Automated Antimicrobial Susceptibility Testing Market Overview 2020, Global Size, Industry Growth, Share, Future Trends, Merger, Competitive Landscape, Top Company Profile

Antimicrobial susceptibility testing (AST) confirms susceptibility, detects resistance, and guides the selection of patient therapy. The tests can guide the physician in drug choice and dosage for difficult-to-treat infections. Antibiotic resistance is a major global health concern which requires action across the globe. It is increased due to antibiotic misuse and has become a major global health concern. Current methods for antimicrobial susceptibility testing (AST) used to probe for resistant or nonresistant (susceptible) phenotypes of pathogens, typically requires between two days to one week from the time of sample collection.

Increasing number of pathogenic bacteria are acquiring antibiotic resistance and new forms of resistance are continuously emerging, which enable clinicians to perform antimicrobial susceptibility testing (AST) on priority. A rapid multiplexed AST platform provides minimum inhibitory concentrations (MICs) within hours at reasonable cost, which enables rapid determination of effective targeted therapy, resulting in short hospital stays, few laboratory tests, and decreasing morbidity and mortality along with associated healthcare expenses.

Key players operating in the global antimicrobial susceptibility testing market include bioMérieux S.A., HiMedia Laboratories, Alifax Holding S.p.A., Creative Diagnostics, Resistell AG, Danaher Corporation, Becton, Dickinson and Company, Thermo Fisher Scientific Inc., Merck KGaA, and Bio-Rad Laboratories, Inc.

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Market Dynamics

Emergence of multidrug resistance, globally is impeding the ability to treat common infectious diseases, thereby resulting in prolonged illness, disability, and death. This is expected to increase the adoption of antimicrobial susceptibility testing during the forecast period. Moreover, the healthcare cost for patients with resistant infections is higher as compared to patients with non-resistant infections, owing to longer duration of illness, additional tests, and use of more expensive drugs. For instance, according to the World Health Organization (WHO), in 2016, around 490,000 people developed multi-drug resistant TB globally. Also, drug resistance is a major restraining factor for manufacturers that are focusing on developing drugs for HIV and malaria.

However, requirement of regulatory clearance by the U.S. Food and Drug Administration (FDA) and respective government authorities before marketing a diagnostic device is a major restraining for the antimicrobial susceptibility testing market growth. Moreover, in some countries such as China, FDA registration may be a requirement in addition to the local registration needs.

Emergence of Multidrug Resistance Worldwide Is Expected To Drive the Antimicrobial Susceptibility Testing Market Revenue

Resistance among various microbial species to different antimicrobial drugs have emerged as a major cause of public health threat. According to World Health Organization (WHO), these resistant microorganisms such as bacteria, fungi, viruses, and parasites are able to combat attack by antimicrobial drugs, which leads to ineffective treatment resulting in persistence and spreading of infections.

Increasing number of multidrug resistance cases in tuberculosis (TB), malaria, HIV, influenza, and others among the global population is expected to result in increasing adoption of antimicrobial susceptibility testing to reduce the resistance exposure during the forecast period. For instance, according to the WHO, in 2016, an estimated 490,000 people worldwide developed MDR-TB. The countries with the largest numbers of MDR/RR-TB cases were China, India and the Russian Federation.

Moreover, development of genotypic-based methods offering rapid and accurate detection or confirmation of antimicrobial resistance is expected to drive the market growth. For instance, the Accelerate ID/AST System or ID/AST System (Accelerate) aims to reduce the turnaround time by using genetic methods. The device can identify infectious pathogens in a matter of hours instead of days, reducing diagnostic time by 30 to 50 hours.

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Antimicrobial Susceptibility Testing Market Restraints

Stringent government regulations is the major restraining factor for the antimicrobial susceptibility testing market growth. Regulatory procedures creates barrier to AST development, as clinical validation and trials are lengthy and often too costly for small-sized or medium-sized enterprises or organizations.

For instance, in the U.S., a manufacturer who intends to market a device of generic type must conform to the general controls of Section 513(a)(1)(B) of the Federal Food, Drug and Cosmetic Act, address the risks to health associated with the AST system, and obtain a substantial equivalence assessment from the FDA.

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