Oral Mucositis Om Market
DelveInsight’s ‘Oral Mucositis (OM) - Market Insights, Epidemiology, and Market Forecast —2030’ report delivers an in-depth understanding of the OM, historical and forecasted epidemiology as well as the OM market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The OM market report provides current treatment practices, emerging drugs, OM market share of the individual therapies, current and forecasted OM market size from 2018 to 2030 segmented by seven major markets. The Report also covers current OM treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2018–2030
Oral Mucositis (OM): Disease Understanding and Treatment Algorithm
Oral Mucositis Overview
Mucositis occurs when cancer treatments break down the rapidly divided epithelial cells lining the gastrointestinal tract (which goes from the mouth to the anus), leaving the mucosal tissue open to ulceration and infection. The mucosa is the thin outer layer that lines most organs including the mouth, throat, esophagus, stomach, and bowel that communicate with the air, such as the respiratory and alimentary tracts, and have cells and associated glands that secrete mucus. The part of this lining that covers the mouth, called the oral mucosa, is one of the most sensitive parts of the body and is particularly vulnerable to chemotherapy and radiation. The oral cavity is the most common location for mucositis. Oral mucositis refers to the oral erythematous and ulcerative lesions commonly observed in patients undergoing cancer therapy. They are painful and affect nutrition and contribute to local and systemic infections.
Oral Mucositis Diagnosis
Clinical signs of mucosal damage and cell death appear after the first 1–2 weeks of radiation therapy and as early as 3 days after chemotherapy. Initial mucosal damage results in patchy erythema, edema, atrophy, and whitening of the mucosal tissue with increased sensitivity—patients report a burning sensation in the mouth. Further loss of mucosal epithelium becomes most prominent in the fourth or fifth week of standard fractionation radiation resulting in fibrinous exudation, confluent inflammation, and ulceration. The mouth sores and swelling can lead to significant oral pain, pain with swallowing, weight loss, and dehydration. Mucosal damage predisposes the patient to oral-super infection leading to further pain and alterations in taste and appetite and decreased quality of life.
Diagnosis is based on the symptoms the patient is experiencing and the appearance of the tissues of the mouth following chemotherapy, bone marrow transplants, or radiotherapy. Red burn-like sores or ulcers throughout the mouth is enough to diagnose mucositis. Oral mucositis is typically diagnosed 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, biopsy, and fungal testing. 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 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, and Oral assessment guide for children & young people.
Oral Mucositis Treatment
Currently, several treatment options are used to prevent or treat mucositis. The interventions include general oral care protocols; interventions to reduce the mucosal toxicity of chemotherapy drugs; mouthwashes with mixed action; immunomodulatory agents; topical anesthetics; antiseptics; mucosal barriers and coating agents; cytoprotectants; mucosal cell stimulants; psychotherapy; and analgesics. Kepivance (palifermin) is the first therapy approved to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant.
Other oral rinse and devices approved for reducing the symptoms of Oral Mucositis are MuGard (Access Pharmaceuticals), Chemo Mouthpiece (Aurora BioScience), and Episil (Camurus).
The OM epidemiology division provides the insights about historical and current OM patient pool and forecasted trends for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
In the year 2020, the total incident cases of Oral Mucositis were 1,480,453 cases in the 7MM. These cases are expected to grow in the study period 2018–2030.
The disease epidemiology covered in the report provides historical as well as forecasted OM epidemiology segmented as [Total Incident Cases of OM, Grade-specific cases of OM, and Treated cases of OM] scenario of OM in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.
Country Wise- OM Epidemiology
- Estimates show that the highest incident cases of OM in the 7MM were in the United States, followed by Japan in 2020.
- The United States, in 2020, accounted for 596,671, OM incident cases, which are expected to grow during the study period, i.e., 2018–2030.
- In the year 2020, the total incident cases of OM in EU5 were 623,424, which are expected to grow during the study period, i.e., 2018–2030.
- In the year 2020, the total incident cases of OM in Japan were 260,358, which are expected to grow during the study period, i.e., 2018–2030.
OM Drug Chapters
The drug chapter segment of the OM report encloses the detailed analysis of OM marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the OM clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
OM Approved Drugs/Devices
Kepivance/palifermin (Amgen/ Swedish Orphan Biovitrum)
Kepivance (palifermin) is a truncated human keratinocyte growth factor (KGF) produced by recombinant DNA technology in E coli. It is a medicine indicated for the prevention and treatment of severe oral mucositis (mouth sores). It is used in patients with certain forms of blood cancer who are undergoing high-dose chemotherapy accompanied by a stem cell transplant and radiation therapy. The prevention and treatment of common side effects of other cancer types are also being studied.
MuGard (Access Pharmaceuticals (now Abeona Therapeutics)
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 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.
Chemo Mouthpiece (Chemo Mouthpiece/Aurora BioScience)
Chemo Mouthpiece is a discreet, secure, and easy-to-use cryotherapy device that can effectively mitigate the debilitating effects of chemotherapy-induced oral mucositis. Chemo Mouthpiece builds upon an established treatment form, cryotherapy, which uses cold temperatures to improve the condition of the body. It is the same strategy that introduced ice chips and popsicles to hospitals and infusion centers. The device includes two chambers, a center core filled with filtered water, and an outer section filled with proprietary saline, which can reach freezing temperatures without solidifying. Two tubes run through the device so the patient can breathe comfortably. Chemo Mouthpiece can help battle the worst of the symptoms of oral mucositis by limiting the number of toxic chemicals that can interfere with the tissues of the cheeks, gums, tongue, lips, and palate.
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.
Note: Detailed Current therapies assessment will be provided in the full report of OM
OM Emerging Drugs/Devices
Avasopasem/GC4419 (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.
SGX942 (Dusquetide) is an investigational agent being developed by Soligenix, SGX942 is a rapid 4-minute infusion administered twice per week during chemotherapy and/or radiation treatment to reduce the duration and severity of severe oral mucositis. It is an intravenous formulation of the Innate Defense Regulator, dusquetide. Dusquetide is the active ingredient in SGX942, which is unique in its mechanism addressing the underlying innate immune dysfunction that contributes to the severity and duration of mucositis.
Cooral is a single-use oral cooling device that links to a portable cooling system and cools the oral mucosa. Cooral is equipped with an ECU200 water cooling unit that circulates 8°C water into an attached mouthpiece which is inserted into the patient’s mouth. The Cooral Device is a distinctive product and today has no rival in the market, as was verified by a very rapid patent approval. The product thus presents a 'breakthrough technology,' that is a revolutionary technology with a major clinical advantage over the drugs commercially available. It is noteworthy that CoolPrevent System is the only system available for the prevention of two of the most severe side effects of cancer treatment, oral mucositis, and neuropathy.
CareMin650 previously ONCORED from NeoMedLight is a device using the light-emitting fabric Lightex – unique patented technology – emitting light through woven optic fibres. It tackles the huge unmet clinical need for mucositis in cancer patients and reduces its societal, emotional, and economic burden. CareMin650’s operating mode is photobiomodulation, which uses the properties of specific light waves. Photobiomodulation, scientifically and clinically proven by numerous studies, is a complex biological mechanism of cell reparation that stimulates proliferation and migration of healthy cells.
Note: Detailed emerging therapies assessment will be provided in the final report.
OM Market Outlook
Currently, clinical management of oral mucositis is largely focused on palliative measures such as pain management, nutritional support, and maintenance of good oral hygiene. Recombinant human keratinocyte growth factor-1 (Palifermin) reduces the incidence of WHO grade 3 and 4 oral mucositis in patients with hematologic malignancies (e.g. lymphoma and multiple myeloma) receiving high-dose chemotherapy and total body irradiation before autologous hematopoietic cell transplantation. The US FDA has also approved Palifermin for patients with hematologic malignancies receiving myelotoxic therapies requiring hematopoietic cell support. The other treatment options may include interventions to reduce the mucosal toxicity of chemotherapy drugs, mouthwashes, immunomodulatory agents, topical anesthetics, mucosal barriers and coating agents, cytoprotectants.
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. Episil provides instant relief that is within five minutes post-application; it acts as an effective oral pain relief lasting up to 8 h that comes in handy with a ready-to-use, pocket-sized device. The device constitutes an oromucosal liquid in a multi-dose container and is without an active pharmaceutical ingredient. In addition to this, MuGard is a mucoadhesive oral wound rinse and 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. Apart from this, Chemo Mouthpiece is a discreet, secure, and easy-to-use cryotherapy device that can effectively mitigate the debilitating effects of chemotherapy-induced oral mucositis. Chemo Mouthpiece uses cold temperatures to improve the condition of the body. It is the same strategy that introduced ice chips and popsicles to hospitals and infusion centers. Kepivance (palifermin) is a truncated human keratinocyte growth factor (KGF) produced by recombinant DNA technology in E coli. It is a medicine indicated for the prevention and treatment of severe oral mucositis. It is used in patients with certain forms of blood cancer who are undergoing high-dose chemotherapy accompanied by a stem cell transplant and radiation therapy. Kepivance is a type of laboratory-made keratinocyte growth factor (KGF). KGF stimulates the growth of cells in the lining of the mouth, stomach, and gut. The candidate was approved in December 2004 by the US FDA making it the first therapy to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant.
There is a high unmet need for new therapies for the treatment of oral mucositis. There are currently no FDA-approved drugs for the treatment of Oral Mucositis other than palifermin. Interventional strategies including coating agents, pain palliation, products, antiseptics, anti-inflammatories, and mouthwashes have little evidence supporting their effectiveness.
At present, some companies have indulged themselves in initiating clinical trials that investigate new treatment options. Key players such as Innovation Pharmaceuticals (Brilacidin), Enzychem Lifesciences Corporation (EC-18), NeoMedLight (CareMin650), Monopar Therapeutics (Validive), MuReva (Lumitex) (MuReva Phototherapy System), EpicentRx/Prothex Pharma (RRx-001), Soligenix (SGX942), Galera Therapeutics (GC4419), BrainCool (Cooral/CoolPrevent), and several others are investigating their candidates for the management of Oral Mucositis in the 7MM.
To summarize many potential therapies are being investigated for the management of Oral Mucositis, and it is safe to predict that the treatment space will experience a significant impact in the coming years owing to the improvement in the rise in the number of healthcare spending across the world.
Note: Detailed Market Outlook will be provided in the final report.
The OM market size in the 7MM is expected to change during the study period 2018–2030. The therapeutic market of OM in the seven major markets is expected to increase during the study period (2018–2030) with a CAGR of 6.4%. According to the estimates, the highest market size of OM is found in the United States followed by Japan and Germany.
The United States Market Outlook
The total market size of OM therapies in the United States is expected to increase in the study period (2018–2030) with a CAGR of 7.0%.
EU-5 Countries: Market Outlook
The total market size of OM therapies in the EU-5 countries is expected to increase in the study period (2018–2030) with a CAGR of 5.8%.
Japan Market Outlook
The total market size of OM therapies in Japan is expected to increase in the study period (2018–2030) with a CAGR of 4.9%.
OM Pipeline Development Activities
The drugs/devices which are in pipeline include:
1.Avasopasem/GC4419 (Galera Therapeutics)
2. SGX942 (Soligenix)
3. CareMin650 (NeoMedLight)
4. Cooral/CoolPrevent (BrainCool)
Note: Detailed emerging therapies assessment will be provided in the final report.
Among emerging therapies, GC4419 from Galera Therapeutics, SGX942 from Soligenix, and Cooral system from BrainCool have the potential to disrupt the oral mucositis market. GC4419 and SGX942 are currently in phase III and targeting the head and neck cancer patients in their pivotal trial.
Growth of the oral mucositis market is expected to be mainly driven by increasing incidence of cancer cases, expected approval and readily penetration of emerging therapies, and an increase in Research and Development activities.
The high cost of treatment, little awareness about the disease, and lack of proper diagnostic methods are some of the factors which are expected to pose hurdles in the growth of the oral mucositis market.
Access and Reimbursement Scenario in OM Therapies
Oral Mucositis is a frequent complication of chemoradiation in head and neck cancer patients. Symptoms include painful and debilitating inflammation and ulceration, which increases a sufferer’s susceptibility to bacterial infections.
Fortovia offers the Fortovia Direct Rx Program, designed to facilitate access for all people who need the products, regardless of their insurance coverage, when fulfilled by a Fortovia Direct Rx specialty pharmacy. Fortovia Direct Rx Program offers:
- Support across the portfolio of products, including Gelclair.
- As little as USD 25 out-of-pocket costs for people who meet eligibility criteria.
- A streamlined Patient Assistance Program for uninsured, underinsured, Medicare, Medicaid, and indigent patients
- Free, 24-48 hour home delivery when ordered from a specialty pharmacy within the Fortovia Direct Rx network.
AMAG Pharmaceuticals launched patient reimbursement and support center for MuGard. Patients primarily received MuGard through specialty pharmacies, which received prescriptions from either MuGard patient reimbursement or support center, or the HUB, or physicians directly. HUB is a centralized patient intake and referral management center to process insurance coverage issues and administer our patient assistance and copayment programs. To provide MuGard to patients as soon as possible, the company has implemented a robust program that delivers a starter kit to clinicians, including a sample bottle and all pertinent information that the patient or caregiver needs to immediately begin MuGard therapy.
Note: Detailed Access and Reimbursement Scenario will be provided in the final report.
To keep up with current market trends, we take KOLs and SME’s opinion working in the OM domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or OM market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform a Competitive and Market Intelligence analysis of the OM Market by using various Competitive Intelligence tools that include – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of OM, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
- Comprehensive insight has been provided into the OM epidemiology and treatment in the 7MM.
- Additionally, an OM-inclusive account of both the current and emerging therapies for OM is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the OM market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the global OM market.
- In the coming years, the OM market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
- The companies and academics are working to assess challenges and seek opportunities that could influence OM R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
- Major players are involved in developing therapies for OM. The launch of emerging therapies will significantly impact the OM market.
- A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for OM.
- Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
OM Report Insights
- Patient Population
- Therapeutic Approaches
- OM Pipeline Analysis
- OM Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
OM Report Key Strengths
- 10 Years Forecast
- 7MM Coverage
- OM Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
OM Report Assessment
- SWOT Analysis
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Conjoint Analysis
- Market Attractiveness
- Market Drivers and Barriers
- What was the OM Market share (%) distribution in 2018 and how it would look like in 2030?
- What would be the OM total market size as well as market size by therapies across the 7MM during the study period (2018–2030)?
- What are the key findings pertaining to the market across the 7MM and which country will have the largest OM market size during the study period (2018–2030)?
- At what CAGR, the OM market is expected to grow in the 7MM during the study period (2018–2030)?
- What would be the OM market outlook across the 7MM during the study period (2018–2030)?
- What would be the OM market growth till 2030 and what will be the resultant market size in the year 2030?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
- OM patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
- How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration, and frequencies based on their clinical trial results?
- Among the emerging therapies, what are the potential therapies which are expected to disrupt the OM market?
- What is the disease risk, burden, and unmet needs of the OM?
- What is the historical OM patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
- What would be the forecasted patient pool of OM in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
- What will be the growth opportunities in the 7MM concerning the patient population pertaining to OM?
- Out of all the 7MM countries, which country would have the highest incident population of OM during the study period (2018–2030)?
- At what CAGR the population is expected to grow in the 7MM during the study period (2018–2030)?
- What are the various recent and upcoming events which are expected to improve the diagnosis of OM?
Current Treatment Scenario and Emerging Therapies:
- What are the current options for the treatment of OM?
- What are the current treatment guidelines for the treatment of OM in the US, Europe, and Japan?
- How many companies are developing therapies for the treatment of OM?
- How many therapies are developed by each company for the treatment of OM?
- How many emerging therapies are in the mid-stage and late stage of development for the treatment of OM?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the OM therapies?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for OM and their status?
- What are the key designations that have been granted for the emerging therapies for OM?
- What is the global historical and forecasted market of OM?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving the OM market.
- To understand the future market competition in the OM market and Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for OM in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for the OM market.
- To understand the future market competition in the OM market.