Digital mammography market looks to nearly double this year in U.S.

Immune to the effects of the Deficit Reduction Act and impervious to concerns of obsolescence, digital mammography this year will achieve nearly triple-digit growth in the U.S. In the first half of 2007, demand for digital mammography almost doubled with about 770 units sold to U.S. customers compared with 400 in the first half of 2006.

Hologic and GE, the two principal vendors of full-field digital mammography equipment, report continued strength in the second half of the year with six-month backlogs as demand outstrips industry's capacity to fulfill it.

"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."

Even the number three vendor, Siemens Medical Solutions, which has only about 10% market share, reports a two-month backlog.

"We have been ramping up production, trying to keep up as much as we can," said Jonny Eser, product manager for women's health at Siemens.

Industry execs estimate that FFDM has penetrated only about one-quarter of the installed base of systems, much of it during the last two years. This leaves plenty of room for further expansion.

GE Healthcare introduced the first commercial FFDM equipment seven years ago. Adoption of the Senographe 2000D was slowed, however, by uncertainty about its clinical value, reimbursement issues, and relatively high cost--about double that of film-based products.

Demand exploded for digital versions of the Senographe and FFDMs made by Hologic and Siemens after results from the Digital Mammographic Imaging Screening Trial were published in late 2005. DMIST documented the clinical advantages of this technology, particularly for patients with dense breasts. Cancers are most easily obscured in dense breasts and, consequently, can be missed on film.

"DMIST showed superior efficacy for digital imaging in dense breasts, where film mammography was poorest, and that got rid of the last concern people had about digital mammography," said Andy Smith, director of imaging science at Hologic.

The DMIST results had only a marginal effect on FFDM shipments in 2005 to U.S. customers, as the number of shipped units climbed to 441 from 413 in 2004. In 2006, however, U.S. shipments skyrocketed to 900. This year, the market could surpass 1700.

These numbers only hint at what could have developed at a much steeper curve. Caught off guard by the sudden demand, vendors could not produce systems fast enough. Growth today is linear, according to Caumartin, kept in check by limited production.

The resulting pattern provides a road map for the rest of 2007 and at least some of next year. The highly predictable linear growth seen in the second half of 2006 and the first half of 2007, supported by an extensive backlog for the three major vendors, is the reason industry execs believe they will sell around 1700 units to U.S. customers this year.

Hologic holds a commanding share of the market--56% of new systems shipped in the U.S., according to the company's estimates. Consolidated market estimates put Hologic's market share around 34% and Siemens' near 10%.

GE claims it is taking market share from its competitors. Although mathematically impossible, Hologic and Siemens make the same claims. In the mammography market, perception is hard to distinguish from reality.

Siemens was the last of the three to enter the U.S. marketplace, and, as such, it began taking share with its first sale. Hologic over the past few years has reported dramatic rises in FFDM shipments and backlogs. GE executives claim triple-digit growth in the first half of 2007, which puts its estimate at least a little ahead of overall industry growth.

"We will do twice as many (FFDM sales) next year as we did this year," Caumartin said.

Helping the company will be a $100 million investment in a new facility dedicated to manufacturing large-format mammography detectors. Production is scheduled to begin in mid-2008, Caumartin said.

He expects demand for FFDM to remain strong for some time. Driving that demand are the inherent diagnostic advantages of the technology and its speed.

"Radiologists are decreasing in number and the number of procedures is increasing," Caumartin said. "Digital is the answer. You can easily do two to three times more throughput with digital compared with film."

While the near future is predictable, the long-term forecast is less certain in both market dynamics and technology. Hologic's merger with Cytyc will give the combined company a very broad base in women's health. Within several months, GE expects to begin chipping away at its backlog at the same time a widely available large-format detector makes its FFDM more attractive to U.S. customers. And Siemens, recognized worldwide as a major provider of sophisticated imaging equipment, will leverage its reputation to take as much of the mammography market as it can.

"We will increase our share more and more, trying to do as well as we can," Eser said. "With Siemens' reputation, we will be there in the running for more sales."

The pending introduction of tomosynthesis, essentially a 3D form of digital mammography, could be the "X" factor. Emerging technologies can stall a market as customers delay decisions to evaluate new products. This will be a risk when all three vendors at the RSNA meeting next week show prototypes of tomo units and present clinical data from the trials of their investigational tomo machines. None has yet submitted an application to the FDA for marketing approval for the experimental systems, but Hologic executives confirm that it may do so in the next few months.

Vendors hope to minimize any negative impact on sales by building tomo units on existing FFDM platforms. Improved detectors are in the works to allow the rapid readout needed for multiple acquisitions when the arm bearing the imaging chain sweeps across the breast. Motors to perform such sweeps are already in hand. Vendors are even hatching plans by which units sold for 2D will allow field upgrades involving mostly software. In this way, the advent of tomosynthesis might actually ignite a sales surge, as early adopters of FFDM replace older units not suited to the new technology.

"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 this happens, it would be in keeping with the character of this technology genre, which so far has rewritten the rules that usually apply to the sale of medical imaging equipment.