This market report is focused on a new, emerging global pandemic, the ongoing eruption of the coronavirus disease (COVID-19). 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 placed Wuhan and other nearby cities on lockdown. However, the disease has now spread to at least 180 countries and territories worldwide.
While there is not yet an approved treatment for COVID-19, the scientific, medical and regulatory agencies are making heroic efforts to bring out new medicines. 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. This report explores each of these product development categories in detail, presenting all known diagnostics, treatments and vaccines under development, the companies developing them, and the timelines for them to reach the market.
New diagnostic tests for COVID-19 are emerging as an essential tool to track the spread of the disease, because the World Health Organization (WHO) is urging health agencies worldwide to make testing for the virus a top priority. Thus far, 41 laboratory tests authorized by regulators are available to identify the virus that causes COVID-19. Of these, 20 COVID-19 diagnostic kits from the U.S. manufacturers have won the emergency use authorization (EUA) from the FDA. On March 27, 2020, the FDA gave EUA to a COVID-19 test from Abbott Laboratories that can provide results in 13 minutes or less, making it one of the fastest to date. It is being scaled to deliver 50,000 tests per day to the U.S. healthcare system. Currently, 7 of the 41 diagnostic tests for COVID-19 require one hour or less.
Thousands of scientific articles have been published electronically or in print since the outbreak of COVID-19 began in late 2019. Thus, the COVID-19 outbreak represents the largest and most rapid global scientific collaboration 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.
To accelerate the development of therapies against COVID-19, the repurposing of existing drugs is being explored by numerous market competitors. 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.
Dozens of companies are rushing vaccine development and proceeding toward clinical trials. As select examples, the U.S. NIH initiated a Phase I trial in Seattle evaluating an investigational vaccine (mRNA-1273) created by NIAID scientists and their collaborators at Moderna, Inc. Sanofi and Regeneron launched a Phase 2/3 trial in New York evaluating the IL-6 targeted Kevzara. Inovio Pharmaceuticals is advancing its vaccine into human trials within the U.S. and intends to produce one million doses of it by the end of the year. Numerous other vaccines are also progressing through preclinical and clinical development.
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, stem cells - mesenchymal stem cells (MSCs) in particular - are showing intriguing potential for the treatment of COVID-19 related complications.
MSCs are receiving 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.
Already, Athersys has reported positive outcomes in other studies using MSCs in treating respiratory disease. Mesoblast’s Remestemcel-L has proved itself to be effective in treating advanced respiratory distress. Similarly, Aspire Health Science, CAR-T (Shanghai) Biotechnology, Celltex Therapeutics, Citius Pharmaceuticals, Pluristem Therapeutics, Cynata Therapeutics, Lattice Biologics, ReeLabs, and Vitro Biopharma are exploring the use of MSC therapeutics for the treatment of COVID-19 related complications. Other market competitors are also involved with the development of stem cell therapeutics related to COVID-19, with the number increasingly steadily. In the recent months, there has been a flurry of activity within the clinical trial sector. When all trial types are considered, there are 587 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 specifically 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.
The aim of this report is to gather existing research on COVID-19, reveal key insights and position the reader to identify emerging market opportunities related to the Coronavirus pandemic. It provides comprehensive coverage of the outbreak, highlights global competitors involved in the fight against COVID-19, and presents every known diagnostic testing approval, treatment under development, and preclinical and clinical vaccine development program. It quantifies regulatory approvals to date, and importantly, presents trend rate data for COVID-19 scientific publications, patents, and clinical trials on a worldwide basis.
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