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Research and Markets: Global Companion Diagnostics (CDx) Market 2013-2016
[April 14, 2014]

Research and Markets: Global Companion Diagnostics (CDx) Market 2013-2016

DUBLIN --(Business Wire)--

Research and Markets ( has announced the addition of the "Global Companion Diagnostics (CDx) Market 2013-2016" report to their offering.

This report reviews the size, segmentation, growth, competitive, and regulatory landscape of the companion diagnostics manufacturing market, focusing on the drug-test combinations that are considered required by the FDA. In this first edition of this CDx report, we provide estimates of the U.S. and worldwide markets for FDA approved CDx tests from 2008 to 2016 and segmentations by regulatory status (IVD, LDT), biomarker (HER2, ALK, KRAS, EGFR, ER/PR, CD20, future tests, others), therapeutic area (breast cancer, lung cancer, colon cancer, leukemia/lymphoma, other cancers, non-cancers), assay technology (FISH, IHC, sequencing, qPCR, flow cytometry, others), testing site (reference lab, hospital lab), geography (U.S., Europe, Japan, APAC, ROW), and company (Qiagen, Abbott, Dako, Roche, reference labs, others). We also identify growth drivers and moderators, as well as challenges and opportunities for the CDx market.

Additionally, this report analyzes the coverage and reimbursement landscape, the impact of macroeconomic events, and the current and future regulatory environment. In this report we categorize CDx tests as either required,' recommended,' or information only' dependingon the regulatory status and testing instructions contained within the drug label.

Other key points discussed here include:

  • Competition and regulatory differences between manufacturers of FDA-approved IVDs and clinical reference labs who offer lower priced laboratory developed tests (LDTs).
  • The expected organic growth of existing tests compared to revenues generated from novel tests for new or expanded indications.
  • The impacts of the global economic slowdown, Affordable Care Act, and Budget Control Act on CDx market growth.
  • CDx regulatory history and current FDA outlook.
  • Potential growth opportunities in non-oncology indications.
  • Physician awareness and adoption of pharmacogenetic testing.

Lastly, this report provides detailed analyses of the companies, biomarkers, and drugs associated with companion diagnostic testing.

Key Topics Covered:

1. Executive Summary

2. Introduction

3. Companion Diagnostics Market Overview

  • In Vitro Diagnostics Market Primer
  • CDx Definition Ambiguity
  • The FDA's CDx Definition
  • CDx Definition by Value Chain Step
  • DeciBio's CDx Definition and Segmentation
  • List of CDx Tests Included in the Report

4. CDx Market Size

  • Biomarker
  • Therapeutic Area
  • Technology
  • Test Location
  • Geography
  • Regulatory Status
  • Competitor

5. Companion Diagnostics Competitors

  • Diagnostic Pure-Play Companies
  • Life Science Research Tools Companies
  • Other Companies

6. Key Factors Impacting the CDx Market

  • CDx Market Penetration
  • CDx Market Growth Drivers and Moderators
  • Impact of the Global Economic Slowdown
  • Impact of the Affordable Care Act
  • Impact of the Budget Control Act (AKA 'The Sequester')
  • Coverage and Reimbursement
  • The Future of CDx Reimbursement

7. CDx Regulation

  • CDx: Market Size, Segmentation, Growth, Competition and Trends
  • Regulatory History in the U.S. - Herceptin and the HercepTest
  • U.S. Regulatory History for CDx Development (2005 - 2013)
  • U.S. Regulatory Changes for CDx Beyond
  • Regulation of CDx Outside of the United States

8. CDx Business Models

  • Historic CDx Business Models: The IVD Kit Model
  • The LDT Model: Trying to Keep the IP In-House
  • The Future of CDx Business Models

9. CDx Opportunities and Challenges

10. Appendix

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