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Hepatorenal Syndrome Market Set to Experience Unprecedented Growth During the Forecast Period (2023-32) - Estimates DelveInsight | Noorik Biopharmaceuticals, Mallinckrodt, BioVie

As per DelveInsight, the Hepatorenal Syndrome Market is anticipated to evolve immensely in the coming years owing to the rise in the number of cases of Hepatorenal Syndrome and the expected launch of emerging therapies like terlipressin (Mallinckrodt) and BIV201 (BioVie).
Published 01 December 2023

DelveInsight's "Hepatorenal Syndrome Market Insights, Epidemiology, and Market Forecast 2032" report provides comprehensive insights into the disease landscape, encompassing historical and forecasted epidemiological data, along with an analysis of the Hepatorenal Syndrome market. The report offers valuable information regarding market size, share, emerging trends, and growth prospects across the seven major markets (7MM), including the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

Additionally, the report delves into emerging therapies for Hepatorenal Syndrome, providing insights into current treatment methodologies, individual therapy market shares, and a comprehensive evaluation of the market size, spanning from 2019 to 2032. It assesses the existing treatment practices and algorithms for Hepatorenal Syndrome, investigates the key factors influencing market growth, identifies barriers, and highlights unmet medical needs. This comprehensive analysis aims to pinpoint opportunities and gauge the market's inherent potential to address the critical aspects of Hepatorenal Syndrome management.

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Hepatorenal Syndrome Market Outlook

Hepatorenal Syndrome: An Overview

Hepatorenal Syndrome (HRS) is a unique form of functional renal failure due to diminished renal blood flow, which occurs typically in histologically normal kidneys. It is a severe complication of advanced liver disease and characteristically affects patients with cirrhosis and ascites.

The definition of Hepatorenal Syndrome evolved with time, and the term became synonymous with severe organ dysfunction that involved both the liver and kidneys simultaneously. According to a new definition recently recommended by the International Club of Ascites (ICA), Hepatorenal Syndrome diagnosis relies on serum creatinine changes instead of a fixed high value. The main change produced by adopting the new definition of Hepatorenal Syndrome is the removal of a rigid, very high cut-off value of sCr (2.5 mg/dL or 220 μmol/L) to start pharmacologic treatment. This change will facilitate early treatment administration and potentially achieve better efficacy.

The approach to Hepatorenal Syndrome in patients with cirrhosis is witnessing significant changes, with a better understanding of the underlying pathophysiological mechanisms. Newer changes in definitions of the syndrome allow better categorization of the patient into different categories of Hepatorenal Syndrome. It also allows earlier identification and earlier institution of pharmacotherapy when it is most effective.

Hepatorenal Syndrome Therapeutics Analysis

The mainstay of treatment remains vasopressor therapy with albumin to reverse splanchnic vasodilation and improve RBF. Vasoconstrictor therapy causes constriction of splanchnic vessels, resulting in increasing the effective circulating blood volume, which increases renal perfusion and glomerular filtration. Vasoconstrictors are often combined with albumin to improve their clinical benefits. Vasoconstrictors used for Hepatorenal Syndrome management are terlipressin, noradrenaline, and the combination of midodrine + octreotide.

Currently, there are no FDA-approved medications explicitly indicated for Hepatorenal Syndrome. In the US, albumin is frequently used to control Hepatorenal Syndrome symptoms. In cases where these treatments cannot be used or are ineffective, beta-blockers, rifaximin, and somatostatin are administered.

With increased knowledge regarding liver cirrhosis, portal hypertension, ascites as well as Hepatorenal Syndrome, new pharmacological treatments such as the administration of terlipressin and albumin have proven useful in improving the short-term outcome of Hepatorenal Syndrome. The future treatment of Hepatorenal Syndrome will likely target the multiple aspects of the pathophysiological process.

To improve the treatment scenario, Several major pharma and biotech companies are developing therapies for Hepatorenal Syndrome. Currently, Noorik Biopharmaceuticals is leading the therapeutics market with its Hepatorenal Syndrome drug candidates in the most advanced stage of clinical development.

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Hepatorenal Syndrome Market Trends

Hepatorenal Syndrome Therapeutic Advancements and Emerging Treatments:

  • Hepatorenal Syndrome Clinical Trial Progression and Key Companies: The market is set to experience significant growth, driven by the progression of emerging therapies expected for launch between 2023 and 2032. Pioneering companies, including Noorik Biopharmaceuticals, Mallinckrodt, BioVie, and others, are actively engaged in developing novel drugs for potential market entry.
  • Hepatorenal Syndrome Emerging and Marketed Therapies: Ongoing research and development activities are fostering the introduction of innovative therapies designed to address the signs and symptoms of Hepatorenal Syndrome. Some of the emerging therapies in the pipeline include Ambrisentan (Noorik Biopharmaceuticals), Terlipressin (Mallinckrodt), BIV201 (BioVie), and others.

Recent Developments in the Hepatorenal Syndrome Market

  • On August 22, 2022, Ocelot Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of Hepatorenal Syndrome. Ocelot Bio is currently enrolling patients in a Phase 2 clinical trial of OCE-205 in Hepatorenal Syndrome with acute kidney injury (HRS-AKI), a serious and rapidly progressive consequence of ESLD that leads to acute renal failure and is associated with high rates of morbidity. 
  • On June 13, 2022, Mallinckrodt plc (OTCMKTS: MNKKQ) announced the resubmission of the Company's New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational agent terlipressin to treat adults with Hepatorenal Syndrome (HRS) involving rapid reduction in kidney function, an acute and life-threatening condition for which there is currently no FDA-approved treatment.

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Clinical, Commercial, and Regulatory Activities in the Hepatorenal Syndrome Market

Gastroesophageal Reflux Disease Market Growth Factors and Associated Trends

The Hepatorenal Syndrome (HRS) market across the seven major markets faces a complex landscape influenced by diverse growth factors, drivers, and barriers. One of the primary growth drivers is the escalating prevalence of liver diseases, particularly cirrhosis, leading to an increased risk of developing Hepatorenal Syndrome. The rise in chronic liver conditions due to factors like alcohol abuse, viral hepatitis infections, and non-alcoholic fatty liver disease significantly contributes to the incidence of Hepatorenal Syndrome. Moreover, advancements in diagnostic techniques and increased awareness among healthcare professionals regarding early detection and management of Hepatorenal Syndrome have augmented market growth. 

However, several barriers impede market expansion. Limited understanding of the pathophysiology of Hepatorenal Syndrome poses challenges in developing targeted therapies. Additionally, stringent regulatory requirements for drug approvals, especially for orphan diseases like Hepatorenal Syndrome, hinder the introduction of new treatments into the market. Financial constraints and the high cost of specialized treatments further restrict access to appropriate therapies for patients. 

Despite these barriers, collaborations between pharmaceutical companies, ongoing research and development efforts, and emerging treatments in the pipeline offer hope for addressing these challenges. Moreover, the growing emphasis on precision medicine and personalized treatment approaches indicates potential breakthroughs, paving the way for sustained growth in the Hepatorenal Syndrome market within these major regions.

Hepatorenal Syndrome Market

The report's market outlook section offers a comprehensive understanding of the historical, present, and projected market size. It scrutinizes the influence of existing and upcoming pipeline therapies for Hepatorenal Syndrome. Moreover, it conducts a thorough evaluation of the factors driving and hindering the Hepatorenal Syndrome market, highlighting unmet needs and emerging technologies poised to shape the market's dynamics in the foreseeable future.

The report meticulously outlines the market trends concerning each marketed Hepatorenal Syndrome drug and mid to late-stage pipeline therapies. This evaluation gauges their impact by considering various aspects such as the annual cost of therapy, Mechanism of Action (MOA), Route of Administration (ROA), molecule types, competitive landscape among therapies, brand value, and their collective influence on the market dynamics.

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Hepatorenal Syndrome Therapeutics Market Forecast

Hepatorenal Syndrome Epidemiology Assessment 

The epidemiology section offers valuable insights into the historical, present, and anticipated trends in Hepatorenal Syndrome epidemiology across the seven major countries (7MM) from 2019 to 2032. This section aims to identify the factors contributing to current and projected Hepatorenal Syndrome epidemiological patterns by examining diverse studies and research findings. Additionally, it furnishes a comprehensive analysis of diagnosed and prevalent patient populations, and future projections, and incorporates perspectives from key opinion leaders to enrich the understanding of this disease landscape.

The Report Covers the Hepatorenal Syndrome Epidemiology, Segmented as -

  • Total Incident Cases of Hepatorenal Syndrome [2019–2032]
  • Total Diagnosed Prevalent Cases of Hepatorenal Syndrome [2019–2032]
  • Type-specific Cases of Hepatorenal Syndrome [2019–2032]

Hepatorenal Syndrome Drugs Uptake and Pipeline Development Activities

The drug uptake section concentrates on evaluating the adoption rate of newly launched or upcoming potential drugs within the Hepatorenal Syndrome market during the study period. This analysis encompasses the assessment of drug uptake in the Hepatorenal Syndrome market, patient adoption across different therapies, and the sales performance of each drug. Furthermore, the therapeutics assessment section facilitates a comprehensive comprehension of market dynamics by examining drug sales trends, identifying drugs with the highest adoption rates, and elucidating the reasons contributing to the widespread use of specific medications. Additionally, it conducts comparative analyses among Hepatorenal Syndrome drugs, considering their sales performance and respective market shares.

The report encompasses comprehensive coverage of ongoing Hepatorenal Syndrome pipeline development initiatives. It furnishes valuable insights into diverse therapeutic candidates at various developmental stages, elucidating the significant companies actively engaged in creating targeted treatments for Hepatorenal Syndrome. Moreover, it conducts an in-depth analysis of recent advancements, including collaborations, acquisitions, mergers, licensing details, and patent information, providing a holistic view of emerging therapies within the field.

Reports Key Features and Analysis

  • Study Period - 2019-32
  • Forecast Period - 2023-32
  • Geography Coverage - 7MM (United States, EU4 [Germany, Spain, Italy, France], the United Kingdom, and Japan)
  • Expected Market Size (by 2032) and CAGR - Download the Sample PDF to Know
  • Major Players Shaping the Market Outlook - Noorik Biopharmaceuticals, Mallinckrodt, BioVie
  • Emerging and Marketed Therapies Analyzed in the Report - Ambrisentan (Noorik Biopharmaceuticals), Terlipressin (Mallinckrodt), BIV201 (BioVie)

For In-depth Insights, Key Report Offerings, and TOC; Access the Sample PDF File @ 

Hepatorenal Syndrome Therapeutics Market Outlook and Forecast

Related Reports:

Hepatorenal Syndrome Epidemiology Forecast report delivers an in-depth understanding of the Hepatorenal Syndrome, historical and forecasted epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Hepatorenal Syndrome Pipeline Insight report, provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Hepatorenal Syndrome pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type.

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