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), By Region, And Segment Forecasts, 2023 - 2030

Research Methodology

A three-pronged approach was followed for deducing the non-alcoholic steatohepatitis biomarkers market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for non-alcoholic steatohepatitis biomarkers market to gather the most reliable and current information possible.

• We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
• We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
• We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
• We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
• We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of non-alcoholic steatohepatitis biomarkers market data depending on the type of information we’re trying to uncover in our research.

• Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

• Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

• Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

• Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

• Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

• Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

• This step also entails the finalization of the report scope and data representation pattern.

• Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

Non-alcoholic Steatohepatitis Biomarkers Market Categorization:

The non-alcoholic steatohepatitis biomarkers market was categorized into three segments, namely type (Serum Biomarkers, Hepatic Fibrosis Biomarkers, Apoptosis Biomarkers, Oxidative Stress Biomarkers), end-use (Pharma & CRO Industry, Hospitals, Diagnostic Labs, Academic Research Institutes), and regions (North America, Europe, Asia Pacific, Latin America, Middle East & Africa).

Segment Market Methodology:

The non-alcoholic steatohepatitis biomarkers market was segmented into type, end-use, and regions. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

• Demand estimation of each product across countries/regions summed up to from the total market.

• Variable analysis for demand forecast.

• Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

• Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

• Used extensively for new product forecasting or analyzing penetration levels.

• Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

• Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

• This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The non-alcoholic steatohepatitis biomarkers market was analyzed at a regional level. The globe was divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, keeping in focus variables like consumption patterns, export-import regulations, consumer expectations, etc. These regions were further divided into eighteen countries, namely, the U.S.; Canada; Germany; the UK.; France; Italy; Spain; China; Japan; India; Australia; South Korea; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; and UAE.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

Non-alcoholic steatohepatitis biomarkers market companies & financials:

The non-alcoholic steatohepatitis biomarkers market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

• Laboratory Corporation of America Holdings (LabCorp) was created after the merger of National Health Laboratory Holdings, Inc. and Roche Biomedical Laboratories, Inc. It is involved in the development of genetic test solutions based on microarray, NGS, and PCR technologies. It serves more than 220,000 clients in 60 countries. Its clients include hospitals, employers, physicians, governmental agencies, and other independent clinical laboratories. Its diagnostic business segment offers a gene-based test for HIV drug-resistance assays, HPV, and molecular genetic testing for cystic fibrosis. It provides a menu of over 4,700 tests in the areas of diagnostic genetics, allergy, CVDs, toxicology, coagulation, oncology, endocrinology, women's health, infectious diseases, pain management, and pharmacogenetics. It has an independent clinical laboratory business that incorporates a network of 39 primary laboratories and approximately 1,700 patient service centers. It has clinical laboratories located in the U.S. and other countries, including the UK, Canada, and the UAE.

• Glympse Bio is involved in the creation of innovative and non-invasive technologies to track disease activities directly within the body. The company was established in 2015 in the UK. Its exclusive synthetic biomarkers, which are biological sensors created using innovations in science, engineering, medicine, and artificial intelligence, can adapt to a wide range of ailments and provide earlier indicators of response to illness and therapy. Glympse Inside is a pan-disease product engine that seeks to improve illness monitoring and treatment response by the integration of real-time biological activity with sophisticated machine learning and AI.

• Quest Diagnostics Incorporated is a publicly held company and a provider of clinical laboratory tests. In 1997, it became an independent corporation called Quest Diagnostics. The company has administrative offices in Lyndhurst, Collegeville, and Pennsylvania. In 2013, Fortune ranked the company at the leading position in pharmacy and other services. The company conducts over 150 million tests each year and it has collaborated with various clinics and hospitals globally.

• BioPredictive is a biotechnology company engaged in the development and commercialization of liver disease diagnostic tests. The company was established in 2002 at the Pitié-Salpêtrière University Hospital in France, to commercialize FibroTest, which is a combination of blood indicators to replace liver biopsies for hepatic fibrosis. The company offers the FibroMax test, along with the following products in the portfolio: NashTest (for evaluating NASH), FibroTest (for hepatic fibrosis/cirrhosis), SteatoTest (for assessing fatty liver), and ActiTest (for evaluating necroinflammatory activity).

• ONE WAY LIVER, S.L. is a biotechnology organization in the metabolomics sector. It offers cutting-edge diagnostic products and R&D services to the scientific community. The company was established in 2002 in Spain. Its focus is on the healthcare sector, intending to identify, validate, patent, and commercialize early diagnostic and/or prognostic systems, as well as therapeutic targets for liver disorders and other complicated pathologies with high prevalence. Metabolomics and bioinformatics have developed a full and highly productive platform that supports the advancement of developments.    

• VLVbio was founded in 2013 in Stockholm, Sweden, after being granted exclusive rights to a special apoptosis marker for cells of epithelial origin that express Keratin 18 (K18). The goal of the company is to continuously create and acquire novel intellectual property for the detection and quantification of various forms of cell death under pathological or normal conditions from academic research and healthcare markets. The company’s quality assurance system has obtained SS-EN ISO 9001 and SS-EN ISO 13485 certifications.

• Bristol-Myers Squibb is a U.S.-based biopharmaceutical company, which has delivered innovative medicines to aid patients in fighting serious diseases. Many of the drugs that were developed helped millions of patients fight against life-threatening conditions such as cancer, cardiovascular diseases, hepatitis B, and HIV. In the last ten years, Bristol Myers has delivered around 15 new drug molecules, of which four are biologics. The company recently entered the gene therapy field through collaboration with uniQure N.V. for the development of novel gene-altering drugs for cardiovascular diseases.

• Siemens Healthineers AG is a provider of healthcare solutions, such as diagnostics (in vitro & in vivo), imaging & therapy systems, clinical products, audiology solutions, and healthcare IT solutions. The company was founded as a separate entity in 2015. It also offers medical accessories, OEM component & medical electronics solutions, refurbished systems for medical imaging & therapy, technical, maintenance, and professional & consulting services. Its products and solutions are used in various areas, including therapeutic drug monitoring cardiology, organ transplant, urology, infectious disease, diabetes, women's health, surgery, oncology, neurology, and growth disorders. The company has around 18,500 patents in over 70 countries.

• Prometheus Laboratories is a clinical-stage biotechnology firm involved in precision medicine by finding, developing, and commercializing innovative therapeutic & companion diagnostic solutions to treat immune-mediated disorders, including NASH and Inflammatory Bowel Disease (IBD). The company utilizes its patented Prometheus360 precision medicine platform, which has one of the largest GI bioinformatics databases and sample biobanks, to discover new therapeutic targets and create treatment candidates. Moreover, the company is developing companion diagnostic tests that can help patients respond better to treatment candidates.          

• GENFIT is a late-stage biopharmaceutical company focused on developing diagnostic products for chronic liver and metabolic diseases. In 1999, the company was established in France. The company has an internal database for developing drugs and diagnostics. In addition, the company has a proprietary NIS4 technology that was developed to help with NASH early detection. A novel, non-invasive blood-based molecular biomarker test that identifies NASH in individuals with metabolic risk factors is based on NIS4.

Value chain-based sizing & forecasting

Supply Side Estimates

• Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

• Segment revenue determination via variable analysis and penetration modeling.

• Competitive benchmarking to identify market leaders and their collective revenue shares.

• Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

• Identifying parent markets and ancillary markets

• Segment penetration analysis to obtain pertinent

• revenue/volume

• Heuristic forecasting with the help of subject matter experts

• Forecasting via variable analysis

Non-alcoholic Steatohepatitis Biomarkers Market Report Objectives:

• Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

• Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

• Understanding market estimates and forecasts (with the base year as 2022, historic information from 2019 to 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

Non-alcoholic Steatohepatitis Biomarkers Market Report Assumptions:

• The report provides market value for the base year 2022 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

• The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

• We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

• All market estimates and forecasts have been validated through primary interviews with the key industry participants.

• Inflation has not been accounted for to estimate and forecast the market.

• Numbers may not add up due to rounding off.

• Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

• Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

• Latin America includes Central American countries and the South American continent

• Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

• Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

• Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.