Chronic Venous Insufficiency - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• In 2023, the total market size of Chronic Venous Insufficiency accounted for ~USD 2.00 billion in the 7MM.
• According to the analyst's estimates, in 2023, there were approximately 470 million total prevalent cases of CVD in the 7MM. These cases are projected to rise during the study period.
• In the US, there were 52 million total diagnosed prevalent cases of CVD in 2020.
• The Duo Venous Stent System was approved by the US Food and Drug Administration (FDA) on December 26, 2023.
• In August 2023, Medtronic announced that an updated ClosureFast radiofrequency ablation (RFA) catheter in a lower 6-F profile received FDA 510(k) clearance and is now available in the United States for the treatment of CVI.
• On January 11, 2022 Philips completed the acquisition of Vesper Medical Inc, a US-based medical technology company that develops minimally-invasive peripheral vascular devices. The acquisition is part of Philips’ Image Guide Therapy segment and expand Philips’ portfolio of diagnostic and therapeutic devices with an advanced venous stent portfolio for the treatment of deep venous disease. The upfront purchase price paid involved an amount of EUR 227 million.

This report delivers an in-depth understanding of Chronic Venous Insufficiency, historical and forecasted epidemiology as well as the Chronic Venous Insufficiency market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Chronic Venous Insufficiency market report provides current treatment practices, emerging drugs/devices, Chronic Venous Insufficiency market share of individual therapies, and current and forecasted Chronic Venous Insufficiency market size from 2020 to 2034, segmented by seven major markets. The report also covers current Chronic Venous Insufficiency treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Chronic Venous Insufficiency (CVI) Disease Understanding and Treatment Algorithm

Chronic Venous Insufficiency Overview

CVD is a prevalent medical condition affecting the venous system, particularly the veins in the lower extremities. It encompasses a spectrum of venous disorders, ranging from mild cosmetic concerns like spider veins to severe and debilitating conditions like venous ulcers. CVI refers to the more advanced stages of CVD, which is a globally prevalent long-term condition in which the impaired blood flow in either superficial or deep veins, leads to increased venous pressure, known as venous hypertension. This condition manifests through various pathological changes, including swelling in the lower extremities, skin changes, and discomfort, all due to elevated venous pressure.

Chronic Venous Insufficiency Diagnosis

The diagnosis of CVI involves a combination of clinical features and confirmatory diagnostic studies. The primary modality used for diagnosis is venous duplex ultrasound, which is a noninvasive imaging technique that provides detailed information about blood flow and venous anatomy. The clinical presentation of CVI typically includes a combination of symptoms such as dependent pitting edema, leg discomfort, fatigue, and itching. Patients may also exhibit telangiectasias, reticular veins, varicose veins, pain, and cramping, itching, prickling, and throbbing sensations. As the disease progresses, patients may develop varicose veins, tenderness, refractory edema, and skin changes, including dermal atrophy, hyperpigmentation, and ulcer formation.

Chronic Venous Insufficiency Treatment

Patients with CVI should be treated based on the severity and nature of the disease. The main objectives of treatment include alleviating discomfort and swelling, improving the skin's condition, decreasing venous reflux and varicose veins, and promoting ulcer healing. The recommended management approach is to utilize conservative treatments (such as leg elevation, resistance exercises, weight management, and compression therapy) alone or in conjunction with other therapies, including medications and interventional procedures.

Chronic Venous Insufficiency (CVI) Epidemiology

For the epidemiology forecast model of CVI, the total prevalent cases of CVD were first calculated for the adult population. Since not all patients with CVD are diagnosed, using the disease diagnosis rate, the number of diagnosed prevalent cases of CVD was determined. From this segmentation, the diagnosed prevalent cases specific to CVI were derived by aggregating the total cases within stages C3-C6 of the CEAP classification. Subsequently, these CVI cases were further segmented to ascertain the number of cases specific to each gender. in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In the 7MM, the total prevalent cases of CVD were 463 million in 2020,
• In the 7MM, the US accounted for the highest number of prevalent cases of Chronic Venous Insufficiency, with nearly 6.2 million in 2020.
• Among EU4 and the UK, Germany accounted for the highest number of cases of Chronic Venous Insufficiency, followed by UK, whereas Spain occupied the bottom of the ladder.
• According to the analyst's epidemiology model for CVD, the C1 stage had the highest diagnosed prevalence in the United States.

Chronic Venous Insufficiency Drug/Device Chapters

The Drug/Device chapter segment of the Chronic Venous Insufficiency report encloses a detailed analysis of the late-stage (Phase III and Phase II/III) and early-stage (Phase I/II) pipeline Drug/Device. The current key players for emerging drugs/devices and their respective drug\device candidates include Verigraft AB (P-TEV), enVVeno Medical Corporation (VenoValve), enVVeno Medical Corporation (EnVVe), and others. The Drug/Device chapter also helps understand the Chronic Venous Insufficiency clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.

Marketed

Venclose System: BD

The Venclose System consists of two main components: 1) Maven Catheter with integrated cable connector and, 2) digiRF Generator which delivers radiofrequency (RF) energy to the Maven catheter. The Maven catheter is a sterile single-use disposable medical device for endovenous radiofrequency ablation. The primary components of the catheter include the shaft, handle and integrated connector cable. The catheter shaft is 6 French (6F = 2.0 mm in diameter) in profile, with an insertable length of 40 cm and a 0.5 cm heating coil. The catheter is energized by the digiRF Generator which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. The Venclose Maven System (digiRF Generator and Maven Catheter) uses resistive radiofrequency ablation (via energy delivered to heat the wall of an incompetent vein) with temperature-controlled RF energy, and an already widely accepted procedure to cause irreversible luminal occlusion. This is followed by fibrosis and ultimately resorption of the vein. The Venclose Maven System (digiRF Generator and Maven Catheter) supports an optional foot pedal.

ActiTouch: Tactile Medical

The ACTitouch™ System applies compression to the leg (lower leg, ankle, and foot). It consists of four main parts:

• The Compression Sleeve consists of four chambers that inflate with air to apply pressure 10 the leg. It's simple wrap-around design with hook and loop fasteners means the Compression Sleeve can be fitted to many differently shaped legs and can be applied and removed with ease.
• The Control Unit fits into the Compression Sleeve during device use. It monitors and adjusts the air pressure to ensure the correct level of compression is applied to the leg.
• The Undersock is designed to draw perspiration and moisture away from the skin and has padding in key areas to provide additional comfort.
• The Power Adapter/Charger is used to power the device directly or to charge the battery for ambulatory use.

The device has two modes of operation: Sustained Compression Mode and Intermittent Pneumatic Compression Mode. Sustained Compression Mode enables the Control Unit to provide accurate and continuously monitored compression levels to the lower limb. Intermittent Pneumatic Compression Mode enables a programmed sequence of cyclical pressures to be applied to the lower limb.

Emerging Devices

VenoValve: enVVeno Medical Corporation

The VenoValve is a first-in-class surgically implanted medical device being developed to treat deep venous Chronic Venous Insufficiency (CVI). The VenoValve is implanted into the femoral vein via a 5-6 inch incision in the upper thigh under general or regional anesthesia. It is designed to act as a one-way valve to help restore proper blood flow up the leg and back to the heart. It has received FDA Breakthrough Device Designation and is the first device to receive IDE approval from the FDA for the treatment of deep venous CVI.

A pivotal clinical trial called SAVVE is currently underway to assess the safety and effectiveness of the VenoValve. The trial has fully enrolled patients across multiple sites in the US. Preliminary 11-month data from the SAVVE trial showed that 94% of patients experienced clinical improvement, with 72% achieving clinically meaningful benefit (=3 point improvement in rVCSS score). The average rVCSS improvement for those with clinically meaningful benefit was 8.46 points. A previous first-in-human study published 1-year and 2-year outcomes demonstrating sustained safety and effectiveness of the VenoValve, supporting further study of this novel treatment for severe deep venous CVI.

Emerging Drugs

P-TEV: Verigraft AB

P-TEV (Personalized Tissue-Engineered Veins) is an advanced therapy medicinal product (ATMP) being developed by Verigraft as an alternative to autologous or synthetic vascular grafts used in reconstructive vein surgery. The P-TEV drug substance consists of an extracellular matrix (ECM) scaffold in the form of a decellularized (DC) allogeneic vein scaffold which is populated with autologous components from the patient's own peripheral whole blood (PWB) in an ATMP manufacturing process performed under GMP. As the allogeneic immunogenic material has been removed from the donated vein segment by DC and as the perfusion uses autologous PWB, no immunosuppression is required.

Long-term studies in pigs showed that P-TEV grafts were fully patent, well recellularized and revascularized at 6, 12 and 14 months after transplantation. Gene expression analysis confirmed the cells were highly similar to native vein cells. A first-in-man clinical trial (TECVI-1) is ongoing in Europe to evaluate the feasibility and safety of P-TEV in 15 patients with chronic venous insufficiency (CVI).

Chronic Venous Insufficiency Market Outlook

In the CVI pipeline among the emerging candidates, SONOVEIN, which is a robotic solution for non-invasive echotherapy treatment using high-intensity focused ultrasound (HIFU) technology. It operates independently without the need for additional accessories such as guide wires, puncture kits, or catheters. The device is being evaluated in a VEINRESET study, which is now transitioning into a 12-month follow-up period, with results projected for release by 2025. The company plans to file the market approval application with the FDA once the study report is available in the second half of 2025.

• The US accounted for the largest market size of Chronic Venous Insufficiency in the 7MM, with nearly USD 1.20 billion in 2023.
• Among EU4 and the UK, Germany accounted for the maximum market size in 2023, while Italy occupied the bottom of the ladder.
• Among all the Non-Pharmacological treatments, Laser Ablation/Radiofrequency Ablation is expected to generate the highest revenue followed by Surgery in the 7MM by 2034.

Chronic Venous Insufficiency Drug/Device Uptake

This section focuses on the rate of uptake of the potential Drug/Device expected to be launched in the market during the study period. The analysis covers Chronic Venous Insufficiency market uptake by Drug/Device; patient uptake by therapies; and sales of each Drug/Device.

Chronic Venous Insufficiency Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for Chronic Venous Insufficiency emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair Department of Critical Care Medicine and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Chronic Venous Insufficiency market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the University of California, Johns Hopkins University School of Medicine, University of Michigan, etc., were contacted. Their opinion helps understand and validate Chronic Venous Insufficiency epidemiology and market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug/device in the trials.

Market Access and Reimbursement

Botulinum toxin injections, commonly referred to as Botox injections, are a primary treatment for Chronic Venous Insufficiency. They work by blocking the signals from the nerves to the muscles, thereby reducing muscle contractions and alleviating symptoms. Since injections of botulinum toxin are usually given every few months, the expense of each injection session can mount up over time. Including the price of the toxin itself as well as any additional costs related to the procedure, like facility and medical professional fees. Additionally, due to the temporary nature of the effects of botulinum toxin injections, they need to be repeated regularly to maintain symptom relief. This can result in ongoing expenses for patients and healthcare systems. Furthermore, the financial cost of treating Chronic Venous Insufficiency with injections of botulinum toxin can add up to a considerable amount.

Therefore, paying for medicines encourages better control and adherence to treatment regimens. In the long run, medication reimbursement can result in cost savings for the healthcare system through promoting adherence to treatment plans and enhanced disease control. Furthermore, better symptom control could mean fewer hospital stays, extra medical services, or interventions for uncontrolled Chronic Venous Insufficiency.

Nevertheless, several organizations in the 7MM are working to provide support to Chronic Venous Insufficiency patients and spread awareness, including the CMS coverage for botulinum toxin types A and B, IPSEN CARES Patient Access Program, BOTOX Savings Program, XEOMIN Savings Program, and others.

Scope of the Report

• The report covers a descriptive overview of Chronic Venous Insufficiency, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into Chronic Venous Insufficiency epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Chronic Venous Insufficiency is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Chronic Venous Insufficiency market; historical and forecasted is included in the report, covering the 7MM Drug/Device outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Chronic Venous Insufficiency market.

Chronic Venous Insufficiency Report Insights

Chronic Venous Insufficiency Report Insights

• Patient Population
• Therapeutic Approaches
• Chronic Venous Insufficiency Pipeline Analysis
• Chronic Venous Insufficiency Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Chronic Venous Insufficiency Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Chronic Venous Insufficiency Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drug/Device Uptake

Chronic Venous Insufficiency Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the Chronic Venous Insufficiency market share (%) distribution in 2020 and what it would look like in 2034?
• What would be the Chronic Venous Insufficiency total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
• What are the key findings about the market across the 7MM and which country will have the largest Chronic Venous Insufficiency market size during the study period (2020-2034)?
• At what CAGR, the Chronic Venous Insufficiency market is expected to grow at the 7MM level during the study period (2020-2034)?
• What would be the Chronic Venous Insufficiency market outlook across the 7MM during the study period (2020-2034)?
• What would be the Chronic Venous Insufficiency market growth till 2034 and what will be the resultant market size in the year 2034?
• What are the disease risks, burdens, and unmet needs of Chronic Venous Insufficiency?
• What is the historical Chronic Venous Insufficiency patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What would be the forecasted patient pool of Chronic Venous Insufficiency at the 7MM level?
• What will be the growth opportunities across the 7MM concerning the patient population of Chronic Venous Insufficiency?
• Out of the above-mentioned countries, which country would have the prevalent population of Chronic Venous Insufficiency during the study period (2020-2034)?
• At what CAGR the population is expected to grow across the 7MM during the study period (2020-2034)?
• How many companies are developing therapies for the treatment of Chronic Venous Insufficiency?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Chronic Venous Insufficiency?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to Chronic Venous Insufficiency therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the clinical studies going on for Chronic Venous Insufficiency and their status?
• What are the key designations that have been granted for the emerging therapies for Chronic Venous Insufficiency?
• What are the 7MM historical and forecasted market of Chronic Venous Insufficiency?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving Chronic Venous Insufficiency.
• To understand the future market competition in the Chronic Venous Insufficiency market and Insightful review of the SWOT analysis of Chronic Venous Insufficiency.
• Organize sales and marketing efforts by identifying the best opportunities for Chronic Venous Insufficiency in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Chronic Venous Insufficiency market.
• To understand the future market competition in the Chronic Venous Insufficiency market.