COVID-19 Impact on Immunoassay in Healthcare Industry

COVID-19 Impact on Immunoassay in Healthcare Industry

  • Healthcare
  • Sep 28, 2020

COVID-19 Impact on Immunoassay in Healthcare Industry

The Coronavirus (COVID-19) pandemic is having a dramatic impact on the immunoassays as numbers of immunoassays have received approval for diagnostic use for COVID-19 pandemic, utilizing assays like ELISA and lateral flow. Currently, PCR and immunoassays are the only means for diagnosis of COVID-19 used by the healthcare professionals in order to detect the spread of Coronavirus across the globe.

Moreover, immunoassays demonstrate some distinct benefits over PCR. Antigens and antibodies are slightly more robust than RNA, rendering them less vulnerable to spoliation during transport and storage, thereby reducing the risk of false-negative outcomes. The quality in research is often improved by the reality that antigens and antibodies are found more consistently in sputum and blood samples. The virus has spread across all regions ranging from North America, Europe, Asia-Pacific, Middle East and Africa up to South America.

The COVID-19 has been declared as a pandemic by WHO due to its increased spread across the globe. After the declaration of the pandemic, various countries announced the complete lockdown such as the U.S., Germany, India, China among others in order to decrease its spread. The lockdown of countries aids in surging of use of immunoassays diagnostic kits in order to screen patients suffering from Coronavirus. According to the situation, the report of 5th August 2020 by WHO stated 18,354,342 cases of Corona has been reported globally and 696,147patients are dead due to the Coronavirus.

IMPACT ON DEMAND

Exponential rise in globally occurring Coronavirus cases is increasing the demand for diagnostic kits for immunoassays. The reasons responsible for the growth in diagnostic demand include rising market appetite for serology-based rapid-test products, a favorable regulatory climate for drug creation and marketing, as well as a substantial rise in target patient population. Because of these factors, different market players were prompted to improve and enhance their current production and distribution capabilities and focus on upgrading and marketing of their product.

Immunoassay is the method of choice for the diagnosis of patient with Coronavirus as major point-of-care testing kits are based on antigen – antibody interaction or immunoassay based. Moreover, the pandemic has led to significant rise in demands for reagents used in immunoassay testing in the recent months, leading to shortages in reagents required for perform the key steps in the testing process such as buffers and test reagents among more.

Immunoassay-based kits manufacturers have taken huge initiatives to enhance patient access to Coronavirus diagnostic testing in laboratories, hospitals and other test sites around the globe to support patient care and improve human health.

The companies listed below developed serology testing based on immunoassay that gained Emergency Use Authorization from the U.S. FDA:

  • Abbott: SARS-CoV-2 IgG assay
  • Autobio Diagnostics Co.: Anti-SARS-CoV-2 Rapid Test
  • Bio-Rad Laboratories, Inc.: Platelia SARS-CoV-2 Total Ab Assay
  • Cellex: qSARS-CoV-2 IgG/IgM Rapid Test
  • Chembio Diagnostic Systems, Inc.: DPP COVID-19 IgM/IgG System
  • DiaSorin: LIAISON SARS-CoV-2 S1/S2 IgG
  • EUROIMMUN US, Inc.: Anti-SARS-CoV-2 ELISA (IgG)
  • Healgen Scientific, LLC: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
  • Ortho Clinical Diagnostics: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
  • F. Hoffmann-La Roche Ltd: Elecsys Anti-SARS-CoV-2
  • Siemens: ADVIA Centaur SARS-CoV-2 Total (COV2T); Atellica IM SARS-CoV-2 Total (COV2T)
  • ACCESS BIO. INC.: CareStart COVID-19 IgM/IgG
  • Beckman Coulter, Inc.: Access SARS-CoV-2 IgGWantai BioPharm: WANTAI SARS-CoV-2 Ab Rapid Test
  • BIOHIT Healthcare (Hefei) Co., Ltd.: Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
  • Diazyme Laboratories, Inc.: Diazym DZ-Lite SARS-CoV-2 IgG CLIA Kit
  • Healgen Scientific, LLC.: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
  • InBios International, Inc. USA.: SCoV-2 Detect IgG ELISA; SCoV-2 Detect IgM Elisa
  • Luminex Corporation: xMap SARS-CoV-2 Multi-Antigen IgG Assay
  • Salofa Oy: Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
  • Xiamen Biotime Biotechnology Co., Ltd.: BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test

The Emergency Use Listing Procedure (EUL) procedure was developed to accelerate the availability of the required diagnosis in emergency situations in public health. It was intended to enable interested procurement agencies and member states to use a particular immunoassay on the basis of a limited collection of available data on quality, health and performance.

The immunoassay eligible to be submitted for EUL includes:

  • Rapid diagnostic tests for the detection of IgM/IgG to SARS-CoV-2

For instance,

  • In May 2020, Roche Diagnostics, North America received Emergency Use Authorization by the Food and Drug Administration for its SARS-CoV-2 antibody test namely Elecsys Anti-SARS-CoV2 assay. This new diagnostic kit launched by the company aids in decreasing the increasing burden of COVID-19 testing by meeting the demand of the population to some extent.

In the first half of 2020 (H1), the U.S. is anticipated to account for the largest share of immunoassay market followed by Europe. This owes primarily to the ongoing marketing of innovative diagnostic products associated with ongoing advances in the field of gene & immunoassay based products, the latest discovery of genetic biomarkers and their clinical significance in immunoassay testing, favorable government policies and their emphasis on the development of new products, and the significant expansion of target population.

Key manufacturers of immunoassay based kits in the U.S. include Abbott, Thermo Fisher Scientific Inc. and F. Hoffmann-La Roche Ltd, among others.

IMPACT ON SUPPLY

Due to the rising demand of immunoassay kits, it has been observed that falsified medical products are flourishing in the market. These fake testing kits render the life of a patient at stake. WHO has received several reports concerning falsified immunoassay kits and laboratory reagents for SARS-CoV-2 detection.

Further, the misuse, stockpiling, and price gouging lead to severe supply chain disruptions. This has increased the risk for healthcare facility with limited access to immunoassay kits during the care of COVID-19 patients. China being the epicenter of the pandemic became the key spot to disrupt the supply of goods.

STRATEGIC DECISIONS BY MANUFACTURERS

With the declining trend and inefficient management of the supply chain, government and manufacturers are taking initiatives to effectively manage the supply of immunoassay kits and make appropriate use of those products in healthcare settings. The capacity to expand reagent and immunoassay kit production is limited, resulting in unmet needs.

Collaboration, product launch, agreements, strategic initiatives by market players in immunoassay market such as Abbott, Bio-Rad Laboratories, Inc., DiaCarta and QIAGEN, among others will help them expand their product portfolio thereby leading to market expansion. This, in turn, will help increase demand for its product in the market thus increasing future sales.

For instance,

  • In May 2020, Thermo Fisher Scientific Inc. collaborated with WuXi Diagnostics and Mayo Clinic in order to develop a complete antibodies test for detection of Corona virus thereby expanding its response for COVID-19.
  • In April 2020, Abbott launched its third diagnostic test for the Coronavirus. The new antibody test launched by the company is a serology test which detects the IgG antibody to SARS-CoV-2 and the test is performed on Abbott's ARCHITECT i1000SR and i2000SR laboratory instruments, that can run up to 100-200 hour tests. As the organization has obtained FDA and CE Label Emergency Use Authorisation (EUA) in Europe, it has made the test available. This new diagnostic kit launched by the company aids in decreasing the increasing burden of testing by meeting the demand of the population to some extent.
  • In March 2020, Epitope Diagnostics, Inc. launched its immunoassay kits namely EDI Novel Coronavirus COVID-19 IgG ELISA Kit and EDI Novel Coronavirus COVID-19 IgM ELISA Kit for the qualitative detection of the COVID-19. This new product launched by the company increases its credibility in the market.

INITIATIVES FOR MEETING SUPPLY GAP BY ABBOTT

In June 2020, Abbott began supplying its laboratory-based serology blood test to detect the antibody, IgG (Immunoglobulin G) in patients suffering from COVID-19 in India, and distribution of antibody testing to leading government and private hospitals and laboratories in West Bengal, Delhi, Maharashtra, Jammu & Kashmir, Uttar Pradesh and Gujarat. This increased the company's stock of test kits enhances its market reputation.

CONCLUSION

The impact of the novel COVID-19 virus is expected to leave a long-lasting impact on each industrial sector. The outbreak of COVID-19 prompted citizens to deal with confusion regarding the virus and its management. The virus poses risk not just to human life but has caused economic distress and severe emotional strain. It produced a ripple effect that gave rise to a new collection of requirements and needs that were not needed earlier.

It has been observed through the vast spread and rising trends of Coronavirus cases each passing day that the novel Coronavirus or COVID-19 is expected to leave a significant impact on every aspect of life or market. The risk pose by the infectious disease is not restricted to health but to the dwindling economy also. The healthcare domain is under a huge pressure to deal with the unimaginably big situation of COVID-19. Moreover, the surge in patients with this infectious disease anticipates in driving the demand for immunoassay in the market.

The market of immunoassays has experienced the growth owing to increased demand of ELISA and lateral flow immunoassay tests per day along with the reagents used to perform these tests. The advancement in technology, favorable support provided by government and ease in regulations are also aiding in its growth across the globe.

The strategic initiatives taken by the key market players like Thermo Fischer Scientific Inc., and others in order to develop novel COVID-19 testing kits in order to expand their market is fueling the market growth. Hence, it can be concluded that immunoassay market is expected to show healthy grow and substantial future demand for the rapid diagnostic testing kits due to the ever-increasing number of patients suffering from Coronavirus.

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