Market Size (2018)
$586.80M
Vertical: HealthcareBase Year: 201811 Sections
Market Size (2018)
$586.80M
Projected (2024)
$1.96B
CAGR (2016–2024)
30.2%
Key Players
17+
Non-alcoholic steatohepatitis (NASH) — a type of non-alcoholic fatty liver disease (NAFLD), is the liver inflammation and damage caused by a buildup of fat in the liver. At present, no single test can diagnose non-alcoholic steatohepatitis. However, the doctor diagnoses the patient based on signs and symptoms. Healthcare professionals use the patient’s medical history, conduct a physical exam, and tests such as blood tests, imaging tests, and liver biopsy in order to diagnose the NASH. Major factors characterizing the market growth are the increasing prevalence of diabetes and obesity, growing demand for non-invasive tests, and rising public and private sector initiatives to increase awareness about NASH. On the contrary, the presence of stringent regulations by the US FDA for the qualification of biomarkers and other medical product development tools are anticipated to restrict the market growth during the forecast period.
The global NASH biomarkers market has been segmented based on type, end user, and region. The global NASH biomarkers market was valued at USD 586.9 million in 2018, and the market is estimated to grow at USD 1,960.6 million by 2024. In 2018, the Americas accounted for the largest market share of 51.9% with a market value of USD 304.3 million, followed by Europe with a market value of USD 188.1 million in 2018.
Based on type, the serum biomarkers segment accounted for the largest market share of 36.9% in 2018, with a market value of USD 216.4 million, which is projected to register a CAGR of 21.13% during the forecast period.
On the basis of end user, the pharmaceutical companies and CROs segment dominated the market and accounted for a share of 38.6% in 2018, with a market value of USD 226.7 million, which is anticipated to register a CAGR of 21.24% over the forecast period.
The NASH Biomarker Market market is projected to grow at a CAGR of 30.2% from 2016 to 2024.
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View Subscription PlansNASH Biomarker Market
Historical performance and future projections (2020–2030, USD Billion)
Market Size (USD Mn)
Non-alcoholic steatohepatitis (a syndrome and a form of non-alcoholic fatty liver disease) is the liver inflammation and damage caused by the accumulation of fat in the liver. Doctors use the patient’s medical history, conduct a physical exam, and tests such as blood tests, imaging tests, and liver biopsies to diagnose non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The market had been categorized on the basis of type, end user, and region wherein quantitative and qualitative analysis of various NASH biomarkers is provided in this report.
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View Subscription PlansThis report applies a rigorous multi-stage research process combining primary interviews, secondary data sources, and bottom-up market modelling to ensure accuracy and completeness across all segments and geographies.
Base Year
2018
Historical Period
2016 – 2017
Forecast Period
2019 – 2024
Primary Interviews
150+
Historical data (2016–2018) and forecast period (2018–2024)
Our research process spans primary interviews with industry stakeholders combined with comprehensive secondary data analysis, validated through triangulation across multiple independent sources.
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View Subscription PlansThe global NASH biomarkers market is characterized by the presence of many global, regional, and local vendors. At the same time, an intense rivalry is observed among the existing manufacturers in the market. Our analysis revealed that market players have adopted different strategies and innovative research and development techniques to expand their business and secure their position in the market.
Increasing demand for non-invasive tests, and the increasing prevalence of chronic liver diseases are key factors that determine the market growth. In recent years, strategic movements by major players included product launches, acquisitions, and approvals, which have been used as market penetration strategies and a means to reduce competition. The major players in the global NASH biomarkers market are Quest Diagnostics, Celerion, Cisbio, Laboratory Corporation of America Holdings and Echosens, among others.
The growth of market vendors is dependent on market conditions, government support, and industry development. Thus, vendors should focus on geographical expansion and the development of novel offerings. International players are likely to strengthen their presence worldwide during the forecast period through acquisitions. It has also been predicted that improvement of the global economic scenario combined with efforts to enhance infrastructure and awareness in emerging nations, can fuel the market growth, making it an ideal time to launch new products and increase the market share.
Vendors with better technical and financial resources could develop innovative products. Therefore, vendors must develop new technologies to stay abreast of emerging technologies that could affect the continuing competitiveness of their product lines in the market.
Bargaining Power of Suppliers
Bargaining power of suppliers in the non-alcoholic steatohepatitis (NASH) biomarkers market is medium. There are a number of suppliers present in the market owing to the high demand, increasing government support, and the availability of huge opportunities for the development of the market. Switching cost of these suppliers is high because suppliers tend to enter into long-term associations, partnership, and deals with the other device manufacturing companies. Also, the key companies thrive to survive in the market with their brand identity and the quality of the product. Therefore, the overall bargaining power of suppliers in the global non-alcoholic steatohepatitis (NASH) biomarkers market is medium.
Bargaining Power of Buyers
The bargaining power of buyers is low to medium in the global non-alcoholic steatohepatitis (NASH) biomarkers market. This is due to the growing preference for non-invasive tools for NASH diagnosis. However, the buyers tend to use the products that are cost-effective and has established brand value; this factor is likely to affect the power of a buyer in the industry.
Threat of New Entrants
The threat of new entrants in the global non-alcoholic steatohepatitis (NASH) biomarkers market is medium. Any company trying to enter the market is required to accept the mandatory regulatory standards issued by government authorities. Moreover, the cost involved in research and development (R&D) is comparatively high, which does not comfort the new entrants to enter the market easily. However, the growing incidence of NASH has created high market potential. This factor has led to an increase in the number of companies entering the global market.
Threat of Substitutes
The threat of substitutes in the global non-alcoholic steatohepatitis (NASH) biomarkers market is low to medium. Currently, as people are shifting from liver biopsy to non-invasive diagnostic tools for NASH, the buyer propensity to substitute is low to medium. However, the buyers tend to purchase quality non-invasive diagnostic products provided by well-established players in the market.
Intensity of Rivalry
The degree of competition in the global non-alcoholic steatohepatitis (NASH) biomarkers market is high. Many manufacturers in the market are focusing on developing novel biomarkers and imaging technologies. Moreover, to overcome the competition, major players are engaged in partnering with the established organizations and welcoming tie-ups.
Market estimates by geography (2024)
InsightNorth America leads with $866.00M by 2024.
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View Subscription Plans| REGION | 2016 | 2018 | 2024 | CAGR | SHARE |
|---|---|---|---|---|---|
| Middle East and Africa | $7.60M | $28.90M | $54.20M | 27.8% | 3% |
| North America | $99.70M | $405.40M | $866.00M | 31.0% | 44% |
| Asia Pacific | $30.60M | $120.80M | $238.40M | 29.3% | 12% |
| Europe | $77.20M | $301.20M | $640.00M | 30.3% | 33% |
| South America | $22.80M | $85.90M | $162.10M | 27.8% | 8% |
| Total | $237.90M | $942.20M | $1.96B | 30.2% | 100% |
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Analytical insights on NASH Biomarker Market covering market dynamics, competitive landscape, and strategic outlook.
The NASH Biomarker Market market is projected to reach $1.96B by 2024, growing at 30.2% CAGR.
A biomarker is a biologic feature used to estimate the presence or progression of a disease in a person. Recently, the incidence of non-alcoholic steatohepatitis (NASH) is increasing at an alarming rate and thus has led to the growing need for effective diagnostic tools. According to the data published by the NASH Education Program, the prevalence of NASH is anticipated to rise by 63% between 2015 and 2030. Factors such as the increasing prevalence of diabetes and obesity, growing demand for non-invasive tests, and growing public and private sector initiatives to increase awareness about NASH are expected to fuel the growth of the global market. Despite the drivers, the unfavorable regulatory scenario is likely to affect market growth over the forecast period negatively.
Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are generally silent diseases with few or no symptoms. NASH is a stage 2 after steatosis (simple fatty liver), in which the liver is damaged, causing it to become inflamed.
Additionally, people with NAFLD are more prone to develop NASH if they are suffering from obesity, type 2 diabetes, high blood pressure, or metabolic syndrome. According to the data published by the National Center for Biotechnology Information in 2018, NAFLD occurs in about 95% of the obese people. The number of people suffering from diabetes and obesity is increasing at a fast pace. As per the data by The British Diabetic Association, in 2017 to 2018, about 3,222,559 people in England, 96,114 people in Northern Ireland, 295,753 people in Scotland, and about 3,809,119 people in the UK had diabetes.
Moreover, according to the National Diabetes Statistics, 2017, about 30.3 million people of all ages had diabetes in the US in 2015. Likewise, the prevalence of obesity is also growing at a significant rate. According to the data published by the National Health Services (NHS), about 58% of women and 68% of men were obese in England in 2017. Therefore, the prevalence of diabetes and obesity is expected to provide favorable backgrounds for the global non-alcoholic steatohepatitis (NASH) biomarkers market to grow over the forecast period.
The increasing incidence rate of NASH globally has led many companies to increase their focus on NASH disease management. The companies are entering into strategic partnerships to develop novel biomarkers. For instance, in April 2019, Novartis AG announced the acquisition of NASH Biotech IFM Tre.
Additionally, in January 2019, LabCorp Diagnostics Inc. and Genfit entered into a strategic collaboration to develop a non-invasive diagnostic test to identify NASH. Moreover, in April 2017, Bristol-Myers Squibb (BMS) and Nordic Biosciences entered into a partnership to develop biomarker technology for diagnosis and monitoring of NASH and other fibrotic diseases. Furthermore, Metanomics Health GmbH aims to partner with pharmaceutical companies for the development of diagnostic tools and drugs for NASH.
Thus, the increasing number of mergers and acquisitions is likely to pose huge opportunities for the global non-alcoholic steatohepatitis (NASH) biomarkers in the future.
High level of regulatory compliance standards set by regulatory agencies to minimize the health risks to patients has made the new product approval process difficult for manufacturers. The US Food Drug and Administration (FDA) is a globally renowned regulatory body engaged in monitoring and approving drugs and medical devices. The FDA has developed processes for the qualification of biomarkers and other medical product development tools. Although regulatory compliance standards help end-users to get quality products. These strict policies create a problem for market players to introduce novel products in the market.
Additionally, the unfavorable reimbursement system for biomarker-based tests may represent a greater problem to the development and adoption of biomarker-based diagnostics for NASH. The process for reimbursement of biomarker medical tests is complex and varies across countries. Moreover, novel molecular biomarker-based tests are more expensive to develop and perform and are not presently well positioned for widespread use in the clinical setting. Thus, the presence of stringent government regulations is likely to hamper the market growth during the forecast period.
Biomarkers are in-vitro diagnostic devices (IVDs) regulated under the FDA’s Medical Device Law. Biomarkers evaluate the disease or progression that defines unique disease characteristics or responses to the ongoing treatment. Biomarker tests are intended to perform a clinical assessment, such as blood analyte levels used to monitor and predict health status in individuals. Moreover, biomarkers may be used alone or in combination to monitor the disease state of an individual.
In the European Union, the European Medicines Agency (EMA) regulates biomarkers used in diagnosis as well as in drug development. Recently, EMA published a guidance document to support organizations to prepare for obligations arising from new EU regulations on medical devices and in-vitro diagnostics. The medical devices regulation (Regulation (EU) 2017/745) and the in-vitro diagnostics regulation (Regulation (EU) 2017/746) were replaced with medical devices (Regulation (EU) 2017/745) and in-vitro diagnostics (Regulation (EU) 2017/746), respectively. The new regulations came into effect on the 25th May 2017; however, a transition period was given to allow manufacturers, notified bodies, and authorities to adapt to the changes. Thus, new regulations are likely to come into full effect on 26 May 2020 for medical devices (Regulation (EU) 2017/745) and 26 May 2022 for in-vitro diagnostics (Regulation (EU) 2017/746).
Near-term growth will likely concentrate in modular bioreactor lines and closed-system media workflows that shorten validation cycles while preserving batch traceability.
Partnerships between CDMOs and instrumentation vendors should accelerate standard datasets for comparability across sites, improving forecasting models used in capacity planning.
Longer horizon, organoid and microphysiological adoption may reshape segment mix; teams that invest early in assay interoperability and cloud QC hooks are better positioned to capture upside without fragmenting their analytics stack.
Profiles of 114 companies operating in the NASH Biomarker Market market, including revenue, employee count, and market positioning where available.
Showing 114 of 114 companies
Siemens Healthineers
Company Headquarters: Founded: 1998 Workforce: 377,000 Company Working: Siemens Healthcare Private Limited is the distinctly managed healthcare business of Siemens AG empowering healthcare providers globally to meet their current challenges and to outperform in their respective environments. Siemens is a leader in medical technology. It is continuously updating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging in laboratory diagnostics and molecular medicine. It is dynamically developing its digital health and enterprise services.
Quest Diagnostics
Company Headquarters: New Jersey, US Founded: 1990 Workforce: ~46,000 Company Working: Quest Diagnostics is one of the leading providers of pre-employment drugs-of-abuse screening and risk assessment services for the employers and life insurance industry. It offers physicians a vast test menu and develops new innovative tests. The company majorly provides services in the field of cancer diagnostics, anatomic pathology services, and interpretive consultation. It has two segments, namely, diagnostic information services business (DIS) and diagnostic solutions (DS). The DIS segment complies with about 95% of the net revenue. It serves in the US and selected locations outside the US, such as Mexico, the UK, and India.
Laboratory Corporation of America Holdings
Company Headquarters: North Carolina, US Founded: 1978 Workforce: ~70,000+ Company Working: Laboratory Corporation of America Holdings (LabCorp) operates worldwide as an independent clinical laboratory company. It operates through two segments, namely, LabCorp Diagnostics and Covance Drug Development. The company’s product & service portfolio comprises a wide range of clinical laboratory tests, such as blood chemistry analyses, urinalyses, blood cell counts, thyroid tests, Pap tests, hemoglobin A1C, prostate-specific antigen, tests for sexually transmitted diseases, hepatitis C tests, vitamin D, microbiology cultures & procedures, and alcohol & other substance-abuse tests. It also offers services to hospitals, physicians, and other healthcare providers and commercial clients to assist in diagnosing, monitoring, and treating diseases and medical conditions by examining substances in the blood, tissues, and other specimens.
GENFIT
Company Headquarters: Loos, France Founded: 1999 Workforce: ~170 Company Working: GENFIT is a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver-related diseases. The company is currently developing a non-invasive and easy-to-access blood-based IVD test to identify patients with NASH. Also, the company’s pipeline drug, Elafibranor is assessed under phase III clinical trial as a potential treatment for NASH. The company operates in only one segment, the research & development of innovative medicines. The company has its operational facilities in Lille and Paris, France, and Cambridge, Massachusetts, US.
Prometheus Laboratories Inc.
Company Headquarters: California, US Founded: 1995 Company Working: Prometheus Laboratories Inc. (Prometheus) is engaged in the development and commercialization of pharmaceutical and diagnostic products that enable physicians to provide individualized patient care. The company offers Anser IFX and Anser ADA monitoring assays, non-invasive tests, and inflammation markers in the smart diagnostic algorithm for added diagnostic clarity, celiac tests, and thiopurine monitoring tests, among others. Prometheus operates as a subsidiary of Nestlé.
Echosens
Company Headquarters: Paris, France Founded: 2001 Workforce: ~9000 (2018) Company Working: Echosens develops, manufactures, and markets non-invasive diagnostic products and services in the field of hepatology. The company offers FibroScan, which is based on proprietary vibration controlled transient elastography technology and is used in routine clinical practice and research; FibroMeter range that provides blood tests; and FibroView, which offers smart connectivity software solutions linking FibroScan to the hospital information systems. Echosens currently possesses more than 22 patent families. The company has six subsidiaries in Germany, Hong Kong, Spain, China, Lebanon, and the US.
12 interactive charts drawn from the NASH Biomarker Market dataset — market size, regional splits and each segment breakdown. Open one to read its full data table and download it.
Global NASH Biomarker Market South America Of South America
Global NASH Biomarker Market Germany, Spain, France, United Kingdom, Italy and Rest Of Europe By Country
Global NASH Biomarker Market Australia, China, India, Japan, South Korea and Rest Of Asia Pacific By Country
Global NASH Biomarker Market United States and Canada Of North America By Country
Global NASH Biomarker Market Middle East And Africa Of Middle East And Africa
Global NASH Biomarker Market By Region
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