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Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Market Set to Surge Across APAC, Europe, USA, and Saudi Arabia with CAGR of 7% Through 2035

11-07-2025 02:40 PM CET | Health & Medicine

Press release from: Future Market Insights

Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Market

Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Market

The global non-alcoholic steatohepatitis (NASH) clinical trials market is poised for significant expansion, with projected market size growing from USD 2.96 billion in 2025 to USD 5.81 billion by 2035, reflecting a compound annual growth rate (CAGR) of 7.0% over the forecast period. This growth is being driven by the rising prevalence of NASH-a progressive liver disease linked to obesity, type 2 diabetes, and metabolic syndrome-and the urgent need for effective therapies.

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NASH often remains asymptomatic in its early stages but can progress to severe liver conditions, including fibrosis, cirrhosis, and hepatocellular carcinoma. This silent progression has prompted a surge in clinical research, attracting pharmaceutical companies, biotech firms, and government agencies to invest heavily in NASH-focused trials.

Global Market Dynamics

The increasing awareness of NASH and its health consequences is fueling clinical trial activity worldwide. In the United States, where nearly 40% of adults are classified as obese and over 10% have type 2 diabetes, the NASH clinical trials market is anticipated to grow at a CAGR of 7.6% from 2025 to 2035. The presence of a robust healthcare infrastructure and efficient patient recruitment networks enhances the country's capacity to conduct large-scale trials.

Europe also represents a strong growth region. Germany, for example, is expected to record a CAGR of 7.0% during the forecast period, driven by awareness campaigns, public health initiatives, and well-established diagnostic infrastructure that facilitates patient enrollment and trial execution. Meanwhile, France and the UK are also experiencing steady market growth, supported by rising obesity and metabolic syndrome prevalence.

In the Asia-Pacific region, China and India are emerging as key contributors. China's market is projected to grow at a CAGR of 8.3% through 2035, bolstered by governmental support, regulatory facilitation, and partnerships among pharmaceutical firms, academic institutions, and contract research organizations (CROs). India leads the region with a projected CAGR of 9.0%, reflecting the rapid rise in metabolic disorders and growing investment in clinical research infrastructure. South Korea's market is also expanding steadily, albeit at a comparatively moderate CAGR of 4.9%.

Saudi Arabia and other GCC countries are witnessing a gradual increase in clinical trial activities, supported by rising lifestyle-related health conditions and government initiatives to enhance healthcare R&D.

Clinical Trial Segmentation and Trends

The market is segmented by study design and trial phase. Interventional trials dominate with a 45.9% share in 2025, reflecting the focus on actively testing new therapies for safety and efficacy. Phase 3 trials, representing 40.2% of the phase segment, are critical in validating the efficacy and safety of potential NASH treatments before regulatory approval.

Pharmaceutical leaders such as Pfizer Inc., Novartis AG, Icon Plc, AbbVie Inc., F. Hoffmann-La Roche Ltd, Eli Lilly, GSK plc., Novo Nordisk, Gilead Sciences Inc., and Viking Therapeutics are driving innovation across these trials. Notably, Viking Therapeutics' VK2809 demonstrated significant improvements in liver fibrosis and metabolic dysfunction-associated steatohepatitis (MASH) in Phase 2b trials, signaling the potential for breakthrough therapies.

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Market Drivers and Investment Trends

Several factors are propelling the NASH clinical trials market:

• Rising Disease Burden: The global surge in obesity, type 2 diabetes, and metabolic syndrome is expanding the patient pool, increasing demand for new therapies.
• Therapeutic Gap: The absence of FDA-approved treatments for NASH fosters a competitive environment among pharmaceutical firms to develop first-in-class drugs.
• Funding and Collaboration: Government agencies, private organizations, and venture capital firms are increasing investments in clinical research, enabling innovation in trial design, diagnostics, and patient recruitment.
• Regulatory Support: Fast-track designations, breakthrough therapy status, and orphan drug designations accelerate clinical development timelines, encouraging further market expansion.

However, high operational costs-including prolonged study durations, patient recruitment challenges, and advanced diagnostics-pose challenges for smaller biotech companies, emphasizing the need for cost-efficient trial designs.

Regional Highlights and Growth Opportunities

• USA: Maintains leadership in North America with an 88.9% market share through 2035.
• Germany: Leads Europe with strong awareness campaigns and healthcare infrastructure.
• China & India: Emerging as high-growth markets, driven by government support, collaborations, and a large patient base.
• Saudi Arabia: Increasing trial initiatives supported by public health programs and rising metabolic disease prevalence.

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Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 400 analystsworldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.

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