Global Nonalcoholic Steatohepatitis Drugs Pipeline Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• Nonalcoholic steatohepatitis (NASH) is a global health crisis linked to obesity, prompting active research into treatments targeting inflammation, cellular stress, and fibrosis. New drugs in phase 2 and 3 trials aim to improve insulin sensitivity, reduce liver inflammation, influence bile acid signaling, and target fibrosis. Additionally, studies explore combination therapies and review lessons from previous unsuccessful trials.

• Merck and Hanmi Pharmaceutical signed a licensing agreement in August 2020 for the development of efinopegdutide (formerly HM12525A), Hanmi's experimental glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist for the treatment of NASH.

In this report, the Global Nonalcoholic Steatohepatitis (NASH) Drugs Pipeline Market is segmented by Drug Class, Mechanism, Development Phase, and Geography. The segmentation by Drug Class includes categories such as anti-diabetic drugs, anti-obesity drugs, antioxidants, and others, each targeting different aspects of NASH pathology and patient needs. This classification allows for a comprehensive understanding of the therapeutic approaches being developed to address NASH.

The segmentation by Mechanism focuses on the underlying biological processes targeted by these drugs, such as inflammation, fibrosis, and lipid metabolism. By categorizing drugs based on their mechanism of action, the report provides insights into the diverse strategies employed to combat NASH. Additionally, the Development Phase segmentation includes early-stage, mid-stage, and late-stage clinical trials, highlighting the progression and maturity of various drug candidates.

Geographically, the market is analyzed across key regions including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. This regional segmentation reflects the global efforts and varying levels of market development and regulatory environments in different parts of the world. Each region's unique challenges and opportunities are considered, providing a detailed view of the market dynamics influencing the growth of NASH drug development worldwide.

Global Nonalcoholic Steatohepatitis Drugs Pipeline Segment Analysis

In this report, the Global Nonalcoholic Steatohepatitis Drugs Pipeline Market has been segmented by Drug Class, Mechanism, Development Phase and Geography.

Global Nonalcoholic Steatohepatitis Drugs Pipeline Market, Segmentation by Drug Class

The Global Nonalcoholic Steatohepatitis Drugs Pipeline Market has been segmented by Drug Class into Drugs Targeting Metabolic Homeostasis, Drugs Acting on Insulin Resistance, Drugs to Prevent and Treat Inflammation and Drugs Preventing Oxidative Stress or Fibrosis.

Drugs Targeting Metabolic Homeostasis aim to restore balance in metabolic processes disrupted in NASH, such as lipid metabolism and glucose regulation. Drugs Acting on Insulin Resistance target insulin resistance, a key feature of NASH development, with the goal of improving insulin sensitivity and metabolic function. Meanwhile, Drugs to Prevent and Treat Inflammation focus on dampening the inflammatory response implicated in NASH progression. Finally, Drugs Preventing Oxidative Stress or Fibrosis aim to mitigate oxidative damage and fibrotic scarring, which are critical aspects of advanced NASH pathology.

This segmentation provides a comprehensive overview of the diverse approaches being pursued in NASH drug development, reflecting the complex nature of the disease and the need for multifaceted therapeutic interventions. It offers insights into the evolving landscape of NASH treatment options and the potential for innovative therapies to address the unmet medical needs of patients with this increasingly prevalent condition.

Global Nonalcoholic Steatohepatitis Drugs Pipeline Market, Segmentation by Mechanism

The Global Nonalcoholic Steatohepatitis Drugs Pipeline Market has been segmented by Mechanism into Farnesoid X receptor Modulation, Peroxisome proliferator-activated receptor agonist, C chemokine receptor Antagonist, Apoptosis signal-regulated kinase-1 inhibitor, Oral acetyl-CoA carboxylase (ACC) inhibitor, Fibroblast growth factor 21 (FGF 21) inhibitor and Others.

Farnesoid X receptor Modulation focuses on modulating the activity of farnesoid X receptor, a key regulator of bile acid metabolism and liver homeostasis, which plays a crucial role in NASH development. Peroxisome proliferator-activated receptor agonist targets a nuclear receptor involved in the regulation of lipid metabolism and inflammation, offering a potential therapeutic avenue for NASH treatment.

C chemokine receptor Antagonist aims to inhibit chemokine receptors involved in immune cell recruitment and inflammation within the liver, while Apoptosis signal-regulated kinase-1 inhibitor targets a kinase involved in cellular stress responses and inflammation. Oral acetyl-CoA carboxylase (ACC) inhibitor targets lipid synthesis pathways, which are dysregulated in NASH, and Fibroblast growth factor 21 (FGF 21) inhibitor aims to modulate metabolic processes and liver function.

These distinct mechanisms highlight the diverse approaches being explored in NASH drug development, reflecting the multifaceted nature of the disease and the need for targeted interventions addressing various aspects of its pathophysiology. By segmenting the pipeline market based on mechanism, this report provides valuable insights into the innovative strategies and potential therapeutic targets driving the advancement of NASH treatment options.

Global Nonalcoholic Steatohepatitis Drugs Pipeline Market, Segmentation by Development Phase

The Global Nonalcoholic Steatohepatitis Drugs Pipeline Market has been segmented by Development Phase into Discovery, Preclinical, Phase 1 CT, Phase 2 CT, Phase 3 CT and IND/CTA Filed.

The Discovery phase involves the initial identification and validation of drug targets and compounds with therapeutic potential for NASH. Preclinical studies follow, wherein promising drug candidates undergo rigorous testing in laboratory and animal models to evaluate safety, efficacy, and pharmacokinetics before advancing to human trials.

Drug candidates move into Phase 1 CT, where they are tested in small groups of healthy volunteers to assess safety, dosage, and pharmacokinetics. Phase 2 CT involves testing the drug in a larger group of patients with NASH to evaluate efficacy and further assess safety. Phase 3 CT represents the final stage of clinical development, involving large-scale trials to confirm efficacy, safety, and dosage optimization for regulatory approval.

The segment IND/CTA Filed indicates drug candidates that have progressed beyond preclinical studies and have submitted Investigational New Drug or Clinical Trial Applications to regulatory authorities for approval to conduct clinical trials. This segmentation offers valuable insights into the maturity and progress of drug candidates within the NASH drugs pipeline, providing stakeholders with a comprehensive understanding of the developmental landscape and potential timelines for market entry.

Global Nonalcoholic Steatohepatitis Drugs Pipeline Market, Segmentation by Geography

In this report, the Global Nonalcoholic Steatohepatitis Drugs Pipeline Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Nonalcoholic Steatohepatitis Drugs Pipeline Market Share (%), by Geographical Region, 2024

North America, comprising the United States and Canada, is expected to dominate the market due to the high prevalence of NASH in the region and significant investments in research and development. Europe follows closely, with countries like the United Kingdom, Germany, and France actively contributing to NASH drug development efforts.

The Asia Pacific region, including countries such as China, Japan, and India, is witnessing rapid growth in the NASH drugs pipeline market due to increasing awareness of the disease and a growing patient population. Similarly, the Middle East and Africa, as well as Latin America, are emerging markets for NASH drug development, driven by rising healthcare infrastructure and awareness of metabolic diseases.

By segmenting the market based on geography, this report provides insights into regional trends, regulatory landscapes, and market potential, enabling stakeholders to make informed decisions regarding investment, partnership, and market entry strategies in the global NASH drugs pipeline market.

This report provides an in depth analysis of various factors that impact the dynamics of Global Nonalcoholic Steatohepatitis Drugs Pipeline Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers :

• Rising NASH Prevalence
• Unmet Medical Need

• Growing Awareness - The Global Nonalcoholic Steatohepatitis (NASH) Drugs Pipeline Market is experiencing growth driven by increasing awareness of NASH as a significant public health concern. With NASH becoming more widely recognized as a leading cause of liver-related morbidity and mortality worldwide, there is a growing urgency to develop effective treatments. Rising awareness among healthcare professionals, patients, and policymakers about the prevalence and impact of NASH is fueling demand for novel therapeutic options.

  This growing awareness is also fostering greater investment in NASH research and drug development initiatives by pharmaceutical companies, academic institutions, and government agencies. As a result, the NASH drugs pipeline is expanding, with an increasing number of drug candidates progressing through preclinical and clinical development stages. Moreover, the heightened awareness of NASH is prompting collaborations and partnerships across the healthcare ecosystem to accelerate the advancement of promising treatments.

  As awareness of NASH continues to grow, there is a greater focus on early detection, diagnosis, and intervention strategies. This shift towards proactive management of NASH is expected to drive further investment in drug development and stimulate market growth. Overall, the increasing awareness of NASH as a global health challenge is catalyzing efforts to address the unmet medical needs of patients and drive innovation in the NASH drugs pipeline.

Restraints :

• Lengthy and Expensive Drug Development
• Stringent Regulatory Requirements

• Reimbursement Challenges -In the landscape of the Global Nonalcoholic Steatohepatitis (NASH) Drugs Pipeline Market, reimbursement challenges pose a significant hurdle to the commercialization and adoption of novel therapies. Given the complex nature of NASH and its associated comorbidities, there is a growing demand for effective pharmacological interventions. However, the lack of clear reimbursement pathways and policies for NASH treatments complicates market access and affordability for patients and healthcare providers alike.

  One of the primary reimbursement challenges stems from the absence of universally accepted diagnostic criteria and endpoints for NASH clinical trials. Without standardized measures of disease severity and treatment response, payers may hesitate to cover the costs of emerging therapies, leading to delays in market entry and uptake. Moreover, the long-term nature of NASH treatment and the need for sustained therapeutic intervention further exacerbate reimbursement uncertainties, as payers grapple with the cost-effectiveness and real-world efficacy of these treatments.

  The evolving understanding of NASH pathophysiology and the emergence of targeted therapies introduce complexities in reimbursement decision-making. Payers must assess the value proposition of these innovative treatments against existing standards of care and consider factors such as comparative effectiveness, safety profiles, and economic impact. As a result, achieving favorable reimbursement status for NASH drugs requires robust clinical evidence, sophisticated health economic analyses, and strategic engagement with regulatory authorities and payers to navigate the reimbursement landscape effectively.

  Addressing reimbursement challenges in the Global NASH Drugs Pipeline Market necessitates collaborative efforts among pharmaceutical companies, healthcare stakeholders, and policymakers to develop transparent and equitable reimbursement frameworks that facilitate timely access to innovative therapies for patients with NASH. Such initiatives are essential to ensure the sustainable advancement of NASH drug development and improve patient outcomes in the face of this growing public health burden.

Opportunities :

• Focus on Novel Mechanisms of Action

• Combination Therapies - In the Global Nonalcoholic Steatohepatitis (NASH) Drugs Pipeline Market, combination therapies represent a promising approach to addressing the multifactorial nature of NASH and improving treatment outcomes. These combination therapies typically involve the simultaneous or sequential administration of two or more drugs with complementary mechanisms of action, aiming to target different aspects of NASH pathology synergistically.

  Combination therapies in the NASH pipeline may include drugs targeting metabolic dysregulation, inflammation, fibrosis, and other key pathways implicated in the disease. By combining agents that act on distinct biological processes, these therapies have the potential to provide more comprehensive and effective treatment compared to single-agent approaches.

  Combination therapies can offer advantages such as enhanced efficacy, reduced side effects, and improved patient compliance. As such, they represent a promising strategy for addressing the complex nature of NASH and meeting the unmet medical needs of patients. Ongoing research and clinical trials focused on combination therapies in the NASH pipeline hold the potential to revolutionize the treatment landscape for this increasingly prevalent liver disease.

Key players in Global Nonalcoholic Steatohepatitis Drugs Pipeline Market include

• Tobira Therapeutics, Inc
• Genfit SA
• Intercept Pharmaceuticals Inc
• Gilead Sciences, Inc
• Bristol-Mayers Squibb Comnay
• Merck KGaA
• NGM Biopharmaceuticals
• Galectin Therapeutics Inc

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis