89bio, Inc. (ETNB): 5 FORCES Analysis [Nov-2025 Updated]

You're trying to get a clear read on 89bio, Inc. (ETNB) right now, mapping out where pegozafermin fits in the MASH and SHTG markets as of late 2025. Honestly, the landscape is defintely getting crowded; with Madrigal's Rezdiffra already approved and Novo Nordisk's Wegovy making waves in MASH, the pressure is on. We see this reflected in their financials-a Q2 2025 net loss of $111.5 million just to keep the lights on and push R&D forward while they invest $42.4 million into commercial manufacturing capacity. So, how does 89bio, Inc. navigate high supplier power for their complex biologic and intense rivalry from both approved drugs and late-stage competitors? Dive into this five-forces breakdown below to see the precise competitive pulse you need for your next decision.

89bio, Inc. (ETNB) - Porter's Five Forces: Bargaining power of suppliers

You're looking at the supplier landscape for 89bio, Inc. (ETNB) as they push pegozafermin through late-stage trials. For a complex biologic like this, the power held by key suppliers-especially those handling manufacturing-is definitely a major factor in the competitive structure.

The power here leans toward high because 89bio, Inc. relies on specialized Contract Manufacturing Organizations (CMOs) for pegozafermin, which is a complex biologic. Biologic drug manufacturing demands unique, highly regulated expertise and capacity that you simply cannot source from a wide pool of vendors. This specialization inherently limits 89bio, Inc.'s immediate options for switching partners.

We see this high reliance reflected directly in the recent financial outlay. 89bio, Inc.'s Research and Development (R&D) expenses for the three months ended June 30, 2025, hit $103.9 million. A significant chunk of that, $42.4 million, was a non-recurring payment tied directly to securing commercial-scale production capacity for pegozafermin. That's a substantial, upfront investment to lock in future supply, showing how critical and costly securing that manufacturing base is.

This investment in capacity is ongoing. As of June 30, 2025, 89bio, Inc. still has a remaining obligation of $13.5 million-a final milestone payment due in 2026 upon the completion of that commercial-scale facility construction. Furthermore, the company made an additional funding commitment of $40.0 million in June 2025 to its collaborator, BiBo, for the construction of the active ingredient manufacturing facility in China. These figures underscore the capital intensity required to satisfy manufacturing needs.

The leverage held by certain upstream partners is also evident through intellectual property (IP) agreements. For instance, the license agreement with Teva Pharmaceutical Industries Ltd. for the glycoPEGylated FGF21 program (pegozafermin) includes future financial commitments. 89bio, Inc. is obligated to pay Teva up to $65.0 million upon the achievement of specified commercial milestones, on top of a $2.5 million clinical development milestone payment already made in the fourth quarter of 2023. This structure means the original IP holder retains financial leverage tied to commercial success.

Here's a quick look at the key financial commitments related to manufacturing and IP licensing as of mid-2025:

The need for unique expertise extends beyond just the final drug substance. The complexity of pegozafermin, an analog with unique glycoPEGylated technology, means that suppliers controlling specific steps or components-like the specialized raw materials or the delivery system components-can command significant pricing power. This is a classic high-leverage supplier scenario in the biotech space.

The September 18, 2025, announcement of Roche's definitive merger agreement to acquire 89bio, Inc. adds a layer of complexity. Post-closing, which was expected in the fourth quarter of 2025, the supplier relationships will fall under Roche's umbrella. Roche, with its massive internal manufacturing and procurement scale, might see a reduction in the bargaining power of some of 89bio, Inc.'s current external suppliers, but the specialized nature of the pegozafermin process itself remains a constraint.

You should keep an eye on these supplier dependencies:

• CMOs with proprietary biologic manufacturing know-how.
• Teva, due to the existing license and milestone structure.
• Suppliers of unique raw materials for the glycoPEGylated technology.

Finance: draft impact assessment of Roche integration on COGS/Supply Chain contracts by next Tuesday.

89bio, Inc. (ETNB) - Porter's Five Forces: Bargaining power of customers

You're analyzing 89bio, Inc. (ETNB) now that Roche has agreed to acquire the company for up to $3.5 billion total value, including an upfront cash payment of $14.50 per share. Even with this acquisition, the bargaining power of customers-primarily major payers like insurance companies and government programs-remains a significant factor for pegozafermin's future commercial success. These payers are accustomed to negotiating hard for high-cost specialty drugs, especially in a crowded therapeutic area like Metabolic Dysfunction-Associated Steatohepatitis (MASH).

The power of these payers is amplified because there are already approved, effective alternatives. Madrigal Pharmaceuticals' Rezdiffra, the first FDA-approved MASH F2-F3 therapy, is already generating significant revenue, with Q3 2025 net sales reaching $287.3 million. As of September 30, 2025, over 29,500 patients were on Rezdiffra, which carries an annual cost of $47,400. Furthermore, Novo Nordisk's Wegovy secured FDA accelerated approval for MASH (F2-F3) in August 2025. Wegovy is priced aggressively for this indication at $499/month. These established price points and market penetration give payers concrete benchmarks to demand discounts from pegozafermin, which is still in Phase 3 trials for MASH, with data expected in 1H 2027 (ENLIGHTEN-Fibrosis).

Physicians and patients, the immediate customers, have options that address the high unmet need. The MASH market is massive, estimated to affect around 22 million people in the U.S. alone, with the global market projected to hit $7.38 billion by 2029. This high prevalence means that any effective drug is valuable, which slightly tempers customer power. However, the efficacy data from competitors sets a high bar. For example, Wegovy showed MASH resolution in 62.9% of patients versus 34.3% on placebo in its trial.

Pegozaferfin's primary leverage against this price sensitivity rests entirely on its differentiation, which Roche clearly valued in the acquisition. The drug is an FGF21 analog that has demonstrated direct anti-fibrotic and anti-inflammatory effects on the liver. Analysts noted that a recently published meta-analysis ranked pegozafermin among the most effective agents for achieving fibrosis improvement and MASH resolution. This potential for 'best-in-disease efficacy,' as Roche noted, is the key differentiator against the existing standard of care and the GLP-1 class. The structure of the contingent value rights (CVRs) in the Roche deal also reflects this leverage, with payments tied to achieving global annual revenues of at least $3 billion and $4 billion.

The bargaining power dynamic can be summarized by comparing the knowns and unknowns:

Ultimately, the power of payers to demand discounts on 89bio, Inc.'s pegozafermin will be directly proportional to the confirmed clinical superiority of the drug over Rezdiffra and Wegovy when the Phase 3 data arrives. Until then, payers hold the upper hand due to the existing approved options and the known cost structures in the market.

89bio, Inc. (ETNB) - Porter's Five Forces: Competitive rivalry

You're looking at a market where the first mover advantage has already been seized, so the pressure on 89bio, Inc. to deliver positive data for pegozafermin is immense. The competitive rivalry in the Metabolic Dysfunction-Associated Steatohepatitis (MASH) space is definitely ramping up, making the race for market share a sprint rather than a marathon.

The MASH landscape is now defined by the presence of approved therapies. Madrigal Pharmaceuticals' Rezdiffra, the first drug approved in 2024, generated $178.31 million in sales for that year alone. Looking ahead, that approved drug segment is projected to surge to $16.82 billion by 2033, growing at an extraordinary 57.05% compound annual growth rate (CAGR). Furthermore, the overall global MASH market is projected by some reports to reach $16 billion by 2033, while others project the total market to hit $31.76 billion by 2033. This massive potential is attracting every major player.

The rivalry intensified significantly in the latter half of 2025. Novo Nordisk's GLP-1 agonist, Wegovy, gained FDA approval for noncirrhotic MASH on August 18, 2025, marking it as the second FDA-approved drug for the condition. This means 89bio, Inc. is now facing competition from established, large-market drugs that already have broad physician familiarity.

Direct competition from other FGF21 analogs, the same class as pegozafermin, is also a major factor. Akero Therapeutics' Efruxifermin is right there with 89bio, Inc., also in Phase 3 trials. The success of pegozafermin, which is an FGF21 analog, hinges on demonstrating superior efficacy or a better safety profile, especially since Phase IIb data suggested pegozafermin managed MASH resolution without worsening fibrosis at a 26% rate at one dosage level.

The Severe Hypertriglyceridemia (SHTG) market, where 89bio, Inc. also has a Phase 3 trial (ENTRUST) with topline data expected in the second half of 2025, is similarly crowded with advanced candidates. Ionis Pharmaceuticals' Olezarsen and Arrowhead's ARO-APOC3 are both in advanced stages, meaning 89bio, Inc. needs a clear win to secure market share in SHTG as well.

To put the financial pressure in context, 89bio, Inc. reported a net loss of $111.5 million for the three months ended June 30, 2025. While the company had cash, cash equivalents, and marketable securities of approximately $561.2 million as of June 30, 2025, this cash runway must fund the final push through Phase 3 and prepare for commercial scale against well-funded competitors.

Here's a quick look at the key players in the MASH space as of late 2025:

The competitive rivalry is shaped by several high-stakes factors:

• MASH market projected to reach $16 billion by 2033.
• Rezdiffra sales reached $178.31 million in 2024.
• Pegozafermin's potential efficacy across MASH and SHTG is a key differentiator.
• Need for positive SHTG data in H2 2025 to counter Ionis and Arrowhead.
• The high cash burn rate for 89bio, Inc. increases the urgency of clinical success.

89bio, Inc. (ETNB) - Porter's Five Forces: Threat of substitutes

The threat of substitutes for 89bio, Inc. (ETNB) is substantial, driven by established, approved, and emerging therapies targeting the same metabolic pathways and patient populations as pegozafermin.

High threat from GLP-1 agonists (e.g., Semaglutide, Tirzepatide) which treat underlying metabolic conditions and have shown MASH efficacy.

• Semaglutide (Wegovy formulation) received accelerated FDA approval in August 2025 for MASH with moderate to advanced fibrosis (F2-F3 fibrosis).
• In a Phase 3 trial, Semaglutide achieved MASH resolution without worsening fibrosis in 62.9% of patients versus 34.3% on placebo after 72 weeks of 2.4 mg/week subcutaneous injection.
• A real-world study of MASLD/MASH, obesity, and T2DM patients showed Tirzepatide was associated with a 29% lower risk of all-cause mortality (RR, 0.71) compared to Semaglutide over two years.
• Tirzepatide also showed a 17% lower risk of MACE (major adverse cardiovascular events) (RR, 0.83) and a 23% lower risk of hospitalization (RR, 0.77) versus Semaglutide.

Approved non-FGF21 MASH drug Rezdiffra is a direct substitute, already establishing a market presence.

Rezdiffra (resmetirom), the first FDA-approved MASH therapy, has demonstrated rapid adoption and revenue generation.

The U.S. F4c MASH patient population under specialist care is estimated to be approximately 245,000 patients.

Current standard-of-care, including generics like fibrates and statins for SHTG, are low-cost substitutes, though less efficacious.

• The global fibrate drugs market size is valued at $3.77 billion in 2025.
• Generics held a 75.53% stake in the fibrate drugs market revenue in 2024.
• Lifetime cost-effectiveness estimates for HMG-CoA reductase inhibitors (statins) ranged from $19,886 to $73,632 per year of life saved.
• Lifetime cost-effectiveness estimates for fibrates ranged from $16,955 to $59,488 per year of life saved.
• Over 60% of patients in a recent study on a new SHTG therapy were already on background fibrate therapy.

Lifestyle changes, while not a drug, are always a substitute for chronic metabolic diseases.

89bio, Inc. (ETNB) reported a net loss of $111.5 million in Q2 2025, reflecting investment into late-stage trials against these competitive threats. The company maintained $561.2 million in cash and equivalents as of Q2 2025.

89bio, Inc. (ETNB) - Porter's Five Forces: Threat of new entrants

You're looking at the barrier to entry in the biopharma space, and for 89bio, Inc. (ETNB), the walls are quite high. Honestly, starting a company today to compete directly with pegozafermin's current development stage would require a war chest that few can assemble.

The capital requirement is massive, plain and simple. Look at 89bio's recent burn rate; for the three months ended June 30, 2025, the net loss hit $111.5 million. A significant chunk of that was R&D expenses, which totaled $103.9 million for the quarter. That kind of spending is necessary to run global Phase 3 trials, but it immediately sets a high hurdle for any new entrant trying to catch up.

Even with that significant spending, 89bio, Inc. still reported cash, cash equivalents, and marketable securities of approximately $561.2 million as of June 30, 2025. Here's the quick math: a new company would need to raise a comparable amount just to fund operations while trying to replicate 89bio, Inc.'s progress, assuming they could even get into Phase 3 immediately, which they can't.

Here is a look at the financial scale 89bio, Inc. is operating at, which new entrants must match or exceed:

Also, consider the regulatory pathway. Pegozafermin already holds a significant advantage: the U.S. Food and Drug Administration (FDA) granted it Breakthrough Therapy Designation for non-alcoholic steatohepatitis (NASH) in September 2023. This designation is designed to expedite development and review, which is a massive head start. A new entrant would have to prove a similar level of promise, which is tough when 89bio, Inc. is already this far along.

The development timeline itself acts as a major deterrent. 89bio, Inc.'s lead asset is deep into its Phase 3 program. Topline data from the ENLIGHTEN-Cirrhosis trial is not expected until 2028, and the ENLIGHTEN-Fibrosis data is anticipated in the first half of 2027. That means a new competitor would be looking at a minimum of three to four years just to generate the primary data needed to even approach the FDA for an accelerated approval pathway, assuming they could initiate Phase 3 trials today.

The specialized expertise needed is another barrier. Developing drugs for complex liver diseases like MASH (Metabolic Dysfunction-Associated Steatohepatitis) and cardiometabolic conditions requires deep, specific knowledge in clinical trial design, regulatory navigation for these specific endpoints, and manufacturing for complex biologics. 89bio, Inc. is pursuing accelerated approval based on histology endpoints, a strategy that required specific alignment with both the FDA and EMA, which is not easily replicated.

To summarize the regulatory and timeline hurdles:

• FDA Breakthrough Therapy Designation already secured for pegozafermin.
• ENLIGHTEN-Fibrosis (F2-F3 MASH) data expected in 1H 2027.
• ENLIGHTEN-Cirrhosis (F4 MASH) data expected in 2028.
• ENTRUST (SHTG) data expected in 1Q 2026.
• 89bio, Inc. is the only company with regulatory alignment for histology-based accelerated approval in both F2-F3 and F4 MASH patients.

Defintely, the combination of high capital burn, established regulatory momentum, and a multi-year clinical data runway makes the threat of new entrants relatively low for 89bio, Inc. right now.