Global Non-Alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market
Non-Alcoholic Steatohepatitis Therapeutics and Diagnostics Market size was valued at USD 4.6 billion in 2024 and is projected to reach a valuation of USD 117 billion by the end of 2037, rising at a CAGR of 28.1% during the forecast period, i.e., 2025-2037. In 2025, the industry size of non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics is evaluated at USD 5.9 billion.
The continuous increase in the number of patients with obesity and metabolic syndrome is stimulating the demand for NASH therapeutics and diagnostics. As the need for good treatment increases, diagnostics and therapeutic technologies are witnessing expansion including non-invasive diagnostic methods and tailored treatments. As demand for effective therapies grows, advancements in diagnostics and therapeutics are accelerating, particularly in non-invasive diagnostic tools and targeted therapies. For example, Madrigal Pharmaceuticals' Rezdiffra (resmetirom) received FDA approval in March 2024 for treating non-cirrhotic NASH. This reflects how governments worldwide are promoting and enhancing healthcare infrastructure to support early detection and management of liver diseases, further driving non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market growth.
Furthermore, precision medicine using AI-driven diagnostics is making treatments for NASH personalized and effective. This transformation is further accelerated by strategic partnerships such as Novo Nordisk and Echosens in June 2022 to address the underdiagnosis of NASH. Their collaboration focuses on non-invasive diagnostic tools with the aim of doubling diagnosis rates by 2025. This approach not only attains early detection but also creates lucrative non-alcoholic steatohepatitis therapeutics and diagnostics market opportunities. Such efforts underscore the industry's commitment to improving patient outcomes through innovation.
Growth Drivers
Challenges
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Base Year |
2024 |
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Forecast Year |
2025-2037 |
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CAGR |
28.1% |
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Base Year Market Size (2024) |
USD 4.6 billion |
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Forecast Year Market Size (2037) |
USD 117 billion |
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Regional Scope |
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Drug Type (Vitamin E and Pioglitazone, Obeticholic Acid (OCA), Lanifibranor, Semaglutide, Resmetirom, Aramchol, Cenicriviroc, Others)
Vitamin E and Pioglitazone segment is anticipated to account for more than 28.7% non-alcoholic steatohepatitis therapeutics and diagnostics market share by the end of 2037. This growth is attributed to their established efficacy in symptomatic alleviation of NASH and liver fibrosis reduction. Both therapies are considered cost-effective for their established clinical outcomes, which is boosting their adoption among healthcare providers. In May 2022, Pfizer Inc. announced that the FDA granted Fast Track designation to its investigational combination therapy for NASH with liver fibrosis, ervogastat (DGAT2 inhibitor) and clesacostat (ACC inhibitor). Such developments play a significant role in driving the demand for this drug type to fulfill unmet needs in the management of NASH.
End user (Hospital Pharmacies, Retail and Specialty Pharmacies, Others)
By 2037, retail and specialty pharmacies segment is projected to hold more than 49.2% non-alcoholic steatohepatitis therapeutics and diagnostics market share, driven by expanding access to advanced therapeutics. For such pharmacies, increasing access to innovative treatments has underlined their growing importance in the healthcare ecosystem. For example, the launch of Rezdiffra by Madrigal Pharmaceuticals in March 2024 further marked the retail and specialty pharmacies segment as a key player in delivering innovative therapies to patients. The specialty pharmacy is anticipated to garner rapid sales revenue as it provides tailored support and timely delivery for complex medications. Furthermore, their strategic positioning increases patient adherence to therapies and optimizes overall patient outcomes, which in turn drives the growth of the overall market.
Our in-depth analysis of the global non-alcoholic steatohepatitis therapeutics and diagnostics market includes the following segments:
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Drug Type |
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End user |
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North America Market Analysis
North America non-alcoholic steatohepatitis therapeutics and diagnostics market is set to hold revenue share of over 36.8% by the end of 2037. The dominance of the region is attributed to the advanced healthcare infrastructure, a high prevalence rate of obesity and diabetes, and significant R&D investments by pharmaceutical companies. The U.S. and Canada are two leading markets in North America. Strong research institutions and supporting regulatory environments enhance the market potential of this region.
The U.S. is leading the non-alcoholic steatohepatitis therapeutics and diagnostics market due to the high prevalence of obesity and type 2 diabetes, which are two major risk factors for NAFLD/NASH. In addition, other ongoing drug development advances, such as the emergence of combination therapies, are being made to take care of unmet medical needs for a growing patient population. In March 2024, Max Biopharma and Metaba announced a collaboration on metabolomics studies to explore novel biomarkers and therapeutic targets for metabolic diseases, including NASH. Such partnerships aim to enhance the understanding of disease mechanisms and support the development of targeted treatments.
The non-alcoholic steatohepatitis therapeutics and diagnostics market in Canada is also steadily growing, along with increased awareness and investments in healthcare infrastructure. An increasing trend toward the integration of lifestyle management programs with pharmaceutical interventions reflects a holistic approach to addressing NASH. Government activities aimed at liver health and diseases associated with obesity also create a favorable climate for trying new methods of treatment. Furthermore, new diagnostic technologies are being presented to the market that are likely to enable better identification of patients and improve outcomes of treatment.
Asia Pacific Market Statistics
Asia Pacific non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market is predicted to grow at CAGR of over 28.8% through 2037, due to better access to healthcare, rising awareness, and proactively conducted screening programs. This growth is further supported by government programs regarding liver health and addressing non-communicable diseases. The large population base of the region and the growing burden of lifestyle-related diseases underpin its significant growth potential in the market.
India is anticipated to record considerable growth in the non-alcoholic steatohepatitis therapeutics and diagnostics market due to growing obesity, diabetes, and sedentary lifestyles among the population. Moreover, the increasing pharmaceutical industry in India facilitates cost-effective production with the distribution of therapeutics at economical rates, hence making treatments more accessible. For example, in July 2022, SRL Diagnostics launched the Fatty Liver Index test in India, which is a big leap toward early identification and management of liver disorders. Such innovations, along with rising efforts taken by the government to take control of metabolic disorders, are projected to drive market expansion.
The non-alcoholic steatohepatitis therapeutics and diagnostics market is expanding at a rapid pace in China due to increasing rates of obesity and diabetes in the country. The government's focus on improving access to healthcare and addressing chronic diseases should fuel further adoption of innovative therapies. Furthermore, partnerships among domestic pharmaceutical firms and international players promote drug development and NASH therapeutics and diagnostics market access. With significant investments in non-invasive diagnostic technologies, China is working to overcome the hurdles to early detection and treatment. As the country has a large pool of patients and increasing healthcare expenditure, there are several opportunities for players to expand.
The presence of major players such as AstraZeneca PLC, Eli Lilly & Company, Galmed Pharmaceuticals Ltd., Pfizer Inc., Genfit SA, Novo Nordisk A/S, Takeda Pharmaceutical Company Ltd., and Arcturus Therapeutics Inc. contributes to the highly competitive nature of the non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market. These players are pushing the boundaries of innovation, making sizeable investments in research and development to study new mechanisms and treatment options. Furthermore, strategic partnerships and collaborations enable these firms to consolidate resources, tap advanced technologies, and extend services to new markets.
In May 2024, SomaLogic entered into a license agreement with OncoHost to develop precision cancer diagnostics, leveraging SomaLogic's proteomics platform. While primarily focused on oncology, the technologies developed may have applications in other diseases, including NASH, by identifying relevant protein biomarkers. This milestone underlines how clinical progress, together with supportive regulatory initiatives, has reshaped the market, urging players to stay innovative in order to expand and thrive in the competition.
Here are some leading companies in the NASH therapeutics and diagnostics market:
Author Credits: Radhika Pawar
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