Primary Hyperoxaluria – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Primary Hyperoxaluria Market Outlook

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

Primary Hyperoxaluria Overview

Primary hyperoxalurias are inborn errors in glyoxylate and oxalate metabolism. They are characterized by excessive oxalate production, a metabolic emend product. The most common type of PH, PH1, is caused by a deficiency of the liver-specific peroxisomal, pyridoxal phosphate-dependent enzyme alanine: glyoxylate aminotransferase. The second type, PH2 is caused by a deficiency in glyoxylate reductase/ hydroxypyruvate reductase, a cytosolic enzyme. The recently identified PH type 3 is linked to the gene DHDPSL, encoding a mitochondrial enzyme, although the metabolic reactions involved remain to be confirmed. Including AGXT, over twenty-five different mutations have been identified so far, and around 30% of patients have the G630A mutations leading to Gly170A amino-acid substitutions. Primary hyperoxaluria types 1, 2, and 3 are caused by mutations in the AGXT, GRHPR, and HOGA1 genes. These genes provide instructions for making enzymes that help with the breakdown and processing of protein building blocks and other compounds.

• Primary Hyperoxaluria in the United States is approximately 1:58,000. PH3 was predicted to be as prevalent as PH1 and twice as common as PH2, indicating that PH3 (and PH2) cases are underdiagnosed and/or incompletely penetrant. As per the registry, most PH patients had PH Type 1, followed by PH Type 2 and PH Type 3. Maximum patients had their first symptom between the ages of 0-4, 5-9, and 10-19.

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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