• 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 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, Drug Class, Diagnostic Modality, End User and Geography. This structure reflects how evolving therapeutic pipelines, emerging diagnostic modalities and care-delivery settings interact to shape adoption. Growing focus on early detection, fibrosis staging and combination-treatment strategies continues to influence investment and clinical decision-making.

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

The Solution segmentation distinguishes between therapeutics aimed at slowing or reversing disease progression and diagnostics that enable accurate staging and treatment selection. Market development is driven by intensifying R&D activity, rising awareness of NASH as a leading cause of liver-related morbidity and a stronger push toward risk-stratification in metabolic disease clinics. Together, these solution categories underpin integrated care pathways from screening to long-term management.

Therapeutic solutions encompass investigational and emerging agents targeting inflammation, steatosis, ballooning and fibrosis pathways. Stakeholders focus on agents with multi-target mechanisms and favorable cardiometabolic profiles, given the high overlap with obesity and type 2 diabetes. Combination regimens, long-term safety data and alignment with non-invasive response markers are becoming key differentiation levers.

Diagnostic solutions include imaging, serum biomarkers and tissue-based techniques that identify NASH and stage fibrosis severity. Demand grows as hepatology and endocrinology services seek non-invasive algorithms to prioritize high-risk patients for treatment. Integration of diagnostic outputs into longitudinal monitoring and clinical-trial enrollment is central to accelerating therapeutic adoption.

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

The Drug Class segmentation highlights leading mechanisms under investigation for NASH treatment. Each class addresses specific metabolic, inflammatory or fibrotic pathways, with developers seeking robust histologic endpoints and improved cardiometabolic outcomes. Regulatory success will depend on balanced efficacy–safety profiles, durability of response and compatibility with co-medications used in metabolic syndrome management.

FXR agonists modulate bile-acid signaling, lipid metabolism and inflammation, making them one of the most advanced classes in NASH development. Clinical programs focus on improving fibrosis regression and NASH resolution while managing pruritus and lipid-related adverse effects. Positioning relative to combination regimens and cardiovascular-risk management will strongly influence long-term uptake.

THR-β agonists target thyroid hormone receptor beta pathways to enhance hepatic fat metabolism and address steatosis. These agents are being evaluated for their impact on liver fat reduction, metabolic parameters and fibrosis markers. Their perceived value will depend on durability of fat reduction and compatibility with broader metabolic disease therapy strategies.

GLP-1 agonists, initially developed for type 2 diabetes and weight management, are being repurposed for NASH due to their effects on weight loss, insulin resistance and hepatic fat content. They are often viewed as cornerstones in patients with overlapping metabolic syndrome, offering potential synergy with liver-specific agents. Real-world evidence on liver outcomes will be critical to guide guideline inclusion.

The Others category includes anti-fibrotic agents, CCR2/CCR5 antagonists, PPAR agonists and novel combination approaches. These mechanisms aim to address complex fibrogenic pathways beyond simple fat accumulation. Strategic partnerships, licensing deals and co-development frameworks are common as companies seek to diversify portfolios and manage development risk.

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

The Diagnostic Modality segmentation reflects the shift from invasive tissue-based assessment toward non-invasive and minimally invasive strategies. Clinicians increasingly combine imaging, biomarkers and elastography in multimodal algorithms to detect advanced fibrosis and track progression. Choice of modality is influenced by access, cost, patient risk profile and the need for histologic confirmation in specific contexts.

Imaging tests, including ultrasound-based techniques and MRI, play a central role in assessing steatosis and evaluating liver structure. The trend toward quantitative imaging biomarkers supports standardized follow-up and trial enrollment. Broader deployment in endocrinology and primary-care settings expands the front line for NASH screening.

Biomarker-based blood tests provide non-invasive estimates of steatosis and fibrosis through proprietary panels and composite scores. These assays help stratify patients for referral, biopsy consideration and treatment prioritization. Commercial traction depends on validated cut-offs, ease of integration into workflows and reimbursement support.

Liver biopsy remains the reference standard for definitive NASH diagnosis and detailed fibrosis staging, particularly in clinical trials. However, its invasiveness and sampling variability encourage ongoing transition toward non-invasive options. Biopsy utilization is increasingly reserved for complex cases, protocol-mandated endpoints and discordant non-invasive findings.

Elastography techniques measure liver stiffness as a surrogate for fibrosis, providing rapid, non-invasive assessment that can be repeated over time. Integration into hepatology clinics and imaging departments supports wider adoption for risk stratification and therapy monitoring. The modality is increasingly utilized as part of multi-step diagnostic algorithms.

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

The End User segmentation highlights how different provider types engage with NASH detection, staging and treatment. As multidisciplinary management becomes standard, hepatologists, endocrinologists, radiologists and primary-care teams coordinate around shared pathways. Infrastructure readiness, access to specialized diagnostics and clinical-trial participation influence uptake across these settings.

Hospitals and clinics serve as primary hubs for advanced diagnostics, biopsy procedures and specialist-led therapy initiation. Tertiary centers often run dedicated NASH clinics that integrate imaging, biomarkers, lifestyle programs and pharmacotherapy. Their role in trial recruitment and real-world evidence generation makes them key partners for industry.

Diagnostic centers provide imaging, elastography and biomarker testing supporting referral networks and specialty clinics. They enable scalable deployment of non-invasive diagnostic pathways, particularly in regions prioritizing early detection of metabolic liver disease. Collaboration with hospitals and payers helps standardize protocols and reporting formats.

Academic and research institutes drive innovation in biomarkers, imaging methods and therapeutic targets. They are central to early-phase trials, translational pathophysiology research and guideline development. Partnerships with biopharma sponsors and technology developers accelerate validation of new diagnostic and treatment paradigms.

The Others category includes specialized hepatology practices, integrated metabolic clinics and contract research organizations. These entities support patient identification, longitudinal follow-up and data-rich cohorts, often working across multiple geographies. Their role in post-marketing studies and registry programs is expected to grow as therapies enter routine use.

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

The Geography segmentation reflects differing prevalence of metabolic syndrome, diagnostic capacity, trial density and access to emerging therapies. High-income regions lead in clinical-trial activity and specialist networks, while emerging markets are expanding screening and referral patterns. Policy initiatives around obesity, diabetes and chronic liver disease strongly influence regional adoption trajectories.

North America leads in NASH research, trial enrollment and early adoption of advanced diagnostics. High prevalence of obesity and type 2 diabetes drives strong demand for risk-stratification tools and future therapies. Robust payer engagement and active guideline bodies will strongly influence speed of therapeutic uptake.

Europe demonstrates significant activity in multicenter trials, biomarker validation and non-invasive diagnostic algorithm development. Coordinated liver and metabolic-disease strategies encourage broader use of screening pathways across primary and specialist care. Health-technology assessments will shape reimbursement and access to new therapies.

Asia Pacific is experiencing rising NASH burden driven by rapid lifestyle changes and increasing metabolic syndrome prevalence. Expansion of hepatology services and imaging capacity supports gradual deployment of non-invasive diagnostics. Regional collaborations and local clinical data will be important to underpin future therapeutic adoption.

Middle East & Africa shows growing awareness of NASH as part of broader metabolic-disease challenges. Leading tertiary hospitals are beginning to adopt standardized liver-assessment protocols and participate in international studies. Access to advanced diagnostics and therapies will expand as infrastructure and specialist training deepen.

Latin America is seeing increasing recognition of NAFLD and NASH within hepatology and diabetes programs. Selected centers are implementing elastography-based screening and biomarker testing for high-risk groups. Economic considerations and public-health priorities will guide the pace of uptake for novel NASH therapies.

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