Companion diagnostics (CDx) is an emerging (+$200M) segment of the ~$50B in vitro diagnostics (IVD) industry, which is growing at double digit rates through 2016. Companion diagnostic tests (also referred to as pharmacogenetic tests) are used to inform patient selection, dosing requirements, or susceptibility to side effects for a particular drug. While many drug labels recommend or provide guidance on pharmacogenetic testing, certain drugs, particularly cancer drugs, require patients to receive a diagnostic test, as the efficacy of these drugs is limited to those with a particular genotype.
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’ depending on the regulatory status and testing instructions contained within the drug label.
Other key points discussed here include:
1) Competition and regulatory differences between manufacturers of FDA-approved IVDs and clinical reference labs who offer lower priced laboratory developed tests (LDTs).
2) The expected organic growth of existing tests compared to revenues generated from novel tests for new or expanded indications.
3) The impacts of the global economic slowdown, Affordable Care Act, and Budget Control Act on CDx market growth.
4) CDx regulatory history and current FDA outlook.
5) Potential growth opportunities in non-oncology indications.
6) Physician awareness and adoption of pharmacogenetic testing.
Lastly, this report provides detailed analyses of the companies, biomarkers, and drugs associated with companion diagnostic testing.
This report contains over 325 pages and over 40 exhibits of brand new, original content. Please, visit our website for articles and insights regarding current topics and news in companion diagnostics and other life-science areas, as well as additional research reports in related markets including next generation sequencing, life science research tools, and single cell genomics. SHOW LESS READ MORE >
1. Executive Summary
Market Sizing Methodology
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
CDx Market by Biomarker
CDx Market by Therapeutic Area
CDx Market by Technology
CDx Market by Test Location
CDx Market by Geography
CDx Market Size by Regulatory Status
CDx Market by Competitor
5. Companion Diagnostics Competitors
Diagnostic Pure-Play Companies
Life Science Research Tools 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
Current Situation in the United States
Current Situation in the EU
Current Situation in Asia-PAC
Current Situation in ROW Geographies
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
Information Only Biomarker Profiles
Individual Biomarker Profiles
Drug Label Information
Table of Exhibits