ALK-positive NSCLC – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

ALK-positive NSCLC Market Outlook

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

ALK-positive NSCLC Overview

In a subset of non-small cell lung cancer (NSCLC) patients, a rare occurrence of rearrangements exists within the Anaplastic lymphoma kinase (ALK) gene. These alterations induce perpetual activation of the ALK kinase, subsequently leading to the formation of ALK-driven tumors. Individuals harboring such rearrangements exhibit heightened sensitivity to ALK inhibitors like crizotinib, ceritinib, and alectinib. ALK-positive NSCLC occurs in approximately 1 out of every 25 NSCLC cases. ALK-positive tumor patients typically skew towards a younger demographic and are more commonly found among never-smokers or light smokers. Indeed, ALK rearrangements are observed in 12% of never-smokers, contrasting to the mere 2% incidence in former or current smokers. Notably, ALK rearrangements seldom coincide with activating mutations in EGFR or KRAS. In comparison to those with EGFR-mutant NSCLC, patients with ALK-positive tumors exhibit a higher likelihood of being male. Furthermore, individuals with advanced ALK-positive NSCLC face an augmented risk of developing brain metastases, a significant contributor to both morbidity and mortality. For diagnostic purposes, the Fluorescence in situ hybridization (FISH) assay, particularly the Vysis® ALK Break-Apart FISH Probe Kit test from Abbott Molecular, stands as the recommended method for detection. Various second and third-generation tyrosine kinase inhibitors (TKIs) have been formulated to address resistance to treatment, effectively targeting numerous ALK resistance mutations. Notably, studies have shown that first-line therapy employing alectinib, ceritinib, lorlatinib, or brigatinib surpasses crizotinib or chemotherapy, where applicable, in managing patients with ALK-rearranged disease.

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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