Tuberous Sclerosis Complex (TSC) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Tuberous Sclerosis Complex (TSC) Market Outlook

Thelansis’s “Tuberous Sclerosis Complex (TSC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" 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 Tuberous Sclerosis Complex treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Tuberous Sclerosis Complex (TSC) Overview

Tuberous Sclerosis Complex (TSC) is a rare genetic neurocutaneous multisystem disorder with a variable clinical phenotype. Autosomal-dominant mutations distinguish it in TSC1 or TSC2, which cause overactivation of the mTOR (mechanistic target of rapamycin) pathway, resulting in increased cell proliferation and a variety of other consequences. The disease's hallmark is benign tumor growth, with the central nervous system (CNS), kidney, and skin being the most commonly affected organs. TSC features develop in an age-dependent manner. Approximately 70% of patients with TSC develop abdominal angiomyolipomas; patients also exhibit two types of lung pathology—noncalcified nodular lesions characterized by multifocal micronodular pneumocyte hyperplasia (MMPH) and cystic lung disease identical in histological appearance to lymphangioleiomyomatosis (LAM).

• The most common clinical feature at diagnosis of TSC was the central nervous system (CNS) involvement in around 73.3% to 81% of patients; among those, 95.2% experienced seizures.
• The overall prevalence of seizure disorders was seen at 69.8%. Cutaneous involvement was seen in 58.1% of patients, with the most common lesion being hypomelanotic macules in 92%. Cardiac rhabdomyoma manifested in half of the patients, 25.6% of these with cardiac arrhythmia.

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: 2023-2033

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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