Global Market for LDT Evolving, Shifting, and Growing (6.3% CAGR)

June 20, 2017

Wellesley, Mass., Jun 20, 2017 – The laboratory-developed test (LDT) market 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. One trend identified by a new BCC Research report is that national and regional reference laboratories are performing more LDTs while smaller laboratories and academic laboratories reduce their testing volumes.  High capital costs and lower reimbursement rates are hindering efforts of smaller laboratories to keep pace with their larger counterparts.

The laboratory-developed test marketplace will grow from nearly $11 billion in 2016 to almost $14.9 billion in 2021, with a CAGR of 6.3%, according to Laboratory-developed Testing: Technologies and Markets. Reference laboratory revenue will grow from nearly $9.4 billion in 2016 to $12.7 billion in 2021, with a CAGR of 6.3%.  Specialty laboratories will demonstrate a 5.9% CAGR to reach $2.1 billion in 2021, up from $1.6 billion in 2016.

Another key market trend is that new genomic and mass spectrophotometry-based tests are replacing and improving serological and molecular diagnostics tests, which are maturing out of the market.  Additionally, new applications based on increased understanding of therapeutic drug selection and monitoring are increasing the opportunities for MS-based tests for use with LDTs.

Research Highlights

  • The Protection of Access to Medicare and Medicaid Act (PAMA) is expected to reduce LDT billing revenues in the serology and molecular diagnostics, and anatomic pathology sectors.
  • The genomic testing sector will grow from $2.1 billion in revenue in 2016 to $3.9 billion in revenue in 2021, with a CAGR of 12.9%.
  • A change in test mix, increased utilization of mass spectrophotometry platforms and interests in using the platform for DNA analysis are driving growth (7.9%) in the MS sector.

"Revenue opportunities and regulatory pathways  for LDTs will continue to be more challenging for the entire marketplace, " says Robert G. Hunter, senior healthcare editor at BCC Research..

Editors and reporters who wish to speak with the analyst should contact Steven Cumming at

Laboratory-developed Testing: Technologies and Markets( HLC179B )
Publish Date: Jun 2017    

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