Exstrophy-Epispadias Complex (EEC) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Exstrophy-Epispadias Complex (EEC) Market Outlook

Thelansis’s “Exstrophy-Epispadias Complex (EEC) 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 Exstrophy-Epispadias Complex treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Exstrophy-Epispadias Complex (EEC) Overview

Exstrophy-Epispadias Complex (EEC) is a spectrum of genitourinary malformations that range in severity from epispadias (E) and classical bladder exstrophy (CEB) to exstrophy of the cloaca (EC), which is the most severe form. EEC encompasses various anatomical structures, including the urinary system, musculoskeletal system, pelvis, pelvic floor, abdominal wall, genitalia, and sometimes the spine and anus. EEC is characterized by a visible defect in the lower abdominal wall, which may manifest as an evaginated bladder plate in classical bladder exstrophy or an open urethral plate in males and a cleft in females in cases of epispadias. This results in urine leakage from the ureteric orifices, which is evident on the bladder surface or through the urethra. In rare cases of cloacal exstrophy, two exstrophied hemibladders, omphalocele, imperforate anus, and spinal defects may be observed at birth. Additionally, there are atypical forms of EEC, including duplicated exstrophy, covered exstrophy, and pseudo-exstrophy. The underlying cause of EEC remains unknown, but it was suggested that a possible genetic component. Environmental factors may also contribute to the etiology of the condition. Diagnosis of EEC is typically made at birth based on clinical presentation, but it can also be detected prenatally through careful ultrasound examinations. Non-visualization of a normally filled fetal bladder in repeated ultrasounds may indicate the presence of EEC. Management of EEC primarily involves surgical intervention, with the primary goals being secure closure of the abdominal wall, achieve urinary continence while preserving renal function, and provide adequate cosmetic and functional genital reconstruction. Currently, various methods for bladder reconstruction, including staged or one-stage approaches, are favored worldwide. Another alternative involves removing the bladder template and creating a complete urinary diversion to a rectal reservoir. After reconstructive bladder surgery, approximately 80% of patients are expected to achieve continence during childhood.

• The prevalence of classic bladder exstrophy in the United States is approximately 2.15 per 100,000 births. Male epispadias occurs in about 1 in 117,000 births, while female epispadias is rarer in 1 in 484,000 births. Cloacal exstrophy is the least common, affecting about 1 in 200,000 to 400,000 births.

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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