Analysis by Type (Serums Biomarkers, Hepatic Fibrosis Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers, and Others) and End-User (Pharma & CRO Industry, Hospitals, Academic Research Institutes, and Others) – Global Supply & Demand Analysis & Opportunity Outlook 2022-2035
Buy NowAn Outline of the Nonalcoholic Steatohepatitis (NASH) Diagnostics Market
3.2.1 Diagnostics Providers
3.2.2 End-Users
The global nonalcoholic steatohepatitis (NASH) diagnostics market is estimated to garner a revenue of USD 10,253.0 million by the end of 2035 by growing at a CAGR of 23.8% over the forecast period, i.e., 2023 – 2035. Further, the market generated a revenue of USD 983.8 million in the year 2022. The growth of the market can be attributed to the high prevalence rate of NAFLD, including both NAFL and NASH, raises the need for advanced nonalcoholic steatohepatitis (NASH) diagnostic techniques. NAFLD, along with both NAFL and NASH, is the most common cause of abnormal liver enzymes in developed nations. The prevalence of NAFLD and NASH in adults in the United States is 30% to 40% and 3% to 12%, respectively, and it has been increasing given the growing prevalence of the predisposing conditions according to the reported data in the year 2017-2018. Most patients with NAFLD and NASH are asymptomatic, and the disease is typically diagnosed incidentally on routine blood work. Therefore, more advanced technologies are in the pipeline to diagnose the condition owing to which the market is accelerating globally.
In addition to these, factors that are believed to fuel the market growth of nonalcoholic steatohepatitis (NASH) diagnostics include the dominant presence of major players and rising product launches for nonalcoholic steatohepatitis (NASH) diagnostics. For instance, in 2021, Siemens Healthineers announced that its Enhanced Liver Fibrosis (ELF) Test was approved for marketing authorization under the De Novo review pathway. The ELF Test, for applications with the ADVIA Centaur XP Immunoassay System, offers a simple numeric score that is automatically produced via an algorithm and is used to enhance patient care by assessing the probability of progression to cirrhosis and liver-related clinical events in patients with progressive fibrosis (F3 or F4) owing to nonalcoholic steatohepatitis (NASH). Thus, expanding product launches and research activities towards nonalcoholic steatohepatitis (NASH) diagnostics accelerates the market growth.
-Diagnostics-Market.jpg )
|
Base Year |
2022 |
|
Forecast Year |
2023-2035 |
|
CAGR |
23.8% |
|
Base Year Market Size (2022) |
USD 983.8 million |
|
Forecast Year Market Size (2035) |
USD 10,253.0 million |
|
Regional Scope |
|
Growth Drivers
Increasing Prevalence of NASH and NAFLD – NAFLD includes nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH), diagnosed when there is evidence of inflammatory activity and hepatocyte injury in steatosis liver tissue. According to a National Center for Biotechnology Information (NCBI) study conducted in 2020, one-quarter of the global population is estimated to have nonalcoholic fatty liver disease (NAFLD). In addition, the incidence of nonalcoholic steatohepatitis (NASH) is projected to increase by up to 56% in the next ten years. NAFLD is already the fastest-growing cause of hepatocellular carcinoma (HCC) in the USA, France, and the UK. Globally, the prevalence of NAFLD-related HCC is expected to increase concomitantly with the growing obesity epidemic, which is also a reason for the higher demands for NASH diagnostic biomarkers globally.
Rising Demand for Providing Novel Diagnostic Tools – Various non-invasive tests are being widely adopted by healthcare professionals to diagnose nonalcoholic steatohepatitis (NASH), is anticipated to propel the market’s growth. Non-invasive tests are used for predicting the severity of fibrosis in NAFLD patients. These include both serologic tests and imaging techniques. The serologic tests include the AST to Platelet Ratio Index (APRI) score, Fibrosis-4 (Fib-4) calculator, and the NAFLD fibrosis score (NFS). A score of greater than 1 with APRI less than 0.676 with NFS and greater than 2.67 with Fib-4 predicts the presence of advanced fibrosis. In contrast, an NFS of less than -1.455 and a Fib-4 score of less than 1.3 suggest a low risk for advanced fibrosis. These advanced testing techniques are projected to boost the growth of the market.
Growing Adoption of Serum Markers and Score System for NAFLD and NASH Diagnosis – In November, a study undertaken by the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE), an initiative of the Foundation for the National Institutes of Health’s Biomarkers Consortium (FNIH), confirmed that NIS4 technology reveals a unique performance in recognizing patients with at-risk Non-Alcoholic Steatohepatitis (NASH). Moreover, it provided evidence that it had the best results of the five blood-based biomarker panels which were evaluated in this study, for the diagnosis of fibrosis stage≥ 2.
Increasing Funding and Collaborations for NASH Detection Techniques – A new project involving a consortium that is part of the Innovative Medicines Initiative (IMI), the world’s most significant public-private partnership of its kind, aims to tackle the glaring lack of diagnostic tools by seeking reliable, measurable medical signs, or biomarkers, that indicate the presence of NASH. The project, co-led by Pfizer, is known as LITMUS, or “Liver Investigation: Testing Marker Utility in Steatohepatitis.” LITMUS is coordinated by Professor Quentin Anstee at Newcastle University in the U.K. and is part of IMI, which is funded jointly by the European Commission and the European pharmaceutical industry, known by its acronym, EFPIA.
Rising Trends of Unhealthy Diet and Lack of Physical Activity– The prevalence of NAFLD rises in parallel with the increasing prevalence of obesity, metabolic syndrome (MetS), and T2D. According to the World Health Organization, overweight and obesity are now rapidly on the rise in low and middle-income countries, particularly in urban settings. A vast majority of overweight or obese children live in developing countries, where the rate of increase has been more than 30% higher than that of developed countries.
Challenges
The global nonalcoholic steatohepatitis (NASH) diagnostics market is segmented and analyzed for demand and supply by type into serum biomarkers, hepatic fibrosis biomarkers, oxidative stress biomarkers, apoptosis biomarkers and others. Out of the five segments, the serum biomarkers segment is estimated to gain the largest market share over the projected time frame. The growth of the segment can be attributed to the serum biomarkers of liver function that precisely target the development and degradation of collagen. In addition, the critical components of fibrotic tissue, that have a diverse advantage over traditional secondary biomarkers such as alanine transaminase and aspartate transaminase considering the fact that they directly imitate the dynamics of hepatic fibrogenesis, providing a substantial reason for their adoption. For instance, as per the reported data in 2022, some serum indicators utilized in analyzing NASH include CK-18-M30, IL-1Ra, and FGF-21. Elevations of CK-18-M30 might be signs of active NASH. It has been demonstrated that CK-18-M30 levels rise as NASH and fibrosis stages advance.
The global nonalcoholic steatohepatitis (NASH) diagnostics market is also segmented and analyzed for demand and supply by end-user into pharma & CRO industry, hospitals, academic research institutes, and others. Amongst these four segments, the pharma & CRO industry segment is expected to garner a significant share. The growth can be attributed to the extensive research activities being carried out by the pharma & CRO companies. Furthermore, there are surging competitions among the pharma companies for the introduction of new drugs, devices, and tests that are further expected to surge the growth of the segment in the market. For instance, Madrigal Pharmaceuticals, Inc. is researching whether 80 or 100 mg of MGL-3196, when compared to a placebo, can treat NASH, lessen liver biopsy fibrosis, and stop the progression of advanced liver disease such as cirrhosis.
Our in-depth analysis of the global nonalcoholic steatohepatitis (NASH) diagnostics market includes the following segments:
|
By Type |
|
|
By End User |
|
The North America nonalcoholic steatohepatitis (NASH) diagnostics market, amongst the market in all the other regions, is projected to hold the largest market share by the end of 2035. This can be attributed to the increasing demand for diagnostics for non-alcoholic fatty liver diseases, along with the surging awareness among the people related to the liver diseases. In addition, there is a presence of large number of market players in the region, that is further anticipated to drive the market’s growth in the North America region. Furthermore, the increasing incidence of people dealing with obesity in countries such as the U.S is projected to drive the growth of the market in the region. Additionally, the surging diabetes cases are further contributing to the non-alcoholic liver disorders, that are further expected to increase the nonalcoholic steatohepatitis (NASH) diagnostics market in the region. According to the data reported in 2019, more than 18 percent of the children ageing between 2 to 19 in the United States fall under the obese category.
The Asia Pacific nonalcoholic steatohepatitis (NASH) diagnostics market is anticipated to witness a notable growth over the forecast period. The growth of the market can be attributed majorly to the increasing burden of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in the Asia Pacific region, that is propelling the market’s growth. Furthermore, the rising investment by the government and pharmaceutical companies for the development of better devices and tests for diagnosing of the diseases is further predicted to increase the growth of the market in the region. According to a study reported, the prevalent NAFLD cases were projected to increase 6‐20% during 2019‐2030, while prevalent NASH cases increase 20%‐35%.
In 2023, market players might incur losses due to huge gap in currency translation followed by contracting revenues, shrinking profit margins & cost pressure on logistics and supply chain.
Controlling Inflation has become the first priority for global economies from last quarter of 2022 and to be followed in 2023. With skewed economic situations, rise in interest rate by governments to control spending and inflation, spiked oil and gas prices, high inflation, geo-political issues including U.S. & China trade war, Russia-Ukraine conflict to intensify the global economic issues.
The interest rates in the U.S. may be less sensitive in 2023 as compared to 2022; sigh of relief for businesses. Positive business sentiments, healthy business balance sheets, growth in construction spending (private construction value in 2022 stood at $1,429.2 billion, 11.7 percent (±1.0 percent) above the $1,279.5 billion spent in 2021, Residential construction in 2022 was $899.1 billion, up by 13.3 percent (±2.1 percent) from $793.7 billion in 2021, non-residential construction touched $530.1 billion, 9.1 percent (±1.0 percent) above the $485.8 billion in 2021.) showcases minimal impact of recession in the country.
Similarly, spiked spending in the European and major Asia economics including, India, China & Japan to showcase less impact on the global demand.
Ans: Increasing prevalence of NASH and NAFLD and rising demand for providing novel diagnostic tools are the major factors driving the market growth.
Ans: The market is anticipated to attain a CAGR of 23.8% over the forecast period, i.e., 2023 – 2035.
Ans: Stringent regulations for biomarkers approval by regulatory bodies and absence of NAFLD/NASH from health policies focused on obesity are estimated to be the growth hindering factors for the market expansion.
Ans: The market in the North America region is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.
Ans: The major players in the market are Echosens, Prometheus Laboratories, GENFIT SA, Siemens Medical Solutions USA, Inc., BioPredictive S.A.S, ONE WAY LIVER, SL, and others.
Ans: The company profiles are selected based on the revenues generated from the product segment, the geographical presence of the company which determines the revenue generating capacity as well as the new products being launched into the market by the company.
Ans: The market is segmented by type, end user, and by region.
Ans: The serum biomarkers segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.
Submit Your Request For Proposal (RFP)
