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Laboratory-Developed Testing: Technologies and Markets

  • January 2015
  • 104 pages
  • BCC Research
Report ID: 2584393

Summary

Table of Contents

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.

However, there are a number of laboratory discoveries useful for clinical diagnostics that are novel, unique or esoteric, and which offer benefits for patients, but are unable
to go through the FDA approval process for a variety of reasons, such as public health, low market demand or the introduction of a new technology. Historically, in the clinical
diagnostics industry tests were marketed by individual clinical laboratories; now, due to a number of new technologies as well as national marketing capabilities, a number
of companies have made the marketing of laboratory-developed tests an industry in and of itself.

SCOPE OF REPORT
This report will focus on companies that rely on laboratory-developed testing for at least 10% of their revenue. This is meant to avoid focusing on companies and laboratories that only occasionally offer laboratory-developed tests to deal with unique patient needs. This report will also focus on suppliers of the analyte-specific reagents used within these laboratory-developed tests, as their contract manufacturing is a key to the successful development of these tests. While various technologies will be highlighted with relation to their use in laboratory-developed testing, we will not explore the markets for these different technologies in depth.

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