In the past few years, the epidemiological burden of infectious diseases across the globe has increased. Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), Ebola, avian flu, swine flu, and Zika are some of the majorly occurring infections. The recent outbreak of COVID-19 is an example of the same.
In 2019, an estimated 71 million people had chronic hepatitis C virus infection. A significant number of those who are chronically infected develop cirrhosis or liver cancer. Approximately 3,99,000 people die every year from HCV, majorly from cirrhosis and hepatocellular carcinoma. This shows an occurrence of the infections over some time intervals, impacting the world population.
In 2019, 37.9 million people were living with HIV, and a majority of people with HIV infection lived in the middle- and low-income countries, out of which 68% lived in sub-Saharan Africa (Source: Avert). Among these, 20.6 million lived in East and Southern Africa, which was 53.0% of new HIV infections globally. Thus, there is an increasing prevalence of chronic and acute diseases across the globe, which, in turn, is increasing the demand for the diagnosis of these diseases for early detection, prevention, and treatment.
The outbreak of the COVID-19 pandemic has created immense opportunities for players operating in the immunoassays market. These players have launched various immunoassay solutions in the market to garner a larger market share. For instance, in October 2020, VEO Diagnostics (U.S.) launched the ACCEL ELISA COVID-19 kit. Similarly, in May 2020, ERBA Diagnostics Mannheim GmbH (Germany) launched its immunoassay-based kit—ErbaLisa COVID-19 ELISA kits to detect IgG and IgM antibodies to SARS-CoV-2.
Two types of tests are validated to detect COVID-19—molecular diagnostic test and immunological assay test. But as molecular diagnostic tests, such as PCR, cannot be used to monitor disease progression, there is a greater demand for immunological assays. Other than the coronavirus detection tests, usual detection methods for specific pathogens include Gram-stains, pathogen culturing, and biochemical methods. These techniques have contributed to the diagnosis, prevention, and treatment of various infectious diseases. However, these techniques are time-consuming & expensive and require complex analytical instruments & skilled technicians, making them unfeasible. On the other hand, point-of-care testing (POCT), which includes lateral flow assay-based testing kits is preferred to prevent transmissible diseases.
Apart from this, immunochromatographic assays or rapid tests are simple devices intended to detect the presence of a target substance in a liquid sample without the need for specialized and costly equipment. Also, lateral flow devices (LFDs) are among the new tools to help detect and fight the COVID-19 pandemic. In the U.K., the government ordered 384 million lateral flow kits at the cost of over GBP 1.3 billion (USD 1.8 billion). In this regard, an additional GPB 0.9 billion worth of contracts have been closed. Lateral flow tests have become a lucrative business in the COVID-19 pandemic.
Due to the growing acceptance of smart devices, companies are developing automated lateral flow readers that can be connected to mobile phones or laptops and produce highly sensitive and quantifiable results and can capture & transmit real-time data. Moreover, in recent years, there has been high adoption of smart devices in healthcare systems for analysis and data management. For instance, in March 2019, Alere, Inc. (U.S.) launched its rapid influenza diagnostic test —BinaxNOW Influenza A & B Card 2. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. BinaxNOW Influenza A & B Card 2 can be read by DIGIVAL.
DIGIVAL accurately reads and interprets lateral flow tests in just seconds, delivering automated, objective results in any healthcare setting. It is a camera-based instrument that can detect the presence of and identify a completed lateral flow assay, analyze the intensity of the test and control line, and display the results (positive, negative, or invalid) on the color touch screen. Product developments like these are expected to further accelerate the growth of this market in the coming years.
The immunoassays market is expected to grow at a CAGR of ~8.0% to reach USD 43.51 billion by 2027, according to the Meticulous Research®.
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