Nonalcoholic Steatohepatitis (NASH) Diagnostics Market Size & Share, by Type (Serums Biomarkers, Hepatic Fibrosis Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers), End-user (Pharma & CRO, Hospitals, Academic Research Institutes) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2023-2033

  • Report ID: 4718
  • Published Date: Mar 06, 2023
  • Report Format: PDF, PPT
  1. Market Definition
    1. Definition
    2. Market Segmentation
    3. Product Overview
  2. Assumptions and Acronyms
  3. Research Methodology
    1. Research Process
    2. Primary Research
    3. Secondary Research
  4. Executive Summary – Global Nonalcoholic Steatohepatitis (NASH) Diagnostics Market
  5. Market Dynamics
    1. Market Drivers
    2. Market Restraints
    3. Market Opportunities
    4. Market Trends
  6. Decarbonization Strategy and Carbon Credit Benefit for Market Players
  7. Regulatory and Standards Landscape
  8. Industry Risk Analysis
  9. Global Economic Outlook: Challenges for Global Recovery and its Impact on Global Nonalcoholic Steatohepatitis (NASH) Diagnostics Market
  10. Technology Advancement in Nonalcoholic Steatohepatitis (NASH) Diagnostics Market
  11. Industry Supply Chain Analysis
  12. Analysis on Diagnostic Models
  13. Analysis on Recent Development or Trends
  14. Analysis on Types of Imaging Biomarkers
  15. Global Nonalcoholic Steatohepatitis (NASH) Diagnostics Market 2022-2033
    1. Market Overview
    2. By Value (USD Million)
    3. Market Segmentation Analysis 2022-2033
      1. By Type
        1. Serums Biomarkers, 2022-2033F (USD Million)
        2. Hepatic Fibrosis Biomarkers, 2022-2033F (USD Million)
        3. Oxidative Stress Biomarkers, 2022-2033F (USD Million)
        4. Apoptosis Biomarkers, 2022-2033F (USD Million)
        5. Others, 2022-2033F (USD Million)
      2. By End User
        1. Pharma & CRO Industry, 2022-2033F (USD Million)
        2. Hospitals, 2022-2033 (USD Million)
        3. Academic Research Institutes, 2022-2033F (USD Million)
        4. Others, 2022-2033 (USD Million)
      3. By Region
        1. North America, 2022-2033 (USD Million)
        2. Europe, 2022-2033 (USD Million)
        3. Asia Pacific, 2022-2033 (USD Million)
        4. Latin America, 2022-2033 (USD Million)
        5. Middle East & Africa, 2022-2033 (USD Million)
  16. North America Nonalcoholic Steatohepatitis (NASH) Diagnostics Market 2022-2033
    1. Market Overview
    2. By Value (USD Million)
    3. Market Segmentation Analysis 2022-2033
      1. By Type
        1. Serums Biomarkers, 2022-2033F (USD Million)
        2. Hepatic Fibrosis Biomarkers, 2022-2033F (USD Million)
        3. Oxidative Stress Biomarkers, 2022-2033F (USD Million)
        4. Apoptosis Biomarkers, 2022-2033F (USD Million)
        5. Others, 2022-2033F (USD Million)
      2. By End User
        1. Pharma & CRO Industry, 2022-2033F (USD Million)
        2. Hospitals, 2022-2033 (USD Million)
        3. Academic Research Institutes, 2022-2033F (USD Million)
        4. Others, 2022-2033 (USD Million)
      3. By Country
        1. US, 2022-2033F (USD Million)
        2. Canada, 2022-2033 (USD Million)
  17. Europe Nonalcoholic Steatohepatitis (NASH) Diagnostics Market 2022-2033
    1. Market Overview
    2. By Value (USD Million)
    3. Market Segmentation Analysis 2022-2033
      1. By Type
      2. By End User
      3. By Country
        1. UK, 2022-2033F (USD Million)
        2. Germany, 2022-2033 (USD Million)
        3. Italy, 2022-2033F (USD Million)
        4. France, 2022-2033 (USD Million)
        5. Spain, 2022-2033F (USD Million)
        6. Russia, 2022-2033 (USD Million)
        7. Netherlands, 2022-2033F (USD Million)
  18. Asia Pacific Nonalcoholic Steatohepatitis (NASH) Diagnostics Market 2022-2033
    1. Market Overview
    2. By Value (USD Million)
    3. Market Segmentation Analysis 2022-2033
      1. By Type
      2. By End User
      3. By Country
        1. China, 2022-2033F (USD Million)
        2. India, 2022-2033 (USD Million)
        3. Japan, 2022-2033F (USD Million)
        4. Australia, 2022-2033 (USD Million)
        5. South Korea, 2022-2033F (USD Million)
        6. Singapore, 2022-2033 (USD Million)
        7. Rest of Asia Pacific, 2022-2033 (USD Million)
  19. Latin America Nonalcoholic Steatohepatitis (NASH) Diagnostics Market 2022-2033
    1. Market Overview
    2. By Value (USD Million)
    3. Market Segmentation Analysis 2022-2033
      1. By Type
      2. By End User
      3. By Country
        1. Brazil, 2022-2033F (USD Million)
        2. Argentina, 2022-2033 (USD Million)
        3. Mexico, 2022-2033F (USD Million)
        4. Rest of Latin America, 2022-2033 (USD Million)
  20. Middle East and Africa Nonalcoholic Steatohepatitis (NASH) Diagnostics Market 2022-2033
    1. Market Overview
    2. By Value (USD Million)
    3. Market Segmentation Analysis 2022-2033
      1. By Type
      2. By End User
      3. By Country
        1. GCC, 2022-2033F (USD Million)
        2. Israel, 2022-2033 (USD Million)
        3. South Africa, 2022-2033F (USD Million)
        4. Rest of the Middle East and Africa, 2022-2033 (USD Million)
  21. Competitive Landscape
    1. Company Market Share Analysis
    2. Company Profiles
      1. Echosens
      2. Prometheus Laboratories
      3. Genfit
      4. Siemens Medical Solutions USA, Inc.
      5. BioPredictive
      6. Quest Diagnostics Incorporated.
      7. Meridian Bioscience, Inc.
      8. Laboratory Corporation of America Holdings
      9. Bristol-Myers Squibb Company
      10. One Way Liver SL
      11. Other Major Players
    3. End User Analysis

Global Market Size, Forecast, and Trend Highlights Over 2023-2033

Nonalcoholic Steatohepatitis Diagnostics Market Size is estimated to cross USD 10,253 Million by the end of 2033, growing at a CAGR of 23.8% during the forecast period, i.e., 2023-2033. In the year 2022, the industry size of nonalcoholic steatohepatitis diagnostics was over USD 983.8 Million. The growth of the market can be attributed to the high prevalence rate of NAFLD, including both NAFL and NASH, raises the need for advanced Nonalcoholic Steatohepatitis (NASH) diagnostics techniques. NAFLD, with both NAFL and NASH, is the most common cause of abnormal liver enzymes in the developed nations. The prevalence of NAFLD and NASH in adults in the United States is 30% to 40% and 3% to 12%, respectively, and it has been increasing given the growing prevalence of the predisposing conditions. Most patients with NAFLD and NASH are asymptomatic, and the disease is typically diagnosed incidentally on routine blood work. Because of this, more advanced technologies are in the pipeline to diagnosis the condition due to which the market is accelerating globally.

In addition to these, factors that are believed to fuel the market growth of nonalcoholic steatohepatitis (NASH) diagnostics include the dominant presence of major players and rising product launches for nonalcoholic steatohepatitis (NASH) diagnostics increases the market. For Instance, in 2021, Siemens Healthineers announced that its Enhanced Liver Fibrosis (ELF) Test was approved for marketing authorization under the De Novo review pathway. The ELF Test, for applications with the ADVIA Centaur XP Immunoassay System, offers a simple numeric score that is automatically produced via an algorithm and is used to enhance patient care by assessing the probability of progression to cirrhosis and liver-related clinical events in patients with progressive fibrosis (F3 or F4) due to nonalcoholic steatohepatitis (NASH). Thus, expanding product launches and research activities towards nonalcoholic Steatohepatitis (NASH) diagnostics accelerates the market growth.


Nonalcoholic Steatohepatitis (NASH) Diagnostics Market Size
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Nonalcoholic Steatohepatitis Diagnostics Market: Key Insights

Base Year

2022

Forecast Year

2023-2033

CAGR

23.8%

Base Year Market Size (2022)

USD 983.8 Million

Forecast Year Market Size (2033)

USD 10,253 Million

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Nonalcoholic Steatohepatitis (NASH) Diagnostics Sector: Growth Drivers and Challenges

Market-Growth-Drivers

Growth Drivers

  • Increasing Prevalence of NASH and NAFLD - NAFLD includes nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH), diagnosed when there is evidence of inflammatory activity and hepatocyte injury in steatotic liver tissue. According to a National Center for Biotechnology Information (NCBI) study conducted in 2020, one-quarter of the global population is estimated to have nonalcoholic fatty liver disease (NAFLD). In addition, the incidence of nonalcoholic steatohepatitis (NASH) is projected to increase by up to 56% in the next ten years. NAFLD is already the fastest-growing cause of hepatocellular carcinoma (HCC) in the USA, France, and the UK. Globally, the prevalence of NAFLD-related HCC is likely to increase concomitantly with the growing obesity epidemic, which is also a reason for the higher demands for NASH diagnostics biomarkers globally.
  • Rising Demand for Providing Novel Diagnostic Tools - Various non-invasive tests are being widely adopted by healthcare professionals to diagnose Nonalcoholic Steatohepatitis (NASH), propelling the market growth. Non-invasive tests are used for predicting the severity of fibrosis in NAFLD patients. These include both serologic tests and imaging techniques. The serologic tests include AST to Platelet Ratio Index (APRI) score, Fibrosis-4 (Fib-4) calculator, and NAFLD fibrosis score (NFS). A score of greater than 1 with APRI less than 0.676 with NFS and greater than 2.67 with Fib-4 predicts the presence of advanced fibrosis. In contrast, an NFS of less than -1.455 and a Fib-4 score of less than 1.3 suggests a low risk for advanced fibrosis. These advanced test techniques are growing the market.
  • Growing Adoption of Serum Markers and Score System for NAFLD and NASH Diagnosis - In November, a study undertaken by the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE), an initiative of the Foundation for the National Institutes of Health’s Biomarkers Consortium (FNIH), confirmed that NIS4 technology reveals a unique performance in recognizing patients with at-risk Non-Alcoholic Steatohepatitis (NASH), and provided evidence that it had the best results of the five blood-based biomarker panels which were evaluated in this study, for the diagnosis of fibrosis stage≥ 2.
  • Increasing Funding and Collaborations for NASH Detection Techniques - A new project involving a consortium that is part of the Innovative Medicines Initiative (IMI), the world’s most significant public-private partnership of its kind, aims to tackle the glaring lack of diagnostic tools by seeking reliable, measurable medical signs, or biomarkers, that indicate the presence of NASH. The project, co-led by Pfizer, is known as LITMUS, or “Liver Investigation: Testing Marker Utility in Steatohepatitis.” LITMUS is coordinated by Professor Quentin Anstee at Newcastle University in the U.K. and is part of IMI, which is funded jointly by the European Commission and the European pharmaceutical industry, known by its acronym, EFPIA.
  • Rising Trends of Unhealthy Diet and Lack of Physical Activity- The prevalence of NAFLD rises in parallel with the increasing prevalence of obesity, metabolic syndrome (MetS), and T2D. According to the WHO, overweight and obesity are now rapidly on the rise in low and middle-income countries, particularly in urban settings. A vast majority of overweight or obese children live in developing countries, where the rate of increase has been more than 30% higher than that of developed countries.

 Challenges

  • Stringent Regulations for Biomarkers Approval by Regulatory Bodies- In-vitro diagnostics are regulated by the FDA and Japan Pharmaceuticals and Medical Devices Agency (PMDA) and will soon have a formal regulatory framework in Europe. However, when the FDA approves novel targeted therapies, EMA, and PMDA, the companion diagnostic test required to select patients receiving the therapy is considered for approval concurrently with the therapy. Therefore, negatively affecting the market growth.
  • Absence of NAFLD/NASH from Health Policies Focused on Obesity
  • Poor Demand in the Underdeveloped Countries


NASH Diagnostics Segmentation

Type (Serums Biomarkers, Hepatic Fibrosis Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers)

The global nonalcoholic steatohepatitis diagnostics market is segmented and analyzed for demand and supply by type into Serum Biomarkers, Hepatic Fibrosis Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers and Others. Out of the five, the Serum Biomarkers segment is estimated to gain the largest market share over the projected time frame. The growth of the segment can be attributed as serum biomarkers of liver function that precisely target the development and degradation of collagens, the critical components of fibrotic tissue, have a diverse advantage over traditional secondary biomarkers such as alanine transaminase and aspartate transaminase because they directly imitate the dynamics of hepatic fibrogenesis providing a substantial reason for their adoption. For instance, some serum indicators utilized in analyzing NASH include CK-18-M30, IL-1Ra, and FGF-21. Elevations of CK-18-M30 might be signs of active NASH. It has been demonstrated that CK-18-M30 levels rise as NASH and fibrosis stages advance.

End-user (Pharma & CRO, Hospitals, Academic Research Institutes)

The global nonalcoholic steatohepatitis (NASH) diagnostics market is also segmented and analyzed for demand and supply by end-user into Pharma & CRO Industry, Hospitals, Academic Research Institutes, and Others. Amongst these four segments, the pharma & CRO industry segment is expected to garner a significant share. The growth can be attributed to the extensive research activities being carried out by the pharma & CRO companies. For instance, Madrigal Pharmaceuticals, Inc. is researching whether 80 or 100 mg of MGL-3196, when compared to a placebo, can treat NASH, lessen liver biopsy fibrosis, and stop the progression of advanced liver disease such as cirrhosis.

Our in-depth analysis of the global prednisone market includes the following segments:

  By Type

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

  By End User

  • Pharma & CRO Industry
  • Hospitals
  • Academic Research Institutes
  • Others

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NASH Diagnostics Industry- Regional Synopsis

APAC Market Analysis

The Asia Pacific nonalcoholic steatohepatitis diagnostics market is projected to hold the largest market share by the end of 2033. The growth of the market can be attributed majorly to the increasing burden of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in the Asia Pacific is propelling the market growth. According to a study published by the NCBI, prevalent NAFLD cases were projected to increase 6-20% during 2019-2030, while prevalent NASH cases increase 20%-35%.

Research Nester
Nonalcoholic Steatohepatitis (NASH) Diagnostics Market
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Companies Dominating the Nonalcoholic Steatohepatitis Diagnostics Landscape

top-features-companies
    • Echosen
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Prometheus Laboratories
    • Genfit
    • Siemens Medical Solutions USA, Inc.
    • BioPredictive
    • Quest Diagnostics Incorporated.
    • Meridian Bioscience, Inc.
    • Laboratory Corporation of America Holdings
    • Bristol-Myers Squibb Company
    • One Way Liver SL

In-the-news

In The News

  • Echosens and Novo Nordisk A/S announced a partnership to advance the early diagnosis of NASH and increase awareness of the disease. They have collaborated to support additional clinical validation, the generation of real-world evidence, and the adoption of non-invasive diagnostic tests for NASH. They decided to collaborate for raising awareness of the condition and the value of early diagnosis and treatment. By 2025, the companies hope to double the rate of advanced-stage to severe NASH diagnoses.

  • GENFIT company announced the launch of the NASHnext, a novel, non-invasive diagnostic test for nonalcoholic steatohepatitis (NASH). The test is offered exclusively in the U.S. and Canada through Labcorp, a leading global life sciences company. NASHnext, GENFIT's proprietary diagnostic technology, is powered by NIS4 and was described in The Lancet Gastroenterology and Hepatology as using a novel blood-based molecular biomarker test to detect NASH and significant fibrosis, also known as at-risk NASH, in patients with at least one metabolic risk factor.


Author Credits:  Radhika Gupta, Shivam Bhutani


  • Report ID: 4718
  • Published Date: Mar 06, 2023
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

Increasing prevalence of NASH and NAFLD and rising demand for providing novel diagnostic tools are the major factors driving the market growth.

The market is anticipated to attain CAGR of 23.8% over the forecast period, i.e., 2023-2033.

Stringent regulations for biomarkers approval by regulatory bodies and absence of NAFLD/NASH from health policies focused on obesity are estimated to be the growth hindering factors for the market expansion.

The market in the North America region is projected to hold the largest market share by the end of 2033 and provide more business opportunities in the future.

The major players in the market are Echosens, Prometheus Laboratories, GENFIT SA, Siemens Medical Solutions USA, Inc., BioPredictive S.A.S, ONE WAY LIVER, SL, and others.

The company profiles are selected based on the revenues generated from the product segment, the geographical presence of the company which determines the revenue generating capacity as well as the new products being launched into the market by the company.

The market is segmented by type, end user, and by region.

The serum biomarkers segment is anticipated to garner the largest market size by the end of 2033 and display significant growth opportunities.
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