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

Industry Insights

The global NASH (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. 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.

The incidence of NASH 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.

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

Increasing demand for noninvasive diagnostic tools coupled with rising levels of patient awareness is expected to augment development of NASH biomarkers over the forecast period. High cost of liver biopsy, invasiveness, and limited acceptance by patients are the factors responsible for 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 usage, 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 market growth.

Increase in number of initiatives pertaining to 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 utilization of NASH therapeutics. In addition, GENFIT started 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 detection of NASH. In addition, introduction of emerging products, such asleptin, 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 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 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 diagnosis of diseases for both patients and physicians. 

End-use Insights

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 pertaining to NASH therapeutics. However, certain factors such as complex pathophysiology, unknown etiology, and high cost of treatment are anticipated to restrain the revenue growth of this end-use segment during the forecast period.

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

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

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

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

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

Competitive 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 rising number of liver transplantation.

The key factor that can be attributed to this boost is growing demand for advanced diagnostic tools that aid in 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 a number of 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. Development of biomarker-based tests with higher specificity & sensitivity and shorter turnaround time would ultimately yield an exclusive market for NASH diagnostics.

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 the purpose of this study, Grand View Research has segmented the global NASH biomarkers market on the basis of 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

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

    • Mexico

  • The Middle East and Africa

    • South Africa