Summary
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.
Scope
The 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.
Companies Mentioned
Abbott Molecular
Amoy Diagnostics
AstraZeneca
Avant Diagnostics
Bayer
BeiGene
bioMérieux
Bristol-Myers Squibb
Clovis Oncology
Dako
Eli Lilly
FoundationMedicine
Genentech
Hoffmann-La Roche
Ignyta
Illumina
InVivoScribe Technologies
Leica
Loxo Oncology
MBL
Merck & Co.
Myriad Genetics
Nanostring Technologies
Oncology Venture
Precision Proteomics
Qiagen
Siemens Healthineers
Sierra Oncology
ThermoFisher Scientific
Ventana Medical Systems
Vyriad
'
1 Table of Contents
1. Preface
1.1 Table of Contents 2
1.2 Abbreviations 4
1.3 Related Reports 5
1.4 Upcoming Related Reports 6
2. Executive Summary 7
2.1 Key Findings 8
2.2 KOL and Payer Insights 9
3. Introduction to Biomarkers and Companion Diagnostics in Oncology 10
3.1 Biomarkers and Companion Diagnostics in the Era of Personalized Medicine 11
3.2 Definitions 12
4. Companion Diagnostic Technologies 15
4.1 Overview 16
4.2 Nucleic Acid-Based Technologies 17
4.3 Protein-Based Technologies 18
4.4 Most Common Marketed Technologies 19
4.5 KOL Perspectives 20
5. Predictive Biomarkers in Oncology 23
5.1 Overview 24
5.2 Predictive Biomarkers in Breast Cancer 25
5.3 Predictive Biomarkers in Non-Small Cell Lung Cancer 26
5.4 Predictive Biomarkers in Melanoma 30
5.5 Predictive Biomarkers in Colorectal Cancer 31
5.6 Predictive Biomarkers in Ovarian Cancer 32
5.7 Predictive Biomarkers in Acute Myeloid Leukemia 33
5.8 Predictive Biomarkers in Site-Agnostic Cancers 34
6. Emerging Areas of Interest 36
6.1 Overview 37
6.2 Trial Design Disruption 38
6.3 Liquid Biopsies 40
6.4 Biomarkers for CAR-T Cell Therapy 43
7. Market Opportunities 45
7.1 Overview 46
7.2 Market Drivers 47
7.3 Market Barriers 49
7.4 Unmet Needs 52
8. Market Access 56
8.1 Overview 57
8.2 Global Regulatory Agencies’ Definitions of CDx 58
8.3 Regulation and Reimbursement in the US 59
8.3.1 Payer Perspective 61
8.4 Regulation and Reimbursement in the EU 64
8.4.1 Payer Perspective 65
8.5 Regulation and Reimbursement in Japan 69
8.5.1 KOL Perspective 71
8.6 Regulation and Reimbursement in China 72
8.6.1 Payer Perspective 74
9. Companion Diagnostic Products and Key Players 77
9.1 Overview 78
9.2 Key Players in the US CDxMarket 79
9.3 Key Players in the Japan CDx Market 80
9.4 Key Player Company Profiles 81
9.5 CDx Business Models and Key Players 83
9.6 Marketed Product Examples 85
9.7 Pipeline Overview 86
10. Market Outlook 88
10.1 Expert Perspectives 89
11. Appendix 92
11.1 Marketed CDx 93
11.2 Pipeline CDx 99
11.3 Methodology 107
11.4 Primary Research 108
11.5 About the Authors 109
11.6 About GlobalData 111
11.7 Contact Us 112
