U.S. Non-alcoholic Steatohepatitis Biomarkers Market (By Type: Serum, Hepatic Fibrosis, Apoptosis; By End-use: Hospitals, Diagnostic Labs) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

U.S. Non-alcoholic Steatohepatitis Biomarkers Market Size and Growth

The U.S. non-alcoholic steatohepatitis biomarkers market size was estimated at around USD 0.65 billion in 2023 and is projected to hit around USD 5.55 billion by 2033, growing at a CAGR of 23.93% from 2024 to 2033.

Key Pointers

• By Type, the serum biomarkers segment generated the maximum market share of 33% in 2023.
• By Type, the hepatic fibrosis biomarkers segment is expected to expand at the highest CAGR from 2024 to 2033.
• By End-use, the pharma and Contract Research Organization (CRO) industry segment held the largest revenue share in 2023.

U.S. Non-alcoholic Steatohepatitis Biomarkers Market Overview

Non-alcoholic steatohepatitis (NASH) is a progressive liver disease characterized by hepatic inflammation and fat accumulation, often leading to fibrosis, cirrhosis, and hepatocellular carcinoma. Early detection and monitoring of NASH are crucial for effective management and prevention of disease progression. Biomarkers play a pivotal role in the diagnosis, prognosis, and therapeutic monitoring of NASH. In the United States, the market for non-alcoholic steatohepatitis biomarkers is witnessing significant growth due to the rising prevalence of NASH and the growing demand for non-invasive diagnostic tools.

U.S. Non-alcoholic Steatohepatitis Biomarkers Market Growth Factors

The growth of the U.S. non-alcoholic steatohepatitis (NASH) biomarkers market is propelled by an increasing prevalence of non-alcoholic fatty liver disease (NAFLD) and its advanced form, NASH, is driving the demand for reliable biomarkers for early detection and monitoring of the disease progression. Additionally, the rising awareness among healthcare professionals and patients about the importance of early diagnosis and treatment of NASH is fueling the adoption of biomarker-based diagnostic tools. Furthermore, the growing investment in research and development activities focused on identifying novel biomarkers for NASH is contributing to market expansion. Moreover, the favorable regulatory landscape and initiatives undertaken by healthcare organizations to address the unmet needs in NASH diagnosis and management are further boosting market growth.

U.S. Non-alcoholic Steatohepatitis Biomarkers Market Trends:

• Advancements in Diagnostic Technologies: Ongoing advancements in diagnostic technologies, such as molecular diagnostics and imaging techniques, are facilitating the development of more accurate and reliable biomarkers for NASH detection and monitoring.
• Focus on Non-Invasive Testing: There's a growing preference for non-invasive diagnostic tests among patients and healthcare providers due to their convenience and reduced risk. This trend is driving the demand for non-invasive biomarker-based tests for NASH diagnosis.
• Rising Adoption of Multi-Biomarker Panels: Multi-biomarker panels are gaining traction in NASH diagnosis as they offer a comprehensive assessment of disease severity and progression. The integration of multiple biomarkers into diagnostic panels enhances diagnostic accuracy and enables personalized treatment approaches.
• Growing Emphasis on Precision Medicine: The shift towards precision medicine in NASH management is driving the demand for biomarkers that can identify patients at higher risk of disease progression and predict response to specific therapeutic interventions. This trend is spurring research efforts to identify predictive biomarkers for personalized treatment strategies.
• Regulatory Initiatives and Guidelines: Regulatory initiatives aimed at addressing the unmet need for NASH diagnostics, such as FDA guidance documents and regulatory pathways for biomarker qualification, are providing a framework for the development and approval of biomarker-based tests. Compliance with regulatory requirements is becoming increasingly important for market players seeking commercialization approval.

U.S. Non-alcoholic Steatohepatitis Biomarkers Market Restraints:

• Limited Validation of Biomarkers: Many biomarkers for NASH are still in the validation phase, lacking robust clinical evidence to support their efficacy and accuracy. This limited validation poses challenges in the adoption of biomarker-based diagnostic tests by healthcare providers and regulatory authorities.
• Complex Pathophysiology of NASH: The complex pathophysiology of NASH, characterized by multiple underlying mechanisms and disease pathways, presents challenges in identifying biomarkers that can accurately reflect disease severity and progression. The heterogeneity of NASH further complicates biomarker discovery and validation efforts.
• High Development Costs and Time: The development of biomarkers for NASH involves significant investment in research and development, clinical validation studies, and regulatory approval processes. The high development costs and lengthy timelines associated with biomarker development can deter investment from pharmaceutical companies and diagnostic manufacturers.
• Regulatory Challenges and Uncertainty: The regulatory landscape for NASH biomarkers is evolving, with uncertainty surrounding regulatory pathways for biomarker qualification and approval. Lack of clear guidance from regulatory authorities can hinder the development and commercialization of biomarker-based diagnostic tests for NASH.
• Interference from Comorbidities and Medications: Patients with NASH often have comorbidities such as obesity, diabetes, and cardiovascular disease, as well as concurrent medications, which can interfere with biomarker accuracy and interpretation. This interference poses challenges in the clinical utility of biomarkers for NASH diagnosis and monitoring.

Type Insights

The market is divided by type into four segments: serum biomarkers, hepatic fibrosis biomarkers, apoptosis biomarkers, and oxidative stress biomarkers. Serum biomarkers led the market in 2023, holding a revenue share of 33%. These biomarkers provide a non-invasive alternative to invasive procedures like liver biopsies, thus witnessing increased adoption among both patients and healthcare providers. Using serum biomarkers for NASH diagnosis and monitoring is often more cost-effective than traditional methods, making it preferable in a healthcare setting that prioritizes efficiency and affordability. The market is anticipated to expand with the introduction of novel biomarkers such as apolipoprotein A1, apolipoprotein B, adiponectin, leptin, ghrelin, tumor necrosis factor-alpha, and free fatty acids. Key players in the market are concentrating on securing FDA approvals for their serum biomarkers-based tests. For example, in 2021, Siemens Healthineers obtained FDA marketing authorization for its Enhanced Liver Fibrosis test.

The hepatic fibrosis biomarkers segment is projected to exhibit the fastest CAGR during the forecast period. The increasing prevalence of NASH, driven by factors like obesity, sedentary lifestyles, and metabolic syndrome, has heightened attention on hepatic fibrosis biomarkers. According to a study published by the National Institutes of Diabetes and Digestive and Kidney Diseases, NAFLD affects one-third to two-thirds of individuals with type 2 diabetes. Research also indicates that over 90% of individuals with extreme obesity and up to 75% of those who are overweight have NAFLD. The clinical significance of fibrosis staging is one of the primary factors propelling the demand for NASH-specific hepatic fibrosis biomarkers. Risks and limitations associated with liver biopsies and non-invasive biomarkers offer a safer and more patient-friendly approach to monitoring hepatic fibrosis progression in NASH patients.

End-use Insights

In 2023, the pharma and Contract Research Organization (CRO) industry segment took the lead in the market and is anticipated to exhibit the fastest compound annual growth rate (CAGR) throughout the forecast period from 2024 to 2033. The significant investments made by pharmaceutical companies and CROs in Research and Development (R&D) activities have been pivotal in driving the discovery and validation of NASH biomarkers. These investments encompass a wide array of activities, including biomarker identification, preclinical studies, clinical trials, and regulatory approvals. Given the substantial unmet medical need for NASH in the U.S., pharmaceutical companies are actively engaged in developing novel drugs and biologics targeting various aspects of the disease, including hepatic fibrosis, inflammation, and metabolic dysfunction.

The pharmaceutical and CRO industries are heavily investing in R&D efforts focused on NASH biomarkers. This includes allocating funds for biomarker discovery, validation studies, and clinical trials aimed at identifying novel biomarkers capable of accurately diagnosing and monitoring NASH progression, including hepatic fibrosis. Collaborations and partnerships between pharmaceutical companies, CROs, academic institutions, and healthcare organizations have emerged as crucial drivers in advancing NASH biomarker research. These collaborative endeavors facilitate the exchange of knowledge, access to diverse patient populations, and the pooling of resources for biomarker validation studies. In September 2023, GENFIT, a biopharmaceutical company, published data showcasing the efficacy of their non-alcoholic steatohepatitis diagnostic technology, NIS4, in the scientific journal Nature Medicine. This study, conducted as part of the FNIH Biomarkers Consortium, evaluated five blood-based panels, including NIS4 and its precursor.

U.S. Non-alcoholic Steatohepatitis Biomarkers Market Key Companies

• GENFIT
• Prometheus Laboratories.
• Siemens Medical Solutions USA, Inc.
• Quest Diagnostics
• AstraZeneca
• Laboratory Corporation of America Holdings.
• Pfizer, Inc.
• Bristol-Myers Squibb Company
• Recent Developments

U.S. Non-alcoholic Steatohepatitis Biomarkers Market Segmentation:

By Type

• Serum Biomarkers
• Hepatic Fibrosis Biomarkers
• Apoptosis Biomarkers
• Oxidative Stress Biomarkers
• Others

By End-use

• Pharma & CRO Industry
• Hospitals
• Diagnostic Labs
• Academic Research Institutes

By Region

• West
• Midwest
• Northeast
• Southwest
• Southeast