DelveInsight’s ‘Ascites-Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the Ascites, historical and forecasted epidemiology as well as the Ascites market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The Ascites market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Ascites market size from 2021 to 2030. The Report also covers current Ascites treatment practice, market drivers, market barriers, SWOT analysis, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2018–2030
Ascites Disease Understanding and Treatment Algorithm
Ascites (hydroperitoneum is a rare synonym) is defined as an abnormal amount of intraperitoneal fluid. Ascites is a condition in which fluid collects in spaces within the abdomen. If severe, ascites may be painful. The problem may keep the patient from moving around comfortably. Fluid may also move into the chest and surround the lungs. This condition can make eating, drinking, and moving around difficult. It can also make it hard to breathe.
Ascites is common in patients with cirrhosis and usually develops when their liver is beginning to fail. The elevation of the pressure in the veins that run through the liver (portal hypertension) and a decrease in liver function due to the scarring on the liver result in the fluid build-up.
The initial evaluation of a patient with ascites includes medical history, physical examination, and laboratory assessment, including electrolytes and liver and renal biochemistry.
Patients with ascites should be questioned about the pattern of body weight gain, change in abdominal girth, and ankle edema. Information about the medical history, medication use, lifestyle, risk factors for liver disease, and infectious disease risk (e.g. migration) are relevant to discover the underlying etiology.
A physical screening exam should be carried out in every patient, with the awareness of signs of liver disease (erythema palmar, spider naevi, splenomegaly), heart failure (peripheral edema, jugular venous distension, third heart sound, pulmonary rales), and malignancy (lymphadenopathy). The abdomen should be inspected for the presence of bulging flanks, and percussion can reveal flank dullness. Flank dullness is found when approximately 1,500 mL of ascites is present.
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The treatment of ascites largely depends on the underlying cause. For example, peritoneal carcinomatosis or malignant ascites may be treated by surgical resection of cancer and chemotherapy, while management of ascites related to heart failure is directed toward treating heart failure with medical management and dietary restrictions.
The most important step to treat ascites is to reduce salt intake strictly. Salt intake is limited to 4–5 g/day (2,000 mg of sodium) or less. As it can be difficult to determine the salt content of various foods, it is generally recommended that a patient with ascites see a nutritionist (dietician) for advice about various foods to avoid. Patients may use salt substitutes, but it is essential to choose one without potassium because the potassium levels can increase with certain medications to treat ascites. It is important to discuss with the doctor or the dietician which salt substitute may be safer to use.
Most often, patients will require water pills (diuretics) to treat ascites. Commonly used water pills are spironolactone (Aldactone) and/or furosemide (Lasix) and their dosages are appropriately adjusted. These water pills can cause problems with blood electrolytes (levels of sodium and potassium) and as such close monitoring by blood tests may be required. It is important to realize that taking water pills is not a substitute for reducing salt intake, as water pills will work only when they are taken together with restricted salt intake. For Refractory Ascites, the therapeutic options include paracentesis, transjugular intrahepatic portosystemic shunt (TIPS), peritoneovenous shunt, and others.
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The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Number of Ascites Cases due to Cirrhosis, Number of Ascites Cases by Malignancies, and Severity-specific Cases of Ascites due to Cirrhosis scenario in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.
- In 2020, the total cases of Ascites due to cirrhosis in the 7MM was 240,730, which is likely to increase by 2030 at a CAGR of 0.61% for the study period (2018–2030).
- Malignant Ascites cases are calculated from ovarian cancer, stomach cancer, breast cancer, and colorectal cancer. In 2020, The number of cases of Ascites from these cancers was 8,521; 3,538; 12,650; and 10,276, respectively, in the US.
- According to DelveInsight’s analysis, in 2020, there were 26,841 and 122,277 cases of Grade I and Grade II & III ascites due to cirrhosis in the United States.
- Among the EU-5 countries, the highest cases of Ascites due to cirrhosis were found in Germany (20,004), followed by the UK (15,845) and France (11,138). The least cases of Ascites due to cirrhosis were found in Spain (4,904).
- There were 29,571 cases of ascites due to cirrhosis in Japan in 2020.
The epidemiology segment also provides the Ascites epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Ascites Drug Chapters
Ascites Emerging Drugs
BIV201 (Terlipressin): BioVie
BIV201 is an investigational therapy containing terlipressin as an active agent. Terlipressin, intravenously administered small molecule vasoconstrictor, can correct ascites by vasoconstricting the blood vessels where the blood is pooling, and restoring blood flow through the kidneys and liver. This reduces portal vein pressure and increases blood volume in the arteries. Consequently, the body may respond by shutting down the renin–angiotensin–aldosterone system (RAAS) system and halting the accelerating fluid generation cycle in ascites patients. In 2019, BioVie submitted a detailed protocol to the FDA to evaluate BIV201 in a large-scale US phase IIb/III clinical trial in refractory ascites patients for a new simplified method for delivering BIV201 therapy in the home care setting. In May 2020, the FDA CMC Division gave clearance to use a new prefilled syringe in the phase II trial (subject to additional standard tests). Room temperature stability of the prefilled syringe has been confirmed at 6 months, with the potential for 12 months or up to 2 years of stability (yet to be confirmed). Room temperature storage presents a key product differentiation versus terlipressin products in countries where the drug is approved. BioVie is planning to initiate a pivotal phase III clinical trial to begin the first half of 2021 and NDA filling in mid-2022. The company estimates that the pivotal Phase III study will involve approximately 120 ascites patients.
N-003 (Ambrisentan): Noorik Biopharmaceuticals AG
Ambrisentan is a receptor antagonist of endothelin, a potent vasoconstrictor. N-003 is a proprietary formulation of ambrisentan suitable for administering alternative doses to patients with advanced liver disease and cirrhosis. Experimental and clinical data have shown that endothelin antagonism rapidly and significantly reduces portal pressure by reversing endothelin-induced intra-hepatic vasoconstriction, a key component of Portal Hypertension. In 2018, Noorik Biopharmaceuticals completed phase IIa study of N-003 (ambrisentan) in patients with cirrhosis and a history of ascites. The successful completion of this phase IIa represented a milestone in the development of N-003. Based on these positive findings, a phase IIb study is initiated to evaluate the effect of N-003 (ambrisentan) on portal pressure as determined by the Hepatic Venous Pressure Gradient (HVPG) in patients with cirrhosis and a history of refractory Ascites Ambrisentan is marketed since 2007 in the US as Letairis and in Europe as Volibris. Ambrisentan (5 and 10 mg) is currently used to treat some forms of pulmonary arterial hypertension. Noorik Biopharmaceuticals is in the process of securing orphan designation for the complications of cirrhosis.
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Ascites Market Outlook
Ascites is a condition in which fluid collects in spaces within the abdomen. If severe, ascites may be painful. The problem may keep you from moving around comfortably. Fluid may also move into the chest and surround the lungs. This makes it hard to breathe. The development of ascites generally suggests that the liver is not working well. The survival rate 5 years after ascites develop is only 30–40%, and the patient and doctor must discuss a referral to a liver specialist and a liver transplant center.
The principles behind the treatment of ascites due to cirrhosis include diuretics, paracentesis, insertion of a transjugular intrahepatic portosystemic shunt (TIPS), as well as managing complications to ascites such as spontaneous bacterial peritonitis (SBP). Mild and moderate ascites due to liver cirrhosis can be treated with dietary sodium restriction, treatment of the underlying disorder, fluid restriction, use of diuretics, and use of therapeutic paracentesis. The treatment of refractory ascites in liver cirrhosis includes optimization of medical management, serial large volume paracenteses, transjugular intrahepatic portosystemic shunt (TIPS), peritoneovenous shunt, and liver transplantation.
Sodium restriction and diuretics are the mainstays of treatment for patients with ascites due to portal hypertension, but patients with low Serum Ascites Albumin Gradient (SAAG) (less than 1.1 g/dL) ascites do not respond well to these measures, except those with nephrotic syndrome.
Tolvaptan, a novel aquaporin modulator, was made available in Japan in 2013 for the treatment of patients with refractory ascites due to cirrhosis. However, it is not approved in Japan for the treatment of ascites.
According to Rudler et al. (2020) when medical therapy fails, transjugular intrahepatic portosystemic shunts (TIPS) are the first-line treatment in patients with ascites as TIPS which have been shown to improve ascites as well as survival compared to repeated paracentesis. TIPS are contraindicated in patients with the most severe presentation, with a high MELD or a high Child–Pugh score, or with hepatic encephalopathy (HE), and liver transplantation is the only curative option. Furosemide is added in non-responders or in patients who develop hyperkaliaemia at a 40 mg/day dose to a maximum dose of 160 mg/day. Other general measures and treatments have also been evaluated: (a) it has not been shown that prolonged maintenance of the supine position improves the resolution of ascites; (b) there is evidence that the treatment of the underlying liver disease can improve ascites, such as abstinence from alcohol or viral suppression; (c) the use of several drugs is contraindicated to avoid renal impairment, such as non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors or aminoglycosides (except in patients with severe bacterial infections); (d) other treatments such as midodrine, terlipressin or clonidine are not recommended.
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- The market size of Ascites due to Cirrhosis in the 7MM was estimated to be USD 993.0 million in 2020, which is further expected to increase by 2030.
- The United States holds the largest market share of the Ascites due to Cirrhosis among the 7MM countries. In 2020, the market size of Ascites due to cirrhosis in the US was USD 757.0 million.
- Among the EU-5 countries, Germany had the highest market share, followed by the UK and France, in 2020.
- Japan holds the third-largest share of the 7MM Ascites market due to Cirrhosis with a market size of USD 54.0 million in 2020 that is expected to increase by 2030.
The United States Market Outlook
This section provides the total Ascites market size and; market size by therapies in the United States.
EU-5 Market Outlook
The total Ascites 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 Ascites market size and market size by therapies in Japan are provided.
Ascites Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched in the Ascites market or expected to get launched in the market during the study period 2018–2030. The analysis covers the Ascites 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 allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Ascites 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 Ascites emerging therapies.
Reimbursement Scenario in Ascites
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Ascites 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 Ascites, explaining its causes, symptoms, pathophysiology, genetic basis, and currently available therapies.
- Comprehensive insight has been provided into the Ascites epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for Ascites is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the Ascites 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 Ascites market.
- The robust pipeline with novel MOA and oral ROA, increasing incidence, effectiveness of drugs as both mono and combination therapy will positively drive the Ascites market.
- The companies and academics are working to assess challenges and seek opportunities that could influence Ascites R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
- Major players are involved in developing therapies for Ascites. The launch of emerging therapies will significantly impact the Ascites market.
- Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
Ascites Report Insights
- Patient Population
- Therapeutic Approaches
- Ascites Pipeline Analysis
- Ascites Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Ascites Report Key Strengths
- 10 Years Forecast
- 7MM Coverage
- Ascites Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Ascites Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- SWOT analysis
- What was the Ascites market share (%) distribution in 2018 and how it would look like in 2030?
- What would be the Ascites total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
- What are the key findings pertaining to the market across the 7MM and which country will have the largest Ascites market size during the forecast period (2021–2030)?
- At what CAGR, the Ascites market is expected to grow at the 7MM level during the forecast period (2021–2030)?
- What would be the Ascites market outlook across the 7MM during the forecast period (2021–2030)?
- What would be the Ascites 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?
- What are the disease risk, burdens, and unmet needs of Ascites?
- What is the historical Ascites patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
- What would be the forecasted patient pool of Ascites at the 7MM level?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Ascites?
- Out of the above-mentioned countries, which country would have the highest population of Ascites during the forecast period (2021–2030)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the treatment of Ascites along with the approved therapy?
- What are the current treatment guidelines for the treatment of Ascites in the US and Europe?
- What are the Ascites 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 Ascites?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of Ascites?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Ascites 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 Ascites and their status?
- What are the key designations that have been granted for the emerging therapies for Ascites?
- What are the 7MM historical and forecasted market of Ascites?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving Ascites.
- To understand the future market competition in the Ascites market and Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for Ascites 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 the Ascites market.
- To understand the future market competition in the Ascites market.