Non-alcoholic Steatohepatitis Biomarkers Market Size, Share & Trends Analysis Report By Type (Serum, Hepatic Fibrosis, Apoptosis, Oxidative Stress), By End-Use (Pharma & CRO Industry, Hospitals, Diagnostic Labs), And Segment Forecasts, 2018 - 2025

Report Overview

The global Non-alcoholic steatohepatitis biomarkers market size was valued at USD 200.04 million in 2016 and is expected to witness a CAGR of 30.1% during the forecast period. The growing prevalence of chronic liver conditions is expected to upsurge demand for noninvasive diagnostic tools, fueling the demand for these products in the coming years.

U.S. NASH biomarkers market revenue by type, 2014 - 2025 (USD million)

The incidence of NASH (Non-alcoholic Steatohepatitis) has progressed over time, and it usually leads to liver failure. Twenty percent of patients suffering from this disease are prone to cirrhosis-a condition wherein healthy tissues are replaced with scar tissues-and 10% succumb to death. According to estimates by the United States Census Bureau in 2009, people older than 65 represented around 13% of the total population in the U.S., and this is expected to grow to an estimated 20% by 2030.

Increasing demand for noninvasive diagnostic tools coupled with rising levels of patient awareness is expected to augment the development of NASH biomarkers over the forecast period. The high cost of liver biopsy, invasiveness, and limited acceptance by patients are the factors responsible for the lower adoption of invasive techniques for disease diagnosis. Identification of NASH is difficult and, currently, liver biopsy is a gold standard for identification of the difference between Nonalcoholic Fatty Liver Disease (NAFLD) and NASH. However, the disadvantages associated with its usages, such as invasiveness and high cost, resulted in shifting of preference toward noninvasive biomarkers. This is anticipated to propel the market growth over the forecast period.

Imaging techniques such as computed tomography, magnetic resonance imaging, and ultrasound scanning can accurately diagnose NAFLD. However, these techniques proved inefficient in the detection of liver fibrosis or NASH. These factors are anticipated to further boost demand for noninvasive diagnostic tools, such as serum biomarkers, for disease diagnosis in the coming years, eventually driving the NASH biomarkers market growth.

An increase in the number of initiatives about the development of NASH drugs also establishes a healthy platform for market growth. The NASH Education Program, an initiative undertaken by the biopharmaceutical company named “GENFIT” in 2016, is a public health initiative intended to create awareness about NASH among patients. These types of initiatives are considered to expedite the utilization of NASH therapeutics. Also, GENFIT started the Pediatric NAFLD/NASH Program in Europe after approval of elafibranor’s Pediatric Investigation Plan by the European Medicine Agency, which is further projected to facilitate the drug development program in the future.

Type Insights

Serum biomarkers held a dominant share as of 2016. These are the most commonly used diagnostic tools for the detection of NASH. Also, the introduction of emerging products, such as leptin, ghrelin & tumor necrosis factor-alpha, free fatty acids, apolipoprotein B, apolipoprotein A1, and adiponectin, that can offer valuable services complementary to the traditional ones is predicted to propel the segment growth.

Also, serum biomarkers are anticipated to dominate the types segment, owing to its associated benefits such as the ability to distinguish simple steatosis from NASH and efficient outcomes. These benefits reduce the need for liver biopsy, which is an added advantage compared to other segments.

Serum biomarkers also found applications in the diagnosis of prostate, ovarian, lung, colorectal, and breast-related disorders. Expanding applications of this segment are considered as major factors responsible for its largest revenue share. The key players responsible for offering these products are GE Healthcare; EUSA Pharma; Eli Lilly & Co.; CytoCore, Inc.; Bruker Daltonics, Inc.; Biomarker Technologies, LLC; BioCurex, Inc.; Agilent Technologies; and Abbott Diagnostics.

However, hepatic fibrosis biomarkers are anticipated to witness the fastest growth during the forecast period, owing to their high accuracy and efficacy. These biomarkers act as an affordable and attractive alternative for the diagnosis of diseases for both patients and physicians. 

End-use Insights

The pharmaceutical industry and Contract Research Organizations (CROs) held a dominant share as of 2016. This segment is expected to exhibit a lucrative growth rate in the coming years. Rising demand for noninvasive NASH diagnostic &monitoring tools in the ongoing clinical trials by CROs and pharmaceutical manufacturers can be attributed to its strong growth.

Many companies are involved in research about NASH therapeutics. However, certain factors such as complex pathophysiology, unknown etiology, and the high cost of treatment are anticipated to restrain the revenue growth of this end-user segment during the forecast period.

During clinical trials, a noninvasive technique for routine monitoring of drug therapy is preferred, which is expected to boost the adoption of biomarker tests in NASH diagnostics. After drug launch, the use of biomarkers in hospitals and diagnostic laboratories for assessing prognosis is anticipated to increase. Hence, by the end of the forecast period, it is anticipated that the market for hospitals and diagnostic laboratories will witness higher growth owing to rising initiatives about the development of novel drugs for NASH treatment.

Products that are currently in the pipeline will be launched and established by 2025, which is expected to boost the adoption of biomarker tests. Increasing demand for companion diagnostic tests and the ability of biomarkers to distinguish simple steatosis from NASH is expected to fuel the segment growth in the coming years.

Regional Insights

The growth of the Non-alcoholic steatohepatitis biomarkers market in North America can be attributed to various factors such as favorable government initiatives and rising prevalence of infectious diseases, cardiovascular diseases, & cancer. Funding for R&D of biomarkers is high, which supports drug development activities, thereby fueling industry growth.

Moreover, government regulations support research activities for the development of novel molecules in North America, which is anticipated to surge industry growth. Also, the local presence of key players in this region can be attributed to strong regional growth. The NASH biomarkers industry in this region is anticipated to witness lucrative CAGR in the coming years.

Global NASH biomarkers market revenue, by region, 2016 (%)

Asia Pacific is expected to witness the expansion of leading industry participants and increase R&D spending. There is a significant rise in R&D spending on biomarkers in countries such as China and Japan, leading to market growth. Also, increasing awareness regarding the benefits of biomarkers among end-use coupled with a rising number of CROs are factors that drive growth in this region.

Other driving factors, such as the vast target population and lower cost of clinical trials attract the U.S. and European companies to invest in the Asia Pacific, which acts as another growth propeller for this industry.

Non-alcoholic Steatohepatitis Biomarkers Market Share Insights

Some of the major market players are GENFIT; Gilead; AstraZeneca; Novartis AG; Bristol-Myers Squibb; Allergan Novo Nordisk A/S; Boehringer Ingelheim GmbH; and Pfizer, Inc. The market is witnessing intense competition owing to the rising number of liver transplantation.

The key factor that can be attributed to this boost is the growing demand for advanced diagnostic tools that aid in the accurate diagnosis of NASH. Industry participants are involved in novel product development and strategic alliances, such as research collaborations and partnership agreements, to aid market penetration.

These factors are expected to influence several local and international companies to invest in this market. A less diversified product portfolio offered by existing market players is further anticipated to attract new players in this vertical, with innovative and distinguished product portfolios.

Furthermore, increasing demand for accurate and efficient diagnostics is a key factor stimulating new players to enter the biomarkers market. The development of biomarker-based tests with higher specificity & sensitivity and shorter turnaround time would ultimately yield an exclusive market for NASH diagnostics.

Non-alcoholic Steatohepatitis Biomarkers Market Report Scope

Segments Covered in the report

This report forecasts revenue growth at global, regional, & country levels and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. For this study, Grand View Research has segmented the global Non-alcoholic steatohepatitis biomarkers market based on type, end-use, and region:

• Type Outlook (Revenue, USD Million, 2014 - 2025)

  • Serum biomarkers

  • Hepatic fibrosis biomarkers

  • Apoptosis biomarkers

  • Oxidative stress biomarkers

  • Others

• End-use Outlook (Revenue, USD Million, 2014 - 2025)

  • Pharma & CRO Industry

  • Hospitals

  • Diagnostic Labs

  • Academic Research Institutes

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • The U.S.

    • Canada

  • Europe

    • UK

    • Germany

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

    • Mexico

  • The Middle East and Africa

    • South Africa