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The Coronavirus Pandemic and the Prevalence of Other Infectious Diseases Have Boosted the Development of Immunoassay-based Diagnostic Kits

   January 15, 2021

The epidemiological burden of infectious diseases worldwide has increased in the past few years. Various infections such as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), Ebola, chikungunya, avian flu, swine flu, and Zika have emerged as major threats to public health. The recent outbreak of the coronavirus (COVID-19) disease is a recent example. According to the WHO, in 2019, an estimated 71 million people had chronic hepatitis C. A significant number of chronically infected patients develop cirrhosis or liver cancer. Approximately 3,99,000 people die every year from HCV, majorly from cirrhosis and hepatocellular carcinoma.

Similarly, the Western African Ebola virus epidemic (2013–2016) was the largest and most complex Ebola outbreak since the discovery of the virus. The swine flu epidemic (2009–2018) affected a large proportion of the world population. These events indicate the intermittent occurrence of infections over time. In 2019, an estimated 38.0 million people were living with HIV (including 1.7 million children), with a global HIV prevalence of 0.8% among adults (Source: World Health Organization). Thus, the increasing prevalence of infectious diseases worldwide has significantly increased the need to diagnose these diseases for early detection, prevention, and treatment, which is expected to drive the growth of the in-vitro diagnostics market during the forecast period.

In recent years, early diagnosis of infectious diseases has led to better treatment and future care. The early diagnosis of infectious diseases helps medical professionals and patients make important medical decisions in terms of care and support. Immunoassays, biochemical characterization, polymerase chain reaction, isothermal nucleic acid amplification tests, and next-generation sequencing are performed to identify a comprehensive range of infectious diseases. Increasing awareness regarding the importance of early disease detection amongst the global population is a major driving factor for the growth of the IVD market. Hence, organizations are taking initiatives to promote early diagnosis to prevent and eradicate mortality caused due to infectious diseases. For instance, in 2019, Public Health England (PHE) launched a 5-year (2020 to 2025) infectious diseases strategy to prevent, detect, and respond to infectious diseases and reduce their impact.

In-vitro diagnostics are the most common tools widely used to diagnose diseases and other health conditions and guide treatment decisions. In-vitro diagnostics include tests that are conducted on samples such as blood or tissue that have been taken from the human body. They can detect diseases and other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. In-vitro diagnoses make use of various technologies to detect infections—immunoassay is the most widely used bioanalytical method among them, in which the quantitation of the analyte depends on the reaction of an antigen and antibody. A wide variety of immunoassay techniques have been developed, with ELISA, rapid tests, microarray, radioimmunoassay, immunocytochemistry, western blotting, and blood screening immunoassays being the most well-known. Immunoassays also find applications in cancer markers, diagnosing infectious diseases, cardiac analysis, therapeutic drug monitoring, and allergen tests. Also, the use of rapid tests has been increasing. In response to the COVID-19 pandemic and shortages of laboratory-based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed and started offering rapid and easy-to-use devices in the market to facilitate testing outside of laboratory settings. These simple test kits detect proteins from the COVID-19 virus in respiratory samples (e.g., sputum, throat swab) or the blood or serum of human antibodies generated in response to an infection.

The COVID-19 pandemic has created immense opportunities for immunoassay providers, becoming a focus area for new product development. For instance:

  • In October 2020, VEO Diagnostics (U.S.) launched the ACCEL ELISA COVID-19 kit indicated for COVID-19.
  • 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. This kit allows qualitative and semi-quantitative detection of IgG and IgM antibodies.
  • In March 2020, Epitope Diagnostics Inc. (U.S.) launched its immunoassay kits—EDI Novel Coronavirus COVID-19 IgG ELISA Kit and EDI Novel Coronavirus COVID-19 IgM ELISA Kit.
  • In February 2020, WuXi Diagnostics (China) launched the nCoV IgM Detection kit, nCoV IgM/IgG Detection Kit, and nCoV Nucleic Acid Detection Kit.

These products are integrated with detection solutions, assisting medical institutions in diagnosing COVID-19 infections quickly & accurately, and improving epidemic prevention & control. According to Meticulous Research®, the emergence of newer immunoassay-based diagnostic kits is expected to boost the adoption of IVD products, driving the growth of the IVD market at a CAGR of 7.0% to reach $118.50 billion by 2027.

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