Global Companion Diagnostics Development Services Market Research Report 2022

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May 09, 2022, 06:45 ET

DUBLIN, May 9, 2022 /PRNewswire/ -- The "Companion Diagnostics Development Services Market: Distribution by Type of Service Offered, Analytical Technique Used, Therapeutic Areas and Key Geographies: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.

The "Companion Diagnostics Development Services Market 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.

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.

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 HercepTestT (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%.

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?

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 Topics Covered:

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
3.4. Applications of Companion Diagnostics across Different Therapeutic Areas
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

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
5.5. 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
6.2.2. Interpace Biosciences
6.2.3. Labcorp (formerly known as Covance)
6.2.4. Quest Diagnostics
6.2.5. Q Solutions
6.2.6. ResearchDx
6.3. Key Players in Europe
6.3.1. Almac Diagnostic Services
6.3.2. Biocartis
6.3.3. Cerba Research
6.3.4. Eurofins
6.3.5. MLM Medical Labs
6.3.6. QIAGEN
6.4. Key Players in Asia-Pacific and Rest of the World
6.4.1. BGI Genomics
6.4.2. MEDx (Suzhou) Translational Medicine (formerly known as QIAGEN (Suzhou) Translational Medicine)
6.4.3. MEDICAL & BIOLOGICAL LABORATORIES (MBL)
6.4.4. Novogene

7. COMPANION DIAGNOSTICS: MARKET LANDSCAPE
7.1. Chapter Overview
7.2. Companion Diagnostics: List of Marketed Products / Investigational Programs
7.3. Companion Diagnostic Devices: List of Developers

8. PARTNERSHIPS AND COLLABORATIONS
8.1. Chapter Overview
8.2. Partnership Models
8.3. List of Partnerships and Collaborations

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
9.5. Likely Partners for Companion Diagnostics Service Providers: Breast Cancer
9.6. Likely Partners for Companion Diagnostics Service Providers: Colorectal Cancer
9.7. Likely Partners for Companion Diagnostic Service Providers: HIV
9.8. Likely Partners for Companion Diagnostics Service Providers: Lung Cancer
9.9. Likely Partners for Companion Diagnostics Service Providers: NASH / NAFLD
9.10. Likely Partners for Companion Diagnostics Service Providers: Ovarian Cancer
9.11. Likely Partners for Companion Diagnostics Service Providers: Prostate Cancer

10. MERGERS AND ACQUISITONS
10.1. Chapter Overview
10.2. Merger and Acquisition Models
10.3. List of Mergers and Acquisitions

11. STAKEHOLDER NEEDS ANALYSIS
11.1. Chapter Overview
11.2. Companion Diagnostics: Needs of Different Stakeholders
11.3. Comparison of Needs of Various Stakeholders

12. VALUE CHAIN ANALYSIS
12.1. Chapter Overview
12.2. Companion Diagnostics Value Chain: Cost Distribution
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
13.5. 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
14.3. Biomarker-Driven Targeted Therapies: Developer Landscape
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
15.3. Precision Medicine Software Solutions: List of Developers

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

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
17.4. Novodiax
17.5. OWL Metabolomics
17.6. NeoGenomics Laboratories

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

19. APPENDIX 1: TABULATED DATA

20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS