Neurofibromas – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Neurofibromas Market Outlook

Thelansis’s “Neurofibromas Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Neurofibromas treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Neurofibromas Overview

Neurofibromas are benign nerve sheath tumors composed of differentiated neoplastic Schwann cells and a mixture of nonneoplastic components. These tumors can present as nodular and well-demarcated or diffuse growths. Intraneural neurofibromas typically grow along the nerve confined within its epineurium. The main cellular constituents of neurofibromas are neoplastic Schwann cells, characterized by small, curved, or elongated nuclei, along with fibroblasts embedded within a myxoid/collagenic matrix in varying proportions. While neurofibromas may exhibit focal resemblance to Antoni B pattern, they lack Antoni A pattern and hyalinized blood vessels, distinguishing them from schwannomas. The Schwann cell component in neurofibromas shows expression of S100 and SOX10 proteins. Both sporadic and syndromic neurofibromas are associated with a deletion in the NF1 gene. Sporadic cases only involve the lesional cells carrying the NF1 mutation, while syndromic cases result from a germline mutation in NF1, which encodes the tumor suppressor protein neurofibromin, located on chromosome 17q11.2. Diagnosing solitary superficial neurofibromas involves physical examination or excisional biopsy with microscopic examination. For larger lesions, additional imaging with CT/MRI is required to assess the extent of involvement and plan for surgical excision. Complete surgical excision is the preferred treatment for most cases, with an exceedingly low rate of local recurrence. Currently, there are no alternative therapies available for cutaneous neurofibromas. In rare instances in which complete surgical excision is not feasible for diffuse or plexiform neurofibromas, partial resection may be performed for cosmetic or symptomatic relief. All types of neurofibromas are benign, and the risk of malignant transformation is exceedingly low. However, around 10% of patients with NF1 may experience malignant transformation, emphasizing the importance of considering NF1 for any patient presenting with a plexiform neurofibroma. Plexiform neurofibromas are the most common precursor to malignant peripheral nerve sheath tumors (MPNSTs). Complications related to localized neurofibromas are typically mild and primarily associated with surgical excision, including pain, scarring, bleeding, and local infection. In plexiform lesions, complications arise from the inherent risks of surgery and the possibility of incomplete lesion removal. Patients with NF1 who have persistent lesions are at an increased risk of malignant transformation to malignant peripheral nerve sheath tumors (MPNSTs).

• Neurofibromatosis type 1 (NF1) accounts for approximately 96% of all neurofibromatosis cases, with a prevalence of 1 in 3000 births. It occurs equally between genders and races, and 50% of cases are associated with spontaneous mutations, while the other half has an inherited mutation. NF1 exhibits a 100% penetrance with variable expressivity.
• Neurofibromatosis type 2 (NF2) makes up around 3% of cases, with a prevalence between 1 in 33,000 births and 1 in 87,410. NF2 does not show gender or race predilection and presents variable manifestations among different families.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2022-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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