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Microbiology Instruments and Reagents

Microbiology is making way for molecular testing

Several emerging molecular diagnostic techniques are increasingly being used for early detection as well as the effective treatment of pathogen-borne diseases. Advanced molecular diagnostic techniques offer several technological benefits as compared to traditional laboratory techniques.

With testing volumes going through the roof, automation is needed more than ever, particularly for small- and mid-sized labs that are in underserved geographic areas. Demand for laboratory testing is increasing. Overall testing volumes are expected to increase 10 to 15 percent per year for the next 20 years, due in part to an aging population that will require more healthcare. The global microbiology instruments and reagents market is expected to grow from USD 3.42 billion in 2021 to USD 3.98 billion in 2022 at a compound annual growth rate (CAGR) of 16.4 percent. The market is expected to grow to USD 6.85 billion in 2026 at a CAGR of 14.6 percent. Technological advancements, rising incidences of infectious diseases, and growing outbreak of epidemics, and increased funding and public-private investments, are some of the key factors driving the growth of the clinical microbiology market.

In addition, the increasing investments in digital health technologies, artificial intelligence, and non-invasive monitoring capability, delivery of gene therapy and regenerative medicines technologies, and customized 3D printing of medical devices are expected to drive the microbiology diagnostic devices market.

Unfavorable regulatory scenarios are the major restraints in the microbiology diagnosis devices market. In the US, section 510(k) of the Food, Drug, and Cosmetic Act states that every device manufacturer must register with FDA, and notify their intent to market a medical device at least 90 days in advance. These pre-market notifications are considered to be lengthy, rigorous, and time-consuming processes for the approval of medical devices.

The Indian market for microbiology instruments and reagents in 2021 is estimated at ₹470 crore, a 34.3-percent increase over 2020. The instruments, along with the instrument-based reagents continued to constitute 56.4 percent of the market, with instruments at ₹40 crore, and reagents at ₹225 crore. The non-instruments-based reagents contributed the balance 43.6 percent to the market at ₹205 crore.

After a dull 2020, the market in 2021 bounced back very strongly leading to a 60-percent increase for instruments over 2020, and the instruments-based reagents a 45.2 percent increase. The non-instruments-based reagents grew by 14.7 percent in 2021, over 2020.

Indian microbiology instruments and reagents market
Major players
Segment Vendors
Indian microbiology automated
instruments market
bioMérieux, BD India, Beckman Coulter, Thermo Fisher, and Trivitron
Indian microbiology instruments based reagents market bioMérieux, BD India, Beckman Coulter, and Thermo Fisher
Indian microbiology non instruments-based reagents
Hi-Media, BD India, Thermo Fisher, Bio-rad, bioMérieux, Beckman Coulter, Microxpress, Merck Millipore, and Titan Biotech
ADI Media Research

Within the analyzers segment, in 2021, the blood culture analyzers dominated with a 57-percent share by quantity and identification, and antibiotic-susceptibility analyzers dominated at 57.5-percent share by value. bioMérieux and BD are the two brands that continue to dominate the instruments and instruments-based reagents segments. The instruments market saw a huge increase in 2021, the increase by value being 66.7 percent for TB cultures, 64 percent for identification and antibiotic-susceptibility analyzers, and 50 percent for blood culture analyzers over 2020.

In the non-instruments-based reagents segment, Hi-Media dominates. This includes ready-to-use plates, antibiotic disks, MICs, etc. Titan Biotech (Microexpress) and Tulip are the other aggressive players.

In 2022, the market is headed for a 15–20 percent increase over 2021. The methods are changing, and microbiology is making way for molecular testing. A gradual shift is observed in favor of molecular, thereby affecting the practice of clinical medicine. For each of these technologies, the additions to healthcare costs are weighed against the potential advantages. The techniques and the technologies are here. The efficacy of these technologies is the deciding factor.

Several emerging molecular diagnostic techniques are increasingly being used for early detection as well as the effective treatment of pathogen-borne diseases. Advanced molecular diagnostic techniques offer several technological benefits, such as faster turnaround time, high sample throughput, multiplexing of reaction, specificity, better accuracy, and increased device sensitivity as compared to traditional laboratory techniques. Advanced molecular diagnostic techniques, such as NGS, real-time PCR, molecular cartridges, and PCR coupled with mass spectrometry are increasingly being recognized for their capabilities in the identification and characterization of several pathogens as well as in the analysis of multiple samples in a single run. This has resulted in the increased preference as well as the growing adoption of these products among key end-users, including healthcare providers (such as hospitals and microbial and clinical centers), research laboratories, and pharmaceutical and biotechnology companies.

The development and commercialization of pathogen-specific reagent/diagnostic kits has led to better sample utilization as well as the adoption of a well-defined clinical methodology for specific disease diagnosis. In line with the changing end-user preferences, many prominent product manufacturers are focusing on developing and commercializing innovative and technologically advanced molecular diagnostic products for infectious disease diagnosis.

Clinical microbiology testing procedures are not adequately reimbursed across several countries, such as India, China, and other emerging countries in the Middle East and Africa, which have a high target patient population base. This is a major factor that limits the preference for clinical microbiology products among patients and healthcare professionals. This directly affects the adoption of premium-priced clinical microbiology products, thereby negatively affecting their market growth. Laboratory tests performed for in-patients are reimbursed along with diagnosis-related group payment only, whereas reimbursements for out-patient laboratory tests are made locally. The lack of national standardization for reimbursements results in significant variation at the regional level. The adoption of microbial tests is further restricted due to limited coverage for operational costs for these test procedures, restricted research-use-only (RUO) diagnostic products, and the slow inclusion of newly developed microbial test procedures in CPT codes for medical reimbursements.

Operational barriers related to the use of diagnostic tests. Diagnostic microbiology tests involve various types of patient samples, such as semen, saliva, tissue, blood, and urine. These diagnostic tests have limited utilization of automated instruments to directly diagnose common pathogens, such as Plasmodium, Staphylococcus, and Escherichia coli. Clinical laboratories must have proper logistic support for timely sample collection, efficient transportation, and safe and standardized sample processing to provide correct and accurate diagnostic results to patients. However, meeting optimal criteria for sample handling and transportation is a key challenge faced by a majority of clinical laboratories. For instance, in the case of preanalytical sample processing, the sample should be procured at room temperature and transported at fixed temperatures only. Additionally, clinical laboratories must verify separate preanalytical and analytical procedures for individual matrix type so as to get optimal and correct results.

The majority of microbiologists would have concurred ten years ago that clinical chemistry-style automation could not be used to streamline the processes in a microbiology laboratory. Aside from sample complexity and procedural variations, no two microbiological labs operate in the same way! Nevertheless, there are now a number of technologies available that automate the cycle from incubation through reporting. In a regulated, considered, and evidence-based approach, microbiologists should realize and perceive the opportunity to rethink microbiology and get rid of some unnecessary, longstanding, and settled habits.

Microbiology needs to move into the twenty-first century.

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