Non-Alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market Size US$ 15.62 Billion by 2030, CAGR 21.6%, North America Leads with 43% Share | Key Players Gilead Sciences & Novo Nordisk

The global Non-Alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market was valued at US$ 6.51 billion in 2025 and is expected to reach US$ 15.62 billion by 2030, growing at a CAGR of 21.6% during the forecast period 2025 to 2030. Market growth is primarily driven by the rising prevalence of obesity, type 2 diabetes, and metabolic syndrome worldwide, which are key risk factors for NASH. Increasing clinical trial activity, strong pipeline development for disease-modifying therapies, and rising pharmaceutical investments are further accelerating market expansion.

NASH is a progressive liver disease characterized by inflammation and fibrosis, creating a significant unmet need for early diagnosis and effective treatment options. Diagnostic solutions such as imaging techniques, biomarker-based tests, and liver biopsies account for a substantial share of the market, supported by the growing shift toward non-invasive diagnostic methods. On the therapeutic side, drugs targeting fibrosis, inflammation, and metabolic pathways are gaining momentum as regulatory approvals advance. Growing disease awareness, improved screening practices, and expanding healthcare infrastructure, particularly in North America and Asia Pacific, are expected to strengthen the long-term growth outlook of the NASH therapeutics and diagnostics market.

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The Non-Alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market refers to the global industry focused on developing drugs and diagnostic tools for the detection, treatment, and management of NASH, a severe form of fatty liver disease.

Key Developments
✅ January 2026: In North America, clinical momentum increased for combination NASH therapies targeting fibrosis, metabolism, and inflammation alongside broader use of non-invasive diagnostic algorithms.

✅ December 2025: In Europe, healthcare providers expanded adoption of advanced imaging and serum biomarker panels to reduce reliance on liver biopsy for NASH diagnosis and monitoring.

✅ November 2025: In Asia-Pacific, pharmaceutical companies accelerated late-stage trials for metabolic-focused NASH drugs to address rising disease prevalence linked to diabetes and obesity.

✅ October 2025: In Latin America, hepatology centers increased screening of high-risk populations using AI-assisted diagnostic tools integrated into routine liver care pathways.

✅ September 2025: In the Middle East, hospitals strengthened multidisciplinary NASH management programs combining diagnostics, lifestyle intervention, and pharmacotherapy planning.

✅ August 2025: In Africa, pilot programs introduced cost-effective blood-based NASH diagnostic tests to support early disease detection in resource-limited settings.

Mergers & Acquisitions
✅ January 2026: In North America, a major biopharmaceutical company acquired a late-stage NASH therapeutics developer to expand its metabolic disease pipeline.

✅ December 2025: In Europe, a diagnostics company acquired a liver biomarker technology firm to enhance non-invasive NASH testing capabilities.

✅ November 2025: In Asia-Pacific, a regional pharmaceutical group acquired rights to a novel NASH drug candidate to strengthen its hepatology portfolio.

Key Players
Allergan plc | Pfizer Inc. | Gilead Sciences, Inc. | Genfit SA | Novartis AG | Intercept Pharmaceuticals | Cadila Healthcare Ltd. | Novo Nordisk | Raptor Pharmaceutical Corp. | Galmed Pharmaceuticals Ltd.

Key Highlights
Gilead Sciences, Inc. holds 22.5% share, driven by its strong hepatology expertise, advanced late-stage NASH pipeline, and continued investment in fibrosis-targeting therapies.

Novo Nordisk holds 18.9% share, supported by expanding GLP-1-based metabolic therapies, strong clinical outcomes in NASH-related indications, and global commercialization strength.

Novartis AG holds 15.4% share, benefiting from a diversified metabolic and liver disease pipeline, strategic collaborations, and strong R&D infrastructure.

Intercept Pharmaceuticals holds 12.8% share, driven by its focused NASH portfolio, leadership in FXR agonist development, and high visibility among hepatology specialists.

Pfizer Inc. holds 9.6% share, supported by metabolic disease research capabilities, broad clinical development experience, and global trial execution strength.

Genfit SA holds 7.1% share, benefiting from dedicated NASH research, novel mechanism-based drug candidates, and partnerships to advance clinical development.

Allergan plc holds 5.8% share, driven by legacy gastroenterology expertise and selective investments in liver disease therapeutics.

Galmed Pharmaceuticals Ltd. holds 4.1% share, supported by targeted NASH drug development and focus on anti-inflammatory and antifibrotic mechanisms.

Cadila Healthcare Ltd. holds 2.4% share, benefiting from cost-effective drug development and growing presence in emerging markets.

Raptor Pharmaceutical Corp. holds 1.4% share, contributing through niche metabolic and rare-disease research relevant to liver disorders.

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Market Drivers
- Rising prevalence of obesity, type 2 diabetes, and metabolic syndrome increasing incidence of NASH.

- Growing awareness of liver diseases and unmet need for effective NASH treatments and early diagnosis.

- Advancements in non-invasive diagnostic technologies reducing reliance on liver biopsies.

- Increasing investments in drug development targeting inflammation, fibrosis, and metabolic pathways.

- Expansion of clinical research and screening programs for fatty liver diseases.

Industry Developments
- Continuous development of novel NASH therapeutics including metabolic modulators and anti-fibrotic agents.

- Rising number of clinical trials evaluating drug candidates for NASH treatment.

- Strategic collaborations between pharmaceutical companies and diagnostic technology providers.

- Advancements in imaging and biomarker-based diagnostics for early-stage NASH detection.

- Growing focus on regulatory approvals and commercialization of NASH-specific therapies and diagnostics.

Regional Insights
North America - 43% share: "Driven by high prevalence of obesity and diabetes, strong clinical research activity, advanced diagnostic infrastructure, and early adoption of NASH screening and treatment."

Europe - 27% share: "Supported by increasing awareness of liver diseases, growing clinical trial activity, and strong healthcare systems."

Asia Pacific - 24% share: "Fueled by rising metabolic disorder prevalence, expanding healthcare access, and increasing focus on early liver disease diagnosis."

Latin America - 4% share: "Driven by growing incidence of metabolic diseases and improving access to liver diagnostics."

Middle East & Africa - 2% share: "Supported by increasing lifestyle-related disease burden and gradual expansion of diagnostic and treatment capabilities."

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Key Segments

By Therapeutics
Ocaliva holds a significant share of the market, driven by its established clinical use and regulatory approvals in liver-related indications. Elafibranor represents a major segment, supported by ongoing clinical development and strong potential in treating metabolic and liver disorders. Cenicriviroc contributes notably due to its anti-inflammatory and antifibrotic properties. Selonsertib accounts for a substantial portion, supported by its role in targeting fibrosis pathways. Other therapeutics include emerging and pipeline candidates that continue to expand the treatment landscape.

By Diagnostics
Imaging techniques dominate the diagnostics segment, driven by widespread use of non-invasive methods for liver disease assessment. Diagnostic tests hold a significant share, supported by routine screening, biomarker analysis, and laboratory-based evaluations. Biopsy contributes steadily as a confirmatory diagnostic approach, particularly in complex and advanced disease cases.

By Sales Channel
Hospital pharmacies represent the leading sales channel, driven by prescription-based therapies and specialist-led treatment. Retail channels hold a notable share, supported by ongoing medication access for chronic disease management. Online channels are growing rapidly, driven by convenience, expanding e-pharmacy platforms, and increased digital healthcare adoption.

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