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Chronic Venous Ulceration (CVU) - Market Insights, Epidemiology and Market Forecast– 2030

Chronic Venous Ulceration (CVU) - Market Insights, Epidemiology and Market Forecast– 2030

  • January 2021
  • 200 pages
  • ID: 6010462
  • Format: PDF
  • Delve Insight

Summary

Table of Contents

‘Chronic Venous Ulceration (CVU) - Market Insights, Epidemiology and Market Forecast– 2030’ report delivers an in-depth understanding of the CVU, historical and forecasted epidemiology as well as the CVU market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The CVU market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM CVU market size from 2017 to 2030. The report also covers current CVU treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017–2030
Chronic Venous Ulceration (CVU) Disease Understanding and Treatment Algorithm

Chronic Venous Ulceration (CVU) Overview
Chronic vein ulceration (CVU) is a defect in the skin below the level of the knee that occurs due to improper functioning of venous valves, persisting for more than six weeks with no tendency to heal after three or more months. Hence, also known as leg ulcers or lower limb ulcers or venous ulcers, or venous insufficiency or stasis ulcer.cancerous or cells along the lining of the colon or rectum mutate and grow out of control, forming a tumor.
The venous abnormality that leads to venous leg ulceration may involve abnormalities at different locations in the venous system, of different extent, and different etiologies. Possible causes of venous ulcers include inflammatory processes resulting in leukocyte activation, endothelial damage, platelet aggregation, and intracellular edema. Venous ulcers are often recurrent, and open ulcers can persist from weeks to many years. Severe complications include cellulitis, osteomyelitis, and malignant change. Although the overall prevalence is relatively low, the refractory nature of these ulcers increase the risk of morbidity and mortality and have a significant impact on patient quality of life
The pathophysiology of venous ulcers is not entirely clear. Venous incompetence and associated venous hypertension are thought to be the primary mechanisms for ulcer formation. Factors that may lead to venous incompetence include immobility; ineffective pumping of the calf muscle; and venous valve dysfunction from trauma, congenital absence, venous thrombosis, or phlebitis.
Risk factors for venous ulcers include varicose veins, history of blood clots in the legs (deep vein thrombosis), blockage of the lymph vessels, which causes fluid to build up in the legs, older age, being female, or being tall, family history of venous insufficiency, obesity, pregnancy, smoking, sitting or standing for long periods (usually for work) and fracture of a long bone in the leg or other serious injuries, such as burns or muscle damage. The symptoms of a venous ulcer include pain, itching, and swelling in the affected area. There may also be discolored, or hardened skin around the ulcer, and the sore may produce a foul-smelling discharge.

Chronic Venous Ulceration (CVU) Diagnosis
On physical examination, venous ulcers are generally irregular and shallow. Granulation tissue and fibrin are often present in the ulcer base. Other findings include lower extremity varicosities, edema, venous dermatitis associated with hyperpigmentation and hemosiderosis or hemoglobin deposition in the skin, and lipodermatosclerosis associated with thickening and fibrosis of normal adipose tissue under the skin.
Currently, widely available duplex scanning is considered the standard test of choice. Venography and imaging with contrast CT scan or MR venography are used infrequently and usually only when there is uncertainty about the Duplex scan information. Other methods of diagnosing venous diseases such as plethysmography and handheld Doppler do not give a good indication of the sites of venous incompetence. In a Duplex scan for chronic venous disease, the deep veins, superficial veins, and the communicating veins are evaluated.

Chronic Venous Ulceration (CVU) Treatment
Treatment options for venous ulcers include conservative management, mechanical treatment, medications, and surgical options. In general, treatment goals are to reduce edema, improve ulcer healing, and prevent a recurrence. Treatment must be multidisciplinary and individualized according to the characteristics of the patient and the illness.
Compression therapy is the standard of care for venous ulcers and chronic venous insufficiency. Studies have found that venous ulcers heal more quickly with compression therapy than without. This reduces edema in the leg that is considered to impede the healing process. The compression may be applied by either bandage or by compression stockings. In patients with an open ulcer, bandages are normally preferred because the exudate damages the stockings and shortens their lifespan. Presently, five categories of the extremities’ compression therapy are available: compression bandages, compression stockings, self-adjustable Velcro devices, compression pumps, and hybrid devices. Compression bandages and compression stockings are most commonly used for short-term application after varicose vein interventions. Methods include inelastic, elastic, and intermittent pneumatic compression. Compression therapy reduces edema, improves venous reflux, enhances healing of ulcers, and reduces pain. Success rates range from 30–60% at 24 weeks and 70–85% after one year. After an ulcer has healed, lifelong maintenance of compression therapy may reduce the risk of recurrence.
Pentoxifylline (400 mg three times per day) has been shown to be an effective adjunctive treatment for venous ulcers when added to compression therapy. Pentoxifylline may also be useful as monotherapy in patients who are unable to tolerate compression bandaging. Like pentoxifylline therapy, aspirin (300 mg per day) combined with compression therapy has been shown to increase ulcer healing time and reduce ulcer size, compared with compression therapy alone. Bacterial colonization and superimposed bacterial infections are common in venous ulcers and contribute to poor wound healing. Oral antibiotics are recommended to treat venous ulcers only in cases of suspected cellulitis. Suspected osteomyelitis warrants an evaluation for arterial disease and consideration of intravenous antibiotics to treat the underlying infection. The role of surgery is to reduce venous reflux, hasten healing, and prevent ulcer recurrence. Surgical options for treatment of venous insufficiency include ablation of the saphenous vein; interruption of the perforating veins with subfascial endoscopic surgery; treatment of iliac vein obstruction with stenting; and removal of incompetent superficial veins with phlebectomy, stripping, sclerotherapy, or laser therapy.

Chronic Venous Ulceration (CVU) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Prevalent Cases of Venous Ulcers, Diagnosed Prevalent Cases of Venous Ulcers , Diagnosed Prevalent Cases of Venous Leg Ulcers, Type-specific Distribution of Venous Ulcers, Gender-specific Distribution of Venous Ulcers and Age-specific Distribution of Venous Ulcers in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.

Key Findings
This section provides glimpse of the Venous Ulcers epidemiology in the 7MM.
• The prevalent population of Venous Ulcers in the seven major markets was be 4,231,024 in 2020.
• The diagnosed prevalent population of Chronic Venous Ulcers in the seven major markets is estimated to be 2,004,905 in 2020.
• The diagnosed prevalent population of Venous Ulcers in the United States was 2,630,551 in 2020.
• The diagnosed prevalent population of Venous Leg Ulcers in the United States was estimated to be 2,104,441 in 2020.
• In the United States, the number of males and females with Venous Ulcers was estimated to 1,052,221 and 1,578,331, respectively, in 2020.
• Depending on the duration for healing, venous ulcers can be of two types: Acute Venous Ulcers, and Chronic Venous Ulcers. The diagnosed prevalent cases of Acute Venous Ulcers and Chronic Venous Ulcers in the United States were 1,407,345 and 1,223,206 in 2020 .
• In 2017, the diagnosed prevalence of Venous Ulcers in the United States, was highest in the age group of >70 years, followed by 60–70 years and <60 years with 2,012,513, 402,503, and 100,626 cases, respectively.
• In the EU5 countries, the diagnosed prevalence of Venous Ulcers was maximum in Germany with 326,283 cases, followed by the France with 229,729 cases in 2017. While, the least number of cases were in Spain, with 176,037 cases in 2017.
• In Japan, the diagnosed prevalence of Venous Ulcers is estimated to be 490,734 in 2020.



Country-wise Chronic Venous Ulceration (CVU) Epidemiology
The epidemiology segment also provides the Chronic Venous Ulceration (CVU)epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

Chronic Venous Ulceration (CVU) Drug Chapters
The drug chapter segment of the Chronic Venous Ulceration (CVU) report encloses the detailed analysis of Chronic Venous Ulceration (CVU) marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Chronic Venous Ulceration (CVU) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.

Chronic Venous Ulceration (CVU) Emerging Drugs
Allogeneic ABCB5-positive Stem Cells: Rheacell
Allo-APZ2-CVU is being developed by Rheacell, a subsidiary of Ticeba, for the treatment of CVU. Administering ABCB5-positive stem cells to the patients leads to anti-inflammation by interacting with immune cells (e.g., macrophages, T-cells, B-cells), switching from a pro-inflammatory to an anti-inflammatory environment giving the body a chance to heal.These ABCB5+ MSCSs are classified by the European Medicines Agency (EMA) as an Advanced Therapy Medicinal Product (ATMP) manufactured by Ticeba in a patented process.
Product details in the report…
EscharEx: MediWound
EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. It is a mixture of proteolytic enzymes for the management of the debridement of chronic and other hard-to-heal wounds. It is easy to use, and it is a non-surgical topical application that demonstrated safety and efficacy in the debriding of chronic wounds in several etiologies within a few daily applications..
Product details in the report…
TTAX01: Tissue Tech
TTAX01 is being developed by Tissue tech for the management of venous leg ulcers and non-healing wounds. It is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. It is based on the company’s proprietary technology CRYOTEK process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue are being used. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP).
Product details in the report…

Chronic Venous Ulceration (CVU) Market Outlook
Complex wounds are those that do not heal after 3 months or more. These wounds are a significant burden on the healthcare system and result in patient and caregiver stress, economic loss, and decreased quality of life. Chronic wounds are those wounds that fail to heal promptly or become stuck in the inflammatory phase of healing. The most common types of chronic wounds are venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs).
The current treatment modalities for venous ulcers include conservative management, mechanical modalities, medications, advanced wound therapy, and surgical options. Although the main goal of treatment is ulcer healing, secondary goals include reducing edema and preventing recurrence. Evidence-based treatment options for venous ulcers include leg elevation, compression therapy, dressings, pentoxifylline, and aspirin therapy. Topical antiseptics, including cadexomer iodine (Iodosorb), povidone-iodine (Betadine), peroxide-based preparations, honey-based preparations, and silver, have also been used to treat venous ulcers. Surgical management may be considered for ulcers that are large in size, of prolonged duration, or refractory to conservative measures. Compression therapy is a gold standard treatment modality for the initial and long-term treatment of venous ulcers in patients without the concomitant arterial disease. Dressings are recommended to cover ulcers and promote moist wound healing. Dressings are chosen based on wound location, size, depth, moisture balance, infection presence, allergies, comfort, odor management, ease and frequency of dressing changes, cost, and availability.
Antibiotics such as aspirin, pentoxifylline, phlebotonics, and other non-inflammatory medications are preferred to combat the ulcer. Venous ulcers that do not improve within four weeks of standard wound care should prompt consideration of adjunctive treatment options, which include skin grafting and the use of cellular and tissue-based products. Like conservative therapies, the goal of operative and endovascular management of venous ulcers (i.e., endovenous ablation, ligation, subfascial endoscopic perforator surgery, and sclerotherapy) is to improve healing and prevent ulcer recurrence.
In terms of current emerging therapies, the pipeline of CVUs holds potential products by several key players, such as Rheacell (Allogeneic ABCB5-positive Stem Cells), Tissue Tech (TTAX01 Allograft), and MediWound (EscharEx). Overall, the increasing prevalence of the disease and the promising emerging pipeline therapies will fuel the market during the forecasted period of 2017–2030.

Key Findings
This section includes a glimpse of the CVU 7MM market.
• The market size of CVU in the seven major markets was estimated to be USD 1,626.4 Million in 2020.
• The United States accounts for the largest market size of CVU in comparison to EU5 (the United Kingdom, Germany, France, Italy, and Spain) and Japan.
• Among the EU5 countries, Germany had the highest market size with USD 92.2 Million in 2017, while Spain had the smallest market size of CVU with USD 49.7 Million in 2017, which is expected to rise during the study period 2017–2030.
• The Japan CVU market accounted for USD 142.8 Million in 2020.

The United States Market Outlook
This section provides the total Chronic Venous Ulceration (CVU) market size and market size by therapies in the United States.

EU-5 Market Outlook
The total Chronic Venous Ulceration (CVU) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook
The total Chronic Venous Ulceration (CVU) market size and market size by therapies in Japan are provided.
Chronic Venous Ulceration (CVU) Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the Chronic Venous Ulceration (CVU) market or expected to get launched in the market during the study period 2017–2030. The analysis covers Chronic Venous Ulceration (CVU) market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Chronic Venous Ulceration (CVU) Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Chronic Venous Ulceration (CVU) emerging therapies.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Chronic Venous Ulceration (CVU) market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

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

Report Highlights
• In the coming years, CVU market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence CVU R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• The analyst analysed gender-specific data of Venous Ulcers, which suggests that Venous Ulcers is more prevalent in females than in males.
• The analyst has also analysed data on types of Venous Ulcers, which suggests that Acute Venous Ulcers was more common than Chronic Venous Ulcers.
• The diagnosed prevalence of venous ulcers and venous leg ulcers was also analyse.
• Age-specific data of Venous Ulcers suggests that prevalence of Venous Ulcers in the US, was highest in the age group of >70 years, followed by 60–70 years and <60 years.
• Currently, the treatment regimen of CVU mainly includes Compression Therapy (monotherapy with or without other classes of drugs (antibiotics, antiseptics), Antibiotics/Antiseptics/anti-inflammatory drugs and others.
• Expected Launch of potential therapies, Allogeneic ABCB5-positive Stem Cells/ Allo-APZ2-CVU (Rheacell), EscharEx (EX-02 Formulation) (MediWound) and TTAX01 Allograft (Tissue Tech), may increase the market size in the coming years, assisted by an increase in the prevalent population of CVU.

Chronic Venous Ulceration (CVU) Report Insights
• Patient Population
• Therapeutic Approaches
• Chronic Venous Ulceration (CVU) Pipeline Analysis
• Chronic Venous Ulceration (CVU) Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Chronic Venous Ulceration (CVU) Report Key Strengths
• Eleven Years Forecast
• 7MM Coverage
• Chronic Venous Ulceration (CVU)Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Chronic Venous Ulceration (CVU) Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:
• What was the Chronic Venous Ulceration (CVU) market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the Chronic Venous Ulceration (CVU) total market size as well as market size by therapies across the 7MM during the forecast period (2020–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Chronic Venous Ulceration (CVU) market size during the forecast period (2020–2030)?
• At what CAGR, the Chronic Venous Ulceration (CVU) market is expected to grow at the 7MM level during the forecast period (2020–2030)?
• What would be the Chronic Venous Ulceration (CVU) market outlook across the 7MM during the forecast period (2020–2030)?
• What would be the Chronic Venous Ulceration (CVU) market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:
• What is the disease risk, burden and unmet needs of Chronic Venous Ulceration (CVU)?
• What is the historical Chronic Venous Ulceration (CVU) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of Chronic Venous Ulceration (CVU) at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Chronic Venous Ulceration (CVU)?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Chronic Venous Ulceration (CVU)during the forecast period (2020–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020–2030)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
• What are the current options for the treatment of Chronic Venous Ulceration (CVU) along with the approved therapy?
• What are the current treatment guidelines for the treatment of Chronic Venous Ulceration (CVU) in the US and Europe?
• What are the Chronic Venous Ulceration (CVU) marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Chronic Venous Ulceration (CVU)?
• How many therapies are developed by each company for the treatment of Chronic Venous Ulceration (CVU)?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Chronic Venous Ulceration (CVU)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Chronic Venous Ulceration (CVU) therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Chronic Venous Ulceration (CVU) and their status?
• What are the key designations that have been granted for the emerging therapies for Chronic Venous Ulceration (CVU)?
• What are the 7MM historical and forecasted market of Chronic Venous Ulceration (CVU)?

Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the Chronic Venous Ulceration (CVU).
• To understand the future market competition in the Chronic Venous Ulceration (CVU) market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Chronic Venous Ulceration (CVU) in the US, Europe (Germany, Spain, Italy, France, and 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 Chronic Venous Ulceration (CVU) market.
• To understand the future market competition in the Chronic Venous Ulceration (CVU) market.

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