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Italy Non Alcoholic Steatohepatitis Biomarkers Market

ID: MRFR/HC/47963-HCR
200 Pages
Rahul Gotadki
October 2025

Italy Non-Alcoholic Steatohepatitis Biomarkers Market Research Report: By Type (Hepatic Fibrosis Biomarkers, Serum Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers, Others) and By End User (Research Institutes and Academics, Diagnostic Centres, Pharmaceutical Companies and CROs, Hospitals and Clinics, Others)- Forecast to 2035

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Italy Non Alcoholic Steatohepatitis Biomarkers Market Summary

As per MRFR analysis, the non alcoholic steatohepatitis biomarkers market size was estimated at 3.0 USD Million in 2024. The non alcoholic-steatohepatitis-biomarkers market is projected to grow from 3.86 USD Million in 2025 to 48.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 28.67% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The Italy non alcoholic-steatohepatitis-biomarkers market is poised for growth driven by increasing awareness and technological advancements.

  • The market is witnessing a rising prevalence of liver diseases, indicating a growing need for effective biomarkers.
  • Technological advancements in biomarker discovery are enhancing diagnostic capabilities and accuracy.
  • Regulatory support for biomarker development is fostering innovation and investment in the sector.
  • Key market drivers include increasing awareness of liver health and rising healthcare expenditure, which are likely to propel market growth.

Market Size & Forecast

2024 Market Size 3.0 (USD Million)
2035 Market Size 48.0 (USD Million)

Major Players

F. Hoffmann-La Roche Ltd (CH), AbbVie Inc. (US), Gilead Sciences Inc. (US), Merck & Co., Inc. (US), Amgen Inc. (US), Pfizer Inc. (US), Bristol-Myers Squibb Company (US), Eli Lilly and Company (US)

Italy Non Alcoholic Steatohepatitis Biomarkers Market Trends

The non alcoholic-steatohepatitis-biomarkers market is currently experiencing notable developments, driven by an increasing awareness of liver diseases and the need for effective diagnostic tools. In Italy, the prevalence of non alcoholic fatty liver disease (NAFLD) has prompted healthcare professionals to seek reliable biomarkers for early detection and monitoring. This growing focus on liver health is reflected in the rising demand for innovative diagnostic solutions, which may lead to advancements in biomarker research and development. Furthermore, collaborations between academic institutions and biotechnology firms appear to be fostering a conducive environment for innovation in this sector. Moreover, regulatory bodies in Italy are likely to play a crucial role in shaping the landscape of the non alcoholic-steatohepatitis-biomarkers market. The emphasis on stringent regulatory frameworks may encourage the development of high-quality biomarkers that meet safety and efficacy standards. As healthcare providers increasingly adopt personalized medicine approaches, the integration of biomarkers into clinical practice could enhance patient outcomes. Overall, the market seems poised for growth, driven by a combination of rising disease awareness, technological advancements, and supportive regulatory initiatives.

Rising Prevalence of Liver Diseases

The increasing incidence of liver-related conditions in Italy is driving the demand for effective biomarkers. As more individuals are diagnosed with non alcoholic fatty liver disease, healthcare providers are seeking reliable diagnostic tools to facilitate early detection and management.

Technological Advancements in Biomarker Discovery

Innovations in biotechnology and genomics are enhancing the capabilities of biomarker discovery. In Italy, advancements in analytical techniques are likely to improve the identification and validation of biomarkers, leading to more accurate diagnostic solutions.

Regulatory Support for Biomarker Development

Italian regulatory agencies are focusing on establishing guidelines for the development and approval of biomarkers. This regulatory support may encourage investment in research and development, fostering a more robust non alcoholic-steatohepatitis-biomarkers market.

Italy Non Alcoholic Steatohepatitis Biomarkers Market Drivers

Growing Aging Population

The demographic shift towards an aging population in Italy is likely to impact the non alcoholic-steatohepatitis-biomarkers market positively. As individuals age, the risk of developing liver diseases, including NASH, increases. By 2025, it is estimated that over 23% of the Italian population will be aged 65 and older, creating a larger patient base susceptible to liver-related conditions. This demographic trend necessitates the development of effective biomarkers for early diagnosis and monitoring of liver health. Consequently, the non alcoholic-steatohepatitis-biomarkers market may experience growth as healthcare providers seek to address the needs of this aging population, ensuring timely interventions and improved health outcomes.

Rising Healthcare Expenditure

Italy's increasing healthcare expenditure is another significant driver for the non alcoholic-steatohepatitis-biomarkers market. The Italian government has been investing more in healthcare services, particularly in preventive care and chronic disease management. In 2025, healthcare spending is projected to reach approximately €200 billion, reflecting a commitment to improving health outcomes. This financial support facilitates the development and adoption of advanced diagnostic tools, including biomarkers for non alcoholic steatohepatitis. As healthcare budgets expand, there is a greater opportunity for research and development in this field, which may lead to innovative biomarker solutions that enhance patient care and management of liver diseases.

Regulatory Framework Enhancements

The evolving regulatory framework in Italy is fostering a conducive environment for the non alcoholic-steatohepatitis-biomarkers market. Regulatory bodies are increasingly recognizing the importance of biomarkers in the diagnosis and management of liver diseases. Recent initiatives aimed at streamlining the approval process for diagnostic tests are likely to encourage innovation and investment in this sector. By 2025, it is anticipated that new guidelines will be established to facilitate the development and commercialization of biomarkers for NASH. This regulatory support may enhance market confidence, leading to increased participation from stakeholders and ultimately driving growth in the non alcoholic-steatohepatitis-biomarkers market.

Increasing Awareness of Liver Health

The growing awareness of liver health among the Italian population is a crucial driver for the non alcoholic-steatohepatitis-biomarkers market. Public health campaigns and educational initiatives have highlighted the risks associated with liver diseases, particularly non-alcoholic fatty liver disease (NAFLD) and its progression to non alcoholic steatohepatitis (NASH). This heightened awareness is likely to lead to increased screening and diagnostic testing, thereby driving demand for biomarkers. In Italy, the prevalence of NAFLD is estimated to be around 25%, which underscores the need for effective biomarkers to identify and monitor liver health. As healthcare providers emphasize the importance of early detection, the non alcoholic-steatohepatitis-biomarkers market is expected to expand significantly in response to this growing public consciousness.

Advancements in Diagnostic Technologies

Technological advancements in diagnostic technologies are propelling the non alcoholic-steatohepatitis-biomarkers market forward. Innovations in biomarker discovery, such as high-throughput screening and next-generation sequencing, are enhancing the ability to identify and validate biomarkers associated with NASH. In Italy, research institutions and biotech companies are increasingly collaborating to develop novel diagnostic tools that can provide accurate and timely assessments of liver health. These advancements not only improve the precision of diagnoses but also facilitate personalized treatment approaches. As the market for non alcoholic steatohepatitis biomarkers evolves, the integration of cutting-edge technologies is expected to play a pivotal role in shaping its future.

Market Segment Insights

Non-Alcoholic Steatohepatitis Biomarkers Market Type Insights

The Italy Non-Alcoholic Steatohepatitis Biomarkers Market is emerging as a crucial domain within the healthcare sector, particularly as a result of the increasing prevalence of non-alcoholic fatty liver disease (NAFLD) among the population in Italy. This rise in instances of metabolic syndrome is propelling the demand for effective biomarkers to diagnose and monitor Non-Alcoholic Steatohepatitis (NASH), which is a more severe form of NAFLD.

The market can be categorized into various types, such as Hepatic Fibrosis Biomarkers, Serum Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers, and others, each playing a distinct role in the overall market dynamics. Hepatic Fibrosis Biomarkers are becoming increasingly significant as they help to assess the degree of liver fibrosis in patients, serving as critical indicators for the progression of liver disease and treatment decisions.

Serum Biomarkers, on the other hand, are widely utilized for their ability to provide information regarding liver injuries and changes in lipid metabolism, thus representing a major component in routine clinical practice for patient evaluation. Further, Oxidative Stress Biomarkers are gaining attention due to their correlation with inflammation and cellular damage, as oxidative stress is a significant contributor to the pathogenesis of NASH.

The ability to measure these biomarkers can provide insights into the severity of liver damage and potentially guide therapeutic interventions. Similarly, Apoptosis Biomarkers play an essential role as they indicate cell death and liver inflammation, which are crucial in understanding the progression of NASH and tailoring personalized treatment approaches.

Other types of biomarkers enrich the landscape by addressing various facets of NAFLD and streamlining patient management. In the Italian context, the government is promoting initiatives aimed at improving liver health, which opens avenues for enhanced research and adoption of these biomarkers in clinical settings.

As healthcare providers and researchers continue to explore these different types of biomarkers, it is evident that the Italy Non-Alcoholic Steatohepatitis Biomarkers Market is on the cusp of substantial evolution, driven by technological advancements and a growing focus on preventive healthcare.

As awareness of NASH and related liver diseases continues to rise and healthcare policies pivot towards early diagnosis and effective management, the relevance of these biomarkers will only amplify, establishing a robust framework for patient care in Italy.

Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

Non-Alcoholic Steatohepatitis Biomarkers Market End User Insights

The End User segment of the Italy Non-Alcoholic Steatohepatitis Biomarkers Market showcases significant diversity, reflecting the comprehensive landscape of healthcare and research in the country. Research Institutes and Academics play a vital role, contributing to innovative studies and the development of biomarkers crucial for understanding non-alcoholic steatohepatitis.

Diagnostic Centres are also essential, providing advanced testing that aids clinicians in diagnosing and monitoring liver diseases, ensuring timely interventions. Furthermore, Pharmaceutical Companies and Contract Research Organizations (CROs) form a critical backbone in developing new therapies and conducting clinical trials, thus driving market growth.

Hospitals and Clinics represent another important part of the end-user landscape, as they are often the first point of contact for patients, facilitating treatment and management through clinical applications of biomarkers. Additionally, other stakeholders in the market contribute to a holistic ecosystem aimed at reducing the burden of non-alcoholic steatohepatitis in Italy.

The increasing prevalence of metabolic disorders in the country further emphasizes the importance of this segment, as more healthcare entities and research organizations prioritize the advancement of biomarker technologies in their endeavors.

Get more detailed insights about Italy Non Alcoholic Steatohepatitis Biomarkers Market

Key Players and Competitive Insights

The non alcoholic-steatohepatitis-biomarkers market in Italy is characterized by a dynamic competitive landscape, driven by increasing prevalence rates and a growing emphasis on early diagnosis and treatment. Key players such as F. Hoffmann-La Roche Ltd (CH), AbbVie Inc. (US), and Gilead Sciences Inc. (US) are actively shaping the market through innovative product development and strategic partnerships. These companies are focusing on enhancing their diagnostic capabilities and expanding their portfolios to include novel biomarkers, which collectively intensifies competition and fosters a more robust market environment.

In terms of business tactics, companies are increasingly localizing manufacturing and optimizing their supply chains to enhance efficiency and reduce costs. The market appears moderately fragmented, with several players vying for market share. However, the collective influence of major companies like Merck & Co., Inc. (US) and Bristol-Myers Squibb Company (US) is significant, as they leverage their extensive resources and expertise to establish a strong foothold in the market.

In October 2025, AbbVie Inc. (US) announced a strategic collaboration with a leading Italian research institution to develop advanced biomarkers for non alcoholic steatohepatitis. This partnership is expected to accelerate the discovery of novel diagnostic tools, thereby enhancing AbbVie's position in the market. The collaboration underscores the importance of leveraging local expertise to drive innovation and improve patient outcomes.

In September 2025, Gilead Sciences Inc. (US) launched a new biomarker assay aimed at improving the accuracy of non alcoholic steatohepatitis diagnosis. This launch is pivotal as it not only expands Gilead's product offerings but also addresses a critical need for reliable diagnostic solutions in the market. The introduction of this assay is likely to enhance Gilead's competitive edge and attract a broader customer base.

In August 2025, F. Hoffmann-La Roche Ltd (CH) expanded its biomarker research initiatives by investing in cutting-edge technologies, including artificial intelligence and machine learning. This investment is indicative of Roche's commitment to innovation and positions the company to lead in the development of next-generation diagnostic tools. By integrating advanced technologies, Roche aims to streamline its research processes and improve the accuracy of its biomarker tests.

As of November 2025, the competitive trends in the non alcoholic-steatohepatitis-biomarkers market are increasingly defined by digitalization, sustainability, and the integration of AI technologies. Strategic alliances among key players are shaping the landscape, fostering collaboration that enhances innovation and accelerates product development. Looking ahead, competitive differentiation is likely to evolve, with a shift from price-based competition to a focus on technological advancements, innovative solutions, and reliable supply chains. This transition may ultimately lead to improved patient care and outcomes in the management of non alcoholic steatohepatitis.

Key Companies in the Italy Non Alcoholic Steatohepatitis Biomarkers Market market include

Industry Developments

The Italy Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market has experienced notable developments recently. In September 2023, Gilead Sciences announced advancements in their biomarker research focused on non-invasive tests that could improve NASH diagnosis and treatment. Additionally, Merck and Co. have been actively investing in Research and Development to enhance their biomarker portfolio for non-alcoholic fatty liver diseases.

On mergers and acquisitions, LabCorp recently acquired a smaller biotech firm specializing in NASH biomarkers in August 2023, aiming to expand its diagnostic capabilities in this segment. The market, worth approximately EUR 500 million in 2022, is projected to grow at a CAGR of 10% through 2025, driven by rising obesity rates and consequent liver diseases in Italy.

This growth is reflected in increased partnerships and collaborations among companies like Bristol-Myers Squibb and Genfit, focused on early diagnosis and management of NASH. The Italian Ministry of Health has also intensified efforts to develop guidelines for the management of non-alcoholic liver diseases, further boosting market activity. Throughout the last two years, significant investments and innovations have continually shaped the landscape of the NASH biomarkers market in Italy.

Future Outlook

Italy Non Alcoholic Steatohepatitis Biomarkers Market Future Outlook

The non alcoholic-steatohepatitis-biomarkers market is projected to grow at a 28.67% CAGR from 2024 to 2035, driven by increasing prevalence and advancements in diagnostic technologies.

New opportunities lie in:

  • Development of AI-driven diagnostic tools for early detection
  • Partnerships with healthcare providers for biomarker testing
  • Expansion of telehealth services for remote patient monitoring

By 2035, the market is expected to achieve substantial growth and innovation.

Market Segmentation

Italy Non Alcoholic Steatohepatitis Biomarkers Market Type Outlook

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

Italy Non Alcoholic Steatohepatitis Biomarkers Market End User Outlook

  • Research Institutes and Academics
  • Diagnostic Centres
  • Pharmaceutical Companies and CROs
  • Hospitals and Clinics
  • Others

Report Scope

MARKET SIZE 2024 3.0(USD Million)
MARKET SIZE 2025 3.86(USD Million)
MARKET SIZE 2035 48.0(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 28.67% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled F. Hoffmann-La Roche Ltd (CH), AbbVie Inc. (US), Gilead Sciences Inc. (US), Merck & Co., Inc. (US), Amgen Inc. (US), Pfizer Inc. (US), Bristol-Myers Squibb Company (US), Eli Lilly and Company (US)
Segments Covered Type, End User
Key Market Opportunities Emerging biomarkers for non alcoholic steatohepatitis enhance early diagnosis and personalized treatment strategies.
Key Market Dynamics Rising demand for non alcoholic steatohepatitis biomarkers driven by regulatory changes and technological advancements in diagnostics.
Countries Covered Italy

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FAQs

What is the expected market size of the Italy Non-Alcoholic Steatohepatitis Biomarkers Market in 2024?

The Italy Non-Alcoholic Steatohepatitis Biomarkers Market is expected to be valued at 3.75 million USD in 2024.

What will be the expected market size in 2035?

By 2035, the market is projected to reach a valuation of 9.38 million USD.

What is the expected compound annual growth rate of the market from 2025 to 2035?

The market is expected to grow at a CAGR of 8.687 percent from 2025 to 2035.

Which market segment is valued the highest in 2024?

In 2024, the Hepatic Fibrosis Biomarkers segment is valued at 1.2 million USD, making it the highest valued segment.

What is the projected market value of the Serum Biomarkers segment in 2035?

The Serum Biomarkers segment is expected to be valued at 2.6 million USD in 2035.

Who are the key players in the Italy Non-Alcoholic Steatohepatitis Biomarkers Market?

Major players include Merck and Co, LabCorp, InterMune, and BristolMyers Squibb among others.

What trends are emerging in the Italy Non-Alcoholic Steatohepatitis Biomarkers Market?

Emerging trends include increased research in biomarkers and rising prevalence of non-alcoholic fatty liver disease.

How is the market expected to evolve in terms of regional growth?

The market is expected to experience significant growth driven by increased awareness and healthcare investments in Italy.

What is the market size for Oxidative Stress Biomarkers in 2035?

The Oxidative Stress Biomarkers segment is projected to be valued at 1.95 million USD in 2035.

What factors are driving the growth of the Non-Alcoholic Steatohepatitis Biomarkers Market in Italy?

Key growth drivers include rising obesity rates and advancements in biomarker technologies.

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