Familial Adenomatous Polyposis (FAP) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2024 To 2034

Familial Adenomatous Polyposis (FAP) Market Outlook

Thelansis’s “Familial Adenomatous Polyposis (FAP) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2024 To 2034" 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 Familial Adenomatous Polyposis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Familial Adenomatous Polyposis (FAP) Overview

Familial adenomatous polyposis (FAP) is an autosomal-dominant disorder stemming from a germline mutation in the adenomatous polyposis coli (APC) gene, situated on chromosome 5q21. The hallmark of FAP is the emergence of numerous adenomatous polyps along the gastrointestinal mucosa, notably in the colon, leading to a high likelihood of colorectal cancer. FAP also presents extracolonic manifestations such as osteomas, epidermal cysts, desmoid tumors, hamartomatous polyps in the upper gastrointestinal tract, congenital hypertrophy of the retinal pigmented epithelium (CHRPE), hepatoblastomas, and thyroid tumors. Thyroid nodules afflict around 38% of FAP patients, with thyroid cancer often diagnosed before FAP detection in a third of cases. Compared to sporadic instances, FAP patients face a tenfold increase in thyroid cancer risk, particularly papillary thyroid carcinoma (PTC) occurring at a frequency ranging from 0.7% to 12%. Predominantly, follicular thyroid carcinoma (FTC) and concurrent PTC and FTC are the primary thyroid malignancies observed in FAP, though isolated cases of medullary thyroid cancer have also been documented. Notably, young women with FAP have a staggering 160 times higher risk for PTC than the general population.

The majority of APC mutations responsible for FAP involve the introduction of a premature stop codon induced by nonsense mutations (30%), frameshift mutations (68%), or large deletions (2%), resulting in truncation of the protein product's C-terminal region. Over 700 distinct disease-causing APC mutations have been identified thus far.

Celecoxib, as adjunctive therapy, has been granted approval from both the US Food and Drug Administration and the European Medicines Agency for FAP patients. While individuals with FAP carry a 100% risk of colorectal cancer, participation in screening and treatment initiatives significantly diminishes this risk.

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: 2024-2034

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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