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Non Alcoholic Steatohepatitis Biomarkers Market

ID: MRFR/HC/6512-CR
111 Pages
Kinjoll Dey
June 2019

Non-alcoholic Steatohepatitis Biomarkers Market Research Report Information By Type (Hepatic Fibrosis Biomarkers, Serum Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers and Others), By End User (Research Institutes and Academics, Diagnostic Centres, Pharmaceutical Companies and CROs, Hospitals and Clinics and Others) And By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2035

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Non Alcoholic Steatohepatitis Biomarkers Market Summary

As per MRFR analysis, the Non-alcoholic Steatohepatitis Biomarkers Market Size was estimated at 0.15 USD Billion in 2024. The Non-alcoholic Steatohepatitis Biomarkers industry is projected to grow from 0.1893 in 2025 to 1.938 by 2035, exhibiting a compound annual growth rate (CAGR) of 26.19 during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The Non-alcoholic Steatohepatitis Biomarkers Market is poised for substantial growth driven by technological advancements and increasing healthcare awareness.

  • Technological advancements in biomarker discovery are reshaping the landscape of non-alcoholic steatohepatitis diagnostics.
  • North America remains the largest market, while the Asia-Pacific region is emerging as the fastest-growing area for biomarker development.
  • Hepatic fibrosis biomarkers dominate the market, whereas serum biomarkers are witnessing rapid growth due to their non-invasive nature.
  • The rising prevalence of non-alcoholic fatty liver disease and increased investment in healthcare infrastructure are key drivers propelling market expansion.

Market Size & Forecast

2024 Market Size 0.15 (USD Billion)
2035 Market Size 1.938 (USD Billion)
CAGR (2025 - 2035) 26.19%

Major Players

Gilead Sciences (US), Intercept Pharmaceuticals (US), Bristol-Myers Squibb (US), Pfizer (US), Novartis (CH), Eli Lilly and Company (US), Merck & Co. (US), Amgen (US), AbbVie (US)

Non Alcoholic Steatohepatitis Biomarkers Market Trends

The Non-alcoholic Steatohepatitis Biomarkers Market is currently experiencing a notable evolution, driven by the increasing prevalence of non-alcoholic fatty liver disease and the growing awareness surrounding liver health. As healthcare professionals seek more effective diagnostic tools, the demand for reliable biomarkers is on the rise. This market appears to be influenced by advancements in technology, which facilitate the identification and validation of new biomarkers. Furthermore, the integration of personalized medicine into treatment protocols may enhance the relevance of these biomarkers in clinical settings. In addition, regulatory bodies are likely to play a crucial role in shaping the landscape of the Non-alcoholic Steatohepatitis Biomarkers Market. The emphasis on stringent approval processes for diagnostic tools may lead to a more robust market, albeit with potential challenges for new entrants. Collaboration between research institutions and pharmaceutical companies seems to be fostering innovation, which could result in the development of novel biomarkers. Overall, the market is poised for growth, with various factors contributing to its dynamic nature.

Technological Advancements in Biomarker Discovery

The Non-alcoholic Steatohepatitis Biomarkers Market is witnessing a surge in technological innovations that enhance biomarker discovery. Advanced techniques such as genomics, proteomics, and metabolomics are being employed to identify potential biomarkers with greater accuracy. This trend suggests a shift towards more precise and personalized diagnostic approaches, which may improve patient outcomes.

Increased Focus on Preventive Healthcare

There is a growing emphasis on preventive healthcare measures, which is influencing the Non-alcoholic Steatohepatitis Biomarkers Market. As healthcare systems prioritize early detection and intervention, the demand for biomarkers that can indicate the risk of developing non-alcoholic steatohepatitis is likely to rise. This trend indicates a proactive approach to managing liver health.

Regulatory Developments and Market Access

Regulatory frameworks are evolving to accommodate the unique challenges of the Non-alcoholic Steatohepatitis Biomarkers Market. Stricter guidelines for biomarker validation and approval processes may impact market access for new products. However, this trend could also lead to increased trust in approved biomarkers, potentially enhancing their adoption in clinical practice.

Non Alcoholic Steatohepatitis Biomarkers Market Drivers

Growing Awareness and Education

The rising awareness and education surrounding liver health are pivotal drivers for the Non-alcoholic Steatohepatitis Biomarkers Market. Public health campaigns and educational initiatives are increasingly informing individuals about the risks associated with NAFLD and NASH. This heightened awareness is likely to lead to earlier diagnosis and treatment, thereby increasing the demand for biomarkers. Healthcare professionals are also becoming more knowledgeable about the importance of early detection, which may result in more frequent screenings and assessments. As patients become more proactive about their health, the market for non-invasive biomarkers is expected to expand. This trend indicates a shift towards preventive healthcare, which is anticipated to further stimulate growth within the Non-alcoholic Steatohepatitis Biomarkers Market.

Advancements in Biomarker Research

Innovations in biomarker research are significantly influencing the Non-alcoholic Steatohepatitis Biomarkers Market. Recent technological advancements, including high-throughput screening and genomic sequencing, have enhanced the identification and validation of novel biomarkers. These developments facilitate the discovery of non-invasive diagnostic tools, which are increasingly preferred over traditional liver biopsies. The market is witnessing a shift towards the integration of multi-omics approaches, combining genomics, proteomics, and metabolomics to provide comprehensive insights into NASH pathophysiology. As a result, the market is expected to grow, with estimates suggesting a compound annual growth rate of over 10% in the coming years. This trend underscores the importance of continuous investment in research and development to foster innovation within the Non-alcoholic Steatohepatitis Biomarkers Market.

Regulatory Support for Biomarker Development

Regulatory bodies are playing a crucial role in shaping the Non-alcoholic Steatohepatitis Biomarkers Market through supportive frameworks for biomarker development. Recent initiatives aimed at expediting the approval process for diagnostic tools are encouraging innovation and investment in this sector. The establishment of clear guidelines for biomarker validation is likely to enhance the credibility and acceptance of new diagnostic methods. As regulatory agencies prioritize the need for effective NASH management, the market is expected to benefit from increased funding and resources allocated to research and development. This supportive environment may lead to a surge in the introduction of novel biomarkers, thereby driving growth in the Non-alcoholic Steatohepatitis Biomarkers Market.

Increased Investment in Healthcare Infrastructure

The escalation of investment in healthcare infrastructure is a significant driver for the Non-alcoholic Steatohepatitis Biomarkers Market. Governments and private entities are recognizing the need for enhanced healthcare systems to address the rising burden of liver diseases. This investment is likely to facilitate the establishment of advanced diagnostic laboratories and research facilities, which are essential for the development and implementation of biomarkers. Furthermore, improved healthcare access and resources may lead to increased screening and diagnostic efforts for NASH, thereby expanding the market. As healthcare systems evolve to meet the demands of a growing patient population, the Non-alcoholic Steatohepatitis Biomarkers Market is expected to experience robust growth.

Rising Prevalence of Non-alcoholic Fatty Liver Disease

The increasing incidence of non-alcoholic fatty liver disease (NAFLD) is a primary driver for the Non-alcoholic Steatohepatitis Biomarkers Market. As obesity rates rise, particularly in developed regions, the prevalence of NAFLD is expected to escalate. Reports indicate that approximately 25% of the adult population may be affected by NAFLD, with a significant portion progressing to non-alcoholic steatohepatitis (NASH). This alarming trend necessitates the development of effective biomarkers for early diagnosis and monitoring, thereby propelling market growth. The demand for reliable diagnostic tools is likely to surge as healthcare providers seek to manage and mitigate the risks associated with liver diseases. Consequently, the Non-alcoholic Steatohepatitis Biomarkers Market is poised for expansion as stakeholders respond to this pressing health challenge.

Market Segment Insights

Non-alcoholic Steatohepatitis Biomarkers Type Insights

The non-alcoholic steatohepatitis biomarkers market segmentation, based on type includes Hepatic Fibrosis Biomarkers, Serum Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers and Others. The serum biomarkers segment dominated the market. The segment's dominance is related to serum biomarkers' success and widespread use as a diagnostic tool for NASH. Additionally, it has a competitive advantage when used to distinguish between primary steatosis and NASH. Apolipoprotein B, leptin, adiponectin, ghrelin, apolipoprotein A1, free fatty acids, and tumor necrosis factor-alpha are a few of the novel blood biomarkers that are anticipated to be released and are projected to accelerate market expansion.

Figure 1: Non-alcoholic Steatohepatitis Biomarkers Market, by Type, 2022 & 2032 (USD Billion) 

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

Non-alcoholic Steatohepatitis Biomarkers End User Insights

The non-alcoholic steatohepatitis biomarkers market segmentation, based on distribution channel, includes Research Institutes and Academics, Diagnostic Centres, Pharmaceutical Companies and CROs, Hospitals and Clinics and Others. The pharmaceutical companies and CROs category generated the most income. The market is expected to expand as a result of the increased demand for non-invasive diagnostic techniques to identify chronic liver disease and the rising prevalence of liver ailments. Additionally, as a result of improved diagnostics, the market for treatments is expanding, which raises the need for pharmaceuticals and ultimately supports the expansion of the entire industry.

Get more detailed insights about Non Alcoholic Steatohepatitis Biomarkers Market

Regional Insights

North America : Market Leader in Innovation

North America is the largest market for Non-alcoholic Steatohepatitis (NASH) biomarkers, accounting for approximately 45% of the global market share. The region's growth is driven by increasing obesity rates, rising awareness of liver diseases, and supportive regulatory frameworks. The FDA's initiatives to expedite the approval of NASH treatments further catalyze market expansion. The United States leads the market, with significant contributions from Canada. Key players such as Gilead Sciences, Intercept Pharmaceuticals, and Bristol-Myers Squibb are heavily investing in research and development. The competitive landscape is characterized by collaborations and partnerships aimed at advancing biomarker discovery and validation, ensuring a robust pipeline of innovative solutions.

Europe : Emerging Regulatory Frameworks

Europe is witnessing a significant rise in the Non-alcoholic Steatohepatitis biomarkers market, holding approximately 30% of the global share. The growth is fueled by increasing prevalence of metabolic disorders and a growing emphasis on early diagnosis and treatment. Regulatory bodies are actively working to establish guidelines that facilitate the development of NASH biomarkers, enhancing market dynamics. Leading countries include Germany, France, and the UK, where healthcare systems are increasingly prioritizing liver health. Major players like Novartis and Eli Lilly are expanding their presence through strategic collaborations. The competitive landscape is evolving, with a focus on innovative biomarker solutions that align with regulatory expectations, ensuring patient access to effective treatments.

Asia-Pacific : Rapidly Growing Market Potential

Asia-Pacific is emerging as a significant player in the Non-alcoholic Steatohepatitis biomarkers market, contributing around 20% to the global market share. The region's growth is driven by increasing urbanization, lifestyle changes, and a rising incidence of obesity and diabetes. Governments are beginning to recognize the importance of addressing liver diseases, leading to supportive health policies. Countries like China and Japan are at the forefront, with a growing number of clinical trials and research initiatives focused on NASH. The competitive landscape features both local and international players, including Merck & Co. and Amgen, who are investing in innovative biomarker research. The region's market is characterized by a collaborative approach among stakeholders to enhance diagnostic capabilities and treatment options.

Middle East and Africa : Untapped Market Opportunities

The Middle East and Africa region is gradually recognizing the importance of Non-alcoholic Steatohepatitis biomarkers, currently holding about 5% of the global market share. The growth is primarily driven by increasing awareness of liver diseases and the rising prevalence of obesity. Governments are beginning to implement health initiatives aimed at improving liver health, which is expected to catalyze market growth. Countries like South Africa and the UAE are leading the charge, with healthcare systems starting to prioritize liver disease management. The competitive landscape is still developing, with opportunities for both local and international players to enter the market. Key players are focusing on educational campaigns to raise awareness and promote early diagnosis, which is crucial for effective treatment.

Non Alcoholic Steatohepatitis Biomarkers Market Regional Image

Key Players and Competitive Insights

Leading market players are investing heavily in research and development in order to expand their product lines, which will help the non-alcoholic steatohepatitis biomarkers market, grow even more. Market participants are also undertaking a variety of strategic activities to expand their footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, non-alcoholic steatohepatitis biomarkers industry must offer cost-effective items.

Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the non-alcoholic steatohepatitis biomarkers industry to benefit clients and increase the market sector. In recent years, the non-alcoholic steatohepatitis biomarkers industry has offered some of the most significant advantages to market.

Major players in the non-alcoholic steatohepatitis biomarkers market attempting to increase market demand by investing in research and development operations include Perspectum Diagnostics Ltd., Shenzhen New Industries Biomedical Engineering Co Ltd, One Way Liver SL, BioPredictive, Cisbio, Celerion, Enterome, Echosens, GENFIT, NGM Biopharmaceuticals, Laboratory Corporation of America Holdings, Pacific Biomarkers, Quest Diagnostics Ltd, Prometheus Laboratories Inc, Regulus Therapeutics Inc., Xeptagen SpA, Boehringer Ingelheim GmbH Inc., Bristol-Myers Squibb, AstraZeneca and Pfizer Inc. 

NGM Biopharmaceuticals Inc. (NGM Bio) is a clinical-stage biopharmaceutical business that creates a pipeline of biological medicines for the treatment of ophthalmic, immuno-oncological, retinal, and liver disorders, as well as cardio-metabolic and immuno-metabolic conditions. Multiple technologies are incorporated into the company's biologic platform to produce and screen monoclonal antibodies.

Through a network of laboratories and business-owned patient service centers, Quest Diagnostics Inc. (Quest Diagnostics) offers diagnostic information services to patients and physicians. It provides a variety of services, including as anatomic pathology, clinical trial testing, life insurer services, genetic testing, gene-based testing, and other specialized tests, as well as a range of medical information technology and diagnostic devices. Among others, Quest Diagnostics offers its services to hospitals, clinics, managed care organizations, other health insurance companies, laboratories, and governmental institutions.

Key Companies in the Non Alcoholic Steatohepatitis Biomarkers Market market include

Industry Developments

April 2023:A ground-breaking imaging biomarker for evaluating NASH was introduced by BioGenomics Inc. The non-invasive imaging technology allows for the precise observation and measurement of liver fibrosis, inflammation, and fat, which is helpful for disease staging and therapy monitoring.

February 2023:The creation of a brand-new blood-based biomarker panel for the early diagnosis of NASH was successfully announced by Biopredictive Biotech. When detecting at-risk patients and distinguishing NASH from other liver disorders, the panel exhibits encouraging accuracy.

September 2021:To create a non-invasive composite biomarker for non-alcoholic steatohepatitis using feces samples, Second Genome and Virginia Commonwealth University worked together on study.

Future Outlook

Non Alcoholic Steatohepatitis Biomarkers Market Future Outlook

The Non-alcoholic Steatohepatitis Biomarkers Market is projected to grow at a 26.19% CAGR from 2024 to 2035, driven by rising obesity rates, increased awareness, and advancements in diagnostic technologies.

New opportunities lie in:

  • Development of non-invasive biomarker tests for early diagnosis
  • Partnerships with healthcare providers for integrated care solutions
  • Investment in AI-driven analytics for personalized treatment plans

By 2035, the market is expected to be robust, driven by innovation and strategic partnerships.

Market Segmentation

Non Alcoholic Steatohepatitis Biomarkers Market Type Outlook

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

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 20240.15(USD Billion)
MARKET SIZE 20250.1893(USD Billion)
MARKET SIZE 20351.938(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR)26.19% (2024 - 2035)
REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR2024
Market Forecast Period2025 - 2035
Historical Data2019 - 2024
Market Forecast UnitsUSD Billion
Key Companies ProfiledMarket analysis in progress
Segments CoveredMarket segmentation analysis in progress
Key Market OpportunitiesAdvancements in biomarker discovery enhance diagnostic accuracy in the Non-alcoholic Steatohepatitis Biomarkers Market.
Key Market DynamicsRising demand for non-invasive diagnostic tools drives innovation in Non-alcoholic Steatohepatitis Biomarkers development.
Countries CoveredNorth America, Europe, APAC, South America, MEA

Market Highlights

Author
Kinjoll Dey
Research Analyst Level I

He is an extremely curious individual currently working in Healthcare and Medical Devices Domain. Kinjoll is comfortably versed in data centric research backed by healthcare educational background. He leverages extensive data mining and analytics tools such as Primary and Secondary Research, Statistical Analysis, Machine Learning, Data Modelling. His key role also involves Technical Sales Support, Client Interaction and Project management within the Healthcare team. Lastly, he showcases extensive affinity towards learning new skills and remain fascinated in implementing them.

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FAQs

What is the projected market valuation for the Non-alcoholic Steatohepatitis Biomarkers Market by 2035?

The market is projected to reach approximately 1.938 USD Billion by 2035.

What was the market valuation for the Non-alcoholic Steatohepatitis Biomarkers Market in 2024?

The market valuation was 0.15 USD Billion in 2024.

What is the expected CAGR for the Non-alcoholic Steatohepatitis Biomarkers Market during the forecast period 2025 - 2035?

The expected CAGR for the market during this period is 26.19%.

Which companies are considered key players in the Non-alcoholic Steatohepatitis Biomarkers Market?

Key players include Gilead Sciences, Intercept Pharmaceuticals, Bristol-Myers Squibb, Pfizer, Novartis, Eli Lilly and Company, Merck & Co., Amgen, and AbbVie.

What are the main segments of the Non-alcoholic Steatohepatitis Biomarkers Market?

The main segments include Hepatic Fibrosis Biomarkers, Serum Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers, and others.

How did the Hepatic Fibrosis Biomarkers segment perform in 2024?

In 2024, the Hepatic Fibrosis Biomarkers segment was valued at 0.045 USD Billion.

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