Laboratory-Developed Tests Market Driven by Cancer Treatment

These are the latest findings of Kalorama Information, (New York, NY, USA), an independent medical market research firm.

The trend of tests produced in a lab or sold commercially as a test service product is growing. Laboratories continue to develop and use LDTs due to the commercial unavailability of clinical needs for LDTs for assays. LDTs were historically low-volume, simple and well characterized tests for low-risk diagnostic applications. Of late, complex LDTs based on technologies such as next generation sequencing have become available for new applications, including oncology.

Currently, oncology is a large segment of the clinical LDT market, in terms of revenue. Several tests 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. Another significant application and market segment is predicting the risk of hereditary cancer. Additionally, new tests have been introduced for screening apparently healthy individuals for cancer, and the cancer screening market is growing at a very rapid pace.

"Cancer treatment is driving this test market, and LDTs are more important, and profitable in cancer testing than any other area," said Bruce Carlson, Publisher of Kalorama Information.

However, the increasing visibility, complexity, and risk of LDT for certain applications, such as oncology have attracted calls for increased regulation of the market. Any sudden changes to the market, such as an abrupt requirement for all LDTs to meet stringent regulations or be removed from the market, could potentially result in several essential clinical tests becoming unavailable. This has raised significant concerns over the 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.

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