10.3. Companion Diagnostics Development Operations: Key Cost Contributors
10.4. Companion Diagnostics Co-Development Operations: Key Cost Contributors

11. CLINICAL RESEARCH ON CANCER BIOMARKERS: BIG PHARMA PERSPECTIVE
11.1. Chapter Overview
11.2. Methodology
11.3. Clinical Trial Analysis
11.3.1. List of Likely Drug Candidates for IVD Developers
11.4. Cumulative Distribution of Biomarker Focused Trials by Registration Year, 2016-2019
11.4.1. Analysis of Trials for Most Popular Biomarkers
11.4.2. Analysis of Trials for Moderately Popular Biomarkers
11.4.3. Analysis of Trials for Less Popular / Preliminary Stage Biomarkers
11.4.4. Other Emerging Biomarkers: Word Cloud
11.4.5. Cumulative Distribution of Trials of the Most Popular Biomarkers by Registration Year
11.4.6. Cumulative Distribution of Trials of the Moderately Popular Biomarkers by Registration Year
11.4.6. Cumulative Distribution of Trials of the Less Popular Biomarkers by Registration Year
11.5. Analysis of Biomarker Focused Trials for Most Popular Indications
11.5.1. Analysis of Trials for Moderately Popular Indications
11.5.2. Analysis of Trials for Less Popular and Other Indications
11.5.3. Other Emerging Indications: Word Cloud
11.5.4. Cumulative Distribution of Trials of the Most Popular Indications by Registration Year
11.5.5. Cumulative Distribution of Trials of the Moderately Popular Indications by Registration Year
11.5.6. Cumulative Distribution of Trials of the Less Popular / Preliminary Stage Indications by Registration Year
11.6. Analysis of Biomarker Focused Trials by Phase of Development
11.6.1. Analysis of Trials of the Most Popular Biomarkers
11.6.2. Analysis of Trials of the Moderately Popular Biomarkers
11.6.3. Analysis of Trials of the Less Popular and Other Biomarkers
11.6.4. Analysis of Trials of the Most Popular Indications
11.6.5. Analysis of Trials of the Moderately Popular Indications
11.6.6. Analysis of Trials of the Less Popular and Other Indications
11.7. Analysis of Biomarker Focused Trials by Sponsor
11.7.1. Analysis of Trials of the Most Popular Biomarkers
11.7.2. Analysis of Trials of the Moderately Popular Biomarkers
11.7.3. Analysis of Trials of the Most Popular Indications
11.7.4. Analysis of Trials of the Moderately Popular Indications
11.8. Analysis of Biomarker Focused Trials by Recruitment Status
11.9. Analysis of Biomarker Focused Trials by Therapy Design
11.10. Analysis of Biomarker Focused Trials by Geography
11.10.1. Analysis of Trials by Phase of Development and Recruitment Status
11.11. Clinical Trials Summary: Analysis of Biomarker Focused Trials by Most Popular Indications
11.12. Clinical Trials Summary: Analysis of Biomarker Focused Trials by Moderately Popular Indications
11.13. Clinical Trials Summary: Analysis of Biomarker Focused Trials by Preliminary Stage Indications

12. MARKET FORECAST AND OPPORTUNITY ANALYSIS
12.1 Chapter Overview
12.2. Key Assumptions and Forecast Methodology
12.3. Global Companion Diagnostics Services Market, 2020-2030
12.3.1. Global Companion Diagnostics Services Market: Distribution by Type of Service Offered, 2020 2030
12.3.2. Global Companion Diagnostics Services Market: Distribution by Type of Analytical Technique, 2020-2030
12.3.3. Global Companion Diagnostics Services Market: Distribution by Region, 2020-2030
12.4. Companion Diagnostics Services Market in North America, 2020-2030
12.4.1. Companion Diagnostics Services Market in the North America: Distribution by Type of Service Offered, 2020-2030
12.4.2. Companion Diagnostics Services Market in the North America: Distribution by Type of Analytical Technique, 2020-2030
12.5. Companion Diagnostics Services Market in Europe, 2020-2030
12.5.1. Companion Diagnostics Services Market in Europe: Distribution by Type of Service Offered, 2020-2030
12.5.2. Companion Diagnostics Services Market in Europe: Distribution by Type of Analytical Technique, 2020-2030
12.6. Companion Diagnostics Services Market in Asia Pacific and Rest of the World, 2020-2030
12.6.1. Companion Diagnostics Services Market in Asia Pacific and Rest of the World: Distribution by Type of Service Offered, 2020-2030
12.6.2. Companion Diagnostics Services Market in Asia Pacific and Rest of the World: Distribution by Type of Analytical Technique, 2020-2030

13. EXECUTIVE INSIGHTS
13.1. Chapter Overview
13.2. Tymora Analytical Operations
13.2.1. Company Snapshot
13.2.2. Anton Iliuk (President, Chief Technology Officer), Tymora Analytical Operations
13.3. Novodiax
13.3.1. Company Snapshot
13.3.2. Paul Kortschak (Senior Vice President, Novodiax)
13.4. OWL Metabolomics
13.4.1. Company Snapshot
13.4.2. Pablo Ortiz (Chief Executive Officer, OWL Metabolomics)
13.5. NeoGenomics Laboratories
13.5.1. Company Snapshot
13.5.2. Lawrence M. Weiss (Chief Scientific Officer, NeoGenomics Laboratories)

14. CONCLUDING REMARKS
15. APPENDIX 1: TABULATED DATA
16. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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