Demand skyrockets for digital mammography

While demand for MR and CT equipment languishes, digital mammography is enjoying a heyday with no end in sight. When the final numbers are tallied, vendors expect to have shipped twice as many full-field digital mammography units in 2007 to customers in the U.S. as in the previous year. And 2009 could be more of the same.

The only thing holding back sales, apparently, is the number of units that can be made. The surge in demand that followed release of the Digital Mammographic Imaging Screening Trial results in late 2005 took FFDM vendors by surprise. Shipments more than doubled from 441 in 2005 to 900 the next year with the trend continuing in 2007. As the year drew to a close, vendors were predicting they would likely ship 1700 or more units in the U.S.

Rather than the typical exponential curve that often accompanies the introduction of new imaging equipment, the FFDM "curve" is a straight line, kept in check by vendors' lack of capacity. Hologic, which owns 56% of the market for turnkey systems, and GE, which owns 34%, report six-month backlogs.

"We are suffering from not being able to supply the demand fast enough," said David Caumartin, general manager for global mammography at GE, "It's a lot different from the old days of mammography, when backlogs were a month at best."

The last to enter the U.S. market, Siemens Medical Solutions, has about a 10% share and a two-month backlog.

Some demand is being filled by Fujifilm Medical Systems USA, whose computed radiography system for mammography offers an alternative to the all-in-one turnkey FFDMs built around flat-panel detectors. Agfa, Carestream Health, and Konica Minolta also have CR mammography systems but lack FDA approval to sell them in the U.S.

Planning to combine CR with digital radiography is Philips Medical Systems, which showed a work-in-progress CR/DR mammography product at RSNA 2007. The CR product is to be sourced from Fuji, the direct capture amorphous selenium flat panel from Analogic subsidiary AnRad. Neither the DR nor CR product has passed through the FDA, but company executives hope either or both will be on the market some time this year.

In the meantime, vendors of currently available digital mammography units hope to pick up at least some of the slack. All three have been tweaking production lines this year to increase capacity. GE expects to make dramatic gains by midyear with the opening of a $100 million facility dedicated to manufacturing its flat-panel mammography detectors.

But no one expects supply to meet demand in the next year or two, regardless of how well GE ramps up production or what other companies do. The one uncertainty in this market is the effect that machines capable of tomosynthesis might have on the market.

The looming introduction of new equipment can stall market demand, as customers weigh the pros and cons of buying now or waiting to see what the new machines have to offer. This has happened repeatedly in CT, when vendors showed early prototypes of 16- and then 64-slice scanners.

Industry executives believe this will not happen in digital mammography, however, as the next generation of machines will be capable of both conventional 2D imaging and 3D tomosynthesis. Soon machines sold with just 2D capability will be field-upgradable to 3D, a strategy that could actually increase rather than decrease demand for digital mammography, according to Andy Smith, director of imaging science at Hologic.

"Tomo will help us continue the huge growth in digital, because it will become the standard of care and help us maintain our sales momentum," Smith said.

If it does, tomosynthesis could make history not only for what it does for women but what it does for its vendors.