89bio's Strategic Position in the MASH Market Amid Expanding Diagnosis and Treatment Demand

The metabolic dysfunction-associated steatohepatitis (MASH) therapeutic landscape is undergoing a seismic shift, driven by an aging population, rising obesity rates, and the urgent need for effective treatments. According to a report by Grand View Research, the global MASH treatment market was valued at $7.87 billion in 2024 and is projected to balloon to $31.76 billion by 2033, growing at a compound annual growth rate (CAGR) of 17.7% [1]. Other analyses, such as those from DataM Intelligence, suggest an even steeper trajectory, forecasting a 28.1% CAGR and a market size of $33.8 billion by 2030 [2]. These figures underscore a critical inflection point for companies like 89bio, whose lead candidate, pegozafermin, is poised to capture a significant share of this expanding pie.

Market Dynamics: A Perfect Storm of Demand

The surge in MASH prevalence is inextricably linked to the global rise in metabolic disorders. Obesity, type 2 diabetes, and metabolic syndrome—conditions that predispose individuals to MASH—are escalating at alarming rates. Data from the Centers for Disease Control and Prevention (CDC) indicates that over 40% of U.S. adults now meet the criteria for obesity, a key risk factor for MASH [3]. Meanwhile, the World Health Organization (WHO) projects that diabetes will affect 700 million people globally by 2045, further fueling the MASH epidemic [4].

North America, already the largest market for MASH therapies, accounts for 47% of global revenue in 2024 [1]. This dominance is driven by high diagnosis rates, advanced healthcare infrastructure, and aggressive treatment adoption. For instance, the FDA’s conditional approval of Resmetirom (Rezdiffra) in March 2024 marked a milestone, but its real-world performance has been marred by 41% adverse event rates, including gastrointestinal issues and pruritus [5]. Such challenges highlight unmet needs in tolerability and dosing convenience—areas where pegozafermin could differentiate itself.

Pegozafermin: A Dosing Innovation in a Crowded Space

89bio’s pegozafermin is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21), engineered to regulate glucose and lipid metabolism while reducing liver inflammation. Its Phase 3 trials—ENLIGHTEN-Fibrosis (non-cirrhotic MASH, F2-F3) and ENLIGHTEN-Cirrhosis (compensated cirrhosis, F4)—are designed to evaluate two dosing regimens: 30mg weekly or 44mg every two weeks [6]. This flexibility addresses a critical gap in current therapies, where frequent dosing and side effects often lead to patient non-adherence.

Compared to Resmetirom, pegozafermin’s prolonged half-life and reduced dosing frequency could enhance patient compliance. Clinical data from Phase 2 trials of FGF21 analogs, including pegozafermin, have demonstrated robust anti-inflammatory and insulin-sensitizing effects, with fewer systemic side effects than thyroid hormone receptor-β agonists [7]. Meanwhile, GLP-1 agonists like tirzepatide (Eli Lilly) have shown promise in reducing liver fat but are primarily indicated for diabetes, limiting their MASH-specific appeal [8].

Financial Resilience and Strategic Investor Alignment

89bio’s financial position further strengthens its commercial prospects. As of June 30, 2025, the company holds $561.2 million in cash, cash equivalents, and marketable securities, providing ample liquidity to fund Phase 3 trials, scale manufacturing, and prepare for potential regulatory approvals [6]. This financial buffer is critical in a high-stakes R&D environment, where the cost of late-stage trials can exceed $1 billion [9].

The company has also prioritized investor engagement, aligning expectations with its clinical milestones. With topline data from the ENTRUST trial (SHTG) expected in Q1 2026 and MASH histology results in mid-2027, 89bio is positioning itself as a best-in-class candidate in a market where first-mover advantage is less relevant than superior efficacy and safety profiles [10].

Competitive Landscape: Navigating a Crowded Field

The MASH market is attracting heavyweights like Intercept Pharmaceuticals, Madrigal Pharmaceuticals, and Gilead Sciences, each pursuing diverse therapeutic mechanisms. However, pegozafermin’s unique value proposition lies in its dosing flexibility and tolerability, which could carve out a niche in the stage 2-3 fibrosis segment—a category expected to grow at a 27.2% CAGR through 2033 [1]. This segment is particularly lucrative, as patients with advanced fibrosis are at higher risk of progressing to cirrhosis and require more aggressive interventions.

Conclusion: A High-Stakes Bet with High Rewards

The MASH market’s explosive growth, coupled with unmet clinical needs, presents a $30+ billion opportunity by 2033. 89bio’s pegozafermin, with its innovative dosing, strong Phase 2 data, and robust financial backing, is well-positioned to capture a significant portion of this market. However, success hinges on positive Phase 3 outcomes and the ability to differentiate from competitors in a post-approval landscape. For investors, the key will be monitoring mid-2027 data and the subsequent regulatory and commercialization strategies. In a field where tolerability and convenience are as critical as efficacy, 89bio’s approach could redefine MASH treatment—and deliver outsized returns.

Source:
[1] Non-alcoholic Steatohepatitis Treatment Market Report, 2030 [https://www.grandviewresearch.com/industry-analysis/non-alcoholic-steatohepatitis-nash-treatment-market-report]
[2] Nash Or Mash Treatment Market Growth Rate, Industry [https://www.datamintelligence.com/research-report/nash-or-mash-treatment-market]
[3] Centers for Disease Control and Prevention (CDC) Obesity Statistics [https://www.cdc.gov/obesity/data/index.html]
[4] World Health Organization (WHO) Diabetes Projections [https://www.who.int/news-room/fact-sheets/detail/diabetes]
[5] Early experience with resmetirom to treat metabolic dysfunction–associated steatohepatitis with stage 2 and 3 fibrosis [https://pmc.ncbi.nlm.nih.gov/articles/PMC11970881/]
[6] 89bio Reports Second Quarter 2025 Financial Results and Corporate Updates [https://www.stocktitan.net/news/ETNB/89bio-reports-second-quarter-2025-financial-results-and-corporate-uztn6hzanv0o.html]
[7] Comparative Analysis of Resmetirom vs. FGF21 Analogs [https://www.mdpi.com/2227-9059/12/10/2328]
[8] MASH UP? Liver disease could be the next big market. [https://www.evaluate.com/thought-leadership/mash-up-liver-disease-could-be-the-next-big-market/]
[9] Pharmaceutical R&D Cost Analysis, Tufts Center for the Study of Drug Development [https://csdd.tufts.edu/2023/06/05/tufts-csdd-estimates-cost-developing-new-drug-has-increased-1-6-billion-2010-2023/]
[10] 89bio's Strategic Investor Engagement and Clinical Progress [https://www.ainvest.com/news/89bio-strategic-investor-engagement-clinical-progress-mash-therapy-2508/]