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COVID-19

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Published Date : Jun 2023
Category : Infectious Diseases
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Uncovering the Science of COVID-19

The Complete Overview of Diagnostic and Treatment Market Players

Coronavirus (COVID-19) is a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 has affected the world, resulting in more than 6 million deaths worldwide. After the first cases of COVID-19 were reported in Wuhan, Hubei Province, China, in late December 2019, SARS-CoV-2 rapidly dispersed worldwide. For this reason, on March 11, 2020, the World Health Organization (WHO) declared it to be a global pandemic. According to NCBI with over 375,000 deaths, COVID-19 ranked as the third most common cause of death in the United States (USA) in 2020, following cancer and heart disease.

Coronaviruses are positive-sense single-stranded RNA (+ssRNA) viruses with a crown-like appearance under an electron microscope due to the presence of spike glycoproteins on the envelope. There are 4 generations of coronavirus - Alphacoronavirus (alphaCoV), Betacoronavirus (betaCoV), Deltacoronavirus (deltaCoV), and Gammacoronavirus (gammaCoV).

BetaCoV genus is further divided into 5 sub-generations. Genomic characterization has shown that the sources of alphaCoVs and betaCoVs are bats and rodents. For deltaCoVs and gammaCoVs avian species are the source. CoVs have become major pathogens of emerging respiratory disease outbreaks. These viruses are capable of infecting humans crossing species boundaries. There are seven known human CoVs (HCoVs) that infect humans. According to the National Center for Biotechnology Information (NCBI), about 5% to 10% of acute respiratory infections are caused by CoVs, out of which 2% is a healthy population.

Common human CoVs: In immunocompetent people, SARS-CoV-2 symptoms are upper respiratory tract infections and the common cold. However, these viruses cause lower respiratory tract infections in elderly and immunosuppressed patients. Other human CoVs: These viruses are more virulent and spread epidemics that manifest as respiratory and extra-respiratory illnesses with varying clinical severity.

The primary ways of SARS-CoV-2 transmission are direct contact with presymptomatic, asymptomatic, or symptomatic carriers of the virus or exposure to respiratory droplets carrying it from close contact. All ages of individuals are at risk of contracting this virus. Patients under 60 and those with underlying medical conditions (such as obesity, cardiovascular disease, chronic kidney disease, diabetes, chronic lung disease, smoking, cancer, solid organ transplant recipients, or recipients of hematopoietic stem cell transplants) are at higher risk of developing severe COVID-19 infection along with Long COVID symptoms.

Data from NCBI suggests that male patients have a higher risk of severe illness and increased mortality due to COVID-19 compared to female patients. A study of the mortality rate in 209 acute care hospitals in the United States of America (USA) from March 1 to November 21, 2020, which included 42K patients with confirmed SARS-CoV-2 infection, revealed that male patients had a higher mortality rate of 12.5% than female patients that is 9.6%.

According to NCBI and in the report from the Chinese Center for Disease Control and Prevention, the overall Case fatality rate (CFR) was 2.3% (1023 deaths among 44672 confirmed cases). The CFR was higher in Italy at 7.2% compared with China. The higher rate of infections among the elderly (≥ 70 years) population is the reason for the high CFR rate in Italy. The age-specific CFR in the age groups below 70 years were similar between China and Italy. But the CFR was higher in Italy (12.8% and 20.2%, respectively) than China (8% and 14.8%, respectively) in age groups between 70 to 79 years and ≥ 80 years. In the Italian cohort, 687 patients were ≥ 90 years old, and in them, the CFR was 22%.38.

Understanding the frequency, symptoms, and causes of COVID-19 infection is critical for public health programs, patient education, and improving global outcomes. The high prevalence of respiratory infection is likely to boost the growth of the worldwide COVID-19 market.

Major stakeholders in the healthcare and pharmaceutical sectors have been actively trying to alleviate the burden of COVID-19 in the face of this health crisis. Pharmaceutical firms, medical device makers, and healthcare services are among the market leaders. They are involved in a variety of initiatives aimed at COVID-19 prevention, detection, and treatment in novel ways.

DiseaseLandscape Insights assists industry participants by offering extensive knowledge about all current market players, their inventions, tactics, and partnerships, as well as assisting in the selection of the appropriate marketplace to develop exponentially and work for improved health outcomes.

Diagnostic Analysis of SARS-COVID-19:

Critical evidence for the diagnosis is a history of exposure or close contact with individuals who are either suspected or confirmed. However, clinical characteristics and imaging appearances indicate possible COVID-19 in people with an unknown history. Then, as a reference standard COVID-19 testing, the real-time reverse-transcription-polymerase-chain-reaction (RT-PCR) test must be performed in these conditions.

The diagnostic tests are:

  • Laboratory Testing:

The three main types of SARS-CoV-2 tests are Nucleic acid tests (NATs), which detect SARS-CoV-2 viral RNA, COVID-19 Rapid antigen tests (RATS), which detect antigen viral proteins from SARS-CoV-2 and Serology tests, which detect IgM and/or IgG antibodies against SARS-CoV-2.

The TGA advises that if COVID-19 is still suspected after a negative test result, repeat testing using a different test (with different genetic targets) should be considered along with clinical observations, the patient's history, and epidemiological data.

Various laboratory tests are done to detect COVID-19, including a CRP test. Normally, the CRP level in blood is less than 5 mg/L but in COVID-19 CRP level is significantly elevated on average of 20 to 50 mg/L.

A decreased WBC count, lymphopenia (lower lymphocytes), or thrombocytopenia (low blood platelet count) with an elevated activated thromboplastin time were present in almost half of the COVID-19-infected people. Procalcitonin (PCT) concentrations were normal, but most patients had elevated C-reactive protein (CRP) levels.

 

  • Imaging Tests:

Fast and accurate diagnosis of COVID-19 is possible with a chest X-ray (CXR) and computed tomography (CT) scan.

Radiological evaluations, mostly thin slice chest computed tomography (CT) scans, have a critical role in the diagnosis, management, and follow-up of COVID-19 infections. CT scans are proposed in cases with suspicious lung abnormalities. CT scan assists in recognizing the initial phase of respiratory infection and provides an opportunity for a quick public health care response.

Comparing CT scans and CXR images, CT scans have shown better performance in detecting positive cases.

 

  • Antigen test:

The antigen test is done using a long COVID-19 nasal swab to get a fluid sample that detects certain proteins in the virus, some antigen tests produce results in minutes. Others were sent to a lab for analysis. When instructions are carefully followed a positive antigen test result is considered accurate. But there's an increased chance of false-negative results like it's possible to be infected with the virus but have a negative result. The healthcare provider recommends an RT-PCR test to confirm a negative antigen test result, depending on the situation.

 

  • Real Time-PCR Test:

 The standard diagnostic test includes a nasopharyngeal swab for SARS-CoV-19 nucleic acid using a real-time PCR assay. Commercial PCR assays have been authorized by the USFDA for the qualitative detection of theSARS-CoV-19 virus using specimens obtained from nasopharyngeal swabs as well as other sites such as oropharyngeal, anterior/mid-turbinate nasal swabs, nasopharyngeal aspirates, and saliva. The adequacy of the specimen, the amount of time after exposure, and the source of the material are some of the variables that affect PCR testing's sensitivity. However, providing there is no cross-contamination during specimen processing, most commercial SARS-CoV-19 PCR tests with FDA authorization have a nearly 100% specificity rate. SARS-CoV19 antigen assays are less sensitive than molecular PCR testing, although they are completed more quickly.

The excellent specificity, sensitivity, and speed of amplification of RT-PCR and CT scan tests have contributed to the rise of the COVID-19 diagnostic industry. The other diagnostic tests like laboratory tests and imagining tests for COVID-19 have been challenged by RT-PCR. However, it has been reported that the sensitivity of chest CT scans is superior, which is ~98% to that of RT-PCR is 71%.

DiseaseLandscape Insights provides data on current market participants and their products to gain a better knowledge of market dynamics, and it also helps industry leaders with the development of different COVID-19 testing guidelines, diagnostic kits, and the use of new technologies to improve current diagnostic procedures. Through improved COVID-19 diagnosis, DLI services help businesses stay competitive, manage the industry's complicated obligations, and improve public health.

Treatment Market Players of SARS COVID-19

Kits

Manufacturer

Allplex 2019‐nCoV assay

See gene

Patho Detect RT‐PCR kit

Mylab

FOSUN COVID‐19 RT‐ PCR Kit

Fosun

TRUPCR SARS‐CoV‐2 RT‐qPCR kit

Black Biotech

TaqPath COVID‐19 Combo Kit

Thermo Fisher Scientific

Lab Gun Real‐Time PCR Kit

Lab Genomics

Real‐Time Fluorescent RT‐PCR Kit for 2019‐ nCoV

BGI Genomics

 

Treatment Analysis of SARS-COVID-19:

Most COVID-19 patients have mild illnesses and recover at home. To feel better, the patient is treated with over-the-counter medications like Acetaminophen or Ibuprofen. Various SARS-CoV-2 treatment options are available that reduce the chances of being hospitalized or dying from the disease. Medications to treat COVID-19 must be prescribed by a healthcare provider or pharmacist and started 5–7 days after SARS-CoV-2 variants and symptoms appear.

People who are more likely to get very sick are older adults (ages 50 years or older), people who are unvaccinated, and people with certain medical conditions, such as chronic lung disease, heart disease, or a weakened immune system.

Antibiotics

The only antiviral drug approved by the US Food and Drug Administration (FDA) to treat COVID-19 is Remdesivir, which is more effective for COVID-19 treatment. There are Emergency Use Authorizations (EUAs) for Ritonavir-boosted Nirmatrelvir, Molnupiravir, and high-titer COVID-19 convalescent plasma to treat COVID-19. EUAs have been granted for the use of Ixagevimab and Cilgavimab, two monoclonal antibodies, as SARS-CoV-2 preexposure prophylaxis (PrEP) in certain patients.

Vaccine

Vaccination for SARS-CoV-2 is indicated for the prevention of coronavirus, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus.

On 11 December 2020, an emergency use authorization (EUA) was granted by the US Food and Drug Administration (FDA) to the BNT162b2 vaccine to prevent COVID-19 illness. After that, on 18 December 2020 the second vaccine, mRNA-1273 SARS-CoV-2, was granted emergency use authorization. Both mRNA vaccines are designated for active immunization to prevent COVID-19 caused by SARS-CoV-2. On 27 February 2021, the third COVID-19 vaccine to receive EUA in the United States was the Ad26.COV2. S. The EUA was later revised and limited its use to people 18 years and above who are unable to access the approved COVID-19 vaccines or those choosing to receive the Ad26.COV2. S vaccination. On 13 July 2022, the fourth vaccination to receive EUA was the NVX-CoV2373 vaccine for COVID-19 vaccine effectiveness.

The FDA approved its first COVID-19 vaccine on 23 August 2021 BNT162b2 - COVID-19 Vaccine, mRNA for individuals 12 years and above. The second approval was given on January 31, 2022, to the mRNA-1273 - COVID-19 Vaccine, mRNA in individuals 18 years and above.

According to WHO, globally as of October 2023, there have been 771,549,718 confirmed cases of COVID-19, including 6,974,473 deaths. As of 15 October 2023, a total of 13,516,459,649 vaccine doses have been administered. The total doses of vaccines administered per 100 population is 173.41, and about 66.12% of people are vaccinated with a complete primary series. Persons vaccinated with at least one booster or additional dose is 31.74%.

Some people have no COVID-19 vaccine side effects. Many have reported side effects like headache, fatigue, and soreness at the injection site that are generally mild to moderate and get away within a few days.

There are several opportunities for business entities in the COVID-19 treatment SARS-CoV-2 research industry. Participants in the market focus on the production of various cost-effective therapeutic goods, as well as the redevelopment of current medicines and vaccines via the application of new technologies to enhance patient health while increasing business profit. COVID-19 vaccine distribution is worldwide for COVID-19 vaccine availability which provides an opportunity for vaccine market players.

DiseaseLandscape Insights conducts extensive research on the COVID-19 treatment guidelines to keep clients one step ahead of the competition. DLI provides information about options for therapy, new drugs, and treatments, as well as goods and services. DLI also performs thorough studies on competitors in the treatment sector and creates unique treatment options for improved patient health.

The worldwide COVID-19 market is extremely competitive and continuously growing. The market leaders listed below are redefining the domain and pushing innovations in the search for better health outcomes and their advanced product names.

Antibiotics Market Players

Vaccines Market Players

Products

Manufacturer

Products

Manufacturer

Veklury®

Gilead Sciences

Comirnaty

Pfizer

Paxlovid

Pfizer

Janssen

Johnson &Johnson

Fabiflu

Glenmark

Covaxin

Bharat Biotech

Cipremi

Cipla

Coronavac

Sinovac

Covifor

Hetero

Covishield

Serum Institute of India

 

Market Trend Analysis:

Researchers found that people who received the primary COVID-19 vaccine or an additional booster dose while pregnant produced protective antibodies against SARS-CoV-2 in both their blood and the umbilical cord blood, indicating that the protective antibodies reached the fetus. This research is completed by the National Institute of Allergy and Infectious Diseases (NIAID).

 

Researchers found that SARS-CoV-2 causes lasting damage to the energy production of mitochondria in many organs of the body, in study supported by the NIAID.SARS-CoV-2, the virus that causes COVID-19, damages the lungs, heart, brain, kidneys, and blood vessels. The main source of this damage is inflammation. As it became clear that parts of the virus bind to proteins in the mitochondria that parts of the cell that produce most cellular energy, researchers realized that compromised mitochondria may also play a role in organ damage from SARS-CoV-2 infection.

 

NIAID, part of the National Institutes of Health explains the reason behind young children having lower rates of severe COVID-19 than adults. A study of SARS-CoV-2 and children found those who acquired SARS-CoV-2 had a strong, sustained antibody response to the virus and high levels of inflammatory proteins in the nose but not in the blood. This immune response contrasts in adults with SARS-CoV-2 infection.

 

The significance of new diagnosis and treatment market developments and studies on vaccines and medications is growing gradually. This increases the effectiveness of currently accessible medications and discovers fresh therapeutic targets for potential future research.

DLI's services make it easier for market players to conduct clinical studies for new drugs and treatments. It also helps with other tasks including patient care, diagnosis, and treatment. DLI also gives industry participants comprehensive information about rivals in the market, market expansion, and new laws and regulations worldwide.

 

Regulatory Framework for SARS Covid19:

DiseaseLandscape Insights (DLI) has greatly reduced the regulatory framework for significant players in the COVID-19 landscape. DLI helps the stakeholders understand government initiatives for the market review of various SARS-CoV-2 variants and vaccines.

In June 2023, the Therapeutic Goods Administration (TGA) undertook a post-market review of all point-of-care (POC) and laboratory tests to identify individuals with COVID-19. The review verified that these tests could accurately detect emerging genetic variants of the SARS-CoV-2 virus.

Since the beginning of the pandemic, several SARS-CoV-2 variations have been emerging and spreading around the world. The World Health Organization (WHO) and the Communicable Diseases Genomics Network (CDGN) are responsible for maintaining the nomenclature system and a list of the variations. The variants are classified as variants of concern (VOC), variants of interest (VOI), variants under monitoring (VUM), and formerly monitored variants (FMV).

The WHO revised its definitions of SARS-CoV-2 variations on March 15, 2023, to manage Omicron sublineages separately rather than categorizing them altogether as a single Omicron VOC. All the present VOIs and VUMs are Omicron sublineages, and it has been discovered that they all have the same coronavirus mutations and phenotypes.

Clinical Trials Assessment:

The government's heightened emphasis on evaluating the effectiveness of studies highlights the crucial function that clinical trials provide in the practice of evidence-based medicine and health care reform. One of the main goals of healthcare reform is achieved when medical therapy is carefully assessed by market participants utilizing clinical data.

The names of the ongoing clinical trial studies and the stages they are in are shown in the table below:

Phase 1

Phase 2

Phase 3

Phase 4

A Phase 1/2, Randomized Double-blind Placebo-Controlled Trial to Test the Safety and Antiviral Activity of ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)

Phase II Study to Evaluate Immunogenicity and Safety in Subjects with Evidence of Prior Immunity to SARS-CoV-2 of a Single Intramuscular or Intranasal Dose of the Live Recombinant Newcastle Disease Virus Based AVX/COVID-12 Vaccine

Prospective, Randomised, Double-blind Trial of Icatibant Compared to Placebo in Patients with Early Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection

Randomized, Controlled, Double-Blind Proof of Concept Trial Assessing the Efficacy and Safety of BioBlock® Intranasally Administered Virus-Neutralizing Bovine Colostrum Nasal Spray in Preventing of COVID-19 Infection in Healthy Volunteer Individuals

Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID-19

Phase 1/2, Randomized Double-blind Placebo-Controlled Trial to Test the Safety and Antiviral Activity of ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)

Multicenter, Adaptive, Randomized, Placebo-controlled, Double-Blind, Parallel-group Phase 2/3 Trial, to Study Efficacy and Safety of Two Doses of Raloxifene in Adult Paucisymptomatic COVID-19 Patients.

Investigating the Therapeutic Role of Topical Medical Treatment in Oral and Nasal Cavities on Patients with Positive Severe Cute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS

Prospective, Randomised, Double-blind Trial of Icatibant Compared to Placebo in Patients with Early Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection

A Multi-Part, Phase 3, Randomized, Observer Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adults Previously Vaccinated with Other COVID-19 Vaccines

A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19

A Phase I/IIa Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers

A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 Infection in Immunocompromised Individuals with Impaired SARS-CoV-2 Humoral Immunity

A Randomized Controlled Study to Assess SARS CoV-2 Infection, Viral Shedding, and Subsequent Potential Transmission in Individuals Immunized with Moderna COVID-19 Vaccine

mRNA Vaccination to Boost Antibodies Against SARS-CoV-2 in Recipients of Inactivated Vaccines (the "mBoost" Study)

A Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

Multicenter, Adaptive, Randomized, Placebo-controlled, Double-Blind, Parallel-group Phase 2/3 Trial, to Study Efficacy and Safety of Two Doses of Raloxifene in Adult Paucisymptomatic COVID-19 Patients.

Open-Label Phase 2/3 Clinical Study to Investigate Safety and Immunogenicity of a Single VLA2001 Booster Vaccination in Adult Volunteers, After Receipt of Nationally Rolled Out mRNA COVID-19 Vaccines and/or Natural SARS-CoV-2 Infection

SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine

COVID-19: A Phase I Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of Anti-SARS-CoV-2 Monoclonal Antibody MAD0004J08 in Healthy Adults.

SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS

A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2

Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection

 

Conclusion:

For SARS-COVID-19-specific diagnostics and treatments, there are many market scenarios in various nations and areas. Governments have made a variety of investments and established institutes in the field of SARS-COVID-19 detection and treatment due to the impact of SARS-COVID-19 and the challenges associated with the economic feasibility of treating SARS-COVID-19.

Disease Landscape Insights (DLI) assists in locating the target market, directing marketing strategies, and informing market players of new trends. By conducting thorough market research, DiseaseLandscape Insights assists manufacturers in creating and implementing efficient medications to stop and control the SARS-COVID-19 pandemic.

The strategic knowledge needed to launch and run a healthcare firm is provided by DLI's thorough market analyses, which also help industry participants make wise and profitable business choices.

SUMMARY
VishalSawant
Vishal SawantBusiness Development
vishal@diseaselandscape.com

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