Chemistry

Do more kinds of tests on increasingly versatile analyzers that perform faster, smarter and require fewer operators. That’s the revenue mantra for the players in today’s $3.5 billion (est.) worldwide clinical chemistry market.

Routine chemistry represents about 55 percent of the in vitro diagnostics (IVD) industry testing volume but accounts for only 17 percent of revenues. The average chemistry segment revenue growth over the next several years is estimated at 3 to 4 percent (Merrill Lynch), but the top three vendors have seen double-digit growth over the past two years and into 2001. The market leaders, with their high-throughput analyzers and seamless LIS connectivity, continue to dominate and are looking forward to revenue growth several times the industry average.

With a reported $1.265 billion in global revenues and 36 percent of the market, Roche Diagnostics is clinical chemistry’s industry forerunner. Its chemistry business is growing at nearly four times the market segment average, said Tom Wilson, director of SerumWorkArea marketing for Roche Clinical Chemistry, Immunochemistry and Laboratory Integration.

At the center of that domination is Roche’s Modular Analytics System and Integra line. The Integra line can perform up to 72 chemistries on board and provides Modular Analytics capability to combine chemistry and immunochemistry on a single platform. Wilson said Roche intends to continue developing solutions to help customers achieve greater efficiency while producing the highest quality results.

“Our products, via consolidation, provide the most efficient use of labor, space and financial assets …,” Wilson said.

Officials at Dade Behring (estimated $533 million in chemistry revenues in 2000) view the chemistry market as an outstanding growth opportunity as well. Immunochemistry tests historically have required specialized instruments and technicians to administer, so Dade Behring takes a modular approach to the design of its analyzers. It has chosen the path of networking individual analyzers to add capacity rather than trying to consolidate more and more tests on one box.

For 2000, Beckman Coulter enjoyed a nearly 12 percent increase in revenue from chemistry sales worldwide. First quarter 2001 chemistry earnings jumped 7.4 percent, according to Ron Berman, director of sales and marketing. Why? He said the company has focused on reducing overall costs and improving test turnaround times for customers. “… Maybe it’s preanalytical automation. Maybe they need to consolidate workstations. Or maybe there are areas where we can help them improve their post-analytical process,” Berman said.

Berman said Beckman is gaining through specialty testing (i.e., its new hemoglobin Alc test). “Now that we have a large menu on our Synchron systems,” Berman said, “labs are moving TDMs and DATs over from their specialty analyzers to the clinical chemistry platform.” Beckman’s new Synchron LX20 PRO, according to Berman, is the only clinical chemistry system available using closed tube sampling.

By automating preanalytical processes, labs can improve turnaround times. Also, the company’s new “proactive rather than reactive” remote diagnostics are helping Beckman-equipped labs improve instrument uptime by monitoring and identifying problems before they happen. The Synchron LX 6302 analyzer can perform 4,320 tests an hour and analyze 11 critical care chemistries in 42 seconds.

Though the company won’t confirm the numbers, Bayer Diagnostics recorded chemistry revenues approaching $400 million last year, according to a recent market analysis by Merrill Lynch. At the heart of the Bayer chemistry market strategy is the high-end Advia 1650 launched this year, said Byron Hewett, Bayer vice president for laboratory testing marketing. A new Universal Rack Handler and WorkCell (due fourth quarter 2001) will enhance the efficiency and productivity of the 1650 and Advia Centaur. “These enable Bayer to broaden its image beyond an instrument and reagent manufacturer to organizational and workflow specialists,” Hewett said.

The new WorkCell connects two to four “like” instruments resulting in streamlined processing of samples. It features a single loading/unloading point and a central computer that controls and monitors instruments and results data. The WorkCell automation, said Hewett, will make Bayer the first diagnostic vendor in the marketplace to integrate clinical chemistry and immunology. “There will still be a need to offer dedicated chemistry analyzers to the hospital lab,” he said. “But a complete menu for chemistry and immunochemistry will be integrated on one system in the next two years.”

Abbott Diagnostics is a chemistry newcomer which reported a $160 million in worldwide revenues (company officials declined confirmation). Its Aeroset technology, developed with Toshiba, performs 2,000 tests per hour. “It meets our customers’ needs for more speed, more intelligence and more flexibility,” said Don Braakman, communications manager. The system features integrated chip technology, touch access and a dual supply center for liquid reagents with 56 reagent positions.

Braakman said Abbott is riding technology to grab more chemistry business. The company is pushing ahead on efforts to integrate immunoassays and chemistry into its Architect platform. “Combining our strength in immunoassay with chemistry represents good potential in this segment for Abbott,” he said.

At Ortho-Clinical Diagnostics, with reported chemistry sales of $365 million in 2000, the Vitros 250 and 950 analyzers are the latest generation of the dried slide-film technology base developed first for the Kodak Ecktachem analyzers. Compared to some liquid reagents, the dried system offers more reagent stability, less cleanup and ease of use.

Kathy Parra, Ortho marketing director for chemistry, would not comment on reports the firm is moving ahead with a liquid system. “Future products will share the ease of use and high efficiency characteristics of our existing products,” Parra said. In March, the company rolled out its new MicroSlide system which reduces patient sample requirements 40 percent per test. “That’s not only good for lab efficiency, it’s also good patient care,” she said. “You don’t want to have to draw two or three patient tubes if one will do.”

Modest segment growth hasn’t stopped Olympus America’s Diagnostic Systems Group from pursuing hospital chemistry business. The leading supplier of analyzers for reference labs, Olympus has developed the AU-Series chemistry-immuno analyzers for all sizes of hospitals, including the AU2700 for the largest: it performs up to 2,133 tests an hour.

“These systems draw from a well designed platform of technology that enables hospitals to make great steps in improving efficiency,” said Bruce Gernaey, group director of marketing. “Maximum efficiency and productivity are among the highest priorities for the lab director and lab manager.” Features include an immediate one-button STAT interrupt, consolidated 122-test menu and the need for 50 percent less reagent consumption compared with other random access analyzers.

While most IVD vendors are focused on consolidating both more tests and more types of tests on their main chemistry platform, the day when all lab tests are performed on one all-purpose analyzer is still in the realm of a Star Trek episode. Until then, the work-horse chemistry analyzers in most labs will chug away at processing results as quickly, efficiently and accurately as technology allows.

Nicholas Borgert is a freelance writer based in Charlotte, N.C.