APOL1-Mediated Kidney Disease (AMKD) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

APOL1-Mediated Kidney Disease (AMKD) Market Outlook

Thelansis’s “APOL1-Mediated Kidney Disease (AMKD) 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 APOL1-Mediated Kidney Disease treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

APOL1-Mediated Kidney Disease (AMKD) Overview

Apolipoprotein L-1 (APOL1) variants pose a heightened risk of end-stage kidney disease (ESRD) among African American individuals. These coding variants are associated explicitly with non-diabetic chronic kidney disease, focal segmental glomerulosclerosis (FSGS), and HIV-associated nephropathy in patients of African descent. APOL1, a small 42 kd protein primarily found in the kidney and enriched in glomeruli, harbors two allelic variants: G1 (S342G and I384M) and G2 (N388del: Y389del), both altering the APOL1 protein sequence within an anti-trypanosome activity domain. The majority of individuals with recent African ancestry diagnosed with HIV-associated nephropathy (HIVAN), FSGS, and hypertension-attributed ESRD exhibit APOL1-associated kidney disease. Clinical studies on kidney transplantation reveal no significant correlation between APOL1 genotype and serum APOL1 protein levels or kidney disease presence. The persistent disparities in long-term outcomes following kidney transplantation from African American versus European American deceased donors, as well as the heightened risk of subsequent nephropathy among African American living kidney donors, have long been recognized without clear etiology. Notably, recipients of kidneys from African American deceased donors lacking APOL1 renal-risk genotypes exhibit comparable allograft survival to those from European American donors lacking APOL1 renal-risk variants. Moreover, healthy African American living kidney donors with APOL1 high-risk genotypes face a significantly increased likelihood of developing Stage 3 or higher CKD, including ESRD, 12 years post-donor nephrectomy compared to counterparts without APOL1 renal-risk genotypes.

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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