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

Gastroschisis Market Outlook

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

Gastroschisis Overview

Gastroschisis is a congenital anomaly characterized by a full-thickness defect in the abdominal wall near the umbilicus, allowing the protrusion of the intestines. It is uncommonly associated with genetic disorders. Unlike other similar conditions, the exposed bowel in gastroschisis lacks a protective membrane, leading to adhesion, dilation, and inflammation of the intestines. Infants with this condition often experience restricted intrauterine growth. Diagnosis is typically made during a 20-week ultrasound when freely floating bowel loops are observed within the uterus. Pregnancies affected by gastroschisis show elevated maternal serum alpha-fetoprotein (AFP) levels. In contrast to other prenatal abdominal wall defects such as omphalocele, only a small percentage (10%) of gastroschisis cases are accompanied by malformations outside the gastrointestinal tract. Infants with gastroschisis can be categorized as either simple or complex, which helps determine their prognosis and guide their care. The complexity classification is based on the presence or absence of complications like intestinal atresia, stenosis, perforation, necrosis, malrotation, or volvulus. The exact cause of gastroschisis is not fully understood. It arises due to a failure in the development and formation of the ventral body wall during embryogenesis, leading to the herniation of the intestines. Several factors have been implicated in the development of gastroschisis, including tobacco use, specific environmental exposures (such as nitrosamines and atrazine), the use of cyclooxygenase inhibitors (such as aspirin and ibuprofen), and certain decongestants (such as pseudoephedrine and phenylpropanolamine). The formation of the abdominal wall occurs during the fourth week of gestation, progressing in the craniocaudal and mediolateral directions. In the sixth week, the liver and midgut herniate through the umbilical cord, followed by the midgut returning to the abdominal cavity by the tenth week after completing the rotation. It generally has a more favorable prognosis, with excellent long-term outcomes, compared to other abdominal wall defects. The overall survival rate for live-born infants with gastroschisis is 98 percent. Infants with gastroschisis are more likely to be born prematurely (28% compared to 6% in unaffected infants). Complications can arise in infants with gastroschisis due to the need for total parenteral nutrition (TPN) and the associated risk of line sepsis, the configuration of the bowel leading to necrotizing enterocolitis (NEC), and infections of the abdominal wound resulting from gastroschisis closure.

• The incidence of gastroschisis in the United States (US) has increased, with an estimated incidence of 4.6 per 10,000 live 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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