According to a study conducted by ClinicalTrials.gov, to prevent screening shortages, an innovative PCR-free alternative strategy was developed based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms.
The COVID-19 pandemic has had a major impact on the US, China, India, as well as many major European countries. Since most of these countries are major manufacturers of the instruments and consumables used for microbial identification, the pandemic and nationwide lockdowns have caused a decline in the sales of these products.
Microbial identification is mainly used for human disease diagnosis. It delivers rapid and reliable results that help in the timely adoption of appropriate therapies. Microbial identification products can improve the management of infectious diseases, especially in areas with inadequate healthcare infrastructure. It is estimated that approximately 1,400 pathogens can cause human diseases.
Pathogenic bacteria alone cause about 350 million cases of foodborne diseases. About 48 million foodborne illnesses occur annually in the US alone, which leads to approximately 128,000 hospitalizations and 3,000 deaths every year. Poor water hygiene can cause 1.7 million deaths a year worldwide, and 9 out of 10 deaths occur in children. Most of these deaths, however, are observed in developing countries (NCBI).
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Over the years, there has been a significant increase in the prevalence of infectious diseases worldwide. According to the WHO, TB is one of the top 10 causes of death. A total of 1.5 million people died from TB in 2018 worldwide. Between 2000–2018, an estimated 58 million lives were saved through TB diagnosis and treatment. ccording to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2019, globally, 1.7 million people were newly infected with HIV, 38 million people are living with HIV, and 690,000 people died of AIDS-related illnesses.
Furthermore, incidents such as the Zika epidemic (2016), Ebola epidemic (2014), H1N1 swine flu pandemic (2009), H5N1 Avian flu pandemic (2004), Severe Acute Respiratory Syndrome (SARS) pandemic (2003), and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic (2019–2020) have caused serious health concerns. They also lead to an increased demand for diagnostic products, including those for microbial identification. Thus, the high prevalence and incidence of different infectious diseases, coupled with the increasing frequency of pandemics, are driving growth in the microbial identification market.
The consumables used for identification techniques are also expensive, and there is an added labor cost. Many of the new rapid tests typically range from USD 100–USD 250; they cost significantly more than the conventional culture methods. The estimated cost for instruments, media, and labor is excessively high for some end users.
Academic research laboratories generally cannot afford such systems as they have limited budgets. In addition, the maintenance costs and several other indirect expenses result in an overall increase in the total cost of ownership of these instruments. This hinders the mass adoption of automated microbial identification systems, especially by relatively small institutions.
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The emerging economies are expected to become a focal point for the growth of the microbial identification market. The Asia Pacific, Middle Eastern, and Latin American regions are relatively untapped markets for microbial identification companies compared to Europe and North America. Owing to this, governments in various Asian countries are supporting the development of the microbial identification market.
These are more complex and stricter regulations. Market players will, therefore, find it challenging to align their processes with the new regulations, which could temporarily impact the time to market for new products, especially in the US and Europe.
The mass spectrometry segment accounted for the largest share in 2019, due to its high speed, high specificity, and applicability for a wide range of microorganisms such as bacteria, archaea, and fungi. The rising adoption of MALDI-TOF technology for microbial identification is another major factor supporting market growth.
The hospitals, diagnostic laboratories, and blood banks segment dominated the microbial identification market in 2019, due to the high prevalence of different infectious diseases, coupled with periodic outbreaks of pandemics.