Analysis by Drug Type (Vitamin E and Pioglitazone, Obeticholic Acid (OCA), Lanifibranor, Semaglutide, Resmetirom, Aramchol and Others); by Distribution Channel (Hospital Pharmacies, and Retail & Specialty Pharmacies) – Global Supply & Demand Analysis & Opportunity Outlook 2023-2035
Buy Now
The global nonalcoholic steatohepatitis (NASH) therapeutics market is estimated to garner a revenue of USD 48,387.6 Million by the end of 2035 by growing at a CAGR of 18% over the forecast period, i.e., 2023 – 2035. Further, the market generated a revenue of USD 5,246.8 Million in the year 2022. The growth of the market can be attributed to the increasing number of people with obesity. Obesity is the primary cause of fatty liver issues, as it increases the accumulation of fatty tissues in the liver. In the United States, around 42% of people are obese out of which black adults have a higher share of approximately 50%. Moreover, Indians are more likely to be obese in 2019–21 than they were in 2015–16. In comparison to one in five people before, about one in four people now are overweight.
In addition to these, factors that are believed to fuel the market growth of nonalcoholic steatohepatitis (NASH) therapeutics include positive results from the clinal trails of therapeutic drugs. For instance, in an analysis of phase-3 regenerate study of obeticholic acid by Intercept, the trails has shown few positive data, such as OCA 25 mg met the primary goals of improvement for liver fibroisis without worsening the condition of NASH. Moreover, compared to placebo, OCA 25 mg showed a twice as high response rate in reducing liver fibrosis without worsening NASH.
-Market-scope.jpg )
|
Base Year |
2022 |
|
Forecast Year |
2023-2035 |
|
CAGR |
18% |
|
Base Year Market Size (2022) |
USD 5,246.8 Million |
|
Forecast Year Market Size (2035) |
USD 48,387.6 Million |
|
Regional Scope |
|
Growth Drivers
Rising Cases of Obesity– NASH tend to develop in the people who are overweight or at a risk of obesity. As per the data of the World Health Organization, around the world, 650 million adults, 340 million teenagers, and 39 million children are obese. Moreover, this count is expected to continuously rise owing to the unhealthy lifestyle of people. It is anticipated that by 2025, there are likely be 167 million adults and children living with obesity.
Growing Burden of Liver Disease With a 25% global prevalence, nonalcoholic fatty liver disease (NAFLD) is the most prevalent liver disease. In addition to liver fat, NASH is a variant of NAFLD in which the liver is also inflamed and damaged.
Growing Success of Medication Developed for NASH- For instance, Madrigal Pharmaceuticals developed a drug, Resmetirom for NASH. In its trial, around 26% of individuals who received the medication in an 80 mg dose had their NASH resolved. Resmetirom also improved fibrosis or scarring in 24% of patients without aggravating their fatty liver disease.
Higher Prevalence of Diabetes – Diabetes raises the risk of cirrhosis and HCC and encourages the development of NAFL into NASH. In 2021, there were nearly 540 million diabetic patients all across the world. Moreover, this count is expected to reach nearly 640 million and 780 million by 2030 and 2045, respectively.
Rising Approvals of Medication for NASH – FDA approved various medication for non-alcoholic steatohepatitis (NASH), including semaglutide developed by Novo Nordisk and Ozempic. Moreover, in 2020, Zydus Cadila, a leading pharmaceutical company, received approval from the Drug Controller General of India (DCGI), for its new drug application for Saroglitazar treatment, developed for the treatment of NASH in India.
Challenges
The global nonalcoholic steatohepatitis (NASH) therapeutics market is segmented and analyzed for demand and supply by drug type into vitamin E and pioglitazone, obeticholic acid (OCA), lanifibranor, semaglutide, resmetirom, aramchol, and others. Out of the seven types of drugs, the vitamin E and pioglitazone segment is estimated to gain the second-largest market size of USD 13,340.4 Million at the end of 2035 by growing at a CAGR of 12.2% over the projected time frame. Moreover, the segment garnered a revenue of USD 4,435.0 Million in 2022. The growth of the segment can be attributed to the increasing effectiveness of vitamin E and pioglitazone in treating NASH patients. In an experiment of using pioglitazone for treating 52 NASH patient with type-II diabetes and 49 with prediabetes. The result showed that compared to 46% of patients without diabetes, 48% of type 2 diabetes patients achieved the primary outcome. Compared to 26% of people without type 2 diabetes, resolution of NASH was achieved in 44% of those patients. On the other hand, few experiments have shown that a dose of 800 IU per day of vitamin E is beneficial for active NASH adult patients without any form of diabetes.
The global nonalcoholic steatohepatitis (NASH) therapeutics market is also segmented and analyzed for demand and supply by distribution channel into hospital pharmacies, and retail & specialty pharmacies. Amongst these two segments, the retail & specialty pharmacies segment is expected to garner a notable revenue by the end of 2035. The segment is to grow at a CAGR of 18.5% over the forecast period. NASH is an chronic disease that forces patient to be on medication for a very long period, that boost the sales of NASH drugs from the retail pharmacies. NASH therapeutic should be continuously received by the patient otherwise it can lead to severe issues, such as liver failure, liver transplantation, and even liver cancer. In the cases of liver cancer, NASH is combined with liver cancer therapeutics which reduces its efficacy. Therefore, it is important to continue the course of drugs for NASH. The segment growth is major attributed to homecare facilities that are connected to retail pharmacies, which in turn boost the demand for off-label drugs. Few pharmaceutical corporations have indicated that the total medication market for NASH is worth around USD 35 Billion.
Our in-depth analysis of the global nonalcoholic steatohepatitis (NASH) therapeutics market includes the following segments:
|
By Drug Type |
|
|
By Distribution Channel |
|
The North American nonalcoholic steatohepatitis (NASH) therapeutics market, amongst the market in all the other regions, is projected to hold the largest market size of USD 16,887.4 million by the end of 2035. The segment is expected to grow at a CAGR of 19.5% over the forecast period. Moreover, the market in North America generated a revenue of 1,597.7 million in 2022. The growth of the market can be attributed majorly to the rising cases of non-alcoholic fatty liver diseases. Around 80 million to 100 million Americans are affected by non-alcoholic fatty liver disease. It has become the leading cause for liver transplant, surpassing hepatitis C. Moreover, out of total people suffering with NAFLD, around 30 million are affected by specifically non-alcoholic steatohepatitis (NASH). Additionally, the rising expenditure on the treatment of NASH patients is expected to boost the market growth in North America. The annual healthcare expense for NASH in the United States is around USD 5 billion. The expenditure entails various facilities, including testing, treatment, transplants, and hospitalization.
The Europe nonalcoholic steatohepatitis (NASH) therapeutics market, amongst the market in all the other regions, is projected to hold a market size of USD 13,789 million by the end of 2035. The segment is expected to grow at a CAGR of 18.6% over the forecast period. Moreover, the market in Europe generated a revenue of USD 1,485.7 million in 2022. The market growth in the region is credited to the rise in the size of the obese population. According to the WHO European Regional Obesity Report 2022, 59% of adults and roughly one in three children (29% of boys and 27% of girls) in the region are overweight or obese.
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 incidences of NAFLD, rising success of several clinal trials, and growing population living with diabetes and obesity are the major factors driving the market growth.
Ans: The market is anticipated to attain a CAGR of 18% over the forecast period, i.e., 2023 – 2035.
Ans: Under reported cases of Nash, difficulty in drug formulation, and other abnormalities associated with NASH are estimated to be the growth hindering factors for the market expansion.
Ans: The market in the North American 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 Pfizer, Inc., Inventiva, Galmed Pharmaceuticals Ltd., Novo Nordisk A/S, Madrigal Pharmaceuticals, Galectin Therapeutics, NGM Biopharmaceuticals, Brsitol-Myers Squibb Company, Can Fite, Zydus Lifesciences Ltd., and Mitsubishi Chemical Group Corporation.
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 drug type, distribution channel, and by region.
Ans: The vitamin E and pioglitazone 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)
