Publish Date: April 6, 2020
Length: 83 Pages
(Last Updated 04/06/2020)
This market report is focused on a new, emerging global pandemic, the ongoing eruption of the coronavirus disease (COVID-19). The virus responsible for the disease is also known as severe acute respiratory syndrome coronavirus 2 and abbreviated as SARS-CoV-2. The eruption started in China on December 29, 2019, and by March 2020 it was reported that it had spread to several countries across the world.
In the final days of 2019, Chinese doctors identified a number of similar cases of pneumonia in the city of Wuhan in China. Wuhan is the capital city of Hubei Province in China accommodating 11 million inhabitants. Soon, it was discovered that the disease was caused by a new strain of virus which was named SARS-CoV-2.
The Latin word ‘corona’ means ‘crown’ since the virus looks like a crown under an electron microscope. The first cases of coronavirus infection outside of China were reported on January 13 in Thailand and January 16 in Japan. Since January 23, 2020, the Chinese government has placed Wuhan and other nearby cities on lockdown. However, the disease has now spread to at least 180 countries and territories worldwide.
COVID-19 Treatment Candidates
While there is not yet an approved treatment for COVID-19, the scientific, medical and regulatory communities are making heroic efforts to bring out new medicines. Dozens of treatment candidates are under development, including promising vaccines that are in use for similar conditions. Numerous COVID-19 product categories have emerged, including vaccines, antibodies, antivirals, repurposed drugs, RNA-based drugs, and cell-based therapies, as well as other approaches, such as enzymes, peptides and glycoproteins.
To accelerate the development of therapies against COVID-19, the repurposing of existing drugs is being given great attention. For example, Barcitinib is being explored because of its anti-inflammatory effect and possible ability to reduce viral entry. A specific dose of the anti-HIV combination, Lopinavir–Nitonavir, is now in clinical trials with Arbidol or Ribavirin. Remdesivir, developed by Gilead Sciences, was earlier tested in patients with Ebola virus and has shown promise in animal models for MERS and SARS. Remdesivir has reached Phase III in the U.S. and China. Favipiravir, a purine nucleoside leading to inaccurate viral RNA synthesis, was previously developed by Toyama Chemical of Japan, and has now been approved for a clinical trial as a drug for the treatment of COVID-19. Chloroquine has shown itself to be effective in treating COVID-19 in China.
This report explores COVID-19 product development categories in detail, presenting products under development and timelines for development.
COVID-19 Diagnostic Tests
New diagnostic tests for COVID-19 are emerging as an essential tool to track the spread of the disease, as the World Health Organization (WHO) is urging health agencies worldwide to make testing for the virus a top priority. On March 23, 2020, the FDA granted Cepheid’s Xpert® Xpress SARS-CoV-2 test “Emergency Use Authorization” (EUA). As an automated molecular test for the detection of the virus, it can provide results in less than 45 minutes.
Only days later, on March 27, 2020, the U.S. FDA approved an even faster test from Abbott Laboratories that can provide results in 13 minutes or less. Abbott’s ID NOW COVID-19 test also received “Emergency Use Authorization” (EUA). It leverages the company’s existing ID NOWTM platform, the most common point-of-care test in the U.S. that is used to detect other common viruses, such as Influenza A & B, Strep A and respiratory syncytial virus (RSV). It is being scaled to deliver 50,000 tests per day to the U.S. healthcare system.
On March 31, 2020, BD and BioMedomics announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The new test, developed and manufactured by BioMedomics, will be available through BD and distributed exclusively by Henry Schein, Inc. to health care providers throughout the U.S.
COVID-19 Publications and Patents
Thousands of scientific articles have been published electronically or in print since the outbreak of COVID-19 began in late 2019. The number of published articles has increased each week since the week of January 13, 2020. Thus, the COVID-19 outbreak represents one of the largest global scientific collaborations to occur in human history.
Patent activity around COVID-19 is surging, with most companies securing intellectual property (IP) related to the development of COVID-19 therapeutics. To a lesser degree, companies are securing IP around vaccines, diagnostic agents, and methods. This report reveals rates of COVID-19 scientific publications and presents a global breakdown of COVID-19 patent activity that includes patent type, sponsoring organization, and method of action.
The Race Toward a COVID-19 Vaccine
Dozens of companies are also rushing vaccine development and proceeding toward clinical trials.
As select examples, the U.S. NIH initiated a Phase 1 trial in Seattle evaluating an investigational vaccine (mRNA-1273) created by NIAID scientists and their collaborators at Moderna. Sanofi and Regeneron launched a Phase 2/3 trial in New York evaluating the IL-6 targeted Kevzara. Inovio Pharmaceuticals is progressing its vaccine into human trials within the U.S. and intends to produce one million doses by the end of the year. Other vaccines are also progressing through development.
Cell Therapy Companies Tackling Coronavirus
Globally, the healthcare industry is using every weapon in its armory to suppress the threat from the virus, including the use of living therapies such as natural killer (NK) cells, T-cells, stem cells and exosomes. While many novel approaches are being investigated, mesenchymal stem cells (MSCs) are showing intriguing potential for the treatment of COVID-19.
MSCs are receiving notable attention, because past studies have found the secretions from MSCs to be effective at treating inflammation and cytokine storms. From early-stage studies, it appears that MSC may exert beneficial effects, potentially by improving the lung microenvironment, inhibiting immune system over-activation, promoting tissue repair, protecting lung alveoli epithelial cells, preventing pulmonary fibrosis, or improving lung function.
In response to the global swell of COVID-19 cases which have surpassed 1 million worldwide, numerous cell therapy companies are exploring potential approaches to the treatment and prevention of COVID-19. For example, AlloVir, a T-cell immunotherapy company, is collaborating with Baylor College of Medicine to development of allogeneic, virus specific T-cell therapies to combat SARS-CoV-2, the virus that causes COVID-19.
Athersys is working to launch a pivotal trial of MultiStem®, its allogeneic “off-the-shelf” bone marrow-derived stem cell product for the treatment of COVID-19 induced acute respiratory distress syndrome (ARDS). The clinical program received a “Highly Relevant” designation for COVID-19 from the Biomedical Advanced Research and Development Authority (BARDA).
Aspire Health Science, LLC, has filed a pre-IND meeting request with the U.S. FDA and Pre-CTA (Clinical Trial Application) with Health Canada for a clinical study that would involve its product candidate, ACT-20.
CAR-T (Shanghai) Biotechnology Co., Ltd., has registered a clinical trial (NCT04302519) to evaluate the use of intravenously injected dental pulp MSCs for the treatment of COVID-19 induced severe pneumonia. The trial plans to enroll 24 patients.
Celltex Therapeutics is in contact with the FDA about a study involving autologous MSCs against COVID-19 induced pneumonia. The company has facilitated over 9,000 MSC therapies for various diseases without incurring any adverse events, including ARDS, inflammatory lung disease, influenza and viruses similar to COVID-19.
Celularity is evaluating the capacity of its cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells (CYNK-001) for the treatment and prevention of COVID-19 infections. Celularity has obtained IND clearance from the U.S. FDA to test CYNK-001 against COVID-19 in a trial that will enroll 100 patients.
Citius Pharmaceuticals signed an exclusive six-month option agreement to in-license a stem-cell therapy for the treatment of ARDS from a subsidiary of Novellus. The patented process uses non-immunogenic synthetic mRNA molecules to create iPSC-derived MSCs.
Cynata Therapeutics is exploring the capacity of its Cymerus™ platform to manufacture iPSC-derived MSCs for the treatment of COVID-19 patients with severe symptoms, including ARDS, sepsis and cytokine release syndrome.
Lattice Biologics is enrolling 10 patients for its Phase 1 clinical trial in Seattle. The trial will address the safety and efficacy of its stem cell technology, AmnioBoost, for the treatment of severe acute respiratory syndrome (SARS) related to COVID-19 infection.
Mesoblast’s Remestemcel-L has proven itself to be effective in treating advanced respiratory distress. On March 9, 2020, Mesoblast announced its plans to evaluate its allogeneic MSC product candidate Remestemcel-L in patients with ARDS caused by COVID-19 in the U.S., Australia, China and Europe.
Pluristem Therapeutics is exploring its PLX cell product candidate for treating respiratory and inflammatory complications caused by the novel Coronavirus infection. The company has dosed three patients in two different hospitals in Israel under a compassionate use program approved by the Israeli Ministry of Health.
ReeLabs is involved in fast tracking a clinical trial using MSCs to treat patients suffering from COVID-19 in conjunction with the Indian Health Ministry.
Tianhe Stem Cell Biotechnologies and its division in China (Jinan Tianhe Stem Cell Biotechnology Co., Ltd.) registered a clinical trial (NCT04299152) for evaluating its “Stem Cell Educator Therapy” against COVID-19.
Vitro Biopharma is positioning its scalable manufacturing platform to provide stem cell therapies for Coronavirus infections, working the government to present its its AlloRx™ stem cell therapy option.
Many other companies are also exploring the potential of living therapies to manage the global surge of Coronavirus infections.
Clinical Trials Against COVID-19
In the recent months, there has been a flurry of activity within the clinical trial sector. When all trial types are considered, there are over 400 studies exploring approaches to diagnosing, treating or preventing COVID-19.
Currently, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) report 29 trials leveraging stem cells against COVID-19. Interestingly, not all of the trials are being pursued. In recent weeks, five of the Chinese Clinical Trial Register (“ChiCTR”) trials and one of the ClinicalTrials.gov (“NCT”) trials have been marked as “Cancelled by the Investigator.” Interestingly, four of the six withdrawn trials were submitted by the same Chinese company, Guangzhou Reborn Health Management Consultation Co., LTD.
Thus, there are 23 active trials exploring the use of stem cells against COVID-19, nineteen of which involve MSCs.
COVID-19 Market Trends
The aim of this report is provide comprehensive coverage of the COVID-19 outbreak, identify global competitors involved in the fight against COVID-19, and present product development pipelines. It features diagnostic testing technologies, vaccine development programs, regulatory approvals, and importantly, trend rate data for COVID-19 scientific publications, patents, and clinical trials on a worldwide basis. With the rapidly developing nature of this global pandemic, claim this global strategic report to become informed about COVID-19 market dynamics and position your company for success during this unprecedented time.
This market report features:
- Worldwide Health Statistics, including Velocity of Disease Progression, Global Case and Death Counts, and Testing Rates by Region
- Volumes and Types of COVID-19 Testing – Traditional vs. Rapid Testing (Abbott, Cepheid)
- Number of Tests per Country/Geography
- Number of Tests per Million per County
- Case Fatality Rate (CFR) Data
- Emerging Treatments for COVID-19, including Antibodies, Antivirals, Vaccines, RNA-based Treatments, Cell Therapies, Other Approaches
- Existing Drugs with Potential Applications for COVID-19
- Market Competitors Developing COVID-19 Vaccines
- Vaccine Development Timelines
- Analysis of the Worldwide Clinical Trial Landscape—All approaches, including Vaccines, Drugs, and Cell Therapies
- Rates and Volume of Scientific Publications about COVID-19
- Global Patent Analysis for COVID-19
- Analysis of Stem Cell Clinical Trials Against COVID-19—Total Trials, Dominance of MSC Trials, and Active vs. Withdrawn Trials
- Cell Therapy Companies Developing Novel Approaches Against COVID-19
- Coverage of Market Competitors Involved with COVID-19 Treatment Technologies
- And Much More
Table of Content: Coronavirus (COVID-19)—Global Market Conditions, Vaccines, Trials & Potential Treatments
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