Non-Alcoholic Steatohepatitis Biomarkers Market 2022-2028 Forecast^J

Non-Alcoholic Steatohepatitis Biomarkers Market 2022-2028 Forecast^J

Global Non-Alcoholic Steatohepatitis Biomarkers Market Size, Share, & Analysis by biomarker type (serum/plasma biomarkers, hepatic fibrosis biomarkers, apoptosis biomarkers, oxidative stress biomarkers, and others), and by end-user (hospitals and diagnostic laboratories, research institute, pharmaceutical, and companies/CRO). NASH (non-alcoholic steatohepatitis) is a type of liver disorder that is caused by a build-up of fat in the liver. This build-up of fat in the liver are mostly asymptomatic and causes no effect on the patient. However, in some patients, this build-up of fat causes an inflammation, and damage cells in the liver that leads to improper functioning of the liver. With time, NASH can get worse and cause liver scarring, which leads to cirrhosis. Unlike other liver diseases that are caused by long-term heavy drinking, NASH occurs in people who do not or rarely consume alcohol. As of now, no biomarker has been approved for the commercial use to diagnose NASH; therefore, doctors recommend other ways to diagnose the diseases. Physicians use a patient’s medical history, a physical exam, and tests to diagnose NAFLD (non-alcoholic fatty liver disease) and NASH. Blood tests, imaging tests, and liver biopsy are some of the tests recommended by the physicians for the diagnosis of NAFLD and NASH. Biomarkers are becoming increasingly crucial in the diagnosis of complex, multifactorial chronic disease including non-alcoholic fatty liver disease (fat accumulation in the liver not due to alcohol overconsumption, or NAFLD) and NASH. NAFLD is the most common chronic liver disease across the globe which affects nearly one-quarter of the global adult population as per the NASH education program. Based on a complex combination of genetic and environmental risk factors ranged between 11.0% to 40.0% of individuals with NAFLD will progress to NASH, which causes inflammation and damage the liver cell.

With hepatic necroinflammation and faster fibrosis progression, NASH is an active form of NAFLD that has significant prevalence around the globe. With the increasing number of patients developing NASH, there is an increasing need to develop biomarkers for NAFLD and NASH diagnosis. Many market players, and research institutes have invested in the development of NASH diagnostic products owing to the high prevalence of liver-related diseases across the globe. Due to these factors, the global NASH biomarker market is estimated to grow impressively at a CAGR of 16.2% during the forecast period (2021-2028). The NASH biomarker market was valued at $446 million in 2021 and is anticipated to reach around $1.3 billion in 2028. Increasing demand for non-invasive diagnostic tools is creating the demand for NASH biomarkers during the forecast period. The available diagnostic option for NASH includes the liver biopsy-based method, which is invasive, uncomfortable, risky, and expensive (around $3,000-$5,000 per patient), hence increase the need for non-invasive diagnostic tools which is contributing to the market growth in the near future.

SEGMENT OUTLOOK

The report analyzes the global NASH biomarker market based on biomarker type and end-users. Based on biomarker type, serum/plasma biomarkers, hepatic fibrosis biomarkers, apoptosis biomarkers, oxidative stress biomarkers, and others. NASH biomarker products such as NIS 4, OWL Liver, PRO-C3, and Siemens (ELF) reflect the activity of different pathways contributing to the etiopathogenesis of NASH. PRO-C3 (N-terminal pro-collagen III peptide, Nordic Biosciences) has been identified from robust collagen, and extracellular matrix research to show promise in both differentiating fibrotic from non-fibrotic patients and reflecting treatment-mediated improvements. Similarly, Siemen’s Enhanced Liver Fibrosis (ELF) test, consisting of three biomarkers of fibrosis (hyaluronic acid, pro-collagen III N terminal peptide (PIIINP), and tissue inhibitor of metalloproteinases 1 (TIMP1). Serum/plasma biomarkers also known as circulating biomarkers held the highest market share. The market for serum/plasma biomarkers is mainly driven by the introduction of emerging products such as leptin, free fatty acid, apolipoprotein B, apolipoprotein A1, ghrelin & tumor necrosis factor-alpha, and adiponectin. Whereas the hepatic fibrosis biomarkers are growing at the highest CAGR of 22.6% attributed to the significant research owing to their high accuracy and efficacy. Further, the hepatic fibrosis biomarkers offer an attractive and affordable diagnosis alternative to both the patient and physician. Apart from being non-invasive, there are several benefits of the hepatic fibrosis biomarkers such as no complications and null sampling errors.

By end-user, pharmaceutical industry and contract research organizations (CROs) held the highest market share. The Pharmaceutical Companies/CRO market is growing at a CAGR of 16.0% owing to the growing demand for non-invasive NASH diagnostic tools by CROs and pharmaceutical manufacturers in the ongoing clinical research for the development of NASH therapeutics can be attributed to its robust growth.

GEOGRAPHICAL OUTLOOK

Geographically, the market is further segmented based on four major regions including North America (the US and Canada), Europe (UK, Germany, France, Italy, Spain, and Rest of Europe (RoE), Asia-Pacific (China, Japan, and Rest of Asia-Pacific), and Rest of the World (RoW) (Latin America and the Middle East and Africa). North America is estimated to contribute a significant market share over the forecast period. The major factor contributing to the growth of the market includes the significant funding provided by the government organizations and pharmaceutical companies for R&D of biomarkers. The presence of market players such as Bristol-Myers Squibb Co., Gilead Sciences, Inc., ALPCO, ProSciento, Inc., and Laboratory Corporation of America Holdings, in North America is also contributing significantly to the market growth. For instance, in July 2021, Glympse Bio, (developers of an injectable chemical biomarker platform for diagnosing the body’s hidden diseases) raised $46.7 million through funding. This includes tests aimed at NASH, which can lead to tissue scarring, organ failure, and cancer as well as other targets in oncology and new programs in infectious diseases. In addition, the presence of sophisticated healthcare amenities, and the growing incidence of diabetes, obesity, and fatty liver disease are supporting the growth of the target market in this region.

COMPETITIVE OUTLOOK

The market is still in the nascent stage with several on-going developments across the globe. The global NASH biomarker market is positively influenced by the contribution from the market players. Some of the key players of the market include Bristol Myers Squibb Co., GENFIT S.A., Laboratory Corporation of America Holdings, Nordic Bioscience A/S, Siemens Healthcare GmbH, OWL Metabolomics, Quest Diagnostics, Inc., and Gilead Sciences, Inc., among others. The global NASH biomarker industry has observed a substantial number of developments in recent years. For instance, in June 2021, for NASH PASS, Pro-Sciento has collaborated, as a site partner, with the High Joint Clinical Trials Center for the next 3 years. NASH PASS is Prosciento’s program designed to combine select qualified sites and a proprietary methodology to improve enrolment outcomes in NASH clinical trials. Moreover, in June 2021, NAFLDsym was introduced by DILIsym. NAFLDsym is a quantitative system pharmacology (QSP) modeling software that is intended to support the development of various NAFLD and NASH treatments. Moreover, in April 2021, the drug discovery start-up Insitro announced its first pharmaceutical partner, Gilead Sciences that will work with Insitro for discovering medicines for the treatment of NASH. Gilead Sciences will pay $15 million to begin a three-year research collaboration.

FEW RECENT DEVELOPMENTS IN THE MARKET

1.In January 2021, LabCorp. and GENFIT, partnered for the discovery and development of innovative therapeutic, and diagnostic solutions in metabolic, and liver-related diseases, announced the signing of a licensing agreement between GENFIT and Covance, LabCorp's drug development business. The agreement will expand access to an innovative NASH liver diagnostic test for the clinical research market.

2.In November 2021, Novartis announced positive interim results from the final part of its phase IIb FLIGHT-FXR adaptive design study, assessing the safety, tolerability, and efficacy of tropifexor in patients with biopsy-confirmed stage 2-3 fibrotic NASH.

3.In June 2021, Metacrine raised $65 million to fund the clinical development of its early-stage program in NASH and gastrointestinal diseases. The lead program of the company is aimed at targeting the farnesoid X receptor, a nuclear hormone receptor linked to hepatobiliary diseases such as primary biliary cholangitis and NASH. Its lead candidate, MET409, a nonbile acid FXR agonist, is slated to enter phase 1 testing after June 2021 with an intent to compete in the global NASH biomarker market.

4.Further, in December 2017, NorthSea Therapeutics, a newly formed biotechnology company raised funds for the treatment of NASH. The company raised a fund of $29 million for the development of icosabutate, a structurally engineered fatty acid (SEFA) as a novel, oral approach to treat NASH. This investment was backed by Forbion and BGV that include Novo Seeds, the early-stage investment arm of Novo Holdings A/S, and New Science Ventures. Such development and initiatives in the market are expected to create ample growth opportunities for the market in the near future.

5.In June 2017, OWL Metabolomics and ProSciento partnered to set up a database of potential clinical study participants that are assessed for the presence of NAFLD and NASH with the use of OWL’s lipidomics-based and non-invasive diagnostic assays. This is expected to improve the identification of people having NASH and NAFLD by utilizing non-invasive blood tests.