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Companion Diagnostics Market (2nd Edition), 2019-2030

  • ID: 4775427
  • Report
  • 300 Pages
  • Roots Analysis
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Nearly 50% of Prescribed Drugs/Therapies Fail to Show Adequate Clinical Benefits

FEATURED COMPANIES

  • AB-Biotics
  • Assurex Health
  • Definiens
  • IDbyDNA
  • MetaStat
  • Q2 Solutions
  • MORE

The introduction of personalized medicine has brought about a paradigm shift within the healthcare sector. Over the years, many cases have been identified where conventional treatment options have failed to demonstrate any therapeutic benefit. It is estimated that nearly 50% of prescribed drugs/therapies fail to show adequate clinical benefits. In fact, adverse drug-related reactions/side effects are reported to be the fourth leading cause of death in the US.  To mitigate challenges associated with adverse drug reactions, there are multiple therapeutic products in the market, and many more under development, which have been tailored to effectively treat disease with unique molecular/genetic signatures.

Personalized therapies demand companion diagnostics to make physicians aware of patients’ unique genetic profiles, thereby, enabling them to make informed decisions. A study of nearly 200 unique pharmacological interventions, across 670 clinical trials, concluded that the likelihood of a lead compound passing through all the phases of clinical development and eventually getting approved is only 11%. The same study highlighted that correlating disease-specific biomarker data with therapeutic susceptibility and using this information to recruit patients for clinical research demonstrated a six fold increase in trial success rates.  It is also worth highlighting that companion diagnostic guided drug development efforts have been estimated to help reduce clinical trial costs by almost 60%. 

Since the approval of the HercepTest™ (in 1998) for identifying patients for treatment with trastuzumab, over 50 companion diagnostics have been developed for various drugs. Further, several companies have also undertaken initiatives to develop biomarker-based therapeutics for other disease indications, such as infectious diseases, neurological disorders and metabolic disorders.  Industry stakeholders are forging strategic alliances with diagnostic developers to develop diagnostic solutions for a diverse array of drugs/therapies. Such initiatives are focused on improving clinical trial success rates, and subsequently optimizing R&D expenditure in the pharmaceutical industry.

Scope of the Report

The “Companion Diagnostics Market (2nd Edition), 2019-2030” report features an extensive study of the current market landscape and the likely adoption of these diagnostic tests over the next decade. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes:

  • A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, corresponding drug(s) / drug class, affiliated biomarker, assay technique involved (in situ hybridization (ISH), immunohistochemistry  (IHC), next-generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others) and the type of sample required (tumor tissue, blood, bone marrow and others).
  • Detailed profiles of developers of companion diagnostics (shortlisted on the basis of the strength of product portfolio), featuring an overview of the company, its financial information (if available), a detailed description of companion diagnostics available / under development and recent collaborations. In addition, each profile includes a list of the likely strategies that may be adopted by these players to support future growth.
  • A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of product portfolio), highlighting the current perceptions regarding their proprietary brands, taking into consideration several relevant aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic focus and overall market position of each company.
  • An analysis of the partnerships and collaborations pertaining to companion diagnostics, featuring a comprehensive set of analyses based on various parameters, such as the type of partnership, affiliated biomarkers, therapeutic areas and the most active players.
  • A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain.
  • A discussion on various steps of the development operations, namely research and development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing/sales activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.
  • A comprehensive analysis of completed, ongoing and planned clinical trials featuring the key biomarkers across different type of therapies and cancer indications. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for companion diagnostics developers, over the next decade. Based on multiple parameters, such as the disease incidence, adoption of companion diagnostic tests and the likely prices, we have provided informed estimates on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer’s disease and HIV/AIDs), [B] important assay techniques (in situ hybridization (ISH), immune histochemistry (IHC), next-generation sequencing (NGS), polymerase chain reaction (PCR) and others) and [C] key geographical regions (US, EU5, Japan, China and Australia). 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. 

The opinions and insights presented in this study were also influenced by discussions conducted with stakeholders in this domain. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • AB-Biotics
  • Assurex Health
  • Definiens
  • IDbyDNA
  • MetaStat
  • Q2 Solutions
  • MORE

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

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Evolution of Personalized Medicine
3.2. An Overview of Companion Diagnostics
3.2.1. Development of Companion Diagnostics
3.2.2. Analytical Techniques Used in Companion Diagnostic Tests
3.2.2.1. Immunohistochemistry
3.2.2.2. In situ Hybridization
3.2.2.3. Polymerase Chain Reaction
3.2.2.4. DNA Sequencing/Next Generation Sequencing
3.2.3. Advantages of Companion Diagnostics
3.3. Applications of Companion Diagnostics across Different Therapeutic Areas
3.4. Regulatory Review and Approval Process for Companion Diagnostics
3.5. Existing Challenges and Future Roadmap

4. CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Companion Diagnostics: List of Developers
4.2.1. Analysis by Year of Establishment of Developer
4.2.2. Analysis by Company Size and Geographical Location
4.3. Companion Diagnostics: List of Available/Under Development Tests
4.3.1. Analysis by Assay Technique Used
4.3.2. Analysis by Target Therapeutic Area
4.3.3. Analysis by Target Indication
4.3.4. Analysis by Type of Biomarker
4.3.5. Grid Analysis: Analysis by Assay Technique Used and Therapeutic Area
4.3.6. Grid Analysis: Analysis by Target Indication and Type of Biomarker
4.3.7. Most Active Players
4.3.8. Analysis by Geographical Location

5. COMPANY PROFILES: COMPANION DIAGNOSTICS
5.1. Chapter Overview
5.2. Roche
5.2.1. Company Overview
5.2.2. Financial Information
5.2.3. Companion Diagnostics Portfolio
5.2.4. Recent Collaborations
5.2.5. Recent Developments and Future Outlook
5.3. Agilent Technologies
5.3.1. Company Overview
5.3.2. Financial Information
5.3.3. Companion Diagnostics Portfolio
5.3.4. Recent Collaborations
5.3.5. Recent Developments and Future Outlook
5.4. Abbott
5.4.1. Company Overview
5.4.2. Financial Information
5.4.3. Companion Diagnostics portfolio
5.4.4. Recent Collaborations
5.4.5. Recent Developments and Future Outlook
5.5. QIAGEN
5.5.1. Company Overview
5.5.2. Financial Information
5.5.3. Companion Diagnostics Portfolio
5.5.4. Recent Collaborations
5.5.5. Recent Developments and Future Outlook
5.6. Myriad Genetics
5.6.1. Company Overview
5.6.2. Financial Information
5.6.3. Companion Diagnostics Portfolio
5.6.4. Recent Collaborations
5.6.5. Recent Developments and Future Outlook
5.7. Foundation Medicine
5.7.1. Company Overview
5.7.2. Financial Information
5.7.3. Companion Diagnostics Portfolio
5.7.4. Recent Collaborations
5.7.5. Recent Developments and Future Outlook

6. BRAND POSITIONING ANALYSIS OF KEY INDUSTRY PLAYERS
6.1. Chapter Overview
6.2. Scope and Methodology
6.3. Brand Positioning Matrix: Roche
6.4. Brand Positioning Matrix: Agilent Technologies
6.5. Brand Positioning Matrix: Abbott
6.6. Brand Positioning Matrix: QIAGEN
6.7. Brand Positioning Matrix: Myriad Genetics
6.8. Brand Positioning Matrix: Foundation Medicine
6.9. Comparison of Therapeutic Areas versus Assay Techniques
6.10. Comparison of Cancer Indications versus Assay Techniques

7. PARTNERSHIPS AND COLLABORATIONS
7.1. Chapter Overview
7.2. Partnership Models
7.3. Companion Diagnostics Market: List of Partnerships and Collaborations
7.4. Analysis by Year of Partnership
7.5. Analysis by Type of Partnership
7.6. Analysis by Type of Partnership 2014-2016 and 2016-2019
7.7. Analysis by Therapeutic Area
7.8. Analysis by Biomarkers Involved
7.9. Analysis by Drug Involved and Type of Partnership
7.10. Analysis by Technology Platform and Type of Agreement
7.11. Analysis by Drug Involved and Phase of Development
7.12. Most Active Players
7.13. Intercontinental and Intracontinental Agreements

8. STAKEHOLDER NEEDS ANALYSIS
8.1. Chapter Overview
8.2. Companion Diagnostics: Needs of Different Stakeholders
8.3. Comparison of Needs of Various Stakeholders
8.3.1. Needs of Drug Developers
8.3.2. Needs of Companion Diagnostics Developers
8.3.3. Needs of Regulatory Authorities
8.3.4. Needs of Testing Laboratories
8.3.5. Needs of Payers/Insurance Providers
8.3.6. Needs of Physicians
8.3.7. Needs of Patients

9. VALUE CHAIN ANALYSIS
9.1. Chapter Overview
9.2. Companion Diagnostics Value Chain: Cost Distribution
9.2.1. Research and Product Development
9.2.2. Manufacturing and Assembly
9.2.3. Clinical Trials, FDA Approval and Other Administrative Tasks
9.2.4. Payer Negotiation and KoL Engagement
9.2.5. Marketing and Sales
9.3. Companion Diagnostics Developer Operations: Key Cost Contributors
9.4. Companion Diagnostics Co-Development Operations: Key Cost Contributors

10. CLINICAL TRIALS AND KEY BIOMARKERS: A BIG PHARMA PERSPECTIVE
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. List of Clinical Trials
10.3.1. Analysis by Trial Registration Year
10.3.2. Analysis by Phase of Development
10.3.3. Analysis by Recruitment Status
10.3.4. Analysis by Therapy Design
10.3.5. Analysis by Type of Biomarkers
10.3.6. Analysis by Target Indications
10.3.7. Most Active Players
10.3.8. Analysis by Type of Cancer Therapy
10.3.9. Analysis of Region of Clinical Trials

11. MARKET FORECAST AND OPPORTUNITY ANALYSIS
11.1 Chapter Overview
11.2. Key Assumptions and Forecast Methodology
11.3. Global Companion Diagnostics Market, 2019-2030
11.3.1. Global Companion Diagnostics Market: Distribution by Region, 2019-2030
11.3.2. Global Companion Diagnostics Market: Distribution by Therapeutic Area, 2019-2030
11.3.3. Global Companion Diagnostics Market: Distribution by Target Indication, 2019-2030
11.3.3.1 Global Companion Diagnostics Market for Breast Cancer, 2019-2030
11.3.3.2 Global Companion Diagnostics Market for Lung Cancer, 2019-2030
11.3.3.3 Global Companion Diagnostics Market for Colorectal Cancer, 2019-2030
11.3.3.4 Global Companion Diagnostics Market for Ovarian Cancer, 2019-2030
11.3.3.5 Global Companion Diagnostics Market for Melanoma, 2019-2030
11.3.3.6 Global Companion Diagnostics Market for Leukemia, 2019-2030
11.3.3.7 Global Companion Diagnostics Market for Lymphoma, 2019-2030
11.3.3.8 Global Companion Diagnostics Market for Alzheimer’s Disease, 2019-2030
11.3.3.9 Global Companion Diagnostics Market for HIV/AIDS, 2019-2030
11.3.4. Global Companion Diagnostics Market: Distribution by Analytical Technique Used, 2019-2030
11.4. Companion Diagnostics Market in the US, 2019-2030
11.4.1. Companion Diagnostics Market in the US: Distribution by Therapeutic Area, 2019-2030
11.4.2. Companion Diagnostics Market in the US: Distribution by Target Indication, 2019-2030
11.4.3. Companion Diagnostics Market in the US: Distribution by Analytical Technique Used, 2019-2030
11.5. Companion Diagnostics Market in EU5, 2019-2030
11.5.1. Companion Diagnostics Market in  EU5: Distribution by Therapeutic Area, 2019-2030
11.5.2. Companion Diagnostics Market in EU5: Distribution by Target Indication, 2019-2030
11.5.3. Companion Diagnostics Market in EU5: Distribution by Analytical Technique Used, 2019-2030
11.6. Companion Diagnostics Market in Japan, 2019-2030
11.6.1. Companion Diagnostics Market in Japan: Distribution by Therapeutic Area, 2019-2030
11.6.2. Companion Diagnostics Market in Japan: Distribution by Target Indication, 2019-2030
11.6.3. Companion Diagnostics Market in Japan: Distribution by Analytical Technique Used, 2019-2030 
11.7. Companion Diagnostics Market in China, 2019-2030
11.7.1. Companion Diagnostics Market in China: Distribution by Therapeutic Area, 2019-2030
11.7.2. Companion Diagnostics Market in China: Distribution by Target Indication, 2019-2030
11.7.3. Companion Diagnostics Market in China: Distribution by Analytical Technique Used, 2019-2030
11.8. Companion Diagnostics Market in Australia, 2019-2030
11.8.1. Companion Diagnostics Market in Australia: Distribution by Therapeutic Area, 2019-2030
11.8.2. Companion Diagnostics Market in Australia: Distribution by Type of Indication, 2019-2030
11.8.3. Companion Diagnostics Market in Australia: Distribution by Type of Analytical Technique Used, 2019-2030

12. CONCLUDING REMARKS

13. EXECUTIVE INSIGHTS

14. APPENDIX 1: TABULATED DATA

15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

List of Figures
Figure 3.1 Evolution of Personalized Medicine, 2012-2017
Figure 3.2 Preclinical Development of Biomarker-based, Targeted Therapies
Figure 3.3 Role of Companion Diagnostics in Clinical Trials
Figure 3.4 Companion Diagnostics: Key Advantages
Figure 3.5 Companion Diagnostics: Primary Development-related Challenges
Figure 3.6 Companion Diagnostics: Market Drivers and Constraints
Figure 4.1 Companion Diagnostics: Distribution by Year of Establishment
Figure 4.2 Companion Diagnostics: Distribution by Company Size and Geographical Location
Figure 4.3 Companion Diagnostics: Distribution by Assay Technique Used
Figure 4.4 Companion Diagnostics: Distribution by Target Therapeutic Area
Figure 4.5 Companion Diagnostics: Distribution by Target Indication
Figure 4.6 Companion Diagnostics: Distribution by Type of Biomarker
Figure 4.7 Grid Analysis: Distribution by Target Indication and Type of Biomarker
Figure 4.8 Grid Analysis: Analysis by Type of Assay Technique Used and Therapeutic Area
Figure 4.9 Companion Diagnostics: Most Active Players
Figure 4.10 Companion Diagnostics: Distribution by Geographical Location
Figure 5.1 Roche: Annual Revenues, 2014-2018 (CHF Billion)
Figure 5.2 Agilent Technologies: Annual Revenues, 2014-2018 (USD Billion)
Figure 5.3 Agilent Technologies Annual Revenues: Distribution by Business Segment, 2018 (USD Billion)
Figure 5.4 Abbott: Annual Revenues, 2013-2018 (USD Billion)
Figure 5.5 Abbott Annual Revenues: Distribution by Business Segment, 2018 (USD Billion)
Figure 5.6 QIAGEN: Annual Revenues, 2014–2018 (USD Billion)
Figure 5.7 QIAGEN Net Sales: Distribution by Region, 2017 (USD Million)
Figure 5.8 Myriad Genetics: Annual Revenues, 2014-2018 (USD Million)
Figure 5.9 Myriad Genetics, Annual Revenues: Distribution by Testing Services, 2018 (USD Million)
Figure 5.10 Foundation Medicine: Annual Revenues, 2014-Q1 2018 (USD Million)
Figure 6.1 Brand Positioning Analysis of Key Industry Players: Unfair Advantages
Figure 6.2 Brand Positioning Analysis of Key Industry Players: Reasons to Believe
Figure 6.3 Brand Positioning Matrix: Roche
Figure 6.4 Brand Positioning Matrix: Agilent Technologies
Figure 6.5 Brand Positioning Matrix: Abbott
Figure 6.6 Brand Positioning Matrix: QIAGEN
Figure 6.7 Brand Positioning Matrix: QIAGEN
Figure 6.8 Brand Positioning Matrix: Myriad Genetics
Figure 6.9 Brand Positioning: Therapeutic Areas and Assay Techniques
Figure 6.10 Brand Positioning: Cancer Indications and Assay Techniques
Figure 7.1 Partnerships and Collaborations: Analysis by Year of Partnership
Figure 7.2 Partnerships and Collaborations: Analysis by Type of Partnership
Figure 7.3 Partnerships and Collaborations: Analysis by Type of Partnership 2014-2016 and 2016-2019
Figure 7.4 Partnerships and Collaborations: Analysis by Therapeutic Area
Figure 7.5 Partnerships and Collaborations: Analysis by Biomarkers Involved
Figure 7.6 Partnerships and Collaborations: Analysis by Drug Involved and Type of Partnership
Figure 7.7 Partnerships and Collaborations: Analysis by Technology Platform and Type of Agreement
Figure 7.8 Partnerships and Collaborations: Analysis by Drug Involved and Phase of Development
Figure 7.9 Most Active Players: Analysis by Number of Partnerships
Figure 7.10 Partnerships and Collaborations: Intercontinental and Intracontinental Distribution
Figure 8.1 Stakeholder Needs Analysis: Comparison of Needs of Different Stakeholders
Figure 8.2 Stakeholder Needs Analysis: Comparison of  Needs of Various Stakeholders
Figure 8.3 Stakeholder Needs Analysis: Comparison of Needs of Companion Diagnostics Developers
Figure 8.4 Stakeholder Needs Analysis: Needs of Regulatory Authorities
Figure 8.5 Stakeholder Needs Analysis: Needs of Testing Laboratories
Figure 8.6 Stakeholder Needs Analysis: Needs of Payers/Insurance Providers
Figure 8.7 Stakeholder Needs Analysis: Needs of Physicians
Figure 8.8 Stakeholder Needs Analysis: Needs of Patients
Figure 9.1 Companion Diagnostics Value Chain: Cost Distribution
Figure 9.2 Companion Diagnostics Value Chain: Research and Product Development
Figure 9.3 Companion Diagnostics Value Chain: Manufacturing and Assembly
Figure 9.4 Companion Diagnostics Value Chain: Clinical Trials, FDA Approval and Other Administrative Tasks
Figure 9.5 Companion Diagnostics Value Chain: Payer Negotiation and KoL Engagement
Figure 9.6 Companion Diagnostics Value Chain: Marketing and Sales
Figure 9.7 Companion Diagnostics Developer Operations: Key Cost Contributors
Figure 9.8 Companion Diagnostics Co-Development Operations: Key Cost Contributors
Figure 10.1 Clinical Trial Analysis: Cumulative Distribution of Trials by Registration Year, 2016-2019
Figure 10.2 Clinical Trial Analysis: Distribution by Registration Year and Type of Biomarker
Figure 10.3 Clinical Trial Analysis: Distribution by Trial Registration Year and Target Indication
Figure 10.4 Clinical Trial Analysis: Distribution by Phase of Development
Figure 10.5 Clinical Trial Analysis: Distribution by Trial Phase and Type of Biomarker
Figure 10.6 Clinical Trial Analysis: Distribution by Trial Phase and Target Indication
Figure 10.7 Clinical Trial Analysis: Distribution by Recruitment Status
Figure 10.8 Clinical Trial Analysis: Distribution by Therapy Design
Figure 10.9 Clinical Trial Analysis: Overall Distribution by Type of Biomarkers
Figure 10.10 Clinical Trial Analysis: Overall Distribution by Target Indications
Figure 10.11 Clinical Trial Analysis: Distribution by Type of Cancer Therapy
Figure 10.12 Clinical Trial Analysis: Most Active Players
Figure 10.13 Clinical Trial Analysis: Geographical Distribution by Number of Trials
Figure 10.14 Clinical Trial Analysis: Geographical Distribution by Enrolled Patient Population
Figure 10.15 Clinical Trial Analysis: Geographical Distribution by Trial Registration Year and Recruitment Status
Figure 11.1 Global Companion Diagnostics Market: 2019-2030 (USD Billion)
Figure 11.2 Global Companion Diagnostics Market: Distribution by Region, 2019-2030 (USD Billion)
Figure 11.3 Global Companion Diagnostics Market: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Figure 11.4 Global Companion Diagnostics Market: Distribution by Target Indication, 2019-2030 (USD Billion)
Figure 11.5 Global Companion Diagnostics Market for Breast Cancer, 2019-2030 (USD Billion)
Figure 11.6 Global Companion Diagnostics Market for Lung Cancer, 2019-2030 (USD Billion)
Figure 11.7 Global Companion Diagnostics Market for Colorectal Cancer, 2019-2030 (USD Billion)
Figure 11.8 Global Companion Diagnostics Market for Ovarian Cancer, 2019-2030 (USD Billion)
Figure 11.9 Global Companion Diagnostics Market for Melanoma, 2019-2030 (USD Billion)
Figure 11.10 Global Companion Diagnostics Market for Leukemia, 2019-2030 (USD Billion)
Figure 11.11 Global Companion Diagnostics Market for Lymphoma, 2019-2030 (USD Billion)
Figure 11.12 Global Companion Diagnostics Market for Alzheimer’s Disease, 2019-2030 (USD Billion)
Figure 11.13 Global Companion Diagnostics Market for HIV/AIDS, 2019-2030 (USD Billion)
Figure 11.14 Global Companion Diagnostics Market, Distribution by Type of Analytical Technique Used, 2019-2030  (USD Billion)
Figure 11.15 Companion Diagnostics Market in the US, 2019-2030 (USD Billion)
Figure 11.16 Companion Diagnostics Market in the US: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Figure 11.17 Companion Diagnostics Market in the US: Distribution by Target Indication, 2019-2030 (USD Billion)
Figure 11.18 Companion Diagnostics Market in the US: Distribution by Analytical Technique, 2019-2030 (USD Billion)
Figure 11.19 Companion Diagnostics Market in EU5, 2019-2030 (USD Billion)
Figure 11.20 Companion Diagnostics Market in EU5: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Figure 11.21 Companion Diagnostics Market in EU5: Distribution by Target Indication, 2019-2030 (USD Billion)
Figure 11.22 Companion Diagnostics Market in EU5: Distribution by Type of Analytical Technique, 2019-2030 (USD Billion)
Figure 11.23 Companion Diagnostics Market in Japan, 2019-2030 (USD Billion)
Figure 11.24 Companion Diagnostics Market in Japan: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Figure 11.25 Companion Diagnostics Market in Japan: Distribution by Target Indication, 2019-2030 (USD Billion)
Figure 11.26 Companion Diagnostics Market in Japan: Distribution by Analytical Technique, 2019-2030 (USD Billion)
Figure 11.27 Companion Diagnostics Market in China, 2019-2030 (USD Billion)
Figure 11.28 Companion Diagnostics Market in China: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Figure 11.29 Companion Diagnostics Market in China: Distribution by Target Indication, 2019-2030 (USD Billion)
Figure 11.30 Companion Diagnostics Market in China: Distribution by Analytical Technique, 2019-2030 (USD Billion)
Figure 11.31 Companion Diagnostics Market in Australia, 2019-2030 (USD Billion)
Figure 11.32 Companion Diagnostics Market in Australia: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Figure 11.33 Companion Diagnostics Market in Australia: Distribution by Target Indication, 2019-2030 (USD Billion)
Figure 11.34 Companion Diagnostics Market in Australia: Distribution by Analytical Technique, 2019-2030 (USD Billion)

List of Tables
Table 4.1. Companion Diagnostics: List of Developers
Table 4.2. Companion Diagnostics: Tests Available and Under Development
Table 5.1. Companion Diagnostics: List Companies Profiled
Table 5.2. Roche: Other Companion Diagnostics
Table 5.3. Roche: Recent Developments and Future Outlook
Table 5.4. Agilent: Other Companion Diagnostics
Table 5.5. Agilent Technologies: Recent Developments and Future Outlook
Table 5.6. Abbott: Other Companion Diagnostics
Table 5.7. Abbott: Recent Developments and Future Outlook
Table 5.8. QIAGEN: Other Companion Diagnostics
Table 5.9. QIAGEN: Recent Developments and Future Outlook
Table 5.10. Myriad Genetics: Other Companion Diagnostics
Table 5.11. Myriad Genetics: Recent Developments and Future Outlook
Table 5.12. FoundationOne CDx: Target Indications
Table 5.13. Foundation Medicine: Other Companion Diagnostics
Table 5.14. Foundation Medicine: Recent Developments and Future Outlook
Table 7.1. Companion Diagnostics: Partnerships and Collaborations, 2014-2019
Table 14.1. Companion Diagnostics: Distribution by Year of Establishment
Table 14.2. Companion Diagnostics: Distribution by Company Size and Geographical Location
Table 14.3. Companion Diagnostics: Distribution by Assay Technique Used
Table 14.4. Companion Diagnostics: Distribution by Target Therapeutic Area
Table 14.5. Companion Diagnostics: Distribution by Target Indication
Table 14.6. Companion Diagnostics: Distribution by Type of Biomarker
Table 14.7. Grid Analysis: Distribution by Target Indication and Type of Biomarker
Table 14.8. Grid Analysis: Analysis by Type of Assay Technique Used and Therapeutic Area
Table 14.9. Companion Diagnostics: Most Active Players
Table 14.10. Companion Diagnostics: Distribution by Geographical Location
Table 14.11. Roche: Annual Revenues, 2014-2018 (CHF Billion)
Table 14.12. Agilent Technologies: Annual Revenues, 2014-2018 (USD Billion)
Table 14.13. Agilent Technologies Annual Revenues: Distribution by Business Segment, 2018 (USD Billion)
Table 14.14. Abbott: Annual Revenues, 2013-2018 (USD Billion)
Table 14.15. Abbott Annual Revenues: Distribution by Business Segment, 2018 (USD Billion)
Table 14.16. QIAGEN: Annual Revenues, 2014–2018 (USD Billion)
Table 14.17. QIAGEN Net Sales: Distribution by Region, 2017 (USD Million)
Table 14.18. Myriad Genetics: Annual Revenues, 2014-2018 (USD Million)
Table 14.19. Myriad Genetics, Annual Revenues: Distribution by Testing Services, 2018 (USD Million)
Table 14.20. Foundation Medicine: Annual Revenues, 2014-Q1 2018 (USD Million)
Table 14.21. Brand Positioning Analysis of Key Industry Players: Unfair Advantage
Table 14.22. Brand Positioning Analysis of Key Industry Players: Reasons to Believe
Table 14.23. Brand Positioning Matrix: Roche
Table 14.24. Brand Positioning Matrix: Agilent Technologies
Table 14.25. Brand Positioning Matrix: Abbott
Table 14.26. Brand Positioning Matrix: QIAGEN
Table 14.27. Brand Positioning Matrix: QIAGEN
Table 14.28. Brand Positioning Matrix: Myriad Genetics
Table 14.29. Brand Positioning: Comparison of Therapeutic Areas and Assay Techniques
Table 14.30. Brand Positioning: Comparison of Cancer Indications and Assay Techniques
Table 14.31. Partnerships and Collaborations: Analysis by Year of Partnership
Table 14.32. Partnerships and Collaborations: Analysis by Type of Partnership
Table 14.33. Partnerships and Collaborations: Analysis by Type of Partnership 2014-2016 and 2016-2019
Table 14.34. Partnerships and Collaborations: Analysis by Therapeutic Area
Table 14.35. Partnerships and Collaborations: Analysis by Biomarkers Involved
Table 14.36. Partnerships and Collaborations: Analysis by Drug Involved and Type of Partnership
Table 14.37. Partnerships and Collaborations: Analysis by Technology Platform and Type of Agreement
Table 14.38. Most Active Players: Analysis by Number of Partnerships
Table 14.39. Partnerships and Collaborations: Intercontinental and Intracontinental Distribution
Table 14.40. Stakeholder Needs Analysis: Comparison of Needs of Different Stakeholders
Table 14.41. Stakeholder Needs Analysis: Comparison of Needs of Various Stakeholders
Table 14.42. Stakeholder Needs Analysis: Comparison of Needs of Companion Diagnostics Developers
Table 14.43. Stakeholder Needs Analysis: Needs of Regulatory Authorities
Table 14.44. Stakeholder Needs Analysis: Needs of Testing Laboratories
Table 14.45. Stakeholder Needs Analysis: Needs of Payers/Insurance Providers
Table 14.46. Stakeholder Needs Analysis: Needs of Physicians
Table 14.47. Stakeholder Needs Analysis: Needs of Patients
Table 14.48. Clinical Trial Analysis: Distribution by Registration Year and Type of Biomarker
Table 14.49. Clinical Trial Analysis: Distribution by Trial Registration Year and Target Indication
Table 14.50. Clinical Trial Analysis: Distribution by Phase of Development
Table 14.51. Clinical Trial Analysis: Distribution by Trial Phase and Type of Biomarker
Table 14.52. Clinical Trial Analysis: Distribution by Trial Phase and Target Indication
Table 14.53. Clinical Trial Analysis: Distribution by Recruitment Status
Table 14.54. Clinical Trial Analysis: Distribution by Therapy Design
Table 14.55. Clinical Trial Analysis: Overall Distribution by Type of Biomarker Biomarkers
Table 14.56. Clinical Trial Analysis: Overall Distribution by Target Indications
Table 14.57. Clinical Trial Analysis: Distribution by Type of Cancer Therapy Evaluated
Table 14.58. Clinical Trial Analysis: Most Active Players
Table 14.59. Clinical Trial Analysis: Geographical Distribution by Number of Trials
Table 14.60. Clinical Trial Analysis: Geographical Distribution by Enrolled Patient Population
Table 14.61. Clinical Trial Analysis: Geographical Distribution by Trial Registration Year and Recruitment Status
Table 14.62. Global Companion Diagnostics Market, 2019-2030: Base, Optimistic, Conservative Case (USD Billion)
Table 14.63. Global Companion Diagnostics Market: Distribution by Region, 2019-2030 (USD Billion)
Table 14.64. Global Companion Diagnostics Market: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Table 14.65. Global Companion Diagnostics Market: Distribution by Target Indication, 2019-2030 (USD Billion)
Table 14.66. Global Companion Diagnostics Market for Breast Cancer, 2019-2030 (USD Billion)
Table 14.67. Global Companion Diagnostics Market for Lung Cancer, 2019-2030 (USD Billion)
Table 14.68. Global Companion Diagnostics Market for Colorectal Cancer, 2019-2030 (USD Billion)
Table 14.69. Global Companion Diagnostics Market for Ovarian Cancer, 2019-2030 (USD Billion)
Table 14.70. Global Companion Diagnostics Market for Melanoma, 2019-2030 (USD Billion)
Table 14.71. Global Companion Diagnostics Market for Leukemia, 2019-2030 (USD Billion)
Table 14.72. Global Companion Diagnostics Market for Lymphoma, 2019-2030 (USD Billion)
Table 14.73. Global Companion Diagnostics Market for Alzheimer’s Disease, 2019-2030 (USD Billion)
Table 14.74. Global Companion Diagnostics Market for HIV/AIDS, 2019-2030 (USD Billion)
Table 14.75. Global Companion Diagnostics Market, Distribution by Analytical Technique, 2019-2030 (USD Billion)
Table 14.76. Companion Diagnostics Market in the US, 2019-2030 (USD Billion)
Table 14.77. Companion Diagnostics Market in the US: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Table 14.78. Companion Diagnostics Market in the US: Distribution by Target Indication, 2019-2030 (USD Billion)
Table 14.79. Companion Diagnostics Market in the US: Distribution by Analytical Technique, 2019-2030 (USD Billion)
Table 14.80. Companion Diagnostics Market in EU5, 2019-2030 (USD Billion)
Table 14.81. Companion Diagnostics Market in EU5: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Table 14.82. Companion Diagnostics Market in EU5: Distribution by Target Indication, 2019-2030 (USD Billion)
Table 14.83. Companion Diagnostics Market in EU5: Distribution by Analytical Technique, 2019-2030 (USD Billion)
Table 14.84. Companion Diagnostics Market in Japan, 2019-2030 (USD Billion)
Table 14.85. Companion Diagnostics Market in Japan: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Table 14.86. Companion Diagnostics Market in Japan: Distribution by Target Indication, 2019-2030 (USD Billion)
Table 14.87. Companion Diagnostics Market in Japan: Distribution by Analytical Technique, 2019-2030 (USD Billion)
Table 14.88. Companion Diagnostics Market in China, 2019-2030 (USD Billion)
Table 14.89. Companion Diagnostics Market in China: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Table 14.90. Companion Diagnostics Market in China: Distribution by Target Indication, 2019-2030 (USD Billion)
Table 14.91. Companion Diagnostics Market in China: Distribution by Analytical Technique, 2019-2030 (USD Billion)
Table 14.92. Companion Diagnostics Market in Australia, 2019-2030 (USD Billion)
Table 14.93. Companion Diagnostics Market in Australia: Distribution by Therapeutic Area, 2019-2030 (USD Billion)
Table 14.94. Companion Diagnostics Market in Australia: Distribution by Target Indication, 2019-2030 (USD Billion)
Table 14.95. Companion Diagnostics Market in Australia: Distribution by Analytical Technique, 2019-2030 (USD Billion)

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FEATURED COMPANIES

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Chapter Summary:

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the market for companion diagnostics, in the short-mid term and 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 the various analytical techniques used in such tests. It also provides details on key market drivers and challenges within this industry.

Chapter 4 provides a list of companion diagnostics designed for different drugs. It includes information on the corresponding drug(s) / drug class and detailed analysis on the affiliated biomarker, assay technique involved (in situ hybridization (ISH), immunohistochemistry  (IHC), next-generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others), the type of sample required (tumor tissue, blood, bone marrow and others) and the developer details (such as company size and location of company headquarters).

Chapter 5 provides detailed profiles of some of the leading stakeholders in this field (shortlisted on the basis of the strength of the product portfolio). Each profile presents a brief overview of the company, financial information (if available), product portfolio, recent collaborations and an informed future outlook.

Chapter 6 provides an elaborative brand positioning analysis of the leading industry players (shortlisted on the basis of the strength of product portfolio) highlighting the current perceptions regarding their proprietary brands across their companion diagnostic portfolio, taking into consideration several aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic areas and the overall market positioning of the players.

Chapter 7 features an elaborate analysis and discussion of the various collaborations and partnerships that have been inked amongst players since 2014. It includes a brief description of various types of partnership models (which include acquisitions, licensing agreements, product development and commercialization agreements, research and development agreements, distribution and supply agreements, service alliances and other agreements) that have been adopted by stakeholders in this domain. It also includes a schematic representation that showcases the companies that have established the maximum number of alliances, highlighting key technologies and disease indications.

Chapter 8 provides information on the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in this domain. The chapter qualitatively assesses the various companion diagnostics-related needs of these stakeholders, highlighting their respective perspectives regarding the importance of each need.

Chapter 9 presents a value chain analysis featuring a discussion on various steps of the development operations, namely R&D development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.

Chapter 10 provides a comprehensive clinical trial analysis of completed, ongoing and planned studies of various therapies for oncological disorders being sponsored by the top pharmaceutical players. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials

Chapter 11 features a comprehensive market forecast analysis, highlighting the likely growth of companion diagnostics until the year 2030. We have provided inputs on the likely distribution of the opportunity  based on the type of therapeutic area (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer’s disease and HIV)), key contributing technologies (in situ hybridization (ISH), immune histochemistry  (IHC), next-generation sequencing (NGS), polymerase chain reaction (PCR) and others), different regions North America (the US), Europe (the UK, Spain, Italy, France and Germany) and Asia Pacific (Japan, China and Australia).

Chapter 12 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the companion diagnostics industry.

Chapter 13 is a collection of interview transcript(s) of discussions held with industry stakeholders, wherever the participants didn’t request anonymity. 

Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 15 is an appendix, which contains a list of companies and organizations mentioned in this report.

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  • AB-Biotics
  • ANGLE
  • ARIAD Pharmaceuticals
  • ARUP Laboratories
  • AVEO Oncology
  • AbbVie
  • Abbott Laboratories
  • Abcam
  • Abnova
  • Acobiom
  • AdnaGen
  • Advanced Cell Diagnostics
  • Agena Bioscience
  • Agendia
  • Agilent Technologies
  • Agios Pharmaceuticals
  • Alere
  • Allele Frequency Community
  • Allergan
  • Almac
  • Alpha Laboratories
  • AltheaDx
  • Altona Diagnostics
  • Amgen
  • Amoy Diagnostics
  • Angsana Molecular & Diagnostics Laboratory
  • Applied Spectral Imaging
  • ArcherDX
  • Arno Therapeutics
  • Array BioPharma
  • Arrayit
  • Assurex Health
  • Astellas Pharma
  • AstraZeneca
  • Asuragen
  • Avant Diagnostics
  • Bayer
  • BeiGene
  • BioGenex
  • BioMarin
  • Biocartis
  • Biodesix
  • Biotype Diagnostic
  • Bliss Biopharmaceutical
  • Blueprint Medicines
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • CANbridge Life Sciences
  • CBLPath
  • Cancer Genetics
  • Celgene
  • Cell Signaling Technology
  • Clovis Oncology
  • Corgenix
  • Counsyl
  • Daiichi Sankyo
  • DalCor Pharmaceuticals
  • Definiens
  • Dian Diagnostics Group
  • Eli Lilly
  • Epic Sciences
  • Epizyme
  • European Organization for the Research and Treatment of Cancer
  • Exact Sciences
  • Exiqon
  • Exosome Diagnostics
  • Ferring Pharmaceuticals
  • Five Prime Therapeutics
  • Flagship Biosciences
  • Flatiron Health
  • Foundation Medicine
  • Galmed Pharmaceuticals
  • GenDx
  • GeneCast Biotechnology
  • Genomas
  • Genomic Health
  • Genoptix
  • Genosity
  • Gilead Sciences
  • GlaxoSmithKline
  • Guangzhou KingMed Diagnostics Group
  • Guardant Health
  • HTG Molecular Diagnostics
  • HalioDx
  • Halozyme Therapeutics
  • Hitachi
  • Horizon Discovery
  • IDbyDNA
  • IQVIA
  • Idera Pharmaceuticals
  • Ignyta
  • Illumina
  • Immuron
  • InDex Pharmaceuticals
  • Incyte
  • IndivuTest
  • Inotrem
  • Invivoscribe
  • Janssen Biotech
  • Jiangsu Hengrui Medicine
  • Johnson & Johnson
  • Lab21
  • LabCorp
  • Labceutics
  • Leica Biosystems
  • Life Technologies
  • LipoScience
  • Locus Biosciences
  • Loxo Oncology
  • Luminex
  • Luxcel Biosciences
  • MDxHealth
  • Medical & Biological Laboratories
  • Medivation
  • Merck
  • Merrimack Pharmaceuticals
  • MetaStat
  • MicroMatrices
  • Mirati Therapeutics
  • MolecularMD
  • Monogram Biosciences
  • Mount Sinai Health System
  • Myriad Genetics
  • N-of-One
  • NanoString Technologies
  • National Institute of Pathology
  • NeoGenomics
  • NeuMoDx Molecular
  • Nichirei Biosciences
  • Novartis
  • Novo Nordisk
  • NuSirt Biopharma
  • OWL Metabolomics
  • OmicSoft
  • OmniSeq
  • OncoMed Pharmaceuticals
  • Ono Pharmaceutical
  • PerkinElmer
  • Pfizer
  • Philips
  • Phoenix Molecular Designs
  • Pierre Fabre
  • ProSciento
  • Protagen
  • Puma Biotechnology
  • Q2 Solutions
  • QED Therapeutics
  • QIAGEN
  • Quest Diagnostics
  • R-Biopharm
  • Resonance Health
  • Riken Genesis
  • Roche
  • SRL Diagnostics
  • STATdx
  • Sanofi
  • Sarah Cannon Research Institute
  • School for Oncology and Developmental Biology
  • Seahorse Bioscience
  • Shuwen Biotech
  • Siemens Healthineers
  • Singulex
  • Sividon Diagnostics
  • Spectrum Pharmaceuticals
  • Streck
  • Sysmex
  • TESARO
  • Takeda Pharmaceuticals
  • Teva Pharmaceutical
  • The Jackson Laboratory
  • Therawis Diagnostics
  • Thermo Fisher Scientific
  • Tokai Pharmaceuticals
  • Turning Point Therapeutics
  • USC Michelson Center for Convergent Bioscience
  • Unilabs
  • Vivia Biotech
  • Walgreens
  • Wondfo
  • XCR Diagnostics
  • bioMérieux
  • uBiome
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