The advent of new technologies, such as mass spectrometry, liquid transport media, molecular techniques, and automated identification and susceptibility systems, has begun to simplify and allow for much greater standardization of the microbiology laboratory. This, combined with high-resolution digital imaging and robotics, has allowed microbiology to accomplish the impossible, i.e., to become automated. Diagnostic microbiology instruments manufacturers are betting that robotics will be used for specimen processing, plate reading, and organism identification in the near future. These systems are highly complex and have large footprints and hefty price tags. However, they are perceived as being more efficient, rapid, and accurate than standard processes. The next decade, and particularly the next few years, should prove intriguing as researchers strive to further impact clinical decision-making for infectious diseases by advances in clinical microbiology.

Indian Market Dynamics

The microbiology instruments and reagents market for the clinical sector in 2014 is estimated at Rs.250 crore. Contributing a major Rs.200 crore, reagents are the mainstay. The balance Rs.50 crore is accounted for by instrumentation into clinical microbiology. bioMérieux, is the leading player in this segment. BD India has aggressive presence. Other players are Beckman Coulter (Siemens products) and Thermo Fisher Scientific. Beckman Coulter entered into a definitive agreement to purchase the clinical microbiology business of Siemens Healthcare Diagnostics in July 2014. The Siemens clinical microbiology business is an active player in microbial identification and antibiotic sensitivity testing (ID/AST).

The instruments-based reagents market in 2014 is estimated at Rs.110 crore. The major vendors are bioMérieux, BD India, Beckman Coulter (Siemens products), and Thermo Fisher Scientific.

The non-instruments-based reagents market, broadly comprising dehydrated culture media, antibiotic sensitivity discs, blood culture bottles, and identification kits, is estimated at Rs.90 crore. Led by HiMedia, this segment has players as Microxpress (Tulip Diagnostics), Bio-rad, BD India, bioMérieux, Beckman Coulter (Siemens products), Thermo Fisher Scientific, Merck Millipore, and Titan Biotech.

There are numerous technologies under development or with only limited objective supporting literature, which are sure to play a role in the future of clinical microbiology. Likewise, investigators continue to push the limits of current technologies, including digital PCR, next-generation sequencing, and MALDI-TOF (matrix-assisted laser desorption/ionization-time of flight) mass spectrometry, to broaden their utility in areas including antimicrobial susceptibility testing and identification of oncogenes. The combined efforts of progressive investigators and availability of increasingly sensitive technologies are sure to improve the quality and add value to the services provided by clinical laboratorians.

Technical Innovation

Among the innovations leading to automation in clinical microbiology, the transition to liquid-based microbiology is the most influential. Advantages of liquid-based microbiology include homogenization of specimens into a liquid phase, which enables more-consistent inoculation of medium. Elution of specimen from newer flocked-style swabs into liquid phase has demonstrated a significant increase in the release of viable organisms from the swab, which translates into increased sensitivity for detection of microorganisms in the specimen. While improvement in the sensitivity of culture is paramount, it is also important to note that the specimen is associated not with the swab but with the liquid phase of the transport device. The presence of the specimen in a liquid-based transport enables inoculation of the specimen and smear preparation with automated liquid-based specimen processors.

A second technical innovation that has driven laboratories to automation is MALDI-TOF mass spectrometry, which has revolutionized microbial identification by providing a cost-effective method that is standardized. The technology offers accurate, rapid, and inexpensive identification of microorganisms isolated from clinical specimens. The future innovations are in the development of broad molecular panels that offer laboratories the ability to respond to clinician, ordering patterns based on their unique patient populations and treatment algorithms, and report and ultimately pay only for the subsets of targets that are relevant for each patient.

Future Trends

Laboratories of the future will no longer be paid based on the services that they perform but instead will be incentivized based on their contribution to delivery of quality care. In other words, healthcare in the future will be paid based upon keeping patients out of the hospital. This shift in reimbursement will mean that laboratories can no longer operate in a vacuum, concerned only about in-laboratory time and cost per test; instead, they will need to add value to patient care.

Beyond changes in the delivery of healthcare, demand by clinicians for new tests continues to grow, not just in total numbers but also for the types of testing performed. The balance between molecular tests and culture-based assays will likely continue to shift toward molecular. Both the trend toward molecular testing and decreasingly shorter lengths of stay for hospital inpatients has led to increased demand for more-rapid turnaround times for infectious disease assays. This will mean that the current and future automation systems will need to incorporate both culture and molecular testing into a single specimen stream and manage both laboratory techniques.

Indian Market Dynamics is based on market research conducted by Medical Buyer in November 2015

"Diagnosis of invasive mycoses and fungemias is usually based on non-specific diagnostic or radiological techniques. Common primary human fungal pathogens are Candida and Aspergillus species. The fungitell assay has been successfully used in diagnosing invasive fungal disease (IFD) in hemato-oncology setting, ICU setting, solid organ transplant setting, gastrointestinal surgery setting, CNS mycosis setting and pneumocystosis setting. The assay is indicated for presumptive diagnosis of fungal infection. It should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples, and radiological examination. The assay is based upon a modification of the limulus amebocyte lysate (LAL) pathway. The fungitell reagent is modified to eliminate Factor C and, thus, it reacts to (1-3)-β-D-Glucan, through the Factor G-mediated side of the pathway. (1-3)-β-D-Glucan activates Factor G, a serine protease zymogen."

Dr B Rayvathy
Assistant Professor of Microbiology, Dr ALM PG Institute of Basic Medical Sciences
University of Madras, Chennai

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