By Marleen and Gary Wolfe
The past year was a busy one worldwide for clinical microbiologists as they responded to one medical crisis after another. Outbreaks of new diseases, such as SARS (severe acute respiratory syndrome), and virulent new strains of human and bird flu engendered enormous public fears about epidemics and pandemics. Such fears were further intensified by sporadic incidences of BSE (bovine spongiform encephalopathy) or “mad cow disease,” ongoing worries of bioterrorism, and an ominous resurgence of tuberculosis, which the World Health Organization estimates will reach 12 million cases globally in 2005.
In view of these occurrences, one might surmise that companies specializing in infectious disease diagnostic products saw rapid growth in their industry. But this is not necessarily the case. In reality, market gains have been modest for the most part. Despite the slow growth, the industry continues to forge ahead, believing that market requirements for new diagnostic products will inevitably accelerate.
We asked representatives of some of the leading diagnostics firms for their perspectives on where the market is heading, and the kinds of developments to expect.
Microbiology Market Growing Slowly but Steadily Overall
“Sales of infectious disease diagnostic products in the US are estimated to represent about $2.76 billion annually, including microbiology, virology, parasitology, and related infectious disease immunoassays,” says Tom Polen, director of worldwide marketing for BD Diagnostics. “Technically, microbiology products are a subset of this infectious disease diagnostic figure, which also includes industrial microbiology applications, such as food testing and pharmaceutical sterility testing. In general, the clinical microbiology segment is growing at a rate of approximately 3% a year, with faster growth in areas such as nucleic acid testing, rapid point-of-care testing, antibiotic resistance detection testing, and laboratory automation.”
Richard Williams, president of Alpha-Tec Systems, sees a number of factors collectively influencing the growth of the microbiology market. “Some of these include immigration and international travel and the increased exposure to microbes and infectious diseases, growing microbial resistance to antibiotics, and a heightened awareness of the role microbiology plays in our everyday lives as well as in bioterrorism weapons,” he says.
Reflecting on market growth, Mike Burke, president of TREK Diagnostic Systems Inc, says, “With the issues confronting us on the infectious disease side, 3% to 5% is less than we would hope. We have a major share of antibiotic testing that pharmaceutical companies perform, so we have a good sense of the number of new compounds coming down. We would like to see more done in the development of compounds to counteract serious resistance issues. There are concerns that the situation will be critical by 2006 or 2007 and that antimicrobic development work—which is a fairly long process—will have to move soon into an accelerated catch-up mode.
“Antibiotic resistance has always been a problem, but in the last 3 to 5 years, because of business consolidations, pharmaceutical companies have been doing less research and outsourcing more of the development work,” Burke says. The value of developing antibiotics is much less than developing drugs that people take for long periods of time. With the growth of pharmacological products other than antibiotics and the payment stream associated with them, far fewer dollars are going to antibiotic development than in the past.”
Public Awareness Impacts Market
On the plus side, public awareness is one of the most important factors influencing the growth of the clinical microbiology marketplace. The one caveat is that its effects tend to be skewed in the direction of issues that capture the most public exposure and engender the most worry among the general populace.
For instance, TREK’s Burke sees some diseases, such as SARS, bird flu, and BSE, achieving disproportionately high levels of notoriety in the mass media. “Publicity often causes concerns to outweigh the true risks. When the potential threat of one disease receives a lot of attention, it diverts money and effort away from other less publicized diseases. The impact can be tremendous,” he says.
“If one cow comes down with mad cow disease, people want to test every cow. By comparison, Johne’s disease (bovine paratuberculosis) attracts little public attention, yet this incurable wasting disease affects 10% to 20% of all cattle herds in the United States. Last year was the first in which we saw growth in funding for Johne’s testing and control.”
BD’s Polen shares a similar view. “While, the general public is becoming increasingly aware of the scope and impact of infectious disease, there is still far to go,” he says. “Septicemia, for example, affects 750,000 people in the US and Europe, has a 30% mortality rate, and causes more deaths than lung and breast cancer combined in the US alone. Yet, the media pays relatively little attention to it, and many people don’t even know about it.”
Nevertheless, public awareness leads to obvious downstream benefits for diagnostic companies. Louise Grant, US senior marketing manager, Microbiology, bioMérieux Inc, notes, “Public awareness fuels opportunities for biotechnology companies and leads to innovation and new products or applications of existing products. As the public becomes more aware of the microbiology around them they will demand more effective treatment and protection from nasty bugs. Much of this is encompassed under the umbrella of patient safety. This is becoming more and more important for health care institutions. As the public becomes more educated, increasing the quality of care will become a driving force. For the health care institution, this is happening within the context of many other challenges, such as staff hiring and retention difficulties and reimbursement issues.
“In this environment of growing public awareness, companies whose products can improve the quality of care while reducing labor requirements and increasing throughput will have a competitive advantage,” says Grant. As an example she cites the American Association of Blood Banks’ new quality-control standards, which became effective March 1 for its members. “This standard requires that all donated platelet units must now be tested for the presence of microorganisms to help prevent the transfusion of contaminated platelets. One result of this standard is increased opportunities for diagnostic companies in new areas of health care,” Grant says.
New Industry Initiatives Speed Technology Development
Whatever the reasons underlying the slow business growth in the microbiology market sector may be, the diagnostic industry remains committed to developing, producing, and marketing new technologies with as much speed as they can muster. As Mimi Healy, PhD, vice president and CSO of Bacterial Barcodes sees it, “Bioterrorism threats and emerging infectious diseases, like SARS, have had a huge impact in the marketplace. Diagnostic companies not only need to develop new assays, they need to accelerate the development process. Validation stands should be addressed so that once new assays are developed, adoption in clinical labs can become more rapid.”
Preparing for such accelerated growth is certain to be a challenge in view of the continued shortage of personnel who are proficient in clinical microbiology and related laboratory disciplines. “Looking forward, I think the key issue will be education in microbiology and molecular biology from grade school to college to the lab,” says Alpha-Tec’s Williams. “Without expanding education in microbiology, we will lose the battle. We need a constant supply of well-educated reinforcements to develop new products, perform the test procedures adequately, and do the research.”
Beyond the human resources issues, BD’s Polen thinks that new initiatives by his and other companies to accelerate technology development cycles and speed the delivery of new products to the marketplace will help spur future advances. “The pace at which new emerging diseases are now being identified, as well as the rate at which science is now linking a number of previously thought to be unrelated conditions to infectious disease is fueling a demand for companies to bring product from R&D into customers’ hands faster than ever before,” he says.
“A recent example was the amazing job by the research community in identifying the pathogen responsible for the SARS epidemic. The need for an accurate, easy-to-use diagnostic test for SARS therefore developed quite quickly, but the ability of the marketplace to meet this demand lagged,” Polen says. “We are now taking a more global approach to product life cycle development. Today our clinical trials are literally chasing the flu around the world testing in the Northern Hemisphere during our winter and the Southern Hemisphere during our summer to ensure that our new tests will be ready in time for next year’s flu season.”
Federal Agencies Actively Support Industry Growth
Historically, the federal government and its myriad agencies, which oversee every aspect of the health care industry, have served crucial regulatory, educational, funding, research, and development roles. Reflecting on the importance of government support, Alpha-Tec’s Williams says. “They are doing a commendable job. We have tremendous support from the CDC [Centers for Disease Control], FDA [Federal Drug Administration], NIH [National Institutes for Health], and other agencies for our laboratories to develop new products.”
As an example of this support, TREK’s Burke cites the ongoing joint USDA/FDA National Antimicrobial Resistance Monitoring System (NARMS) project, a major multiyear surveillance study looking for antibiotic resistance patterns among animals. He considers this significant because “humans share many of the same pathogens as animals, and overdosing of herds adds to the growing resistance issues in humans.”
Healy at Bacterial Barcodes also credits the government with making efforts to achieve more rapid acceptance of new diagnostic products. “The FDA has done a good job modifying some of their own processes so they can increase the number of applications they review and make more timely decisions on the worthiness and usefulness of each new assay,” she says.
Automation Breeds Crucial Labor and Time Savings
One of the waves of the future for clinical microbiology is certain to be automation. BD’s Polen notes, “Laboratory automation is something new for microbiology, which has traditionally relied on manual methods. Automation reduces test complexity, cuts the number of required steps, can improve turnaround time, reduces requirements for highly skilled personnel, and allows fewer personnel to do more work cost effectively. All of these factors are important to hospital administrators who continue to face a chronic shortage of skilled microbiologists and laboratory personnel.”
According to Healy, “A major reason for the growing trend to automated molecular microbiological assays is the shortage of qualified lab technicians and the number of tests that still require excessive hands-on time, such as traditional biochemical assays. Automation moves us to a realm where assays can be performed faster with less materials and a smaller workforce.”
Concurring with Healy, Steve Shumoski, US clinical marketing manager, Molecular Systems, bioMérieux, says, “The earlier-generation molecular techniques and platforms required specially trained personnel and subsequently found their place in academic facilities and large reference/core laboratories. Newer systems platforms that consolidate and automate the various steps required for nucleic acid testing will put molecular microbiology within reach of more and more laboratories. This should result in the placement of molecular-based tests with high clinical values closer to the patient. This could be very positive in that there will be opportunities to develop new standards of care that significantly impact the patient and the health care system in general.”
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Alpha-Tec Systems Inc
Bacterial Barcodes Inc
BD Diagnostics
bioMérieux
TREK Diagnostic SystemsMarleen and Gary Wolfe are contributing writers for Clinical Lab Products.
