Venous Leg Ulcers (VLUs) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Venous Leg Ulcers (VLUs) Market Outlook

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

Venous Leg Ulcers (VLUs) Overview

Venous leg ulcers (VLUs) result from chronic venous insufficiency (CVI) and venous hypertension, typically appearing in later stages. Under normal circumstances, the contraction of calf muscles and functioning intraluminal valves encourage forward blood flow while preventing backflow. However, when retrograde flow or obstructions occur, chronic venous hypertension develops, leading to dermatologic and vascular complications that eventually lead to VLU formation. Although CVI is a well-recognized cause of VLU development, ulceration occurs infrequently (5.1%), and the reasons behind this are not entirely clear. CVI may arise from blood reflux, obstruction, or both, disrupting macro- and micro-circulatory functions. This heightened intraluminal pressure results in the leakage of proteins and the creation of fibrin cuffs, hindering the diffusion of oxygen and growth factors and triggering an inflammatory response. At the cellular level, vein wall remodeling, and varix formation involve mast cell degranulation, recruitment of leukocytes, increased presence of matrix metalloproteinase inhibitors and prostacyclin, transformation of smooth muscle cells into a non-contractile secretory phenotype, and differentiation of fibroblasts into myofibroblasts. The inflammatory environment is sustained mainly by M1 macrophages, which release IL-1α, IFN-γ, and TGF-β1. Ultimately, this sequence of chronic inflammation and compromised blood flow contributes to blood clots forming, further exacerbating fibrosis and damage to valves. This cascade of inflammatory events impairs the natural healing process, leading to the development of ulcers when injuries occur. Most risk factors for VLU development cannot be altered, and patients often have multiple factors. These include a family history of CVI, older age, female gender, previous thrombosis or pulmonary embolism, multiple pregnancies, lipodermatosclerosis, and musculoskeletal and joint disorders. Modifiable risk factors such as obesity and a sedentary lifestyle also affect venous disease. The established treatment approach for VLUs involves two main strategies: compression therapy and direct wound care. Effectively reducing leg edema is crucial for successful wound closure. Various conservative options address venous hypertension, including medical, intermittent pneumatic compression (IPC), manual lymphatic drainage, and extracorporeal shockwave therapy. For VLUs that are less than a year old and smaller than 10 cm2 upon initial assessment, the likelihood of failing to close within six months stands at 29%. This probability rises to 78% for wounds over a year old and larger than 10 cm2. Additional risk factors associated with poor healing include older age, non-white ethnicity, high body mass index, impaired calf muscle pump function, venous reflux, thrombosis, deep vein involvement, and insufficient high-level compression.

• The estimated annual incidence of Venous leg ulcers in the USA is 0.73 cases per 1000 person-years.

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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