By Alex Nussbaum
March 12 (Bloomberg) -- Genetic tests may become a $25 billion annual market in the U.S. within a decade, highlighting the need to identify which exams work the best, insurer UnitedHealth Group Inc. said.
A majority of the 1,800 DNA tests developed to identify or manage medical conditions still haven’t been studied enough to prove their effectiveness, UnitedHealth, the biggest U.S. insurer by sales, said in a report today. The technology generated $5 billion in 2010, the insurer said, and three to five new tests are being introduced each month.
The projections bode well for diagnostics companies including Genomic Health Inc., Myriad Genetics Inc. and Life Technologies Corp., said Daniel Leonard, a Leerink Swann & Co. analyst in New York. They also raise questions about the effect on consumers, doctors and governments struggling with rising medical bills, UnitedHealth said.
While genetic exams “hold great promise for better health and medical care,” the Minnetonka, Minnesota-based insurer said in the report. “They also pose significant challenges to a system that is increasingly unaffordable.”
The paper, released to coincide with a Washington D.C. conference on gene testing, calls for cheaper, quicker methods to evaluate the quality of the technology, as well as better education for consumers about privacy protections.
The report echoed concerns from a study last week in the New England Journal of Medicine that found cancer screening may be less useful than hoped because of the wide variety of mutations found in tumors. That may explain why some oncology drugs become less effective even when targeted at specific genes, scientists from the U.K. said.
Genetic tests can be used to identify cancers, judge a person’s predisposition to Alzheimer’s disease or gauge how well a particular medicine will work in a specific patient.
UnitedHealth, which covers 36 million people in its medical plans, spent about $500 million for genetic exams and molecular diagnostics in 2010, mostly to detect cancers and infectious diseases like HIV, today’s report said.
The national figure may swell to $15 billion to $25 billion in 2021, with annual growth rates of more than 10 percent, the company said. It based the projections on internal claims and government Medicare and Medicaid data. The ultimate number depends on how popular the tests grow, how expensive they get and insurers’ willingness to pay, among other factors.
The predictions seem “reasonable” given the field’s past growth, said Leerink Swann’s Leonard, in a telephone interview. Illumina Inc., a San Diego-based gene mapper, drew a $5.7 billion hostile takeover bid from Roche Holding AG in January, in a sign of the market’s attractiveness, Leonard said. Two years ago, General Electric Co. paid $580 million for diagnostic company Clarient Inc.
Industry leaders include Life Technologies, of Carlsbad, California; Myriad, of Salt Lake City; and Genomic Health, of Redwood City, California, Leonard said.
“It’s going to be a very good place for investors to participate” given “the broad need to reduce health care costs,” Leonard said. “If you use these tests, you could forego expensive and toxic therapies or forego surgery.”
For older, relatively simple scans like those for newborn screening or infectious disease, there’s usually evidence of what UnitedHealth called “clinical utility” -- an improvement in the delivery or outcome of patient care.
For most tests, that’s not the case, often because of the high cost of evaluating products or the newness of a particular exam. The Food and Drug Administration could help by allowing more flexible clinical trial designs, while insurers could offer incentives by tying payments to the amount of data backing a test, UnitedHealth said.