동반진단 개발 서비스 시장(제2판) : 제공 서비스 유형별(타당성 조사, 어세이 개발, 분석적 증명, 임상 검증, 제조), 사용 분석 기법별

Title:
Companion Diagnostics Development Services Market (2^nd Edition):
Distribution by Type of Service Offered (Feasibility Studies, Assay Development, Analytical Validation, Clinical Validation and Manufacturing), Analytical Technique Used (Next Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Immunohistochemistry / in situ Hybridization (IHC / ISH), Liquid Biopsy and Others), Therapeutic Areas (Oncological and Non-oncological) and Key Geographies (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035.

Example Insights:

Overview

Over the past few years, the improved understanding of molecular mechanisms involved in disease pathogenesis has resulted in the development of several targeted therapies. These therapies are tailored to target specific disease-related molecular signatures and require appropriate companion diagnostics (CDx) in order to make physicians aware of patients' unique genetic profiles, enabling them to make informed treatment related decisions. These tests are most often developed parallel to an investigational drug in order to identify the latter's safety and efficacy and measure its therapeutic effect on the target. With the approval of trastuzumab and HercepTest™ (an IHC-based companion diagnostic assay designed for determination of HER2 overexpression) by the USFDA in 1998, several novel targeted cancer drugs guided by a diagnostic assay, have progressed into clinical stages or are approved for commercial use. In fact, since 2020, a total of 44 companion diagnostics have been approved by the USFDA. Further, a study of nearly 200 unique pharmacological interventions evaluated across more than 670 clinical trials, suggests that the likelihood of a lead compound passing through various phases of clinical development and eventually getting approved is only 11%. The use of disease-specific biomarker information to recruit patients not only increases the success rates of the studies, but also reduces the trial costs by nearly 60%.

Given the various benefits, the healthcare industry is gradually shifting from the conventional, one-drug-for-all, paradigm to using tailored pharmacological interventions, which is expected to increase the need for companion diagnostics as well. However, given the complexities involved in the co-development of a drug and the affiliated companion diagnostic test, drug developers have demonstrated the preference to outsource the diagnostics development operations. In fact, around 80% of the companies are known to rely on third-party service providers for companion diagnostics development, primarily owing to the lack of in-house expertise for the development of these tests. As a result, many companies have made heavy investments in order to install robust tools and technologies, such as polymerase chain reaction (PCR), immunohistochemistry (IHC), in situ hybridization (ISH), next generation sequencing (NGS) and offer end-to-end services to sponsor companies engaged in this domain. In addition to conventional analytical techniques, several innovators have made latest upgrades in their portfolio by installing novel solutions, including digital PCR (dPCR) and digital immunoassay, in order to cater to the evolving needs of their customers. Given the growing demand for personalized therapies and ongoing innovations in technologies, we are led to believe that the opportunity for companion diagnostic developers / service providers is likely to witness a sustained growth over the coming years.

Scope of the Report

The "Companion Diagnostics Development Services Market (2^nd nd Edition): Distribution by Type of Service Offered (Feasibility Studies, Assay Development, Analytical Validation, Clinical Validation and Manufacturing), Analytical Technique Used (Next Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Immunohistochemistry / in situ Hybridization (IHC / ISH), Liquid Biopsy and Others), Therapeutic Areas (Oncological and Non-oncological) and Key Geographies (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035" report features an extensive study of the current market landscape, offering an informed opinion on the likely outsourcing of diagnostic development and manufacturing operations during 2022-2035. It features an in-depth analysis, highlighting the capabilities of various stakeholders involved in the companion diagnostics development value chain. Amongst other elements, the report includes:

• A detailed review of the overall landscape of the companion diagnostics development services market, highlighting the contributions of industry players, along with information on their year of establishment, company size, ownership, geographical location of headquarters, types of services offered, types of analytical techniques used, therapeutic areas assessed and regulatory certifications / accreditations.

• A region-wise competitiveness analysis of companies, highlighting the prominent companion diagnostics service providers, by taking into consideration their supplier power (in terms of their experience and company size) and portfolio specifications (in terms of number of services offered, number of analytical techniques used, therapeutic areas assessed, and number of precision medicine related deals signed since 2017).

• Elaborate profiles of prominent service providers in this domain. Each company profile includes a brief overview of the company, its financial information (if available), information on its companion diagnostics-related service portfolio, recent developments, and an informed future outlook.

• A comprehensive assessment of the current market landscape of companion diagnostics that are either marketed / being developed by various stakeholders, providing information on the assay technique used, target disease indication, therapeutic areas, type of biomarker detected and its chemical nature, type of sample used, regulatory authority involved and expediated review designation (for marketed products), and year of initiation of development (for investigational programs). It also provides details on the diagnostic developers, highlighting their year of establishment, company size, ownership and geographical location of their headquarters.

• An analysis of the partnerships and collaborations established for companion diagnostics services during 2017- 2021, featuring a detailed set of analyses based on various parameters, such as the type of partnership, year of partnership, therapeutic areas involved, geographical location of the companies involved and the most active players.

• An insightful analysis of companies segregated on the basis of their likelihood to enter into collaborations with companion diagnostics service providers. The chapter features a list of 300+ drug developers sponsoring clinical trials of therapies targeting several disease-specific biomarkers. The players have been shortlisted based on relevant parameters, namely number of biomarker-focused clinical trials sponsored and the time to market their proprietary personalized medicine products.

• A detailed analysis of various mergers and acquisitions of companies in this domain, highlighting the trend in the number of companies acquired during the time period between 2017- 2021, based on several relevant parameters, such as year of agreement, type of deal, geographical location of headquarters, company size, key value drivers and acquisition deal multiples (based on revenues). In addition, it presents an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.

• A qualitative assessment of the current and long-term needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. In addition, it highlights key areas of concerns associated with this industry, along with our opinion (based on past and prevalent trends) on how the industry is anticipated to address them over the coming years.

• A value chain analysis featuring a discussion on various steps of development operations, namely R&D, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, of a companion diagnostic, as well as the cost requirements across each of the aforementioned stages.

• An assessment of the completed, ongoing and planned biomarker-driven oncology clinical trials sponsored by prominent big pharmaceutical companies, in the last five years. The chapter highlights the key trends associated with these clinical studies across various parameters, such as trial registration year, phase of development, trial sponsors, recruitment status, therapy design, enrolled patient population, popularity of biomarkers, and popularity of target indications.

• A case study on various therapies in use with companion diagnostics, providing information on their commercial availability, type of molecule, route of administration, and number of corresponding marketed companion diagnostics products / investigational programs. In addition, it provides details on drug developers, including information on their year of establishment, company size, ownership and geographical location of their headquarters.

• A case study on the current market landscape of precision medicine software solutions that offer intelligent insights to diagnostic developers, service providers, patients and healthcare experts, for making informed decisions. The chapter features information on the type of platform utilized, purpose of software solution, type of data processed, therapeutic area, and types of end users. In addition, it presents a list of developers of the software solutions, along with analysis on their year of establishment, company size, ownership and geographical location of headquarters.

One of the key objectives of the report was to estimate the existing market size and the potential future growth opportunities for companion diagnostics development service providers. Based on multiple parameters, such as the service cost of various steps involved in companion diagnostics development and manufacturing, and partnerships inked in the last few years for outsourcing of such operations, we have developed informed estimates on the evolution of the market for the time period 2022- 2035. Our year-wise projections of the current and forecasted opportunity have further been segmented across key services offered (feasibility studies, assay development, analytical validation, clinical validation and manufacturing), analytical techniques used (NGS, PCR, IHC-ISH, liquid biopsy and Others), therapeutic areas (oncological and non-oncological), and key geographical locations (North America, Europe and Asia- Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth. In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The opinions and insights presented in the report were influenced by discussions held with several key players in this domain. The report features detailed transcripts of interviews held with the following industry stakeholders:

• Mike Klein (Chief Executive Officer, Genomenon)

• Mark Kiel (Founder and Chief Scientific Officer, Genomenon)

• Candace Chapman (Vice President of Marketing, Genomenon)

• Anton Iliuk (President and Chief Technology Officer, Tymora Analytical Operations)

• Paul Kortschak (Former Senior Vice President, Novodiax)

• Pablo Ortiz (Chief Executive officer, OWL Metabolomics)

• Lawrence M. Weiss (Former Chief Scientific Officer, NeoGenomics Laboratories)

Key Questions Answered:

• Who are the leading players offering services for the development of companion diagnostics?

• What are the key geographies where companion diagnostics development service providers are located?

• Which analytical techniques are leveraged by the service providers engaged in this domain?

• Who are the leading companion diagnostics developers?

• Which biomarkers are most commonly targeted by the marketed products / investigational programs?

• Which partnership models are commonly adopted by stakeholders offering companion diagnostics development services?

• Which drug developers are most likely to partner with the service providers to seek their expertise?

• What are the key value drivers of the merger and acquisition activity within this domain?

• Which biomarker-focused targeted drugs developed by big pharmaceutical companies are likely to be administered with companion diagnostics?

• How is the current and future opportunity likely to be distributed across key market segments?

Chapter Outlines

Chapter 2 is an executive summary of the insights captured in our research. It offers a high- level view on the likely evolution of the companion diagnostics services market in the mid to long term.

Chapter 3 is an introductory chapter that highlights the importance of companion diagnostics in relation to personalized medicine. The chapter describes the approaches used to develop a companion diagnostic, along with information on various analytical techniques that form the basis for such tests. In addition, the chapter highlights the key considerations while selecting a contract diagnostics partner (CDO), along with key market drivers and challenges associated with outsourcing the development and manufacturing of companion diagnostics.

Chapter 4 provides an overview of the companion diagnostics services market, including information on 150 players offering contract services for one or multiple steps involved in the development and manufacturing of companion diagnostics. It features an in-depth analysis of the industry players, based on a number of parameters, such as year of establishment, company size, ownership, geographical location of headquarters, companion diagnostics-related service portfolio (biomarker discovery / identification, biomarker development, assay development, feasibility studies, analytical validation, clinical validation, regulatory assistance, commercialization, manufacturing and other supporting services), analytical techniques used (enzyme-linked immune sorbent assay (ELISA), flow cytometry, in situ hybridization (ISH), immunohistochemistry (IHC), microarray, next generation sequencing (NGS), polymerase chain reaction (PCR), sanger sequencing and spectroscopy), and regulatory certification / accreditation (College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and International Organization for Standardization (ISO)).

Chapter 5 provides an insightful competitiveness analysis of the companion diagnostics development service providers based in North America, Europe and Asia- Pacific and Rest of the World. The analysis compares the capabilities of companies on the basis of their supplier strength (in terms of experience and company size) and service portfolio strength (in terms of number of services offered, number of analytical techniques used, therapeutic areas assessed, and number of precision medicine related deals signed since 2017).

Chapter 6 includes detailed profiles the key players offering companion diagnostics development services. Each company profile features a brief overview of the company, its financial information (if available), information on its companion diagnostics-related service portfolio, recent developments, and an informed future outlook.

Chapter 7 provides a list of companion diagnostics along with information on their commercial availability (approved / investigational), assay technique used (enzyme-linked immune sorbent assay (ELISA), flow cytometry, in situ hybridization (ISH), immunohistochemistry (IHC), micro array, next generation sequencing (NGS), polymerase chain reaction (PCR), sanger sequencing and spectroscopy), target disease indications, therapeutic areas (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others), type of sample analyzed (tumor tissue, blood, bone marrow and saliva), type of biomarker detected (alteration(s) in ALK, BCR, BRAF, BRCA, ErbB, MET, MSI / dMMR, NTRK, PD-L1, RAS, PGR, ROS and PIK3CA), chemical nature of biomarker (gene and protein), regulatory certification / accreditation (FDA PMA, CE Mark, MHLW, PMDA, NMPA and others) and expediated review designation (for marketed products), and year of initiation of development (for investigational programs). It also provides details on the developers, highlighting their year of establishment, company size, ownership and geographical location of their headquarters.

Chapter 8 presents an analysis of the partnerships and collaborations for companion diagnostics services established during 2017- 2021, featuring a detailed set of analyses based on various parameters, such as the type of partnership, year of partnership, analytical technique used, geographical location of involved companies and the most active players.

Chapter 9 features a list of 300+ stakeholders that are anticipated to partner with companion diagnostics services providers in the foreseen future. The players have been shortlisted based on a detailed analysis of relevant parameters, namely number of biomarker-focused clinical trials sponsored and the time to market their proprietary personalized medicine products.

Chapter 10 presents insights from a detailed analysis of the mergers and acquisitions reported in this domain, during the period 2017- 2021. It is worth mentioning that the data captured during our research was analyzed based on multiple parameters, such as year of agreement, type of deal, geographical location, size and ownership of the companies involved, key value drivers, and acquisition deal multiples (based on revenues).

Chapter 11 provides a qualitative assessment of the current and long-term needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. In addition, it highlights key areas of concerns associated with this industry, along with our opinion (based on past and prevalent trends) on how the industry is anticipated to address them over the coming years.

Chapter 12 presents a value chain analysis featuring a discussion on various steps of the companion diagnostics development operations, namely R&D, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, as well as the cost requirements across each of the aforementioned stages.

Chapter 13 provides a detailed clinical trial analysis of completed, ongoing and planned biomarker-driven oncology clinical trials sponsored by prominent big pharmaceutical companies, in the last five years. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial registration year, phase of development, trial sponsors, recruitment status, therapy design, enrolled patient population, popularity of biomarkers, and popularity of target indications.

Chapter 14 is a case study presenting a list of therapies currently in use with companion diagnostics, providing information on their commercial availability, type of molecule, route of administration, and number of corresponding companion diagnostics products / programs. In addition, it provides details on drug developers, including information on their year of establishment, company size, ownership and geographical location of their headquarters.

Chapter 15 is a case study focused on the current market landscape of precision medicine software solutions that offer intelligent insights to facilitate informed decision making to different stakeholders in this industry. It presents a list of software solutions, along with information on the type of platform utilized, purpose of software solution, type of data processed, therapeutic area, and types of end users. In addition, it presents a list of developers of software solutions, along with analysis on their year of establishment, company size, ownership and geographical location of headquarters.

Chapter 16 presents an insightful market forecast analysis, highlighting the future potential of the companion diagnostics development and manufacturing services market, till 2035. We have segregated the opportunity of the market on the basis of Type of Service Offered (Feasibility Studies, Assay Development, Analytical Validation, Clinical Validation and Manufacturing), Analytical Techniques Used (NGS, PCR, IHC / ISH, Liquid Biopsy and Others), Therapeutic Areas (Oncological and Non-oncological Disorders), and Key Geographies (North America, Europe, Asia- Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022- 2035.

Chapter 17 summarizes the entire report, highlighting various facts related to contemporary market trend and the likely evolution of the companion diagnostics development services market.

Chapter 18 is a collection of interview transcripts of the discussions held with stakeholders in this market. In this chapter, we have presented the details of interviews held with Mike Klein, (Chief Executive Officer, Genomenon), Mark Kiel (Founder and Chief Scientific Officer, Genomenon), Candace Chapman (Vice President of Marketing, Genomenon), Anton Iliuk (President and Chief Technology Officer, Tymora Analytical Operations), Paul Kortschak (Former Senior Vice President, Novodiax), Pablo Ortiz (Chief Executive Officer, OWL Metabolomics) and Lawrence M. Weiss (Former Chief Scientific Officer, NeoGenomics Laboratories).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix, which provides a list of companies and organizations mentioned in this report.

TABLE OF CONTENTS

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. Q² 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

List Of Figures

• Figure 3.1 Companion Diagnostics: Role in Clinical Trials
• Figure 3.2 Advantages of Companion Diagnostics
• Figure 3.3 Failure Rates: Distribution by Type of Drug Class
• Figure 3.4 Challenges Associated with the Development of Companion Diagnostics
• Figure 3.5 Key Considerations for Selecting a CDO Partner
• Figure 4.1 Companion Diagnostics Service Providers: Distribution by Year of Establishment
• Figure 4.2 Companion Diagnostics Service Providers: Distribution by Company Size
• Figure 4.3 Companion Diagnostics Service Providers: Distribution by Company Ownership
• Figure 4.4 Companion Diagnostics Service Providers: Distribution by Location of Headquarters
• Figure 4.5 World Map Representation: Analysis by Geography
• Figure 4.6 Companion Diagnostics Service Providers: Distribution by Type of Service Offered
• Figure 4.7 Companion Diagnostics Service Providers: Distribution by Other Affiliated Services Offered
• Figure 4.8 Companion Diagnostics Service Providers: Distribution by Type of Analytical Technique Used
• Figure 4.9 Companion Diagnostics Service Providers: Distribution by Therapeutic Area
• Figure 4.10 Grid Representation: Distribution by Company Size, Location of Headquarters and Type of Service Offered
• Figure 4.11 Grid Representation: Distribution by Company Size, Location of Headquarters and Analytical Technique Used
• Figure 4.12 Companion Diagnostics Service Providers: Distribution by Regulatory Accreditation / Certification
• Figure 5.1 Competitiveness Analysis: Companion Diagnostics Service Providers in North America
• Figure 5.2 Competitiveness Analysis: Companion Diagnostics Service Providers in Europe
• Figure 5.3 Competitiveness Analysis: Companion Diagnostics Service Providers in Asia-Pacific and Rest of the World
• Figure 5.4 Competitiveness Analysis of Companion Diagnostics Service Providers: Competitiveness Score of Top Service Providers
• Figure 6.1 Interpace Biosciences: Annual Revenues, FY 2016-Q3 2021 (USD Million)
• Figure 6.2 Labcorp Drug Development: Annual Revenues, FY 2016-2021 (USD Billion)
• Figure 6.3 Quest Diagnostics: Annual Revenues, FY 2016-2021 (USD Billion)
• Figure 6.4 Q² Solutions: Annual Revenues, FY 2016-2021 (USD Million)
• Figure 6.5 Almac Group Diagnostics: Annual Revenues, FY 2016-2021 (GBP Million)
• Figure 6.6 Biocartis: Annual Revenues, FY 2016-H1 2021 (EUR Billion)
• Figure 6.7 Eurofins: Annual Revenues, FY 2016-H1 2021 (EUR Billion)
• Figure 6.8 QIAGEN: Annual Revenues, FY 2016-2021 (USD Billion)
• Figure 7.1 Companion Diagnostics: Distribution by Assay Technique Used
• Figure 7.23 Companion Diagnostics: Distribution by Target Disease Indication
• Figure 7.3 Companion Diagnostics: Distribution by Therapeutic Area
• Figure 7.4 Companion Diagnostics: Distribution by Type of Biomarker Detected
• Figure 7.5 Companion Diagnostics: Distribution by Chemical Nature of Biomarker
• Figure 7.6 Companion Diagnostics: Distribution by Type of Sample Used
• Figure 7.7 Companion Diagnostics: Distribution by Commercial Availability and Therapeutic Area
• Figure 7.8 Companion Diagnostics: Distribution by Year of Initiation of Development of Investigational Programs
• Figure 7.9 Companion Diagnostics: Distribution by Year of Approval of Marketed Products
• Figure 7.10 Companion Diagnostics: Distribution by Regulatory Authority Involved in the Approval of Marketed Products
• Figure 7.11 Companion Diagnostics: Distribution by Expediated Review Designation and Type of Biomarker
• Figure 7.12 Heat Map Representation: Distribution by Assay Technique Used and Target Disease Indication
• Figure 7.13 Companion Diagnostics Developers: Distribution by Year of Establishment
• Figure 7.14 Companion Diagnostics Developers: Distribution by Company Size
• Figure 7.15 Companion Diagnostics Developers: Distribution by Company Ownership
• Figure 7.16 Companion Diagnostics Developers: Distribution by Location of Headquarters
• Figure 7.17 World Map Representation: Distribution by Geography
• Figure 7.18 Most Active Players: Distribution by Number of Marketed Products and Investigational Programs
• Figure 7.19 Most Active Players: Distribution by Number of Marketed Products
• Figure 7.20 Most Active Players: Distribution by Number of Target Disease Indications
• Figure 8.1 Partnerships and Collaborations: Distribution by Year of Partnership
• Figure 8.2 Partnerships and Collaborations: Distribution by Type of Partnership
• Figure 8.3 Partnerships and Collaborations: Distribution by Type of Partner
• Figure 8.4 Partnerships and Collaborations: Distribution by Year of Partnership and Type of Partner
• Figure 8.5 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Partner
• Figure 8.6 Partnerships and Collaborations: Distribution by Therapeutic Area
• Figure 8.7 Most Active Players: Distribution by Number of Partnerships
• Figure 8.8 Partnerships and Collaborations: Regional Distribution
• Figure 8.9 Partnerships and Collaborations: Intercontinental and Intracontinental Agreements
• Figure 9.1 World Map Representation: Regional Distribution of Amyloid Beta Biomarker Focused Clinical Trials
• Figure 9.2 World Map Representation: Regional Distribution of Tau Biomarker Focused Clinical Trials
• Figure 9.3 World Map Representation: Regional Distribution of BRCA Biomarker Focused Clinical Trials
• Figure 9.4 World Map Representation: Regional Distribution of HER Biomarker Focused Clinical Trials
• Figure 9.5 World Map Representation: Regional Distribution of HR Biomarker Focused Clinical Trials
• Figure 9.6 World Map Representation: Regional Distribution of PD-L1 Biomarker Focused Clinical Trials
• Figure 9.7 World Map Representation: Regional Distribution of BRAF Biomarker Focused Clinical Trials
• Figure 9.8 World Map Representation: Regional Distribution of EGFR Biomarker Focused Clinical Trials
• Figure 9.9 World Map Representation: Regional Distribution of KRAS Biomarker Focused Clinical Trials
• Figure 9.10 World Map Representation: Regional Distribution of MSI Biomarker Focused Clinical Trials
• Figure 9.11 World Map Representation: Regional Distribution of NRAS Biomarker Focused Clinical Trials
• Figure 9.12 World Map Representation: Regional Distribution of CCR5 Biomarker Focused Clinical Trials
• Figure 9.13 World Map Representation: Regional Distribution of ALK Biomarker Focused Clinical Trials
• Figure 9.14 World Map Representation: Regional Distribution of EGFR Biomarker Focused Clinical Trials
• Figure 9.15 World Map Representation: Regional Distribution of PD-L1 Biomarker Focused Clinical Trials
• Figure 9.16 World Map Representation: Regional Distribution of RET Biomarker Focused Clinical Trials
• Figure 9.17 World Map Representation: Regional Distribution of ROS Biomarker Focused Clinical Trials
• Figure 9.18 World Map Representation: Regional Distribution of AST Biomarker Focused Clinical Trials
• Figure 9.19 World Map Representation: Regional Distribution of BRCA Biomarker Focused Clinical Trials
• Figure 9.20 World Map Representation: Regional Distribution of CA-125 Biomarker Focused Clinical Trials
• Figure 9.21 World Map Representation: Regional Distribution of AR-V7 Biomarker Focused Clinical Trials
• Figure 10.1 Mergers and Acquisitions: Distribution by Type of Deal
• Figure 10.2 Mergers and Acquisitions: Distribution by Year of Deal
• Figure 10.3 Mergers and Acquisitions: Regional Distribution
• Figure 10.4 Mergers and Acquisitions: Continent-wise Distribution
• Figure 10.5 Mergers and Acquisitions: Intercontinental and Intracontinental Deals
• Figure 10.6 Mergers and Acquisitions: Country-wise Distribution
• Figure 10.7 Mergers and Acquisitions: Distribution by Company Size
• Figure 10.8 Mergers and Acquisitions: Ownership Change Matrix
• Figure 10.9 Mergers and Acquisitions: Distribution by Key Value Drivers
• Figure 10.10 Mergers and Acquisitions: Valuation by Acquisition Deal Multiples
• Figure 10.11 Key Players: Distribution by Number of Deals
• Figure 11.1 Companion Diagnostics: Stakeholder Needs
• Figure 11.2 Comparison of Needs of a Drug Developer
• Figure 11.3 Comparison of Needs of a Companion Diagnostic Developer
• Figure 11.4 Comparison of Needs of a Regulatory Authorities
• Figure 11.5 Comparison of Needs of Testing Laboratories
• Figure 11.6 Comparison of Needs of Payers / Insurance Providers
• Figure 11.7 Comparison of Needs of Physicians
• Figure 11.8 Comparison of Needs of Patients
• Figure 12.1 Companion Diagnostics Value Chain: Cost Distribution
• Figure 12.2 Cost Distribution Across the Companion Diagnostics Value Chain
• Figure 12.3 Costs Associated with Research and Product Development
• Figure 12.4 Costs Associated with Manufacturing and Assembly
• Figure 12.5 Costs Associated with Clinical Trials, FDA Approval and Other Administrative Tasks
• Figure 12.6 Costs Associated with Payer Negotiation and KOL Engagement
• Figure 12.7 Costs Associated with Marketing and Sales
• Figure 13.1 Clinical Trial Analysis: Distribution by Trial Registration Year
• Figure 13.2 Clinical Trial Analysis: Distribution by Phase of Development
• Figure 13.3 Clinical Trial Analysis: Distribution by Sponsor
• Figure 13.4 Clinical Trial Analysis: Distribution by Recruitment Status
• Figure 13.5 Clinical Trial Analysis: Distribution by Therapy Design
• Figure 13.6 Clinical Trial Analysis: Distribution by Geography
• Figure 13.7 Clinical Trial Analysis: Distribution by Enrolled Patient Population
• Figure 13.8 Clinical Trial Analysis: Distribution by Most Popular Biomarkers
• Figure 13.9 Clinical Trial Analysis: Distribution by Moderately Popular Biomarkers
• Figure 13.10 Clinical Trial Analysis: Distribution by Less Popular / Preliminary Stage Biomarkers
• Figure 13.11 Other Emerging Biomarkers: Word Cloud
• Figure 13.12 Clinical Trial Analysis: Distribution of Trials of Most Popular Biomarkers by Trial Registration Year
• Figure 13.13 Clinical Trial Analysis: Distribution of Trials of Moderately Popular Biomarkers by Trial Registration Year
• Figure 13.14 Clinical Trial Analysis: Distribution of Trials of Less Popular and Other Biomarkers by Trial Registration Year
• Figure 13.15 Clinical Trial Analysis: Distribution of Trials of Most Popular Biomarkers by Phase of Development
• Figure 13.16 Clinical Trial Analysis: Distribution of Trials of Moderately Popular Biomarkers by Phase of Development
• Figure 13.17 Clinical Trial Analysis: Distribution of Trials of Less Popular and Other Biomarkers by Phase of Development
• Figure 13.18 Clinical Trial Analysis: Distribution of Trials of Most Popular Biomarkers by Sponsors
• Figure 13.19 Clinical Trial Analysis: Distribution of Trials of Moderately Popular Biomarkers by Sponsors
• Figure 13.20 Clinical Trial Analysis: Distribution of Trials of Less Popular and Other Biomarkers by Sponsors
• Figure 13.21 Clinical Trial Analysis: Distribution of Trials for Most Popular Indications
• Figure 13.22 Clinical Trial Analysis: Distribution of Trials for Moderately Popular Indications
• Figure 13.23 Clinical Trial Analysis: Distribution of Trials for Less Popular and Other Indications
• Figure 13.24 Other Emerging Indications: Word Cloud
• Figure 13.25 Clinical Trial Analysis: Distribution of Trials of Most Popular Indications by Trial Registration Year
• Figure 13.26 Clinical Trial Analysis: Distribution of Trial of Moderately Popular Indications by Trial Registration Year
• Figure 13.27 Clinical Trial Analysis: Distribution of Trials of Less Popular and Other Indications by Trial Registration Year
• Figure 13.28 Clinical Trial Analysis: Distribution of Trials of Most Popular Indications by Phase of Development
• Figure 13.29 Clinical Trial Analysis: Distribution of Trials of Moderately Popular Indications by Phase of Development
• Figure 13.30 Clinical Trial Analysis: Distribution of Trials of Less Popular and Emerging Indications by Phase of Development
• Figure 13.31 Clinical Trial Analysis: Distribution of Trials of Most Popular Indications by Sponsor
• Figure 13.32 Clinical Trial Analysis: Distribution of Trials of Moderately Popular Indications by Sponsor
• Figure 13.33 Clinical Trial Analysis: Distribution of Trials of Less Popular and Emerging Indications by Sponsor
• Figure 13.34 Clinical Trial Analysis: Distribution of Trials of Lung Cancer by Affiliated Biomarkers
• Figure 13.35 Clinical Trials Summary: Distribution of Trials of Breast Cancer by Affiliated Biomarkers
• Figure 13.36 Clinical Trials Summary: Distribution of Trials of Lymphoma by Affiliated Biomarkers
• Figure 13.37 Clinical Trials Summary: Distribution of Trials of Ovarian Cancer by Affiliated Biomarkers
• Figure 13.38 Clinical Trials Summary: Distribution of Trials of Prostate Cancer by Affiliated Biomarkers
• Figure 13.39 Clinical Trials Summary: Distribution of Trials of Melanoma by Affiliated Biomarkers
• Figure 13.40 Clinical Trials Summary: Distribution of Trials of Colon / Colorectal Cancer by Affiliated Biomarkers
• Figure 13.41 Clinical Trials Summary: Distribution of Trials of Head and Neck Cancer by Affiliated Biomarkers
• Figure 14.1 Biomarker-Driven Targeted Therapies: Distribution by Commercial Availability
• Figure 14.2 Biomarker-Driven Targeted Therapies: Distribution by Type of Molecule
• Figure 14.3 Biomarker-Driven Targeted Therapies: Distribution by Commercial Availability and Type of Molecule
• Figure 14.4 Biomarker-Driven Targeted Therapies: Distribution by Route of Administration
• Figure 14.5 Leading Biomarker-Driven Targeted Therapies: Distribution by Number of Companion Diagnostic Products / Programs
• Figure 14.6 Biomarker-Driven Targeted Therapy Developers: Distribution by Year of Establishment
• Figure 14.7 Biomarker-Driven Targeted Therapy Developers: Distribution by Company Size
• Figure 14.8 Biomarker-Driven Targeted Therapy Developers: Distribution by Company Ownership
• Figure 14.9 Biomarker-Driven Targeted Therapy Developers: Distribution by Location of Headquarters
• Figure 14.10 Leading Players: Distribution by Number of Biomarker-Driven Targeted Therapies
• Figure 14.11 Heat Map Representation: Distribution by Company Size, Location of Headquarters and Commercial Availability of Therapy
• Figure 15.1 Precision Medicine Software Solutions: Distribution by Type of Platform
• Figure 15.2 Precision Medicine Software Solutions: Distribution by Purpose of Software Applications
• Figure 15.3 Precision Medicine Software Solutions: Distribution by Type of Data Handled
• Figure 15.4 Precision Medicine Software Solutions: Distribution by Therapeutic Area
• Figure 15.5 Precision Medicine Software Solutions: Distribution by Type of End User
• Figure 15.6 Precision Medicine Software Solution Developers: Distribution by Year of Establishment
• Figure 15.7 Precision Medicine Software Solution Developers: Distribution by Company Size
• Figure 15.8 Precision Medicine Software Solution Developers: Distribution by Location of Headquarters
• Figure 15.9 World Map Representation: Distribution by Geography
• Figure 16.1 Global Companion Diagnostics Development Services Market, 2022-2035 (USD Million)
• Figure 16.2 Global Companion Diagnostics Development Services Market: Distribution by Type of Service Offered, 2022-2035 (USD Million)
• Figure 16.3 Global Companion Diagnostics Development Services Market: Distribution by Type of Analytical Technique Used, 2022-2035 (USD Million)
• Figure 16.4 Global Companion Diagnostics Development Services Market: Distribution by Therapeutic Area, 2022-2035 (USD Million)
• Figure 16.5 Global Companion Diagnostics Development Services Market: Distribution by Region, 2022-2035 (USD Million)
• Figure 16.6 Companion Diagnostics Development Services Market in North America, 2022-2035 (USD Million)
• Figure 16.7 Companion Diagnostics Development Services Market in North America: Distribution by Type of Service Offered, 2022-2035 (USD Million)
• Figure 16.8 Companion Diagnostics Development Services Market in North America: Distribution by Type of Analytical Technique Used, 2022-2035 (USD Million)
• Figure 16.9 Companion Diagnostics Development Services Market in North America: Distribution by Therapeutic Area, 2022-2035 (USD Million)
• Figure 16.7 Companion Diagnostics Development Services Market in Europe, 2022-2035 (USD Million)
• Figure 16.8 Companion Diagnostics Development Services Market in Europe: Distribution by Type of Service Offered, 2022-2035 (USD Million)
• Figure 16.9 Companion Diagnostics Development Services Market in Europe: Distribution by Type of Analytical Technique Used, 2022-2035 (USD Million)
• Figure 16.10 Companion Diagnostics Development Services Market in Europe: Distribution by Therapeutic Area, 2022-2035 (USD Million)
• Figure 16.11 Companion Diagnostics Development Services Market in Asia-Pacific and Rest of the World, 2022-2035 (USD Million)
• Figure 16.12 Companion Diagnostics Development Services Market in Asia-Pacific and Rest of the World: Distribution by Type of Service Offered, 2022-2035 (USD Million)
• Figure 16.13 Companion Diagnostics Development Services Market in Asia-Pacific and Rest of The World: Distribution by Type of Analytical Technique Used, 2022-2035 (USD Million)
• Figure 16.14 Companion Diagnostics Development Services Market in Asia-Pacific and Rest of the World: Distribution by Therapeutic Area, 2022-2035 (USD Million)
• Figure 18.1 Concluding Remarks: Overall Market Landscape of Companion Diagnostics Service Providers
• Figure 18.2 Concluding Remarks: Overall Market Landscape of Companion Diagnostics
• Figure 18.3 Concluding Remarks: Partnerships and Collaborations
• Figure 18.4 Concluding Remarks: Likely Partners
• Figure 18.5 Concluding Remarks: Mergers and Acquisitions
• Figure 18.6 Concluding Remarks: Big Pharma Initiatives
• Figure 18.7 Concluding Remarks: Market Sizing and Opportunity Analysis