Homologous Recombination Deficiency (HRD) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Homologous Recombination Deficiency (HRD) Market Outlook

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

Homologous Recombination Deficiency (HRD) Overview

Homologous recombination deficiency (HRD) is a cellular phenotype characterized by the inability to repair double-strand DNA effectively breaks through the homologous recombination repair (HRR) pathway. This condition can arise from mutations in BRCA1, BRCA2, and other HRR pathway genes. Various tumor types, including breast, ovarian, prostate, and pancreatic cancers, have been linked to deficiencies in the HRR pathway. Cells lacking functional HRR must rely on alternative, less precise DNA repair pathways. These pathways can lead to widespread genomic alterations, including insertions, deletions, copy number changes, and structural rearrangements. Molecular techniques can detect these genomic scars, which are indicative of HRD. Alterations in these genes have been identified as potential "causes" of HRD, encompassing genetic and epigenetic events. HRR is a vital DNA repair mechanism that corrects various types of DNA damage, particularly double-strand breaks and interstrand cross-links, using the sister chromatid as a repair template. While other genes in the HRR pathway, such as ATM, PALB2, and RAD51, have also been linked to HRD, their associations with different cancers are less consistent than BRCA1/2. The FDA has approved multiple companion or complementary diagnostics. These diagnostics aim to aid in selecting appropriate PARP inhibitor (PARPi) treatments based on the HR status of patients. Among these diagnostics are FoundationOne CDx and the Myriad myChoice CDx test, which evaluate chromosomal instability. They help identify ovarian cancer patients who could benefit from an FDA-approved therapy. These assays take into account both the causes and consequences of HRR impairment, setting them apart from other FDA-approved tests like BRACAnalysis CDx, FoundationOne Liquid CDx, and FoundationOne CDx, which primarily focus on detecting potential causes of HRR impairment. Lynparza (olaparib), Zejula (niraparib), and Rubraca (rucaparib), these PARPi drugs utilize HRD as biomarkers for patient selection in both initial and recurrent cases of epithelial ovarian, fallopian tube, or primary peritoneal cancers.

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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