Microbiology as a science has expanded by leaps and bounds in the past few decades, with advancements in sophisticated instrumentation and recombinant DNA technology, which have added a new dimension and revealed the understanding of the subject at molecular level. This has resulted in the emergence of several applications of this domain.
The global clinical microbiology market is rapidly growing due to the increasing adoption of automated and advanced technologies for laboratory instruments and analyzers in the developed countries. The market was valued at USD 8.4 billion in 2015 and is projected to grow at a CAGR of 7.3 percent, during 2016 to 2024.
The market is witnessing rising investment in research and development (R&D). Almost all analytical and therapeutic research projects demand reagents and chemicals; thus the penetration of reagents is growing. In addition, repeat purchase of reagents results in more revenue generation for the segment compared to instruments. Thus, the reagent segment accounted for the largest market share of around 35 percent in 2015.
Commercialization of research projects is increasing the overall sample processing volume in each project. As a result, demand for automated clinical systems is rapidly increasing to maintain uniformity and to reduce human errors associated with manual processing. Thus, the laboratory instrument segment is expected to grow with a CAGR of 8.5 percent from 2016 to 2024.
Indian Market Dynamics
The microbiology instruments and reagents market for the clinical sector in 2015-16 was valued at 290 crore. Contributing a major 238 crore, reagents are the mainstay. The instruments-based reagents increased by
22 percent in value over 2014-15, and while the non-instruments-based reagents also increased by 22 percent in volume, they increased 15 percent in value terms. The balance 52 crore is accounted for by instrumentation into clinical microbiology, which increased by a mere 3–4 percent over 2014-15.
bioMrieux, is the leading player in this segment. BD India has aggressive presence too, closely followed by Beckman, with the Siemens product range.
The main challenge is that microbiology testing has yet to gain widespread acceptance. These practices need to be used more frequently. Perhaps it needs to be mandated that all antibiotic prescriptions need to be informed by a test so that use of inappropriate antibiotics is decreased, thereby reducing risk of antibiotic resistance, patient morbidity, and mortality.
Also it is an ongoing challenge that while top- level clinicians are aware of the intricacies of the procedures and methodologies, this does not travel to the mid-level and junior staff, hence compromising on patient care. Automation being expensive is yet to gain prominence.
Hospitals want hassle-free supply. Ready- prepared media products, ready-to-use, prepared, and cultured media available in choice of plates, tubes, and bottles for the identification of microorganisms are being sought. These products have brought to the microbiological laboratory the highest levels of quality and performance. They are time- and cost-saving, easy and convenient to use, and provide constant high quality, ensuring that patients receive safe products.
There is an increase in awareness of aspects as drug resistance, antibiotic sensitivity, and in what concentration the antibiotic must be used among healthcare professionals, policy-makers and patients. This is expected to drive this market.
Microbiology automation is not without challenges. Cost is a significant barrier to automation, with the initial investment in capital acquisition, facility modifications, and, importantly, IT and connectivity to integrate the entire process from test requisition and specimen collection to final result. Overcoming the initial resistance of lab personnel is also sometimes a factor.
While many labs have implemented some automation solutions, especially in molecular diagnostics, the majority of labs are still in the planning process or are looking to build on what they started. As with any significant initiative, thorough need assessment, planning, and securing the buy-in of all stakeholders are the key. In this context, it is difficult to overemphasize the importance of two areas of focus in the planning stage – workflow and IT.
Automation cannot be done in a vacuum, and it is important to consider the overall workflow of the lab, not just specific processes being automated. Studies have shown that implementing automation without considering the overall workflow makes little impact on quality of care. To understand the overall lab workflow and the clinical workflow and how best to derive the maximum value from automation, labs need to review all facets of current lab operations. These include, for example, the mix of specimen types (i.e., whether processing can be automated), time they arrive at the lab, and expected time to result. The goal is to make sure there is clear understanding of how automation will be incorporated and how it will impact the overall workflow and, ultimately, patient care.
A second planning parameter that is sometimes left as an afterthought is IT. In the current imperfect world of connectivity, making sure that computer systems – from automation technology to MALDI-TOF to LIS to HIS – talk to each other is paramount. The need for integrated information flow cannot be overemphasized. Thus, getting the IT team involved from the beginning is a critical success factor. As higher-quality information is generated in a more timely manner, it is just as important to get it into the physician's hands without delay.
Of course, there are myriad of other factors to consider in planning automation – space planning is one example. Mapping out the post-automation workflow to reallocate staff time is another. A clear picture of the expected results and metrics for post-automation assessment will help track progress and guide adjustments once implementation begins.
Indian Market Dynamics is based on market research conducted by Medical Buyer in November 2016.