The non-alcoholic steatohepatitis therapeutics and diagnostics market was valued at USD 7932.91 million in 2018 and is expected to reach USD 26776.58 million by 2024, with an anticipated CAGR of 25.89%, during the forecast period (2019-2024). The major factors driving the growth of the market studied are the increase in nash-affected population, the rising global prevalence of diabetic and obese populations, and increasing awareness about NAFLD/NASH. Currently, there are no FDA-approved therapies for NASH. Hence, there is a huge need to find appropriate therapeutic targets for the treatment of NASH. However, the understanding of the pathogenesis and progression of NASH has evolved and several promising novel therapies associated with the same are being evaluated. However, there is no specialized diagnostic test available in the market for NAFLD, and thus, the lack of effective diagnostic tests for non-alcoholic fatty liver disease, the slow advancements in the therapeutics field has been limiting the growth of the market.
Scope of the Report
Non-alcoholic steatohepatitis (NASH) is a type of NAFLD. NASH is the liver inflammation and damage caused by the buildup of fat in the liver. It is part of a group of conditions called non-alcoholic fatty liver disease (NAFLD). The products used in the diagnosis and treatment are covered under this report.
Key Market Trends
Selonsertib is Expected to Experience a Lucrative Growth During the Forecast Period
Selonsertib is an orally bioavailable inhibitor of apoptosis signal-regulating kinase 1 (ASK1), with potential anti-inflammatory, antineoplastic, and anti-fibrotic activities. The major factors driving the growth of the market are the rising prevalence of NASH across the world. The drug targets and binds to the catalytic kinase domain of ASK1 in an ATP-competitive manner, thereby preventing its phosphorylation and activation. It plays a vital role in the development of certain cardiovascular and neurodegenerative diseases, diabetes, and certain types of cancer. In February 2019, one of the market players, Gilead Sciences, announced that STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), did not achieve its primary endpoint. Thus, in April 2019, it failed the Phase 3 trial, again. However, the drug was generally well tolerated, and safety results were consistent with previous studies. The company is making considerable investments in the development of drugs for NASH. Recently, in April 2019, Gilead Sciences used the AI-based platform of insitro to discover and develop treatments for NASH. Therefore, such type of activities is expected to increase the process of drug development, leading to rapid approval of the drug over the forecast period.
North America Dominates the NASH Therapeutics and Diagnostics Market
The North America market is expected to witness a CAGR of 26.12% during the forecast period. The prevalence of the nonalcoholic fatty liver disease is due to the rising trend of obesity in the region. Nonalcoholic fatty liver disease (steatohepatitis) is considered as the most common form of chronic liver disease. According to a study conducted by the Intermountain Healthcare researchers, on the economic impact of the disease, the nonalcoholic fatty liver disease affects approximately 100 million Americans every year, and the cost of the disease impacting the US healthcare system is nearly USD 32 billion, annually. Another driving factor is the rising number of obese patients in the country. For instance, as per the OECD data, 47% of the adult population in the United States may suffer from obesity by 2030, as compared to 37.7% in 2014. This represents an estimated 25% increase in obesity, by 2030. Therefore, with an increasing number of patients, the diagnostics and therapeutics are also expected to rise in the future in North America.
Several major players, such as Galmed, Intercept, Genfit, Conatus, MediciNova, and Shire, among others, have their NASH drugs in the last stage of clinical trials. The ongoing scientific developments in the pathogenesis of NASH and the identification of novel agents targeting the disease activities are necessary for the further expansion of capacities to treat NASH and to reduce long-term clinical outcomes, such as cirrhosis, liver failure, and cancer. Investors and analysts are still somewhat skeptical about the approval chances of many of the most advanced NASH candidates. Apart from demonstrating the safety and efficacy of NASH treatments, the companies are also dealing with pricing decisions. The NASH pipeline is, therefore, worth keeping an eye on, owing to the rising prevalence of the disease, lack of available proper treatments, and the developing treatment landscape.
1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increase in NASH-affected Population
4.2.2 Rising Global Prevalence of Diabetic and Obese Populations
4.2.3 Increasing Awareness about NAFLD/NASH
4.3 Market Restraints
4.3.1 Lack of Effective Diagnostics for Non-alcoholic Fatty Liver Disease (NAFLD)
4.3.2 Slow Advancements in the Therapeutic Field
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Product
126.96.36.199 Other Therapeutics
188.8.131.52 Imaging Techniques
184.108.40.206 Diagnostic Tests
5.2.1 North America
220.127.116.11 Rest of Europe
5.2.3 Asia Pacific
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
5.2.4 Middle East and Africa
126.96.36.199 South Africa
188.8.131.52 Rest of Middle East and Africa
5.2.5 South America
184.108.40.206 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Allergan PLC
6.1.2 Novartis AG
6.1.3 Madrigal Pharmaceuticals
6.1.4 Galmed Pharmaceuticals
6.1.5 Intercept Pharmaceuticals Inc.
6.1.6 Gilead Sciences Inc.
6.1.7 Genfit SA
6.1.8 Novo Nordisk A/S
6.1.9 Zydus Cadila
6.1.10 Merck & Co.
6.1.11 Viking Therapeutics
7 MARKET OPPORTUNITIES AND FUTURE TRENDS