全球非酒精性脂肪性肝炎(NASH)治療藥及診斷市場:開發平台治療藥，診斷技術，治療方法，各地區 - 成長，趨勢，預測(2018年∼2023年)
Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
The non-alcoholic steatohepatitis therapeutics and diagnostics market is anticipated to reach a CAGR of 25.89%, during the forecast period. The major factors driving the growth of the market studied are the increase in the NASH-affected population, the rising global prevalence of diabetic and obese populations, and the increasing awareness about NAFLD/NASH.
Currently, there are no FDA-approved therapies for NASH. Hence, there is a pressing 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, and the slow advancements in the therapeutics field have been limiting the growth of the market.
As there are limited specific diagnostic tests are available for the NASH, the lipid profile tests, liver function tests, and fibrosis assessment tests are commonly used diagnostic tests. NASH is diagnosed when examination of the tissue with a microscope shows fat along with inflammation and damage to liver cells. Furthermore, many of the in vitro diagnostic tests are planned to be released by the end of 2020, which may augment the growth rate.
Since liver-related mortality is increasing in developed markets, such as the United States, the companies are focusing more toward proper diagnostic tests, which can directly target the developed markets and benefit both, patients and the firm. For instance, OWL Metabolomics has developed OWLiver, non-invasive assay, to detect NASH, that use highly sensitive laboratory processes to determine the form of disease present in the patient's liver
In January 2019, Genfit took the first step toward making this test available, as it had signed a licensing agreement with LabCorp, leading drug development and NASH clinical trial company, to expand the access to NIS4 in the global clinical research community. The company is planning to market its IVD test for NASH, as a laboratory developed test (LDT), in 2019. Furthermore, it is planning to submit the same for FDA marketing authorization, in 2020. Hence, owing to aforementioned factors and growing burden of risk factors such as obesity is fulling the market for diagnostic tests expected to have significant growth over forecast period,
The North American market is expected to grow due to the increasing prevalence of non-alcoholic fatty liver disease. Non-alcoholic 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 non-alcoholic 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 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 obese patients, the usage of diagnostics and therapeutics is also expected to rise in the future.
Several major players, such as Galmed, Intercept, Genfit, and OWL Metabolomics are among others, have their NASH drugs in the last stage of clinical trials. Moreover, there has been an increasing demand for advanced diagnostics, as there are very limited tests available in the market.