Unties States Hepatorenal Syndrome Market Growth, Drivers, Future outlook | Major Companies 2026 - Mallinckrodt plc, LEXICARE PHARMA PVT. LTD., Wellona Pharma

Leander, Texas and Tokyo, Japan - Jan.06.2026
As per DataM intelligence research report" Hepatorenal Syndrome Market is anticipated to grow at a high CAGR during the forecast period 2024-2031." Chronic liver disease prevalence and treatment innovation are driving demand for hepatorenal syndrome therapies.

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United States: Recent Industry Developments

✅ In November 2025, Mallinckrodt Pharmaceuticals released new data on Terlipressin for HRS-AKI The data showed improved survival rates in patients with Grade 3 acute-on-chronic liver failure It reinforces the drug's position as the standard of care in U.S. ICUs

✅ In October 2025, BioVie initiated a Phase 3 trial for a novel drug targeting portal hypertension The oral drug aims to prevent the development of HRS in cirrhotic patients It addresses the unmet need for preventative therapies in hepatology

✅ In September 2025, A U.S. medical device firm received FDA clearance for a liver support system The albumin dialysis machine removes toxins to bridge patients to liver transplant It offers a lifeline for severe HRS patients failing drug therapy

✅ In August 2025, The American Association for the Study of Liver Diseases updated HRS guidelines The guidelines recommend earlier use of vasoconstrictors to preserve kidney function It changes clinical practice in U.S. hospitals

Japan: Recent Industry Developments

✅ In December 2025, Otsuka Pharmaceutical launched a new oral vasopressin V2-receptor antagonist The drug manages fluid retention in liver cirrhosis to reduce the risk of HRS It provides a home-care option for managing ascites in Japanese patients

✅ In November 2025, Takeda Pharmaceutical partnered with a U.S. firm to import Terlipressin The partnership aims to secure regulatory approval for the drug in Japan It addresses the "drug lag" for critical care medications

✅ In October 2025, A Japanese university hospital developed a new biomarker panel for HRS risk The urine test detects kidney injury markers earlier than serum creatinine It enables preemptive intervention in Japanese liver centers

✅ In September 2025, The Japanese Society of Gastroenterology launched a registry for HRS patients The registry collects real-world data to optimize treatment protocols It improves the quality of evidence for managing this rare complication

Hepatorenal Syndrome Market: Drivers
The hepatorenal syndrome market is expanding due to rising prevalence of chronic liver diseases and associated renal complications. Increasing demand for effective treatment options drives market growth. Technological advancements in pharmacological therapies improve patient outcomes. Regulatory approvals and clinical validation strengthen adoption. Healthcare infrastructure supporting critical care and liver transplantation enhances accessibility. Research into novel therapeutics fuels innovation. Awareness campaigns increase early diagnosis and timely intervention.

Market growth is supported by increasing geriatric population and lifestyle-related liver disorders. Hospitals and specialty clinics are expanding hepatology and nephrology services. Combination therapies and biologics improve treatment effectiveness. Investment in R&D accelerates new drug development. Emerging markets show rising access to advanced treatments. Hepatorenal syndrome therapies remain critical for managing liver-related renal complications.

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Hepatorenal Syndrome Market: Major Players
Mallinckrodt plc, LEXICARE PHARMA PVT. LTD., Wellona Pharma, Taj Pharmaceuticals Limited, SiNi Pharma Pvt Ltd, MANUS AKTTEVA BIOPHARMA LLP, New Medicon Pharma Lab, B JOSHI AGROCHEM PHARMA, Cygnus Healthcare Specialities Pvt. Ltd. among others.

Segment Covered in the Hepatorenal Syndrome Market:
By Type
The market is segmented into Type I (HRS-AKI) 60% and Type II (HRS-CKD) 40%, with Type I dominating due to its acute onset, rapid progression, and high mortality rate requiring immediate medical intervention. Type II is characterized by a slower progression and chronic kidney dysfunction, contributing to steady long-term treatment demand. Increasing incidence of liver cirrhosis drives growth across both types.

By Treatment
Treatments include Terlipressin Infusion 30%, Albumin Infusion 20%, Liver Transplantation 15%, Vasoconstrictors 15%, Hemodialysis 10%, and Antibiotic Therapy 10%, with terlipressin infusion dominating due to its effectiveness in improving renal function and being widely recommended in clinical guidelines. Albumin infusion is commonly used in combination therapies. Liver transplantation remains the definitive treatment for eligible patients. Supportive therapies help manage complications. Advances in pharmacological management support treatment adoption.

By End-User
End-users include Hospitals 65%, Specialty Clinics 20%, Ambulatory Surgical Centers (ASCs) 10%, and Others 5%, with hospitals dominating due to availability of intensive care units, advanced diagnostic facilities, and multidisciplinary liver care teams. Specialty clinics manage long-term liver disease patients. ASCs play a limited role mainly in supportive procedures. Rising hospitalization rates drive end-user adoption.

Regional Analysis
North America - 40% Share
North America leads with 40% share, driven by advanced hepatology care, high diagnosis rates, and availability of terlipressin and transplant services in the U.S. and Canada. Hospitals dominate end-users. Strong clinical research and reimbursement frameworks support market growth.

Europe - 25% Share
Europe holds 25% share, supported by widespread adoption of standardized treatment protocols and access to liver transplantation services in Germany, France, and the UK. Terlipressin and albumin infusion dominate treatments. Hospitals and specialty clinics are key end-users. Government-supported liver disease programs drive regional expansion.

Asia Pacific - 20% Share
Asia Pacific accounts for 20% share, driven by high prevalence of liver diseases, improving healthcare infrastructure, and growing awareness in China, Japan, and India. Terlipressin and supportive therapies dominate. Hospitals are primary end-users. Increasing healthcare investment supports market growth.

South America - 8% Share
South America records 8% share, with increasing diagnosis and treatment access in Brazil and Argentina. Albumin infusion and vasoconstrictors dominate therapy. Hospitals are primary end-users. Improving healthcare services support gradual market growth.

Middle East & Africa - 7% Share
The Middle East & Africa holds 7% share, driven by rising incidence of liver disease and improving hepatology care in the UAE, Saudi Arabia, and South Africa. Supportive therapies dominate. Hospitals are primary end-users. Expanding healthcare infrastructure supports market adoption.

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