Biomarkers and Companion Diagnostics in Oncology

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A biomarker is a defined molecular characteristic, for example a genetic mutation, that can tell a physician more about a patient’s disease state, or how they might respond to treatment. Predictive biomarkers indicate how likely a patient is to respond to a treatment, and are used in clinical decision making. In some cases, a patient must possess a particular biomarker to receive a particular drug. For example, breast cancer patients must test positive for HER2 in order to receive anti-HER2 therapy. Companion diagnostics (CDx) are in vitro diagnostics used to measure biomarkers deemed essential for the use of a particular drug, and their use is on the rise, particularly in oncology. In fact, over 90% of FDA-approved CDx are for cancer indications. This is likely because oncology treatments have a relatively high ‘failure’ rate compared to other diseases, and treating a patient with the right drug is often very time-sensitive due to the aggressive nature of some cancers. Biomarkers are of high interest to multiple stakeholders in oncology and have been a major focus of the major international medical congresses in recent years, reflecting the rapidly growing oncology CDx market.
In this report, GlobalData provides an overview of oncology-specific biomarkers and CDx in the 8MM (US, 5EU, Japan and China) including key opinion leader and payer perspectives throughout. Coverage includes insights into select biomarkers across seven oncology indications, CDx technologies, market access trends, market drivers, barriers and unmet needs, key products and companies, emerging areas of interest, and market outlook.


GlobalData’s Biomarkers and Companion Diagnostics in Oncology report combines primary research from key opinion leaders and payers with in-house analyst expertise to provide an assessment of the development landscape.

Components of the slide deck include primary and secondary research:

• Quotes from 7 US-, 5EU-, Japan- and China-based key opinion leaders and from 2 payers (EU and US)

• Provides an overview of biomarkers and CDx in the 8MM

• Explains the terminology surrounding CDx, which is still evolving across the 8MM and can have implications for how CDx are used and accessed

• Highlights the aspects of healthcare systems and national regulatory landscapes that are important in achieving market and patient access to CDx in the 8MM

• Identifies the market drivers, barriers and unmet needs in the global CDx market

• Provides an overview of the different types of CDx technologies and highlights which ones will drive market growth in the next five years

• Gives an overview of the main biomarkers currently used in clinical practice and in clinical trials

• Gives an overview of marketed and pipeline CDx products, and key pharma, biotech and diagnostic companies

• Provides detailed insights from leading physicians and payers and identifies emerging topics of interest within this field

• Insight from GlobalData’s specialist oncology analysts

Reasons to Buy

Develop business strategies by understanding the opportunities and challenges for biomarkers and CDx in the 8MM

Drive revenues through understanding the market trends and unmet needs in the global CDx market

Become acquainted with how CDx are regulated and reimbursed in the 8MM, and the associated opportunities and challenges

Understand the emerging technologies that are being used for CDx platforms and how these will drive market growth

Find out who the key CDx players are and the business models they use to achieve success in this growing market

Abbott Molecular
Amoy Diagnostics
Avant Diagnostics
Bristol-Myers Squibb
Clovis Oncology
Eli Lilly
Hoffmann-La Roche
InVivoScribe Technologies
Loxo Oncology
Merck & Co.
Myriad Genetics
Nanostring Technologies
Oncology Venture
Precision Proteomics
Siemens Healthcare
Sierra Oncology
ThermoFisher Scientific
Ventana Medical Systems

Table of Contents

1 Table of Contents (PowerPoint Deck)

1. Preface

1.1 Table of Contents

1.2 Abbreviations

1.3 Related Reports

1.4 Upcoming Related Reports

2. Executive Summary

2.1 Key Findings

2.2 KOL and Payer Insights

3. Introduction to Biomarkers and Companion Diagnostics in Oncology

3.1 Biomarkers and Companion Diagnostics in the Era of Personalized Medicine

3.2 Definitions

4. Companion Diagnostic Technologies

4.1 Overview

4.2 Nucleic Acid-Based Technologies

4.3 Protein-Based Technologies

4.4 Most Common Marketed Technologies

4.5 KOL Perspectives

5. Predictive Biomarkers in Oncology

5.1 Overview

5.2 Predictive Biomarkers in Breast Cancer

5.3 Predictive Biomarkers in Non-Small Cell Lung Cancer

5.4 Predictive Biomarkers in Melanoma

5.5 Predictive Biomarkers in Colorectal Cancer

5.6 Predictive Biomarkers in Ovarian Cancer

5.7 Predictive Biomarkers in Acute Myeloid Leukemia

5.8 Predictive Biomarkers in Site-Agnostic Cancers

6. Emerging Areas of Interest

6.1 Overview

6.2 Trial Design Disruption

6.3 Liquid Biopsies

6.4 Biomarkers for CAR-T Cell Therapy

7. Market Opportunities

7.1 Overview

7.2 Market Drivers

7.3 Market Barriers

7.4 Unmet Needs

8. Market Access

8.1 Overview

8.2 Global Regulatory Agencies’ Definitions of CDx

8.3 Regulation and Reimbursement in the US

8.4 Regulation and Reimbursement in the EU

8.5 Regulation and Reimbursement in Japan

8.6 Regulation and Reimbursement in China

9. Companion Diagnostic Products and Key Players

9.1 Overview

9.2 Key Players in the US CDx Market

9.3 Key Players in the Japan CDx Market

9.4 Key Player Company Profiles

9.5 CDx Business Models and Key Players

9.6 Marketed Product Examples

9.7 Pipeline Overview

10. Market Outlook

10.1 Expert Perspectives

11. Appendix

11.1 Marketed CDx

11.2 Pipeline CDx

11.3 Methodology

11.4 Primary Research

11.5 About the Authors

11.6 About GlobalData

11.7 Contact Us

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