COVID-19 Vaccine & Therapeutics Clinical Trial Analysis Report 2020: Regulatory Framework for COVID-19 Therapeutics and Vaccines Marketing Approvals
DUBLIN, Nov. 30, 2020 /PRNewswire/ -- The "COVID-19 Vaccine & Therapeutics Clinical Trial Analysis 2020" report has been added to ResearchAndMarkets.com's offering.
Major players in the COVID-19 vaccine and therapeutics clinical trial analysis market are Pfizer, GlaxoSmithKline (GSK), Inovio Pharmaceuticals, Johnson & Johnson (J&J), Novavax Inc., Heat Biologics, Sanofi, BioNTech, Vaxart, and Vir Biotechnology.
The urgent need to develop vaccines or therapeutics in response to the outbreak of the 2019 Novel Coronavirus (COVID-19) has resulted in a significant increase in clinical trials worldwide. Many research institutes, healthcare organizations and biopharmaceutical companies worldwide are conducting clinical trials for COVID-19 vaccines and therapeutics. According to the ClinicalTrials.gov database, there are more than 1,300 clinical trials registered (195 in phase I, 817 in phase II, 442 in phase III, 188 in phase IV). For instance, 'Solidarity' is an international clinical trial to help find an effective treatment for COVID-19 launched by the World Health Organization and its partners.
The COVID-19 vaccine and therapeutics clinical trial analysis report consists of drugs and vaccines which are under clinical trials for the treatment of COVID-19. The various drugs and vaccines trials are categorized under 4 phases i.e. Phase I (drug or vaccine safety is tested on a small group of humans), Phase II (efficacy and safety are tested on a large group of humans), Phase III (efficacy and safety are tested on thousands of humans), and Phase IV (obtaining government approval and market launch, many vaccines undergo more monitoring).
By region, Europe registered the highest number of trials (616 trials), followed by the Americas (418). Asia-pacific registered around 158 trials, and the Middle-East and Africa registered about 137 trials.
The COVID-19 vaccine and therapeutics clinical trial analysis covered in this report is segmented by product type into small molecules, biologics, blood & plasma derivatives, monoclonal antibodies, vaccines, others. It is also segmented by the phase of development into clinical phase I (active trial & discontinued trials), clinical phase II (active trial & discontinued trials), clinical phase III (active trial & discontinued trials), clinical phase IV (active trial & discontinued trials), by route of administration into oral, intravenous, subcutaneous, other routes of administration, and by type of sponsor into pharma/biotech company, academic research/institution, others (such as Government Organizations and CROs).
In June 2020, Moderna Inc. collaborated with Catalent to fill-finish manufacturing of Moderna's COVID-19 vaccine candidate. The collaboration is expected to utilize Catalent filling and packaging capacity and staffing for manufacturing operations for producing an initial 100 million doses of the vaccine. Moderna Inc is a clinical-stage biotechnology organization that spent significant time in messenger RNA (mRNA) therapeutics and immunizations to make another age of transformative drugs. Catalent is the main supplier of cutting-edge conveyance advances, improvement, manufacturing drugs, biologics, cell, and quality treatments.
The long and costly drug development process is anticipated to limit the growth of the COVID-19 vaccine & therapeutics clinical trials in the coming days. The safety and efficacy of drugs and vaccines are tested in various stages of the clinical trials. A vaccine takes an average of two to five years to develop.
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the average cost of research and development of a new drug is approximately $2.6 billion. Moreover, the stringent regulations imposed by the various regulatory authorities such as European Medicines Agency and the US Food and Drug Administration (FDA) in regards with clinical trials during COVID-19 outbreak attributing to the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity is a major challenge faced in COVID-19 vaccine & therapeutics clinical trials.
New programs launched by companies and organizations to develop vaccines for protection against COVID-19 are expected to be a major trend shaping the growth of the COVID-19 vaccine and therapeutics clinical trials. For instance, in March 2020, Heat Biologics Inc., a clinical-stage biopharmaceutical company specializing in the development of therapeutic vaccines, announced the launch of a program within its subsidiary Zolovax, Inc. to develop a vaccine using its immune-activating gp96 vaccine platform for prevention and treatment against SARS-CoV-2 that causes coronavirus. Various programs being launched by the companies are likely to act as a key factor driving the COVID-19 vaccines & therapeutics clinical trials in the coming days.
Key Topics Covered:
1. Executive Summary
2. Disease Epidemiology
2.1 Novel Coronavirus Etiology and Disease Pathogenesis
2.2 COVID-19 Clinical Features - Signs and Symptoms
2.3 Disease Epidemiology and Epidemic Statistics for Major Countries
3. Global Clinical Trial Analysis of COVID-19 Therapeutics and Vaccines
3.1 Global Clinical Trial Analysis, By Region
3.1.1 United States
3.1.2 Europe
3.1.3 Others
3.2 Global Clinical Trial Analysis, By Product Type
3.2.1 Small Molecules
3.2.2 Biologics
3.2.2.1 Blood & Plasma Derivatives
3.2.2.2 Monoclonal Antibodies
3.2.2.3 Vaccines
3.2.2.4 Others
3.3 Global Clinical Trial Analysis, By Phase of development
3.3.1 Clinical Phase I (Active trial & Discontinued Trials)
3.3.2 Clinical Phase II (Active trial & Discontinued Trials)
3.3.3 Clinical Phase III (Active trial & Discontinued Trials)
3.3.4 Clinical Phase IV (Active trial & Discontinued Trials)
3.4 Global Clinical Trial Analysis, By Route of Administration
3.4.1 Route of Administration
3.4.1.1 Oral
3.4.1.2 Intravenous
3.4.1.3 Subcutaneous
3.4.1.4 Other Route of Administration
3.5 Global Clinical Trial Analysis, By Type of Sponsor
3.5.1 Pharma/Biotech Company
3.5.2 Academic Research/Institution
3.5.3 Others such as Government Organizations and CROs
4. Top 10 Late Staged Therapeutics and Vaccine Clinical Trials Analysis
4.1 Company Overview
4.2 Trial Description (including trial design)
4.3 Trial Status & Trial Enrollment
4.4 Trial Results
4.5 Licensing and Collaboration Agreements
4.6 Milestones & Future Plans
5. Regulatory Framework for COVID-19 Therapeutics and Vaccines Marketing Approvals
5.1 Regulatory Framework in the USA
5.2 Regulatory Framework in EU & Other Countries
6. Recommendations & Conclusion
Companies Mentioned
- Pfizer
- GlaxoSmithKline (GSK)
- Inovio Pharmaceuticals
- Johnson & Johnson (J&J)
- Novavax Inc.
- Heat Biologics
- Sanofi
- BioNTech
- Vaxart
- Vir Biotechnology
- Moderna Therapeutics
- Emergent BioSolutions
- Dynavax
- Geovax
- Curevac
- Zydus Cadila
- Serum Institute
- Biological E
- Bharat Biotech
- Indian Immunologicals
- Mynvax
- A2A Pharmaceuticals
- AbbVie
- Abbott
- Adaptive
- Agastiya Biotech
- Alexion
- Algernon
- Alnylam Pharmaceuticals, Inc.
- Altimunne
- Amgen
For more information about this report visit https://www.researchandmarkets.com/r/lxrcxa
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