Covid-19 Impact on In-Vitro Diagnostics in the Healthcare Industry

The coronavirus (COVID-19) pandemic is having a dramatic impact on the in-vitro diagnostics (IVD) including technologies such as PCR, NGS, ELISA, clinical chemistry, rapid-tests, hematology, hemostasis, urinalysis, microbiology testing, and others. Currently, in-vitro diagnostic is the only diagnosis used by the healthcare professionals in order to detect the spread of corona virus across the globe. 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 and China among more in order to decrease its spread. The lockdown of countries aids in surging of use of diagnostic kits in order to screen patients suffering from coronavirus. According to the situation, the report of 4th June 2020 by WHO stated 6,416,828 cases of corona has been reported globally and 382,867 patients are dead due to the coronavirus.

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IMPACT ON DEMAND

Exponential rise in cases of corona virus across the globe is increasing the demand of in-vitro diagnostic kits. The factors responsible for the rise in demand of IVD includes increased market demand for PCR, NGS, serology-based rapid-test products, a supportive regulatory environment for product development and marketing along with sharp increase in target patient population. Due to these factors, various market players have been prompted to improve and strengthen their current production and distribution capabilities and to focus on upgradation and marketing of their product.

A RT-PCR based assay is the common method used to diagnose patients with COVID-19. The pandemic has led to significant rise in demands for reagents used in RT-PCR in the recent months, leading to shortages in reagents required to perform the key steps in the testing process such as RNA extraction kits.

Manufacturers of in-vitro diagnosis (IVD) have taken huge initiatives to increase patient access to diagnostic testing for coronavirus in hospitals, laboratories, and other test sites across globe to guide patient care and protect public health.

The companies listed below developed IVDs that gained Emergency Use Authorization from the U.S. FDA:

Molecular Diagnostic Tests for Detection of COVID-19
Abbott : Abbott RealTime Sars-CoV-2 assay; ID NOW COVID-19; Alinity m SARS-CoV-2 assay
altona Diagnostics GmbH : RealStar SARS-CoV02 RT-PCR Kits U.S.
Rhenonix : Rheonix COVID-19 MDx Assay
F. Hoffmann-La Roche Ltd : Cobas SARS-CoV-2
Shengxiang Biotechnology Co., Ltd. : Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
ScienCell Research Laboratories, Inc. : ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
SEASUNBIOMATERIALS : U-TOP COVID-19 Detection Kit; AQ-TOP COVID-19 Rapid Detection Kit
Seegene Inc. : Allplex 2019-nCoV Assay
Applied DNA Sciences : Linea COVID-19 Assay Kit
AtilaBiosystems : iAMP COVID-19 Detection Kit
BD : BioGX SARS-CoV-2 Reagents for BD MAX System; BD SARS-CoV-2 Reagents for BD MAX System
Primerdesign Ltd : COVID-19 genesig Real-Time PCR assay
QIAGEN : QIAstat-Dx Respiratory SARS-CoV-2 Panel
Quidel : Lyra SARS-CoV-2 Assay; Lyra Direct SARS-CoV-2 Assay
SD Biosensor, INC. : STANDARD M nCoV Real-Time Detection Kit
Sherlock BioSciences : Sherlock CRISPR SARS-Cov-2 Kit
SolGent Co., Ltd.. : DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
Thermo Fisher Scientific Inc. : TaqPath COVID-19 Combo Kit
Trax Management Services Inc. : PhoenixDx 2019-CoV
Zymo Research : Quick SARS-CoV-2rRT-PCR Kit
BGI : Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV
Biocore company : BioCore 2019-nCoV Real Time PCR Kit
BioFire Defense : Bio Fire COVID-19 Test
BioFire Diagnostics : BioFire Respiratory Panel 2.1 (RP2.1)
bioMérieux SA : SARS-COV-2 R-GENE
Bio-Rad Laboratories Inc. : Bio-Rad SARS-CoV-2 ddPCR Test
Cepheid : Xpert Xpress Sars-CoV-2
Co-Diagnostics, Inc : Logix Smart Coronavirus Disease 2019 (COVID-19) Kit
DiaCarta : QuantiVirus SARS-CoV-2 Test Kit
DiaSorin Molecular LLC : SimplexaCOVID-19 Direct Kit
SpectronRx : Hymon SARS-CoV-2 Test Kit
Fast Track Diagnostics Luxembourg S.à r.l. : FTD SARS-CoV-2
Fosun Pharma USA : Fosun COVID-19 RT-PCR Detection Kit
GeneMatrix, LLC : NeoPlex COVID-19 Detection Kit
GenMark Diagnostics, Inc. : ePlex SARS-CoV-2 Test
GenoSensor Corporation : GS COVID-19 RT-PCR KIT
Gnomegen LLC : Gnomegen COVID-19 RT-Digital PCR Detection Kit; Gnomegen COVID-19-RT-qPCR Detection Kit
Hologic Inc. : Panther Fusion SARS-CoV-2 Test; Aptima SARS-CoV-2 assay
InBios International, Inc. USA : Smart Detect SARS-CoV-2 rRT-PCR Kit
LABGENOMICS. : LabGun COVID-19 RT-PCR Kit
Luminex Corporation : NxTAG CoV Extended Panel Assay; ARIES SARS-CoV-2 Assay
Maccura Biotechnology Co. : SARS-Cov-2 Fluorescent PCR Kit
Mesa Biotech : Accula SARS-Cov-2 Test
NeuMoDx Molecular : NeuMoDx SARS-CoV-2 Assay
IDEXX Laboratories, Inc. : OPTI SARS-CoV-2 RT PCR Test
OSANG Healthcare : GeneFinder COVID-19 Plus RealAmp Kit
PerkinElmer Inc. : Coronavirus Nucleic Acid Detection Kit

Serology Tests or Blood Based Test for Detection of COVID-19

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)

The EUL procedure was developed to accelerate the availability of the required IVDs in emergency situations in public health. It was aimed to aid interested procurement agencies and member states in the appropriateness of using a specific IVD, based on a limited set of data available on quality, safety and performance.

The IVDs eligible to be submitted for EUL includes -

Assays for the detection of SARS-CoV-2 nucleic acid
Rapid diagnostic tests for the detection of IgM/IgG to SARS-CoV-2

For instance,

In May 2020, Thermo Fisher Scientific Inc.’s Applied Biosystems TaqPath COVID-19 Combo Kit was initially granted EUA on March 13th and subsequently expanded on April 20th, is designed to deliver results of the test within four hours of a sample collection and processed by a CLIA high-complexity laboratory.

In the first half of 2020 (H1), the U.S. is anticipated to account for the largest share of in-vitro diagnostics industry 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 IVD 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 for in-vitro diagnostic (IVD) 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 in-vitro diagnostics (IVDs) and laboratory reagents for SARS-CoV-2 detection. Further, the misuse, stockpiling, and price gouging leads to severe supply chain disruptions. This has increased the risk for healthcare facilities with limited access to IVD 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, the government and manufacturers are taking initiatives to effectively manage the supply of in-vitro diagnostic kits and make appropriate use of those products in healthcare settings. The capacity to expand reagent and IVD kit production are limited, resulting in unmet needs.

Collaboration, agreements, strategic initiatives by market players in IVD diagnostic markets such as Abbott, Bio-Rad Laboratories, Inc., DiaCarta, QIAGEN among more 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.

Initiative for Meeting Supply Gap by Abbott:

In May 2020, Abbott has shipped nearly 2.5 million of their rapid ID NOW tests to all 50 states, including Washington DC, Puerto Rico and the Pacific Islands.
It manufactures 50,000 tests per day and planning to further increase the manufacturing capacity of ID NOW to 2 million tests a month by June.
CONCLUSION

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 the dwindling economy also. The healthcare domain is under 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 in-vitro diagnostics (IVD) in the market.

The market of in-vitro diagnostic has experienced growth owing to increased demand for nucleic acid amplification tests per day along with the reagents used to perform these tests. The advancement in technology, favorable support provided by the government, and ease in regulations are also aiding in its growth across the globe. The strategic initiatives are taken by the key market players such as Thermo Fischer Scientific Inc., and others to develop novel COVID testing kits to expand their market is fueling the market growth. Hence, it can be concluded that the in-vitro diagnostics (IVD) market is expected to show healthy growth 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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