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US Companion Diagnostics Market Trends and Insights

  • April 2014
  • -
  • Frost & Sullivan
  • -
  • 121 pages

A complete companion diagnostic market analysis must include both developers of targeted drugs and developers of companion diagnostic tests. This research deliverable discusses important trends in the U.S. companion diagnostics market including emerging opportunities with novel drug classes and new clinical markers like circulating tumor cells. Emerging therapeutic areas beyond oncology for companion diagnostics are also discussed along with key competitors, rx-cdx partnerships, regulatory overview, and therapeutic pipelines with companion biomarkers.


Key Findings

There were at least 387 targeted medicines in the pipeline or currently marketed for oncology in 2013. breast cancer, non-small cell lung cancer (NSCLC), and colorectal cancer have the most targeted drug development activity.

Novartis and Roche lead with the most targeted therapies currently marketed and in development. AstraZeneca, GSK, Pfizer, Sanofi, and BMS are also focused on targeted therapies marketed with or likely requiring a companion diagnostics (CDx).

Key market drivers include the unmet need for Cdx in highly mutationally driven cancers such as NSCLC and melanoma and the growing interest in novel clinical epigenetic biomarkers and circulating tumor cells.

A promising new drug class, the antibody drug conjugate (ADC), may provide new opportunities for CDx. Roche, ImmunoGen, and Seattle Genetics all have a high number of ADCs in the pipeline and may be attractive targets for CDx partnering.

Advances such as highly sensitive microfluidic biosensors, single cell analysis, and deep sequencing of circulating cell-free tumor DNA are making the concept of the liquid biopsy, or the ability to monitor a tumor noninvasively, a near-term reality.

Oncology is the primary therapeutic area for CDx development, but neurological, cardiovascular, gastrointestinal, and muscular diseases are growing areas for CDx. Within oncology, lung cancer was the most prominent area where most partnerships between manufacturers were observed.

Most CDx partnerships were defined over the regions of the United States and Europe, the two most important CDx markets.

Table Of Contents

US Companion Diagnostics Market Trends and Insights
Table of Contents


Executive Summary 4
Market Overview and Trends 6
Product Analysis: BRAF, EGFR, KRAS 12
Companion Biomarker Opportunities in Drug Development 21
Competitive Playbook 25
US Regulatory Overview 37
Appendix 43
Therapeutic Pipeline with Companion Biomarker—By Pharmaceutical Company 48
Therapeutic Pipeline with Companion Biomarker—By Cancer Type 54
The Frost and Sullivan Story 114

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