• by Bruce Carlson
  • November 15 2017


Oncology Remains Most Active, Highest-Growth Area for LDTs

Oncology Remains Most Active, Highest-Growth Area for LDTs

Historically, LDTs were low-volume, simple and well characterized tests for low-risk diagnostic applications. More recently, there have been more complex laboratory developed tests based on technologies such as next generation sequencing for new applications in oncology and certain other applications.  Oncology, and the search for better oncology treatment is the driver.  That’s the finding in a recent report from Kalorama Information:  The Worldwide Market for Laboratory-Developed Tests: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs).  The market research firm with an IVD focus pegs the market at $13.2 billion dollars.  While the market will grow near ten percent each year, oncology tests will grow 60% faster than other types of LDTs, according to the report. 

 “There are clinical needs for LDTs for assays that are not available commercially, said Bruce Carlson, Publisher of Kalorama Information.  “That is why laboratories continue to develop and use LDTs.”

Companies in the Oncology Lab-Developed Test Space

Genomic Health, OPKO Health, Quest Diagnostics, Rosetta Genomics Ltd, TrovaGene, Inc., Veritas, Myriad Genetics, Inc., Genoptix, Inc., NeoGenomics, Inc., Biocept, Inc. are among the companies in the market.    Oncology is a large segment of the clinical laboratory developed test market (at least in terms of revenue). Today, the largest subsegment of this market consists of the many tests that have been developed for diagnosis, predicting prognosis, providing information to aid in determining the best treatment for an individual patient, and for monitoring treatment – all aspects of personalized medicine in cancer.Predicting risk of hereditary cancer is also a significant application and market segment. Recently, tests have been introduced that can be used to screen apparently healthy individuals for cancer. While cancer screening is currently the smallest subsegment of the oncology LDT services market, the cancer screening market is growing very rapidly.

  • Cancer Screening
  • Hereditary Risk of Cancer
  • Diagnosis, Prognosis, Treatment Decisions

The increasing visibility, complexity, and risk of LDT for certain applications (such as oncology) has drawn increasing attention to this market, including calls for increased regulation of the market. While the eventual outcome of these calls for increased regulation is uncertain, the laboratory developed test market is not expected to disappear. LDTs meet clinical needs that are not otherwise being addressed. As a result, sudden changes to the market (such as a sudden require that all LDTs be meet stringent regulations or be removed from the market) could potentially result in many essential clinical tests being no longer available. Significant concerns continue about potential future changes in the regulation of LDTs, including FDA regulation of LDTs.   

“This is a very crowded market. Not all companies will succeed,” said Lucy Sannes of Sannes & Associates, who authored the report. 

Regulation of Lab-Developed Tests, Potential for Future Regulation

The report says that while the FDA has approved a long list of companion diagnostic tests to determine which therapy should be used to treat a specific patient, there are limitations with these FDA approved companion diagnostic tests. One significant limitation is that, with the exception of Thermo Fisher’s Oncomine Dx Target Test, which was approved in June of this year, all of the FDA approved companion diagnostic tests each analyze mutations in only one gene. This means that if a physician is considering selecting from multiple therapies with different targets, the physician will need to order multiple tests. This can be expensive and time consuming. Also, the amount of tissue from the tumor is typically limited, and there may be an insufficient amount of tumor tissue available to do all of the desired tests.

The report The Worldwide Market for Laboratory-Developed Tests: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs), is available from Kalorama Information.  The report specifies the opportunity (market size, forecast, companies in the market) for each disease segment of lab-developed testing.