U.S. Severe Oral Mucositis Market: Increasing prevalence of head and neck cancer in the U.S. is expected to drive the market growth | Innovation Pharmaceuticals Inc.*, Monopar Therapeutics Inc

Central members are focusing on novel strategies and fundraising, as most would consider being normal to boost the development of the market. For instance, in June 2016, Monopar Therapeutics Inc., a medical organization, executed a choice and license concurrence with Onxeo S.A., a public France-based organization, which gave Monopar the exclusive choice to license Validive (active pharmaceutical fixing) to pursue treating severe oral mucositis in patients undergoing chemoradiation therapy for head and neck disease.

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Effect of Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic caused significant disruptions to clinical preliminary executions in the U.S., affecting key stakeholders across the industry. Investigative site capabilities experienced disturbances, driven by staff furloughs, social-distancing protocols, monetary losses, and concerns over understanding safety. Sponsors, contract research organizations, and different organizations that support drug improvement shifted to remote workplaces.

As of late, the U.S. FDA guidance (March 2020 and updated in July 2020) recognized that the effect of pandemic might demand enterprises conducting clinical trials in order to consider virtual patient visits or include advanced ways for conducting clinical trials instead of current protocols. Consequently, nowadays there are more opportunities for using distant medical services including conducting site-less clinical trials, decentralized or virtual trials, and use of other modern approaches that do not affect in-person visits.

Besides, regulatory bodies are focusing on imposing guidelines to forestall the spread of the COVID-19 disease while conducting clinical trials on participants/subjects. As indicated by the U.S. Food Drug and Administration, clinical trials performed by the companies and research institutes during COVID-19 should keep the guidelines prescribed by the U.S. FDA such as participants in clinical trials should undergo COVID-19 screening procedures to keep away from the spread of COVID-19 infections during clinical trials, participants are not permitted to visit the investigational site, sponsors should evaluate alternative methods for reaching participants/subjects through various methods such as telephone contact, virtual visit, alternative area for assessment, including neighborhood labs or imaging centers, and sponsors should design the visit of participants to the investigational site to keep away from the spread of COVID-19 contamination.

Also, to study the effect of COVID-19 on clinical devices as well as pharmaceutical drugs in continuous clinical preliminary studies, various research institutes are conducting surveys to understand the effect of COVID-19 on continuous clinical trials globally. For instance, on April 23, 2020, Medidata innovation and solutions, a global stage that supports clinical trials, played out an electronic (video gathering) survey of 9,952 staff at various preliminary investigator sites globally. The survey had a low response pace of 10.3% as just a couple of respondents answered the survey in an aggregate of 1,030 participants. Most of the respondents in the survey were from the U.S. (North America; 58.3%), trailed by the Asia Pacific (23.8%), Europe (8.1%), Latin and Central America (7.1%), and Middle East/Africa (2.7%). The respondents included in the study were study coordinators, investigators, site managers/directors, clinical nurses, and others. The survey results showed that the capacity to conduct progressing clinical trials during the COVID-19 pandemic had impacted 69%, whereas 78% referenced that this situation impacted the inception of new trials.

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Furthermore, various research institutes, scholastic institutes, and key companies are focusing on performing clinical trials and creating possible treatments for COVID-19 contamination. For instance, in January 2021, Innovation Pharmaceuticals, a clinical biopharmaceutical organization, announced that the U.S. Food and Drug Administration (FDA) has designated a Fast Track designation for clinical investigation of Brilacidin as an expected treatment for COVID-19. Brilacidin has three distinct clinical indications including COVID-19 including oral mucositis, acute bacterial endlessly skin structure disease.

In addition, key companies receiving vagrant drug designation from regulatory bodies for boosting the research and improvement for the treatment of severe oral mucositis are supposed to augment the market development. For instance, in February 2020, the Innovation Pharmaceutical organization announced that the organization had received a patent for Brilacidin from U.S. Patent and Trademark for the treatment of oral mucositis.

Key Takeaways of the U.S. Severe Oral Mucositis Market:

• The U.S. severe oral mucositis market is supposed to show a CAGR of 19.2% during the forecast time frame, inferable from key companies focusing on research and advancement of severe oral mucositis, as would be considered normal to drive the market development over the forecast time frame. For instance, in February 2021, Monopar Therapeutics Inc. announced that it dosed the first tolerance in its Validive Phase 2b/3 VOICE preliminary for the avoidance of chemoradiotherapy-induced severe oral mucositis in patients with the oropharyngeal disease (VOICE).
• Among Drug Types, the Palifermin segment is accounted for the largest market share in U.S. severe oral mucositis market in 2021. Various research institutes focusing on the R&D in Palifermin for the administration of severe oral mucositis are supposed to drive the market. For instance, in 2015, the American College of Physicians journal (Annals of Internal Medicine) stated that Kepivance is effective in overseeing severe mucositis in patients undergoing chemotherapy.
• Based on the cause, the radiotherapy segment is estimated to stand firm on a prevailing footing in the U.S. severe oral mucositis market in 2021. The increasing commonness of radiotherapy-induced severe oral mucositis is supposed to drive the segment development. For instance, as indicated by the U.S. Public Library of Medicine report in 2017, around 56% of patients suffering from neck and head malignant growth treated with radiotherapy suffered from severe oral mucositis in the U.S. in 2017.
• Central players working in the U.S. severe oral mucositis market are Covis Pharma Group, Amgen, Inc., Galera Therapeutics, Inc., Enzychem Lifesciences, Oragenics, Inc., Soligenix, Inc., Monopar Therapeutics Inc., and Innovation Pharmaceuticals Inc.

The Study Objectives are:

✔ A comprehensive insight into key players operating in the U.S. Severe Oral Mucositis Market and their corresponding data.
✔ It includes product portfolio, annual revenue, expenditure on research and development, geographical presence, key developments in recent years, and growth strategies.
✔ Regional analysis, which includes insight into the dominant market and corresponding market share.
✔ It also includes various socio-economic factors affecting the evolution of the market in the region.
✔ The report offers a comprehensive insight into different individuals from value chains such as raw materials suppliers, distributors, and stockholders.

Table of Content

Chapter 1 Industry Overview
1.1 Definition
1.2 Assumptions
1.3 Research Scope
1.4 Market Analysis by Regions
1.5 U.S. Severe Oral Mucositis Market Size Analysis from 2022 to 2028
11.6 COVID-19 Outbreak: U.S. Severe Oral Mucositis Industry Impact

Chapter 2 U.S. Severe Oral Mucositis Competition by Types, Applications, and Top Regions and Countries
2.1 U.S. Severe Oral Mucositis (Volume and Value) by Type
2.3 U.S. Severe Oral Mucositis (Volume and Value) by Regions

Chapter 3 Production Market Analysis
3.1 Global Production Market Analysis
3.2 Regional Production Market Analysis

Chapter 4 U.S. Severe Oral Mucositis Sales, Consumption, Export, Import by Regions (2017-2022)
Chapter 5 Company Profiles and Key Figures in U.S. Severe Oral Mucositis Business
Chapter 6 U.S. Severe Oral Mucositis Market Forecast (2022-2028)
Chapter 7 Conclusions
Research Methodology