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Market Dynamics
Patient Compliance Challenges May Hinder Market Growth
Patient compliance remains a key challenge that could restrain market expansion. Despite increasing awareness of these diseases and the benefits of early diagnosis, treatment adherence continues to be a major issue. Poor compliance with prescribed therapies, lifestyle modifications, and long-term management plans can reduce treatment effectiveness, accelerate disease progression, and limit market growth.
Managing MASH requires sustained efforts, including regular medication, routine medical check-ups, and significant lifestyle changes such as weight loss, exercise, and dietary adjustments. However, many patients struggle to maintain these commitments, particularly when immediate, visible improvements are not evident.
Additionally, some medications especially those in clinical trials or recently approved have side effects that further impact adherence. Symptoms like gastrointestinal discomfort, fatigue, and liver-related complications may discourage patients from following their treatment plans, posing a significant barrier to long-term disease management.
Market Segments
By Drug (Resmetirom (Rezdiffra), Lanifibranor, Semaglutide, Survodutide, Pegozafermin, Efruxifermin, Denifanstat, Others)
By Stage (Stage 0-1, Stage 2-3, Stage 4)
By Age-Group (Pediatrics, Adults, Geriatrics)
By Gender (Male, Female)
By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)
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Market Regional Share
North America Leads the NASH/MASH Treatment Market
In 2024, North America held the largest share47%of the NASH/MASH treatment market. This dominance is driven by a higher prevalence of the disease, increased diagnosis and treatment rates, and the availability of the approved drug Resmetirom.
The growing burden of metabolic disorders such as obesity, type 2 diabetes, and hypertension is a key factor fueling market growth in the region. According to the Centers for Disease Control and Prevention (CDC), 40.3% of U.S. adults are obese, with no significant gender differences.
Additionally, more than 38 million Americans have diabetes (approximately 1 in 10), with 9095% diagnosed with type 2 diabetes. Hypertension affects nearly 1 in 2 adults (116 million), and these numbers are projected to rise, leading to a significant increase in MASH cases.
As per DataM Intelligence estimates, the total number of prevalent MASH cases in the U.S. was approximately 17.50 million in 2024 and is expected to reach 23.33 million by 2030, further driving the demand for effective treatment options.
Market Key Players
Madrigal Pharmaceuticals
Novo Nordisk A/S,
Boehringer Ingelheim International GmbH.,
89bio, Inc.,
Inventiva.,
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD,
Sagimet Biosciences.
Akero Therapeutics, Inc.
Recent Developments
In March 2024, the U.S. Food and Drug Administration (FDA) approved Rezdiffra (resmetirom), the first-in-therapy drug for adult patients diagnosed with MASH, and have moderate to advanced fibrosis (F2- F3). Rezdiffra developed by Madrigal Pharmaceuticals, Inc. is a once-daily, oral THR-β agonist that has proven its safety and efficacy in Phase 3 MAESTRO-NASH trial.
In October 2024, survodutide, a GLP-1 receptor agonist developed by Boehringer Ingelheim International GmbH. received the U.S. FDA Breakthrough Therapy designation for the treatment of adult MASH patients with moderate to advanced fibrosis (F2- F3).