Biomarkers and Companion Diagnostics in Oncology

Biomarkers and Companion Diagnostics in Oncology

Summary

The Global Companion Diagnostics (CDx) market will be shaped by next-generation sequencing (NGS) technologies over the next five years. Measuring many biomarkers in one test using NGS panels will become increasingly important as targeted therapies continue to become embedded in treatment algorithms for many different types of cancer.

A biomarker is a defined molecular characteristic, for example a genetic mutation, which 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.

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.

This technology is likely to transform the companion diagnostics market in the next five years due to its high efficiency and gradually decreasing cost. There are currently five marketed next-generation sequencing CDx in the US as it leads the way in terms of clarity on CDx regulation, the first of which was approved in 2016. The FDA’s guidance is stringent regarding analytical and clinical validity, but it does facilitate CDx market entry by providing multiple marketing authorization pathways, and the agency is pursuing tighter regulation of laboratory-developed tests. CDx regulation in Japan is less advanced than in the US in certain aspects, while CDx were only recently formally defined in Europe and remain undefined in China in terms of regulatory processes.

Roche will be a major player in the global CDx market, due in part to its recent acquisition of Foundation Medicine. Roche currently has the highest number of marketed CDx products in the US and Japan, including those developed by its subsidiary companies Ventana Medical Systems and Foundation Medicine. Altogether, Roche owns 31% of the products on the US market. In addition, Foundation Medicine has existing CDx partnerships with other companies such as Merck and AstraZeneca, from which Roche now stands to benefit financially.

The report, "Biomarkers and Companion Diagnostics in Oncology", provides an overview of oncology-specific biomarkers and CDx in the 8MM (US, Germany, Italy, France, UK, Spain, 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 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.