Lymphatic Malformations - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights

• Lymphatic malformations result from abnormalities in the development of the lymphatic vascular system during embryonic growth. In a large number of patients, the lymphatic malformations have an activating mutation in the PIK3CA gene.
• There are currently no treatments approved by the US FDA for lymphatic malformations. The current standard of care treatment options is mainly limited to procedural interventions such as surgery and sclerotherapy.
• Treatment success rates for surgery vary, especially for large infiltrative disease, and sclerotherapy, which involves an injection of a sclerosant into the vascular structure, is associated with a higher response rate of up to 75% in macro cystic lymphatic malformation but much less successful in microcystic lymphatic malformation.
• Sirolimus, although off-label could be an effective treatment for children with large complicated lymphatic malformations of the head and neck. As not all patients will benefit from treatment, the decision to treat sirolimus should be made by a multidisciplinary team.
• Currently, only a few pipeline products are in clinical development for the treatment of lymphatic malformations. Palvella Therapeutics, Protara Therapeutics, and Novartis are some of the key players.

DelveInsight's “Lymphatic Malformations – Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of the indication of lymphatic malformations, historical and forecasted epidemiology as well as the lymphatic malformations market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The lymphatic malformations market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM lymphatic malformations market size from 2020 to 2034. The report also covers current lymphatic malformations 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

Lymphatic Malformations Understanding and Treatment Algorithm

Lymphatic Malformations Overview, Country-Specific Treatment Guidelines and Diagnosis

Lymphangiomas are uncommon, benign malformations of the lymphatic system that can occur anywhere on the skin and mucous membranes. Lymphangiomas can be categorized as deep or superficial based on the depth and size of the abnormal lymphatic vessels or as congenital or acquired.

The deep forms of lymphangioma include two specific well-defined congenital entities: cavernous lymphangiomas and cystic hygromas. Superficial forms of lymphangioma include lymphangioma circumscriptum and acquired lymphangioma, which are also referred to in the literature as lymphangiectasia. Although both entities share similar clinical and histologic features, the term lymphangioma circumscriptum infers lymphatic channel dilation due to a congenital malformation of the lymphatic system. Whereas, the term lymphangiectasia, or acquired lymphangioma, denotes dilated lymphatic channels of previously normal lymphatics that have become obstructed by an external cause.

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

Lymphatic Malformations Treatment

Both superficial and deep lymphangiomas can be difficult to treat. When feasible the treatment of choice for any type of lymphangioma, however, remains surgical excision. Wide local excision of the affected lymphatic channels is necessary as recurrence is common.

Destructive treatments with carbon dioxide (CO2) laser, long-pulsed Nd-YAG laser, and electrosurgery have been reported to improve symptoms. Cryotherapy, superficial radiotherapy, and sclerotherapy with 23.4% hypertonic saline are less commonly used modalities. Direct injection of a sclerosing agent, including 1% or 3% sodium tetradecyl sulfate, doxycycline, or ethanol, can be made into lymphatic malformations. Compression may reduce swelling caused by lymphedema. Infection prevention is crucial.

Lymphatic Malformations Epidemiology

The lymphatic malformations 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 Lymphatic Malformations epidemiology is segmented with detailed insights into Total Prevalent Cases of Lymphatic Malformations, Diagnosed Prevalent Cases of Lymphatic Malformations, Location-specific Cases of Lymphatic Malformations, Total Treated Cases of Lymphatic Malformations in the 7MM [2020-2034].

• According to the National Organization for Rare Disorders (NORD), lymphatic malformations affect males and females in equal numbers. Most lymphatic malformations are evident at birth or within two years of age, and the prevalence is approximately 1:4000 live births.
• As per Orphanet, the prevalence of lymphatic malformations is nearly 1-5 /10,000.
• Most significant lymphatic malformations are seen by age 2, after lymph fluid has built up and stretched the vessels of the lymphatic malformation or there is bleeding into it. But some aren't found until the teen years or later.

Lymphatic Malformations Drug Chapters

The drug chapter segment of the lymphatic malformations report encloses a detailed analysis of Lymphatic Malformations emerging drugs. It also deep dives into the lymphatic malformations pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Emerging Drugs

TARA-002: Protara Therapeutics

TARA-002 is an investigational cell therapy in development for the treatment of lymphatic malformations. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with the release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-1b, IL-6, IL-12, granulocyte-macrophage colony-stimulating factor (GM-CSF) and natural killer cells. TARA-002 is a biologic product derived from the same cell bank as OK-432, a lyophilized mixture of Streptococcus pyogenes, and works as an immunomodulator to induce an immune response against tumor cells.

• Protara Therapeutics is currently conducting a Phase II (STARBORN-1) clinical trial for patients with lymphatic malformations. TARA-002 has been granted Rare Pediatric Disease Designation (RPDD) by the US FDA for the treatment of lymphatic malformations.

QTORIN rapamycin: Palvella Therapeutics

QTORIN rapamycin 3.9% is designed to target the PI3K/AKT/mTOR pathway, which is over-activated in Micro LM. QTORINTM rapamycin 3.9% topical gel delivers rapamycin deep into the dermis, the area where the disease originates.

• Palvella Therapeutics has completed a Phase II clinical study for people with micro-lymphatic malformations.

Alpelisib: Novartis

Alpelisib works by selectively inhibiting Class I PI3K p110α, which is the catalytic subunit of PI3K, a lipid kinase that plays a role in various biological processes, including proliferation, survival, differentiation, and metabolism.

• Novartis is currently conducting a Phase II/III study of alpelisib in pediatric and adult patients with lymphatic malformations associated with a PIK3CA mutation.

Lymphatic Malformations Market Outlook

The market size of lymphatic malformations in the seven major markets is expected to increase substantially from 2024 with upcoming emerging therapies.

Lymphatic Malformations 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…

Lymphatic Malformations Activities

The report provides insights into different therapeutic candidates. 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 Lymphatic Malformations 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 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as Nationwide Children’s Hospital, Columbus, OH, the United States, University Hospitals Dorset NHS Foundation Trust, North Shore University Health System, Evanston, Illinois, etc., were contacted. Their opinion helps understand and validate current and emerging treatment patterns of Lymphatic Malformations. 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 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.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Lymphatic Malformations, 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 Lymphatic Malformations 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 Lymphatic Malformations.

Lymphatic Malformations Report Insights

• Patient Population
• Therapeutic Approaches
• Lymphatic Malformations Pipeline Analysis
• Lymphatic Malformations Market Size and Trends
• Existing and future Market Opportunity

Lymphatic Malformations Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Lymphatic Malformations Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on emerging therapies
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Lymphatic Malformations 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 Lymphatic Malformations treatment market?
• What was the Lymphatic Malformations 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 off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of Lymphatic Malformations?
• How many companies are developing therapies for the treatment of Lymphatic Malformations?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Lymphatic Malformations 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.
• 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 emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• 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.

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