Full-field digital mammography has turned into a superstar of x-ray, doubling in revenue and units shipped last year over 2003. Growth is expected to continue, although the pace may slow as the backlog of ordered systems shrank by year’s end to just 10% more than the number shipped.
Full-field digital mammography has turned into a superstar of x-ray, doubling in revenue and units shipped last year over 2003. Growth is expected to continue, although the pace may slow as the backlog of ordered systems shrank by year's end to just 10% more than the number shipped.
The market for FFDM reflects the same kind of excitement that's being seen in the digital radiography market (see cover story this issue). Both experienced significant growth at the expense of analog systems. The number of analog mammography units shipped in 2004 was 560, compared with 800 in 2003, according to industry estimates.
The opposite is happening in the FFDM segment. Last year, the industry shipped about 410 units to U.S. customers, compared with about 200 in 2003.
"The mammography market is transitioning from analog to digital," said Erica Rouleau, national sales director of women's health for Siemens. "We're seeing former analog customers moving into the newer technology because of the benefits, because analog technology is getting older, or a combination of those factors. For people making purchasing decisions, the foremost desire is to have digital."
Digital mammography has been building strength since GE launched the first commercial product some five years ago.
"Right now we're at a high-momentum peak," said Michelle Heying, general manager for the x-ray business at GE Healthcare.
GE offers the Senographe DS, a full-field digital mammography system, and the SenoAdvantage multimodality workstation.
Last year's high-water mark of more than 400 systems showed that demand for FFDM systems is steady. At midyear, vendors estimated they had shipped about 200 units to sites in the U.S.
Total revenues for FFDM were $130 million last year compared with $70 million the year before. This is a little lower than might be expected but in line with what industry executives had calculated.
Prices typically drop as volume increases. The dip in price for FFDM units was not significant, however, considering the extraordinary growth in demand. Units once priced at about $325,000 dropped only about $10,000 on average.
Don Alvarez, director of women's health within the special products division at Siemens, points out how the market is being segmented.
"We don't have new low-cost solutions," he said. "Rather, we have two price points within the market. The lower price point is for first-generation systems with limited detector size. The higher price point is for the larger, newer detector technology."
Siemen's FFDM product, the Mammomat Novation, was released commercially late last year. It should allow the company to capitalize on growth in the market, according to Alvarez. The system, which features a flat-panel detector, provides digital screening, diagnosis, and stereotactic biopsy capabilities in a single unit.
Demand for FFDM is expected to level off, possibly in the next several years, with the first signs of a slowdown becoming apparent in 2005. Before then, however, vendors may have a new technology that will reignite interest in digital mammography: tomosynthesis. This technology arcs a flat detector around the breast to capture multiple views from different angles, allowing the digital subtraction of tissue that might obscure tumors.
Hologic already has been trying to whet the appetite of potential customers for such a device, showing a prototype tomosynthesis system at each of the last two RSNA meetings. Siemens exhibited the first images from its tomosynthesis prototype at the 2004 RSNA meeting. GE Healthcare, which built the first such device to be used in clinical trials, has adopted a lower profile, describing but not highlighting results.
Clinical experience with tomosynthesis is limited at present, but the numbers of installed sites and cases are growing steadily. Well over a dozen luminary sites are expected to be operating by the end of this year.
The introduction of new technologies is typically preceded by a spurt in luminary usage, which naturally precedes the presentation of results at scientific meetings and in peer-reviewed journals. Vendors have hinted at the release of such products in the next two or three years. GE has even begun working with several major third-party payers to set the foundation for tomosynthesis reimbursement. The company plans to provide to these insurers early clinical results from the 10 luminary sites expected to be operating by the end of this year.
When exactly these systems will enter the market, however, is impossible to predict. Fundamental decisions remain to be made.
To ease the transition to this next generation of technology, manufacturers are considering designing equipment capable of both tomosynthesis and full-field digital mammography. Alvarez believes the possibility will be addressed as the technology gets closer to market. It may be necessary, however, to look at this issue early, as the design of the product will affect each company's approach to the FDA.