by High Demand for Non-invasive NASH Treatment to Augment Market
Over the past couple of decades, the number of obesity, diabetes, and non-alcoholic fatty liver diseases (NAFLD) cases have increased at a rapid pace. The range of NAFLD extends from steatosis to non-alcoholic steatohepatitis (NASH). The rise in the prevalence of NAFLD has caused a great amount of economic burden on nations worldwide and as per trends, patients suffering from NAFLD-related diseases have emerged as one of the major subset of people requiring liver transplant. One of the major factors that is likely to propel the adoption of NASH biomarker is the high prevalence of NAFLD and the undesirable outcomes. The adoption of conventional techniques to address NAFLD such as biopsy is steadily declining due to limitations, including sampling bias, complications such as pain, bleeding, mortality, and poor acceptability.
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The demand for non-invasive techniques to treat NAFLD has witnessed a consistent growth over the past decade. Non-invasive techniques that have gained significant popularity to combat NAFLD include NASH, NAFLD-based fibrosis, and steatosis, among others. The surge in demand for these non-invasive techniques is expected to boost the demand for NASH biomarkers during the forecast period. In recent times, players operating in the global NASH biomarkers are increasingly investigating the algorithms that consist non-imaging and imaging biomarkers to diagnose fibrosis and minimize biopsies in clinical settings. Technological advancements, research and development activities coupled with high prevalence of NAFLD are some of major factors that are likely to drive the expansion of the non-alcoholic steatohepatitis (NASH) biomarkers market during the assessment period. At the back of these factors, the global non-alcoholic steatohepatitis (NASH) biomarkers market is expected to attain a market value of ~US$ 2 Bn by the end of 2027.
Adoption of NASH Biomarkers to Address Idiopathic Pulmonary Fibrosis
Advancements in the healthcare sector, along with research activities are likely to play a key role in the growth of the global non-alcoholic steatohepatitis (NASH) biomarkers market. In recent times, a considerable amount of research has been undertaken in discovering the potential treatments for idiopathic pulmonary fibrosis (IPF). In the past decade, the progression from NAFLD to NASH has increased at a rapid pace and has emerged as one of the most prevalent chronic liver conditions particularly in the Western regions, including North America and Europe– a factor due to which the production of NASH biomarkers is set to witness a considerable growth.
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At present, while researchers are increasingly focusing on improving the efficacy of NASH biomarkers, healthcare providers, medical professionals, and healthcare workers are projected to increase awareness regarding NASH. Medical experts are of the opinion that the prevalence of NASH is set to grow at a rapid pace in the coming decade due to which, robust measures are required to combat the same. Public health groups, along with government organizations particularly in developed regions are focusing on formulating new guidelines that govern the management of NASH. Innovations within the non-alcoholic steatohepatitis (NASH) biomarkers market are primarily targeting improvements in non-invasive screening and diagnostic testing. In addition, companies operating in the current market landscape are increasingly focusing on different molecules for the treatment of NASH. Moreover, at present, while a large number of drugs are in phase three trials, multiple drugs are in the pipeline across world. Companies operating in the current market landscape are primarily focusing on replacing painful and invasive biopsies with non-invasive NASH biomarkers. The launch of the new project by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium aimed toward standardizing biological markers to improve the diagnosis of NASH. The Non-Invasive Biomarkers of Metabolic Liver Disease project is expected to make a direct comparison between conventional and non-conventional techniques to address NASH and suggest the best tools to diagnose NASH. Such projects are expected to promote the sales of NASH biomarkers during the forecast period and thus, will augment the growth of the non-alcoholic steatohepatitis (NASH) biomarkers market.
Companies Adapt, Adjust, and Assess Pipeline Products, Seek FDA Approval
The advent of the novel coronavirus pandemic is expected to create major roadblocks for companies operating in the current non-alcoholic steatohepatitis (NASH) biomarkers market. Mobilization of researchers, front-line clinicians, manufacturers, and other participants in the value chain has emerged as a major area of concern amidst the chaos. On the heels of the health and economic crisis worldwide, The Global Liver Institute, recently revealed its plans to address the global pandemic by adapting and provide creative solutions. While supply chains within the non-alcoholic steatohepatitis (NASH) biomarkers market are likely to be disrupted, companies should focus on formulating effective business continuity strategies and focus on product diversification to address the business challenges put forward by the global pandemic.
Analysts’ Viewpoint
The global non-alcoholic steatohepatitis (NASH) biomarkers market is expected to grow at a staggering CAGR of ~21% during the forecast period. The market growth can be attributed to a host of factors, including high demand for non-invasive techniques to address NASH, research and development activities, government support for the development of NASH biomarkers, and high focus on curbing the prevalence of diabetes and NAFLD. Market players are anticipated to focus on the development of new NASH biomarkers and attain the approval from the FDA. Moreover, North America and Europe are likely to be the hotbeds of development within the global non-alcoholic steatohepatitis (NASH) biomarkers market.
Non-alcoholic Steatohepatitis (NASH) Biomarkers Market: Overview
The global non-alcoholic steatohepatitis (NASH) biomarkers market was valued at ~US$ 300 Mn in 2018 and is projected to expand at a rapid pace from 2019 to 2027. Rise in NAFLD and NASH conditions; increase in patient pool suffering from obesity and metabolic diseases; rise in geriatric population; growth in Type 2 diabetes and pre-diabetes in adult patients; surge in demand for non-invasive diagnostic techniques; and increase in awareness about NASH condition and innovative diagnosis tools, especially in developing markets, are anticipated to propel the global non-alcoholic steatohepatitis (NASH) biomarkers market.
NASH, also known as non-alcoholic steatohepatitis, is a progressive form of non alcoholic fatty liver disease (NAFLD). NAFLD is a condition in which fat is accumulated in the liver and the continuous fat deposition may cause liver inflammation and liver cell damage. This is termed as NASH condition. Increase in worldwide prevalence of obesity, type 2 diabetes, pre-diabetes, and metabolic diseases are major reasons for increase in prevalence of non-alcoholic steatohepatitis condition. Thus, innovative diagnostic tools are introduced in the market to accurately diagnose the non-alcoholic steatohepatitis condition. Liver biopsy is one of the standard tools for diagnosis of NASH condition. However, due to high cost of this procedure, many companies have introduced biomarkers as a diagnostic tool for NASH patients. Various non-invasive biomarkers are available for detection of the NASH condition, including serum biomarkers, biomarker panels, fibrosis biomarkers, imaging biomarkers, gene biomarkers, oxidative stress biomarkers, and Cytokeratin-18.
As per research, worldwide prevalence of NASH is estimated to be in a range of 1.5%–6.45%, respectively, in 2019. NASH prevalence across globe is expected to grow by 63% by 2030. Several pharmaceutical and biotechnology companies are investing in development of therapeutics for NASH. Currently, 95 drug candidates from different players are in pipeline ranging from preclinical to phase 3 trials. These players would require NASH biomarker diagnostics to monitor and evaluate drug effectiveness during clinical trials. Various companies have entered into collaboration to further strengthen and develop biomarkers, thereby augmenting the NASH biomarkers market in the near future.
Non-alcoholic Steatohepatitis (NASH) Biomarkers Market: Segmentation
The global non-alcoholic steatohepatitis (NASH) biomarkers market has been segmented based on biomarker type, end user, and region
In terms of biomarker, the global non-alcoholic steatohepatitis (NASH) biomarkers market has been classified into serum biomarkers, biomarker panels, fibrosis biomarkers, imaging biomarkers, and others. The serum biomarkers segment is further classified into cytokeratin-18 (CK 18) marker, inflammatory markers, and others. The serum biomarkers segment held a largest market share, owing to availability of various tests in the market. The segment also has higher accuracy in differentiating NASH indications. Cell apoptosis increases during the progression of NASH. Markers such as fragments of cytokeratin-18 and ferritin are measured and found to be promising markers of NASH. CK-18 is considered as the popular and potential biomarker for detecting NASH indication. The others segment includes gene biomarkers and oxidative stress biomarkers which offer promising results in terms of higher accuracy and are considered to be inexpensive and simple non-invasive techniques.
In terms of end user, the global non-alcoholic steatohepatitis (NASH) biomarkers market has been segregated into hospitals, diagnostic centers, and others. The diagnostic centers segment dominated the global non-alcoholic steatohepatitis (NASH) biomarkers market in 2018, owing to increase in awareness about the NASH indication for early diagnosis followed by its effective treatment. Availability of technically advanced tools such as biomarkers tests in diagnostic centers coupled with presence of expertise is likely to drive the diagnostic centers segment.
Non-alcoholic Steatohepatitis (NASH) Biomarkers Market: Regional Segmentation
In terms of region, the global non-alcoholic steatohepatitis (NASH) biomarkers market has been split into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
North America dominated the global non-alcoholic steatohepatitis (NASH) biomarkers market in 2018, owing to rise in prevalence of NASH associated conditions such as obesity and type 2 diabetes in the region. Several market players such as Quest Diagnostics for Hepascore and Exalenz Biosciences Ltd. are opting to enter North America through collaborations and alliances. Demand for non-invasive diagnostic tests for NASH and related diseases is high due to accuracy and operational limitations and associated hazards of liver biopsy. Rise in adoption of minimal invasive surgeries, growing geriatric population, and investments by key players in R&D to develop innovative and promising biomarkers are estimated to boost the non-alcoholic steatohepatitis (NASH) biomarkers market in the region.
The non-alcoholic steatohepatitis (NASH) biomarkers market in Latin America and Middle East & Africa is anticipated to expand at a faster pace than other regions during the forecast period. Rising patient population suffering from NASH condition is a major factor likely to propel the market in Latin America and the Middle East. Latin America likely to exhibit highest CAGR, owing to prevalence of NASH condition. For instance, in Brazil, the prevalence rate of NASH condition is 35.2%, in Chile, it is 23%, in Mexico, it is around 17%, and in Columbia it is around 26.6%. As per NCBI, the prevalence of NASH indication in Middle East & Africa is estimated to reach more than 12,534,000 cases in Saudi Arabia and 372,000 cases in the UAE by 2030. All these statistics are likely to boost the NASH biomarkers market in the region.
Non-alcoholic Steatohepatitis (NASH) Biomarkers Market: Major Players
Key players operating in the global non-alcoholic steatohepatitis (NASH) biomarkers market include
- Biopredictive
- Quest Diagnostics
- Exalenz Bioscience Ltd
- GENFIT
- Siemens Healthineers
- ONE WAY LIVER
- S.L
- Prometheus Laboratories Inc
- Gilead Sciences Ltd.
Key Questions Answered in Non-alcoholic Steatohepatitis (NASH) Biomarkers Market Report
- What is the sales/revenue generated by the global non-alcoholic steatohepatitis (NASH) biomarkers market across all the regions during the forecast period?
- What are the key trends in the global non-alcoholic steatohepatitis (NASH) biomarkers market?
- What are the major drivers, restraints, and opportunities in the global market?
- Which region is set to expand at the fastest CAGR during the forecast period?
- Which segment will have the highest revenue globally in 2027 and which biomarker type will expand at the fastest CAGR during the forecast period?
Non-alcoholic Steatohepatitis (NASH) Biomarkers Market – Segmentation
Biomarker Type
- Serum Biomarkers
- Cytokeratin-18 (CK 18)-Biomarker
- Inflammatory Markers
- Others
- Biomarker Panels
- Fibrosis Biomarkers
- Imaging Biomarkers
- Others
End User
- Hospitals
- Diagnostic Centers
- Others
Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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