COVID-19 Diagnostics Market

Worldwide Battle Prevails against Mutated Variants of Novel Coronavirus

The COVID-19 Diagnostics Market  is valued at USD 4.6  Bn in 2026 and is projected to reach USD 6.69  Bn,  growing at a CAGR of 6% by 2033. COVID-19 has been casting a devastating impact on every industry. Even after a year of its first appearance, populous countries like India, and Brazil are still struggling with the containment of the viral outbreak. Healthcare infrastructure has almost kneeled down in developed as well as emerging economies as the world continues to witness an acute spike in COVID-19 cases. Despite the beginning of vaccination programmes in several parts of the world, the pressure of multiple mutated variants of the novel coronavirus prevails.

The battle against SARS-CoV-2 has entered the next phase characterised by an even greater spreading and damaging capabilities of the virus. COVID-19 diagnostics has been playing a pivotal role since the beginning of the pandemic and the World Health Organization (WHO) has prioritised COVID-19 testing since the pandemic has been declared. The demand for molecular diagnostic tests in North America and Europe witnessed almost 20-fold expansion during March to September in 2020.

COVID-19 Diagnostic Tools Record Remarkable Consumption as Number of Cases Continues to Rise

On 23^rd April, 2021, the global 7-day average cases recorded were ~0.8 Mn, which was the highest ever since the COVID-19 pandemic breakout. There are roughly 148 million cases of coronavirus infections worldwide, with ~ 3.13 Mn deaths as of April, 2021 and still counting. Similarly, high positive percentage (~20%) 7-day average has been recorded in India out of the total number of tests (~1.63 Mn) occurred. These numbers are alarming amid mass vaccination programmes worldwide. The demand for COVID-19 screening kits is thus witnessing a sudden spike (as of the month of April) and will keep the momentum for a while.

Uncertainty hovering over the availability of any appropriate disease cure treatment regimen further adds to the woes of the already stressed-out healthcare industry. So far, the proven methods of response are accelerating testing and contributing towards curtailing the community spread through isolation centers. However, the lack of sufficient training provided to medical professionals regarding handling of the COVID-19 testing kits remains the key impediment facing the market for COVID-19 diagnostics.

COVID-19 Diagnostics Market Grows Strong, with Regulatory Push for Screening Methods

The US Food and Drug Administration (FDA) has cleared around 189 different diagnostic tests for the testing of novel coronavirus SARS-CoV-2 to date. Also, many are in different phases of development cycle. Still, it is said to be not enough to mitigate the global pandemic situation. In the month of April (2021), FDA re-issued the Emergency Use Authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit. This is the first of its kind clearance for a diagnostic test with a home collection option for COVID-19.

COVID-19 Screening Methods Taking a Big Leap Forward amid Technological Advancements and Government Spending

Research institutes have been investing innovative efforts in pursuit of a novel point-of-care (POC) product for COVID-19 diagnosis. One such initiative from the University of Connecticut Health Centre to develop an All-in-one dual assay based on CRISPR-Cas12a (AIOD-CRISPR) for detection of SARS-CoV-2 in minutes. There are technological advancements towards integration of advanced information technologies like Artificial Intelligence (AI) and Mach in Learning with COVID-19 testing methods.

Strong healthcare expenditure and funding by public as well as private agencies are expected to boost the development of COVID-19 diagnostics, thereby driving the market. With swelling patient population around the world and meagre chances of the world discovering any specific and effective treatment options anytime soon, the role of diagnostics will be of paramount importance. In addition, integration of novel technologies and software solutions is expected to open new avenues for market expansion.

Market Potential of Asia Pacific High; Strengthens Further amid Second Wave in India

Europe and North America are leading the pack on account of high spread levels, coupled with increased spending by governments and regulatory authorities towards the management of COVID-19 outbreak. This has in turn resulted in accelerated clearances to diagnostic products. The US has performed ~409.41 million tests as reported in Our World in Data. Globally, ~232.7 billion tests have been conducted as of April 2021.

The market in Asia Pacific is expected to exhibit robust growth during the forecast period. Testing has been aggressively pursued by populous countries like India and China. India is ramping up its diagnostic capabilities by setting up 2,458 testing labs across the country, with half of these being government labs. RT-PCR tests alone are being conducted across 1,419 labs. In developing economies such as India, the testing capacity has seen more than 1000-fold expansion over the past year.

While all this is afoot in order to achieve containment of the viral outbreak and manage the pandemic on a global level, the operational, financial, and regulatory support of governments and healthcare entities would be highly instrumental to speed up efforts. As the pandemic continues to gather force, the demand for testing soars to its peak – not only faster but also of the larger volumes.

Market Players are Witnessing Unprecedented Incremental Opportunity amid Pandemic

Thermo Fisher Scientific, a top producer of laboratory hardware, diagnostic test kits, and supplies collected revenues worth $2 Bn in coronavirus-related areas; fuelling a 36% year-over-year increase in its overall sales during Q3 2020. Roche Diagnostics has reported 28% sales growth in Q4 2020, continuing the momentum it built up earlier in the year as COVID-19 products. Meanwhile, Abbott Laboratories reported COVID-19 testing sales worth of $2.2 Bn for Q1 2021, with $1.8 Bn in sales from Abbott's Panbio, BinaxNow, and ID Now rapid tests. A number of regional entrants are also providing efficient COVID-19 diagnostic solutions; for instance, Mylab Discovery Solutions (India) received approval for its Mylab PathoDetect COVID-19 qualitative PCR kit in March 2020.

Some of the key players operating in COVID-19 diagnostics market include 

• Abbott Laboratories
• Thermo Fisher Scientific Inc.
• Roche Diagnostics (F. Hoffmann-La Roche Ltd.)
• Siemens Healthineers AG
• Danaher Corporation (including Beckman Coulter)
• Bio-Rad Laboratories, Inc.
• QuidelOrtho Corporation
• Becton, Dickinson and Company (BD)
• PerkinElmer, Inc.
• Hologic, Inc.
• Cepheid (Danaher Group)
• Mesa Biotech (now part of Thermo Fisher)
• Abbott Rapid Diagnostics (Alere)
• Seegene, Inc.
• Meridian Bioscience, Inc.

Global COVID-19 Diagnostics Market Segmnetation

By Product

• Instruments
• Reagents & Kits

By Technology

• Polymerase Chain Reaction (PCR)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Lateral Flow Immunoassay (LFIA)
• Others

By Sample Type

• Oropharyngeal & Nasopharyngeal Swabs
• Nasal Swabs
• Blood

By Setting

• Lab-based
• Point of Care

By End-user

• Hospitals & Clinics
• Laboratories & Diagnostic Centers
• Home Testing
• Others

By Geography

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa