Laboratory-Developed Testing: Technologies and Markets

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Dec 31, 2014, 08:01 ET

NEW YORK, Dec. 31, 2014 /PRNewswire/ -- This BCC Research study focuses attention on the laboratory developed testing market, commonly referred to as LDTs. It also explores the unique regulatory scheme behind LDTs, how they are marketed and used, and the analyte-specific reagents necessary for development.

Use this report to:
- Identify the various technologies with relation to their use in laboratory-developed testing (LDT).
- Learn about the unique regulatory scheme behind LDTs, how they are marketed and used, and the analyte-specific reagents necessary for development.
- Receive a deeper analysis of various issues and concerns within the laboratory-developed test industry.
- Focus on suppliers of the analyte-specific reagents used within LDTs.

Highlights
- The laboratory-developed test market within the U.S. was valued at $8.1 billion in 2013 and $9.7 billion in 2014. The market is expected to reach roughly $17.7 billion in 2019, a compound annual growth rate (CAGR) of 12.7% from 2014 to 2019.
- Laboratory-developed clinical assay segment within the U.S. market is expected to increase from nearly $8.6 billion in 2014 to $16.1 billion in 2019, a CAGR of 13.4% from 2014 to 2019.
- The related analyte-specific reagent segment within the U.S. market is expected to grow from $1.1 billion in 2014 to about $1.6 billion in 2019, with a CAGR of 7% from 2014 to 2019.

Introduction & Scope

INTRODUCTION

STUDY GOALS AND OBJECTIVES
This study is designed to focus attention on the laboratory-developed testing market, commonly referred to as LDTs or "home brews." BCC Research has focused on the
marketplace within the United States, as it is the only industrialized country that allows wide usage of LDTs. This report explores the unique regulatory scheme behind LDTs,
how they are marketed and used, and the analyte-specific reagents necessary for development. BCC Research also provides a look at the unique players within the
marketplace and how they interact with each other.

REASONS FOR DOING THE STUDY
Laboratory discoveries have long been a source of clinical diagnostic products and have routinely developed into FDA-regulated in vitro diagnostics. This transition involves a number of preclinical and clinical testing steps to validate both the accuracy of the test and the clinical relevance of the test prior to FDA marketing and approval. The goal is to make sure such a product is safe and effective for the treatment and diagnosis of disease, and the regulatory regime has been effective in protecting the public from clinical diagnostics that are not effective.
Read the full report: http://www.reportlinker.com/p02584393-summary/view-report.html

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