• The growing prevalence of metabolic disorders such as obesity and type-2 diabetes is boosting demand for both diagnostics and therapies for NASH, with estimates showing more than 20 % of adult NAFLD patients progressing to NASH.

• Despite strong demand, a major constraint remains the lack of approved therapies historically — the first therapy approval in key markets emerged only recently, underscoring a long period of unmet need and innovation gap.

• Emerging diagnostics technologies such as non-invasive biomarkers and advanced imaging are gaining traction — for instance the serum biomarker segment accounted for over 30 % share in key regions in recent years.

• Regional momentum is skewed toward North America, which held more than half of the global biomarker and diagnostics market revenue in 2024—indicating strong adoption of advanced tools and favourable reimbursement frameworks.

• Therapeutics pipeline is intensifying as leading biopharma firms pursue partnerships, acquisitions and late-stage trials — this competitive push is shaping the market structure and setting the stage for future growth.

• High diagnostic and treatment costs, combined with the complexity of disease staging (fibrosis, inflammation) and biopsy-based gold standards, remain barriers to broad market penetration and early intervention.

• Looking ahead, growth will hinge on successful commercial launches of first-in-class therapies, wider deployment of non-invasive diagnostics and expansion in emerging geographies—these will drive a strategic shift in how NASH is managed and monetised.

• In March 2024, Madrigal Pharmaceuticals received the first U.S. regulatory approval for its NASH drug Resmetirom, representing a major breakthrough in the treatment of nonalcoholic steatohepatitis.

• In October 2025, Novo Nordisk announced the acquisition of Akero Therapeutics to access its lead NASH candidate Efruxifermin, strengthening its pipeline in liver and metabolic disease therapies.

• In September 2025, Roche acquired 89bio to gain rights to its investigational NASH therapy Pegozafermin, expanding its presence in the growing market for metabolic and liver disorder treatments.

In this report, the Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market has been segmented by Solution, End User and Geography. The market is expanding due to rising prevalence of NASH, advancements in diagnostic technologies, and growing therapeutic research initiatives.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market, Segmentation by Solution

The Solution segmentation reflects the distinction between therapeutic interventions and diagnostic tools. Key strategies involve innovative drug development, precision diagnostics, and clinical research collaborations.

Therapeutics

Therapeutics include pharmaceutical and biologic interventions targeting liver inflammation and fibrosis reduction. The focus is on efficacy, safety profiles, and clinical trial advancements to meet unmet patient needs.

Diagnostics

Diagnostics comprise non-invasive and invasive tests for early NASH detection and disease progression monitoring. Market growth is driven by accuracy improvements, imaging technologies, and biomarker identification.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market, Segmentation by End User

The End User segmentation outlines the key stakeholders involved in patient care, diagnostics, and clinical research. Market strategies focus on partnerships, technology integration, and service expansion.

Hospitals & Clinics

Hospitals and Clinics serve as primary points for diagnosis, monitoring, and treatment of NASH patients. Investment in advanced diagnostic tools and therapeutic protocols enhances patient outcomes.

Diagnostic Centers

Diagnostic Centers specialize in non-invasive and invasive testing for early NASH detection. Focus areas include high-throughput testing, imaging innovations, and biomarker analysis.

Academic & Research Institutes

Academic and Research Institutes contribute to novel therapeutic discoveries and clinical studies. Collaborations with biotech and pharmaceutical companies accelerate market innovation.

Others

Other end users include specialized laboratories and healthcare service providers engaged in research, testing, and patient management. These segments support market penetration and outreach strategies.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market, Segmentation by Geography

In this report, the Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market has been segmented by Geography into five regions: North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

North America

North America leads the market due to high NASH prevalence, advanced healthcare infrastructure, and strong clinical research capabilities. Market strategies include collaborations with biotech companies and adoption of cutting-edge diagnostics.

Europe

Europe shows robust growth driven by regulatory support for innovative diagnostics and therapeutics. The market benefits from clinical research initiatives and partnerships with leading healthcare institutions.

Asia Pacific

Asia Pacific is expanding due to increasing awareness of NASH, rising healthcare spending, and growing research initiatives. Manufacturers focus on local collaborations and expanding diagnostic services.

Middle East and Africa

Middle East and Africa exhibit gradual growth, influenced by emerging healthcare infrastructure and rising clinical research activities. Companies are exploring strategic partnerships and service expansion.

Latin America

Latin America is witnessing growth due to increasing patient awareness, healthcare improvements, and adoption of novel therapies. Market strategies emphasize distribution network enhancement and clinical collaborations.

This report provides an in depth analysis of various factors that impact the dynamics of Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Rising global obesity and diabetes prevalence
• Increasing awareness of liver-related disorders
• Growing demand for non-invasive diagnostics

• Advances in biomarker-based diagnostic tools - Playing a transformative role in the NASH diagnostics landscape. The traditional reliance on liver biopsy—a painful, invasive, and often expensive procedure—is rapidly being replaced by non-invasive biomarker technologies that offer quicker and safer diagnosis. These innovations are not only increasing physician and patient confidence but are also accelerating the detection of early-stage NASH, which is critical for effective therapeutic intervention.

  Companies and research institutions are heavily investing in genomic, proteomic, and metabolomic biomarkers that can pinpoint disease progression with high specificity and sensitivity. Blood-based markers such as cytokeratin-18, and imaging techniques like FibroScan and MR elastography, are gaining clinical traction. These solutions reduce patient burden and support broader population screening, making diagnostics more accessible and acceptable.

  Moreover, the development of companion diagnostics integrated with emerging therapeutic candidates is enabling precision medicine approaches in NASH care. This convergence of diagnostics and therapeutics is streamlining treatment decisions and improving patient outcomes. As these technologies evolve, the market is likely to witness stronger regulatory approvals, reimbursement support, and product adoption.

  In summary, the shift toward advanced biomarker diagnostics is a pivotal driver for the NASH diagnostics market. It supports early detection, facilitates real-time monitoring, and aligns with the global move toward personalized healthcare. As stakeholders prioritize innovation and data-driven diagnostics, the sector is poised for sustainable growth.

Restraints

• Lack of approved pharmacological treatments
• High cost of NASH drug development
• Invasive diagnostic procedures limiting adoption

• Limited awareness among general population - A significant barrier in the growth of the NASH diagnostics and therapeutics market. Despite the rising prevalence of obesity and metabolic syndrome, the lack of clear symptoms in early NASH stages leads to underdiagnosis. Many individuals remain unaware of the condition until it progresses to irreversible liver damage, often requiring intensive treatment or even transplant.

  Public health initiatives and educational campaigns around liver health and NASH are still in their infancy, especially in developing regions. Compared to better-known liver diseases like hepatitis B or C, NASH receives considerably less attention, resulting in fewer health check-ups, screenings, or referrals. This results in a lower number of diagnosed cases and limited market penetration for diagnostic and therapeutic products.

  The issue is further compounded by insufficient training and awareness among primary care providers. Many general practitioners are not fully equipped to detect early signs or refer patients for specialized diagnostics. As a result, the condition often gets misdiagnosed or overlooked entirely, impacting early intervention and timely treatment.

  Until significant efforts are made to improve public and healthcare professional awareness of NASH, this restraint will continue to hinder market growth. Collaborative efforts by government agencies, pharmaceutical companies, and healthcare providers are necessary to address this gap and drive early diagnosis through better outreach and educational strategies.

Opportunities

• Development of innovative diagnostic technologies
• Expansion of clinical research funding
• Collaborations in drug discovery pipelines

• Increasing focus on early disease detection - A powerful growth opportunity for the NASH diagnostics and therapeutics market. With the disease often remaining silent in its early stages, there is growing consensus on the need for proactive screening, especially among high-risk populations such as those with obesity, type 2 diabetes, and metabolic syndrome. This proactive approach enables intervention before severe liver fibrosis or cirrhosis develops.

  Healthcare systems across the globe are adopting preventive healthcare frameworks to reduce long-term costs and disease burden. This paradigm shift is driving investments in screening programs and the integration of NASH testing into routine check-ups. Government agencies and private stakeholders are launching pilot programs that include liver function screening panels, particularly in regions with high prevalence of lifestyle diseases.

  Additionally, advancements in AI-powered imaging tools and algorithm-based screening platforms are making it easier to identify early-stage NASH non-invasively. These tools enable primary care settings to screen and triage patients efficiently, reducing referral delays and increasing diagnostic throughput. As these technologies become more scalable and cost-effective, their uptake is expected to grow.

  Overall, the global healthcare shift toward early detection and disease prevention aligns perfectly with the need to identify NASH before it progresses. This opportunity not only improves patient prognosis but also supports market expansion across diagnostics, therapeutics, and healthcare services targeting chronic liver conditions.

Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market is characterized by intense competition as pharmaceutical firms and diagnostic companies advance their portfolios. With over 40% of companies investing in strategic collaboration, the sector is defined by merger activities, partnerships, and expansion. Innovation in therapeutic approaches and diagnostic accuracy remains a primary driver of market growth and future outlook.

Market Structure and Concentration
The market shows a semi-consolidated structure, with top players accounting for nearly 55% of the share. Concentration is increasing as leading firms secure competitive advantages through mergers and partnerships. Strategies are shaped around diagnostics precision and therapeutic development, fueling expansion. Smaller companies contribute innovation, but large players dominate the growth trajectory and technological advancements.

Brand and Channel Strategies
Brand visibility and strong distribution channels form the backbone of competitive success. Over 60% of companies employ dual-channel strategies, integrating traditional healthcare providers with digital platforms. Effective branding relies on innovation and partnerships, while collaborations with hospitals strengthen access. Firms increasingly emphasize market differentiation, creating expansion opportunities and sustaining long-term growth momentum.

Innovation Drivers and Technological Advancements
Technological advancements play a central role, with nearly 45% of firms directing R&D investments toward improved diagnostic accuracy. The market’s growth is fueled by innovation in imaging techniques, biomarker-based testing, and targeted therapeutics. Partnerships between diagnostic firms and pharmaceutical companies accelerate expansion. Merger-driven strategies further strengthen pipelines, ensuring a competitive edge through advanced solutions and future outlook development.

Regional Momentum and Expansion
Regional expansion defines competitive positioning, with more than 50% of players enhancing their footprint in emerging markets. Growth is shaped by collaborative strategies with local healthcare systems and research institutions. Partnerships across diagnostic and therapeutic providers accelerate adoption. Market leaders focus on regional innovation, tailoring approaches that maximize expansion potential and secure competitive advantages for long-term growth.

Future Outlook
The future outlook emphasizes collaboration and innovation as pivotal to maintaining competitiveness. Over 65% of stakeholders prioritize partnerships to strengthen diagnostic and therapeutic pipelines. Strategies focus on accelerating growth through mergers and expansion into high-demand regions. Technological advancements in diagnostics and therapies will shape the market trajectory, driving sustainable growth and reinforcing leadership in the evolving competitive landscape.

Key players in Nonalcoholic Steatohepatitis (NASH) Diagnostics and Therapeutics Market include:

• Madrigal Pharmaceuticals
• Novo Nordisk
• Gilead Sciences
• Merck & Co.
• Novartis
• Intercept Pharmaceuticals
• AbbVie
• Pfizer
• Eli Lilly and Company
• Zydus Therapeutics
• Inventiva Pharma
• Galmed Pharmaceuticals
• Akero Therapeutics
• Viking Therapeutics
• 89bio, Inc.

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

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