The global sales of non-alcoholic steatohepatitis clinical trials is estimated to be worth USD 2,964.4 million in 2025 and anticipated to reach a value of USD 5,806.8 million by 2035. Sales are projected to rise at a CAGR of 7.0% over the forecast period between 2025 and 2035. The revenue generated by Non-Alcoholic Steatohepatitis Clinical Trials in 2024 was USD 2,829.5 million.
NASH is an inflammatory liver disease associated with the accumulation of fat in the liver. It is independent of alcoholic liver disease and usually involves people who drink very little or no alcohol at all.
It tends to present coincidentally or as an overlap of the conditions that generally include obesity, insulin resistance, type 2 diabetes, and metabolic syndrome. The result of this chronic damage in NASH is liver fibrosis, cirrhosis, and rarely, liver cancer over the time frame. This mostly comprises nonspecific symptoms, such as simple fatigue or abdominal discomfort, which do not allow for early diagnosis.
Management is mainly about lifestyle modification, such as exercise and weight loss, apart from new pharmacological treatments. Growing at a rapid rate, obesity, type 2 diabetes, and metabolic syndrome have caused increased demand for NASH clinical trials globally.
Global Non-Alcoholic Steatohepatitis Clinical Trials Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2024 | USD 2,829.5 million |
| Estimated Size, 2025 | USD 2,964.4 million |
| Projected Size, 2035 | USD 5,806.8 million |
| CAGR (2025 to 2035) | 7.0% |
The increase in R&D expenditure is one of the major reasons responsible for the growth in the global non-alcoholic steatohepatitis clinical trials market. It depicts the growing interest by the pharmaceutical and biotech firms in pursuing the critical unmet medical need for NASH therapies.
The lack of an FDA-approved drug for NASH enhances the competitive area wherein companies are deep into heavy research and development to gain a first-mover advantage in this space.
Development in NASH seeks new therapeutic targets and optimization of trial designs while rapidly moving candidates through clinical phases. High-technology platforms, from genomics to AI techniques, are employed to hasten the pace and precision of preclinical and clinical investigations.
Given its multi-faceted nature-metabolic, inflammation, and fibrosis pathways-research into combination therapies and precision medicine approaches continues to drive investment in NASH.
The nature of the market is competitive, with a large number of clinical trials in both Phase II and III stages. Regulatory incentives, on their part, through the provision of fast-track designation and priority review that reduces timelines for approval of such drugs, further support the same.
Increased R&D spend would then consequently translate into an increase in the number and scope of clinical trials and therefore would be a major contributor to the development of this market.
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The global non-alcoholic steatohepatitis clinical trials market's compound annual growth rate (CAGR) for the first half of 2024 and 2025 is compared in the table below. This analysis provides important insights into the performance of the industry by highlighting significant shifts and trends in revenue generation.
The first half (H1) is the period from January to June, and the second half (H2) is July to December. In the first half (H1) of the decade from 2024 to 2034, the business is predicted to surge at a CAGR of 8.0%, followed by a slightly lower growth rate of 7.6% in the second half (H2) of the same decade.
| Particular | Value CAGR |
|---|---|
| H1 | 8.0% (2024 to 2034) |
| H2 | 7.6% (2024 to 2034) |
| H1 | 7.0% (2025 to 2035) |
| H2 | 6.7% (2025 to 2035) |
Moving into the subsequent period, from H1 2025 to H2 2035, the CAGR is projected to decrease slightly to 7.0% in the first half and remain relatively moderate at 6.7% in the second half. In the first half (H1) the industry witnessed a decrease of 100 BPS while in the second half (H2), the industry witnessed a decrease of 90 BPS.
Rising prevalence of NASH is driving the market growth
A gradually increasing prevalence of non-alcoholic steatohepatitis propels the growth in the NASH clinical trials market. Accordingly, the growing incidence of NASH is strongly associated with an increasing spread of the sedentary life style that augments obesity, type 2 diabetes, and metabolic syndrome.
While the prevalence of obesity has nearly tripled from that in 1975, the prevalence of type 2 diabetes and metabolic syndrome has drawn millions into its fold, especially in both developed and developing economies.
The growing disease burden has installed a need for active therapeutic interventions, thereby fueling need for the conduction of clinical trials for testing novel treatments.
NASH is often asymptomatic in its initial stages and progresses silently via liver fibrosis to cirrhosis or liver cancer. Therefore, an increasing prevalence underlines an urgent requirement for the development of novel treatments; hence, it places NASH to the front row of the research pipeline of pharmaceutical and biotech companies.
This has also accelerated patient recruitment for trials because trials have to be representative in order to enable assessment of efficacy and safety of treatments in a variety of populations.
Therefore, an increasing patient pool, coupled with huge demand to find a cure for the burgeoning health concern, is driving the growth of the NASH clinical trials market.
Lack of approved therapies is driving the industry growth
The lack of approved drugs with respect to NASH makes it one of the strong drivers toward growing the NASH clinical trials market. Not a single FDA-approved drug for this disease's treatment is yet to be recorded, and such diseases are foreseen to create an increased trend in NASH, thereby gradually progressing into such severe conditions such as fibrosis, cirrhosis, and hepatocellular carcinoma.
Such a therapeutic gap is fostering an intensely competitive environment among several pharmaceutical and biotech companies, making substantial investments in the development of innovative drugs.
The majority of companies are competing to be the first to market with effective solutions, given that there are no established therapies available currently and NASH represents a high-priority area for research and innovation.
The urgent need for drugs, acknowledged by the regulatory bodies, has motivated the conferral of fast-track designations, breakthrough therapy status, and orphan drug designations to encourage investment by offsetting timelines for development and hastening the approval for clinical trials.
The absence of approved therapies further accelerates patient enrollment in trials, as patients with NASH continue self-searching for options through experimental treatments. This forces a continuous stream of clinical trials to be set up in unmet need, hence hastening the steps toward improvement in the NASH therapeutic landscape.
Increased investments in NASH research by governments and private organizations creates further growth opportunity
Government and private funding is a great avenue of opportunity to increase growth in the NASH clinical trials market. Since the global burden of NASH has grown with severe health implications, governments and private organizations have enhanced investment in R&D to expedite the process of finding an effective treatment.
Public funding will, in all probability, succeed in giving a push to innovation in collaboration with different stakeholders like academic institutions, research organizations, and pharmaceutical companies in most countries that are well developed.
A lot of the fund covers preclinical research-based studies, biomarker development, and clinical trials; this decreases the financial burden on researchers and brings promising drug candidates into the limelight.
Private organizations also play a significant role in financing the latest research in NASH by venture capital firms and philanthropic organizations. This helps bridge the financing gap that often occurs for early-phase clinical trials critical to de-risking drug development.
This increase in financial backing quickens the pace of clinical trials, fostering innovation in trial design and execution, which allows the development of more sophisticated approaches: combination therapies and precision medicine. Increased funding is likely to further enhance the overall competitiveness and growth of the NASH clinical trials market.
High cost of clinical trials may restrict market growth
The treatment of NASH is highly expensive since it is a complicated disease and its progression is a challenge. Generally, longer study durations are needed for endpoints such as the regression of liver fibrosis or the development of cirrhosis while assessing the efficacy and safety of treatments in NASH trials.
This extends the operational costs related to patient recruitment, monitoring, and data collection. The specialized diagnostic requirements of liver biopsies and other advanced imaging have also increased the costs. Because of the heterogeneity of NASH, large and diverse populations are in demand, inflating the costs of recruitment.
High drop-out rates, possibly due to either the invasive nature of the procedure or the length of the time commitment involved in the trials, further complicate the financial burden by requiring even more recruitments.
These costs are huge entry barriers for smaller biotech and greatly reduce innovative activities in this space. Further, high attrition rates of NASH drug development pose high financial risks on larger pharmaceutical companies.
The economic challenges in NASH force requirements for cost-effectively designed trials and, most importantly, funding alternatives to assure sustainable clinical research in this therapeutic area.
The global non-alcoholic steatohepatitis clinical trials industry recorded a CAGR of 5.6% during the historical period between 2020 and 2024. The growth of non-alcoholic steatohepatitis clinical trials industry was positive as it reached a value of USD 5,806.8 million in 2035 from USD 2,964.4 million in 2025.
Historically, the clinical trial industry for non-alcoholic steatohepatitis, or NASH, saw very little activity. Recognition of the disease process and overall awareness were low.
Diagnostics were underdeveloped, and research in general was slowed down by the intricateness of NASH with limited biomarkers and endpoints that were recognized for clinical trials. Pharmaceutical interest was poor since NASH is frequently left out of major diseases of the liver. Currently, the NASH clinical trials market is rapidly developing.
High unmet needs are driven by growing prevalence, driven by obesity and metabolic syndrome, and the lack of approved therapies. Better diagnostics, such as non-invasive biomarkers, have helped accelerate clinical trial activity, along with growing investment from governments and private parties.
The FDA and EMA offer fast-track designation, breakthrough therapy status, and orphan drug status for treatments related to NASH. These initiatives are directed at accelerating the development and review processes by reducing timelines for the approval of drugs.
Such incentives either attract the pharmaceutical and biotech enterprises via reduced regulatory barriers or offer new possibilities of extended market exclusivity. Such a milieu allows for more investments in NASH clinical trials, creating an environment for innovative therapies that can bring treatment solutions for this unmet need one-step closer to full potential.
Tier 1 companies are the industry leaders with 56.3% of the global industry. These companies stand out for having a large product portfolio and a high production capacity.
These industry leaders also stand out for having a wide geographic reach, a strong customer base, and substantial experience in manufacturing and having enough financial resources, which enables them to enhance their research and development efforts and expand into new industries.
The companies within tier 1 have a good reputation and high brand value. These companies frequently get involved in strategies such as acquisition and product launches. Prominent companies within tier 1 include Pfizer Inc., Novartis AG and Icon Plc.
Tier 2 companies are relatively smaller as compared with tier 1 players. The tier 2 companies hold a market share of 31.7% worldwide. These firms may not have cutting-edge technology or a broad global reach, but they do ensure regulatory compliance and have good technology.
The players are more competitive when it comes to pricing and target niche markets. Key Companies under this category include AbbVie Inc., F. Hoffmann-La Roche Ltd, Eli Lilly and GSK plc.
Compared to Tiers 1 and 2, Tier 3 companies offer non-alcoholic steatohepatitis clinical trials, but with smaller revenue spouts and less influence. These companies mostly operate in one or two countries and have limited customer base.
The companies such as Novo Nordisk, Gilead Sciences Inc., Viking Therapeutics and Others, and others falls under tier 3 category. They specialize in specific products and cater to niche markets, adding diversity to the industry.
The market analysis for non-alcoholic steatohepatitis clinical trials in various nations is covered in the section below. An analysis of important nations in North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia & Pacific, and Middle East & Africa of the world has been mentioned below.
It is projected that the United States will maintain its leading position in North America through 2035, holding a value share of 88.9%. By 2035, China is expected to experience a CAGR of 8.3% in the Asia-Pacific region.
| Countries | Value CAGR (2025 to 2035) |
|---|---|
| United States | 7.6% |
| Germany | 7.0% |
| France | 6.8% |
| UK | 6.0% |
| China | 8.3% |
| India | 9.0% |
| South Korea | 4.9% |
Germany’s non-alcoholic steatohepatitis clinical trials market is poised to exhibit a CAGR of 7.0% between 2025 and 2035. The Germany holds highest market share in European market.
Prevalence and awareness for screening of NASH, along with other factors, are some of the factors that promise a bright future for the clinical trial industry in Germany. Awareness about NASH, especially its relation to obesity, type 2 diabetes, and metabolic syndrome, is created by campaigns for public health and healthcare organization initiatives.
The very high prevalence of these conditions in the country, with over 23% of adults falling in the category of obesity and nearly 10% diagnosed with diabetes, calls for early detection and intervention.
It enables the identification of patients with NASH in screening programs and supports it with advanced diagnostic means such as non-invasive biomarkers and imaging techniques. Considering the very good infrastructure within the German healthcare system, since most people can have access to preventative care, the pool of participants increases in number.
Besides, some pharmaceutical companies and academic institutions in Germany are leveraging the increasing awareness to facilitate and streamline patient recruitment. This proactive approach will help enhance trial efficiency, reduce timelines of recruitment, and thereby support the overall expansion of NASH clinical research in the country.
United States is anticipated to show a CAGR of 7.6% between 2025 and 2035.
One of the highest rates of obesity is seen in the country, with almost 40% of its adult population classified under obesity, while more than 10% of the population is reported to suffer from type 2 diabetes.
In addition to these, metabolic syndrome affects about 34% of the adult population of the USA, increasing the burden on NASH. As these are major risk factors for NASH, their prevalence is directly proportional to the disease's incidence rate.
This vast pool of patients has generated enormous demand for clinical trials in this quest for appropriate treatments for NASH. The pharmaceutical industry increases investment in the research and development of drugs against the unmet medical need since effective therapies have to be sought for liver diseases.
In addition, the USA has a mature healthcare infrastructure for easy access by diagnostic tools as well as by patient recruitment networks, making this location ideal for NASH clinical trials. In this regard, the trend fuels innovative therapies' development and therefore propels growth in the market.
China is anticipated to show a CAGR of 8.3% between 2025 and 2035.
High burden of NASH is believed to be supported by growing obesity, diabetes, and metabolic syndrome within the country. The well-recognized pharmaceutical firms have been looking forward to the successful execution of the efficient clinical trials to put an end to these fast-growing health crises.
Pharmaceutical companies, academic institutions, and CROs showed keen interest in various collaborations aimed at accelerating the development of researches.
Such collaboration enhances trial efficiency due to the pooling of resources, expertise, and technology. The academic institutions bring a deep understanding of NASH pathophysiology, while CROs develop the operational know-how related to patient recruitment, regulatory compliance, and data management for trials. Furthermore, pharmaceutical firms enjoy the advantage of China's large population to recruit greater numbers from a broader section of demographics more quickly.
This has been further helped by the supportive regulatory environment in China, with policies aimed at attracting foreign investments and smoothing the approval process for clinical trials. The synergy between stakeholders accelerates the development of NASH therapies and, consequently, the rapid growth of the clinical trials market in China.
The section contains information about the leading segments in the industry. Based on study design, the Interventional segment is expected to account for 45.9% of the global share in 2023.
| By Study Design | Interventional |
|---|---|
| Value Share (2025) | 45.9% |
The interventional segment is projected to be a dominating segment in terms of revenue, accounting for almost 45.9% of the market share in 2025.
The interventional study design is likely to lead the NASH clinical trials market as it plays a crucial role in the assessment of the efficacy and safety of new therapies.
Interventional trials involve the active administration of investigational treatments to participants, thus allowing researchers to directly assess therapeutic outcomes and identify potential adverse effects.
Because the FDA has yet to approve drugs for NASH treatment, interventional studies play an essential role in developing and validating novel alternatives. Most interventional studies use firm methodologies, with RCTs being considered gold standard while developing clinical data.
For a company to meet the regulatory requirements and offer efficacy results, interventional studies are crucial. Thus, it is one of the primary reasons why the segment leads the market.
| By Phase | Phase 3 |
|---|---|
| Value Share (2025) | 40.2% |
The Phase 3 segment will dominate the industry in terms of revenue, accounting for almost 40.2% of the market share in 2025.
The Phase 3 segment is likely to hold the highest market share as this is a crucial stage to ascertain the safety, efficacy, and overall benefit-risk profile of the investigational therapies. Phase 3 trials are large studies, with heterogeneous populations, and designed to produce sufficient data for the approval process.
In the NASH context where no FDA-approved therapies are in place, advancing promising candidates towards commercialization, Phase 3 trials are essential. These trials tend to focus more on long-term outcomes, which include liver fibrosis regression as well as preventing disease progression with key clinical endpoints critical for acceptance by regulatory agencies.
The industry's commitment toward addressing this unmet medical need is reflected by the high number of NASH drug candidates now progressing to Phase 3. As pharmaceutical companies and contract research organizations (CROs) continue to focus more on advanced-stage trials, the Phase 3 segment becomes the dominant contributor to market growth.
The non-alcoholic steatohepatitis clinical trials industry faces a high competition as there are large number of companies conducting clinical trials for non-alcoholic steatohepatitis. These manufacturers are focused on constantly innovating and improving their product portfolio.
Prominent producers of Non-Alcoholic Steatohepatitis Clinical Trials are concentrating on growing internationally in order to increase their revenue and increase the size of their sales footprint in developing nations through the acquisition of regional small players.
Manufacturers utilize various key strategies such as agreements, product launches, research sponsorship, and strategic collaborations to boost product sales and establish their market presence.
Recent Industry Developments in Non-Alcoholic Steatohepatitis Clinical Trials Market
The global non-alcoholic steatohepatitis clinical trials industry is projected to witness CAGR of 7.0% between 2025 and 2035.
The global non-alcoholic steatohepatitis clinical trials industry stood at USD 2,829.5 million in 2024.
The global non-alcoholic steatohepatitis clinical trials industry is anticipated to reach USD 5,806.8 million by 2035 end.
China is expected to show a CAGR of 8.3% in the assessment period.
The key players operating in the global non-alcoholic steatohepatitis clinical trials industry Pfizer Inc., Novartis AG, Icon Plc, AbbVie Inc., F. Hoffmann-La Roche Ltd, Eli Lilly, GSK plc., Novo Nordisk, Gilead Sciences Inc., Viking Therapeutics and Others.
In terms of study design, the industry is divided into Interventional, observational and expanded access.
In terms of phase, the industry is segregated into phase 1, phase 2, phase 3, and phase 4.
Key countries of North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe and Middle East and Africa (MEA) have been covered in the report.
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Non-Alcoholic Steatohepatitis Clinical Trials Market
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