NASH Market is projected to reach revenue of $5.6 billion by 2024, and is estimated to grow at a CAGR of 55% during the forecast period 2019-2024. NASH (Non-Alcoholic SteatoHepatitis) is a severe form of liver disease that can further lead to fibrosis, cirrhosis and cancer. Changes in lifestyle have contributed to the rising prevalence of NASH disease. The factors such as increase of diabetic and obese population are also driving the growth of the
NASH market. Other secondary disorders such as lysosomal acid lipase deficiency, can also lead to liver cirrhosis and ultimately result in NASH.
Key Takeaways
- NASH Market is estimated to grow at a CAGR of 55% owing to the rising prevalence of diabetes and obesity. The NASH market size in 2018 is $0.41 billion.
- North America held the largest market share terms of revenue owing to its research in healthcare sector. A large population in North America are also affected by NASH providing a large market here. The NASH market share for North America in 2018 was 42%.
- The increase in the number of patients affected by NASH has boosted the need for NASH diagnosis and treatment. The increase in investments by companies for research and clinical studies has also contributed to market growth. However, regulatory approvals are hard to get and thus there are no approved drugs in the market for NASH.
Type – Segment Analysis
Demand for non-invasive and cost-efficient diagnostic tools for NASH techniques such as biomarker tests has been increasing. This is set to drive the demand for NASH biomarkers in the coming years. Serum biomarkers had major share by revenue, due to its high diagnostic efficiency. Serum biomarkers have the ability to distinguish simple steatosis from NASH and thus provide efficient result. Thus it will reduce the reliance on liver biopsy.
End-Use – Segment Analysis
The end-use segment is dominated by the Pharmaceutical CRO (Contract Research Organization) industry, owing to the ample funding for research activities being carried out for developing NASH drug. The ongoing clinical trials by CROs and pharmaceutical manufacturers can be contribute to the market growth. The Pharmaceutical CRO segment is estimated to grow with a CAGR of 52.8% during the forecast period.
Geography – Segment Analysis
North America is estimated to hold largest share in NASH market in 2018 and is projected to maintain its dominance during the forecast period. NASH prevalence in the U.S. is 12%, according to The NASH Education Program. The disease is one of the leading cause of liver cirrhosis in the U.S. Along with this people of U.S. are also affected by diabetes and obesity which are responsible for NASH. Government initiatives favoring drug development and funding for R&D is high in the U.S, thereby fueling the market growth.
Drivers – NASH Market
- Increase in number of patients affected by NASH
It has been observed that with a change in the lifestyle during the past few years, the number of people with diabetes and obesity is high. This has contributed to the rising prevalence of NASH among them. Some NASH cases are life threatening and require liver transplants. However, the use of drugs will be viable in most other cases. Patients also prefer non-invasive and low cost methods for treatment of NASH, such as using biomarkers. Currently there are no approved drugs to treat NASH, making the need for drugs rise and thus contributing to the market growth.
Rising healthcare expenditure
With the increasing prevalence of liver cirrhosis among non-alcoholic patients, the need for NASH drugs has increased. There has been an increase in investment by pharmaceutical companies for the research and development of NASH drugs. The rising expenditure for developing new drugs is due to the increase in demand for such drugs.
- Rising studies and drugs developments
Many companies are developing alternative drugs for treatment of NASH. NASH is different from hepatic steatosis and is more severe as it has increased chances of mortality. Elafibranor, a drug for treatment of NASH is currently undergoing Phase 3 study by Genfit and will be the first NASH monotherapy. Drugs like Cenicriviroc, which are used for other disease are being studied to treat NASH efficinetly.
Challenges – NASH Market
- Absence of low-cost and definitive diagnostic methods
NASH is presently diagnosed by methods such as blood test, imaging or a liver biopsy. These tests are time consuming and have less certainty as they are generic tests. Imaging techniques like CT, MRI and Ultrasound scans were inaccurate to diagnose NASH. These tests are not just incorrect for NASH diagnosis but also cost a lot. This absence of conclusive diagnostic methods in order to detect NASH, is the major challenge to the NASH market.
- Challenge due to regulatory bodies and drug approval
Most NASH drugs have still not passed their approval stage. Presently there are no drugs sold for NASH disease, though many drugs are being found. This slow approval process has hindered the NASH market. Also, the drugs are being made with high cost incurred to the companies, so the drugs when marketed will be of high cost. This will also challenge the market growth.
NASH Industry Outlook
Research & development and strategic alliances are some of the key strategies adopted by players in the NASH market. NASH top 10 companies are Ashland, Inc., Avery Dennison Corporations, Basf Se, Beardow Adam Adhesive Inc, Bostik S A, Eastman Chemical Company, H.B. Fuller, Henkel Ag, Nd Industry Inc, The 3M Company, Sika Ag and others.
Acquisitions/Research & Development Launches:
- November, 2018: Genentech (subsidiary of Roche Holding AG) acquired Jecure Therapeutics to gain access to its discoveries and expertise in the nonalcoholic SteatoHepatitis (NASH) market.
- October, 2019: Novartis added another NASH drug candidate to its pipeline by entering an agreement with US biotech Pliant Therapeutics. The agreement focuses on PLN-1474, a preclinical-stage drug that inhibits scarring of liver in NASH patients.
- September, 2019: Intercept Pharmaceuticals, Inc. submitted a New Drug Application, to FDA for obeticholic acid (OCA) for treating patients with NASH.
NASH Market Research Scope:
The base year of the study is 2018, with forecast done up to 2024. The study presents a thorough analysis of the competitive landscape, taking into account the market shares of the leading companies. These provide the key market participants with the necessary business intelligence and help them understand the future of the NASH market. The assessment includes the forecast, an overview of the competitive structure, the market shares of the competitors, as well as the market trends, market demands, market drivers, market challenges, and product analysis. The market drivers and restraints have been assessed to fathom their impact over the forecast period. This report further identifies the key opportunities for growth while also detailing the key challenges and possible threats.
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