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U.S. Severe Oral Mucositis Market, By Drug Type (Palifermin, Amifostine, Chlorhexidine, Sucralfate, Late Phase (Avasopasem and Dusquetide)), By Cause (Chemotherapy and Radiotherapy), By Grade (Grade III and Grade IV), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) is estimated to be valued at US$ 78.5 Mn in 2021 and is expected to exhibit a CAGR of 19.2% during the forecast period (2021-2028), as highlighted in a new report published by Coherent Market Insights.

Key players are focusing on inorganic strategies and fund raising, which is expected to boost growth of the U.S. severe oral mucositis market over the forecast period. For instance, in June 2016, Monopar Therapeutics Inc., a healthcare company, executed an option and license agreement with Onxeo S.A., a public France-based company, which gave Monopar the exclusive option to license Validive (active pharmaceutical ingredient) to pursue treating severe oral mucositis in patients undergoing chemoradiation treatment for head and neck cancer.

U.S. Severe Oral Mucositis Market– Impact of Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic caused major disruptions to clinical trial executions in the U.S., impacting key stakeholders across the industry. Investigative site capabilities experienced disturbances, driven by staff furloughs, social-distancing protocols, financial losses, and concerns over patient safety. Sponsors, contract research organizations, and other organizations that support drug development shifted to remote working environments.

Recently, the U.S. FDA guidance (March 2020 and updated in July 2020) acknowledged that the impact of COVID-19 may require companies conducting clinical trials to consider virtual patient visits or include novel ways for conducting clinical trials in place of current protocols. Therefore, nowadays there are more opportunities for using remote healthcare including conducting virtual or decentralized trials, site-less clinical trials, and use of other nontraditional approaches that does not involve in-person visits.

Moreover, regulatory bodies are focusing on imposing guidelines to prevent the spread of the COVID-19 infection while conducting clinical trials on participants/subjects. According to the U.S. Food Drug and Administration, clinical trials performed by the companies and research institutes during COVID-19 should follow the guidelines prescribed by the U.S. FDA such as: participants in clinical trials should undergo COVID-19 screening procedures to avoid the spread of COVID-19 infections during clinical trials, participants are not allowed to visit investigational site, sponsors should evaluate alternative methods for contacting participants/subjects through various methods such as phone contact, virtual visit, alternative location for assessment, including local labs or imaging centres, and sponsors should plan the visit of participants to the investigational site to avoid the spread of COVID-19 infection.

Moreover, to study the impact of COVID-19 on the medical devices as well as pharmaceutical drugs on ongoing clinical trial studies, various research institutes are conducting surveys to understand the impact of COVID-19 on ongoing clinical trials globally. For instance, on April 23, 2020, Medidata technology and solutions, a global platform that supports clinical trials, performed an electronic (video conference) survey of 9,952 staff at various trial investigator sites globally. The survey had a low response rate of 10.3% as only few respondents answered the survey in a total of 1,030 participants. Most of the respondents in the survey were from the U.S. (North America; 58.3%), followed by Asia pacific (23.8%), Europe (8.1%), Latin & 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 ability to conduct ongoing clinical trials during the COVID-19 pandemic had affected 69%, whereas 78% mentioned that this situation affected the initiation of new trials.

Furthermore, various research institutes, academic institutes, and key companies are focusing on performing clinical trials and developing potential treatments for COVID-19 infection. For instance, in January 2021, Innovation Pharmaceuticals, a clinical biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has designated a Fast Track designation for clinical investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin has three different clinical indications including COVID-19 including oral mucositis, acute bacterial skin, and skin structure infection.

Browse 12 Market Data Tables and 22 Figures spread through 116 Pages and in-depth TOC on “U.S. Severe Oral Mucositis Market”- Forecast to 2028. U.S. Severe Oral Mucositis Market, By Drug Type (Palifermin, Amifostine, Chlorhexidine, Sucralfate, and Late Phase (Avasopasem and Dusquetide)), By Cause (Chemotherapy and Radiotherapy), By Grade (Grade III and Grade IV), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies)

To know the latest trends and insights prevalent in this market, click the link below:

https://www.coherentmarketinsights.com/market-insight/us-severe-oral-mucositis-market-4571

Moreover, key companies receiving orphan drug designation from regulatory bodies for boosting the research and development for treatment of severe oral mucositis is expected to augment the market growth. For instance, in February 2020, the Innovation Pharmaceutical company announced that the company had received 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 expected to exhibit a CAGR of 19.2% during the forecast period, owing to key companies focusing on research and development of severe oral mucositis, which is expected to drive the market growth over the forecast period. For instance, in February 2021, Monopar Therapeutics Inc. announced that it dosed the first patient in its Validive Phase 2b/3 VOICE trial for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE).
  • Among Drug Type, 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 management of severe oral mucositis is expected to drive the market. For instance, in 2015, American College of Physicians journal (Annals of Internal Medicine) stated that Kepivance is effective in managing severe mucositis in patients undergoing chemotherapy.
  • On the basis of Cause, Radiotherapy segment is estimated to hold a dominant position in the U.S. severe oral mucositis market in 2021. Increasing prevalence of the radiotherapy induced severe oral mucositis is expected to drive the segment growth. For instance, according to the U.S. National Library of Medicine report 2017, around 56% of patients suffering from neck and head cancer treated with radiotherapy suffered from severe oral mucositis in the U.S. in 2017.
  • Major players operating in the U.S. severe oral mucositis market are Innovation Pharmaceuticals Inc.*, Monopar Therapeutics Inc., Soligenix, Inc., Oragenics, Inc., Enzychem Lifesciences, Galera Therapeutics, Inc., Amgen, Inc., and Covis Pharma Group.
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