Otoferlin Gene-Mediated Hearing Loss – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032

Otoferlin Gene-Mediated Hearing Loss Market Outlook

Thelansis’s “Otoferlin Gene-Mediated Hearing Loss Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 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 Otoferlin Gene-Mediated Hearing Loss treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Otoferlin Gene-Mediated Hearing Loss Overview

Hearing loss is a common congenital sensory disorder, affecting 1 in 500 newborns with bilateral hearing impairment. Around 50% to 60% of these cases have a genetic cause, with 80% attributed to autosomal recessive hearing loss. The OTOF gene, which encodes otoferlin, is a prominent contributor to non-syndromic recessive sensorineural hearing loss. OTOF-related deafness has two distinct forms: prelingual non-syndromic auditory neuropathy spectrum disorder (ANSD) and temperature-sensitive auditory neuropathy spectrum disorder (TS-ANSD). OTOF-related ANSD is characterized by severe-to-profound bilateral deafness from birth without inner-ear anomalies visible on MRI or CT scans of the temporal bones. Otoacoustic emissions (OAEs) are present, but auditory brain stem response is abnormal at birth. Newborn hearing screenings relying on OAEs alone may miss this condition in most cases, as OAEs can decrease or disappear with age in 20%-80% of individuals. TS-ANSD typically presents with mild to moderate hearing loss (0-55 dB) at normal body temperature. However, an increase in body temperature (approximately 0.5°C or more) can trigger sudden and severe-to-profound bilateral hearing loss, which usually resolves within hours of returning to baseline body temperature.

• The prevalence of OTOF pathogenic variants in individuals with congenital autosomal recessive non-syndromic deafness varies depending on their ethnic background.

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: 2021-2032

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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