Radiation induced-Oral Mucositis (RIOM) in Head and neck Cancer (HNC) Market

• Radiation-induced oral mucositis (RIOM) in HNC is one of the major ionizing radiation toxicities and normal tissue injuries that result from radiotherapy.
• RIOM is a normal tissue injury lasting between 7 and 98 days, which starts as an acute inflammation of the oral mucosa, tongue, and pharynx after RT exposure.
• Radiation-induced mucositis is initiated by direct injury to basal epithelial cells and cells in the underlying tissue.
• Common signs and symptoms present in RIOM are red, swollen mouth and gums; mouth bleeding; mouth, gum, or tongue sores; mouth or throat soreness; swallowing or talking difficulty; dryness, mild burning, or pain when eating; white patches or pus in the mouth or on the tongue; and increased mucus or thicker saliva.
• The RIOM market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs, the expected market launch of one-time gene therapies, and raised awareness.
• The United States accounts for the largest market size of Radiation-induced Oral Mucositis in Head and Neck Cancer (HNC), in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• RIOM injury in HNC patients challenges radiation oncologists in many aspects, such as radiation dose limitations, changes in dose fractionation protocol, and dramatic negative effects on patients’ quality of life.
• The major clinical consequences of RIOM include hospital admission or extended hospitalization for total parenteral nutrition, intravenous (IV) analgesia, and IV antibiotics.
• A wide variety of scales have been used to record the extent and severity of oral mucositis in clinical practice and research. The most commonly used scales are the World Health Organization (WHO) Oral Toxicity score, The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Radiation Therapy Oncology Group (RTOG) Scale, RTOG/EORTC Scale, and Oral assessment guide for children and young people.
• The treatment of RIOM is essentially symptomatic, with the treatment of complicated infections and the promotion of wound healing of the oral mucosa. If the patient develops severe RIOM, the suspension of RT may be required.
• The Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ ISOO) Clinical Practice Guidelines are commonly used to treat RIOM.
• The growth of the RIOM disease market is expected to be mainly driven by the increasing patient pool, ongoing development of future therapeutical options, and increasing understanding of the disease.

DelveInsight's “Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC), historical and forecasted epidemiology as well as the market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM market size from 2020 to 2034. The report also covers current treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Understanding and Treatment Algorithm

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Overview, Country-specific Treatment Guidelines and Diagnosis

Oral mucositis primarily results from the direct and indirect toxic effects of cancer chemotherapy and ionizing radiation on the rapidly dividing oral epithelium, with other areas along the gastrointestinal tract also commonly affected. Radiation-induced oral mucositis (RIOM) is one of the major ionizing radiation toxicities and normal tissue injuries that result from radiotherapy. RIOM is a normal tissue injury lasting between 7 and 98 days, which starts as an acute inflammation of the oral mucosa, tongue, and pharynx after radiotherapy (RT) exposure. Radiation-induced mucositis is initiated by direct injury to basal epithelial cells and cells in the underlying tissue. DNA-strand breaks can result in cell death or injury.

The diagnosis is typically based on the appearance, location, and timing of oral lesions, as well as the medical history, which may show a medication or treatment form that is highly linked with Oral Mucositis. Useful laboratory tests for confirming diagnosis and etiology, especially if local fungal, bacterial, or viral infections infection is suspected, are complete blood count, Viral Culture, fungal testing, and biopsy.

Further details related to country-based variations in diagnosis are provided in the report...

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Treatment

Pain is the most common symptom among patients with RIOM. Evaluating oral pain is necessary for every patient, and the treatment regime is determined by the level of pain reported by the patients. When RIOM is accompanied by mild pain, acetaminophen and lidocaine can be applied. Acetaminophen with codeine suspension can be used for moderate pain, and strong opioids such as morphine or fentanyl need to be used when mucositis progresses to cause severe pain. A morphine mouthwash (0.2%) may effectively treat pain due to RIOM to reduce the need for systemic morphine.

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Epidemiology

The Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) epidemiology is segmented with detailed insights into Total Incident Cases, Total Grade-specific Cases, and Total Treated Cases of RIOM in HNC.

• The United States accounted for the highest total incident cases of Radiation-induced Oral Mucositis in 2023.
• The RIOM incident cases are further segmented into grade-specific cases of RIOM. In 2023, Grade III cases were estimated to be the highest in grade-specific cases in the United States.
• In 2023, the United States accounted for the majority of treated cases of radiation-induced oral mucositis in the 7MM.
• Among EU4 and the UK, the UK accounted for the highest incident cases of radiation-induced oral mucositis.

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Drug Chapter

The drug chapter segment of the Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) report encloses a detailed analysis of Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

MuGard: AMAG Pharmaceuticals/SpePharm

MuGard is a mucoadhesive oral wound rinse Rinse is a viscous hydrogel polymer solution that is dispensed in a ready-to-use form. This device is supplied in plastic bottles and is intended for the treatment of oral wounds such as mucositis, stomatitis, traumatic ulcers, and aphthous ulcers. The mucoadhesive formulation results in the development of a protective coating over the oral mucosa when swirled carefully across the mouth. Patients should use MuGard 4 to 6 times daily, 5 mL of ready-to-use MuGard coats the oral cavity, and up to 10 mL can be used if needed.

Episil: Camurus

Episil is a lipid-based fluid that transforms into a thin bioadhesive film when in contact with the buccal membrane, alleviating pain by protecting mucous membranes. In clinical trials, episil has been proven to reduce pain in the mouth by up to 40%, with a long-lasting effect of up to eight hours. The outstanding features of Episil are that it provides instant relief that is within five minutes post-application, in addition to this, it is convenient to consume food and drink within the same time only, and it acts as an effective oral pain relief lasting up to eight hours that comes handy with a ready-to-use, pocket-sized device.

On July 22, Camurus AB and Solasia Pharma K.K. announced their agreement, wherein Solasia acquired EPISIL oral liquid. Additionally, Solasia obtained pertinent intellectual property rights as part of the agreement.

Note: Detailed current therapies assessment will be provided in the full report of Radiation-induced...

Oral Mucositis (RIOM) in Head and Neck Cancer (HNC)

Emerging Drugs

GC4419 (avasopasem): Galera Therapeutics

Avasopasem, also known as avasopasem manganese or GC4419 is Galera’s lead product candidate. It is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic that is being developed for the reduction of radiation-induced severe oral mucositis. Avasopasem manganese is designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen, protecting normal tissue from damage associated with radiation therapy. Recently, the drug completed a Phase III (ROMAN; NCT03689712) clinical study, investigating the effects of GC4419 on Radiation-induced Oral Mucositis in Patients with Head/Neck Cancer.

RRx-001: EpicentRx/Prothex Pharma

RRx-001 is an anticancer immunotherapeutic small molecule of the next generation that downregulates the CD47/SIRP axis and repolarizes tumor-associated macrophages (TAMs) as well as other immunosuppressive cells to an immunostimulatory phenotype in the tumor microenvironment. RRx-001 is intended to be included either as monotherapy or in combination with chemotherapy, radiation therapy, or immunotherapy. It is assumed that this small molecule acts through the induction of species of reactive oxygen and nitrogen, contributing to mild tissue oxidative stress. This contributes, among other results, to the induction of protein expression of Nrf2 (nuclear factor erythroid 2-related factor 2) in healthy tissues, which in turn regulates a number of cytoprotective proteins.

Currently, the drug is in a Phase II clinical trial study (NCT05966194; Recruiting) to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers.

Note: Detailed emerging therapies assessment will be provided in the final report...

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Market Outlook

Key players, such as Galera Therapeutics, EpicentRx, Prothex Pharma, Soligenix, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC).

Lack of public awareness and information about oral mucositis, lack of diagnostic methods, reimbursement limitations of RIOM in HNC, and additional economic burden of RIOM in HNC patients will hit the disease market.

A robust pipeline activity can be observed in the RIOM market in HNC patients and the possible hurdles might be the rarity of awareness, reimbursement limitations of RIOM in HNC patients, and efficacy concerns for the available treatment options.

The growth of the RIOM disease market is expected to be mainly driven by the increasing patient pool, ongoing development of future therapeutical options, and increasing understanding of the disease.

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies drug uptake in the report...

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 35+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC). This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country-specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) market.

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Report Insights

• Patient Population
• Therapeutic Approaches
• Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Pipeline Analysis
• Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Market Size and Trends
• Existing and future Market Opportunity

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the growth rate of the 7MM Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) treatment market?
• What was the Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC)?
• How many companies are developing therapies for the treatment of Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Radiation-induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.