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Laboratory-developed Testing: Technologies and Markets

  • June 2017
  • 84 pages
  • BCC Research
Report ID: 2584393

Summary

Table of Contents


- The global market for laboratory-developed tests reached nearly $9.7 billion in 2015. This market is expected to increase from nearly $11.0 billion in 2016 to $14.9 billion in 2021 at a compound annual growth rate (CAGR) of 6.3% for 2016-2021.
- Specialty lab market is expected to grow from $1.6 billion in 2016 to nearly $2.1 billion at a CAGR of 5.9% from 2016 through 2021.
- Reference lab market is expected to grow from nearly $9.4 billion in 2016 to $12.7 billion in 2021 at a CAGR of 6.3% from 2016 through 2021.

Study Goals and Objectives
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 occasionally offer laboratory-developed tests to deal with unique patient needs.

This report will also focus on the suppliers of the analyte-specific reagents used within these laboratory-developed tests, as their contract manufacturing is key to the successful development of these tests. While various technologies will be highlighted in relation to their use in laboratory-developed testing, we will not explore the markets for these different technologies in depth.

Reasons for Doing This Study
Laboratory discoveries have long been a source of clinical diagnostics products, and these discoveries have regularly developed into Food and Drug Administration-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 approval and product marketing.

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 from being broadly marketed.

However, there are a number of laboratory discoveries useful for clinical diagnostics that are novel, unique or esoteric. These particular tests offer particular benefits for patients, but it may not be feasible 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. The clinical diagnostics market has long seen tests marketed by individual clinical laboratories, and a number of new technologies, along with the ability to market nationally, have made it possible for some companies to make 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 occasionally offer laboratory-developed tests to deal with unique patient needs.

This report will also focus on the suppliers of the analyte-specific reagents used within these laboratory-developed tests, as their contract manufacturing is 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.

Information Sources
Information sources for this report include research of scientific articles, primary sourcing interviews with key contacts within the industry, and review of industry financial statements and government regulatory and patent filings.

Methodology
The intended audiences for this are those who work around the clinical diagnostics industry. This includes laboratory professionals, management, quality control, and sales and marketing staff within clinical laboratories.

Firms that manufacture analyte-specific reagents will take a particular interest in this report as well, as demand for their reagents will be significantly influenced by the development of laboratory-developed tests. People with an interest in the biotechnology industry as a whole will have an interest in this report, as biotechnology firms are broadening their interest beyond pharmaceutical treatments in part or in whole, and the laboratory-developed testing industry is a strong part of such an industry.


Summary and Highlights
The laboratory-developed test marketplace will grow from nearly $11 billion in 2016 to almost $14.9 billion in 2021, with a compound annual growth rate (CAGR) of 6.3%. Reference laboratory revenue in this marketplace will grow from nearly $9.4 billion in 2016 to $12.7 billion in 2021, with a CAGR of 6.3%.

Specialty laboratories will grow from $1.6 billion in revenue in 2016 to $2.1 billion in 2021, with a CAGR of 5.9%. The laboratory-developed test marketplace is evolving due to a variety of technological, financial and regulatory factors that will shift the testing mix and drive higher usage of these tests within the wider clinical diagnostics marketplace.

Key Trends
PAMA Is Taking a Hammer to Laboratory Test Prices
The Protection of Access to Medicare and Medicaid Act, commonly referred to as PAMA, gives the federal government the authority to survey prices for all laboratory tests and come up with a standard price to pay for such tests. Such standard prices are anticipated to be lower than what many laboratories currently charge. For LDTs (Laboratory Developed Tests), PAMA is anticipated to have a major impact due to the way they are currently billed. As private insurance payment rates are commonly based on a premium to Medicare and Medicaid rates, any rate cuts have a potential for widespread financial impact to LDT providers.

Regulatory Discretion Impacts Certain LDTs
The FDA has decided to only target laboratories that provide LDTs that present a particular risk to human health. However, a series of recent forums has displayed the agency’s thinking on such tests. In particular, serology and molecular diagnostics tests appear to be in the regulatory crosshairs. There are notable concerns about what constitutes a medical device versus a service, which has wide-ranging impacts on what tests may be allowed.

Genomics Testing Comes of Age
Genomics testing has matured enough that laboratories are investing significantly in sequencing equipment, and genomic-based tests are rolling out on these new platforms. Testing is being introduced that both replaces and complements existing molecular diagnostics. It is also creating new opportunities for pathologists to perform analyses that have been heretofore technically difficult or even impossible.

Testing Mix Shifts within LDTs
As genomic testing comes of age and the sensitivity of mass spectrophotometry (MS) testing has come to be recognized, there are broader platform shifts going on within the LDT marketplace. Serological and molecular diagnostics tests are maturing out of the market, while new genomic and MS-based tests are being introduced to replace and improve those tests.

Consolidation of the LDT Marketplace
As a part of the wider clinical diagnostics marketplace, more LDTs are being performed by national and regional reference laboratories. Smaller laboratories and academic laboratories are reducing testing volumes. While a number of smaller specialty players exist, high capital costs and lower reimbursement rates are making it difficult for smaller laboratories to keep up with their larger counterparts.

The Understated Importance of Mass Spectrophotometry LDTs
Mass spectrophotometry (MS)-based tests have long been a key part of the LDT marketplace. However, the increased sensitivity of such technology is being leaned on for a variety of applications traditionally dependent on serological testing. In addition, new applications based on increased understanding of therapeutic drug monitoring and DNA (deoxynucleic acid) analysis are increasing the opportunities for this platform to be used with LDTs.

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